[Senate Hearing 117-878]
[From the U.S. Government Publishing Office]
S. Hrg. 117-878
A SYSTEM IN NEED OF REPAIR:
ADDRESSING ORGANIZATIONAL FAILURES
OF THE U.S.'S ORGAN PROCUREMENT AND
TRANSPLANTATION NETWORK
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
__________
AUGUST 3, 2022
__________
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
__________
U.S. GOVERNMENT PUBLISHING OFFICE
56-327--PDF WASHINGTON : 2024
COMMITTEE ON FINANCE
RON WYDEN, Oregon, Chairman
DEBBIE STABENOW, Michigan MIKE CRAPO, Idaho
MARIA CANTWELL, Washington CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN CORNYN, Texas
THOMAS R. CARPER, Delaware JOHN THUNE, South Dakota
BENJAMIN L. CARDIN, Maryland RICHARD BURR, North Carolina
SHERROD BROWN, Ohio ROB PORTMAN, Ohio
MICHAEL F. BENNET, Colorado PATRICK J. TOOMEY, Pennsylvania
ROBERT P. CASEY, Jr., Pennsylvania TIM SCOTT, South Carolina
MARK R. WARNER, Virginia BILL CASSIDY, Louisiana
SHELDON WHITEHOUSE, Rhode Island JAMES LANKFORD, Oklahoma
MAGGIE HASSAN, New Hampshire STEVE DAINES, Montana
CATHERINE CORTEZ MASTO, Nevada TODD YOUNG, Indiana
ELIZABETH WARREN, Massachusetts BEN SASSE, Nebraska
JOHN BARRASSO, Wyoming
Joshua Sheinkman, Staff Director
Gregg Richard, Republican Staff Director
(II)
C O N T E N T S
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OPENING STATEMENTS
Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee
on Finance..................................................... 1
Grassley, Hon. Chuck, a U.S. Senator from Iowa................... 3
WITNESSES
Shepard, Brian, chief executive officer, United Network for Organ
Sharing (UNOS), Richmond, VA................................... 5
Brockmeier, Diane, R.N., BSN, MHA, president and CEO, Mid-America
Transplant, St. Louis, MO...................................... 7
Friedman, Barry S., R.N., BSN, executive director, AdventHealth
Transplant Institute, Orlando, FL.............................. 9
Henry, Calvin, Region 3 Patient Affairs Committee (PAC)
representative, Organ Procurement and Transplantation Network
(OPTN), Dacula, GA............................................. 10
Locke, Jayme E., M.D., MPH, director, Division of Transplantation
Surgery, Heersink School of Medicine, University of Alabama,
Birmingham, AL................................................. 12
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Brockmeier, Diane, R.N., BSN, MHA:
Testimony.................................................... 7
Prepared statement with attachments.......................... 37
Responses to questions from committee members................ 48
Friedman, Barry S., R.N., BSN:
Testimony.................................................... 9
Prepared statement........................................... 57
Responses to questions from committee members................ 60
Grassley, Hon. Chuck:
Opening statement............................................ 3
Henry, Calvin:
Testimony.................................................... 10
Prepared statement with attachment........................... 63
Responses to questions from committee members................ 68
Locke, Jayme E., M.D., MPH:
Testimony.................................................... 12
Prepared statement........................................... 71
Responses to questions from committee members................ 76
Shepard, Brian:
Testimony.................................................... 5
Prepared statement with attachments.......................... 79
Responses to questions from committee members................ 140
Wyden, Hon. Ron:
Opening statement with attachments........................... 1
Prepared statement........................................... 186
Communications
Abraham, Jaison M................................................ 199
American Society of Nephrology................................... 199
Association of Organ Procurement Organizations................... 202
Center for Fiscal Equity......................................... 206
Guidehouse, Inc.................................................. 209
Hughes, Suzanne.................................................. 213
Hypertrophic Cardiomyopathy Association.......................... 214
Ischemic Injured Organs and Limbs Foundation..................... 215
Ison, Michael G., M.D., MS et al................................. 223
Mississippi Organ Recovery Agency................................ 225
National Down Syndrome Society................................... 226
National Kidney Foundation....................................... 227
Organ Donation Consortium........................................ 233
Organ Procurement and Transplantation Network Patients Affairs
Committee...................................................... 234
Paragonix Technologies, Inc...................................... 236
Science in Donation and Transplant............................... 239
Silverstein, Amy................................................. 243
Starzl Network for Excellence in Pediatric Transplantation....... 245
Tennessee Donor Services......................................... 247
Transplant Families.............................................. 248
Transplant Surgeon............................................... 254
University of Pittsburgh Medical Center.......................... 254
Vanderbilt University Medical Center............................. 258
A SYSTEM IN NEED OF REPAIR:
ADDRESSING ORGANIZATIONAL FAILURES
OF THE U.S.'S ORGAN PROCUREMENT AND
TRANSPLANTATION NETWORK
----------
WEDNESDAY, AUGUST 3, 2022
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 2:30 p.m.,
in Room SD-215, Dirksen Senate Office Building, Hon. Ron Wyden
(chairman of the committee) presiding.
Present: Senators Cardin, Brown, Casey, Cortez Masto,
Warren, Grassley, Thune, Portman, Cassidy, Young, and Barrasso.
Also present: Democratic staff: Melissa Dickerson,
Investigator; Daniel Goshorn, Chief Investigative Counsel;
Joshua Sheinkman, Staff Director; and Ryder Tobin,
Investigative Counsel. Republican staff: John O'Hara,
Republican Trade Policy Director and Counsel; and Caitlin Soto,
Senate Committee on the Judiciary Oversight Counsel for Senator
Grassley.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The Finance Committee will come to order.
The last place anybody wants to hear about gross
mismanagement and incompetence is in the business of saving
lives. That's precisely and unfortunately what the Finance
Committee meets to discuss today. This morning's hearing is an
update on an investigation Senator Grassley and I, along with
Senator Cardin and Senator Young, have been conducting for more
than 2\1/2\ years. It examines the network of dozens of
organizations that manage organ transplants, and particularly
the group that oversees and coordinates them, the United
Network for Organ Sharing, or UNOS.
We have reviewed 100,000 UNOS documents totaling more than
a half-million pages. Before I get to specific findings, I want
to frame what we have learned as simply as possible.
Far too many Americans are dying needlessly because UNOS
and many of the transplant organizations it oversees are
failing and seem uninterested in improving. These issues
involve an alphabet soup of acronyms and organizations, so I
will start out with a bit of background. A 1984 law created the
first computerized system to match sick patients with the
organs they need. It was named the Organ Procurement and
Transplantation Network. Someone needed to manage that system
for the whole country, so the government sought to contract an
organization to run it. UNOS was the only bidder for that first
contract in 1986. The contract has come up for bid seven other
times. UNOS has won all seven.
Today, the network UNOS oversees is made up of nearly 400
members, including 252 transplant centers and 57 regional
organizations known as organ procurement organizations, or
OPOs. Each OPO has a defined geographic service network. A
family sitting in a hospital room thinking about donating a
loved one's organ does not have a choice of OPOs.
Those are the important terms to remember here. When a
kidney donated in Corvallis needs to get to a patient in
Portland, that is where an OPO comes in. UNOS oversees the
OPOs. As our investigation shows, UNOS does this job quite
poorly.
Serious errors in the procurement and transplant system are
shockingly common. Between 2010 and 2020, more than 1,100
complaints were filed by patients and families, staff,
transplant centers, and others. The nature of these complaints
runs the gamut. For example, in a number of cases OPOs had
failed to complete critical, mandatory tests for matters like
blood types, diseases, and infection.
Our investigation found one patient died after being
transplanted with lungs that a South Carolina OPO marked with
the wrong blood type. Similar blood-type errors happened
elsewhere, and patients developed serious illness. Some had to
have organs removed after transplant. Another patient was told
he would likely die within 3 years after an OPO in Ohio
supplied him with a heart from a donor who had died of a
malignant brain tumor. UNOS did not pursue any disciplinary
action. In a case from Florida, another patient contracted
cancer from transplanted organs, and the OPO sat on the
evidence for months.
In total, our investigation found that between 2008 and
2015, 249 transplant recipients developed a disease from
transplanted organs. More than a quarter of them died.
Delivering organs has been another source of life-
threatening errors. We found 53 such complaints between 2010
and 2020, as well as evidence that this was just the tip of the
iceberg. In some cases, couriers missed a flight. In others,
the organs were abandoned at airports. Some organs were never
picked up. Many of these failures resulted in organs being
discarded.
It is reasonable to assume that many more errors are going
unreported. Why? Because filing official complaints with UNOS
appears to accomplish zero productive oversight or reform.
Organ transplant professionals repeatedly told the Finance
Committee that the UNOS complaint process was--and I quote
here--``a black hole.'' Complaints went in, UNOS went quiet.
In interviews with the committee, UNOS leaders have dragged
their feet, dodged tough questions, and shifted responsibility
onto others. Investigations and disciplinary measures rarely
amount to much more than a slap on the wrist. Only one time--
just once--has UNOS recommended that an OPO lose their
certification.
The bottom line is that the failures we uncovered cost
lives. Thousands of organs donated each year wind up discarded,
including one in four kidneys. Yet according to Federal data,
roughly 6,000 Americans die every year while waiting for an
organ transplant. This kind of mismanagement has a
disproportionate impact on minority Americans. African
Americans, for example, have a greater need for kidney
transplants than other demographic groups.
The Centers for Medicare and Medicaid Services recently
issued new standards for OPO performance, and more than a third
of OPOs are failing to meet them. Fixing what's broken could
substantially increase the supply of lifesaving organs
available for transplant.
Finally, another area of the committee's investigation has
examined the IT, the information technology, used by UNOS to
run the transplant network. This system is outdated,
mismanaged, and insecure. Using such decrepit technology to run
the transplant network puts lives in danger and puts sensitive
data at risk, and apparently there is no solution in sight.
In a report issued last year titled ``Lives Are at Stake,''
the U.S. Digital Service flatly concluded that UNOS does not
have the technical capability to modernize the system.
I am going to close like this: if you looked at the staff
at UNOS and many of the Nation's OPOs, I would wager the vast
majority are hardworking, good people doing their best to save
lives. The glaring issues uncovered in our investigation stem
from failures at the top--leadership failures. Our
investigation is ongoing. It's clear the system needs reform
badly. We are going to keep digging into issues at UNOS and the
OPOs, as well as the policies that need changing at the Federal
level. This is not a partisan subject. Everybody wants the
system to work with as few errors as possible.
We have been conducting a bipartisan investigation on this
for some time. I want to commend Senators Grassley, Cardin, and
Young. The three of them have been working very closely with
us. This is a thoroughly bipartisan inquiry. I want to thank
Senator Cardin, who is here, Senator Grassley who is here. I
also see Senator Thune here. So, we are going to have a lot of
members interested in this. I see Senator Warren as well.
And I want to thank our witness panel for joining the
committee today.
[The prepared statement of Chairman Wyden appears in the
appendix.]
The Chairman. Senator Grassley?
OPENING STATEMENT OF HON. CHUCK GRASSLEY,
A U.S. SENATOR FROM IOWA
Senator Grassley. Yes, thank you, Mr. Chairman. Today we
want to talk about the U.S. Organ Procurement and
Transplantation Network and its government contractor
overseeing this program, the United Network for Organ Sharing.
In 1984, Congress passed the National Organ Transplant Act,
a bill cosponsored by the late Senator Orrin Hatch, a friend of
mine and former chairman of this committee. A few years later
in 1998, the Federal Government contracted with the United
Network for Organ Sharing to oversee the transplantation
network.
The network performs three critical functions on behalf of
the Federal Government: policymaking, technology delivery, and
oversight of member compliance with its policies and with its
procedures. However, for more than a decade now, government
watchdogs and the media have questioned the adequacy of the
network's oversight. That is because of multiple reports of
fraud, waste, and abuse; criminality; deadly patient safety;
and failure to recover organs.
Some have even observed that the network is 15 times more
likely to lose, damage, or mishandle an organ in transit than a
passenger airline is to lose its luggage. I have written about
all these issues and more, going way back to 2005.
Sadly, the Federal Government has only recently begun to
take action. As a result, thousands of organs go to waste each
year, resulting in lives lost and billions of dollars wasted.
This system is even worse for people of color and rural
residents, who are less likely to get on the wait list, and
less likely to find a match. At least among themselves, the
network's senior leadership admits these facts.
One official's response to these concerns was to suggest
rural Americans were dumb and should be just moved somewhere
else to obtain lifesaving treatment. And of course, that
attitude is totally unacceptable.
Now a bit more about the investigation into the network. In
February of 2020, this committee sent a letter to the network
requesting information and data on its oversight of the
transplantation organization. We found that there is a huge
variability in how well organ procurement organizations, known
as OPOs, are serving their communities. In fact, according to
the Centers for Medicare and Medicaid Services, as many as 22
of the 57 OPOs are failing outcome and performance metrics.
This variability has negative consequences for the
transplantation network and causes transplant hospitals to have
fewer organs for patients on the wait list.
We also found that the network has a broken governance
system that fails to hold its members accountable for
reoccurring patient safety issues. Now as I said, once again
when I started looking into this way back in 2006, the network
acts like, quote, ``the fox guarding the chicken house,'' end
of quote, instead of a trustworthy and independent oversight
body that holds its members accountable. As such,
transportation failures, ABO blood type testing, and allocation
errors are common occurrences at underperforming OPOs.
So, Mr. Chairman, it is about time, and very timely that we
hold this hearing. Congress has waited too long to fix a broken
system. We must insist upon accountability moving forward.
Patients' lives are at stake.
Thank you.
The Chairman. Thank you very much, Senator Grassley. As I
noted in my opening statement, I am very glad that we have
Senator Young here as well. Senator Young, Senator Grassley,
Senator Cardin, and I have been at this for some time, and this
has been thoroughly bipartisan.
The committee has made a number of important findings
during this bipartisan inquiry. We believe it is in the
public's best interest to see these results.
Therefore, I ask unanimous consent to enter the committee's
hearing memo and all supporting documents related to that memo
into the record.
[The documents have been posted to the committee's
website.]
The Chairman. Let me now introduce our guests. We are
pleased that they are here. Mr. Shepard is the chief executive
officer of United Network for Organ Sharing. His organization
currently holds the government contract for the Organ
Procurement and Transplantation Network. He has been in this
role since 2012. Prior to joining UNOS, he served for 15 years
in various positions with the Virginia State Government.
Diane Brockmeier is here. She is the president and CEO of
Mid-America Transplant, an organ procurement organization
located in St. Louis, MO. A nurse by training, Ms. Brockmeier
started her career at Mid-America as the organ procurement
coordinator in 1986. In 2016, she became the president and CEO,
overseeing the organization's operations, including
partnerships with more than 120 hospitals and transplant
centers located throughout Missouri, northeast Arkansas, and
southern Illinois.
Mr. Barry Friedman is here. He is the executive director of
the AdventHealth Transplant Institute in Orlando, FL. This is a
position he has held since January of 2020. He began his
civilian career in organ transplantation as an ICU staff nurse
in St. Louis, MO in 1985 and has over 30 years of experience in
the transplant community, including roles in leadership
positions at transplant centers around the country. He has also
had a distinguished military career.
Calvin Henry is the Region 3 representative on the OPTN
Patient Affairs Committee. In 2012 he received a double lung
transplant at Houston Medical Hospital after being diagnosed
with an untreatable lung disease considered to be a terminal
illness. Now a successful lung transplant recipient, he runs
marathons. Mr. Henry has a professional background in health
information. He also volunteers as a patient mentor for his
local transplant center in Georgia to connect those on the wait
list with education on financial resources. Mr. Henry asked
that a letter from the Patient Affairs Committee urging
immediate reforms in the transplant system be entered into the
record. Before he begins his statement, I ask unanimous consent
to do so.
And Dr. Jayme Locke is an abdominal transplant surgeon at
the University of Alabama, Birmingham, where she is a professor
and the chief of the Division of Transplantation, among other
positions. A graduate of Duke University, she completed her
medical degree at East Carolina University and her surgical
residency at Johns Hopkins.
We want to thank all our guests for their participation,
and we will begin with Mr. Brian Shepard.
STATEMENT OF BRIAN SHEPARD, CHIEF EXECUTIVE OFFICER, UNITED
NETWORK FOR ORGAN SHARING (UNOS), RICHMOND, VA
Mr. Shepard. Thank you, Mr. Chairman, members of the
committee. Thank you for inviting me to discuss our Nation's
organ donation and transplant system, the role of the United
Network for Organ Sharing, or UNOS, and our community's ongoing
efforts to increase transplantation.
My name is Brian Shepard. I am the CEO of UNOS, the
mission-driven nonprofit which holds the Federal contract to
serve as the U.S. organ donation and transplant network. In my
role, I have seen up close the power of organ donation and
transplants, lifting and sustaining the families of organ
donors and restoring and inspiring transplant recipients.
Through NOTA, Congress intentionally put organ allocation
policy in the hands of the clinical, professional, and patient
community. UNOS works with transplant hospitals, OPOs, and
patients to address the most important issues in donation and
transplant, and we leverage experts in the fields of technology
research and science to continually improve the national
system.
We convene a community of diverse professionals and
patients, sometimes with very strongly held opinions, and
leverage that very diverse set of opinions into a system that
provides the greatest possible benefit to patients awaiting
transplants. In fact, all of the committed individuals on this
panel with me have served on or even led at least one OPTN
committee, and two of them have even served on the board of
directors. And their opinions and insights have helped shape
the system that we have today.
Today I look forward to having a conversation about that
system, a system that just marked its ninth consecutive record-
setting year of lifesaving transplants and surpassed 41,000
transplants in the year 2021, a total never before achieved in
a single year by the United States or any other country in the
world.
Transplantation on that scale would have been hard to
imagine in 1984 when Congress passed the National Organ
Transplant Act. The law established the OPTN to maintain a
national registry for organ matching, and specified that that
network would be a private, nonprofit entity. And it has been
an honor to serve the Nation for over 3 decades. But we also
realize that UNOS is not the final word in donation and
transplant. We are part of a multifaceted system of improvement
and oversight that includes multiple Federal agencies,
including important roles for HRSA, CMS, CDC, FDA, and NIH.
Consistent with the Institute of Medicine recommendations
and best practices in health-care quality, the OPTN's
authorizing regulation creates a role of peer monitoring and
quality improvement that complements but is very different from
the regulatory certification and oversight role granted to CMS
to support their role.
UNOS's work is bounded by NOTA, the OPTN final rule, and
the OPTN contract, and focuses on three main areas: developing
equitable allocation policies; maintaining the national wait
list and offering matches to patients through safe, secure, and
modern technology; and continuing to improve performance
through peer review. All of our work is closely overseen by
HRSA, who serve as members on all of our 19 committees and our
national board of directors.
That is the community that UNOS is so proud to be a part
of, a community dedicated to the equitable distribution of
organs, no matter who you are or where you live. We have made
rapid and remarkable changes in the past few years alone,
changes that have expanded equitable access to transplants for
candidates on the list; increased priority for the sickest
patients; and reduced disparities between races, ethnicities,
and geographies. But there is always more to do.
There are over 100,000 Americans waiting for an organ as we
speak. Even as 115 patients are successfully transplanted every
day, another 17 die waiting. We cannot rest until every patient
who needs a transplant is able to get one.
By building on the successes of our national system and our
community's ongoing efforts, we can come together around that
vision. And when we do, our work literally saves lives. UNOS
stands ready to work with any Senator on potential legislation,
to provide information, or to serve as a resource.
Thank you again for inviting me to discuss the status of
donation and transplant, and I look forward to taking your
questions.
[The prepared statement of Mr. Shepard appears in the
appendix.]
The Chairman. Thank you, Mr. Shepard.
Ms. Brockmeier?
STATEMENT OF DIANE BROCKMEIER, R.N., BSN, MHA, PRESIDENT AND
CEO, MID-AMERICA TRANSPLANT, ST. LOUIS, MO
Ms. Brockmeier. Chairman Wyden and members of the
committee, my name is Diane Brockmeier, and I am the president
and CEO of Mid-America Transplant, the organ procurement
organization serving eastern Missouri, southern Illinois, and
northeastern Arkansas. Thank you for the opportunity to speak
today.
At our organization, we follow the ethos of ``every donor,
every time.'' Our team is committed to giving donors and their
families the care they deserve, while stewarding their gifts to
patients desperately in need.
Mid-America Transplant depends on the broader national
transplant system administered by UNOS to accomplish this work.
We need to urgently address patient safety. Each organ lost due
to system or provider failure has a consequence to the
thousands of patients waiting for a transplant. Furthermore, a
discarded organ fails to honor the heroic gift from a selfless
donor and compounds the family's sense of loss.
UNOS lacks urgency and accountability around identifying
and remediating this preventable loss of organs, and they are
not required to publicly report adverse events when patients
are harmed, organs are lost, or the quality of patient care is
deemed unsafe.
UNOS does not require clinical training, licensure, or
certification standards for OPO staff delivering critical
patient care. In this environment, who is looking out for the
patient? Who is being held accountable for poor patient care?
No OPO has ever actually been decertified, regardless of its
performance or its safety record.
UNOS has failed to align its efforts to ensure patient
safety at the system level, and this decision has tragic and
deadly consequences. We must update the archaic technology
system at UNOS. As OPOs, we are required to work with UNOS's
technology--DonorNet--every day. DonorNet is outdated,
difficult to use, and often slow to function when every minute
counts. Manual entry subjects it to error, and OPO and
transplant center staff are not empowered with the right
information when time is critical. I did serve in leadership
roles on the OPO committee from 2017 to 2022. Committee members
and industry leaders voiced repeated requests to improve
DonorNet. The consistent response was: UNOS IT did not have the
bandwidth to address this work.
The limitations of the UNOS technology are delaying and
denying transplants to patients who are dying on the wait list.
Poor technology impacts the disturbingly high kidney discard
rate in the United States, where one in four kidneys never make
it to a patient for transplantation.
Critical time is lost due to the inefficiency of DonorNet,
wasting time on offers that will not be accepted. Of course, an
available organ should be offered to the patient in list
sequence. However, far too much of the matching, particularly
on older donors and organs that are difficult to place, is left
to the individual OPOs and transplant centers to find each
other despite, rather than facilitated by, UNOS technology.
Mid-America Transplant intentionally identifies surgeons
who accept kidneys that have been repeatedly turned down many
times. These are lifesaving options for those patients.
In May of 2022, one of these patients was number 18,193 on
the list. Relying on DonorNet alone, that kidney would never
have been placed, and the chance to save a life would have been
wasted. When an OPO goes out of sequence to place an organ that
would otherwise be thrown away, UNOS requires an explanation.
However, when organs are recovered and discarded, UNOS remains
silent.
We must remove conflicts to ensure effective governance.
From 2018 to 2020, I served as a board member for the OPTN.
Serving on the board of the OPTN automatically assigns
membership to the UNOS board. My board experience revealed that
at times UNOS's actions are not aligned with its fundamental
vision of a lifesaving transplant for everyone in need.
How can you fairly represent the country's interest and a
contractor's interest at the same time? Board members are often
kept in the dark about critical matters and are marginalized,
particularly if they express views that differ from UNOS
leadership.
Preparatory small group calls are conducted prior to board
meetings to explore voting intentions. And if the board member
was not aligned with the opinion of UNOS leadership, follow-up
calls were initiated. Fellow board members reported feeling
pressured to vote in accordance with UNOS leadership.
I implore the committee, along with CMS and HRSA, to ensure
that those who speak out in support of system reform are not
penalized. Patients deserve a transparent, accountable system
that works on their behalf.
To protect patients, I urge Congress and the administration
to separate the OPTN functions into different contracts so that
patients can be served by best-in-class vendors; to immediately
separate the boards of the OPTN and OPTN contractors; and to
ensure that patients are safeguarded through open data from
both the OPTN and OPOs. Your immediate action on this matter
will save lives.
[The prepared statement of Ms. Brockmeier appears in the
appendix.]
The Chairman. Thank you very much, Ms. Brockmeier.
Next will be Mr. Barry Friedman.
STATEMENT OF BARRY S. FRIEDMAN, R.N., BSN, EXECUTIVE DIRECTOR,
ADVENTHEALTH TRANSPLANT INSTITUTE, ORLANDO, FL
Mr. Friedman. Chairman Wyden, Ranking Member Crapo, Senator
Grassley, and members of the committee, on behalf of
AdventHealth, I am honored to provide testimony on the current
state of organ transplant policy in the United States. My
testimony reflects 30 years of health-care and transplant
experience and my direct leadership involvement in the United
Network for Organ Sharing, and the Organ Procurement
Transplantation Network.
I currently serve as the executive director of the
AdventHealth Transplant Institute, one of the busiest centers
in the United States, having performed nearly 5,000
transplants. I take very seriously our sacred duty to the
families and patients who entrust us with the gift of life to
provide for organ transplants.
It is our duty to be good stewards of these organs,
honoring the faith of these families and the health of our
communities. Families in need of lifesaving organs have no
other option but to trust the organ transplantation system that
is in place. This system has failed many patients waiting for
organ transplants, due to the lack of oversight and
accountability. Approximately 23 percent of kidneys procured
from deceased donors are not used and instead discarded,
resulting in preventable deaths.
It is our responsibility to address this issue. Organ
transportation is a process left to federally designated organ
procurement organizations, OPOs. Currently, they develop their
own relationships with carriers, rely on airlines, charter
flights, ground transportation, and Federal agencies to
facilitate transportation. In many cases, organs must connect
from one flight to another, leaving airline personnel
responsible for transfers. While anyone can track their Amazon
or FedEx package, there is currently no consistent way of
tracking these lifesaving organs.
The transplant community promoted the use of GPS tracking
of organ shipments, and UNOS piloted an organ tracking system.
This system was not dependable, therefore we opted out and now
are working with a company that uses less-expensive, higher-
quality trackers and can monitor shipments in real time.
Currently there is no requirement for OPOs to use tracking
systems. Data availability and transparency are key to
improving organ procurement, and UNOS has not proven capable of
providing this function.
OPTN technology has significant interoperability challenges
and lags behind other technology platforms. This contributes to
a fractured flow of information between OPOs, donor hospitals,
and transplant programs. I also believe there is a conflict of
interest related to the management of IT functions by UNOS, as
the IT tools they offer transplant centers come with additional
costs, despite them being essential for the safety and
management of organs.
UNOS is not effectively screening organ donors so that they
can be quickly directed to transplant programs. UNOS asks
centers to voluntarily opt out of certain organs via a
filtering process. As a result, OPOs waste valuable time making
organ offers to centers that will never accept them.
Time wasted equates to prolonged cold ischemic time and
organs not placed, resulting in lost organ transplant
opportunities. This creates a vicious cycle that disadvantages
patients on the wait list. Due to the limited expertise that
UNOS has in the placement of organs, it would be best if they
were no longer responsible for the development of organ
placement practices.
The UNOS policymaking process lacks transparency. Currently
OPTN board members concurrently serve as the board members of
UNOS, which creates a conflict of interest that contributes to
this lack of transparency. UNOS committees are formed in a
vacuum. There is no call for nominations, and no data shared
with the transplant community to explain the rationale behind
decisions that create policy change.
A perfect example of this was seen recently during the
kidney allocation change in policy where a geography committee
was formed. This committee that was created, created an
inequitable distribution of organs. The committee was
instrumental in creating this policy, which resulted in a high
kidney discard rate, which also caused increased cost and
challenges with transportation.
Most importantly in this equation, we are jeopardizing the
trust of our most precious resource--organ donors and their
families, and the recipients of those who receive these organs.
The challenges that I have detailed to you are fixable, and
we need to reempower the UNOS membership and increase patient
advocacy representation within the policymaking process. We can
implement interoperable technology, increase transparency,
adopt real-time GPS tracking of organs, improve organ offers
with the placement of friendly strategies, and reduce organ
discard rates.
We applaud the Senate Finance Committee for listening and
learning today and thank you for providing the United States of
America the opportunity to maintain the stellar clinical care
for patients who require lifesaving organ transplants.
[The prepared statement of Mr. Friedman appears in the
appendix.]
The Chairman. Thank you very much, Mr. Friedman.
Next, we are going to have Mr. Calvin Henry, who I believe
is going to be testifying virtually. Mr. Henry, are you out
there in cyberspace?
Mr. Henry. I am.
The Chairman. Wonderful. We would like to hear from you.
STATEMENT OF CALVIN HENRY, REGION 3 PATIENT AFFAIRS COMMITTEE
(PAC) REPRESENTATIVE, ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK (OPTN), DACULA, GA
Mr. Henry. Good afternoon, Chairman Wyden, Ranking Member
Crapo, and members of the committee. My name is Calvin Henry,
and I serve on the OPTN Patient Affairs Committee, the Region 3
representative for the southeastern United States and the U.S.
territories of the Virgin Islands and Puerto Rico.
I am also a double-lung transplant recipient of 9\1/2\
years. I have spent much of that time as a dedicated patient
advocate, in direct support of transplant candidates and
recipients, organ donation, and as a strong proponent for
system-wide improvements and transparency throughout the organ
procurement and transplantation process.
It is a privilege to be invited here today to share my
thoughts regarding the current state of this system. Let me
share my experience navigating the transplant system.
Fifteen years ago, I was diagnosed with a terminal lung
disease that was later identified as scleroderma and informed
that my only option for survival was to receive a double-lung
transplant. I was told, however, that I was unlikely to receive
one, and that I should just begin making end-of-life
preparations.
The next several years after that diagnosis were perilous.
On three separate occasions, I nearly lost my life due to the
adverse effects of the disease. I was also diagnosed with
achalasia, a serious and disqualifying disorder for transplant.
The rejection I received from that program launched an arduous
solo effort, without the assistance of any organization, to
locate another program that would take me on as a patient.
The specific circumstances of my own experiences may be
unique, but the constant difficulties in accessing transplant
services are all too common. I was fortunate because I had the
means, including access to good insurance, that allowed me to
travel to another State to receive care.
That is not always the case. I want to highlight the
disparities and inequitable access to transplant services that
disproportionately harm Black people and people to color who do
not have the resources to access transplants in these
circumstances.
This committee has previously highlighted that the organ
donation system's failures are an urgent health equity issue.
Across the board, the numbers for kidney failure for Hispanic
Americans, Black Americans, and Native Americans are far worse
than White Americans.
We also know that Black people and people of color are less
likely to receive transplants. Research has also documented
that often Black families receive differential treatment from
OPOs. As former Surgeon General Dr. Ken Moritsugu noted:
``Often, misallocation of OPO resources found that OPOs do not
respond to all donation cases, or do not properly train and
support their front-line staff.''
The impact of this, he said, unsurprisingly falls
disproportionately on families of color. The donor study showed
the U.S. may be recovering as few as 28,000 organs each year.
According to the chief of transplant at Vanderbilt, who
testified at the House Oversight hearing last year, if the
system were fully functioning, there would be no waiting list
for livers, hearts, or lungs within 3 years, and the kidney
wait list would be dramatically reduced.
The leaders, and several of my colleagues on the OPTN
Patient Affairs Committee, asked me to submit a letter,
included in my full written testimony. I have joined them.
Among the messages to you: antiquated technology and an
apathetic culture cause patients to languish with incomplete
and often incorrect information and leave people to die every
day on the wait list.
OPTN PAC members have raised these points often with UNOS
leadership and have seen our calls for reform ignored. We have
been aghast at the absolute failure of UNOS to operate the
practice and business of transplant, and to acknowledge, much
less effectively serve, patients who are waiting and dying on
the organ wait list.
We ask that you ensure that the Federal Government makes
the fast-approaching contracting OPTN cycle competitive for the
first time since the original OPTN contract was awarded in
1986, and we implore you to ensure that UNOS does not hold
patients hostage in the process.
Senators, I urge you all to act to ensure that we make
better use of the organs that are donated, to ensure that
health equity issues with Black people and people of color are
addressed, and that the glaring technology issues causing
patients harm are quickly remedied.
I thank you for your time.
[The prepared statement of Mr. Henry appears in the
appendix.]
The Chairman. Mr. Henry, thank you very much, sir, for your
participating. And also, colleagues, I want to note that he has
asked that a letter from the Patient Affairs Committee urging
immediate reforms in the transplant system be entered into the
record. Mr. Henry and colleagues, that has been done.
[The letter appears in the appendix on p. 66.]
The Chairman. Dr. Jayme Locke is next.
STATEMENT OF JAYME E. LOCKE, M.D., MPH, DIRECTOR, DIVISION OF
TRANSPLANTATION SURGERY, HEERSINK SCHOOL OF MEDICINE,
UNIVERSITY OF ALABAMA, BIRMINGHAM, AL
Dr. Locke. Chairman Wyden and members of the committee, my
name is Dr. Jayme Locke, and I am the director of the Division
of Transplantation Surgery at the University of Alabama at
Birmingham.
At UAB we currently have 1,022 patients wait-listed for
kidneys. The majority self-identified as African Americans or
Blacks. Transplantation was always supposed to be about the
patient, but the system we operate now has almost a complete
lack of ownership and responsibility, whether it is a failing
OPO or UNOS failing at the most basic responsibilities of
getting recovered organs matched and safely to their intended
recipients.
These are the government's own contractors. My patients,
your constituents, need your help. We know that thousands of
kidneys are recovered and discarded every year, and that
thousands more are never recovered at all. Discards have
increased since the most recent allocation change, as the new
system increased complexity, and to date, UNOS has shown no
ability to manage even simple logistics.
The most powerful thing to know about this is that every
organ represents a life. We can never forget that. Imagine
having a medication you need to live being thrown away simply
because someone took too long to get it to you--your life,
quite literally, in a trash can.
Organs are no different. They too have shelf lives, and
they are measured in hours. Discarded organs and transportation
errors may sound abstract, but let me make this negligence real
for you.
In 2014, I received a kidney that arrived frozen. It was
hard as a rock, like an ice cube you could put in your drink.
The intended recipient was sensitized, meaning difficult to
match. The only thing we could do was tell the waiting patient
that due to the lack of transportation safeguards, the kidney
had to be thrown in the trash--the final generous act of a
donor in Maryland.
In 2017, I received a kidney that arrived in a box that
appeared to have tire marks on it. The box was squished, and
the container inside had been ruptured. We were lucky and were
able to salvage the kidney for transplant. But why should luck
even play a role?
Since the frozen kidney and the box with tire marks, I have
received other kidneys that had to be discarded, either due to
handling issues or UNOS transportation errors. But one week
this May was particularly difficult. In one week, I received
four kidneys from four different OPOs, each with basic errors
that led to the need to throw away those lifesaving organs; one
due to a botched kidney biopsy into the kidney's collecting
system, another because of a lower artery that had been cut
during procurement that could have been fixed if someone
involved had assessed the kidney for damage and flushed it
before packing. But that did not happen. Two others arrived to
me blue, meaning they had not been flushed either.
Opacity at UNOS means that we have no idea how often basic
mistakes happen across the country, nor can we have any
confidence that anything is being done to redress such errors
so they do not keep happening.
All I know is that in one week I received four kidneys, two
from Tennessee, one from Florida, and one from Georgia, that
could not be used. What was particularly heart-breaking was
that two of these kidneys were for sensitized African American
or Black women. Women who have been pregnant, especially
multiple times, are harder to match, contributing to both
gender and racial disparities in access to transplant.
This is a very real example of how a constrained pool of
organs and high discards disproportionately hurt women and
women of color, who are more likely to have multiple
pregnancies.
I know others have spoken up, and more still who want to
speak up, but, Senators, please know that every person I have
talked to who has spoken up about system failures has told me
they have been punished in some way, through both micro- and
macro-
aggression.
The very highest level of leadership within UNOS is an
insular club that has turned its back on patients by ignoring
their own unconscious biases, and even impugning patients
behind closed doors.
We need reform now. I am asking for your urgent help on
behalf of my patients and all the other patients waiting around
the country.
Number one, immediately separate the OPTN board from any of
the boards of any contractors. Number two, bring in real
experts to ensure our patients are served by the best of the
best in each field, separating out key functions of the OPTN,
including policy, technology, and logistics. And number three,
ensure that patients are safer by holding all contractors
accountable through event reporting and immediate redressing of
problems.
One final and critical point. I cannot tell you how
disturbing it was to read of the way UNOS has allegedly held
the UNOS transplant system hostage. According to The Washington
Post, quote, ``UNOS also has at times even threatened to walk
away and continue operating without a contract, despite the
fact that it would be illegal,'' end quote.
Doing anything to jeopardize patients, even threatening to
walk away, violates a basic principle of health care. It is
called ``patient abandonment.'' You simply cannot do that, or
even threaten to do that. I would lose my medical license for
walking away from a patient.
If it is true that UNOS has suggested that it might walk
away or not cooperate with a transition to new contractors,
that would make it an organization that cannot be responsible
for taking care of lives. There is very little in health care
that has the immediate life-and-death stakes of organ
transplantation.
Please realize that every day that passes that these
failing systems are in place, it means more of our neighbors
will die. My patients need the Senate to act.
Thank you.
[The prepared statement of Dr. Locke appears in the
appendix.]
The Chairman. Thank you all. And these are terrible
accounts that you have just given us, Dr. Locke: the idea that
kidneys arrive with tire marks; the reprisals against those who
speak the truth about the inefficiencies and gaps in quality
with respect to these services. I mean, this is really a wake-
up call, and you have delivered it powerfully, and I thank you.
I will start with this question that a number of you have
referred to: the issue of the recovered organs being discarded.
And obviously, the purpose of the transplant network is to
match organs with patients who need them.
Unfortunately, one in seven organs recovered by an organ
procurement organization is not transplanted, at a rate, as far
as I can tell, that is increasing and has been since 2018. For
kidneys, the most needed organ, the situation is even worse.
One in four recovered kidneys are discarded before transplant,
a rate that is also increasing.
Now obviously, there are instances where an organ cannot be
transplanted for legitimate medical reasons, but in the course
of this Finance investigation, we discovered an endless number
of cases of organs being discarded because of errors at the
OPOs. In several cases, organs were discarded because they were
delayed or lost on their way to a transplant center. In another
case, a heart was discarded because an OPO had a policy
disagreement with a hospital. And yet in another case, an OPO
literally threw two kidneys in the trash--in the trash--
immediately after recovering them.
So, Mr. Henry, let me start with you. We have over 90,000
people waiting for a kidney transplant in this country, yet one
in four kidneys recovered are not being transplanted. So my
question to you, Mr. Henry--you have been a patient advocate,
and spoken eloquently today--how does this high discard rate,
and the practices that are being documented and that you found,
how does this affect the public's willingness to donate when
they hear this?
Mr. Henry. Well first, hearing about the, in my mind,
inexcusable recovery rate, it is absolutely heartbreaking. And
we talk about the fact that a little over 90,000 kidney
candidates are on the waiting list, and 106,000 total organ
recipients. As an advocate, I am asked to go out into the
community, which I willingly do, because organ donors save
lives.
So I willingly and eagerly advocate for organ donation. But
when you hear about this high non-use rate, people think, ``We
are asked to donate, and the individuals, the OPOs and UNOS,
who are in charge and are supposed to be stewards of ensuring
efficient recovery, do not seem to be doing the job
necessary.''
So again, it is absolutely heartbreaking.
The Chairman. So, Mr. Shepard, we have this tremendous
sacrifice by donors and families. You heard what Mr. Henry
said: all the time and money and effort, and recovered organs
are not being translated into patients who need them.
Is it acceptable that 25 percent of kidneys are being
discarded? Is that okay with you?
Mr. Shepard. No, Senator, absolutely not.
The Chairman. So, it is not acceptable?
Mr. Shepard. We find that number to be entirely too high
and think that every missed opportunity for transplant is a
tragedy.
The Chairman. So why are they too high? And what are you
doing about it?
Mr. Shepard. There are any number of reasons that an organ
would not be used. There are a few that are specific
operational events at OPOs, and I think your research and your
review of the MPSC files shows that. I think a much larger
number are simply deemed not viable for transplant by the
centers that they are being offered to.
One of the things that UNOS is doing about it, we just
adopted a new metric for our evaluation of transplant centers.
This year we have adopted a metric to measure transplant
centers on their organ acceptance rate. So, in the past we have
measured them--and we still will--on their post-transplant
success rate. How long did their patients last? How long did
their grafts last? But now we will also be measuring transplant
hospitals on whether or not they are accepting organs at an
acceptable rate.
The Chairman. Ms. Brockmeier, do you think that is the
heart of the problem? I mean, Mr. Shepard says the big problem
is you have a high discard rate because the transplant centers
are refusing organs for medical reasons. That seems pretty far-
fetched to me, but I would like your thoughts.
Ms. Brockmeier. Certainly, Senator, there are at times
occurrences when we would discover that a potential donor might
have cancer or something during the interoperative procedure.
So those kidneys obviously could not be allocated for
transplantation. So on occasion, yes, sir, that does happen.
But the cumbersomeness of the technology by which we can
identify the best homes for those kidneys certainly complicates
and, I think, compounds the discard rate.
The Chairman. That is, to me, the heart of the problem,
that, yes, there are medical instances where it is warranted.
You said that. I have said that. I think that is the consensus
sentiment. But I think the heart of the problem is that the
system does not work, and it is way too cumbersome and
inefficient, and we have got to turn it around.
Senator Grassley?
Senator Grassley. I would like to have any one or two of
you who could answer this question to do it. You heard me in my
opening comments refer to the fact that the system does not
seem to be fair to racial minorities or people living in rural
communities.
So what are your efforts underway to understand the root
causes and help make the system fairer to patients on the
waiting lists? Explain the factors that result in the disparity
for minorities and rural populations in the process, and how
can the Federal Government address the problem if we have to be
involved in addressing it?
Dr. Locke. One of the most important things that we do not
currently do is, we do not actually account for disease burden
in terms of examining our waiting list. So we have no way of
knowing if we are actually serving the correct people, if the
correct people are actually making it to the waiting list.
Disease burden is super important because it not only
identifies the individuals who are in need of transplantation,
but it also speaks to supply. So areas of high rates of end-
stage kidney disease burden like the southeastern United States
are going to have much lower supply. And they also are
predominantly--those waiting lists predominantly consist of
African American or Black individuals.
So, if you want to make a truly equitable organ system, you
have to essentially get more organs to those areas with higher
disease burdens.
I think the other thing is that we have to have more focus
on how we approach donor families and make sure that we have
cultural competence as a part of our OPOs in how they approach
families to ensure that we are not marginalizing minority
families with regard to the organ donation process.
Senator Grassley. Mr. Shepard, UNOS has responsibility to
conduct oversight of membership. There is little indication
that your organization is capable of doing it. So if, in fact,
this committee found that less than 40 percent of all patient
safety cases are referred to the Membership and Professional
Standards Committee--which is responsible for monitoring member
compliance with the transplantation network's policies and
procedures--how does UNOS staff determine what cases are
referred to this committee?
Mr. Shepard. Thank you, Senator. UNOS staff refers cases to
the MPSC--that is the peer committee--and again, our statute
and regulation require us to use peer review to do the quality
improvement work that we do.
Our staff is approved by the peer committee. The peer
committee has given them a set of guidance rules to say, these
are the types of cases that we would like to see, these are the
types of cases that, when you evaluate them, do not need to be
referred to the committee.
Our staff do not make those judgments independently. All of
those staff decisions as to whether a case meets the MPSC
rubric for referral are referred in a group of the member
quality staff, including the chief medical officer of UNOS.
Senator Grassley. Well, with the committee's findings in
mind, should your organization reevaluate its oversight efforts
so that more cases are referred to the committee? And if you
disagree with that, why not?
Mr. Shepard. I would say one of the things that our
conversation with your staff has led us to understand is that
the current committee may not be as aware of some of the past
decisions that past committees have made in establishing those
rubrics. So we have created a new process where, at the seating
of each new MPSC committee, we go over that rubric so that each
committee can endorse, amend, or otherwise alter the
description of what types of cases they would like to see, and
not simply rely on what a past committee has decided.
Senator Grassley. Mr. Friedman, in 2021 the U.S. Digital
Service found that UNOS cannot properly modernize its IT system
and its core systems are fragile. This is concerning,
especially since the organization is the only government
contractor responsible for making transplants possible.
Can you give us an example of a time when UNOS's technology
caused an adverse patient safety event? And generally, do you
think AdventHealth is getting the best value with regard to the
services offered by UNOS?
Mr. Friedman. Senator Grassley, I agree with you that the
IT system is fractured. There are situations where organs are
not offered in a timely manner. The IT system that UNOS
currently utilizes does not easily allow transplant centers
opportunities to turn down organs or ensure that the right
organ is going to the right patient.
I also believe with IT technology, as I stated, monitoring
organs and organ placement--when I was in the military, I did
medical airlift. My crews out of Scott Air Force Base knew
where I was, worldwide, with my patient.
I could not even get a kidney that was 20 miles away from
my transplant center with UNOS thinking that it was in Miami,
when it was actually in Orlando, 20 miles away. Lack of IT
systems, lack of technology, has caused harm potentially to
patients, or delayed patient treatment, or increased the cost
of care for patients.
This is deplorable and needs to be fixed.
The Chairman. Thank you, Senator Grassley.
Senator Cardin?
Senator Cardin. Thank you, Mr. Chairman. And I thank you
for your leadership on this issue, and I want to thank our
witnesses today.
Our committee report verifies our fears that the system
today is badly broken. And our witnesses today have reinforced
that view. That is a tragedy that needs to be corrected.
Unless you have transparency, unless you have
accountability, there is no way that you can correct a system.
And if those who want to report a problem are retaliated
against, it makes the matter much, much worse.
If we have to change the law to accomplish that, then we
have to change the law to do that. I am hearing about numerous
mistakes in harvesting and preparations and matching and
transportation. But if you do not have timely knowledge of
those errors, you cannot correct those errors. And from what I
can tell, most of these errors are being hidden rather than
acted upon and changed.
So you know, all of us are involved in buying products that
are tracked, and we are amazed at how we can see where they are
at every step of the process. The technology is widely
utilized.
So, Mr. Shepard, let me just ask you about the technology
that you are using. According to our reports, your system has
crashed on several occasions. And when your system is down, you
cannot do the match, so time is lost. We are seeing all these
challenges.
Is there a financial problem as to why you cannot update
the technology? Is there a reason why we cannot get much better
performance on vital organs being tracked or matched? What is
the problem here?
Mr. Shepard. Senator, the OPTN IT system that UNOS operates
has 99.99 percent up-time. It is a highly reliable system. We
are audited annually by HRSA.
Senator Cardin. My information is you have had 17 days down
since, I think, 1999. That is not correct?
Mr. Shepard. In 23 years, yes, sir.
Senator Cardin. Okay. Well, every day there is a loss of
life, isn't it?
Mr. Shepard. That is the total amount of time over the----
Senator Cardin. I hope our national defense system is not
down 17 days a year.
Mr. Shepard. The system has never been down for a day, to
my knowledge. And I have not been here since 1999, but to my
knowledge there has been maybe one event that was longer than
an hour, and that was 3 hours. But the total amount of time
since 1999----
Senator Cardin. So you are satisfied with your technology?
You think you have the right technology? You are satisfied with
your tracking systems now and you think everything is okay?
Mr. Shepard. We constantly improve our technology. We are
subject to 3 million attempts a day to hack into the patient
database, and we successfully repel them all. So we are never
satisfied with our technology, but we do maintain 99.99 percent
up-time. We disagree with the USDS analysis of our systems.
Senator Cardin. I understand you may feel that you have
restrictions by law that you cannot do certain things, but then
you should try to change those laws if the system is not
working right.
What I do not understand is, I have heard so many examples
here of mistakes that need to be corrected, whether they are
surgical mistakes, whether they are testing mistakes, whether
they are shipping mistakes or matching mistakes, and they are
not being corrected.
Why are you not proactive in working with us if laws need
to be changed so that we can get a higher efficiency on making
these organs available?
Mr. Shepard. We would be happy to work with the committee
and anyone who is interested in legislation that would improve
the safety of the system.
We work directly in a peer review process with OPOs and
transplant hospitals for any--either an incident, and many of
our incidents, nearly half of our incidents that are reviewed
by our peer committee, are self-reported.
Senator Cardin. Self-reported is the way it should be. That
is a good thing to have self-reporting.
Mr. Shepard. Yes.
Senator Cardin. Dr. Locke, who retaliates against people
who are making--you mentioned the intimidation factor about
making reports. Can you just shed a little more light on that
as to what is happening out there?
Dr. Locke. I personally have had people come up to me and
make comments. We submitted--I signed a letter, along with the
members of Region 3, related to some of the emails that were
unsealed that disparaged our population in the southeastern
United States. And I submitted that letter to UNOS, along with
other colleagues from Region 3, and had two different board
members approach me and suggest that I should not have done
that, and that that was inappropriate. And so that makes it
very challenging. That is just one example.
I have had other colleagues who feel that they have been
blocked from being on committees and other things. And we have
all been silenced at our region meetings on more than one
occasion when we have spoken up about what we think is not
appropriate.
We have been told ``that's something that you can't vote
on,'' that you can't present data, that only they control the
data that can be presented. And certainly, we are members of
the OPTN, and the purpose of those meetings is to be able to
have representation and have dialogue about what we think is
going well and what is not going well. And it is incredibly
proscribed, and we are routinely silenced.
Senator Cardin. Well, thank you for coming forward. I
appreciate it.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Cardin. And I also want to
note this important question you asked, Senator Cardin, about
all the mistakes that are taking place. As far as I can tell,
there is a pretty serious operation for keeping them secret.
The committee was forced to issue a subpoena to obtain
information from UNOS on the number and nature of safety events
that were reported to it.
So this whole question that Senator Cardin is talking
about, about additional transparency in dealing with mistakes,
I think is very much on point, and I thank my colleague for
raising it.
Next in order of appearance will be Senator Portman.
Senator Portman. Thank you, Mr. Chairman.
And, Mr. Shepard, I am going to follow on some of the
questions that Senator Cardin raised. Twenty-eight hundred
Ohioans are on the transplant waiting list right now; you
probably know that. And according to the information obtained
by the committee, nationally in a 7-year period at least 249
transplant recipients have developed diseases from infected
organs, and at least 70 of these patients have died.
One of those troubling cases was in Ohio. The recipient
came for a routine follow-up and was informed that he had
accidentally received a transplant from a donor with cancer.
Tragically, it was not on the initial report, and the recipient
had a 3-week period when he did not even know. But the donor
had a brain tumor, and that was on the pathology report that
was not available, for some reason. So this recipient has now
been told he is likely to die within 3 years.
There are four organ procurement organizations in Ohio,
OPOs, and they all do lifesaving work, but we need to give them
better tools to ensure that lives are not lost, and we do not
have additional tragic situations like this one due to testing
failures.
Can you tell us, Mr. Shepard, what more UNOS can do to
ensure that these 2,800 Ohioans we talked about awaiting
transplants do not receive infected organs?
Mr. Shepard. Yes, Senator; thank you. UNOS has created, in
their operation of the OPTN, a Disease Transmission Advisory
Committee, which also includes CDC. So, in addition to the peer
review committee, which is studying the specific techniques,
the specific operations that may need to be improved or changes
that OPO or a transplant hospital might need to make in
practice, the disease transmission committee actually reviews
transmissions and ensures rapid communication between OPOs and
all the recipient transplant hospitals. So, if one transplant
hospital were to find that they had received an infected organ,
there is a quick communication chain back through the rest of
the organs that were recovered from that donor. And we
continue--that committee routinely provides guidance, most
recently offered on COVID. They offered quarterly guidance as
new information came out about COVID.
Senator Portman. You said earlier there is no regulation of
these OPOs. Again, there are a lot of great ones that save
lives every day, but others obviously fall short of the goal.
So you are saying that there is a monitoring of this, and
information provided, but there is no assurance that these best
practices, as an example, would be followed, even on disease.
Is that true?
Mr. Shepard. If you are asking whether UNOS can prevent an
OPO from operating, or from being an OPO, then the----
Senator Portman. Not prevent them, but require them to do
something. You do not have the ability to require them----
Mr. Shepard. The peer review process has significant
persuasive authority, but all the payment authority and all the
certification and decertification authority lives at CMS.
Senator Portman. So you do not have the ability to require
that they do things. A lot of suggestions have come out in the
context of this report. It has been recommended by the
University of California that we should automate data entry.
They indicate that 85 percent of data entry is automated in
other health-care records, and these should be automated. Right
now, an individual is required to enter the data manually,
which costs time and allows for error, human error. Do you
agree with that?
Mr. Shepard. We absolutely agree that data entry should be
automated. Sixty-five percent of UNOS's forms are available to
be electronically filled out for APIs, and more than 200
transplant hospitals and OPOs are using electronic APIs now to
automatically deliver data to UNOS.
Senator Portman. Does OPTN require that?
Mr. Shepard. OPTN does not require them to use the API.
Senator Portman. We also hear that upgrading technology at
OPTN will protect it from cyber-attacks that could be the
difference between life and death for people. Do you have a
response to that?
Mr. Shepard. I am sorry, Senator?
Senator Portman. Do you believe you are protected from
cyber-attacks?
Mr. Shepard. We never are satisfied with our protection
from cyber-attacks, but we do know that we are attempted to be
hacked into more than 3 million times a day and have not yet
been successfully hacked, but we continue to upgrade those
protections on a regular basis.
Senator Portman. Do you think there should be tracking of
organs in transit?
Mr. Shepard. I think that is a very beneficial thing. UNOS
provides an optional service that a quarter of OPOs use. Many
OPOs also use other commercially available trackers to do that.
There is not a single requirement to use a particular system.
Senator Portman. So the 21-percent discard rate, I
understand, has a lot to do with the transporting of organs,
and the lack of tracking is part of the problem. In one report,
organs were 15 times more likely to be lost or damaged than
your luggage when taken through an airport.
Could that be possible?
Mr. Shepard. I have not seen that number, and we will get
you--I would certainly be surprised.
Senator Portman. That is part of what came out of this
report. You talked about the app that you are developing to
offer transport options. Is this app fully operational?
Mr. Shepard. It has been fully utilized by our organ center
and is in a pilot phase with several OPOs.
Senator Portman. Is that something you are going to have
beyond pilot soon, so people can get best practices on transit?
Mr. Shepard. Yes.
Senator Portman. And how about manual entry? Do you have a
plan to make the network safer for patients and protect from
cyber-attacks by using more automation? Is there a plan to do
that?
Mr. Shepard. Yes. We continue to expand the number of APIs
that are available. That also depends on the OPOs and hospitals
making the changes to their IT systems on the other end to
communicate across that bridge.
Senator Portman. I did not mean to leave you out [motioning
to the other witnesses]. We will have some questions for the
record for you all.
And again, I thank you for holding this hearing--more
importantly, for this committee and its thorough report. Thank
you, Mr. Chairman.
The Chairman. Thank you, Senator Portman.
Next is Senator Warren.
Senator Warren. Thank you, Mr. Chairman.
So, in the United States, when people need an organ
transplant, their lives are in the hands of one Federal
contractor that our government hires to run the entire national
organ donation program. Today this system is run by UNOS, which
first got its contract back in 1986. In fact, UNOS is the only
entity that has ever been awarded, or even bid for this Federal
contract.
Now UNOS is responsible for overseeing local organ
procurement organizations, or OPOs. Because UNOS's oversight is
so bad, some OPOs are disasters: testing errors, lost organs,
never collecting healthy organs that could have been donated.
And without competition, the organ transplant system overall
has become a dangerous mess. Right now, UNOS is 15 times more
likely to lose or damage an organ in transit as an airline is
to lose or damage our luggage. That is a pretty terrible
record.
Mr. Shepard, you are the CEO of UNOS, and we have
documented these problems. And you have received more than
1,000 complaints in the last decade alone.
So tell me. In the 36 years that UNOS has had the contract
to run our national organ system, how many times has UNOS
declared its OPO members, any OPO members, not in good
standing?
Mr. Shepard. Two times, Senator.
Senator Warren. Two times. So that's it. Two times. UNOS
has run the program for 3 decades, and in the past 10 years it
has received over 1,000 complaints. At least 249 recipients
have developed diseases from infected organs after a
transplant; at least 70 people have died from those diseases.
And you looked the other way when one of your members was part
of an illegal kickback scheme that eventually sent an OPO
executive to Federal prison.
So 36 years, a list of deadly problems, a kickback scheme,
and yet UNOS has only twice declared one of its members, quote,
``not in good standing,'' a designation that is so toothless
that it does not even require the OPO to pause its operations.
So let me get one other piece of data out here. Mr.
Shepard, how many times has UNOS put an OPO on probation?
Mr. Shepard. I do not know right off the top of my head,
but it is not a large number.
Senator Warren. It is not large. In fact, it is three.
Three times in 36 years. Look, this is not oversight. This is
sitting on your hands while people die. And UNOS has been
allowed to look the other way because it has never faced any
competition.
Finally, HRSA, the Federal agency that awards your
contract, is now heading into this contracting cycle that
stakeholders have said must break up the monopoly for the first
time ever. But faced with the prospect of accountability in the
past, UNOS has demanded tens of millions of dollars to hand
over the archaic technology system that it developed with
taxpayer funding.
UNOS has even threatened to walk away and illegally
continue to operate the organ transplant system without a
contract.
So, Mr. Shepard, can you commit that UNOS will not in any
way attempt to hijack the United States' transplant system
during a transition to future contractors?
Mr. Shepard. UNOS would never make an attempt to take any
actions regarding a transplant system that would harm patients.
And in fact, the discussion that has come to light in the USDS
report was our attempt to assure HRSA that, despite coming very
close to the negotiating deadline, we would not turn the system
off and walk away from patients, even if bureaucratic paperwork
pushed us beyond----
Senator Warren. So you are not going to walk away and turn
the system off? You are also not going to demand millions of
dollars for a system that was developed at taxpayer expense?
Mr. Shepard. The system has been paid for in part by
taxpayers. Approximately 10 percent of the budget of this
contract is
taxpayer-funded. The rest of that is paid by hospitals when
they list patients. The government has not, over the years,
paid for the software.
Senator Warren. So you are still planning to get millions
of dollars for the system? That is what you want to do? Sell it
back to the government, if you do not get this contract?
Mr. Shepard. The contract allows the government to purchase
the software from----
Senator Warren. At what price? I mean, we have obviously a
monopoly on both sides here.
Tell you what: we will go into the pricing. I just want to
be careful about my time.
I will just be clear. You should lose this contract. You
should not be allowed anywhere near the organ transplant system
in this country, and if you try to interfere with the process
of turning the contract over to someone who could actually do
the job, you should be held accountable for that.
There are a whole lot of reforms that are needed in the
system, but this is a good place to start. Patients and
families deserve better than they are getting right now from
UNOS.
Thank you, Mr. Chairman.
The Chairman. That last sentence sums it up: patients and
families deserve better.
Senator Young?
Senator Young. For many years, I have taken an active,
personal interest in the organ donation system. I had a very
good friend I served with in the U.S. Marine Corps. His name
was David McFarland. I have gotten to know his wife, Jennifer.
We called him ``Gunny McFarland.'' I reconnected with Gunny
McFarland when I moved back to Indiana after service in the
Marines, and he died waiting on a heart. And that was a really
powerful experience for me.
So, when I was elected to the U.S. House of
Representatives, I resolved to do whatever I could to bring
more organs into the system. I came to find out there was
seemingly very little I could do. I scrutinized an existing
system that was highly opaque, and that really frustrated me. I
think it is frustrating to a lot of Americans.
In recent years, as some of my colleagues have indicated,
there have been a number of complaints submitted to UNOS--
1,118. Less than 40 percent of those were referred for
additional review. Of that small number, only 1 case, 1 case
out of 1,118 complaints, resulted in probation. It is either a
very impressive record of success, or it is a very low record
of probation.
My strong suspicion is that more of these complaints are
indeed valid and should result in probation. Two of these
complaints have led to a designation of a member being ``not in
good standing.''
There have been multiple documented incidents of OPO poor
performance, serious allegations ranging from illegal financial
arrangements to testing failures resulting in patient deaths.
I am going to ask for a really short explanation. Maybe,
Mr. Shepard, you can provide it. Please explain why UNOS very
rarely uses the probation and member ``not in good standing''
ratings?
Mr. Shepard. Thanks, Senator. The reason would be that the
primary tool for UNOS to promote improvement is the peer review
process that is established in our regulation and in our
contract. It calls for us to be the confidential coaching and
best-practice arm, in contrast to the regulatory and financial
oversight rules that CMS provides.
Senator Young. Okay. And yet we still have a large gap
between the need for organs and the number of organs that are
brought forward. It does not seem like we are rewarding
success. It does not seem like we are holding people
accountable for falling short of success.
Once an OPO is designated ``not in good standing''--Senator
Warren referred to this; it is toothless. It does seem
toothless to me. I will give you an opportunity, Mr. Shepard,
to disabuse me of that notion, and indicate for me what
penalties or sanctions are actually placed on an OPO when they
are designated ``not in good standing.''
Mr. Shepard. The statute does not give UNOS any authority
to offer sanctions like that. The certification,
decertification, payment authorities belong entirely to CMS.
The UNOS statute does not give us the ability----
Senator Young. So it is toothless, in that sense?
Mr. Shepard. It is designed to be, by regulation and
contract--it is designed to be a quality improvement process,
in contrast to the oversight process operated by a Federal
agency.
Senator Young. Okay. What corrective actions must occur for
the OPO to get back in good standing?
Mr. Shepard. It depends on the situation. A member not in
good standing is generally in an environment where multiple
things have gone wrong, where there seems to be not simply an
incident. An organization that has a strong culture can recover
from an incident. An organization that has more systemic issues
is likely to be a member not in good standing.
Senator Young. Is there a formal audit or a review process
in place to ensure OPOs and other OPTN members are complying
with appropriate rules and policies?
Mr. Shepard. Yes. A member not in good standing goes
through monthly meetings with the MPSC peer committee for
usually 2 or 3 years to come off of that standing. All OPOs and
transplant centers are reviewed routinely.
Senator Young. Okay.
On the topic of failing to perform like the American people
would expect the system to perform, I would like to turn to
reports of donor organs that are lost or delayed in transport,
and an apparent lack of ability to solve or even improve this
issue.
To what extent does UNOS currently track the status of all
the organs in transit at any given time?
Mr. Shepard. UNOS does not coordinate transportation or
track organs in transit. We do provide a service that OPOs can
use to use GPS trackers. Some OPOs use ours, and some use other
commercially available products.
Senator Young. So why is it that--and how does UNOS plan to
optimize organ delivery if you do not have a 100-percent
visibility into where they are at any given time?
Mr. Shepard. I think that the GPS products that we offer,
and that other people offer, are valuable. They do help in the
delivery of kidneys--only kidneys travel unaccompanied. So this
is a kidney issue. But I do think the GPS trackers are
valuable, and I think that is why you have seen more OPOs using
them.
Senator Young. My son can order a pair of shoes, or a toy,
and get a pretty good sense of where it is at a given period of
time. This is lifesaving, of course, in so many instances. So
it seems like that ought to be locked in.
So okay; well, we will continue--I know that the chairman
and ranking member have made this a real priority, and my
colleagues, many of them have been dialed into the importance
of this issue for some time, and others are beginning to get
energized and animated about it. And I am encouraged by that.
So we will keep fighting on behalf of our constituents.
Thank you, Mr. Chairman.
The Chairman. We will. And thank you for your
participation.
Before we go to Dr. Cassidy, just very quickly, colleagues,
I want to make a point so that it is clear for the record.
Mr. Shepard has said twice, with respect to this whole
question of the power to decertify an OPO, that CMS has the
power to do it. UNOS also has the power to refer an OPO for
decertification under the OPTN final rule. That has been done
exactly once.
So I just wanted it understood with respect to making sure
the committee knows what is really going on with respect to
decertifying OPOs.
Dr. Cassidy?
Senator Cassidy. Mr. Shepard, before I go on to some of the
other stuff, I just would like to ask procedurally: according
to committee staff, they have on multiple occasions sought
documents relevant to the committee's inquiry, and you were not
cooperative; that records were not given; that after the
committee issued a subpoena to UNOS on February the 3rd, UNOS
continued to withhold relevant information from the committee
without asserting a recognized constitutional, Federal
statutory, or Federal common law privilege, et cetera.
Finally, information was given with redactions. But these
redactions were not of patients, it was not HIPAA-compliant. It
was of senior OPO employees, time zones, addresses, and other
contextual information.
Now first, why was UNOS refusing to respond to subpoenas?
And why were you stonewalling and, by all accounts, hiding
information from the committee?
Mr. Shepard. Thanks, Senator. We did not refuse the
subpoena. In fact, we explained that because of the peer review
protection of the evaluation process, the MPSC process, that it
required a subpoena to open that box----
Senator Cassidy. So the subpoena was given, and then you
continue to withhold information from the committee without
asserting a recognized right to do so. So what happened there?
Mr. Shepard. We provided redacted documents----
Senator Cassidy. So the redactions included senior OPO
employees. That hardly seems on a doc--you know, the hospital
administrator is not someone to be redacted if the patient is
going to be redacted.
So why were you redacting senior OPO employees?
Mr. Shepard. Because the participation--the full and frank
participation in our peer review process is what we believe
leads to a full understanding of an adverse event. We asked the
committee staff if redacted versions would allow them to
understand how our oversight worked, and what had happened in
these events. They said, ``no.'' And we submitted documents
that were unredacted.
Senator Cassidy. Now, next. You mentioned the transport
system. I think a lot of what is going on here is--as you
mentioned earlier, almost ironically it seems--continuous
improvement, quality improvement. But it seems as if that has
been lacking in UNOS. I am a doc. I am a liver specialist. I
had a lot of patients who died from lacking transplants because
of a lack of organs.
I have worked among poor patients, and I had a lot of
patients who died, just like Dr. Locke, who were Black, with
renal failure who could not get transplanted. And so the
remarks of your board member are particularly insulting to the
patients for whom I cared for many years.
And I had a sense of indignation, and Dr. Locke shares my
indignation. I don't know if you allowed her to continue to
serve on your board. It is amazing that she would have been,
after revealing such prejudice.
With that said, my Louisiana OPO tells me that they asked
UNOS for a tracker; that they did not hear back; that they
emailed more. ``We need more trackers.'' They did not hear
back. Seven weeks later they get an organ, a kidney. They ship
it. It gets lost in transit because they do not have a tracker,
and eventually it expires.
Now if this is a continuing quality, whatever, improvement
process, and they are relying upon you--they say their emails
were not being answered.
Now what kind of breakdown do we have in a system where
emails are not being answered, much less where the trackers are
not being sent, which results in a kidney being lost and
therefore a patient going without the transplant?
Mr. Shepard. Senator, I am not aware of that situation. It
is disturbing. It is certainly something I will look into. I
know the leadership of the OPO, and I certainly wish, if they
had had trouble getting an answer----
Senator Cassidy. Well, they said they emailed the
organization twice. And Dr. Locke has this specific incident in
her testimony, so apparently it was known outside of Louisiana.
So it just seems like a failure of the organization.
What case would you make for UNOS continuing to have the
contract that CMS would award? What would give us confidence
that there will be a change in direction where there is a
responsiveness to emails like ``I need a tracker,'' and then
the obvious failure when the tracker does not come, and an
organ is lost and the patient does not get her transplant? What
case could you make?
Mr. Shepard. I believe that by bringing together the
transplant and donation community, UNOS has a unique
understanding of how organ donation and transplant works. I do
not understand the particular situation, and I certainly find
that as troubling as you do. But I also think that UNOS has a
long track record of promoting increases in transplantation,
equitable transplantation. We have a public equity tracker that
says that, once listed, rural patients and African American
patients are transplanted at very similar rates to other
patients. It is getting to the wait list that is the real
equity challenge. UNOS has a long track record of success. And,
while I think that we can improve, and we do every day, I do
think that it is a strong organization that has served patients
well.
Senator Cassidy. We heard a lot of testimony today, and
committee reports that suggest that that is not the case.
With that, I yield.
The Chairman. Thank you very much, Dr. Cassidy. And they
are very important questions. And I am just going to walk
everybody through what we have turned up with respect to
transportation of organs, because this is a major focus of the
committee's investigation.
We asked about it. UNOS told us, and I quote, ``It does not
collect transportation data on a national systematic basis.''
That strikes me as a showstopper kind of response. UNOS doesn't
track its donated organs' arrival at transplant centers? How in
the world can we give people confidence if the organization
that runs this says that?
It turns out UNOS only tracks the shipment handlers
themselves. Four percent of organ shipments--even in this very
small sample, dozens of organs are thrown away each year after
transportation.
UNOS does not know if the other 96 percent of shipments are
just as bad because they do not ask. UNOS has not made any
policies on safe organ transportation, and OPOs are not
required to report these issues. And when complaints about
transportation failures are made, UNOS does not even reply.
So, Dr. Locke, you have been outspoken about this whole
area with respect to the deficiencies in the operation. Tell us
a little bit more about organ transplant problems, and what
your response from them has been when you have reported
problems with transportation?
Dr. Locke. Thank you, Senator. Obviously, people have
described that we have about a 25-percent kidney discard. So,
one in four. If you look at numbers last year--these are rough
numbers--it would be about 8,000 kidneys. And really, I think
in some ways these were kind of a victim of entrenched and
cumbersome allocation algorithms that are very ordinal. We have
to go sort of in order, when data clearly have shown that
introduction of multiple simultaneous expiring offers would
result in more efficient placement of kidneys, and this would
decrease our cold ischemia time.
Also I think it reflects a failure of transportation
logistics. So, if you take UNOS's organ center, they have a
very rigid system, for example, for finding flights, and lack
either an ability or interest in thinking outside the box.
So, for example, if there are no direct flights from
California to Birmingham, AL, instead of looking for a flight
from San Francisco to Atlanta, understanding that a courier
could then pick it up in Atlanta and drive it the 2 hours, they
instead put it on a flight from SFO to Birmingham via Atlanta
and allow it to go to a cargo hold over night where it
literally is rotting, if you will, and so we are putting extra
cold ischemia time on, waiting to catch the flight to
Birmingham the next morning----
The Chairman. Let's make sure everybody gets this. You are
saying you have seen instances of something being put in cargo
hold when it is very likely to rot?
Dr. Locke. That is correct. So, if the kidney arrives after
10 p.m. at the Atlanta Airport, it goes to cargo hold. We
discovered that and made calls to the airlines ourselves, and
after several calls, the airlines--of course they were
mortified, not understanding that that was what was happening,
and actually had their manager meet our courier, and we were
able to get the kidney out of cargo hold. But this went on
before we figured out what was happening. Because essentially,
they fly it in. It sits in cargo hold. It comes out the next
morning to catch the next flight.
Instead of thinking outside the box--if we just get it to
Atlanta, it is driveable to Birmingham. And those hours make a
big difference.
The Chairman. That sounds way too logical for what UNOS has
been up to.
So please go ahead.
Dr. Locke. So I think, from our perspective, one of the
things that we really want to understand is why have we not
engaged experts in applied mathematics to really optimize our
matching algorithms and organ placement? And why haven't we
really engaged experts in logistics around transportation?
I mean, I think of the FAA, for example; what a remarkable
entity, the fact that every day thousands of flights across the
U.S. are in the air at the same time and don't crash into each
other. And they know exactly where a given plane is. And it
happens almost seamlessly every day.
We should be able to do the same thing for our transplant
system, for our organs.
The Chairman. As I said, too logical.
Ms. Brockmeier, UNOS has developed this organ tracking
system. Do you all use it? And I am curious what you think of
it.
Ms. Brockmeier. Senator, thank you for the question.
Senator, we did use and participate in the beta pilot through
UNOS and made the decision to not move forward using their
product and have sought a commercial alternative.
The Chairman. And why was that?
Ms. Brockmeier. Part of the issues were some service-
related issues, the lack of the interconnectivity that we
wanted, to be able to facilitate a more expedited visual
tracking for the organ.
The Chairman. Was the tracking technology low-quality?
Ms. Brockmeier. Yes, sir.
The Chairman. I will have some additional questions, but my
time is up.
Senator Grassley?
Senator Grassley. We are done.
The Chairman. Okay.
Mr. Shepard, in your statement to the committee today, you
highlighted how people who work on the organ transplant
network's board and committees come from all corners of the
transplant system. You noted that this diverse group of people
is essential to making difficult policy decisions for the
transplant network, and how effectively the system works to
protect patients.
Yet the way you describe these people and the peer review
process in the documents you provided to the committee was very
different. So I would like to enter into the record two emails
that you wrote. Here is how you described the principal
transplant oversight committee in one of your emails produced
to the committee.
You said, and I quote, ``Allowing the committee to fill
these jobs increases the community's belief in the validity of
the documents,'' end quote. You go on to say, and I quote, ``It
is like putting your kid's artwork up at home. You value it
because of how it was created rather than whether it is well
done. Only in this case, we persuade ourselves that it is well
done anyway.''
One more. In this email you describe the organ transplant
network that you are in charge of as nothing more than, and I
quote, ``an overgrown homeowners association.''
Now, when you compare the organ transplant network you
oversee to an overgrown homeowners association, doesn't that
call into question the effectiveness of the oversight and
governance process used by the organ transplant system that you
are saying works so well?
[The emails appear in the appendix beginning on p. 188.]
Mr. Shepard. Senator, I don't recall those particular
emails, or the context----
The Chairman. They are yours.
Mr. Shepard. I assume that they are, sir.
The Chairman. They are yours, Mr. Shepard, and they are
central to your belief, as you try to tell us, that everything
is hunky dory; that you have confidence in the people.
You just wrote a bunch of emails that go 180 degrees in the
other direction.
Let me turn now to the issue with respect to information
technology. So the principal function of UNOS is to manage the
electronic database and to keep track of organ donations, and
match them to people on the transplant waiting list.
The technology that is used here is woefully out of date.
The government report entitled ``Lives Are at Stake: The
Government's Role in Modernizing the OPTN'' concluded that UNOS
lacks sufficient technical capabilities to modernize their
systems, which the current system requires. Instead of a
modern, integrated cloud-based system, the UNOS system requires
manual information updates at every stage. UNOS's transplant
computers have crashed for a total of 17 days, with one
February 2021 outage lasting 3 hours. When asked by our
investigators, Mr. Shepard said improving the systems to meet
industry standards was not a priority for UNOS, ``because it is
not like air traffic control.''
Mr. Henry, I think you are still with us, and we are glad
that you are. These organs are very perishable. As somebody who
received a lifesaving transplant, my guess is you believe every
minute counts when you are on the transplant waiting list?
Mr. Henry. Yes, absolutely. And like everyone else, we have
read the USDS reports. We have read The Washington Post reports
from earlier this week. And the IT services have been, in our
opinion, inadequate for quite some time. The Patient Affairs
Committee, our leadership, has voiced their concerns about the
IT systems for quite some time, without much of a response.
The Chairman. Mr. Henry, excuse me. How long have you been
voicing your concerns about how outdated the IT systems are?
Mr. Henry. I am speaking in this instance about Patient
Affairs leadership. I have been recently appointed as a
representative for the Patient Affairs Committee this year. So
as far--I have read through a lot of the emails and background
information, and spoken with leadership about these issues,
including the IT services, and that is what I am referring to
as far as our concerns about the IT systems being voiced but
not addressed.
The Chairman. Okay.
Mr. Henry. So you are correct, Senator Wyden. Every minute
counts; every second counts. When we hear about down time as a
result of IT issues, those are lives that are potentially lost.
Patients die while IT systems are down.
So again, heartbreaking issues that we feel should be
addressed.
The Chairman. So, Ms. Brockmeier, again because you are on
the front lines, tell us your experiences with UNOS systems.
And let's talk, for example, about something like DonorNet. Why
has that not been modernized?
Ms. Brockmeier. The response, Senator Wyden, that we were
provided when the committee that I was chairing asked
repeatedly about improvements was that there wasn't bandwidth
within the UNOS IT department to address those problems.
The Chairman. So they just did not have current technology?
Ms. Brockmeier. I cannot say what garnered their response,
but that was their response.
The Chairman. If you don't have bandwidth for something
that is a priority, that says your technology is not up to
date.
All right, let's go next to OPO failure rates. Again, like
everywhere in our society, there are performers that do well
and some that do not. But the range of performance of organ
procurement organizations is massive. The high-performing OPOs
successfully recover and transplant four times as many organs
as the poorly performing OPOs. After several years of debate on
how to improve the performance of the subpar OPOs, the Centers
for Medicare and Medicaid Services adopted a rule setting
performance standards for the OPOs.
When measured against these standards, more than one-third
of the 57 OPOs are failing--not 1 or 2, but 22.
Ms. Brockmeier, a lot of people in the OPO community oppose
the CMS rule, including UNOS. When you see a large number of
OPOs that are failing to meet the standard, I guess you can
understand why.
Your OPO is not one of them. Do you think the measure is a
step in the right direction for holding OPOs more accountable?
Ms. Brockmeier. Yes, Senator Wyden. Our organization went
on the record very early on in strong support of the proposed
metrics. While they may not be perfect, they are certainly an
improvement over what we had had year-to-date.
The metrics are designed in such a way that everyone can
accomplish that. We can all be Tier 1 performers. It takes a
dedicated effort, the right staff, the appropriate training,
and resourcing to ensure that your OPO is able to respond every
time the phone rings to ensure all the organs are recovered.
The Chairman. All right.
Let's talk for a moment about the boards that are supposed
to be overseeing these, because it looks to me like there is a
serious conflict of interest here. And I will send this to Ms.
Brockmeier, and perhaps you would like to get to it as well,
Mr. Friedman.
The Organ Procurement and Transplantation Network--which is
the formal title of the organ network that operates under
Federal contract administered by HHS--and UNOS, which is the
contractor that operates the network and controls information
about the network, have the same boards of directors, despite
efforts by the government to separate them.
That means the people who look out for the best interests
of UNOS's multimillion-dollar nonprofits are the same people
who look out for the interests of the entire organ transplant
network. It sure sounds like a conflict to me.
Ms. Brockmeier, Mr. Friedman, UNOS claims the two boards
must be the same. Okay, that is their claim. They have to be
the same. And there is no need for the board of the OPTN to be
independent from the board of the government contractor that
runs it.
Why shouldn't the network have an independent board--an
independent board that can make its own judgments about whether
the contractor is performing adequately?
Your thoughts, Ms. Brockmeier and Mr. Friedman?
Ms. Brockmeier. Yes, Senator Wyden, I think there should be
an independent board. I think the division of the
responsibilities of the board, and the inherent way that they
are structured do pose conflicts. It would be like if you had
an organization that was a supporting organization, you would
want to hold it accountable for its performance. And the
current structure really limits that opportunity.
The Chairman. Mr. Friedman?
Mr. Friedman. Chairman Wyden, actually HRSA and CMS, they
actually changed board complexity for OPOs, requiring non-
transplant individuals. And the same thing can be employed here
as well.
As we make organ allocation changes, people win, people
lose. And what we have done in this country, through the
efforts of this board, is really allowed individuals to express
their opinion at the board level, and the executive board
level, that were based more towards their own individual needs.
And this has to change. And that is why I, at our Region 3
meetings, continuously recommend that we separate that out and
allow the membership of UNOS--this is a membership-driven
organization--to bring us up to speed so that we have
transparencies, and so that we regain the trust of our
providers, our hospitals, our OPOs, the patients, and the donor
families. We cannot lose that trust, and I fully support you as
the chairman of this, to enact that immediately. That can be
part of the contract.
The Chairman. We are just trying to determine if we have
any Senators on the way. Let me ask our Republican colleagues.
And we do. We do not? Thank you for your participation in this.
We are very pleased a strong advocate of patients, Senator
Casey, is here. And let's let him get settled, and then we will
go to him for his questions. And then I have a couple of other
areas that we need to look at briefly.
Senator Casey, are you all set?
Senator Casey. Mr. Chairman, thanks very much. I wanted to
start by thanking you for the hearing and for the work that you
and the ranking member have done in conducting this important
investigation.
This is a subject area that obviously does not get nearly
enough attention in Washington. Not so in the context of this
hearing and the work that was done by this committee and the
staff. All of their good work should be held up for
commendation.
I also want to say I know I am late for the hearing, so I
know I may have missed some of the engagement and some of the
answers to questions. So if my questions are redundant, or
duplicative, I apologize for that in advance.
I come to this issue not just in the context of a public
official and a member of a committee, but also in a very
personal way. My father was the beneficiary of a double organ
transplant in June of 1993, a heart and liver. Not many, at the
time, 61-year-olds had been the beneficiary of that kind of
transplantation. In fact, when he had it, I was told he was one
of only--or I should say there had been, I think, only six in
the Nation at that point, and four of those six were dead. So
his chances were not great. But thankfully, he came through it
and was able to live 7 more years, almost to the day. So we
were blessed and fortunate.
About a hundred separate things had to go right for him not
to die before receiving that double organ transplantation. So
we are grateful for that.
But I guess I wanted to focus on the--I guess the last two
recommendations that call for both transparency and
accountability for the chain of custody and the transport of
organs. We know that thousands of Americans are anxiously
awaiting these lifesaving, life-changing operations, and
waiting for that call to save the life of a family member.
So I guess I wanted to start with Dr. Locke in terms of
both transparency and accountability. How would a greater
degree of both, a greater degree of transparency and a greater
degree of accountability, improve the transplant system?
Dr. Locke. I think, quite simply, it would result in more
lives saved. If you think about the three sort of areas that
UNOS is supposed to oversee, greater transparency and
accountability around policy would have led us to address, for
example, gender disparities in liver allocation much sooner.
So in 2002, the model for end-stage liver disease was
introduced, and we knew fairly quickly on that that created
huge gender-based disparities in allocation because serum
creatinine, one of the measures incorporated in MELD, does not
reflect kidney function in women as well as it does in men. It
is just this year that we finally updated the model to address
that, some 20 years later. So that is a policy example that
should have been addressed much sooner. And there were multiple
cries from the community to do so.
If you think about transportation--I gave an example a
minute ago: having a UNOS organ center that is really more
flexible in their ability to sort of figure out logistics,
instead of thinking about trying to get a kidney from San
Francisco to Birmingham, and only looking at flights that get
you all the way to Birmingham, and having the kidney go from
San Francisco, to Atlanta, getting there so late that it gets
stuck in cargo hold overnight like lost luggage, where it has
increased cold time and is literally rotting until it can get
on a plane the next day.
And then, as the surgeon getting the kidney, you have to
make the decision, can I use this? Is it going to be okay? Is
there too much time? Am I going to put the patient at risk for
a primary nonfunction? Or should I go for it? Versus having the
ability to get that kidney to Atlanta, have a courier pick it
up and drive it to Birmingham, and save about 12 hours of cold
time. Those things really matter.
And if you think about IT, something as simple as having a
system where we can more easily put in unacceptable antigens--
this was a debate for many years. So for context, we list
unacceptable antigens in the system, and it allows us to better
match kidneys so that, when someone comes up on the match run,
we have a high probability that they will be a good tissue
match.
Well, that took forever. And we could not really get our
unacceptable antigens in. So routinely, people get offered
kidneys that are not going to be a match, and you have to get
to all of those before you can get to the person that they
really should go to.
Those are simple examples. But if we could really have
transparency and accountability around those kinds of things,
we could save more lives.
Senator Casey. Thanks very much. That is compelling. And I
think for those of us who are concerned about the work of a
committee like the Finance Committee being done, this kind of
an investigation being done, of course a report and
investigation study is only as good as the implementation of
it.
I'm sorry; I guess I would turn to you, Mr. Shepard, and,
just having heard from Dr. Locke about the benefits of both
increasing accountability and transparency, would you commit to
implementing--and you may have already been asked this, so I
may be redundant, and I'm sorry if I am--but would you commit
to implementing the bipartisan recommendations with regard to
both transparency and accountability when it comes to organ
transplantation?
Mr. Shepard. We are always looking, Senator, for ways to
improve the process, and I look forward to receiving and
reading the committee's recommendations on how to do that. I
cannot commit to them because I have not seen them yet.
Senator Casey. You have not seen the recommendations? Well,
I hope that part of the follow-up of the work of the committee
can be that kind of engagement with you and others, because we
live in a world now where we can use technology and all the
innovations that our economy presents to virtually have
instantaneous retrieval of goods--everything from ordering food
to ordering groceries or goods online. And the idea that we
cannot have in place some of the practices and procedures and
pathways to move organs faster, I hope would be something that
would be the subject of history, as opposed to where we are
headed in the future.
But I look forward to talking to you more about it.
But, Mr. Chairman, thanks very much for your time, and I
know I am over, and I appreciate the work you have done.
The Chairman. Thank you, Senator Casey, chairman of the
Aging Committee, which has a great interest in these topics as
well.
I need to make another correction to something Mr. Shepard
said, and we are going to get close to wrapping up, unless any
other Senators on the committee are here.
Mr. Shepard told Senator Warren that only 10 percent of
UNOS funds come from taxpayer money and the rest comes from
fees paid by transplant centers who add patients to the list.
But the fact is, Medicare is the largest payer of the fees, for
example for kidneys. So we are talking about inefficiency.
Inefficiency that puts patients at risk, and certainly taxpayer
dollars are used to cover some of these practices.
So we have been at it for a couple of hours, and this has
certainly been an ominous portrayal that you all have made. We
have heard about organs with tire tracks. We have heard about
organs left behind to spoil in airports. We have heard about
reprisals against people who try to speak the truth about what
is going on. We have heard about the culture of secrecy that
dominates UNOS.
We have emails that in effect have Mr. Shepard ridiculing
employees he says that he counts on. And we have gone through
some of the details with respect to the transportation system.
And probably the best way I would describe it is, it is not
even a system. It just sounds like it is confusing, at best, if
not bedlam.
So we heard testimony from witnesses today. And certainly,
according to witnesses representing OPO transplant center
patients, it is obvious that there are serious problems in the
organ procurement and transplant system. And it is not keeping
up with the demand for organs. Patients die every day while
they wait.
The committee is going to continue its investigation. We
have already looked at over 1,100 safety complaints filed with
UNOS. They provide example after example of patient deaths and
near-misses after people have been selected from the list for
transplant. One-third of the Nation's organ procurement
organizations failed to meet even the minimum standards--the
minimum standards--set out by the agency that certifies them to
operate.
One in four kidneys recovered for transplant is never
transplanted. The Federal experts on information technology say
that the network's IT systems are not up to the task and that
UNOS, the contractor that operates them, simply does not have
the technical capability to update them.
Now, the testimony from UNOS, which is the organization
that has run this for decades, is unrepentant. We have not
heard anything resembling, ``You know, we learned this and this
over the last decade. We should have done that, but we are
going to get it fixed soon.'' According to Mr. Shepard, things
have never been better.
That is really what we have heard today. We have had the
contract, claims Mr. Shepard, and we are doing fine, and people
should be satisfied with us. The patients and the families, the
physicians, basically are sending a very different message,
that the situation is dire. The organization responsible for
fixing it says there really is not anything to fix.
So we have certainly found in our investigation thus far
that there is a lot to fix. So we are going to continue the
investigation. The committee will be looking more closely at
the role of Federal agencies--the Centers for Medicare and
Medicaid Services, HRSA--that are charged with overseeing the
system, and we will be looking at that. And the Federal
contract that UNOS has had for decades is up for renewal, and
this is an opportunity to fix things.
And on this committee, in a bipartisan way, we are
determined not to miss this opportunity to get this fixed.
Thanks to Senator Grassley, Senator Cardin, Senator Young, for
their interest. They have been working with the committee for a
long time. This is not a partisan issue. This is a national
issue.
And, as we have touched on repeatedly over the course of
the afternoon, patients waiting for organs, and families of
donors, deserve better. And we are going to stay at it until
they get those fixes.
And let me also note, procedurally, that members have 14
days to submit any questions or statements for the record. I
want to thank our witnesses--Mr. Henry, who has patiently been
out there giving us good information from cyberspace--for their
patience.
The Finance Committee is adjourned.
[Whereupon, at 4:28 p.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Diane Brockmeier, R.N., BSN, MHA,
President and CEO, Mid-America Transplant
Chairman Wyden, Ranking Member Crapo, and members of the committee,
my name is Diane Brockmeier, and I am the president and CEO of Mid-
America Transplant, the organ procurement organization (OPO) serving
eastern Missouri, southern Illinois, and northeastern Arkansas. Thank
you for the opportunity to submit a written statement.
I joined Mid-America Transplant in 1986 as a registered nurse
talking to families about organ donation on the worst days of their
lives. These donor families, and the organ transplant recipients whose
lives they save, remain at the forefront of my thoughts every day.
At our organization, we follow the ethos of ``every donor, every
time.'' Our clinical team is committed to giving donors and their
families the care they deserve and stewarding their gifts to patients
desperately in need. Mid-America Transplant depends on the broader
national transplant system, administered by UNOS, to accomplish this
work.
From 2018 to 2020, I served as a board member for the Organ
Procurement Transplantation Network (OPTN). As an OPTN Board Member, I
concurrently served on the UNOS board. My board experience revealed
that UNOS's actions are often not aligned with its fundamental vision--
a lifesaving transplant for everyone in need.
But change is possible; these problems can be corrected. It is
critical that we urgently address patient safety, update the archaic IT
system, remove conflicts to ensure good governance, and return the
focus of the OPTN to providing high-quality care and exceptional system
performance to all patients, both donor patients and transplant wait-
list patients.
We need to urgently address patient safety.
Each organ lost due to system failure or provider failure has a
consequence to the thousands of patients waiting for a transplant.
Furthermore, a discarded organ fails to honor the heroic gift from a
selfless donor and compounds the family's sense of loss.
Errors and adverse events do happen in organ procurement and
transplant, just like in any other field of health care. However,
unlike the rest of health care, we have few, if any, mechanisms to
protect patient safety and prevent adverse events. Specifically:
There are no clinical training, licensure, or certification
standards required for OPO staff, even those operating in matters that
directly affect patient care.
There is no public adverse event reporting required of or by
UNOS when patients are harmed, organs are lost, or the quality of
patient care is unsafe.
UNOS lacks urgency and accountability around identifying and
remediating the preventable loss of organs and addressing poor quality
patient care. The process by which errors are reported and reviewed is
woefully inadequate. Errors are not disclosed to the broader transplant
community preventing practice improvement. In this environment, who is
looking out for patients? Who is being held accountable for poor
quality care? No OPO has ever been decertified, regardless of its
performance or safety record.
While decertification falls to the Centers for Medicare and
Medicaid Services (CMS), the entire system relies on member compliance
from the OPTN. UNOS has failed to align its efforts to ensure patient
safety at the system level. It is a decision with tragic and deadly
consequences.
We must update an archaic technology system at UNOS.
As OPOs, we are required to work with UNOS's technology--DonorNet--
every day. DonorNet is outdated, difficult to use, and often slow to
function when every minute counts. Manual entry subjects it to error,
and OPO and transplant center staff are not empowered with the right
information when time is crucial.
I served in leadership roles on the OPO Committee from 2017-2022.
Committee members and industry leaders voiced repeated requests to
address the need for DonorNet improvements. Year after year, these
requests were consistently met with the response that UNOS IT did not
have the bandwidth to address this work.
The limitations of UNOS technology are delaying and denying
transplants to patients dying on the wait list. Poor technology impacts
the disturbingly high kidney discard rate in the United States; where
one in four never makes it to a patient for transplantation.\1\
---------------------------------------------------------------------------
\1\ Available at: https://optn.transplant.hrsa.gov/about/
committees/kidney-transplantation-committee/; OPTN Kidney
Transplantation Committee Meeting Summary, June 24, 2022.
---------------------------------------------------------------------------
Consider:
UNOS policy requires use of their Organ Center for national
kidney placement. The Organ Center is highly inefficient, although UNOS
does not report data about the Center's effectiveness. At our OPO, we
have consistently observed that the Organ Center is rarely successful
at placing kidneys and often discards kidneys after failed placement
attempts leaving many OPOs aware they are better off not using it at
all.\2\,\3\
---------------------------------------------------------------------------
\2\ Noreen, SM, Klassen, D, Brown, R, et al. Kidney accelerated
placement project: Outcomes and lessons learned. Am J Transplant. 2022;
22: 210-221, doi:10.1111/ajt.16859.
\3\ Mohan, S and Scheid, JD (2022), Accelerating deceased donor
kidney utilization requires more than accelerating placement. Am J
Transplant. 2022; 22: 7-8. https://doi.org/10.1111/ajt.16866.
Critical time is lost due to the inefficiency of DonorNet--
wasting time on offers that will not be accepted and delaying or
denying a transplant. Of course, an available organ should be offered
to patients on the list in sequence. However, far too much of
matching--particularly on harder to place organs from older donors--is
left to individual OPOs and transplant programs to find each other
despite, rather than facilitated by, UNOS technology.\4\
---------------------------------------------------------------------------
\4\ Doby, BL, Ross-Driscoll, K, Yu, S, Godwin, M, Lee, KJ, Lynch,
RJ. Examining utilization of kidneys as a function of procurement
performance. Am J Transplant. 2022; 22: 1614-1623, doi:10.1111/
ajt.16985.
UNOS has millions of data points that could, and should,
facilitate faster, more efficient organ placement, providing the
centers and OPOs with real-time information to increase transplants.
Leveraging this rich data source is a national imperative to improving
---------------------------------------------------------------------------
patient outcomes.
Mid-America Transplant intentionally identifies surgeons who
accept kidneys that have been declined many times. These are lifesaving
options for those patients. In May 2022, one of these patients was
number 18,193 on the list. Relying on DonorNet alone, that kidney never
would have been placed, and a chance to save a life would have been
wasted.
It is worth noting that when an OPO goes out of sequence to
place an organ that would otherwise be thrown away, UNOS requires an
explanation. However, when organs are never recovered or placed at all,
UNOS remains silent. Organ Procurement Organizations are never
penalized for discarding an organ. Conversely, they are penalized for
placing organs out of sequence.
We must remove conflicts to ensure good governance.
Serving on the board of the OPTN automatically assigns membership
on the UNOS board. How can you fairly represent the country's interests
and a contractor's interests at the same time?
Board members are kept in the dark about critical matters, and
are marginalized, particularly if they have views that differ from UNOS
leadership. As a board member, I do not recall the subject of the
Senate Finance investigation being raised by UNOS leadership.
Preparatory small group board member calls were conducted
prior to the board meetings to explore voting intentions on upcoming
issues. If the board member was not in agreement with the opinion of
UNOS and board leadership, follow-up calls were initiated. Fellow board
members reported feeling pressured to vote in accordance with UNOS and
board leadership.
Conflicts in the current structure, combined with the actions
of UNOS leadership, have led to a deeply concerning perception that
speaking out can lead to exclusion from critical decision-making, or
worse--retaliation.
After I left the board, I was disturbed to see UNOS leadership
lobbying against Federal regulations for OPOs which would drive
transparency, accountability, and improve performance.
I implore the committee--along with CMS and HRSA--to ensure those
who speak out in support of system reform are not penalized. Patients
deserve a transparent, accountable system that works on their behalf.
We must refocus on patients.
To protect patients, I urge Congress and the administration to:
Separate the OPTN functions into different contracts so
patients can be served by best-in-class vendors,
Immediately separate the boards of the OPTN and the OPTN
contractors,
Require public disclosure of all potential conflicts for the
contractor and board members, and
Ensure that patients are safeguarded through open data from
both the OPTN and OPOs.
Inaction by UNOS causes real harm to patients. This harm is
measured in how many patients die waiting for a transplant. Your
immediate action on this matter will save lives. Thank you.
______
appendix a: morning consult opinion piece in support
of the opo rule, october 13, 2020
Organ Donation Can Save More Lives Through Reform
By Ginny McBride and Diane Brockmeier
Last December, the Department of Health and Human Services proposed
new regulations to reform the U.S. organ donation system. It would
accomplish this by creating objective criteria by which to evaluate the
government contractors, called organ procurement organizations, who are
charged with recovering transplantable, lifesaving organs from deceased
donors. These bipartisan reforms could save countless lives. It's
important the Trump administration finalize them now.
As CEOs of two OPOs, this is an issue we have followed closely, and
we applaud these measures as long overdue.
Our constituents are the more than 100,000 Americans currently
waiting for a lifesaving transplant, with 33 dying every day for lack
of an organ. Given that COVID-19 can cause organ failure, reform is
even more urgent today than it was a year ago. HHS estimates that its
proposal will mean an estimated 5,000 to 10,000 more lifesaving organ
transplants every year.
Central to the problem is that, historically, the government has
not used objective criteria to evaluate OPO performance. OPOs are
allowed to self-interpret and self-report our own performance data. As
a result. no OPO has ever lost its government contract, even as wildly
variable performance across OPOs has led to unnecessary deaths for
patients in need of transplants.
Compounding the problem is that all OPOs operate as geographic
monopolies, which means we have neither regulatory nor competitive
pressure to provide high service to patients. And while there may be
legitimate reasons for at least some monopolism (e.g., potential donor
families should not have two OPOs competing for their attention), the
trade-off must be increased transparency and oversight.
HHS's proposal, rightly, promises to implement much-needed
accountability measures, with real consequence for our counterparts
that fail to meet them--including replacing OPOs who simply do not get
the job done. In response, many OPOs have responded with aggressive
lobbying campaigns to block these proposed reforms by confusing the
issue or proposing unworkable alternatives.
But the more future-minded OPOs, like ours, are embracing change.
HHS's new proposal signals something potentially game-changing for
patients: allowing the highest performing OPOs to replace those who
have proven themselves incapable of serving their communities. To the
extent that an OPO is not able to rise to the challenge of a high
standard, the focus of our attention and energy must be on better
serving patients on the national wait list, not on protecting specific
OPOs.
This, of course, is threatening for OPOs who have grown a bit too
comfortable. Some of our colleagues have tried to paint any changes as
destabilizing and unprecedented, positing that it will lead to
situations in which areas of the country do not have OPOs at all. But
this is simply not grounded in HHS's proposal, which explicitly states
that ``our goal is to ensure continuous coverage of an OPO service area
in the event an OPO is decertified.''
There were originally 128 OPOs, and after decades of consolidations
there are now 58 OPOs; never has this process been disruptive. Forcing
OPOs to continually earn their contracts is a patient-centric
accountability mechanism, ensuring that OPOs operate with the urgency
befitting the life-and-death consequences of this work.
Additionally, many OPOs have argued that the standard for OPO
performance HHS has proposed is ``arbitrary.'' But the more important
question is whether the improvements HHS seeks to drive are
realistically achievable, and we believe unequivocally that they are;
HHS data show the difference between the best and worst OPOs is almost
500 percent. Put another way, some OPOs recover 4 or 5 times as many
organs as their peers.
So if we accept that higher performance is possible--and we
understand that it would also be lifesaving--realizing these gains is
not simply a policy question, but a social imperative. As patient
advocates have argued, and with which we whole-heartedly agree, ``In a
chronically underperforming system, patients should fear a perpetuation
of the status quo, not a disruption of it.''
It's time that HHS unleashed the best weapon it has against the
life-threatening organ shortage: OPOs who have already proven
themselves motivated and capable. HHS should finalize its proposal as
urgently as possible, trusting the best among us to rise to that
challenge. Any weakening of HHS's proposed standard will--
definitionally--result in lives lost, which is directly antithetical to
our mission. Patients deserve nothing less.
Ginny McBride is the CEO of OurLegacy, a Florida-based OPO. Diane
Brockmeier is the CEO of Mid-America Transplant, which serves parts of
Missouri, Illinois, and Arkansas; she also is the past president of the
Association of Organ Procurement Organizations.
______
appendix b: rfi response with other pro-reform ceos
to cms re. opos, february 1, 2022
To: Administrator Chiquita Brooks-Lasure, Centers for Medicare and
Medicaid Services
From: Diane Brockmeier, Mid America Transplant
Virginia McBride, OurLegacy
Patti Niles, Southwest Transplant Alliance
Kelly Ranum, Louisiana Organ Procurement Agency
Matt Wadsworth, Life Connection of Ohio
Janice Whaley, Donor Network West
Jennifer Erickson, Federation of American Scientists
The FAS Organ Procurement Organization Innovation Cohort is
committed to using data science and transparency to accelerate improved
patient outcomes and to inform ongoing, data-driven policy development.
The seven organ procurement organizations that are leading in
opening up their data include: Donor Network West, Life Connection of
Ohio, LiveOn New York, Louisiana Organ Procurement Agency, Mid-America
Transplant, OurLegacy, and Southwest Transplant Alliance.
During a transformative period in the organ procurement industry,
the Innovation Cohort will help shape the future of organ recovery in
America, improving OPO practice and informing OPO policy. Most
importantly, the Innovation Cohort will strive toward new heights of
operational excellence in order to increase organ transplants in an
effort to best serve the public, organ donors, donor families and
patients waiting for transplants.
The FAS Organ Procurement Organization Innovation Cohort has
publicly committed to:
Transparency: public sharing of data/analysis in order to set
a standard to which all OPOs can be held;
Accountability: support for the OPO final rule, and any
efforts to move up implementation date so all parts of the country can
be served by high-
performing OPOs as soon as possible in 2024; and
Equity: commitment to analyzing/publishing data to ensure all
parts of community served.
Reducing disparities--p. 68599
1. Are there revisions that can be made to OPO CfCs to reduce
disparities in organ transplantation?
Given bipartisan congressional leaders have called for
accelerations of reforms of the donation and transplant ecosystem as an
``urgent health equity issue'' exacerbated by the COVID pandemic, we
call on CMS to make the public disclosure of all OPO process data a
requirement of the OPO CfCs immediately.
To reduce disparities in organ transplantation, it is critical to
enforce the final rule as quickly as possible, and to update CfCs:
The metrics contained in the final rule, are already best
suited to measure OPO performance and hold OPOs accountable to the
highest performance and to the idea of pursuing every donor and organ
every time to save as many lives as possible.
It is critical that the final rule be:
Enforced as quickly as possible. moving up the
implementation date so that all parts of the country can be served by
high-performing OPOs;
Not be revised in a way that dilutes or
distorts its impact.
CMS should maintain its earlier correct judgment
disallowing both race-based adjustments (which could harm patient
outcomes) and zero donors (which could allow for gaming of metrics).
To have evidence of effective and equitable service, CMS
should make all OPO process data publicly available.
It is undeniable that a number of the questions
raised in the RFI could be answered or resolved if all OPO process data
were required to be made public, giving regulators the opportunity to
understand and identify where performance gaps and inequitable service
and outcomes exist.
This data-driven transparency would ensure all
OPOs are accountable to the highest levels of operational excellence,
and would offer opportunities to design interventions to address
particular gaps in service.
OPO metrics/performance--p. 68601, 68602, 68603
1. Independent of CMS's specific outcome measures, what other
metrics or attributes reflect a model or highest performing OPO?; 2.
What are quantitative or qualitative indicators of excellent
performance and how can CMS incorporate these with outcome measures
when assessing OPOs for recertification purposes?; 3. Should CMS
consider additional metrics, such as those that measure equity in organ
donation or an OPO's success in reducing disparities in donation and
transplantation, and how should this be measured?; 4. Are there ways to
scale, or rate, performance of other (new) factors that CMS may
consider in assessing OPO performance? 5. Can the OPO CfCs address the
issue of organs that are lost during transport to a transplant program?
In answer to the above questions, CMS should look for evidence of
effective and equitable service as seen in open and transparent OPO
process data.
The OPO Innovation Cohort is committed to transparency,
accountability, and equity, and is already taking steps to make these
commitments a reality through its collaboration with the Massachusetts
Institute of Technology to make de-identified process data publicly
available.
This level of transparency should be required of all OPOs. This
addresses the questions above as well as a range of questions related
to OPO operational practices (e.g., organ tracking and lost organs;
operational differences between high- and low-performing OPOs;
standardization of definitions and practices; the potential impact of
organ recovery centers; best practices regarding automated referrals,
and so on).
Competition--68601
1. Are there additional factors or criteria that CMS should
consider when determining which OPO should be selected for an open
service area?; 2. Should CMS consider other performance measures when
selecting an OPO for an open DSA?; 3. What would be the anticipated
impact from consolidation or expansion of the OPO community? Would
consolidation or expansion of OPOs facilitate increased competition and
improved performance or have a negative impact?; 4. Any other helpful
information that could inform potential changes to the current
recertification and competition processes.
Appreciating the principles of the Biden Executive Order on
Competition, the FAS OPO Innovation Cohort agrees with bipartisan
congressional leaders that given COVID makes reform an ``urgent health
equity issue,'' all parts of the country deserve to be served by high-
performing OPOs as soon as possible.
As CMS considers elements for competition, transparency,
accountability, and equity are critical. In addition to overall donor
and recovery rates, through requiring all OPO process data to be
publicly available, CMS will have evidence of an OPO's ability to
equitably serve all donors in a designated service area (including by
race/ethnicity), as well as improvements over potential, and
transparency of key financial and organizational data to understand
capacities to best serve OSAs (including transparency in any conflicts
that may exist in an OPO's governance structure).
The FAS OPO Innovation Cohort has already committed to these
principles, and extending these practices to all OPOs via CfCs can
allow CMS to best evaluate OPOs as they compete for serving an
underserved community.
For example, publicly available OPO process data via CfCs will
allow CMS to consider evidence of effective and equitable treatment of
donor patients/families (e.g., no disparities in response rates/times
based on race/ethnicity).
The anticipated outcome of both increased competition as well as
replacing lower performing OPOs with higher performing OPOs would be
more lives saved. See:
The Bridgespan Group guidance on how CMS can oversee and
implement the DSA competition process in a manner that is pro-patient
and foregrounds racial equity;
OPO CEOs in the news:
Diane Brockmeier and Ginny McBride in Morning
Consult: ``HHS's new proposal signals something potentially game-
changing for patients: allowing the highest performing OPOs to replace
those who have proven themselves incapable of serving their
communities. To the extent that an OPO is not able to rise to the
challenge of a high standard, the focus of our attention and energy
must be on better serving patients on the national wait list, not on
protecting specific OPOs . . . forcing OPOs to continually earn their
contracts is a patient-centric accountability mechanism, ensuring that
OPOs operate with the urgency befitting the life-and-death consequences
of this work.''
Patti Niles in The Dallas Morning News: ``The
performance gaps seen in the OPO community would not be acceptable in
any other sector of health care. There is no reason to accept them in
the life-and-death context of organ donation. Many organ procurement
organization leaders are on the record in favor of reform. We have
worked together with patient groups, doctors, researchers, senior Obama
and Trump administration officials, philanthropies and bipartisan
members of Congress to get this right. . . . Lives are at stake.
Patients deserve better. Our communities deserve better. We must do
better.''
Oversight--p. 68601
5. Are the current CMS requirements for a governing body and
advisory board adequate for OPO governance? Have OPOs included
additional board positions or structures beyond what is required by CMS
to improve operations? What structure best serves accountability, and
efficient and effective organ procurement?
The FAS OPO Innovation Cohort believes the principle of
transparency should apply throughout the entire ecosystem, and that it
is critical for CMS to:
Release information related to OPO performance quickly and in
an understandable way so that boards are aware and can exercise
fiduciary responsibilities;
Require transparency of potential conflicts of interest
throughout the entire donation and transplantation ecosystem as a top
priority, following the transparency commitment of FAS OPO Innovation
Cohort.
appendix c: rfi response with other pro-reform ceos
to hrsa re. optn, may 2022
To: HRSA Administrator
From: Diane Brockmeier, Mid-America Transplant
Ginny McBride, OurLegacy
Kelly Ranum, Louisiana Organ Procurement Agency
Matt Wadsworth, Life Connection of Ohio
This letter Is in response to a Request for Information (RFI)
regarding the contract to operate the national Organ Procurement and
Transplantation Network (OPTN). Each of our organ procurement
organizations (OPOs) supports HRSA's stated objectives of:
Increasing accountability in OPTN operations, Including board
governance, financial structures, data transparency, and policy
development;
Enhancing the usability and performance of the OPTN IT system
and related tools; and
Strengthening equity, access, and transparency in the organ
donation, allocation, procurement, and transplantation process.
With the above objectives in mind, key recommendations for HRSA to
reform the OPTN in such a way that best serves patients, focusing on
core competencies and removing conflicts, include:
Ensure patient-centered governance of the OPTN, separating the
OPTN board from any contractor(s) serving OPTN functions; and
Revise the OPTN contract so that it subdivided into areas
where the OPTN contractors can provide critical and expert functions:
Policy: reforming OPTN governance (above) is
critical to de-conflicting policy. Policymaking by an OPTN contractor
should then be transparent, fueled by openly available data, aided by
experts in government and the wider community, and with all potential
conflicts publicly known and acted on accordingly.
IT: the IT components of OPTN operations be
outsourced by HHS in ways that are independent of, but complimentary
to, the rest of the OPTN contract
The Office of the National Coordinator (ONC) at
HHS should work with the tech contractor on matters critical to
national/health IT and organ donation/transplantation, including
exploring better use and/or integration of hospital EMRs.
Organ placement and shipping: these should be
separate from existing OPTN contract, with best in class options
available for OPOs to opt into as appropriate.
Note: the Membership and Professional Standards Committee
should cease its activities to evaluate OPO performance and conduct
peer review, with OPO oversight being the purview of CMS, instead of
fractured between CMS and OPTN.
All of the above functions--both from HHS and OPTN
contractors--should have strengthening equity, access, and transparency
at their core, including ensuring all de-identified data are publicly
available to best serve patients, and enable continuous innovation and
improvement.
A. OPTN Technology--IT System: (A.1-4)
We are acutely aware OPTN technology lags significantly behind
other technology platforms because our OPOs use it every day. As
citizens of the U.S. we enjoy the use of numerous corporate IT
platforms to perform the most basic functions of life. These platforms
have been developed by enterprising companies whose survival relies on
capturing market share. Ease of use, convenience and continuous
innovation are among the most prized factors. Companies compete against
each other to satisfy and retain customers. Poor performers do not
survive.
Companies succeed because they prioritize continuous, rapid IT
system improvement because IT is a core function. The current OPTN
contractor has not positioned itself to provide state-of-the-art
service and does not view evolving technology as a priority. The OPTN
Board of Directors and committees and the current contractor's board
and committees lack the needed expertise to make the necessary changes
because the OPTN Bylaws restrict the involvement of individuals who
could expand its capabilities. From an IT perspective, the current OPTN
contractor is slow and reactive.
It is our recommendation that the IT components of OPTN operations
be separated from the monolithic OPTN contract by HHS In ways that are
Independent of, but complimentary to, the rest of the OPTN contract.
HRSA could require any other OPTN contractors to incorporate the
services of the independent technology provider into its workflows.
That independent contractor should be answerable to and benefit from
digital service experts within the govemment--including HHS and the
ONC--who can competently exercise oversight on behalf of patients and
taxpayers.
The flow of information among OPOs, donor hospitals, transplant
programs and the OPTN in support of successful donation and
transplantation, while constant, remains fractured. Donor hospitals and
transplant hospitals utilize their own electronic health record
systems. OPOs and transplant programs utilize customized, built-to-
purpose databases that interact with the OPTN only to transfer donor,
candidate and recipient data that are, for the most part, not used for
the critical functions of organ matching, offer and acceptance. The
OPTN database operates in a one-way fashion in which members provide
data but very little information is provided directly to them in
return, and the entire process is hindered by the current OPTN
contractor's inability to deploy APIs.
The use of multiple databases to operate a network dependent on
timely and accurate communication to achieve maximum performance is not
efficient. The OPTN technology contractor should be working toward
seamless integration from hospital EHR to OPTN database. The rules of
engagement with the OPTN database should be changed so OPOs are no
longer required to maintain an additional database to collect and store
donor information. OPOs should be able to transfer donor clinical
information directly from the hospital EHR to the OPTN database for the
purpose of communicating donor evaluation information and organ
allocation. OPOs should be able to enter and extract data from the
national database utilizing their own internal capabilities, aided by
APIs, rather than pay for an expensive database ``middleman.''
Additionally, there should be mutually agreed upon national OPO
datasets that can be used for research and analysis purposes (see
earlier response to CMS RFI on data transparency). Data availability
and transparency are key to improving organ procurement. The database
should be managed by the OPTN technology contractor in a way that
prioritizes data transparency. The current OPTN contractor has not
proven capable of this function.
Historically, motivation for the OPTN to accelerate improvements to
its technology platform have come from outside the OPTN. Pressure to
create DonorNet came from HRSA. More recently, calls to implement a GPS
system to track organ movements went unheeded by the OPTN until media
accounts exposed the lack of a systematic method to protect vulnerable
organs while in transit Incorporation of technology requirements into a
single OPTN contract has not sufficiently served the needs of OPOs, and
the noncompetitve monopoly structure has relieved all pressure from the
current OPTN contractor to keep current with even basic technology
standards, creating risks to patient safety and data security. HRSA
must create opportunities to incorporate a wider array of contractors
to serve technology needs, including by opening the pool to the widest
range of innovative applicants. There are numerous U.S. companies with
the ability to track and deliver packages. It would serve the interests
of organ sharing better if one of those companies could establish a
national organ shipping system that would monitor the progress of all
shipments in real time on behalf of OPOs that opt in.
B. Data Collection Activities: 1. Describe how you would/how
vendors could develop performance metrics and benchmarks for the organ
donation, procurement, allocation and transplant system, including
through expert consultation, subcontracting, and engagement with
transplant candidates, transplant recipients, organ donors and their
families about the metrics they value. 2. Describe how you would/how
vendors could structure data collection and reporting mechanisms for
the system: a. To report OPTN performance metrics including process,
outcome, and patient engagement measures. b. To establish OPTN member
performance benchmarks. c. To capture patient and donor demographics,
including race, ethnicity, language, and socioeconomic factors. d. To
create public OPTN national, regional and local performance dashboards.
e. To track long-term patient outcomes and health and non-health-
related factors that contribute to outcomes.
CMS recently finalized new, objective OPO regulations which we
supported along with patient groups, bipartisan congressional leaders,
and equity advocates. The performance measures recently published by
the CMS are already having substantial influence on OPO performance.
One case in point is the Arkansas Organ Recovery Agency (ARORA), an OPO
which had never recovered organs from more than 77 deceased donors in a
single year. Because of leadership changes driven by years of
underperformance, a new executive director achieved 108 deceased organ
donors in 2021. It seems unlikely this leadership change would have
occurred without external pressure from CMS to change course.
HRSA, and other HHS entities, must establish national goals in
collaboration with leading experts external to the OPTN but can use the
donation and transplantation community as sources of data, information
and insights. Additionally, all de-identified OPTN data should be
publicly available to allow for oversight, innovative research, and
donation/transplantation stakeholders to improve patient outcomes based
on data.
Additionally, we and the aforementioned groups have advocated for
HHS to publish OPO process data (see CMS RFI response), which will not
only inform best practices for OPO management, but help inform policy
considerations at the intersection of multi-stakeholders, including in
regards to best practices and thoughtful regulation related to donor
hospital referrals and organ discards. Regardless of whether HHS takes
on some of these responsibilities directly (including potentially
through an Office of Organ Policy), or outsources them to an external
vendor, all metrics and benchmarks should be informed by transparent
process data, in line with international best practice standards.
C. (d) OPTN Finances
The OPTN board and any OPTN operational contractor board must
achieve complete separation. The OPTN board, populated mostly by
transplantation professionals, does not have the expertise or
background to oversee a financial, technological, human resources,
customer service enterprise. UNOS's performance as the OPTN contractor
bears this out. Its ability to keep pace with technological advances
has been in question for many years, as evidenced by board and OPTN
members who are frustrated at the time it takes to implement policy
changes. The current board does not have the background enabling it to
build wider corporate relationships enabling it to achieve strategic
goals. The OPTN community has suffered as a result. UNOS's current
strategy of using one board to serve two purposes must be abandoned.
Any new contractor boards should commit to develop an independent
operational plan that focuses on human resources needs, financial
strategies, corporate IT objectives and other strategies to enable goal
achievement that allows for HHS to meet its objectives for the
transplant community. The OPTN board and staff should be financed by
OPTN registration fees. Because both the OPTN board and the contractor
operational board would be in accountability relationships with HRSA,
they both would report on successes and barriers in meeting the
strategic objectives of the OPTN. This reporting process could be
extended to all elements within HHS with a stake in the operations of
the OPTN to ensure alignment of goals and communication transparency.
Ideally, NOTA should be updated, including to create a financing
structure that aligns incentives for any OPTN contractors with the
actual goals of HHS and patients in mind, which is to constantly
increase transplant availability through improved stakeholder
performance, something which is not accomplished in the current
financing structure.
Any donation and transplantation clinician who is a member of the
OPTN board and employed by an OPO or transplant hospital is in a
conflict of interest when voting on certain OPTN policies. And since at
least 50 percent of the board meets this criterion (because of OPTN
final rule requirements for board composition), a method of addressing
the conflict must be identified. Currently, conflicts are self-
reported, narrowly defined, and not disclosed. One strategy specific to
organ allocation could be that policies are voted on by non-OPO and
transplant program members. This leaves patients, donor families, trade
organizations (which would each get a single vote to represent each
industry) and other non-allied members to vote. Board members would be
prohibited from lobbying the patients and donor families to gain their
votes. However, the best and most sustainable strategy would be to
eliminate inherent conflicts entirely through subdivision of the OPTN
contract. For example, organ allocation could be handled by a separate
contractor with no financial or other business relationships to the
stakeholders with a vested interest in the outcome of organ allocation
policy.
D. Increasing Organ Donation and Improving Procurement: 1. Describe
how you would/how vendors could structure, finance and staff an OPTN
board of directors independent of membership of the OPTN operational
contractor's board of directors. 2. Describe the conflict of interest
policies you would/vendors could implement to ensure independence of
the OPTN board of directors. 3. Describe the reporting mechanisms you
would/vendors could utilize to hold operational contractors'
accountable tor system performance and outcomes. 4. Describe the
additional factors and process steps you would/vendors could take to
ensure effective operations of such an independent board of directors.
The OPTN contractor should no longer be actively engaged in
supporting OPO performance improvement activities. There should not be
contract activities to support OPO performance and the Membership and
Professional Standards Committee should cease its activities to
evaluate OPO performance and conduct peer review. Neither of these
activities has resulted in immediate and sustained donation increases
and the OPTN has permitted some severely underperforming OPOs to
continue practicing rather than make referrals to the HHS Secretary to
decertify the underperformers. The MPSC began evaluating OPO
performance many years ago at a time when CMS's OPO performance
standards were vague and Incapable of identifying poor performers. At
HRSA's request, the OPTN and SRTR stepped in to develop measures that
would identify low performing OPOs. Despite having a set of standards,
the OPTN has done little to positively impact the number of donors and
organs transplanted. This inability came into stark relief in 2003 when
HRSA launched the breakthrough collaboratives and, with almost no
assistance from the OPTN except data analysis support, achieved
unprecedented donation increases. Any funding to improve OPO
performance could be better spent and allocated through a formal CMMI
process of the best available data-driven options. The OPTN could then
stay focused on evaluating OPOs for compliance with OPTN policies, such
as following official OPTN allocation processes.
CMS is already demonstrating with its new performance outcome
standards that, despite the OPTN's 20-year history of OPO performance
evaluation and improvement activities, more than a third of OPOs are
failing. The Scientific Registry of Transplant Recipients (SRTR) data
used by the OPTN MPSC to evaluate OPOs also seem ineffective in
identifying poor performance. Therefore, it has been extremely ill-
structured for the OPTN, rather than CMS, to have unique visibility
into the day-to-day issues necessary for CMS to exercise such oversight
responsibility. Given this, HHS should reabsorb all OPO oversight
functions from the OPTN.
If, as alluded to earlier, HHS publishes full process data, this
will help generate a multitude of solutions for remediating OPO
performance failures during the course of a contracting cycle. For
example, with specific deficiencies identified. including issues
related to diversity, equity, and inclusion, OPOs will be able to
engage external partners (including partners both traditionally within
and outside of the OPO industry) to implement data-driven solutions.
Such process data, in line with international best practice for data
transparency, should include: whether OPOs are appropriately staffed to
serve their communities; data about referral and request outcomes based
on potential donor and family race; and other issues that could
identify any deficiencies in any OPOs' service of communities of color.
Using these data, HRSA could then also partner with multiple
organizations to develop strategies to improve equity in organ donation
at a systems-level.
E. Organ Usage: 1. Describe how you would a vendor could support
the OPO performance Improvement activities to decrease discarded organs
and further increase the use of organs. 2. How can OPTN organ matching
activities be modified to decrease non-usage (discards) of procured
organs? 3. Describe the steps you would/vendors could take to improve
transparency around the organ matching and acceptance process for
transplant candidates, transplant recipients, other affected patients,
organ donors and family members served by the OPTN.
The most effective way to discourage OPOs from recovering organs is
to ensure they don't get transplanted. This is the biggest problem
facing the OPTN. From an OPO perspective, the OPTN is unintentionally
enabling organ discards because organ allocation policies, particularly
kidney allocation policies, prioritize how candidates are ranked on the
waiting list rather than ensuring a transplantable kidney is implanted
into a compatible recipient The balance between ensuring equity in
candidate selection and ensuring viable organs are transplanted has
been lost. This is partly because the people driving kidney allocation
policy development (the OPTN Kidney Committee) are predominantly
transplant professionals. There are no OPO voices advocating for better
kidney utilization during the policy development phase. Discard rates
are also influenced by an OPOs inability to get an offer to a program
willing to use the kidney in a timely manner. High KDPI kidneys are
``at risk'' from the moment of aortic crossclamp. But they aren't
treated with sufficient priority. OPOs, or the Organ Center, must use
precious time to wade through offers to transplant programs that
rarely, if ever, use high KDPI kidneys. Kidney filters only do so much.
Rather than rely on voluntary engagement of transplant programs to
filter offers, high KDPI kidney allocation should prioritize the
programs with a track record of using them.
Much of the problem also results from the frictionful and otherwise
insufficient UNOS technology system over which organ offers as made,
leading to calls from the House Appropriation Committee for HHS to
promote competition for the IT component of the OPTN contract for this
explicit reason.
Honoring donors and donor families by ensuring their kidneys are
transplanted is our national obligation. Anything less is a disservice
to those who have donated.
Not every OPO agrees that handing kidneys to the Organ Center for
the purpose of national placement is an effective means of getting
kidneys transplanted. OPOs generally are not confident that placement
will occur when relying on the Organ Center. The Organ Center's organ
placement outcomes are not widely shared and OPOs deserve to be better
informed about the likelihood of their organs being placed and should
have a choice about whether to ask the Organ Center for assistance.
OPOs are more invested than the Organ Center in placing organs because
we know the families who have donated them and we will work to get them
placed. Unfortunately, current OPTN policy makes this difficult.
But there could be a different option to place difficult organs.
Because transplant programs and OPOs are relying more frequently on
staffing and operational support from third parties or call centers, it
may be possible to create an organization whose sole purpose is to
place kidneys. This organization could be operated under a separate
section of the OPTN contract but receive financial support from OPOs
that would be willing to utilize it (e.g., a fee-for-service, which
would be optional for OPOs and applied on an opt-in, voluntary, case-
by-case basis). The objective would be to place high KDPI kidneys
faster. Such an organization could quickly learn which centers are more
inclined to transplant certain organs and collaborate with the host
OPOs to develop a placement strategy. We must develop an increased
level of national urgency to place the kidneys OPOs have successfully
made available. It is our experience that transplant programs do not
feel urgency when a kidney is at risk. But the OPOs feel that risk very
acutely. Perhaps it is time to move away from the Organ Center concept
and toward a more independent process.
1. Describe how you would/vendors could incorporate, to the full
extent permitted under applicable law, the NASEM report's
recommendations on increasing racial, ethnic, professional, and gender
diversity on the boards and committees responsible for developing OPTN
policies. 2. Describe how you would/vendors could engage with experts
in quality improvement and stakeholder collaboration in executing OPTN
deliverables. Page 6 of 7. 3. Describe what you would/vendors could
include in their code of business ethics and conduct for the entity
that holds this contract to ensure the highest standards of conduct and
integrity are observed. 4. What other improvements to OPTN operations
and policy development processes can and/or should be incorporated into
the OPTN contact?
F. OPTN Operations and Policy Development Improvements
We support NASEM's recommendation that improvements to the OPTN's
policymaking process to increase racial, ethnic, professional and
gender diversity on the OPTN's board and committees are urgently
needed. This can be accomplished by increasing or changing the number
or type of medical/scientific members or public members and permitting
them, via the OPTN bylaws, to serve on committees and the board. HRSA
and the OPTN should actively recruit membership of organizations with
expertise in health-care delivery to DEI communities. HHS should also
clearly articulate its goals, as well as to foster a dynamic in which
any OPTN contractor(s) understand that they will likely lose their
contract should they fail to meet these goals.
Many OPTN members are losing confidence in the OPTN policymaking
process. It seems that significant time and resources are devoted to
changes that make only small, incremental differences in the number of
organs donated and transplanted. Many policies are also perceived to be
tainted by the conflicts of interest inherent in the current OPTN
structure, which again underscores the need for HHS to subdivide the
OPTN. Although OPTN policies are developed by members, their impact is
felt far beyond OPTN membership. Their ability to success is dependent
on factors also beyond the membership of the OPTN. If the OPTN is to
improve its success it is essential that we allow those societal
factors that can affect our success be part of the policy development
process. And to do that, we must re-examine that process, specifically
our public comment process. Currently, the OPTN is reliant on
commenters coming to regional meetings or depositing feedback on a
website to obtain public feedback. To build trust in our system, we
must consider how we can more actively engage influential communities
to help us understand how we can do better. OPTN policies aren't just
medical policies, they are public trust policies. The OPTN must build a
community that is willing and capable to provide honest feedback. And
we must have a public comment process that honestly and transparently
incorporates that feedback so participants feel heard and valued. We
strongly support the involvement of organizations such as the National
Academy of Public Administration to assess the OPTN's current policy
making process and advise on strategies to diversify how its
development is influenced.
Additionally, given how critical DEI is to all aspects of a high-
functioning organ donation and transplantation system. all OPTN
contractors should include DEI expertise within its core leadership and
DEI metrics as part of its transparent reporting.
Creating strong foundations for the policy making process is what
will drive how the OPTN ensures its code of ethics and integrity is
maintained. Many perceive the OPTWs integrity has suffered and it is
our belief that this is because the policymaking process lacks
transparency and accountability.
______
Questions Submitted for the Record to Diane Brockmeier, R.N., BSN, MHA
Questions Submitted by Hon. John Barrasso
Question. As a doctor for over 20 years, I've seen how complex and
fragile the organ procurement and transplant system in the United
States is. A single, seemingly minor mistake can cascade into the loss
of the most important thing of all--a human life. That's why we need to
make sure those involved in the procurement and transplant system are
held accountable so patients--our constituents--are afforded the
opportunity for a longer, healthier life.
The committee's report highlighted multiple shortcomings in the
U.S. Organ Procurement and Transplantation Network (OPTN).
Specifically, it documented instances over the past years where OPOs'
clear mistakes were not elevated within United Network of Organ Sharing
(UNOS) to the appropriate staff, or the same mistakes were repeated
with seemingly inadequate corrective action, investigation, oversight,
or guidance from UNOS. This suggests a part of the problem could be
systemic organizational failure.
What regulatory or legislative actions could be taken to enhance
accountability and performance within the OPTN, especially within UNOS
or other potential OPTN contract recipients?
Answer. I thank Senator Barrasso for this important question, and I
appreciate how the Senator's experience as a physician brings attention
to what is at stake: the lives of patients.
As I testified, to protect patients, I urge Congress and the
administration to separate the OPTN functions into different contracts
so patients can be served by best-in-class vendors; immediately
separate the boards of the OPTN and the OPTN contractor; require public
disclosure of all potential conflicts for the contractor and board
members; and ensure that patients are safeguarded through open data
from both the OPTN and OPOs.
Inaction by the current OPTN contractor, UNOS, has caused real harm
to patients; the harm is measured in how long patients wait, and how
many patients die waiting for a transplant.
I agree with the bipartisan Senate Finance Committee
recommendations (released on August 3, 2022) that the OPTN monopoly
needs to be broken up. Having one entity--UNOS, or any singular OPTN
monopoly contractor--is not serving patients.
Question. The committee report briefly discussed how the legal
requirement that the OPTN contract be awarded to only one entity may
deter bidding and competition from other potential contract recipients.
Similarly, the report suggests that the OPTN's responsibilities could
be better carried out through multiple contracts with entities
specialized in one function, like IT or compliance.
What are the advantages and disadvantages of the current OPTN
contract that allows only one entity to operate the Network?
What potential trade-offs exist between having only one contract
entity versus multiple specialized entities?
Answer. Per my response above, it is critical to break up the OPTN
contract and ensure transparency and accountability in the procurement,
administration, and competition of the contract moving forward. In my
opinion, the current OPTN contract structure does not permit
competition, and through this lack of competition, innovation is
stifled, suboptimal practice is calcified, and opportunities to improve
are lost through the failures of UNOS leadership.
Question. This committee has obviously been hard at work trying to
identify shortcomings in the organ procurement and transplantation
system over the past couple years. Also within the past couple years,
the Trump administration proposed and the Biden administration
finalized the OPO final rule. This rule established new performance
metrics for OPOs as well as helped promote more frequent oversight and
competition among OPOs.
Are there other regulatory or legislative actions Congress or the
administration should take to ensure the OPTN is performing to its
maximum potential for patients and providers?
Answer. I reiterate my support for the bipartisan recommendations
released by the committee on August 3, 2022. As stated in my answers
above, I believe that the most important steps Congress and HHS can
take are to separate the OPTN functions into different contracts so
patients can be served by best-in-class vendors; immediately separate
the boards of the OPTN and the OPTN contractor; require public
disclosure of all potential conflicts for the contractor and board
members; and ensure that patients are safeguarded through open data
from both the OPTN and OPOs.
______
Questions Submitted by Hon. Todd Young
Question. Are there minimum standards and/or training at Organ
Procurement Organizations (OPOs) set in Federal regulations or by the
OPTN? If not, should there be? What is being done to make sure everyone
is performing at their best at OPOs?
Answer. I believe this is a critical issue facing our industry and
our transplant system, and I am grateful for the opportunity to
describe what can be done to support improvement and increased patient
safety at OPOs.
Under current regulations and OPTN policies, there are insufficient
standards for OPO provider qualifications and inadequate safety
monitoring and protections for patients. OPOs provide clinical care to
critically ill patients, and those patients deserve highly qualified
clinical providers. Right now, standards in Federal regulations, CMS
audits, and OPTN policies do not require that all clinical care
provided to donor patients is provided by licensed or certified health-
care workers. To ensure patient safety, to protect quality of patient
care, and to increase OPO performance, regulations must be revised to
include a minimum standard of licensure/certification and a minimum
training requirement for any OPO staff who provide clinical care to
donor patients.
In my response, I will describe the current state of requirements,
and also provide recommendations for actions legislators and regulators
can take to address insufficiencies.
First, as the Senator references, the Code of Federal Regulations
does contain language that references qualifications of organ
procurement organization (OPO) staff. The regulation reads in full:
42 Sec. 486.326 Condition: Human resources.
All OPOs must have a sufficient number of qualified staff,
including a director, a medical director, organ procurement
coordinators, and hospital development staff to obtain all
usable organs from potential donors, and to ensure that
required services are provided to families of potential donors,
hospitals, tissue banks, and individuals and facilities that
use organs for research.
(a) Standard: Qualifications.
(1) The OPO must ensure that all individuals who provide
services and/or supervise services, including services
furnished under contract or arrangement, are qualified to
provide or supervise the services.
(2) The OPO must develop and implement a written policy that
addresses potential conflicts of interest for the OPO's
director, medical director, senior management, and procurement
coordinators.
(3) The OPO must have credentialing records for physicians and
other practitioners who routinely recover organs in hospitals
under contract or arrangement with the OPO and ensure that all
physicians and other practitioners who recover organs in
hospitals with which the OPO has agreements are qualified and
trained.
(b) Standard: Staffing.
(1) The OPO must provide sufficient coverage, either by its own
staff or under contract or arrangement, to assure both that
hospital referral calls are screened for donor potential and
that potential donors are evaluated for medical suitability for
organ and/or tissue donation in a timely manner.
(2) The OPO must have a sufficient number of qualified staff to
provide information and support to potential organ donor
families; request consent for donation; ensure optimal
maintenance of the donor, efficient placement of organs, and
adequate oversight of organ recovery; and conduct QAPI
activities, such as death record reviews and hospital
development.
(3) The OPO must provide a sufficient number of recovery
personnel, either from its own staff or under contract or
arrangement, to ensure that all usable organs are recovered in
a manner that, to the extent possible, preserves them for
transplantation.
(c) Standard: Education, training, and performance evaluation.
The OPO must provide its staff with the education, training,
and supervision necessary to furnish required services.
Training must include but is not limited to performance
expectations for staff, applicable organizational policies and
procedures, and QAPI activities. OPOs must evaluate the
performance of their staffs and provide training, as needed, to
improve individual and overall staff performance and
effectiveness.
(d) Standard: Medical director. The OPO's medical director is a
physician licensed in at least one of the States or territories
within the OPO's service area or as required by State or
territory law or by the jurisdiction in which the OPO is
located. The medical director is responsible for implementation
of the OPO's protocols for donor evaluation and management and
organ recovery and placement. The medical director is
responsible for oversight of the clinical management of
potential donors, including providing assistance in managing a
donor case when the surgeon on call is unavailable.
In the text of 42 Sec. 486.326, OPOs are only held to a standard of
``sufficient number of qualified staff'' under the regulation. The
definition of ``qualified'' is left to the interpretation of the OPO.
Such ambiguity in the regulatory text allows for an unacceptable level
of variability in training, credentialing/licensing, and verification
of qualifications in OPO staffing.
In my opinion as an OPO CEO and critical care nurse, I believe that
CMS should define the term ``qualified'' for any OPO role that includes
patient clinical care and interaction with patient health data. An
unqualified or underqualified OPO staff person with a role in direct
patient care and/or clinical evaluation of health information presents
a safety risk to potential donor patients and transplant wait-list
patients who rely on the safe, effective procurement of organs.
Right now, some OPOs hire non-licensed health-care workers, or non-
health-care workers, in roles with direct patient care. This is
permissible under the current regulatory environment. And, since
neither CMS nor the OPTN contractor collect information about the
number of OPO employees with clinical responsibilities or patient care
interactions, our system does not have a way to quantify what lax
standards for training and qualification may lead to in terms of
adverse events, safety issues, or quality of patient care.
For example, at Mid-America Transplant, we require that any staff
member with patient interaction and/or clinical care responsibilities
for in our Organ Recovery Center is a registered nurse with a minimum
of 2 years of critical care experience. Our definition of ``qualified''
is based on 3 decades of organizational data and clinical care
delivery. Our independently run Donor Care Unit has made this a more
salient issue; when donor patients are moved to our facility, outside
of a hospital, it is imperative that our team of care providers have a
rich experience basis, clinical discernment, and the ability to address
a wide range of clinical challenges.
We know that potential donor patients (1) are critically ill with
multi-system dysfunction; (2) are unable to personally advocate for
their care, due to their condition; and (3) may provide lifesaving
organs for transplant only if provided appropriate, safe, evidence-
based donor management and monitoring in the course of clinical care at
our facility, or in our partner hospitals.
The stakes for the care OPOs provide could not be higher. And, as
more OPOs open organ recovery centers outside of hospitals, the
qualifications, abilities, and experience level of OPO staff becomes
more relevant to quality of care. When a donor patient is in an OPO
recovery center, there is no way to rely upon other health-care
providers and expertise that would be available in a hospital. A highly
qualified OPO workforce is not just an issue of quality, but also
safety, for the donors, OPO, transplant centers, and potential organ
recipients.
I also wish to direct the Senator to the section of the CMS audit
that covers OPO personnel. The relevant text is below:
State Operations Manual Appendix Y from CMS QSOG/CCSQ
Part I--Survey Protocol for Organ Procurement Organizations
E. Task Three--Personnel Record Review and Interview (Rev.)
This task covers requirements of the CfC on Human Resources
(Sec. 486.326).
The surveyor should use the organizational chart and/or staff
list of OPO staff to select a sample of full-time and contract
personnel. Request the personnel records for the selected
sample. The personnel interviews and personnel file reviews
should cover all staff positions. Review a minimum of five
employee files for the clinical and family support staff at the
OPO including contract employees in those positions. Expand the
sample as necessary based on other survey findings.
1. Personnel Review
1. Review the personnel records of OPO employees and contract
employees to ensure that the OPO is meeting all requirements in
the OPO CfCs at Sec. 486.326.
i. Review current licensure records, orientation records,
position description, performance evaluations, conflict of
interest evaluations, and training records for the staff.
ii. Verify that the staff are licensed and/or registered
in their State.
iii. Verify that orientation and periodic in-service
training are provided to the staff.
2. Confirm that the OPO verified prior to recovery that
recovery surgeons were currently credentialed.
3. Review the file for the OPO medical director to verify that
he/she is currently licensed as a physician in one of the
States within the OPO DSA or as required by State or local law.
The position description for the medical director clearly
delineates his/her roles and responsibilities for
implementation of the OPO's protocols for donor evaluation and
management and organ recovery and placement.
Under this language, a CMS audit checks for current licensure and
certifications held by a sample of 5 staff members. The audit does not
verify whether all staff members with patient care or patient health
record evaluation responsibilities are licensed or certified. The audit
also does not define which licenses or certifications are acceptable.
CMS can remediate this problem by modifying the Task Three
Personnel Review to include:
The roles of staff members with direct patient care and/or
clinical evaluation of patient health records.
The number of staff that occupy these roles at the OPO.
Require a threshold for licensed/certified health-care workers
who occupy roles with direct patient care and/or clinical evaluation of
patient health records.
There are OPTN policies that reference the requirement that
``licensed health-care workers'' complete certain tasks or hold certain
responsibilities (see: OPTN policy 3.3, 5.8, 14.5). However, all but
one of these OPTN policies reference transplant center activities. The
only reference to OPO qualifications is in OPTN policy 2.14.B, which
reads: ``Review the OPO's internal policies, procedures, and protocols
to verify that it has a written protocol(s) that includes: Definition
of qualified health-care professionals to perform the pre-recovery
verification [of organs].''
The current OPTN contractor does demonstrate understanding that
having qualified health-care workers is important for the care provided
by transplant centers. I cannot explain to the committee why the
contractor has neglected to ensure that donor patients are cared for by
qualified health-care workers, and that the only time at which a
qualified health-care professional is necessary for an OPO role under
OPTN policy is at the time of verifying the organ being allocated for
transplant.
An OPO can decide, as an organization, that a person without
medical training, without a relevant license or certification (R.N.,
LPN, paramedic, respiratory therapist, APP, etc.) can occupy a role
that requires the ability to evaluate patient health information, make
clinical determinations, and even provide clinical care to patients.
The OPO would remain in compliance with 42 Sec. 486.326, pass the
associated CMS audit requirements, and adhere to current OPTN policy as
long as their staffing remained ``sufficient'' and their own internal
employee training declared the person as ``qualified.''
I cannot speak for anyone else, but I can speak for myself and my
family: I would not want a person who is not a licensed or certified
health-care provider to perform a physical examination, or evaluate my
medical records, or perform a medical procedure on me or someone I
love. OPOs provide clinical care to patients. Patients, even those at
the end of their lives, deserve high quality, safe, and dignified
clinical care performed by highly trained, licensed or certified,
health-care workers. Congress, and CMS, must act on this issue in order
to ensure patient safety, and increase quality of care provided by
OPOs.
______
Question Submitted by Hon. Maggie Hassan
Question. In 2019, the National Council on Disability (NCD)
released a report finding that people with disabilities are often
excluded as organ transplant candidates due to their disabilities. Does
your organization have a policy that covers organ transplant access for
individuals with disabilities?
Answer. As an organ procurement organization (OPO), Mid-America
Transplant does not have a direct role in evaluating and listing
patients for transplantation. Instead, our work is with potential donor
patients who are referred to our OPO by hospitals.
Our OPO strongly supports equitable access to transplantation for
people with disabilities. Although our own practice is with potential
deceased donor patients, instead of potential transplant recipients, we
have ensured in our clinical processes that no potential deceased donor
patient may be excluded from consideration for organ, eye, and tissue
donation due solely to disability.
Our team has provided high-quality, compassionate care to deceased
donor patients with documented disabilities and their families. We
believe that equitable access to care for people with disabilities
should be a goal for both organ procurement and transplant center
providers. People with disabilities who are able to be organ donors
should receive equitable, safe, high quality care from all organ
procurement organizations. We believe that people with disabilities who
have become deceased organ, eye, and tissue donors have provided a
lifesaving gift, and should be honored and recognized for the legacy
they create as donor heroes.
______
Question Submitted by Hon. Bill Cassidy
Question. Section 413.408 of CMS Proposed Rule 1752 sought to
clarify that when a donor is transferred from a certified transplant
center (CTC) to an Organ Procurement Organization Recovery Center, the
CTC would be allowed to count the organs recovered at the OPO center in
their cost report. This portion of the proposed rule has not been
finalized by CMS. What is your view on this proposed change?
Answer. I feel very strongly that the CTC should be allowed to
count the organs on their cost report that are recovered at OPO
Recovery Center. The recognition and incentive for CTCs, who are also
donor hospitals, to identify, refer, and provide early clinical
management for the potential donor patients remains imperative to
increasing the volume of donors and transplantable organs. Currently,
the financial barrier placed on the CTCs who transfer their cases to
OPO ORCs handicaps growth and cost savings. The location where the
organs are excised, which is the defining statement today for how this
count is determined, is contained in an instruction line on the cost
report at the CTC. This action in the donation process is not the
driver of increased supply of organs, and as such, should not serve as
the financial incentive for donation.
Equally concerning is that this methodology for organ counting
provides tremendous financial benefit for organ recovery centers based
at CTCs, as some OPOs have adopted. The drain on the CMS trust fund has
increased as donor patients are transferred from many outside hospitals
to the CTC, where all the organs can be counted based on this
instruction line. This serves as an additional revenue stream for the
CTC and while this practice has certainly been deemed appropriate,
leaving the financial barrier in place for independent ORC transfers
from CTCs does not seem to be in the best interests of increasing lives
saved through transplantation.
These two distinct actions appear to be in conflict. I urge the
committee, and CMS, to consider what can be done to address this
financial conundrum while ensuring we are all good stewards of CMS
dollars. Allowing the CTCs to define success as ``where the potential
donor patient was identified and declared dead'' would equalize the
incentive to aid in increasing the transplantable organ supply.
______
Questions Submitted by Hon. Rob Portman
staff requirements
Question. In your opening statement you mentioned that there are
not any clinical training, licensure, or certification requirements for
OPO staff. It is my understanding that CMS has standards from 2005
relating to OPO practitioners and states that OPO staff must be
qualified and trained. Clearly this ambiguity has been an issue.
Could you elaborate on the requirements that you think should be
mandatory for OPO staff?
Answer. I believe this is a critical issue facing our industry and
our transplant system, and I am grateful for the opportunity to
describe what can be done to support improvement and increased patient
safety at OPOs.
Under current regulations and OPTN policies, there are insufficient
standards for OPO provider qualifications and inadequate safety
monitoring and protections for patients. OPOs provide clinical care to
critically ill patients, and those patients deserve highly qualified
clinical providers. Right now, standards in Federal regulations, CMS
audits, and OPTN policies do not require that all clinical care
provided to donor patients is provided by licensed or certified health-
care workers. To ensure patient safety, to protect quality of patient
care, and to increase OPO performance, regulations must be revised to
include a minimum standard of licensure/certification and a minimum
training requirement for any OPO staff who provide clinical care to
donor patients.
In my response, I will describe the current state of requirements,
and also provide recommendations for actions legislators and regulators
can take to address insufficiencies. First, as the Senator references,
the Code of Federal Regulations does contain language that references
qualifications of organ procurement organization (OPO) staff. The
regulation reads in full:
42 Sec. 486.326 Condition: Human resources.
All OPOs must have a sufficient number of qualified staff,
including a director, a medical director, organ procurement
coordinators, and hospital development staff to obtain all
usable organs from potential donors, and to ensure that
required services are provided to families of potential donors,
hospitals, tissue banks, and individuals and facilities that
use organs for research.
(a) Standard: Qualifications.
(1) The OPO must ensure that all individuals who provide
services and/or supervise services, including services
furnished under contract or arrangement, are qualified to
provide or supervise the services.
(2) The OPO must develop and implement a written policy that
addresses potential conflicts of interest for the OPO's
director, medical director, senior management, and procurement
coordinators.
(3) The OPO must have credentialing records for physicians and
other practitioners who routinely recover organs in hospitals
under contract or arrangement with the OPO and ensure that all
physicians and other practitioners who recover organs in
hospitals with which the OPO has agreements are qualified and
trained.
(b) Standard: Staffing.
(1) The OPO must provide sufficient coverage, either by its own
staff or under contract or arrangement, to assure both that
hospital referral calls are screened for donor potential and
that potential donors are evaluated for medical suitability for
organ and/or tissue donation in a timely manner.
(2) The OPO must have a sufficient number of qualified staff to
provide information and support to potential organ donor
families; request consent for donation; ensure optimal
maintenance of the donor, efficient placement of organs, and
adequate oversight of organ recovery; and conduct QAPI
activities, such as death record reviews and hospital
development.
(3) The OPO must provide a sufficient number of recovery
personnel, either from its own staff or under contract or
arrangement, to ensure that all usable organs are recovered in
a manner that, to the extent possible, preserves them for
transplantation.
(c) Standard: Education, training, and performance evaluation.
The OPO must provide its staff with the education, training,
and supervision necessary to furnish required services.
Training must include but is not limited to performance
expectations for staff, applicable organizational policies and
procedures, and QAPI activities. OPOs must evaluate the
performance of their staffs and provide training, as needed, to
improve individual and overall staff performance and
effectiveness.
(d) Standard: Medical director. The OPO's medical director is a
physician licensed in at least one of the States or territories
within the OPO's service area or as required by State or
territory law or by the jurisdiction in which the OPO is
located. The medical director is responsible for implementation
of the OPO's protocols for donor evaluation and management and
organ recovery and placement. The medical director is
responsible for oversight of the clinical management of
potential donors, including providing assistance in managing a
donor case when the surgeon on call is unavailable.
In the text of 42 Sec. 486.326, OPOs are only held to a standard of
``sufficient number of qualified staff'' under the regulation. The
definition of ``qualified'' is left to the interpretation of the OPO.
Such ambiguity in the regulatory text allows for an unacceptable level
of variability in training, credentialing/licensing, and verification
of qualifications in OPO staffing.
In my opinion as an OPO CEO and critical care nurse, I believe that
CMS should define the term ``qualified'' for any OPO role that includes
patient clinical care and interaction with patient health data. An
unqualified or underqualified OPO staff person with a role in direct
patient care and/or clinical evaluation of health information presents
a safety risk to potential donor patients and transplant wait-list
patients who rely on the safe, effective procurement of organs.
Right now, some OPOs hire non-licensed health-care workers, or non-
health-care workers, in roles with direct patient care. This is
permissible under the current regulatory environment. And, since
neither CMS nor the OPTN contractor collect information about the
number of OPO employees with clinical responsibilities or patient care
interactions, our system does not have a way to quantify what lax
standards for training and qualification may lead to in terms of
adverse events, safety issues, or quality of patient care.
For example, at Mid-America Transplant, we require that any staff
member with patient interaction and/or clinical care responsibilities
for in our Organ Recovery Center is a registered nurse with a minimum
of 2 years of critical care experience. Our definition of ``qualified''
is based on 3 decades of organizational data and clinical care
delivery. Our independently run Donor Care Unit has made this a more
salient issue; when donor patients are moved to our facility, outside
of a hospital, it is imperative that our team of care providers have a
rich experience basis, clinical discernment, and the ability to address
a wide range of clinical challenges.
We know that potential donor patients (4) are critically ill often
with multi-system dysfunction; (5) are unable to personally advocate
for their care, due to their condition; and (6) may provide lifesaving
organs for transplant only if provided appropriate, safe, evidence-
based donor management and monitoring in the course of clinical care at
our facility, or in our partner hospitals.
The stakes for the care OPOs provide could not be higher. And, as
more OPOs open organ recovery centers outside of hospitals, the
qualifications, abilities, and experience level of OPO staff becomes
more relevant to quality of care. When a donor patient is in an OPO
recovery center, there is no way to rely upon other health-care
providers and expertise that would be available in a hospital. A highly
qualified OPO workforce is not just an issue of quality, but also
safety, for the donors, OPO, transplant centers, and potential organ
recipients.
I also wish to direct the Senator to the section of the CMS audit
that covers OPO personnel. The relevant text is below:
State Operations Manual Appendix Y from CMS QSOG/CCSQ
Part I--Survey Protocol for Organ Procurement Organizations
E. Task Three--Personnel Record Review and Interview (Rev.)
This task covers requirements of the CfC on Human Resources
(Sec. 486.326).
The surveyor should use the organizational chart and/or staff
list of OPO staff to select a sample of full-time and contract
personnel. Request the personnel records for the selected
sample. The personnel interviews and personnel file reviews
should cover all staff positions. Review a minimum of five
employee files for the clinical and family support staff at the
OPO including contract employees in those positions. Expand the
sample as necessary based on other survey findings.
1. Personnel Review
1. Review the personnel records of OPO employees and contract
employees to ensure that the OPO is meeting all requirements in
the OPO CfCs at Sec. 486.326.
i. Review current licensure records, orientation records,
position description, performance evaluations, conflict of
interest evaluations, and training records for the staff.
ii. Verify that the staff are licensed and/or registered
in their State.
iii. Verify that orientation and periodic in-service
training are provided to the staff.
2. Confirm that the OPO verified prior to recovery that
recovery surgeons were currently credentialed.
3. Review the file for the OPO medical director to verify that
he/she is currently licensed as a physician in one of the
States within the OPO DSA or as required by State or local law.
The position description for the medical director clearly
delineates his/her roles and responsibilities for
implementation of the OPO's protocols for donor evaluation and
management and organ recovery and placement.
Under this language, a CMS audit checks for current licensure and
certifications held by a sample of 5 staff members. The audit does not
verify whether all staff members with patient care or patient health
record evaluation responsibilities are licensed or certified. The audit
also does not define which licenses or certifications are acceptable.
CMS can remediate this problem by modifying the Task Three
Personnel Review to include the roles of staff members with direct
patient care and/or clinical evaluation of patient health records; the
number of staff that occupy these roles at the OPO; and require a
threshold for licensed/certified health-care workers who occupy roles
with direct patient care and/or clinical evaluation of patient health
records.
There are OPTN policies that reference the requirement that
``licensed health-care workers'' complete certain tasks or hold certain
responsibilities (see: OPTN policy 3.3, 5.8, 14.5). However, all but
one of these OPTN policies reference transplant center activities. The
only reference to OPO qualifications is in OPTN policy 2.14.B, which
reads: ``Review the OPO's internal policies, procedures, and protocols
to verify that it has a written protocol(s) that includes: Definition
of qualified health-care professionals to perform the pre-recovery
verification [of organs].''
The current OPTN contractor does demonstrate understanding that
having qualified health-care workers is important for the care provided
by transplant centers. I cannot explain to the committee why the
contractor has neglected to ensure that donor patients are cared for by
qualified health-care workers, and that the only time at which a
qualified health-care professional is necessary for an OPO role under
OPTN policy is at the time of verifying the organ being allocated for
transplant.
An OPO can decide, as an organization, that a person without
medical training, without a relevant license or certification (RN, LPN,
paramedic, respiratory therapist, APP, etc.) can occupy a role that
requires the ability to evaluate patient health information, make
clinical determinations, and even provide clinical care to patients.
The OPO would remain in compliance with 42 Sec. 486.326, pass the
associated CMS audit requirements, and adhere to current OPTN policy as
long as their staffing remained ``sufficient'' and their own internal
employee training declared the person as ``qualified.''
I cannot speak for anyone else, but I can speak for myself and my
family: I would not want a person who is not a licensed or certified
health-care provider to perform a physical examination, or evaluate my
medical records, or perform a medical procedure on me or someone I
love. OPOs provide clinical care to patients. Patients, even those at
the end of their lives, deserve high quality, safe, and dignified
clinical care performed by highly trained, licensed or certified,
health-care workers. Congress, and CMS, must act on this issue in order
to ensure patient safety, and increase quality of care provided by
OPOs.
declined organs
Question. You noted in your opening statement that time is wasted
by organs being declined and that your organization has been successful
at identifying surgeons that accept kidneys that would otherwise be
declined.
Can you explain the differences in why some surgeons are more
willing to accept organs for transplant that would otherwise be
declined?
Answer. Our system's transplant center metrics--those produced by
the Scientific Registry of Transplant Recipients--monitor and grade
even minute areas of transplant center practice, such that half of
transplant centers are rated as ``aggressive'' or ``not aggressive'' in
their organ acceptance practices in a given year.\1\ Emphasis on
flagging transplant center practice means that much of our information
about discarded or utilized organs is, as a system, related to
transplant centers, not OPOs.
---------------------------------------------------------------------------
\1\ Doby, B.L., Ross-Driscoll, K., Yu, S., Godwin, M., Lee, K.J.,
and Lynch, R.J. (2022). Examining utilization of kidneys as a function
of procurement performance. American Journal of Transplantation:
Official Journal of the American Society of Transplantation and the
American Society of Transplant Surgeons, 22(6), 1614-1623, https://
doi.org/10.1111/ajt.16985.
In contrast, only 1 in 5 OPOs received a similar, definitive
message from SRTR on their organ procurement performance over the same
period.\1\ We can, as a system, improve organ utilization, but we must
understand all of the drivers of under-utilization of organs at both
transplant centers and OPOs, and create standards for donor management,
organ offers, and allocation practice across OPOs.\1\,
\2\, \3\, \4\
---------------------------------------------------------------------------
\2\ Lentine, K.L., Fleetwood, V.A., Caliskan, Y., Randall, H.,
Wellen, J.R., Lichtenberger, M., Dedert, C., Rothweiler, R., Marklin,
G., Brockmeier, D., Schnitzler, M.A., Husain, S.A., Mohan, S., Kasiske,
B.L., Cooper, M., Mannon, R.B., and Axelrod, D.A. (2022). Deceased
Donor Procurement Biopsy Practices, Interpretation, and Histology-Based
Decision-Making: A Survey of US Kidney Transplant Centers. Kidney
International Reports, 7(6), 1268-1277, https://doi.org/10.1016/
j.ekir.2022.03.021.
\3\ Giorgakis, E., Ivanics, T., Khorsandi, S.E., Wallace, D.,
Burdine, L., Jassem, W., Mathur, A.K., and Heaton, N. (2022).
Disparities in the Use of Older Donation After Circulatory Death Liver
Allografts in the United States Versus the United Kingdom.
Transplantation, 106(8), e358-e367, https://doi.org/10.1097/
TP.0000000000004185.
\4\ Cannon, R.M., Nassel, A.F., Walker, J.T., Sheikh, S.S., Orandi,
B.J., Lynch, R.J., Shah, M.B., Goldberg, D.S., and Locke, J.E. (2022).
Lost potential and missed opportunities for DCD liver transplantation
in the United States. American Journal of Surgery, 224(3), 990-998,
https://doi.org/10.1016/j.amjsurg.2022.05.001.
Little data exists about why some OPOs appear to be more successful
at allocating organs to transplant centers that accept them.\4\ What I
can tell you is that our OPO has navigated our own way to increasing
utilization of organs, and that efforts made by the current OPTN
contractor to improve organ acceptance have not just been unhelpful,
but have actually worsened the problem.\5\
---------------------------------------------------------------------------
\5\ Schold, J.D., Mohan, S., Huml, A., Buccini, L.D., Sedor, J.R.,
Augustine, J.J., and Poggio, E.D. (2021). Failure to Advance Access to
Kidney Transplantation over Two Decades in the United States. Journal
of the American Society of Nephrology: JASN, 32(4), 913-926. Advance
online publication, https://doi.org/10.1681/ASN.2020060888.
Additionally, I can share that from Mid-America Transplant's own
experience, not all OPOs allocate organs in the same way, with the same
staffing model, or with the same emphasis on making every donor organ
offer as amenable to acceptance or consideration by surgeons. There is
significant variation between OPOs in how organs are described in organ
offers, allocated, and even how they are procured and transported to
transplant centers. Some of us have dedicated allocation staff who are
trained to maximize utilization. Some of us have a dedicated process to
establish relationships with transplant centers outside of our area
that are less risk averse in their organ acceptances. Some of us see
that this variation between how OPOs work leads to longer case times,
longer times to organ acceptance, and what can be a very inefficient
system of communication between surgeons and OPOs. All of these issues
could, and should, be addressed by a functional OPTN contractor. To
---------------------------------------------------------------------------
date, UNOS has not.
______
Prepared Statement of Barry S. Friedman, R.N., BSN,
Executive Director, AdventHealth Transplant Institute
Chairman Wyden, Ranking Member Crapo, Senator Grassley, and members
of the committee, on behalf of AdventHealth, I am honored to be
extended the opportunity to provide testimony on the current state of
organ transplant policy in the United States. My testimony reflects
more than 30 years of health care/transplant experience and my direct
leadership involvement in the United Network for Organ Sharing (UNOS)
and the Organ Procurement Transplantation Network (OPTN), including the
UNOS board of directors and the Membership Professional Standards
Committee. I also proudly served 30 years in the United States Air
Force--including two tours of duty during Operation Iraqi Freedom.
I currently serve as the executive director for the AdventHealth
Transplant Institute, one of the busiest transplant centers in the
Nation, having performed more than 4,000 transplants. Our survival
rates are among the highest in the country, making us one of the most
highly-sought adult and pediatric multi-organ transplant programs in
the United States. We were the first hospital in central Florida to
successfully perform a heart transplant. Today, we offer a wide range
of transplant options, including, heart, kidney, lung, liver, pancreas,
and blood and marrow. We are also home to a comprehensive living donor
kidney program.
As the executive director of the Institute, I take very seriously
our sacred duty to the families and patients who entrust us with the
gift of life to provide organs for transplant. It is our duty to be
good stewards of these organs, honoring the faith of these families and
the health of our communities. I offer testimony specifically on UNOS/
OPTN oversight of transplant policy, data and interoperability
challenges, and opportunities to improve transplant equity across the
Nation.
unos's oversight of transplant policy
Families in need of a lifesaving organ have no option but to trust
the organ transplantation system that is in place. Unfortunately, that
system has failed many awaiting organ transplant due to lack of
oversight and accountability. An organ is the greatest gift someone can
give and yet, we have created a system that does not result in the good
stewardship of that gift. Approximately 23 percent of kidneys procured
from deceased donors are not used and discarded, resulting in
preventable deaths.\1\ It is our responsibility to address this issue.
---------------------------------------------------------------------------
\1\ How to Decrease the Discard Rate of Donated Organs, The
American Society of Nephrology, https://www.sciencedaily.com/releases/
2017/10/171005190255.htm.
---------------------------------------------------------------------------
Avoidable Organ Loss
Organ transportation is a process left to each federally designated
organ procurement organization (OPO) to implement. OPOs currently
develop their own relationships with transportation couriers, relying
on them to engage with airlines, charter flights, ground transportation
and Federal agencies to facilitate transportation. If an organ leaves
the OPO's custody, OPOs and transplant centers are solely dependent on
airline personnel to move organs on and off commercial flights in an
expedited manner. In many cases, organs must connect from one flight to
another, leaving airline personnel responsible for transfers. Neither
OPOs nor couriers have control of an organ upon surrendering it to the
airlines. While anyone can now track where their Amazon or FedEx
package is, there is currently no consistent way of tracking organs.
The OPTN recently broadened kidney-sharing policies with the goal
of increasing the number of organs available. However, this policy is
being instituted in an environment where the kidneys may be unescorted
and unprotected during transit, making them more vulnerable to discard.
This problem has been exacerbated due to industry staffing shortages
caused by the pandemic and flight delays. There are occasions when we
try to put the organs on charter flights, however, there are not enough
charter flights available and the costs are significantly higher. When
the transplant community raised these issues to UNOS at the regional
meetings, UNOS staff stated that UNOS was not responsible for providing
this service and that it was ``out of scope for discussion.''
Many news articles have promoted the use of GPS tracking during
organ shipments.\2\, \3\, \4\ UNOS developed an
organ-tracking system to pilot with OPOs and transplant centers.
However, staff from the UNOS Organ Center did not participate in organ
tracking. There were no built-in warnings when an anticipated check
point was not met. Further, the system depended on recycling the GPS
trackers for repeated use, which was difficult if not impossible to do.
Due to these challenges, we opted out of the UNOS tracking system and
are now working with a different courier company that uses less
expensive and higher quality trackers which can be discarded and
monitor shipments in real time.
---------------------------------------------------------------------------
\2\ For All Transplant Programs: The UNOS Organ Tracking Beta Test.
UNOS, 2021, https://unos.org/news/labs-organ-tracking-beta-test/.
\3\ How BrickHouse Security's GPS Tracking Helps the National
Kidney Registry Save Lives. Fierce Healthcare, 2010, https://
www.fiercehealthcare.com/healthcare/transplants-transformed-how-
brickhouse-security-s-gps-tracking-helps-national-kidney.
\4\ How Lifesaving Organs for Transplant Go Missing in Transit.
Kaiser Health News, 2020, https://khn.org/news/how-lifesaving-organs-
for-transplant-go-missing-in-transit/.
To address these organ transportation issues, this committee should
---------------------------------------------------------------------------
recommend the following:
1. Promote increased transparency by requiring the reporting
of all organ loss and ``near misses'' due to transportation
issues. UNOS has a safety reporting system; however, our
program has reported these near misses with no feedback or
follow-up to the safety report submission.
2. Establish a national organ shipping system that would
monitor the progress of all shipments (e.g., aircrafts, ground
transport, train transportation) in real time on behalf of OPOs
and transplant centers that opt in. This could be done through
a partnership with a third-party organization that actually has
expertise in this.
3. Require all OPOs to utilize GPS technology to transport
unaccompanied organs. GPS tracking should be constantly
monitored by either OPO staff or a contracted service.
4. Require the development of safety standards for courier and
airline companies to follow when transporting human organs for
transplant.
Inferior Data Availability and Interoperability
Data availability and transparency are key to improving organ
procurement, UNOS has not proven capable of this function. OPTN
technology lags significantly behind other technology platforms. In
daily use by our transplant center, we have found the current OPTN IT
contractor to be slow and reactive, one that does not provide state-of-
the-art service and does not prioritize being technologically current.
This contributes to a fractured flow of health IT between OPOs, donor
hospitals, transplant programs, and UNOS with significant data
interoperability challenges. During regional meetings, this issue was
raised and even though transplant centers voted for a resolution, UNOS
called these concerns ``sentiments,'' and they were not given serious
consideration.
I also believe there is a conflict of interest related to the
management of IT functionalities by UNOS, as the IT tools that they
offer transplant centers come with an additional cost despite these
being essential for the safely management of organs.
To help improve the availability and useability of data, Congress
should:
1. Separate the IT components of UNOS operations from the
broader OPTN contract with HHS.
2. Authorize and require OPOs and the OPTN to participate in
Health Information Exchanges.
3. No longer require OPOs to maintain additional, separate
databases with donor information, instead allowing them to
transfer donor information directly from hospital EHRs to the
OPTN database.
Ineffective Organ Screenings
UNOS is not effectively screening organ offers so they can be
quickly directed to transplant programs. Rather, UNOS asks transplant
centers to voluntarily opt out of certain organ offers via an organ
offer filtering process. History has repeatedly demonstrated that
transplant programs desire to be informed of every organ available,
even if they would never transplant it. Thus, they have a poor track
record of voluntarily filtering offers. As a result, OPOs must waste
valuable time making organ offers to centers that will never accept
them. Time wasted equates to prolonged cold ischemic time, which
equates to lost transplant opportunities. It is a vicious cycle that
disadvantages patients on the waiting list. Thus far, UNOS refuses to
adopt a more ``placement friendly'' philosophy. Additionally, while
UNOS is proposing to increase their patient registration fees, they are
not offering any increase in value or improvements in their processes.
Due to the limited expertise that UNOS has in the placement of
organs, it would be best if they were no longer responsible for
developing organ placement practices. In the early years of UNOS, the
placement of organs was stellar. If UNOS cannot perform this task, we
recommend high-performing OPOs and transplant centers be partnered with
technology and artificial intelligence experts using predictive models
about organ utilization. Prioritizing organ offers to the centers most
likely to use them will drive change in transplant center organ
acceptance practices.
The UNOS policymaking process lacks transparency. Currently, OPTN
board members concurrently serve as the board members of UNOS, which
creates a conflict of interest that contributes to the lack of
transparency. The board then further delineates with an executive
board, where closed-session decisions are made and sent out to the
transplant community for implementation. UNOS has formed many
committees throughout the years to develop policy changes. However,
these committees are formed in a vacuum; there is no call for
nominations and no data shared with the transplant community to explain
the rationale behind a given policy change. A perfect example of this
is the recent organ allocation change of policy where a geography
committee was formed; this policy resulted in the inequitable
distribution of organs and higher kidney discard rates.
UNOS requires transplant centers to pay a registration fee for
adding patients to the OPTN wait list to receive an organ transplant.
Since 2021, these fees have increased from $926.00 to $990.00 in 2022;
UNOS has proposed to increase the registration fees to $1,044.00 in
2023. These are additional costs that go into the Medicare cost report,
costing the Federal Government more money, with little transparency as
to why. Transplant center leaders in the past have not been given a
reason for these increases.
There is no representation from patient advocacy groups or experts
in quality measurement and improvement. The OPTN should be required to
ensure that all populations, including ethnic minorities and persons
with disabilities, are represented in the transplant policy development
process. Finally, there should be representation of organizations, like
the National Quality Forum, that have experience in quality
measurement. Failure to make these changes will result in the continued
development of inequitable policies and practices that do not result in
measurable quality improvements.
Overall and most importantly in this equation, we are jeopardizing
the trust to our most precious resource--organ donors and their
families and the recipients of those organs.
We applaud the Senate Finance Committee for listening and learning
today and thank you for providing the United States of America the
opportunity to maintain the stellar clinical care for our patients who
require lifesaving organ transplants.
______
Questions Submitted for the Record to Barry S. Friedman, R.N., BSN
Questions Submitted by Hon. John Barrasso
Question. What regulatory or legislative actions could be taken to
enhance accountability and performance within the OPTN, especially
within UNOS or other potential OPTN contract recipients?
Answer. First, I would like to endorse the bipartisan findings of
the Senate Finance Committee's August 2022 investigation into the
Nation's organ transplant system.\1\ My recommended actions to be taken
align with that report's recommendations, particularly: removing
barriers to competition; increasing the pool of potential bidders by
clarifying that the OPTN functions described in NOTA and subsequent
amendments may be operated by more than one contractor; and promoting
innovation in all OPTN functions (e.g., policy development, compliance
and patient safety mentoring, IT infrastructure, coordinating transport
of organs, etc.) as the best qualified entities with distinct skill
sets could compete for contracts for these functions.
---------------------------------------------------------------------------
\1\ A System in Need of Repair Hearing Report. The United States
Senate Committee on Finance (August 3, 2022), https://
www.finance.senate.gov/imo/media/doc/UNOS%20Hearing
%20Memo.pdf.
In order to enhance accountability, Congress should require that
---------------------------------------------------------------------------
any entities managing the OPTN:
Establish a public comment process for stakeholders to
suggest innovations and new methods to improve the system. The
goal of this suggestion is to improve the level of trust
between any OPTN contractors and OPTN member institutions
during the policy development process. Currently, OPTN members
are encouraged to submit written comments regarding policies
under development. However, unlike the Federal public comment
process, the OPTN is not required to respond publicly and in
writing as to the OPTN committee's response to each comment and
whether/why the comment was adopted or rejected. If OPTN
committees were to engage in this process it would improve the
accountability relationship among the committees, any OPTN
contractors and the members. A similar process could be
implemented at OPTN member regional meetings in which comments
could be provided during discussion, catalogued by contractor
staff, and provided to committees for review and written
response. This process would help foster transparency and
create an environment for self-improvement within the OPTN.
These written summaries could also help establish a record of
issues brought to the OPTN and how they were addressed.
Develop a feedback loop in the decision-making process,
allowing members to quickly share any opportunities for
improvement or refinement of a policy after a change. Currently
there is not a rapid response process available to OPTN members
when a policy change creates unintended consequences or is not
achieving the intended effect. The only rapid response
mechanism available to OPTN members is the patient safety
portal but this suggestion is not consistent with the portal's
current purpose. Members become frustrated when occurrences
happen and there is nowhere to catalogue events that provide
needed insights about the ``real-world'' implications of a
policy change. The absence of a feedback loop perpetuates
distrust between members and the OPTN/contractor and
discourages opportunities for rapid course corrections when
required.
Promote increased transparency by requiring the public
reporting of all organ loss and ``near misses'' due to
transportation issues. There is currently no OPTN policy
requiring members to report the failure to transplant organs.
Organ loss can result from:
Insufficient efforts to match an organ with a
candidate;
Insufficient efforts to optimize organ
function prior to placement attempts;
A turndown in the donor operating room
leading to a non-transplantable organ;
Mishandling the organ acceptance/candidate
notification process; and
Lateness/damage/loss during transportation.
Current OPTN data vastly underreport the incidence of organ loss
during transportation, which has resulted in a lack of urgency from the
OPTN to address the issue. Although UNOS has a safety reporting system,
which could be deployed for the purpose of documenting organ loss or
near loss, there is no public reporting, feedback, or follow up to
members when the system is used. Because problems submitted by OPOs and
transplant centers go unaddressed, there is no incentive for members to
report occurrences. This is a glaring omission in need of rapid
correction.
In order to enhance performance, Congress should:
Require the establishment of a national organ shipping
system that monitors the progress of all shipments (e.g.,
aircrafts, ground transport) in real time on behalf of OPOs and
Transplant Centers that opt in. This could be done through a
partnership with a third-party organization with demonstrated
logistics expertise. This logistics system could be awarded via
contract, with operational fees paid for by OPOs and transplant
programs that utilize it. Responsibility for tracking and
trending logistics problems would lie with the system; it would
also be accountable for developing relationships with national
commercial airline carriers to support better treatment of
organs while in transit.
Require that all OPOs utilize GPS technology to transport
unaccompanied organs. GPS tracking should be constantly
monitored by either a contracted service, the OPO, or the
Transplant Centers.
Require the development and adoption of safety standards,
with involvement of the Federal Aviation Administration, for
OPOs as well as courier and airline companies when transporting
human organs for transplant. The lack of safety standards for
the management of organs results in them being often handled as
any ordinary piece of merchandise.
Separate the IT components of the OPTN contract so that a
third-party with expertise in this area can manage this
function.
Require OPOs and the OPTN participate in Health Information
Exchanges.
Encourage automated exchange of data between OPOs and
hospital electronic health records (EHRs) for the purpose of
potential organ donor referral and evaluation. This process
would allow hospitals to have an electronic notification option
so that clinicians don't have to cease their work to make
donation referrals. Further, all OPOs should have the
technological capability to receive these referrals
electronically.
Ensure that any OPTN contractor(s) develop and maintain
Application Programming Interfaces (APIs) that automatically
provide required data to the OPTN and ease access of data for
researchers/other contractors, stakeholders, and outside
organizations. OPTN and transplant program databases should no
longer be the mechanism through which data are provided to the
OPTN. The This will allow for better access to OPTN data and
operations information (e.g., data generated during the process
of making and receiving organ offers) so efficiencies can be
created to decrease the number of discarded organs.
Question. What are the advantages and disadvantages of the current
OPTN contract that allows only one entity to operate the network?
Answer. I strongly encourage Congress to ensure the OPTN contract
can be opened to multiple contractor bids, particularly by separating
out the IT function from the rest of the contract. Having a single
entity manage the entire OPTN contract puts all the decision-making
power into the hands of one organization, making it more difficult to
hold it accountable to Federal oversight agencies, OPTN members or the
patients it is intended to serve. In the current environment,
policymaking becomes self-serving to the needs and capabilities of the
contractor rather than what is in the best interest of recipient and
donor patients. For example, when UNOS was tasked by the Federal
Government to create an IT system, they built it but did not seek
feedback on what capabilities members needed or what the price point of
using the technology should be. Because the current OPTN contractor is
not, per se, an IT company, the choice of technologies it adopts cannot
be rapidly altered to keep up with industry advances. Consequently, the
OPTN's current IT infrastructure is inefficient, outdated and
inadequately serves patients and OPTN members. Implementing even small
changes to the system takes months to years to accomplish, as
illustrated by several sources.\2\
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\2\ National Library of Medicine. Restructuring the OPTN contract
to achieve policy coherence and infrastructure excellence, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC6494733/.
UNOS also determines the transplant candidate registration fees
with little input or transparency beyond a small subset of board
members as to how those fees will be used or why they are necessary.
Currently, members have no other choice but to pay whatever rate is set
by UNOS with no explanation. Registration fees have increased from
$926.00 in 2021 to $990.00 in 2022 and UNOS has already proposed to
increase the registration fees to $1,044.00 in 2023. These price hikes
are then reflected on the Medicare Cost Report, costing the Federal
Government more money, with little transparency as to why they are
necessary. Additionally, the Senate Finance Committee noted the issue
of UNOS double charging transplant centers (and ultimately payers,
including Medicare) for each wait-listed patient--charging a fee once
as the OPTN and once as UNOS. UNOS fees are also not subject to
contractual controls from HRSA, allowing UNOS to spend taxpayer dollars
---------------------------------------------------------------------------
for self-benefit and entrenchment, rather than to benefit patients.
When one organization is tasked with fulfilling so many different
functions, it can essentially become an expert at nothing, contributing
to inefficiencies. For example, UNOS currently requires information
from our providers that they have already been provided but fail to
retain in a way that allows ongoing use. When transplant programs hire
a new physician that comes from another transplant center, the
physician has to resubmit all their cases and certifications to UNOS
despite having already provided the same information to UNOS from their
previous transplant center. Even though these physicians have worked
for other member transplant centers and have previously submitted all
the same cases and certifications, they must resubmit that same
information in its entirety when they move facilities. Because UNOS
does not fear the loss of its OPTN contractor responsibilities, it does
not have any sufficient incentive to build efficiencies into an
outdated process.
Question. What potential trade-offs exist between having only one
contract entity versus multiple specialized entities?
Answer. I believe that one organization operating in today's health
care and technology environment cannot achieve the operational quality
required to fulfill all aspects of the OPTN contract. If another
singular organization were to replace UNOS, similar issues would
eventually arise. There are many aspects to organ procurement and
transplantation, including identifying organs, transporting organs,
tracking organs and quality improvement, to rely on a single contractor
to achieve high performance levels. It would be very difficult for one
sole organization to deliver the best quality on every aspect or to be
an expert in all these functions.
To ensure the greatest quality, entities could submit bids to
fulfill one or more responsibilities of the OPTN. The best organization
equipped for that responsibility should be granted a contract. For
example, a technology-focused organization would be better suited to
develop a national system of automated, electronic notifications for
organ donation than a company with limited IT capabilities.
I believe that multiple organizations could achieve functionality
together provided there is engaged and collaborative oversight by
Federal entities. Involving multiple contractors in OPTN operations is
not a new concept. In 2000, HRSA chose for the first time to award the
Scientific Registry for Transplant Recipients (SRTR) to an entity other
than UNOS and while it took time to adapt to the changes, UNOS did
collaborate with the SRTR. This arrangement has benefitted the donation
and transplantation community, particularly around data transparency.
It is not unreasonable to expect that if the existing OPTN contractor
(or any future OPTN contractors) were awarded only a portion of current
OPTN contracted responsibilities, cooperation and collaboration with
other entities would develop.
Question. Are there other regulatory or legislative actions
Congress or the administration should take to ensure the OPTN is
performing to its maximum potential for patients and providers?
Answer. Congress or the administration should ensure that there is
more meaningful engagement from UNOS with patient advocacy groups, as
well as experts in quality measurement and improvement. The OPTN should
be required to ensure that all populations, including racial/ethnic
minorities and persons with disabilities, are represented in the
transplant policy-development process. Further, the OPTN should ensure
that the voices of patients and donor families who volunteer on OPTN
boards and committees are heard and their priorities for better
service/resources for patients are acted upon.
Next, Congress should require for the OPTN board and any contractor
boards to be separated. This would help prevent any conflict of
interest, enable the OPTN board to focus on service to patients, and
allow members to provide feedback more openly to contractors.
Congress or the administration should also ensure that all
organizations that are managing the OPTN follow security guidelines to
protect member data. UNOS requires significant information about our
transplant centers and practices. Now, more than ever, it is critical
that this information be protected. Managing organizations should be
required to follow security requirements to ensure that patient data is
protected.
______
Question Submitted by Hon. Maggie Hassan
Question. In 2019, the National Council on Disability (NCD)
released a report finding that people with disabilities are often
excluded as organ transplant candidates due to their disabilities. Does
your organization have a policy that covers organ transplant access for
individuals with disabilities?
Answer. AdventHealth Transplant Institute adheres to guidelines set
up by HHS and the U.S. Public Health Service (USPHS) to determine who
is qualified to receive an organ. AdventHealth maintains policies
addressing how we provide equitable care to patients with disabilities
across our system. AdventHealth Transplant Institute evaluates every
patient's intellectual and adaptive functioning in a clear,
evidence-based and systematic manner. If a patient's disability hinders
their ability to receive an organ, we do everything in our power to
provide special accommodations for them. For example, having someone
available to support the patient through the transplant process is a
requirement in being a candidate for an organ. If someone does not have
anyone or cannot support themselves, AdventHealth Transplant Institute
would help find them a caretaker so they could meet the criteria to
receive an organ transplant.
______
Prepared Statement of Calvin Henry, Region 3 Patient Affairs Committee
(PAC) Representative, Organ Procurement and Transplantation Network
(OPTN)
Chairman Wyden, Ranking Member Crapo, and members of the committee,
my name is Calvin Henry, and I serve on the OPTN Patient Affairs
Committee as the Region 3 Representative for the southeastern U.S. and
the U.S. territory of Puerto Rico. I am also a double lung transplant
recipient of 9\1/2\ years and have spent much of that time as a
dedicated patient advocate in direct support of organ transplant
candidates and recipients, as a community advocate for organ donation,
and as a strong proponent for system-wide improvements and transparency
throughout the organ procurement and transplantation process. It is a
privilege to be invited here today to share my thoughts regarding the
current state of this system.
I would like to share with the committee a bit of my experience
navigating the transplant system in order to get wait-listed and then
receive a transplant.
Fifteen years ago, I was diagnosed with a terminal lung disease
that was later identified as scleroderma and informed that my only
option for survival was to receive a double lung transplant. I was
told, however, that I was unlikely to receive one and that I should
just begin making end of life preparations. I quickly moved on to
another practitioner who subsequently made the referral for me.
The several years after that initial diagnosis were perilous. On
three separate occasions, I nearly lost my life due to the adverse
effects of the disease. First, during the early progression of my
disease, I traveled to a high elevation destination without the
realization that my scarred lungs could not process oxygen at a
sufficient rate in order for me to adequately breath. A local doctor
who checked my symptoms found that I had a blood oxygen level of 53
percent and noted I likely would have suffered from a stroke within
that same day without immediate care. Secondly, during year 3 of my 5-
year journey to transplant, I went into respiratory arrest primarily
due to the weakened lungs during a medical procedure and had to be
resuscitated. Finally, just a few months before the transplant, I was
hospitalized with a lung infection so widespread that it required
hospitalization for a period of time that was 2 weeks longer than my
post-transplant stay. The medical team later informed me that clearing
the infection may not have been possible if I had sought treatment 8-12
hours later than I did. I've also had more instances of a collapsed
lung than I would care to remember.
During this period, I was also diagnosed with achalasia. This is a
disorder characterized by the inability of the esophagus to properly
move food and liquids into the stomach. I was told after going through
the evaluation process that this disorder disqualified me from
receiving a transplant at my State's only lung transplant program since
the risks of my surgery outweighed the benefits of receiving donor
lungs. The rejection I received from that program launched a solo
effort, without transplant program assistance, to locate another
program that would take me on as a patient. Over the next several
months I reached out to one program after another, slowly losing hope
as each new month brought a new letter of rejection in the mail until I
eventually found a program by happenstance while traveling out of State
for work.
Several things stood out to me during this experience: the absence
of a basic standard of care from the specialty physician who did not
give a referral to an appropriate transplant hospital so that I could
receive follow up care, the void in guidance to an appropriate
transplant hospital when my first-choice program disqualified me from
theirs which left me ill-informed and on my own, and the lack of
clarity as to which programs would automatically exclude me as a
potential candidate based on my medical complications.
When finally wait-listed, patients also do not have the visibility
to know which organ offers are declined on their behalf. This lack of
visibility disenfranchises the patient from the decision-making process
and deprives us of opportunities to receive a life-saving transplant.
These gaps in care and guidance are opportunities for improvement. We
need a system that works for patients, is easily navigable, and is
unambiguous.
The specific circumstances of my own experience may be unique but
the consistent difficulties in accessing transplant services are all
too common. I was fortunate that I had the means, including access to
good insurance, that allowed me to travel to another State to receive
care. That is not always the case. Many studies highlight the
disparities and inequitable access to transplant services that
disproportionately harm Black people and people of color who do not
have the resources to access transplant in these circumstances.
This committee has previously highlighted that organ donation
system failures are an ``urgent health equity issue.''\1\ Consider the
numbers for kidney failure \2\--Hispanic Americans are 1.5 times more
likely to experience kidney failure than White Americans; Black
Americans are 3 times more likely; and Native Americans are 4 times
more likely. Yet we also know Black people and people of color are less
likely to receive transplants. One particularly troubling piece of
data: organ procurement organizations (OPOs) have massive disparities
amongst recovery rates of donors of color across the country. Axios
highlighted a tenfold disparity \3\ of Black recovery rates between
OPOs across the country. Since same ethnicity matches are more likely,
Axios \4\ was clear about ``why [that] matters: Fewer Black donors
correlates to fewer Black recipients, which has led to more Blacks
dying on the organ transplant wait list.''
---------------------------------------------------------------------------
\1\ https://www.finance.senate.gov/chairmans-news/bipartisan-
bicameral-members-of-congress-commend-federal-efforts-to-reform-organ-
donation-system-urge-acceleration-of-rules-impact-.
\2\ https://opodata.org/equity/.
\3\ https://www.axios.com/2021/11/09/organ-donation-recovery-worse-
people-of-color.
\4\ https://www.axios.com/2021/11/09/organ-donation-recovery-worse-
people-of-color.
As a transplant recipient, I am committed to taking the best care
of my organ as possible. Not only is it a necessity for my health,
safety, and best long-term outcome success, but I also consider it an
almost sacred duty. It is the bare minimum for me to be the best
steward possible to show the proper respect and honor for my donor.
---------------------------------------------------------------------------
Patients resoundingly agree on this point.
It is troubling to see, then, that we as Americans are asked to
donate our organs but our OPOs do not appear to be the best stewards of
the organs that we are donating. It is heartbreaking that thousands of
recovered organs each year are not used while thousands more are not
recovered at all. In addition, 23 percent of kidneys are wasted that
could have made a significant dent in our transplant wait list and
saved lives.
Here is some additional data that is equally troubling:
Thirty-three \5\ Americans die every day for lack of a transplant,
while thousands of organs go unrecovered and not transplanted every
year. That number includes both patients dying on the wait list and the
removal from the wait list of those who have died from being too sick
to transplant.
---------------------------------------------------------------------------
\5\ https://www.washingtonpost.com/opinions/many-die-waiting-for-
organs-the-trump-administration-could-help/2020/07/31/77e3a102-dfd6-
11e9-b199-f638bf2c340f_story.html.
The federally funded deceased donor potential study showed the U.S.
may be recovering as few as one in five \6\ potential organ donors.
---------------------------------------------------------------------------
\6\ https://optn.transplant.hrsa.gov/media/1161/ddps_03-2015.pdf.
To make this shocking status quo real: 28,000 \7\ organs go
unrecovered each year, including: 17,000 kidneys; 8,000 livers; 1,500
hearts; and 1,500 lungs.
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\7\ https://www.bridgespan.org/bridgespan/Images/articles/
reforming-organ-donation-in-america/reforming-organ-donation-in-
america-01-2019.pdf.
For scale, according to the chief of transplant at Vanderbilt \8\
who testified at the House Oversight hearing last year, if the system
were fully functioning, there would be no waiting list for livers,
hearts, or lungs within 3 years, and the kidney wait list would be
dramatically reduced.
---------------------------------------------------------------------------
\8\ https://www.youtube.com/watch?v=TnKo8Q-Hemk&t=2748s.
According to data released by the Centers for Medicare and Medicaid
Services this April, the majority \9\ of organ procurement
organizations are failing to miss performance standards; again, which
translates into thousands of organs unrecovered each year.
---------------------------------------------------------------------------
\9\ https://qcor.cms.gov/main.jsp.
Research has documented that often Black families receive
differential treatment from OPOs. As former Surgeon General Dr. Ken
Moritsugu \10\ noted: ``Often, misallocation of OPO resources means
OPOs do not respond to all donation cases, or do not properly train and
support their front-line staff. The impact of this, unsurprisingly,
falls disproportionately on families of color.'' When I have personally
spoken at donor remembrance ceremonies or other events in my community
these same anecdotes supporting Dr. Moritsugu's research have been
shared with me. Similar anecdotes have been shared with me by mainly
Spanish-speaking families who have had the hurdle of language barriers
that are difficult to clear.
---------------------------------------------------------------------------
\10\ https://opodata.org/equity/.
Senators, the leaders and several of my colleagues on the OPTN
Patient Affairs Committee asked me to submit a letter (Appendix A) for
---------------------------------------------------------------------------
the record. I have joined them. Among their messages to you:
Antiquated technology and an apathetic culture cause patients
to languish with incomplete and often incorrect information,
and leave people to die every day on the list. OPTN PAC members
have raised these points often with UNOS leadership, and have
seen our calls for reform ignored. We have been aghast at the
absolute failure of UNOS to operate the practice and business
of transplant, and to acknowledge--much less effectively
serve--patients who are waiting and dying on the organ wait
list. . . .
The alarming revelations in The Washington Post . . .\11\
[including] covering for failures of organ procurement
organizations; and lack of cooperation with the government,
even devolving to UNOS having ``threatened to walk away,'' lead
us to believe that UNOS has proven itself incapable of
functioning as the OPTN.
---------------------------------------------------------------------------
\11\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
We ask that you ensure that the Federal Government makes the
fast-
approaching contracting OPTN cycle competitive for the first
time since the original OPTN contract was awarded in 1986,
opening critical functions up to best-in-class innovators
across the country; and we implore you to ensure that UNOS does
---------------------------------------------------------------------------
not hold patients hostage in the process.''
Senators, I urge you all to act to ensure that we make better use
of the organs that are donated, to ensure that health equity issues
with Black people and people of color are addressed, and that the
glaring technology issues causing patients harm are quickly remedied.
I thank you for your time.
______
appendix a: unos hearing pac letter, august 2, 2022
Dear members of the Senate Finance Committee,
As the leaders of the OPTN Patients Affairs Committee (PAC), we are
reaching out to share our experiences on the committee that we believe
indicate a systemic failure of UNOS to serve patients as the OPTN. This
is all the more urgent in light of investigative reporting from The
Washington Post.\12\
---------------------------------------------------------------------------
\12\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
Antiquated technology and an apathetic culture cause patients to
languish with incomplete and often incorrect information, and leave
people to die every day on the list. OPTN PAC members have raised these
points often with UNOS leadership, and have seen our calls for reform
ignored. We have been aghast at the absolute failure of UNOS to operate
the practice and business of transplant, and to acknowledge--much less
effectively serve--patients who are waiting and dying on the organ wait
---------------------------------------------------------------------------
list.
On July 28th, in preparation for the upcoming August 3rd Senate
Finance Committee hearing into UNOS, PAC leaders received an email from
UNOS CEO, Brain Shepard, referring to your investigation, in which he
makes four assertions that UNOS has shared with the committee.
We wish to correct the record for your urgent consideration.
Shepard: ``Our IT system remains safe, secure and routinely meets
and surpasses Federal standards''
The Washington Post \13\ reported ``The system for getting donated
kidneys, livers and hearts to desperately ill patients relies on out-
of-date technology that has crashed for hours at a time and has never
been audited by Federal officials for security weaknesses or other
serious flaws.''
---------------------------------------------------------------------------
\13\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
We hope the committee asks UNOS how many patients have died due to
the inability to match organs during downtime, as well as other
technological inefficiencies such as data error due to manual entry, as
well as how many patient life-years have been lost due to delays in
organ transportation. That said, given the lack of transparency in the
UNOS tech system, it is difficult to imagine anyone at UNOS could
---------------------------------------------------------------------------
answer this question with any confidence.
Shepard: ``We have worked together as a community to improve the
transport of organs with innovative, evidence-based products.''
The UNOS transportation record on organs is woefully--and fatally--
inadequate, as outlined by investigative reporting from Kaiser Health
News \14\--as well as cases brought before the Senate Finance
Committee. Put simply, UNOS operates as an antiquated, closed system
that keeps out external innovators that could help patients with better
tools and services.
---------------------------------------------------------------------------
\14\ https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/.
Shepard: ``Our committees and staff are proud to work
---------------------------------------------------------------------------
collaboratively with all members to serve as partners in improvement.''
PAC members have often sought--and not received--clarity on how
patient input is used. When PAC takes clear positions (such as the need
to fast-track proposed changes to using eGFR results to list people of
color), UNOS has refused to act. Compare this to a recent UNOS fast
track process that addressed a hardware defect in a mechanical heart
that went through in less than a month. Black patients deserved this
kind of speedy remedy when eGFR was proven to have racial bias. We also
note Washington Post \15\ reporting that UNOS's policy making processes
have been so divisive that they have ``spark[ed] open conflict'' among
OPTN members.
---------------------------------------------------------------------------
\15\ https://www.washingtonpost.com/national/health-science/liver-
transplant-rules-spark-open-conflict-among-transplant-centers/2019/05/
16/91b37f84-781c-11e9-bd25-c989555e7766_story.html.
Shepard: ``The system we are all so honored to be a part of just
surpassed 41,000 transplants in 2021, while continuing to expand
---------------------------------------------------------------------------
equitable access to transplant.''
UNOS obscures its underperforming record behind recent increases in
organ donation rates that have resulted from tragic spikes in opioid
overdoses, gun deaths, and car accidents, including as second-order
effects of the COVID pandemic, not from UNOS's own performance. See the
former U.S. Chief Data Scientist making this point in MedPage,\16\ and
research in the Journal of the American Medical Association \17\
finding that, after controlling for public health trends and scientific
advancements which have increased the size of the donor pool, organ
donation rates have not even kept pace with population growth.\18\
---------------------------------------------------------------------------
\16\ https://www.medpagetoday.com/opinion/second-opinions/98363.
\17\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
\18\ https://bloomworks.digital/organdonationreform/assets/PDF/
donation-increase.pdf.
The alarming revelations in The Washington Post \19\ (antiquated
technology; covering for failures of organ procurement organizations;
and lack of cooperation with the government, even devolving to UNOS
having ``threatened to walk away'') lead us to believe that UNOS has
proven itself incapable of functioning as the OPTN.
---------------------------------------------------------------------------
\19\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
We ask that you ensure that the Federal Government makes the fast-
approaching contracting OPTN cycle competitive for the first time since
the original OPTN contract was awarded in 1986, opening critical
functions up to best-in-class innovators across the country; and we
implore you to ensure that UNOS does not hold patients hostage in the
---------------------------------------------------------------------------
process.
We urge you to continue with your oversight and institute urgent
reforms that will literally result in lives saved.
Signed,
Garrett Erdle
Chair, OPTN PAC
Living Kidney Donor, Alexandria, VA
Molly J. McCarthy
Vice Chair, OPTN PAC
3-time Kidney Transplant Recipient, Redmond, WA
Chris Yanakos
Former Member of OPTN PAC
Living Liver Donor, Caregiver and Donor Family Member, Pittsburgh,
PA
Steve Weitzen
Region 2 Representative, OPTN PAC
Heart Recipient, Randolph, NJ
Calvin Henry
Region 3 Representative, OPTN PAC
Lung Recipient, Dacula, GA
Lorrinda Gray-Davis
Region 4 Representative, OPTN PAC
Liver Recipient, Yukon, OK
Julie Spear
Region 8 Representative, OPTN PAC
Donor Family Member, Boulder, CO
Eric Tanis
Region 10 Representative, OPTN PAC
Liver Recipient, Highland, IN
______
Questions Submitted for the Record to Calvin Henry
Questions Submitted by Hon. John Barrasso
Question. This committee has obviously been hard at work trying to
identify shortcomings in the organ procurement and transplantation
system over the past couple years. Also within the past couple years,
the Trump administration proposed and the Biden administration
finalized the OPO final rule. This rule established new performance
metrics for OPOs as well as helped promote more frequent oversight and
competition among OPOs.
Are there other regulatory or legislative actions Congress or the
administration should take to ensure the OPTN is performing to its
maximum potential for patients and providers?
Answer. Opinions are mine only and do not reflect OPTN policy or
views.
1. Pass the Living Donor Protection Act (S. 377/H.R. 1255).
2. Require UNOS, as the OPTN contractor, to work with Organ
Procurement Organizations (OPO) and transplant centers to expand
transplants performed under the HIV Organ Policy Equity (HOPE) Act
(Pub. L. 113-51).
3. Require UNOS, as the OPTN contractor, to begin work to require
transplant centers to implement informed, shared decision making with
transplant candidates when considering organ offers.
4. Require UNOS, as the OPTN contractor, to collaborate with OPOs
in evaluating OPO personnel makeup to ensure that they appropriately
represent the demographics of the patients and communities that they
serve.
5. Allow research pilot studies to determine if providing
incentives can increase U.S. organ donor availability.
Because of the depth of supporting material available, it is
challenging to fully detail these proposed actions within this response
from my viewpoint as a transplant recipient and patient advocate for
the past decade, so I will briefly state what I think are the pertinent
points. I welcome the opportunity to clarify or further discuss these
in greater detail. These proposed actions address goals of reducing the
donated organ non-use rate and increasing the number of transplants
performed while improving access and equity in transplant.
1. Pass the Living Donor Protection Act (S.377/H.R.1255).
The organ donation and transplant community has long advocated for
Congress to enact law to provide protections for living organ donors.
Bipartisan legislation has been introduced to Congress in successive
sessions over the past 25 years in order to accomplish this goal. In
the absence of Federal guidance, at least 28 States have enacted law to
protect living organ donors and improve the number of transplants
performed but these laws are not all consistent or comprehensive; my
State of Georgia being the latest to pass such a law earlier this year.
Only 8 more of your Senate colleagues are needed for cosponsor in order
to push a standardized and comprehensive bill forward to a historic
vote in the Senate. Passing this bill would not only be a lifesaving
aid for many living donors, recipients, and their families in
navigating the transplant process, I also believe it would help improve
living donor rates by removing disincentives to the donation process. I
ask that you urge your colleagues to action in cosponsoring and
subsequently passing this bill.
2. Require UNOS, as the OPTN contractor, to work with the Organ
Procurement Organizations (OPO) and transplant centers to expand
transplants performed under the HIV Organ Policy Equity (HOPE) Act
(Pub. L. 113-51).
Approximately 240 HIV+ transplants have been performed under the
HOPE Act, but currently less than 15 percent of the approximately 250
U.S. transplant centers perform these organ transplants.\1\ Expansion
of transplants performed under this act can save many more lives per
year per the latest recommendations from the HHS Advisory Council on
Organ Transplantation (ACOT) and also reduce the burden on organ donor
availability.\2\ The council also unanimously agreed that there was
cause to examine potential inefficiencies in organ procurement from
HIV+ organ donors and to determine how many potential organs that could
have been donated were not recovered.
---------------------------------------------------------------------------
\1\ OPTN. Transplant centers approved for Hope Act. https://
optn.transplant.hrsa.gov/media/ex3bmasx/hope-act-hospitals.pdf
(accessed October 3, 2022).
\2\ U.S. Department of Health and Human Services Recommendations 66
through 67. https://www.hrsa.gov/advisory-committees/organ-
transplantation/recommendations/66-67 (accessed September 19, 2022).
3. Require UNOS, as the OPTN contractor, to begin the work to
require transplant centers to implement informed, shared decision
---------------------------------------------------------------------------
making with transplant candidates when considering organ offers.
As patients, we should have the ability to participate in the
decision-making process when determining how transplantation will
affect our lives. Our goals for quality of life post-transplant don't
always coincide with expectations of transplant centers. Overwhelming
patient sentiment supports our willingness to sometimes accept
higher-risk organs that transplant centers traditionally would not
consider. These transplant center practices contribute to the rate of
organ non-use when organs that are considered higher-risk could have
been used to satisfy unique patient needs, but are too often not used
at all. Also, on average, people who die while waiting for a kidney
transplant had 16 kidney offers that were ultimately transplanted into
other patients.\3\ CMS rules may also need to be addressed in order to
support transplant centers when accepting higher risk organs.
---------------------------------------------------------------------------
\3\ Husain, S.A., K.L. King, S. Pastan, R.E. Patzer, D.J. Cohen, J.
Radhakrishnan, and S. Mohan. 2019. Association between declined offers
of deceased donor kidney allograft and outcomes in kidney transplant
candidates. https://jamanetwork.com/journals/jamanetworkopen/
fullarticle/2749266 (accessed October 12, 2022).
4. Require UNOS, as the OPTN contractor, to collaborate with OPOs
in evaluating OPO personnel makeup to ensure that they appropriately
represent the demographics of the patients and communities that they
---------------------------------------------------------------------------
serve.
I shared in my August 3rd testimony that it has been my experience
that OPOs do not consistently treat all organ donors in the same
manner.\4\ Also, surveys of organ donor attitudes have shown that
Black, Hispanic, Native American, and other historically disadvantaged
populations are willing to become organ donors, yet OPOs often do not
take steps necessary to recruit these donors. I believe UNOS should
collaborate with OPOs and use best industry practices to ensure that
OPO personnel makeup throughout the entire organization, and especially
within executive leadership, is representative of the community
demographics that it serves. Precedence exists to show that having such
a structure in place can rapidly improve organ donation rates,
especially in these historically disadvantaged populations.
---------------------------------------------------------------------------
\4\ Hearing of the Senate Finance Committee: ``A System in Need of
Repair: Addressing Organizational Failures of the U.S.'s Organ
Procurement and Transplantation Network,'' 117th Cong. (2022)
(testimony of Calvin Henry, OPTN Patient Affairs Committee). https://
www.
finance.senate.gov/imo/media/doc/
SenateFinanceCmte_832022_HenryCalvin_v2.pdf (accessed September 15,
2022).
5. Allow research pilot studies to determine if incentivizing
---------------------------------------------------------------------------
organ donation can increase U.S. organ donor availability.
We discussed in this recent hearing that the demand for donated
organs continues to increase and outpace the supply available to
provide lifesaving transplantation, and I believe that newer approaches
should be considered when determining methods to increase the organ
supply since current and long-standing practices are not effective in
reducing the size of the organ wait list. NOTA currently prohibits both
the giving and receiving of incentives for organ donation as well as
research to even determine if providing incentives would be effective.
Public attitudes continue to show a positive view of incentives of some
type for organ donation even though transplant professional concerns
regarding the commodification of organs and the potential exploitation
of vulnerable populations are well documented, but recent views suggest
that Federal management of incentives is viable.\5\ Some States have
already included forms of financial incentives in their respective
living organ donor protection laws.\6\ I believe that providing
incentives, other than direct compensation for organs, such as deceased
donor funeral costs or reimbursement of living donor medical and life
insurance premiums is not only a decent act, but could significantly
increase organ donor rates and it is already demonstrated that
reimbursements from the National Living Donor Assistance Center (NLDAC)
are insufficient.\7\ Other countries that have enacted similar laws
have realized a rapid increase in organ donor rates post-
implementation.\8\ An amendment to NOTA is required to allow HRSA
funding for a research pilot program to allow for examination of
viability.
---------------------------------------------------------------------------
\5\ HRSA 2019 National Survey of Organ Donation Attitudes and
Practices: Report of Findings. 4.13 Payments and Organ Donation, Q18.
Payments Would Increase Likelihood of Organ Donation. https://
www.organdonor.gov/sites/default/files/organ-donor/professional/grants-
research
/nsodap-organ-donation-survey-2019.pdf (accessed September 14, 2022).
\6\ S.B. 330, 2021 Biennium, 2022 Reg. Sess. (GA 2022). https://
www.legis.ga.gov/api/legislation/document/20212022/203236 (accessed
September 27, 2022).
\7\ Sarah Glazer, ``Organ Trafficking: Can the illicit trade be
stopped?'', pgs. 31, 32. June 2022. https://library.cqpress.com/
cqresearcher/document.php?id=cqresrre2022062405 (accessed September 27,
2022).
\8\ J. Lavee, T. Ashkenazi, A. Stoler, J. Cohen, R. Beyar. 2012.
Preliminary Marked Increase in the National Organ Donation Rate in
Israel Following Implementation of a New Organ Transplantation Law.
https://doi.org/10.1111/ajt.12001 (accessed September 27, 2022).
______
Question Submitted by Hon. Maggie Hassan
Question. The Organ Procurement and Transplantation Network's 2021-
2024 Strategic Plan includes priorities to help ensure broad access to
transplants. That effort should include individuals with disabilities.
How is the network ensuring that individuals with disabilities have
equal access to organ transplants?
Answer. The OPTN does not currently have a policy addressing
disabilities nor does it explicitly offer a position on whether
disabilities should be removed as exclusionary criteria for transplant.
This absence of policy is a barrier that helps prevent equal access to
organ transplants for individuals with disabilities. The OPTN,
beginning in 2017, completed a significant amount of work in resolving
this topic, but was notified by HRSA in early 2019 that the Health and
Human Services (HHS) Office of Civil Rights (OCR) should be the agency
first issuing guidance on this topic and that the OPTN would need to
halt work on publishing any white papers or guidance representing the
official position of the OPTN until the OCR completed their own
guidance. My understanding is that the halting of this work was due, in
part, to the then pending release of the Organ Transplant
Discrimination Against People with Disabilities Report by the National
Council on Disability (NCD) which was completed against the backdrop of
increased widespread interest in this topic.\9\ The OPTN subsequently
sent a memo to HRSA in August 2019 summarizing the progress to date as
well as recommendations to aid the OCR as they began their work on a
guidance document. The OPTN is not aware of any guidance document or
further developments from the OCR subsequent to this memo, but a
general public Request for Information from interested stakeholders was
solicited by the office in January 2021.\10\
---------------------------------------------------------------------------
\9\ Organ Transplant Discrimination Against People With
Disabilities, September 2019. https://www.ncd.gov/sites/default/files/
NCD_Organ_Transplant_508.pdf (accessed September 21, 2022).
\10\ OCR Seeks Information on Addressing Disability Discrimination
in Health Care and Child Welfare Contexts, January 2021. https://
www.hhs.gov/about/news/2021/01/15/ocr-seeks-information-addressing-
disability-discrimination-health-care-child-welfare-contexts.html
(accessed September 21, 2022).
It is my strong belief that excluding patients for organ
transplantation solely on the basis of disability is discriminatory and
undercuts access to health care for an already vulnerable population.
Removal of this barrier is critical to the success of ensuring
equitable access to transplant services and restoring trust in the
transplant system. In the absence of Federal or OPTN guidance, 34
States have enacted laws prohibiting transplant programs from excluding
individuals with disabilities solely on the basis of disability,
recognizing the need to protect the rights afforded under the Americans
with Disabilities Act, section 504 of the Rehabilitation Act, and
section 1557 of the Affordable Care Act.\11\ I urge the HHS and the OCR
to accelerate their process in issuing Federal guidance on this matter
to help ensure that equal access to transplant is available for those
with disabilities.
---------------------------------------------------------------------------
\11\ National Down Syndrome Society (NDSS). Policy and Advocacy.
Organ Transplant Discrimination State-Level Legislation. https://
ndss.org/advocacy#p_health (accessed September 30, 2022).
______
Prepared Statement of Jayme E. Locke, M.D., MPH, Director, Division of
Transplantation Surgery, Heersink School of Medicine, University of
Alabama
Chairman Wyden, Ranking Member Crapo, and members of the committee,
my name is Dr. Jayme Locke, and I am the director of the Division of
Transplantation Surgery at the University of Alabama at Birmingham
(UAB), where I also serve as the Director of the Comprehensive
Transplant Institute. I have dedicated my career to serving vulnerable
populations with the goal of eliminating or at least mitigating health
disparities. I believe that patients should be the focus of everything
we do.
At UAB, we currently have 1,022 patients wait-listed for kidneys,
the majority self-identified as African American/Black. We have
performed more than 10,000 kidney transplants and have performed the
most living donor kidney transplants among African American/Black
persons than any other program in the country. Our center is located in
the southeastern United States, an area known to have one of the
highest end-stage kidney disease burdens as well as communities with
extreme social vulnerability--characteristics that drive demand for
transplantation and reflect a limited supply.
Transplantation was always supposed to be about the patient, but
the system we operate now has almost a complete lack of ownership and
responsibility--whether it is an OPO failing to show up at donor
hospitals and engage families, or UNOS failing at the most basic
responsibilities of getting recovered organs matched and safely to the
recipients at the other side. These are the government's own
contractors.
My patients, your constituents, need your help.
We know that thousands of kidneys are recovered and discarded every
year, and that thousands more are never recovered at all. Discards have
increased steadily and transportation errors are frequent particularly
since the most recent allocation change, as the new system increased
complexity, and to date UNOS has shown no ability to manage even simple
logistics.
The most powerful thing to know about this is that every organ
represents a life. You could argue it represents more than one life; it
has a profound impact on the patient, their family, and their
community. We can never forget that. Imagine having a medication you
need to live being thrown away simply because someone took too long to
get it to you. Your life quite literally in a trash can. Organs are no
different. They too have shelf lives, and they are measured in hours.
Discarded kidneys and transportation errors may sound abstract. Let
me make this negligence real for you--and please remember the
disregarded donors whose families trusted us with the most sacred of
gifts, and the sick and dying patients waiting for these transplants.
Think of the young girl looking forward to not having to miss the prom
for dialysis, the mom who wants to live long enough to see her children
grow-up, the parent who needs to be able to hold down a job to provide
for his/her family. The things we take for granted are the things that
end-organ disease robs our patients of. Transplant is the cure--that is
if the organ ever makes it to the patient.
In 2014, I received a kidney that arrived frozen. It was hard as a
rock, like an ice cube you could put in your drink. The intended
recipient was highly sensitized--meaning difficult to match. The only
thing we could do was tell the waiting patient that, due to the lack of
safeguards regarding transportation of organs, the kidney had to be
thrown in the trash--the final, generous act of a donor in Maryland.
In 2017, I received a kidney that arrived in a box with tire marks
on it. The box was squished, and the container inside had been ruptured
(Image 1). We were ``lucky'' and were able to salvage the kidney for
transplant. Why should luck even play a role?
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
This is the level of care too many kidneys receive. How does
UNOS allow this?
Once the kidney is packaged and leaves, no one really knows what
happens, and that is as shocking as it is unacceptable.
Consider this: for our patients in Birmingham, most of our kidneys
fly through Atlanta. When they were arriving on flights after 10 p.m.,
they were being taken down to sit in cargo hold like lost luggage, only
to be taken out in the morning when flights restarted.
But Birmingham is only 2 hours away from Atlanta by car--and delays
in transplanting organs literally mean life or death. Think of cold
ischemia time this way: like shelf life. Each minute, each hour, that
an organ is out of the donor's body, those cells are dying, which
increases risk to the receiving patient. Increased cold ischemia time
can mean delayed graft function--meaning the patient requires dialysis
after transplant. Delayed graft function is a known risk factor for
acute rejection and reduced long-term graft survival.
When we realized what was happening with kidneys stuck in cargo
hold at Atlanta airport, we called the airlines and dealt with it
ourselves. I don't blame the airlines--their job is to move hundreds of
thousands of people around the country each day. But where was UNOS?
How did it ever let organs sit in cargo hold?
Another even simpler example: instances of UNOS saying that no
flights are available, when my team has hopped on Expedia and found
available flights themselves.
UNOS has failed at its responsibility for the efficient matching
and distribution of organs. There are countless stories of inefficient
algorithms and process that led to organs accruing unacceptably long
cold ischemia times resulting in discard. In an era of same-day
delivery of household goods from Amazon, the OPTN and its contractors
have relied on outdated logistical systems akin to the Pony Express.
Moreover, UNOS has abdicated its duty to hold under-performing OPOs
responsible for failing to convert eligible donors and manage organs on
their end, and as such, have not optimized the number of organs
available for transplant.
Since the frozen kidney, and the box with tire marks--I have
received other kidneys that had to be discarded either due to surgical
and OPO handling issues or UNOS transportation errors. But one week
this May was particularly difficult.
In 1 week, I received four kidneys from four different OPOs--each
with basic errors that led to the need to throw away those lifesaving
organs (Images 4 and 5).
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
One kidney had to be thrown away due to a botched biopsy
into the kidney's collecting system, which means urine would
have leaked from the kidney once transplanted;
Another kidney had to be thrown away because the lower pole
artery had been cut during procurement. That would have been
fixable if someone involved in the procurement had assessed the
kidney for damage and flushed it before packing, but that
didn't happen; and
Two other kidneys arrived to me blue--meaning they hadn't
been flushed.
Errors happen. We all understand that. However, opacity at UNOS
means that we have no idea how often basic mistakes happen across the
country, nor can we have confidence that anything is being done to
redress such errors so they don't keep happening.
All I know is that in 1 week I received four kidneys--two from
donors in Tennessee, one from a donor in Florida, and one from a donor
in Georgia--that had to be thrown away.
What was particularly heartbreaking was that two of these kidneys
were for highly sensitized African American/Black women--meaning they
were the proverbial needle-in-a-haystack kidneys for patients that are
hard to match. Our patients become sensitized through prior exposure to
foreign tissue--previous transplant, blood transfusion, and/or
pregnancy.
Women who have been pregnant--especially multiple times--are more
sensitized/harder to match, and pregnancy related sensitization
contributes to both gender and racial disparities in access to kidney
transplantation. So when we talk about the system being inequitable,
this is a very real example of how a constrained pool of organs for
transplant, and high discards, are failures that disproportionately
hurt women, and women of color who are more likely to have multiple
pregnancies.
Somewhere along the way we forgot why we're here--saving people's
lives. We have to do better, and that includes transplant centers, too.
I know others in my field have spoken up, and more still who want
to speak up. But, Senators, please know that every person I have talked
to who has spoken up about system failures has told me they have been
punished in some way through both micro- and macroaggressions. The very
highest levels of leadership within UNOS is an insular club that has
turned its back on the very patients they purport to support by
ignoring their own unconscious biases, and even impugning patients
behind closed doors.
For example, a UNOS board member in an email to the UNOS CEO,
labeled patients from the southeastern United States as ``dumb f*$#''.
This is not who we are as medical professionals. We are here to serve
all people and in particular those who are the most vulnerable among
us. We need reform now.
The solutions are clear and I am asking for your urgent help on
behalf of my patients and all the other patients waiting around the
country:
Immediately separate the OPTN board from any of the boards
of any contractors;
Bring in the real experts to ensure our patients are served
by the best-of-the-best in each field, separating out key
functions of the OPTN: for example, policy, technology/
matching, and logistics; and
Ensure that patients are safer by holding all contractors
accountable, including through public adverse event reporting
and immediate redressing of problems.
One final and critical point. I can't tell you how disturbing it
was to read recent reporting of the way UNOS has allegedly held the
U.S. transplant system hostage. According to The Washington Post:
``UNOS also `has at times even threatened to walk away and continue
operating the [transplant network] without a contract, despite the fact
that it would be illegal.' ''
Doing anything to jeopardize patients--including even threatening
to walk away--violates a basic principle of health care. It's called
patient abandonment. You simply can't do that--or even threaten to do
that. I would lose my medical license for walking away from a patient.
If it is true that in any way UNOS has suggested that it might walk
away, or in any way not cooperate with a transition to new OPTN
contractors, that would make it an organization that cannot be
responsible for taking care of lives.
There is very little in health care that has the immediate life and
death stakes as organ transplantation. Please realize that every day
that passes with these failing systems in place means more of our
neighbors will die. My patients need the Senate to act.
______
attachment: optn region 3 letter, february 23, 2022
Dear Chairman Wyden, Senator Grassley, Senator Young, and Senator
Cardin,
We are writing to you as Region 3 members of the Organ Procurement
Transplantation Network (OPTN) about grave concerns we have about the
leadership of the OPTN (current contractor, UNOS) and to express our
strongest possible objection to the content of recently published email
communications among OPTN leaders.
At the February 1, 2022 OPTN Region 3 meeting, several members
sought to raise the issue of leadership, as a Federal judge recently
unsealed deeply concerning emails from the UNOS CEO (Brian Shepard) and
a then-OPTN/UNOS board member (Alexandra Glazier).
In policymaking deliberations, we note the following exchanges:
Glazier to Shepard: ``The fact that some States do better than
others in preventing preventable deaths and providing health-care
insurance coverage and access means you're a dumb fuck for living
there.''
Shepard to Glazier: ``Only people who have means can get a
transplant. So this isn't a `give txs to poor people argument; its a
`give txs to those of us who have to live near poor people' argument.''
These exchanges are only a fraction of the concerning
transgressions found in the unsealed emails, representing a serious
failure of leadership and breach of trust. Irrespective of positions on
any given policy, these comments are disqualifying for positions of
public service. It does not represent who we are as leaders of the
organ donation and transplantation community. It is equally concerning
that the OPTN/UNOS Board of Directors has failed to apologize or
publicly denounce these disparaging opinions voiced by Shepard and
Glazier, suggesting that these views are truly those of the OPTN. UNOS
speaks often of the importance of ``maintaining public trust'' in the
organ donation system; it is unfortunate that its executives have so
flagrantly flaunted it, and, as such, must be held accountable.
At the most recent meeting, Region 3 member representatives wished
to raise that (1) we believe Shepard should resign as the CEO of UNOS;
and (2) that Glazier should no longer be permitted the privilege of
OPTN/UNOS policymaking positions. However, we were told we could not
raise this issue at the OPTN meeting as it was intended only for OPTN
policy development purposes, not other matters pertaining to the OPTN
or UNOS. Unfortunately, UNOS has offered no other public venues to
discuss our concerns.
Having been denied the opportunity to vote on our concerns for
patient welfare, we and others in the community were further stifled in
our discussion by repeated statements that we should discuss our
opinions ``offline'' with OPTN/UNOS board president Dr. Matthew Cooper.
During the public meeting, Mr. Shepard and Dr. Cooper misrepresented
the OPTN/UNOS board's discussions of the emails and actions we have
outlined above. The continued attempts to suppress conversations about
vulnerable patients and avoid accountability for reprehensible views
and actions has broken our faith in UNOS's ability to self-regulate its
leaders, so, instead, we are writing to you.
As you are aware, OPTN board members concurrently serve as the
board members of UNOS. This creates a serious conflict of interest as,
too often, the principal goal of UNOS is maintaining its status as the
monopoly OPTN contractor, rather than focusing on issues that will
actually help more patients and steward the use of precious donated
organs. In fact, in 2018, the Government Accountability Office agreed
with a directive from HRSA that the OPTN and the OPTN contractor
(currently UNOS) must maintain separate boards, though, nearly 4 years
later, UNOS still has not done so.
It was more than 20 years ago that Forbes called UNOS the
``cartel'' that's ``chilling the supply of transplantable organs and
letting Americans who need them die needlessly,'' and--in the absence
of structural reform to the OPTN--this dynamic remains today.
The quashing of dissenting voices within the OPTN is both ongoing
and deeply damaging to the patients we serve. If the OPTN/UNOS had
proper governance, not only do we believe there would be clear
leadership changes, we trust that there would be more attention--and
action--on issues that cost patients their lives, rather than a primary
focus on UNOS continually maintaining its monopoly hold on the U.S.
organ donation system.
Thirty-three Americans die every day for lack of an available organ
transplant. Please ensure that proper governance is in place to help
change this.
Yours sincerely,
Keith Wille, M.D.
OPTN Board of Directors
Region 3 Councilor 2020-2022
Professor of Medicine
Medical Director, Advanced Lung Diseases Program
University of Alabama
Birmingham, Alabama
Christopher Anderson, M.D.
OPTN Board of Directors
Region 3 Councilor 2018-2020
James D. Hardy Chair
Professor and Chair, Department of Surgery
Chief Perioperative Services Physician
Medical Director, Transplant Service Line
University of Mississippi Medical Center
Jackson, Mississippi
Virginia McBride, R.N., MPH
OPTN Board of Directors
Region 3 Councilor 2022-2024
Executive Director
OurLegacy Organ and Tissue Donation Services
Maitland, Florida
Kelly Ranum
OPTN Board of Directors
2019-2021
Chief Executive Officer
Louisiana Organ Procurement Agency
Covington, Louisiana
Raymond Lynch, M.D., MS, FACS
Associate Professor of Surgery Executive Director
Director of Public Policy and Community Relations
Emory Transplant Center
Atlanta, Georgia
Barry Friedman
AdventHealth Transplant Institute
AdventHealth Orlando
Orlando, Florida
Jayme Locke, M.D., MPH, FACS, FAST
Professor of Surgery
Director
UAB Comprehensive Transplant Institute Chief, Division of
Transplantation
Arnold G. Diethelm Endowed Chair in Transplantation Surgery
Birmingham, Alabama
Jonathan Hundley, M.D.
Surgical Director
Liver Transplantation
Piedmont Transplant Institute
Piedmont Healthcare
Atlanta, Georgia
M. Kevin Stump
Chief Executive Officer
Mississippi Organ Recovery Agency
Jackson, Mississippi
______
Questions Submitted for the Record to Jayme E. Locke, M.D., MPH
Questions Submitted by Hon. John Barrasso
Question. As we know, OPOs are overseen by UNOS, as well as the
Centers for Medicare and Medicaid Services (CMS). One would think for
organizations overseen by two different entities, serious mistakes
would not frequently occur. Yet, as the committee report shows, grave
mistakes, like testing errors and transportation failures, still plague
OPTN members and cost numerous lives.
Are there specific gaps in oversight between UNOS activities and
those of CMS, and if so, can you shed some light on these?
Answer. One of the biggest gaps in our transplant system is
accountability with regard to organ transport. Once the kidney has been
procured and packaged and begins its journey to the transplant center
where it will be transplanted, the kidney, a lifesaving organ, is
reliant on the goodwill of complete strangers (e.g., airport personnel,
couriers, etc) who quite likely are unfamiliar with transplantation and
the need for efficient and timely transport of the gift of life. No
transplant-specific entity wants to ``own'' the kidney or be
responsible for its care for the duration of the transport process.
There is no system for holding a particular entity responsible or
accountable for ensuring the kidney arrives in good condition and on
time (e.g., ``on time'' being defined as a transportation route
resulting in as little cold storage or cold ischemia time as possible;
decreasing cold storage time has been associated with improved patient
outcomes post-transplant).
For all intents and purposes, kidneys in transit are on their own,
with no metrics for delivery. This is a profound failure of the OPTN
contractor.
HRSA and CMS should reform this issue with urgency, as it relates
to alarmingly high rates of kidney discards in the United States.
According to the most recent data highlighted at the Senate Finance
Committee hearing, one in four kidneys from generous donors in America
are thrown in the trash. Much of this senseless waste is due to
failures of clinical standards, processes, and technology from HHS's
own contractors. Given patients of color are disproportionately
impacted by kidney disease, these failures impact communities of color
most, and further emphasize the fact that the organ shortage and kidney
discards represent an urgent health equity issue.
The government has a role to play in transparency and reform on
this life-and-death issue. HHS (HRSA or CMS) should publish a lost
organ reporting system--a dashboard of all kidneys recovered and not
transplanted. These data are available to HHS agencies via the OPTN,
and would allow for a near-real time reporting of: (1) total number of
kidneys recovered and not transplanted; (2) where those kidneys
originated (i.e., from which OPO); (3) where those kidneys were due to
arrive (i.e., to which transplant center or State); and (4) why the
kidney was discarded (e.g., clinical problems in recovery;
transportation problems in delivery).
It may also be worth reaching out to the FAA to understand how this
agency has so successfully collaborated with stakeholders to ensure
precise times in transit. In short, we have figured out complex systems
with airplanes, understanding arrival and delay times . . . and imagine
if we hadn't. . . . This should be possible with kidneys too.
Question. This committee has obviously been hard at work trying to
identify shortcomings in the organ procurement and transplantation
system over the past couple years. Also within the past couple years,
the Trump administration proposed and the Biden administration
finalized the OPO final rule. This rule established new performance
metrics for OPOs as well as helped promote more frequent oversight and
competition among OPOs.
Are there other regulatory or legislative actions Congress or the
administration should take to ensure the OPTN is performing to its
maximum potential for patients and providers?
Answer. I support the bipartisan recommendations of the Senate
Finance Committee \1\ to break up the OPTN monopoly, and open
competition to the best-of-the-best in each field for the good of
patients.
---------------------------------------------------------------------------
\1\ https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Confidential%20Me
mo%20(FOR%20RELEASE).pdf.
As I included in my testimony:\2\ ``The solutions are clear, and I
am asking for your urgent help on behalf of my patients and all the
other patients waiting around the country:
---------------------------------------------------------------------------
\2\ https://www.finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Final
v2.pdf.
Immediately separate the OPTN board from any of the boards
of any contractors;
Bring in the real experts to ensure our patients are served
by the best-of-the-best in each field, separating out key
functions of the OPTN; for example, policy, technology/
matching, and logistics; and
Ensure that patients are safer by holding all contractors
accountable, including through public adverse event reporting
and immediate redressing of problems.''
The OPTN should never again be allowed to be a monopoly. Having one
organization/contractor performing a vast and disparate array of
functions is a mistake, leading to a situation where a single
organization acts as the proverbial ``jack of all trades'' while being
the master of none.
Separate contracts will allow for expertise, for example in
allocation/mathematical modeling and transportation/logistics. What's
more, for the good of patients, not only must the upcoming OPTN
contracting cycle be transparent and competitive, every future cyclet
should be transparent and competitive as well.
As I said in my testimony, \3\ ``There is very little in health
care that has the immediate life and death stakes as organ
transplantation. Please realize that every day that passes with these
failing systems in place means more of our neighbors will die. My
patients need the Senate to act.''
---------------------------------------------------------------------------
\3\ https://www.finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Final
v2.pdf.
______
Question Submitted by Hon. Maggie Hassan
Question. In 2019, the National Council on Disability (NCD)
released a report finding that people with disabilities are often
excluded as organ transplant candidates due to their disabilities. Does
your organization have a policy that covers organ transplant access for
individuals with disabilities?
Answer. At the University of Alabama at Birmingham (UAB), I have
transplanted patients with a range of disabilities, and similar, to
their non-disabled counterparts they too have achieved a significant
survival benefit from the lifesaving gift of transplantation. In short,
people with disabilities should not be excluded from transplantation. A
belief that my institution supports. The UAB Comprehensive Transplant
Institute (CTI) does not discriminate against individuals with
disabilities. Specifically, UAB CTI has a list of absolute and relative
contraindications for each organ program, and neither category includes
disabilities.
______
Question Submitted by Hon. Benjamin L Cardin
Question. Given the overrepresentation of Black Americans waiting
on a kidney, do transportation problems that seem to disproportionately
impact kidneys impact the disparity we observe?
Answer. Transportation problems--along with all problems that
unnecessarily constrain the supply of kidneys--exacerbate disparities
in access to transplantation.
As I testified before the Senate Finance Committee, highly
sensitized patients are hard to match, and finding kidneys for these
patients can be like finding the proverbial needle in a haystack. Our
patients become sensitized through prior exposure to foreign tissue--
previous transplant, blood transfusion, and/or pregnancy. Women who
have been pregnant--especially multiple times--are more sensitized/
harder to match, and pregnancy related sensitization contributes to
both gender and racial disparities in access to kidney transplantation.
So when we talk about the system being inequitable, this is a very real
example of how a constrained pool of organs for transplant, and high
discards, are failures that disproportionately hurt women, and women of
color who are more likely to have multiple pregnancies.
Therefore, it's critical that HHS (HRSA and CMS) immediately
address the kidney discard problem, which is exacerbated by a lack of
clinical standards and a lack of process standards in transportation.
HHS (HRSA or CMS) should publish a lost organ reporting system--a
dashboard of all kidneys recovered and not transplanted. These data are
available to HHS agencies via the OPTN, and would allow for a near-real
time reporting of: (1) total number of kidneys recovered and not
transplanted; (2) where those kidneys originated (i.e., from which
OPO); (3) where those kidneys were due to arrive (i.e., to which
transplant center or State); and (4) why the kidney was discarded
(e.g., clinical problems in recovery; transportation problems in
delivery).
Additionally, it is paramount that we evaluate whether the
government's own contractors are using the most efficient/effective
modes of transportation. For example, UAB is in the southeastern United
States, an area with particularly high rates of end-stage kidney
disease and health disparities. It is also a region where it is harder
to get flights, and where missed flights can have calamitous
consequences, yet too often simpler modes of transportation--such as
driving--are not consistently explored and used.
______
Question Submitted by Hon. Tim Scott
Question. During the hearing, our committee heard that organs in
transport are 15 times more likely to go missing than customer luggage.
You provided an example of an organ that was flown late at night and
was placed in airport holding. Were it not for the quick actions of
your team and cooperative airport staff, this organ likely would have
been lost.
Are there additional process improvements that were not discussed
during this hearing that should be considered with regard to organ
transportation to improve transplantation rates and care outcomes?
Answer. HHS (HRSA or CMS) should publish a lost organ reporting
system--a dashboard of all kidneys recovered and not transplanted.
These data are available to HHS agencies via the OPTN, and would allow
for a near-real time reporting of: (1) total number of kidneys
recovered and not transplanted; (2) where those kidneys originated
(i.e., from which OPO); (3) where those kidneys were due to arrive
(i.e., to which transplant center or State); and (4) why the kidney was
discarded (e.g., clinical problems in recovery; transportation problems
in delivery).
It may also be worth reaching out to the FAA to understand how this
agency has so successfully collaborated with stakeholders to ensure
precise times in transit. In short, we have figured out complex systems
with airplanes, understanding arrival and delay times . . . and imagine
if we hadn't. . . . This should be possible with kidneys.
Simply put: we are not currently working with people/organizations
who are experts in logistics and transportation. Whether that is the
FAA or external organizations such as UPS and FedEx (as well as
specialized logistics companies), transplant is too critical to be left
to non-experts in logistics and supply chain issues.
______
Prepared Statement of Brian Shepard, Chief Executive Officer,
United Network for Organ Sharing (UNOS)
Chairman Wyden, Ranking Member Crapo, and members of the committee,
thank you for inviting me to discuss our Nation's organ transplant
system and the role of United Network for Organ Sharing, or UNOS. I am
Brian Shepard, the CEO of UNOS, the nonprofit organization which holds
the Federal contract to serve as the U.S. organ donation and
transplantation network.
I look forward to having a conversation with you about our Nation's
diverse and thriving organ transplant system that just marked its 9th
consecutive record-setting year of lifesaving transplants.
In 1984, Congress passed the National Organ Transplant Act (NOTA)
to address the Nation's critical organ donation shortage and improve
organ matching and placement. The law called for an Organ Procurement
and Transplantation Network (OPTN) to maintain a national registry for
organ matching, and specified that the network would be a private,
nonprofit entity.
UNOS is proud to have been awarded the OPTN contract successively
since 1986. Each contract rebid is based on a competitive process. We
welcome this competitive process, and it has been our honor to serve
the Nation for over 3 decades.
From UNOS's inception as a mission-based non-profit and since we
began serving as the Federal contractor, we have never once taken this
privilege lightly; UNOS staff, volunteers--including transplant
professionals, recipients, and donor families--and others dedicate
their time and expertise every day to saving lives and improving the
system. Our work focuses on three main areas: developing equitable
allocation policies that ensure the fair distribution of organs;
maintaining the national wait list with safe, secure and modern
technology; and continuing to improve overall performance.
But we do not exist in a vacuum; we convene a community of 40,000
organ donation and transplant professionals and work in concert with
our Federal partners.
The OPTN contract is awarded and managed by the Health Resource
Services Administration (HRSA). The Centers for Medicare and Medicaid
Services (CMS), meanwhile, covers the cost for many of the Nation's
lifesaving transplants and related services. Through its reimbursement
programs, CMS regulates transplant hospitals, and is also charged with
certifying and overseeing organ procurement organizations (OPOs).
Together, UNOS, HRSA and CMS each play important roles in ensuring
both the integrity and continuity of the complex national system on
which so many rely. UNOS strives to align its efforts with those of
HRSA and CMS so that we all work in concert as we fulfill our
respective roles, while recognizing that there will always be room for
improvement.
optn background
The OPTN, as described in the statute, is a membership
organization. We count amongst our members physicians, patients,
transplant hospitals, organ procurement professionals, living donors,
donor families, professional organizations, advocates, and volunteers,
all of whom make the system what it is. And that is by design.
When Congress developed the framework for the OPTN, it did so
knowing that it was entrusting physicians and patients with the
responsibility to make critical, medically complex policy decisions
based on firsthand experience, shared values, and their ongoing
participation in the organ donation and transplant process. We still
agree with that prescient decision.
That is the community UNOS is so proud to represent--a community
dedicated to the equitable distribution of organs no matter who you are
or where you live to save as many lives as possible through transplant.
With this commitment to equity underpinning everything we do, we
have seen rapid and remarkable changes in the past few years alone;
changes that have expanded equitable access to transplants for
candidates on the wait list, increased priority for the sickest
patients on the wait list, addressed disparities by increasing
transplants for historically marginalized communities, and so much
more.
However, while access to a transplant once a patient has been added
to the wait list is largely equitable, there are systemic shortcomings
within the larger U.S. health-care system that make getting added to
the wait list inequitable. We must confront this issue as a Nation and
we are committed to addressing it within our purview as the OPTN.
Ours is a complex system; one that is dedicated to continuously
improving, monitoring and adapting; one that involves thousands of
people coming together every single day across the country in order to
save lives.
It is a system Congress set in motion nearly 40 years ago, and
which, thanks to the decisions and expertise of those who laid the
foundation, allows us to best serve patients in need of a transplant.
ongoing successes
UNOS works to save lives every day, and the numbers bear out our
successes in both improving the system and identifying new areas for
enhancement.
In 2021, for instance, the national system made global history: for
the first time in a single year, the United States surpassed 41,000
lifesaving transplants. That same year, the system also saw record
numbers of liver, heart and lung transplants. These exciting milestones
are the result of year-over-year increases in organ transplants for the
past decade and occurred in the midst of worldwide pandemic.
Additionally, post-implementation monitoring reports show the
positive impact of recent modifications to kidney and liver allocation
policies. According to the 1-year monitoring report analyzing changes
to kidney allocation (the most transplanted organ), we saw an ongoing
increase in kidney transplants nationally, especially for historically
marginalized communities, patients on dialysis, and others. This
includes increases of:
23 percent for Black patients;
29 percent for Hispanic patients;
20 percent for Asian patients;
36 percent for patients with long wait-times on dialysis;
and
63 percent for pediatric patients.
Meanwhile, the 2-year monitoring report for changes to liver
allocation policy continued to show increases, with national rates
increasing by 4.3 percent, including for the sickest patients,
historically marginalized communities, and others.
Again, these successes have taken place in the midst of the global
pandemic that imperiled access to health care. Deceased donor
transplant rates dipped in March of 2020, but quickly rebounded to pre-
pandemic levels by April 2020. This was the result of the collective
effort of physicians, professionals and others on the front lines.
It should also be noted that these successes are not stand-alone
achievements, but instead the product of years of ongoing policy
development, inclusive debate, rigorous discussion, monitoring, and a
commitment to continuous improvement.
While the votes to enact these policies were not unanimous, the
changes were enthusiastically supported by a vast majority of Board
members. Additionally, our policy development process has now been
reviewed by HHS and the General Accounting Office, as well as multiple
courts, and these policies are now in effect and benefitting patients
across the country.
Unfortunately, an ongoing misconception is that our Nation's
success in donation and transplant is due to the ongoing and tragic
opioid crisis and to the prevalence of gun violence.
The national increase in transplants predates the beginning of the
opioid crisis and the recent rise in violent crime. Additionally, both
policy changes and technological advancements have played a role in
increasing transplants. Yet there is another, more important point to
be made here.
Every death is tragic. However, regardless of the manner in which a
potential donor dies, the Organ Procurement Organization (OPO) is still
there to counsel the family, surgeons are still there to recover the
selfless donor's organs, and the transplant hospital is still there to
give the gift of life to a grateful recipient.
As previously mentioned, we have seen dramatic increases in the
number of transplants taking place over the past decade. We are also
focused intently, not just on the number of transplants, but the
equitable distribution of lifesaving organs.
The OPTN Minority Affairs Committee (MAC) has been looking at these
issues for years, resulting in the policies that have helped drive
increases in transplants for patients of color.
Just recently, following the efforts of a diverse workgroup made up
of both patients and physicians, the OPTN Board passed a new rule
requiring that all transplant hospitals must use race-neutral measures
of kidney function.
role of unos
With the creation of the OPTN, Congress designed a system to
address the Nation's critical organ donation shortage and improve organ
matching and placement. To accomplish this, Congress did not create a
centralized, government-run process to determine policies impacting
these life-saving actions. Instead, Congress believed that patients and
physicians should lead the way. This was the correct decision then, and
remains the best choice today.
Thanks to congressional foresight, we now have an OPTN with a board
and committees populated by patients, physicians, living donors, donor
families and patient advocates who help make policy through rigorous
debate and based on their unique experiences. There are currently 26
OPTN Committees, including committees dedicated to specific organ
transplant types, technology, minority affairs, patient affairs, policy
oversight, safety, and others.
These experiences are essential to making difficult, complex, and
often emotional policy decisions that impact the lives of thousands
across the country.
So much of the ongoing discussion of our shared successes,
collaborative efforts, and everything this diverse and thriving
national community has accomplished is muddled by a basic
misunderstanding of UNOS's role in our complex national system.
Some think of UNOS as a regulator, with codified regulatory
authority and congressionally mandated powers to oversee and penalize
those not in compliance.
However, based on the law Congress enacted, UNOS, in its role as
the OPTN, is not a regulator.
Regulatory authority of the Nation's organ donation and transplant
system rests with CMS, and the delineation of our different roles is
clear, established in both statute and policy, and essential to our
ongoing collaboration and alignment.
Our particular role is multifaceted, complex and essential:
UNOS members work alongside each other as partners in
improvement;
We operate a rigorous peer review process which includes
site visits, reviews, helping to develop plans of action,
offering educational opportunities, and other limited oversight
functions;
We built, monitor and continuously improve the IT
infrastructure that makes it possible to match donor organs
with recipients in need of a transplant;
We develop, implement, and monitor equitable organ
allocation policies; and
We serve as both a convener of the transplant community and
as an advocate on behalf of the Nation's organ donation and
transplant system.
membership and professional standards committee (mpsc)
The Membership and Professional Standards Committee (MPSC) is an
operational committee of the OPTN. In this role, the committee
maintains OPTN membership criteria, monitors OPTN member compliance
with this criteria, as well as compliance with OPTN bylaws, policies,
and the OPTN final rule. As needed, the MPSC takes action or makes
recommendations for further action to the OPTN board of directors.
The MPSC also identifies opportunities for individual member
improvement and opportunities for transplant community education, all
in an ongoing effort to improve patient safety and safeguard the
integrity of the transplant system.
The MPSC is made up of volunteers who reflect the transplant
community at large, including physicians with expertise in each organ
transplant type and OPO volunteers. Health Resources Services
Administration (HRSA) representatives also participate as ex officio
members.
Integral to UNOS's success in supporting continuous improvement
among members and the community at large is the MPSC's confidential
medical peer-review process--a vital process required by the OPTN final
rule and the Federal contract that allows the OPTN to review member
performance, conduct investigations, and fact-find within a
confidential setting.
Confidential peer review is a common practice across the U.S.
health-care system. This was driven in large part by a landmark
Institute of Medicine (IOM) report from 2000, which emphasized the
importance of confidential peer-review to boost performance, ensure
patient safety and encourage continuous improvement.
This report led to a national sea change and spurred the adoption
of confidential peer review across the health-care landscape. HHS
incorporated this approach into the final rule in 2000 and this
critical tool was included into the OPTN contract soon after.
The ``peer review'' component is essential. Clinicians and
professionals on the MPSC represent all the primary disciplines
involved in transplantation. This expertise makes it possible to view
member actions within the proper context, including what should have
been known and what actions should have been taken under any given
circumstance.
Confidentiality is equally important, as it increases the
possibility that OPTN members are more likely to come forward to report
issues that occur at their organization. Without willing members able
to provide critical information, the committee would not be able to
fully assess a given event, and suggest needed improvements. Removing
confidentially protections would imperil the process and may have a
chilling effect on those who might otherwise report troubling behavior.
The protection afforded by confidential medical peer-review also
includes the opinions, statements and deliberations of MPSC committee
volunteers themselves, ensuring their participation in the process
without fear of professional reprisal or litigation.
A range of actions are available if, after investigation and
deliberation, the MPSC finds a member has not followed OPTN
requirements. Some of those sanctions are not public, such as notices
of noncompliance or letters of warning. However, if the MPSC recommends
that the OPTN board of directors take an ``adverse action,'' which
includes placing a member on probation or declaring a member not in
good standing, and the Board acts on the recommendation, these
designations are made public.
The board may also decide a member's non-compliance with OPTN
requirements risks patient health or public safety, or that the member
consistently fail to improve while under an adverse action. In these
cases, the Board must make an official referral to the U.S. Secretary
of HHS.
This complex but essential process helps ensure the Nation's organ
donation and transplant system holds itself to the highest standards,
drives member improvement and makes it possible to work with our
community partners to address issues and arrive at workable, patient-
centered solutions, all with appropriate governmental oversight.
The MPSC works collaboratively with every member in our community
as a partner in improvement, and its rigorous process ensures prompt
responses and swift action if necessary.
national academies of sciences, engineering, and mathematics (nasem)
report
UNOS has continued to pursue efforts to improve the Nation's organ
donation and transplant system, increase equity, expand access,
increase patient opportunities for involvement, and save even more
lives.
NASEM's February 2022 report addressed many of these issues. We
were pleased that their in-depth analysis recognized many of our
ongoing efforts, which aligned with their recommendations and reflect
work already underway within and across our community, in many
instances led by, in collaboration with or made possible by the support
of UNOS.
These include:
Enhancing current educational offerings for patients;
Emphasizing shared-decision making between patients and
physicians;
Establishing new patient-centric transplant program
performance metrics that go into effect this year;
Adjusting payment policies to incentivize the utilization of
harder to place organs; and
Increasing transparency and accountability by launching a
new list of codes for transplant programs to use when they
refuse an order offer.
And other efforts outlined in more detail below.
equity
The NASEM report emphasized the importance of increasing equity in
access to the national wait list, regardless of where the patient lives
or who they are. We agree, and have been dedicated to this proposition
since our inception, both as a condition of our own organizational
values and as a condition of the law which first established the OPTN.
One recent example is the development of the ``Continuous
Distribution'' framework, an approach the NASEM committee vigorously
supported. The Continuous Distribution policy will erase hard
boundaries, ensuring that no single attribute will determine if a
patient gets a transplant. Importantly, this framework is also designed
to be augmented over time, allowing for ongoing feedback from a wide
range of stakeholders and giving patients an important seat at the
table.
As mentioned earlier in this statement, the OPTN board of directors
voted in June on an equity-based proposal to prohibit the use of race-
based estimation of kidney health in OPTN policy.
systemic improvements
The NASEM Committee also made several recommendations for the OPTN
and the donation and transplant community overall to improve the
system. One of these was the development and adoption of national
performance metrics, which we fully support. Other tools we currently
offer to the public and policymakers to monitor ongoing progress are
the OPTN Metrics Dashboard and the OPTN Equity Dashboard. Both can be
found on the OPTN website.
NASEM also made recommendations for maximizing organ use. In its
capacity as the OPTN, UNOS already has developed, tested and now offers
the Kidney Offer Filters tool to transplant hospitals, which is in
keeping with this NASEM recommendation. Our innovative tool, first
available in January of 2022, allows kidney transplant programs to
preemptively screen out offers they are unlikely to accept, reducing
administrative burden, accelerating organ placement and making it
easier for OPOs to find best-fit candidates quicker. We also must
continue to reduce differences in practices from hospital to hospital
and do our part to make sure everyone understands the organ offer
review and acceptance process.
As a part of overall system improvement, NASEM also recommended
that the U.S. Department of Health and Human Services (HHS) conduct an
evaluation of the OPTN IT system within 1 to 2 years. UNOS welcomes
this evaluation; as of this writing, one has not been conducted.
Beyond and before NASEM's recommendations, UNOS has always
undertaken efforts to continuously improve the national system, bolster
performance and support others within our community.
While the above efforts, projects and tools are in no way a
comprehensive list of ongoing work, they do represent an accurate
picture of UNOS, as a Federal contractor, responding to the needs of
patients, physicians, and the organ donation and transplant community
at large.
transportation
Transportation is essential to the success of the organ donation
and transplant system. Unless a recovered organ happens to be accepted
by a candidate in the same hospital where the organ was recovered, the
organ must necessarily be transported from the donor hospital to the
transplant hospital. The vast majority of organ shipment logistics are
determined between the OPO and the transplant hospital on the ground,
although the OPO may request OPTN assistance in rare cases.
Additionally, the OPTN has multiple policies in place that address the
safety of organs in transport, particularly regarding packaging,
labeling, and ultimately verifying successful delivery to the patient
who accepted the organ.
Additionally, except for kidneys, most organs (hearts, lungs,
livers, etc.) are transported in the company of the transplant
physician who will be conducting the surgery. Disruptions are rare, but
can still have a direct and serious impact on a patient in need of an
organ.
Like many things within this national system, transporting an organ
is extremely complex. Something as simple as a courier taking a wrong
turn can delay the delivery of an organ.
That is why we have engaged in several collaborations with the
community to improve the transport of organs through the development
and adoption of innovative, evidence-based products to ensure patient
safety.
The UNOS organ tracking service, for example, is now in use by 15
OPOs across the country and allows users to oversee organ shipments in
real time. The tool provides OPOs with real-time location data, package
updates and maps with easy-to-read visualizations. It also fully
integrates with existing tools and systems, all in an effort to improve
performance, speed, and patient outcomes.
We have also conducted a successful pilot of a UNOS Travel App,
which will allow OPOs to select the best options for transporting
organs. Once fully operational, the app will allow OPOs to view and
select the most efficient options for shipping lifesaving organs on
commercial flights. While these are all important innovations, we
continue to pursue efforts to further improve the transport of donor
organs.
it infrastructure
Our focus on continuous improvement also includes constantly
enhancing our safe, secure and efficient IT infrastructure; a
modernized system that we built, maintain, and enhance to ensure the
highest performance on behalf of all those who have come to rely on it.
Our system is audited by both Federal authorities and third-party
cybersecurity firms. We regularly meet and exceed both their standards
and our rigorous Federal contract obligations. Additionally, the OPTN's
Network Operations Oversight Committee (NOOC) assists the OPTN Board in
overseeing a variety of essential IT functions, including organ
matching and data collection.
We have spent years developing and improving our infrastructure,
building and incorporating technological innovations, partnering with
industry leaders, and leveraging Cybersecurity and Infrastructure
Security Agency (CISA) resources to ensure robust performance and
security on behalf of the communities we serve. This is why, despite
more than 3 million hacking attempts each day, our system has remained
safe and secure.
Our modern infrastructure was designed to make the Nation's complex
allocation policies possible; an effective, one-of-a-kind approach that
weds robust technological capabilities with in-depth policy knowledge
and has maintained, outside of periodic scheduled maintenance, a system
uptime of 99.99 percent.
While the votes to enact these policies were not unanimous, the
changes were enthusiastically supported by a vast majority of board
members. Additionally, our policy development process has now been
reviewed by HHS and the General Accounting Office, as well as multiple
courts, and these policies are now in effect and benefiting patients
across the country.
Our IT developers and business analysts are experts in both
technology and transplant and donation; it requires this kind of unique
background to successfully and thoughtfully integrate effective
technology and lifesaving policy.
a shared vision for the future
Our vision for the U.S. donation and transplant system is
straightforward: being able to provide a lifesaving transplant for
everyone who needs one. There is still much work to do, but in
collaboration with our community partners, physicians, patients, OPOs,
hospitals, policymakers, advocacy organizations, volunteers and others,
we are making this vision a reality. From transportation to technology,
from equity to system-wide improvements, by building on the successes
of our national system and our community's ongoing efforts on all
fronts, we can come together around these shared goals. It is
challenging and sometimes controversial; we welcome constructive
debates. But when we come together, our work can literally change
someone's life.
This collaborative, ambitious vision is transforming the system as
we know it, building an even stronger national system we can be proud
to call our own.
I would like to thank Chairman Wyden, Ranking member Crapo, and the
entire Senate Committee on Finance once again for inviting me to
discuss the status of donation and transplant today and what we can
accomplish when we work together to further improve this lifesaving
system. I look forward to your questions.
______
Attachments Follow
For Submission to the U.S. Senate Committee on Finance (October 12, 2022)
Confidential treatment requested pursuant to Committee on Finance Rule XXVI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retired Supporting
Rule Type Approved By Approved Date Date Documentation Active Comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Process for member waiving Process MPSC 7/23/2009 Memo Yes Changes to Appendix L 6/
interview. If a member waives 13/18 have made slight
an interview, we will take the changes to this, but
issue back to the MPSC to we would still go back
determine what action they want to the committee and
to take. ask their opinions on
it.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large and Small volume outcome Outcomes PAIS Varying dates 7/1/2022 Guidance doc Ending soon Retiring with
review principles: how the MPSC introduction of new
approaches outcomes reviews. performance metrics--
may reintroduce
something for recently
released programs as
time goes on.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inactivity Review principles: Outcomes PAIS Varying dates Guidance doc Yes
how the MPSC approaches
inactivity reviews.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Compliance cases on Process PCSC 3/27/2012 Slides Yes Documents refer to PCSC
Committee Management. but subcommittee does
not exist anymore, all
cases go to Committee
Management.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allocation--reportable Policy PCSC 4/1/2013 Documents Yes Even if the allocation
allocation events: provides a meets these criteria,
list of criteria for allocations can be
allocations that the MPSC does referred if there are
not need to review because questions or something
members are acting to prevent seems unusual. Updated
organ wastage. 4/22/21.
--------------------------------------------------------------------------------------------------------------------------------------------------------
LDAE--not reporting outside 2 Process MPSC Chair 10/27/2015 Yes
years as FYI: previously all
living donor events, even those
that occurred longer than 2
years after donation, were
reported to the MPSC as an FYI.
Changed process to only refer
those cases to the MPSC if the
event appears that it could be
Pdonation-related.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vessel Storage--do not send Policy MPSC 1 0/27/2016 Summary Yes
members to the MPSC the first
time they store prohibited
vessels (HCV, HBV).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Site survey--support for Policy Internal 10/27/2016 Summary Yes Staff Summary
changing sample sizes, creating
a CAP template. NO OFFICIAL
RULE CHANGE.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Two tiered review of SRTR 1-year Outcomes PAIS 10/27/2016 7/1/2022 Minutes Ending soon MPSC approved 37-0-0.
post-transplant outcomes for Eliminated with change
kidney--if meets threshold for to metrics and
review with full cohort of reduction in number of
transplants, remove higher risk programs identified.
kidney transplants and only
send inquiry if meet threshold
for review.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allocation--do not review Policy MPSC 7/13/2017 Staff summary Yes Approved 30, 0, 0
extrarenal organs turned down Updated 4/22/21.
in OR.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Elimination of identification of Outcomes PAIS 7/13/2017 7/1/2022 Minutes Ending soon MPSC approved 30-1-0
programs for outcomes review (Small volume no
based on small volume criteria. longer in bylaws after
7/2022).
--------------------------------------------------------------------------------------------------------------------------------------------------------
NUV (now Notice of Application MPSC 7/15/2017 Staff summary Yes Approved 30, 0, 0
Noncompliance) for late key
personnel reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wait-list inactivity monitoring: Process MPSC 1/30/2018 Staff Summary Yes MPSC approved 19-0-0
the first instance of
improperly notifying patients
of wait-list inactivity will
require a CAP, the second
instance will be referred to
the MPSC.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of non-institutional Application MPSC 3/1/2018 Staff summary Yes MPSC approved 32-0-0
member renewals: non-
institutional renewal
applications will be placed on
a consent agenda if all
requirements are met.
--------------------------------------------------------------------------------------------------------------------------------------------------------
KPC Application Review Process Application MPSC 7/18/2018 Staff summary Yes MPSC approved 34-0-0
Change: key personnel change
applications will be placed on
a consent agenda if the
application clearly meets
criteria.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Late Report to the OPTN of Policy MPSC 7/18/2018 Staff summary Yes MPSC approved 34-0-0
Potential Donor-Derived Disease with two changes: all
Transmissions: if a member members start with a
reports a potential disease clean slate, and FTNC
transmission appropriately to time frame is 3 years,
other members, but does not to be consistent with
report to the OPTN, the first compliance history
instance will not be sent to time frame when
the MPSC. reviewing cases.
--------------------------------------------------------------------------------------------------------------------------------------------------------
SET Tool introduction and Policy MPSC 7/18/2018 Staff summary Yes MPSC approved 34-0-0
implementation: approved use of
Survey Evaluation Tool and for
staff to close or review again
without MPSC review.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revising Outcomes operational Outcomes MPSC 2/27/2019 7/1/2022 Staff summary Ending soon MPSC approved 35-0-0
rule to no inquiry for 2 SRTR Eliminated with change
reporting cycles after release. to metrics, will
likely reintroduce as
metric review matures.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Determining that the minimum two Application MPSC 2/27/2019 Minutes Yes Made a decision on
year (2-5 yr) time in the interpretation, then
Bylaws for physician/surgeon approved an
logs can be fulfilled by the application with this
person's employment at issue to set
designated transplant programs, precedent.
not just by the dates of the
actual transplants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Add application rejections to Application MPSC 2/26/2020 Staff summary Yes Approved 37-0-0
Membership consent agenda:
after an application has been
rejected unanimously by the ad
hoc subcommittee, the rejection
will be placed on a consent
agenda.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Update older decision to close Process MPSC 4/22/2021 Staff summary Yes Approved 26-0-0
self- reported issues with no
action to include placing self-
reported issues directly on the
consent agenda unless
significant concerns with
response or patient safety.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Update use of Survey Evaluation Process MPSC 4/22/2021 Staff summary Yes Approved 27-0-0
tool to use SET to evaluate
both routine and first desk
review, place first desk review
directly on consent.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Made adjustments to allocation Process MPSC 4/22/2021 Staff summary Yes Approved 26-0-0
operational rules based on
changes to policy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of lung donor COVID-19 Process MPSC 5/24/2021 Staff summary Yes Approved 28-0-0
testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
______
united network for organ sharing (unos)
700 North 4th Street
Richmond, VA 23219
tel: 804-782-4800
fax: 804-782-4816
www.unos.org
MEMORANDUM
To: OPTN/UNOS Membership and Professional Standards Committee
From: Suzanne Gellner, Assistant Director, Department of Evaluation and
Quality
Date: July 23, 2009
Re: MPSC action following member waiver of rights to an interview
Historically, if a member waived its right to an interview for a
proposed action, the department of evaluation and quality would, on
behalf of the MPSC, issue the proposed sanction without further
committee deliberation. It has come to our attention that this process
has never been formally adopted by the Committee. Therefore, the
department of evaluation and quality requests that the MPSC consider
whether it would like to formally standardize this practice in all
cases where a member waives its right to an interview.
According to OPTN Bylaws, Section 3.01A (3) (Interviews), except in the
case of Category I potential violations, if the MPSC or MPSC/PCSC
considers recommending an adverse action such as Probation or Member
Not in Good Standing or is considering issuing a Letter of Reprimand,
the applicant or member is entitled to an interview. OPTN Bylaws,
Section 2.11 A (Procedural Rights) states that if a member waives its
right to an interview, the MPSC may proceed to implement its proposed
action. In order to exercise its rights to an interview before the MPSC
or the MPSC/PCSC, the member must deliver a written request for an
interview to UNOS within 14 days following its receipt of the notice of
the MPSC's proposed action. In accordance with Section 2.11A of the
OPTN Bylaws, if the member does not deliver a written request for an
interview, the MPSC may proceed to implement its proposed action.
Since 2006, the MPSC has issued seven letters of reprimand to members
who have waived the right to an interview. The MPSC issued letters of
reprimand for site survey results that remained below thresholds, organ
refusals after acceptance that led to an organ's discard, failure to
comply with data submission requirements, and repeated violation of
policy 5.3. No member recommended for Probation or Member Not in Good
Standing has ever waived its rights to an interview. Historically, when
a member waived the right to an interview, it did not submit additional
materials for MPSC consideration; therefore, the MPSC did not review
additional evidence or reconsider its original decision. Standardizing
this process for future MPSC recommendations would be consistent with
historical practice; however, proceeding directly with the MPSC's
proposed action offers no opportunity for the committee to reevaluate
its decision.
If the MPSC decides to formally standardize this practice, the
resolution to consider recommending an adverse action or issuing a
Letter of Reprimand, combined with the member's waiver of its right to
an interview, will result in the MPSC imposing its proposed action.
Operational Principles
Outcomes--applies to Large and Small Volume outcomes
Is the program active?--Membership database.
Is the program already under review?--CMRS.
If program released in last 2 meeting cycles, no action required--
CMRS.
Has program had a death or graft failure since the date of most
recent release from review?--Transplant Log Access Database.
Small Volume Outcomes--all of the above and then #2 below.
1. SRTR data provided includes all programs with 9 or fewer
transplants that had at least one event in the 2.5 year cohort.
2. Review to determine if the program has had a subsequent event
in the year since the end of cohort. If not, no action required--
Transplant log Access Database.
Additional Small Volume Guidance
To memorialize discussions regarding how to proceed with the several
cases where programs that are currently under review have had a second
component flagged (adult or pediatric) or are under review for
inactivity.
If a small volume program is flagged for outcomes that is
already under review for inactivity, an outcomes case will be created,
the inactivity case will be closed. No subsequent event is required.
If a small volume component is flagged for outcomes when the
program is already under review for the other component, the outcomes
case will be combined into an all ages review without a subsequent
event.
In both situations, instead of automatically sending an initial
outcomes survey, analyst should contact the reviewers for the existing
case and determine if:
An initial outcomes survey should be sent.
If no initial outcomes survey, do the reviewers
want to request:
Only synopses and activity information for the newly
flagged component/program.
Request additional information on the new flagged
component/program.
______
Guidelines for Inactivity Review
Transplant inactivity.
Once receive Turndown Reports:
1. Is program currently active? If no, no action required--
Membership database.
2. Is program currently under review--check Active PAIS Case
report--CMRS.
3. Has program been in active status for one year? If not, no
action required.
4. Has program been released in last 2 meeting cycles? If yes, no
action required--CMRS.
5. No offers received/no candidates on wait list--get a pass for
one cycle--review turndown report/wait list.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
MPSC/PCSC Allocation Review
Exclusionary Criteria
The MPSC Allocation Analysis work group recommended that the UNOS staff
not forward allocation cases involving the criteria listed below to the
MPSC/PCSC for review.
1. Hep C positive donors.
2. Hep B Core positive donors.
3. Donors with age > 70.
4. DCD--for all organs EXCEPT kidney.
5. Local back up (Originally only in cases of actual vs. intended
transplants associated with transplant center reviews. In October 2014
the MPSC work group expanded the scope to include OPOs that grant
centers local back up to avoid organ wastage after late declines or try
to and place organs that would otherwise be wasted).
For kidney allocations ONLY:
1. ABO non-identical allocation not on a match run with
appropriate documentation.
2. Medical urgency with appropriate paperwork that local centers
agreed.
______
The PCSC also discussed a number of possible improvements to PCSC/MPSC
operational rules associated with site surveys and an educational
referral to the OPTN Operations and Safety Committee. Specifically, the
PCSC discussed potential changes to the process for requesting
corrective action plans for each site survey violation, the timing and
intent of follow-up focused desk reviews and the site survey sample
size. The PCSC generally supported the following ideas, with the
understanding that staff would continue to develop the ideas and bring
them back to the PCSC for further discussion:
The creation of a corrective action plan template for members.
A tiered approach to which violations require a formal
corrective action plan for MPSC review and which require another
response such as self-audits, or potentially no response, if the
member's policies and templates are updated at the time of the survey.
A ``check in'' by UNOS staff after the routine survey to ensure
the member has implemented its corrective actions and that the
corrective actions are effective. This check in may delay the PCSC's
review of the routine survey report, but would potentially provide
enough information to allow the PCSC to close the review with no action
instead of requesting a follow-up review.
The creation of operational rules to identify which routine
surveys automatically require follow-up reviews and which cases must go
to the MPSC for the MPSC to determine whether a follow-up review, or
more significant action is required.
The PCSC noted that smaller sample sizes, such as five records for
small volume programs, would not provide statistically significant
data. However, the PCSC supported the idea of considering other methods
of identifying the appropriate sample size, such as a percentage of the
program's total volume, and including the program's total volume as a
reference point. The PCSC supported focusing reviews on the most recent
and relevant data (by shortening the time frame of review) and focusing
the review on identifying systematic issues.
The PCSC also reviewed the results of the UNOS staff analysis of
prohibited vessel storage cases. Staff identified common root cause
analyses and corrective action plans, and asked the PCSC to confirm
whether their findings aligned with the PCSC members' review of these
cases. The PCSC supported sharing the findings with the Patient Safety
Advisory Group of the OPTN Operations and Safety Committee, to support
the PSAG's development of educational resources for the transplant
community. The PCSC generally supported the ongoing creation of such
resources to share with the community.
In addition, based on its review of a number of prohibited vessel
storage cases, the PCSC also approved a new operational rule to
facilitate its review of these cases. Going forward, UNOS staff will
automatically close with no action a member's first violation of the
prohibited vessel storage policy. Staff will provide members with any
educational materials available, will advise the member that the MPSC
expects the member to implement a corrective action plan, and will
advise the member that any additional instances of the member storing
prohibited vessels will be forwarded to the MPSC for review. Staff will
also inform the member that MPSC's review would include the initial
violation.
______
UNOS Site Survey Discussion
PCSC Meeting
October 25, 2016
Staff Summary
Item for Consideration:
At the October 2016 PCSC/MPSC meeting, Member Quality staff would like
the PCSC to provide feedback on:
The need for corrective action plans/member responses to survey
violations.
A draft corrective action plan (CAP)/response template for
members to use in response to their site surveys.
The purpose and timing of follow-up desk reviews.
Site survey sample sizes.
This feedback will help Member Quality staff as it continues to
evaluate options and implement improved processes to promote value-
adding monitoring and increasing efficiencies to reduce the burden on
members, the MPSC and staff.
Site Survey Corrective Action Plans:
Currently, Member Quality staff requires members to submit a CAP for
each potential violation that will be forwarded to the MPSC for review.
(Please note: we do not specify that the response must be a formal CAP
with root cause analysis. Depending on the situation, a simple
explanation may be sufficient, and we leave it up to the member to
evaluate whether a RCA and CAP are appropriate. However, despite this
guidance, we believe many members often feel obligated to provide a
full RCA and CAP. In the rest of this document, we use the term CAP to
mean any sort of formal response to the MPSC.)
During the site survey process, members receive an initial site survey
report that details all potential policy violations identified during a
site survey or focused desk review. Members are asked to either submit
new documentation to verify compliance, or to submit a CAP to address
the non-compliance. (We do not typically review or require a CAP for a
policy that is no longer in effect at the time of the survey.) The
final site survey report forwarded to the MPSC for review includes all
potential violations and the member's corrective actions.
Staff are interested in the PCSC's feedback on what information it
needs in order to decide on the appropriate action after a site survey?
Does every identified violation need a CAP, or are there specific
instances when the PCSC does need or want a formal response from
members? Potential alternatives approaches include not requiring
corrective actions for certain policies or issues such as data entry
errors or not requiring corrective action plans for surveys that we
know are going straight on the consent agenda.
Corrective Action Plan Template:
Member Quality staff are also evaluating whether to create a CAP
template that members can fill out to address the violations. The idea
is similar to the template plan for quality improvement that members
receive in response to MPSC-directed peer visits. Member Quality staff
want to make sure that this tool is useful for members as they create
their CAP and also useful for PCSC members in your review of site
survey reports.
Please review the enclosed template and be prepared to provide feedback
during the PCSC meeting. Are any fields missing that you think should
be added? Are there any fields that you think can be removed? Is the
formatting easy to read?
Please note that the attached version assumes that all policy
violations require a response of some kind according to the current
process, but the form could be adapted as needed to fit a revised
process for requesting CAPs. We can also consider whether the MPSC
wants to specify which policy violations require a CAP and which do not
and update the template accordingly.
Follow-Up Desk Reviews
Follow-up focused desk reviews are a key component of the site survey
and MPSC monitoring process. Since July 2015, the MPSC has requested
follow-up desk reviews in approximately 17.5% of transplant program and
OPO site surveys and has requested follow-up desk reviews in
approximately 38% of living donor surveys.
Historically, the MPSC has requested Member Quality staff conduct
follow-up focused desk reviews when a member's site survey report shows
non-compliance with one or more particular policies, and the MPSC
continues to request follow up reviews until the member has
demonstrated compliance and/or satisfactory improvement.
For example, if a member has errors in five of 10 records regarding
informed consent, the MPSC will likely request a follow up focused desk
review of compliance with the informed consent policy. If the follow up
review finds errors in four or five records, the MPSC will likely
request another follow-up desk review. This pattern would continue
until the member shows improvement. On the other hand, if the follow up
review finds no errors or just one error, it is likely that the MPSC
would close the review. They key is that the member typically must have
records available for review that show compliance before being
released.
In another example, assume the member had errors in five records from
2015, but no errors in the other five records from 2016. The program
explained that they self-identified and corrected the error in late
2015 by updating its informed consent template. Because the program has
five records in their sample after they updated the template, the MPSC
would consider the more recent records to be evidence of compliance and
would typically not request a follow-up desk review. However, if the 10
records in the sample were all from 2015, prior to the template update,
the member would have no records in the sample to show that its
corrective action was working, and the MPSC would likely request a
follow up review. Similarly, if the member updated the template
immediately before the site survey and provided it to surveyors during
the visit, the MPSC would likely request a follow up focused desk
review to ensure the template is properly implemented and used.
Items to consider:
Does the MPSC wish for the standard to remain that members must
actively demonstrate compliance, or is having an appropriate template
or policy in place by the conclusion of the survey sufficient to close
a review with no action? Should the standard be different for
administrative policies or policies with patient safety or allocation
implications?
If the MPSC wants to ensure members are showing improvement and
compliance, would the MPSC consider having a ``staff check in'' in lieu
of a formal follow up focused desk review in some cases? Example: the
member with errors in five of 10 records submits an updated template
during the site survey visit. Site surveyors check in with the member a
certain amount of time after the site survey and review additional
records to confirm the new process is working, and includes that
information in the site survey report to send to members. This may
delay the site survey report making it to the MPSC for review, but may
give the MPSC sufficient information to close the review with no action
rather than requesting a formal follow-up desk review. The MPSC may
need to identify which situations are appropriate for such ``check
ins'' to avoid following up on every potential policy violation.
Are there any other factors or data the MPSC would like to
consider when deciding whether a follow up survey is appropriate?
Examples include any other information surveyors may already obtain or
start obtaining during site visits, the member's compliance history,
and/or the member's outcomes.
Site Survey Sample Sizes (for Transplant Program Surveys)
In addition to considering potential changes to the follow-up desk
review process, staff are also considering ways in which the emphasis
of site surveys can change from an intensive chart review to an
evaluation of a member's practices from evaluation through to
transplant, death or removal. The living donor surveys currently review
a selected sample of donors throughout the evaluation process.
Current process:
Routine on-site surveys are conducted approximately once every 3
years. The applicable timeframe from which records are identified for
review is typically the two to three years prior to the survey.
The number of records available for review varies by organ group
and the type of policy being reviewed. Generally speaking,
administrative policies such as notification of listing, removal, and
the option to multiple list, as well as informed consent are limited to
10 records in the sample. Clinical policies such as verification of
candidate status include up to 30-45 records in the sample depending on
the organ group. This may include anywhere from 60 to more than 100
individual listings for review.
Proposed process:
In order to incorporate and focus on an overall process review rather
than strict data review, to ensure surveyors are focusing on the most
recent and relevant data, and to promote consistency across the number
of records reviewed between organ groups and surveys, staff are
evaluating whether to implement new and smaller sample sizes in their
surveys.
Centers will be categorized by size (based on the number of
transplants performed the previous year and the nationwide percentile
distribution of center volume per organ type).
The program size category determines the number of records
reviewed for all policies:
Small centers--5 records.
Medium programs--10 records.
Large programs--15 records.
Living donor kidney and liver programs would have 5 records for
review.
Surveys would still be scheduled approximately every three
years. Rather than reviewing 2 to 3 years' of data, surveyors would
limit the review period to the most recent 12 month timeframe. This
would promote the review of the most recent and relevant practices and
policy requirements. (Less but more relevant records.).
Limiting the survey review period to the most recent year
provides the most relevant data, but means we may never know if the
program had significant issues in the other time between the surveys.
A smaller sample may influence the effectiveness of current
scorecards and thresholds. For example, intestine and pancreas programs
do not currently have scorecards due to their low volumes, so we may
need to discontinue using them in the smaller volume programs. We can
of course revise the scorecards as needed, or develop an alternative
method to identify surveys that can be placed on the consent agenda to
close with no action.
A smaller sample size may promote inconsistent review. If a
survey shows errors in two of five records, will MPSC reviewers
perceive that as only two errors, or as a 60 percent compliance rate?
There is not a clear historical action in these cases.
Items to consider:
Does the MPSC support the proposed sample sizes? If the site
survey reports included fewer records, would the MPSC need any
additional information to determine an appropriate action? If so, what
information is needed? Examples include any other information surveyors
may already obtain or start obtaining during site visits, the member's
compliance history, and/or the member's outcomes.
______
Scientific Registry of Transplant Recipients (SRTR) Proposed
Evaluation Plan for Transplant Program Performance
Measures (Outcome Measures) Proposal
The proposal focuses on improving the utilization of high-KDPI kidneys
through reduced oversight of ``high-risk transplants,'' i.e., high-KDPI
kidneys transplanted into high-EPTS candidates. The reduced oversight
of high-risk transplants has raised concerns that unadjusted survival
of high-risk transplants may worsen after the implementation of the
proposal. It is therefore critical that the proposal has a detailed
evaluation plan to ensure improved utilization of high-KDPI kidneys
while maintaining adequate survival of high-risk transplants. The
evaluation plan outlines the schedule and corresponding analysis to:
1. Estimate the impact of the proposal on the utilization of high-
KDPI kidneys.
2. Estimate the impact of the proposal on the survival rate of
high-risk transplants.
The proposal should impact the utilization of high-KDPI kidneys
relatively quickly after implementation. Therefore, one year after the
implementation of the operational rule, the discard rate of high-KDPI
kidneys one-year pre-and post-implementation will be compared.
Specifically, data for recovered kidneys with KDPI = 85% along with
donor characteristics will be pulled from the SRTR database. An initial
descriptive analysis will compare the unadjusted discard rates pre- and
post-
implementation. For the primary analysis, a generalized linear mixed
model (GLMM) with a logit-link will estimate the effect of the proposal
on the probability of discard with an indicator for recovery pre-or
post-implementation. It is critical to account for differences in the
donor pool as the proposal may lead to more aggressive OPO placement of
high-KDRI kidneys. Thus, based in part on the June 2016 SRTR OPO yield
model, the GLMM will account for potential differences in the donor
pool pre-and post-implementation by including covariates for: age,
KDRI, blood type, DCD donation, cause of death, cigarette use,
circumstance of death, clinical infections (blood, lung, urine and
other), cocaine use, gender, Hepatitis B serology, HCV serology, heavy
alcohol use, CDC high infectious risk, history of cancer, history of
diabetes, history of hypertension, insulin dependence, mechanism of
death, organ recovery outside of contiguous 48 states and terminal
serum creatinine. Penalized splines will estimate the effect of age,
KDRI, and terminal serum creatinine. Finally, a random effect for donor
will account for the potential correlation between kidneys from the
same donor. The proposal will be determined to have a significant
effect on discard rates of high-KDPI kidneys by having a one-sided p-
value less than 0.05 on the indicator for recovery pre- or post-
implementation. Missing data will be handled by indicators and
continuous variables will additionally be set to the median of the non-
missing values.
Due to the follow-up required for assessing post-transplant survival,
the evaluation of the proposed operational rule on the survival rate of
high-risk transplants will be completed two years after implementation.
Specifically, data on high-risk transplants completed one-year pre-and
post-implementation will be pulled from the SRTR database. Similar to
the evaluation of post-transplant outcomes, recipients will be
administratively censored after one year of survival. An initial
descriptive analysis will compare the unadjusted one-year survival
rates. For the primary analysis, a Cox proportional hazards model will
estimate the effect of the proposal on post-transplant graft survival
with an indicator for pre-or post-implementation transplant. Due to
potential differences in recipient and donor characteristics, the Cox
proportional hazards model will adjust for KDRI, EPTS, CDC high
infectious risk and DCD donation. Penalized splines will estimate the
effect of KDRI and EPTS. Every covariate in the SRTR post-transplant
graft survival model cannot be used due to the relatively low number of
expected events over two years within the subset of high-risk
transplants. Missing data will be handled through multiple imputation
as implemented in the most recent PSR cohort.
A non-inferiority test will determine whether post-implementation graft
survival is appropriately maintained with the non-inferiority margin
set to a hazard ratio of 1.75. That is, the proposal will be determined
to have maintained appropriate graft survival if the indicator for pre-
or post-implementation transplant has a one-sided p-value less than
0.05 for the null hypothesis that the hazard ratio is greater than
1.75. The non-inferiority margin was selected because the one-year
graft survival rate for kidneys with KDPI = 85% was approximately 85%
in the 2014 OPTN/SRTR Annual Data Report, and a hazard ratio of 1.75
would ensure that the one-year graft survival rate for kidneys with
KDPI = 85% remains above 75%.
Sensitivity analyses will be completed for both objectives of the
proposal. To assess the sensitivity to the assumptions made within
GLMMs, the utilization of high-KDPI kidneys will include an analysis
based on generalized estimating equations (GEE) with an exchangeable
working correlation structure for donors. Post-
transplant survival will include an analysis based on a frailty model
accounting for potential correlation between kidneys from the same
donor. Additional sensitivity analyses will be completed that consider
covariates or interactions that were not included in the primary
analyses, especially for covariates included in the SRTR post-
transplant graft survival model. Finally, a sensitivity analysis will
investigate the potential presence and impact of temporal trends on
organ utilization and post-transplant survival.
The significant advantage of the evaluation plan is the primary
analysis for both objectives is a priori specified including covariates
for adjustment and their functional form. This improves the scientific
validity by ensuring the false-positive rate of 5% is not adversely
impacted by stepwise variable selection methods (e.g., backwards
selection). Additionally, the analysis is not biased by post-hoc
selection of statistical methods (e.g., the selection of GLMM versus
generalized estimating equations) or the post-hoc selection of clinical
outcomes (e.g., graft versus patient survival). A potential
disadvantage is the omission of potentially important covariates or
interactions in the primary analysis although appropriate sensitivity
analyses should alleviate these concerns. Additionally, important risk
factors may not be collected (e.g., cardiovascular risk factors) and
could confound the analysis if the prevalence of the risk-factors in
high-risk transplants increases post-implementation. Finally, the
analysis may also be confounded by temporal trends in the organ
utilization of high-KDPI kidneys or graft survival of high-risk
transplants.
______
MPSC STAFF SUMMARY
Allocation Operational Rule Updates
July 11, 2017
Item for Consideration:
At the July 2017 MPSC meeting, the MPSC will be asked to consider an
update to its existing allocation operational rule. The proposed rule
would automatically close cases with no action when an OPO expedites
placement of an extra-renal organ if a transplant program declines the
organ in the donor OR.
Background:
Member Quality staff review the match run for all deceased donor organ
allocations that result in a transplant. Each month, the Quality
Assurance Analysts identify approximately 250-300 transplants with
deviations from the match run. The analysts inquire with members and
forward potential policy violations to the MPSC. Possible violations
include instances when an OPO skips or bypasses patients on the wait
list (``allocation out of sequence''), a transplant program accepts an
organ offer for one patient but transplants another patient on the
match run (``actual versus intended''), or a transplant program
transplants a patient not on a match run (``not on the match run'').
Analysts send the MPSC one summary per year for each member. The
summary allows the MPSC to review any potentially concerning patterns
of behavior over time.
The MPSC has closed almost all allocation deviations with no action;
most members attempt to follow the match run as much as possible but
deviate from the match run to avoid organ wastage. To streamline the
review process, the MPSC developed operational rules to automatically
close cases with no action when it is likely that allocation deviation
was necessary to avoid organ wastage. The MPSC developed the current
operational rules through 2012 and 2013, and the committee approved
them in April 2013.
The MPSC does not review allocations when:
An OPO expedites placement of any organ from a Hepatitis C
positive donor.
An OPO expedites placement of any organ from a Hepatitis B core
positive donor.
An OPO expedites placement of any organ from a donor more than
70 years old.
A program transplants any organ into a patient other than the
original intended recipient and the Host OPO granted the transplant
program local back up.
A program transplants a kidney patient out of sequence due to
medical urgency as permitted by Policy 8.2.A.
A program transplants a kidney recipient who does not appear on
the match run as described in Policy 5.4.E.
An OPO expedites placement of any organ except kidneys from a
DCD donor.
Proposed Operational Rule:
MPSC leadership asked Member Quality staff to review relevant data and
suggest possible updates to the existing operational rules.
2016 MPSC Allocation Reviews:
270 total allocation reviews.
162 extra-renal organ allocations.
28 heart allocations, 3 declined in the donor OR.
36 lung allocations, 7 declined in the donor OR.
98 liver allocations, 66 declined in the donor OR.
The MPSC closed all 76 extra-renal allocations where a transplant
program declined the organ in the donor OR with no action. While
reviewing these cases, MPSC members often commented that the OPOs
appropriately expedited placement to avoid organ wastage.
Does the MPSC wish to add instances where an OPO expedites placement of
an extra-renal organ after a transplant program declines the organ in
the donor OR to its list of exclusionary criteria? This could eliminate
approximately 25 percent of the allocation cases the MPSC currently
reviews. Staff can make details of any case automatically closed with
no action available at any time. In addition, staff can provide data on
organs declined in the OR as needed for any allocation review projects.
The Subcommittee also considered whether the current criteria for
identification of small volume programs for lower than expected graft
or patient survival be removed from the Transplant Program Performance
bylaw. New criteria for identification of programs for review was
implemented in January 2015. The bylaw included new Bayes criteria for
identification of large volume programs and retained the previous
criteria for small volume programs of one death or graft failure in a
two and half year cohort. Programs that perform 9 or less transplants
in two and a half years are considered small volume under the
Transplant Program Performance bylaw. The MPSC uses operational rules
to decrease the number of small volume programs that receive an initial
inquiry.
The MPSC retained the small volume criteria in the proposal because of
some concerns that the Bayes methodology may not adequately identify
small volume programs that need improvement. However, the MPSC
committed to evaluate whether this small volume criteria could be
eliminated post-implementation. The Subcommittee reviewed data
regarding small volume program reviews since implementation of the new
bylaw. Based on this review, the Subcommittee recommended that the MPSC
approve elimination of the small volume criteria from OPTN Bylaws,
Appendix D.11.A.Transplant Program Performance. The Subcommittee
further recommended that the MPSC approve implementation of an
operational rule that would operationalize this change until the Bylaws
can be revised. The operational rule would provide that only those
small volume programs that are identified using the large volume Bayes
criteria be sent an initial outcomes inquiry.
The Committee approved the following resolution by a vote of 30
For; 1 Against; 0 Abstentions:
RESOLVED, the MPSC approves the elimination of the separate
small volume program criteria from OPTN/UNOS Bylaws, Appendix
D.11.A. Transplant Program Performance; using the current Bayes
criteria for identification of programs regardless of volume;
and implementation of an operational effective immediately to
operationalize this change until the OPTN/UNOS bylaws can be
revised.
______
MPSC Staff Summary
Late Notification of Key Personnel Departure
Proposed Operational Rule
Item for Consideration:
At the July meeting, the MPSC will be asked to consider an operational
rule to automatically place late notifications of key personnel
departures on a MPSC consent agenda with a recommendation to issue a
Notice of Uncontested Violation.
Summary:
Transplant programs and histocompatibility laboratories must notify
UNOS within 7 days of learning of a key personnel departure. These
members must also submit a key personnel change application 30 days
prior to the current key personnel's departure. (If the member receives
less than 60 days notice of the key personnel's planned departure, the
program must submit the key personnel change application within 30 days
of the departure). These requirements are in place to allow the member
to submit and the MPSC to review any key personnel change applications
prior to the current key personnel's departure and to avoid periods
where a program is without approved key personnel.
The following is a description of the current MPSC process for late
notifications of key personnel changes:
Staff identify a late notification and prepare a staff summary.
Staff present each late notification as a discussion item at the
in-person MPSC meeting.
The MPSC issues an action, generally a Notice of Uncontested
Violation.
The MPSC will discuss six late notification cases at the July 2017
meeting.
In an effort to reduce the MPSC's workload and to promote consistent
MPSC actions, staff are constantly evaluating potential operational
rules to place items on the MPSC's consent agenda. This minimizes the
number of cases posted for MPSC reviewers and the meeting time spent
discussing cases.
Based on the number of late notifications, the consistent MPSC action
and limited discussion or debate typically associated with these cases
at MPSC meetings, staff have developed the following operational rule
for the MPSC's consideration:
Staff identify a late notification.
If the member notified UNOS more than 7 days after hospital
learned of key personnel departure and submits a key personnel change
application at least 30 days before the current key personnel departs,
staff will document and close the late notification with no further
action needed. Staff will educate the member on the late notification
requirements.
If the:
Member fails to notify UNOS within 7 days after
the hospital learned of a key personnel departure; and
The failure to timely notify results in an
inability to submit a key personnel change application at least
30 days before the current key personnel departs; and
This is the member's first late notification.
Staff will place the item on the Applications Consent agenda with
a recommendation to issue a Notice of Uncontested Violation.
If the:
Member fails to notify UNOS within 7 days after
the hospital learned of a key personnel departure; and
The failure to timely notify results in an
inability to submit a key personnel change application at least
30 days before the current key personnel departs; and
The member has at least one previous late
notification in its compliance history or if there are any
extenuating or unusual circumstances.
Staff will post a staff summary and case packet for reviewers.
If reviewers agree on a recommendation, staff
will add the recommendation to the Applications Consent Agenda.
If reviewers disagree on a recommendation, the
MPSC will discuss the issue at its next meeting.
The MPSC will receive a copy of the consent agenda in advance of
the meeting. An MPSC member may request to see the corresponding
documentation and/or move any consent agenda item to the discussion
agenda.
Examples:
Notice of Uncontested Violation: Program notifies UNOS 2 days
after primary surgeon departed. Upon inquiry, the member states that
the surgeon notified the hospital of the departure date 6 months
earlier.
Notice of Uncontested Violation: Program notifies UNOS 15 days
prior to primary surgeon departure and states that the surgeon had
given notice of his departure to the hospital 6 months earlier.
Application cannot be completed, processed and approved by MPSC prior
to departure resulting in a period where the program is without an
approved primary surgeon.
Document and close with no action: Program notifies UNOS 2
months prior to primary surgeon departure and states that the surgeon
had given notice of his departure to the hospital 6 months earlier.
Application sent to member and received 30 days prior to departure
date.
No Bylaw Violation: Primary surgeon notifies hospital that he is
departing effective that day. Hospital notifies UNOS and submits
application within 30 days.
Relevant OPTN Bylaw or Policy:
Appendix C.5 Changes in Key Laboratory Personnel
A. Change in Laboratory Director, Technical Supervisor, or Clinical
Consultant
When the histocompatibility laboratory is informed that the laboratory
director, technical supervisor, or clinical consultant plans to leave
or otherwise ends active participation in the laboratory, the
laboratory must:
1. Notify the OPTN contractor in writing within 7 business days of
when the laboratory becomes aware of the change in key personnel.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the end of the individual's
active employment or change in status. The Personnel Change Application
must document that the new or acting laboratory director, technical
supervisor, and clinical consultant meet the requirements of these
Bylaws.
3. Submit an updated Laboratory Coverage Plan no less than 30 days
before the date of departure that specifies how continuous coverage
will be provided at the laboratory by all key personnel during and
after the transition period to a new or acting laboratory director,
technical supervisor, or clinical consultant.
4. If the histocompatibility laboratory receives less than 60 days
notice of the key personnel change, then the laboratory must submit a
completed Personnel Change Application and updated Laboratory Coverage
Plan to the OPTN contractor within 30 days of the date of departure.
Appendix D.7 Changes in Key Transplant Program Personnel
Designated transplant programs must have key personnel, specifically a
primary surgeon and a primary physician, who meet the required minimum
levels of commitment to and knowledge of organ procurement and
transplantation as specified in these Bylaws. All transplant programs
should develop a succession plan that addresses changes in these key
personnel.
When a designated transplant program is informed of a change in key
personnel, it must notify the OPTN contractor within 7 business days in
writing and follow the procedures that are described below. A change in
key personnel can be any of the following:
Departure of the primary surgeon or primary physician.
Change in position from primary surgeon or primary physician to
an additional surgeon or physician.
Temporary leave.
Reinstatement of the previously designated primary surgeon or
physician.
Transplant programs are also responsible for maintaining Program
Coverage Plans as described in Section D.6.B. Surgeon and Physician
Coverage (Program Coverage Plan) above during changes in key personnel.
The Program Coverage Plan must address instances when key personnel are
unavailable to perform their transplant duties for short periods of
time.
A. Primary Surgeon or Primary Physician Departure
When the transplant hospital is informed that either the primary
surgeon or primary physician plans to leave the hospital or otherwise
end their active participation in the transplant program, the
transplant hospital must:
1. Notify the OPTN contractor in writing within 7 business days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the end of the individual's
active employment. The Personnel Change Application must document that
the new primary surgeon or primary physician meets the requirements of
these Bylaws.
If the transplant hospital receives less than 60 days advance notice of
the key personnel change, then the transplant hospital must submit a
completed Personnel Change Application to the OPTN contractor within 30
days from the date the OPTN contractor was notified.
If a program is unable to demonstrate through a completed Personnel
Change Application that it has on site both a transplant surgeon and a
transplant physician who meet the requirements for primary surgeon and
primary physician, the transplant hospital must either:
Inactivate the designated transplant program.
Withdraw its designated transplant program status as described
in Section K.4: Withdrawal or Termination of Designated Transplant
Program Status of these Bylaws.
B. Primary Surgeon or Primary Physician Change in Role
When the transplant hospital plans to propose a new primary surgeon or
primary physician and the currently designated primary surgeon or
physician will remain on staff as an additional surgeon or physician,
the transplant hospital must:
1. Notify the OPTN contractor in writing within 7 business days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the change will take effect. The
Personnel Change Application must document that the new primary surgeon
or physician meets the requirements of these Bylaws.
The transition to the new primary surgeon or primary physician is
effective after the application has been reviewed and approved by the
MPSC or an Ad hoc Subcommittee of the MPSC, as described in Appendix A:
Membership Application and Review of these Bylaws.
C. Primary Surgeon or Primary Physician Temporary Leave
If the primary surgeon or physician must take a temporary leave of
absence or otherwise temporarily cease their active participation with
the transplant program, the transplant hospital must:
1. Notify the OPTN contractor in writing within 7 business days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the individual's leave begins.
The Personnel Change Application must document that the replacement
primary surgeon or physician meets the requirements of these Bylaws.
Temporary leave is defined in these Bylaws as greater than 30 days but
less than one year. If the transplant hospital receives less than 60
days advance notice of the leave, then the transplant hospital must
submit a complete Personnel Change Application to the OPTN contractor
within 30 days from the date the OPTN contractor was notified.
If a program is unable to demonstrate through a completed Personnel
Change Application that it has on site both a transplant surgeon and a
transplant physician who meet the requirements for primary surgeon and
physician, the transplant hospital must either:
Inactivate the designated transplant program.
Withdraw its designated transplant program status as described
in Appendix K of these Bylaws.
D. Reinstatement of Previously Designated Primary Surgeon or Primary
Physician
If the previously designated primary surgeon or primary physician
returns to the same transplant program within one year of departure the
individual can be considered for reinstatement as the primary surgeon
or primary physician. The transplant hospital must submit a written
reinstatement request to the OPTN contractor.
The written reinstatement request must include all of the following:
1. A letter from the Transplant program director, department chair, or
chief of the division, verifying the individual's current working
knowledge and experience.
2. A letter from the individual confirming the individual's on-site
availability and commitment to the program.
3. A current letter from the hospital credentialing committee
verifying that the individual meets the requirements and is qualified
and able to resume as primary surgeon or primary physician.
The MPSC or an Ad hoc Subcommittee of the MPSC will review requests for
reinstatement, as described below. In cases where reinstatement of a
surgeon or physician affects the transplant program's current status,
the MPSC will recommend the appropriate new program status, along with
any resulting special conditions.
E. Failure to Notify the OPTN Contractor of Key Personnel Changes
Any member who fails to inform the OPTN contractor of a change in the
primary surgeon or primary physician or to submit the required
Personnel Change Application within the periods specified above will be
reviewed by the MPSC. The MPSC may impose a sanction, including any of
the following:
A Notice of Uncontested Violation.
Letter of Warning.
Letter of Reprimand.
Each of these sanctions and other adverse actions that may be taken by
the MPSC are further described in Appendix L: Reviews, Actions, and Due
Process of these Bylaws.
Failure to inform the OPTN contractor of changes in primary surgeon or
primary physician or to submit the required Personnel Change
Application will result in a recommendation that the Board of Directors
take appropriate adverse actions. Additionally, the Board of Directors
may notify the Secretary of Health and Human Services (HHS) of the
violation.
______
MPSC STAFF SUMMARY
Wait-List Inactivity Operational Rule
Proposed Operational Rule
January 30, 2018
Item for Consideration:
During the January 30, 2018 teleconference meeting, staff will present
a proposed operational rule regarding member compliance with the
requirements for patient notification in OPTN Bylaws Appendix D.11.B
which require a member to notify all candidates on its wait list when a
threshold of 15 consecutive days of inactivity and/or 28 cumulative
days of inactivity is met. The MPSC will be asked to vote to approve
the rule.
Summary:
Historically, compliance with this bylaw was reviewed at each PAIS
meeting. Notification letters submitted to staff were posted to
committee management for review, and the committee would often issue a
Notice of Uncontested Violation for any instance of noncompliance
identified.
The site survey team has assumed responsibility for reviewing member
compliance with this bylaw and will perform member reviews on an annual
basis. Site Survey would like to propose an operational rule, similar
to the rules that Safety Analysts and Allocation Analysts use; a first
event of noncompliance would be ``closed'' and not forwarded to the
committee, and language would be communicated to the member that any
subsequent instance would then be forwarded on for committee review (as
well as the first event).
Proposed rule: ``Site survey staff will request members to implement
corrective actions for first event of identified noncompliance with the
wait-list inactivity notifications bylaw and will not forward the
matter to the MPSC for review. If staff identifies a second event of
noncompliance in a subsequent annual review, staff will gather
documentation from the member and provide all events' documentation to
the MPSC for review.''
If approved, the rule will be effective immediately.
Examples:
Member ABCD's kidney transplant program met the 28 cumulative day
inactivity threshold in 2016. UNOS's Research department provides to
the site survey team a random sample of 10 candidates on member ABCD's
kidney wait list. Site Survey mails an inquiry letter with the patient
sample to Member ABCD and requests that the member submit all required
patient notifications. Member ABCD responds that they failed to notify
their candidates when they met the cumulative day inactivity threshold,
although they had notified their candidates of their plan to inactivate
their list per other bylaw requirements. Site Survey requests a
Corrective Action Plan and provides education to Member ABCD about the
requirements in Bylaws Appendix D.11.B. Site Survey mails a Closing
Letter to Member ABCD notifying them that the review is closed, that
the event will not be forwarded to the MPSC, and that if another event
of noncompliance is identified on a future annual review, all events
will be forwarded to the MPSC at that time.
Relevant OPTN Bylaw or Policy:
OPTN Bylaws Appendix D.11.B Patient Notification Requirements for
Waiting List Inactivation.
A transplant program must provide written notice to candidates if it
does either or both of the following:
1. Inactivates its waiting list for 15 or more consecutive days.
2. Inactivates its waiting list for 28 or more cumulative days
during any calendar year.
A transplant program must provide written notice each time it reaches
either of the inactive waiting list thresholds listed above. Written
notice must include all of the following:
1. The reason for the inactivity.
2. The expected length of time that the waiting list will be
inactive.
3. The explanation that during the period of inactivity, organs
cannot be accepted on the candidate's behalf at this transplant
program.
4. The options available to the candidate during this period,
including multiple listing or transferring of accrued waiting time to
another Transplant Hospital.
5. How the candidates will be notified when the waiting list is
reactivated or if the expected length of inactivation is extended.
6. A copy of the OPTN contractor's Patient Information Letter.
Note: If written notice is required because a transplant program
exceeded the inactive waiting list threshold due to cumulative periods
of inactivation, then the written notice must also include the dates of
each instance of waiting list inactivation.
Written notice must be provided within the periods defined in the table
below:
------------------------------------------------------------------------
Written Notice Must Be
For . . . Provided . . .
------------------------------------------------------------------------
Periods of waiting list inactivation 30 days before inactivity
scheduled at least 30 days in advance. begins.
------------------------------------------------------------------------
Periods of waiting list inactivation No more than 7 days
scheduled less than 30 days in advance. following the initial date
of waiting list
inactivation.
------------------------------------------------------------------------
Any periods of waiting list inactivation No more than 7 days
related to a cumulative period of following the last date of
inactivation. the inactive period that
caused the transplant
program to exceed the
inactive waiting list
threshold.
------------------------------------------------------------------------
______
MPSC Staff Summary
MPSC Review of Non-institutional Member Renewals
Proposed Operational Rule
March 1, 2018
Item for Consideration:
During the Applications agenda review at the MPSC meeting on March 1,
2018, staff will present a proposed operational regarding MPSC review
of non-institutional member renewals under OPTN Bylaws Article 1. Non-
institutional members are required to renew their OPTN membership every
2 years. Staff are proposing that the MPSC adopt an operational rule
that would place these renewal applications directly on an MPSC Consent
Agenda if all requirements are met. The MPSC will be asked to vote to
approve the operational rule.
Summary
Non-institutional members of the OPTN include:
Medical/Scientific.
Public Organization.
Business.
Individuals.
Non-institutional members must meet the fairly minimal requirements for
membership contained in OPTN Bylaws, Article 1. For example, a medical/
scientific member needs to be a non-profit organization whose members
include medical or scientific professionals with an interest in organ
donation or transplantation and that has either of the following:
Been in operation for at least one year.
Letters of recommendation from at least three OPTN transplant
hospital, OPO, histocompatibility laboratory, public organization or
medical/scientific Members.
The non-institutional members have two year terms and need to apply for
renewal of their membership at the end of each term.
Currently, all of the applications, new members and renewals, are
posted for review by an ad hoc subcommittee and then placed on the
applications consent agenda for the full MPSC.
UNOS staff is proposing that renewals for non-institutional members be
placed directly on the MPSC consent agenda to approve if all
requirements under OPTN Bylaws, Article 1 are met.
Below are the non-institutional member application numbers for 2016 and
2017:
------------------------------------------------------------------------
2017 2016
Member type -------------------------------------------
New Renewals New Renewals
------------------------------------------------------------------------
Medical/Scientific 0 2 0 11
------------------------------------------------------------------------
Public Organization 1 3 0 2
------------------------------------------------------------------------
Business 1 2 0 1
------------------------------------------------------------------------
Individual 0 6 0 2
------------------------------------------------------------------------
Totals 2 13 0 18
------------------------------------------------------------------------
Relevant OPTN Bylaw or Policy:
OPTN Bylaws, Article 1:
1.5 Medical/Scientific Members
A medical/scientific member is a non-profit organization whose members
include medical or scientific professionals with an interest in organ
donation or transplantation and that has either of the following:
1. Been in operation for at least one year.
2. Letters of recommendation from at least three OPTN transplant
hospital, OPO, histocompatibility laboratory, public organization, or
medical/scientific Members.
1.6 Public Organization Members
A public organization member is an organization with an interest in
organ donation or transplantation and must have been in operation for
at least one year. A public organization member must also be one of the
following:
1. A hospital that refers at least one potential organ or tissue donor
per year.
2. A non-profit organization that engages in organ donation
activities, or represents or directly provides support and services to
transplant candidates, recipients or their families.
3. A non-profit organization that has letters of recommendation from
at least three OPTN transplant hospital, OPO, histocompatibility
laboratory, public organization, or medical/scientific members.
1.7 Business Members
A business member must be an organization in operation for at least one
year that engages in commercial activities with two or more active OPTN
transplant hospital, OPO, or histocompatibility laboratory members.
1.8 Individual Members
An individual member must be a person who meets any of the following
criteria:
1. Has served or is presently serving on the OPTN Board of Directors
or an OPTN committee.
2. Is a transplant candidate, recipient, or organ or tissue donor.
3. Is the family member of a transplant candidate, recipient, or organ
or tissue donor.
4. Is presently employed by or is an independent contractor to OPO,
transplant hospital, or histocompatibility laboratory members.
5. Is formerly employed by or is formerly an independent contractor
for OPO, transplant hospital, or histocompatibility laboratory members.
6. Is formerly employed by a Federal or State government agency
involved in organ donation or transplantation, and who demonstrates
continued interest and involvement in organ donation or
transplantation.
7. Has an active interest and involvement in organ donation or
transplantation demonstrated by at least three letters of
recommendation for membership from three other OPTN individual members.
______
MPSC STAFF SUMMARY
Proposed Process Change
Key Personnel Change
Applications
July 18, 2018
Item for Consideration:
During the July 18, 2018 meeting, staff will present a proposed process
change regarding moving Transplant program Key Personnel Change
applications directly to an MPSC consent agenda if staff review reveals
the application clearly meets the OPTN bylaws membership criteria. The
MPSC will be asked to vote to approve the rule at this meeting.
Summary:
Ad hoc subcommittees of the MPSC review every key personnel change
application for compliance with the membership requirements in the OPTN
bylaws. In 2017, these subcommittees reviewed 175 transplant program
key personnel change applications. The OPTN bylaw membership
requirements are detailed and the membership applications request
specific information designed to demonstrate whether a proposed primary
surgeon or primary physician meet the requirements. Most proposed
transplant program key personnel clearly meet the requirements of the
OPTN bylaws. Therefore, MPSC ad hoc subcommittee review does not appear
to be a value added activity and is not a productive use of MPSC
members review time.
Proposed rule: Transplant program key personnel change applications
that clearly meet the OPTN bylaw membership requirements will be placed
directly on the MPSC consent agenda for the next scheduled meeting
(conference call or in person). UNOS staff will post for MPSC ad hoc
subcommittee review any application where expert judgment is needed to
determine if the application should be approved.
If approved, the rule will be effective immediately.
Example(s):
UNOS staff have identified the following examples that would require
posting of an application for MPSC ad hoc subcommittee review:
The program is requesting conditional approval for key personnel
or extensions of conditional approval.
Coverage plans that require approval of exceptions provided for
in the OPTN bylaws.
Letters of recommendation that do not clearly contain all
requirements.
Situations where a letter of attestation must be used such as
for procurements from a long time ago.
Relevant OPTN Bylaw or Policy:
OPTN Bylaws, Appendix D, D.7 Changes in Key Transplant Program
Personnel
Designated transplant programs must have key personnel, specifically a
primary surgeon and a primary physician, who meet the required minimum
levels of commitment to and knowledge of organ procurement and
transplantation as specified in these Bylaws. . . .
A. Primary Surgeon or Primary Physician Departure
When the transplant hospital is informed that either the primary
surgeon or primary physician plans to leave the hospital or otherwise
end their active participation in the transplant program, the
transplant hospital must:
1. Notify the OPTN contractor in writing within 7 business days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the end of the individual's
active employment. The Personnel Change Application must document that
the new primary surgeon or primary physician meets the requirements of
these Bylaws.
If the transplant hospital receives less than 60 days advance
notice of the key personnel change, then the transplant hospital must
submit a completed Personnel Change Application to the OPTN contractor
within 30 days from the date the OPTN contractor was notified.
If a program is unable to demonstrate through a completed
Personnel Change Application that it has on site both a transplant
surgeon and a transplant physician who meet the requirements for
primary surgeon and primary physician, the transplant hospital must
either:
Inactivate the designated transplant program.
Withdraw its designated transplant program status as
described in Section K.4: Withdrawal or Termination of Designated
Transplant Program Status of these Bylaws.
B. Primary Surgeon or Primary Physician Change in Role
When the transplant hospital plans to propose a new primary
surgeon or primary physician and the currently designated primary
surgeon or physician will remain on staff as an additional surgeon or
physician, the transplant hospital must:
1. Notify the OPTN contractor in writing within 7 business
days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the change will take effect. The
Personnel Change Application must document that the new primary surgeon
or physician meets the requirements of these Bylaws.
The transition to the new primary surgeon or primary physician
is effective after the application has been reviewed and approved by
the MPSC or an Ad hoc Subcommittee of the MPSC, as described in
Appendix A: Membership Application and Review of these Bylaws.
C. Primary Surgeon or Primary Physician Temporary Leave
If the primary surgeon or physician must take a temporary
leave of absence or otherwise temporarily cease their active
participation with the transplant program, the transplant hospital
must:
1. Notify the OPTN contractor in writing within 7 business
days.
2. Submit a completed Personnel Change Application to the OPTN
contractor no less than 30 days before the individual's leave begins.
The Personnel Change Application must document that the replacement
primary surgeon or physician meets the requirements of these Bylaws.
Temporary leave is defined in these Bylaws as greater than 30
days but less than one year.
If the transplant hospital receives less than 60 days advance
notice of the leave, then the transplant hospital must submit a
complete Personnel Change Application to the OPTN contractor within 30
days from the date the OPTN contractor was notified.
If a program is unable to demonstrate through a completed
Personnel Change Application that it has on site both a transplant
surgeon and a transplant physician who meet the requirements for
primary surgeon and physician, the transplant hospital must either:
Inactivate the designated transplant program.
Withdraw its designated transplant program status as
described in Appendix K of these Bylaws.
D. Reinstatement of Previously Designated Primary Surgeon or Primary
Physician
If the previously designated primary surgeon or primary
physician returns to the same transplant program within one year of
departure the individual can be considered for reinstatement as the
primary surgeon or primary physician. The transplant hospital must
submit a written reinstatement request to the OPTN contractor.
The written reinstatement request must include all of the
following:
1. A letter from the Transplant program director, department
chair, or chief of the division, verifying the individual's current
working knowledge and experience.
2. A letter from the individual confirming the individual's
on-site availability and commitment to the program.
3. A current letter from the hospital credentialing committee
verifying that the individual meets the requirements and is qualified
and able to resume as primary surgeon or primary physician.
The MPSC or an Ad hoc Subcommittee of the MPSC will review
requests for reinstatement, as described below. In cases where
reinstatement of a surgeon or physician affects the transplant
program's current status, the MPSC will recommend the appropriate new
program status, along with any resulting special conditions.
Applicable membership requirements for organ specific primary
transplant surgeons and physicians can be found in:
Appendix E: Membership and Personnel Requirements for Kidney
Transplant Programs.
Appendix F: Membership and Personnel Requirements for Liver
Transplant Programs.
Appendix G: Membership and Personnel Requirements for Pancreas
and Pancreatic Islet Transplant Programs.
Appendix H: Membership and Personnel Requirements for Heart
Transplant Programs.
Appendix I: Membership and Personnel Requirements for Lung
Transplant Programs.
______
MPSC STAFF SUMMARY
Proposed Process Change
Late Reports of Potential
Disease Transmissions to the OPTN
July 18, 2018
Item for Consideration:
During the July 18, 2018 meeting, staff will present a proposed process
change regarding late reports of potential disease transmission to the
OPTN required in Policies 15.4, 15.5, and 15.6. The MPSC will be asked
to vote to approve the rule.
Summary:
Policies 15.4.A and 15.4.B require host OPOs to submit certain
potential donor-
derived disease transmissions to the OPTN Improving Patient Safety
Portal as well as to the receiving transplant centers within 24 hours.
Policy 15.5.B requires transplant centers to notify both the host OPO
and the OPTN Improving Patient Safety Portal within 24 hours after
learning of a potential donor-derived disease transmission. Policy
15.6.A requires recovery hospitals to notify the receiving transplant
program and the OPTN Improving Patient Safety Portal within 7 days when
new information is learned about a living donor that indicates a risk
of potential disease transmission or malignancy within two years post-
donation.
Currently, events that are appropriately reported to the applicable
members within required time frames but submitted late to the OPTN are
referred to the MPSC for review, even though the patient safety risk
was appropriately mitigated.
In an effort to reduce MPSC and UNOS staff workload and promote process
improvement, staff are proposing a First-Time Non-Compliance (FTNC)
process change in certain late reports of potential disease
transmission to the OPTN. If a case meets FTNC criteria, Safety
Analysts would investigate the cause of the delayed report, request the
results of any root cause analyses (RCA) performed, and request
documentation of any corrective action plans (CAP) per the normal
investigative process. Assuming the RCA and CAP appropriately address
the gap that led to the late report, the new process change would allow
Safety Analysts close the case instead of sending it to the MPSC for
review. This allows the member to develop corrective actions without a
MPSC referral and reduces the workload of MPSC members and UNOS staff.
FTNC Conditions:
Member has no late report non-compliances since August 1, 2016, and
meets one of the following three circumstances as appropriate:
1. A host OPO who did not report a Pathogen of Special Interest,
malignancy or other finding highly suggestive of malignancy recognized
after procurement, or discovery of recipient disease to the Improving
Patient Safety Portal within 24 hours, but did make the required
notifications to all recipient centers per OPTN Policy 15;
2. A transplant center who did not report to the Improving Patient
Safety Portal within 24 hours when an organ recipient has, is suspected
to have, or has died from a potentially donor-derived transmissible
disease, infection or malignancy, but did notify the host OPO within 24
hours per OPTN Policy 15;
3. A living donor recovery hospital who notified the receiving
transplant program of new information indicating a risk of potential
disease or malignancy transmission during the first two years post-
donation, but did not report it to the Improving Patient Safety Portal
within 7 days per OPTN Policy 15.
The FTNC process change can only be applied to a member one time. Thus,
if a member has a subsequent case of a late report to the OPTN, that
case would be referred to the MPSC even if the other members were
notified within time frames required. If a second case is identified
and referred to the MPSC for review, the first case will also be
included for MSPC review.
Since August 2014, Member Quality has investigated 26 cases of
potential donor-derived disease transmissions and malignancies reported
late to the OPTN and/or to the required members. Of these 26 cases, 14
(54%) were reported to the necessary members as required by policy and
were reported late only to the OPTN. To date, none of those centers
have reported a potential donor-derived disease transmission late a
second time, which suggests the member implemented appropriate
corrective actions in response to those events.
Proposed rule: Cases that meet FTNC conditions would be investigated,
with RCAs and CAPs obtained and reviewed by Safety Analysts, but would
be closed and would not be referred to the MPSC for review. Should
subsequent non-compliances be identified, those cases would be sent to
the MPSC for review and the first case initially closed would be
included.
If approved, the rule will be effective August 1, 2018.
Example(s):
OPO ABCD received donor test results that resulted positive for Chagas
in the left kidney recipient of a donor who also donated a right
kidney, heart, and liver. OPO ABCD notified all other recipient centers
immediately upon receiving the notification, but did not submit the
information to the OPTN Improving Patient Safety Portal for five days.
Investigation into the late reporting revealed that internal policy did
not specify the need to report Pathogens of Special Interest to the
OPTN Improving Patient Safety Portal within 24 hours so staff believed
the timely reporting to the receiving centers was all that was
required. Internal policy was updated and staff were re-educated on
Policy 15.4. Because the appropriate notifications were made to protect
patient safety and the OPO had no prior non-compliances with regard to
reporting potential disease transmissions, this case would not be
referred to the MPSC for review.
Hospital EFGH identified adenocarcinoma in the heart recipient and upon
review of donor and recipient records, had substantial concern that the
malignancy could be donor-derived. The Hospital immediately notified
the OPO but did not submit a report to the OPTN Improving Patient
Safety Portal. During the investigation, the hospital reported that
they believed hospitals were only responsible for notifying the OPO and
that the OPO was responsible for all notifications and reports
thereafter. The Hospital updated all process checklists, internal
policy, added a note in their EMR to remind staff to notify the OPO and
the OPTN, and re-educated staff. The hospital notified the OPO within
24 hours and had not had a prior late report to the OPTN, so this case
would not be referred to the MPSC for review.
A living kidney donor is diagnosed with breast cancer one year post-
donation. The hospital documented the information in the donor's chart,
but did not notify the receiving center until two months later when a
new coordinator identified the error during chart review. The hospital
had no prior non-compliances related to potential disease
transmissions, but had not made the required notification to the
receiving transplant program so this case would be referred to the MPSC
for review.
Relevant OPTN Bylaw or Policy:
15.4.A Host OPO Requirements for Reporting Post-Procurement Donor
Results and Discovery of Potential Disease Transmissions
The host OPO must report all positive test results and other relevant
information received post-procurement for each donor as soon as
possible but no later than 24 hours after receipt as follows:
1. All results indicating Pathogens of Special Interest must be
reported to the receiving transplant program's patient safety contact
and the OPTN Improving Patient Safety Portal. The OPTN contractor
provides a list of Pathogens of Special Interest, including any results
that can be excluded from reporting. The OPTN contractor reviews and
updates this list at least annually.
2. All other positive test results and relevant information must be
reported according to Table 15-1 below.
Table 15-1: Host OPO Reporting Requirements for Positive Post-
Procurement Donor Results and Discovery of Potential Disease
Transmissions
------------------------------------------------------------------------
The host OPO must report all of the
following positive results: To:
------------------------------------------------------------------------
Samples relevant to all recipients
------------------------------------------------------------------------
Serologic, NAT, or antigen results The receiving transplant program's
indicating presence of parasites, patient safety contact
virus, or fungi
------------------------------------------------------------------------
Cultures from the following The receiving transplant program's
specimens: patient safety contact
Ascites
Blood
Cerebrospinal fluid (CSF)
Deep wound
Genital
Pericardial
Pleural fluid
------------------------------------------------------------------------
Mycobacterial smears and cultures The receiving transplant program's
patient safety contact
------------------------------------------------------------------------
Fungal smears and cultures with the The receiving transplant program's
exception of Candida species patient safety contact
------------------------------------------------------------------------
Relevant information
------------------------------------------------------------------------
Respiratory samples (bacterial or The receiving transplant program's
Candida species) only to patient safety contact
transplant programs receiving
lungs or head and neck VCAs
------------------------------------------------------------------------
Urine cultures (bacterial or The receiving transplant program's
Candida species) only to patient safety contact
transplant programs receiving
kidneys or genitourinary VCAs
------------------------------------------------------------------------
Malignancy or other findings highly 1. The receiving transplant
suggestive of malignancy program's patient safety contact
recognized after procurement
2. The OPTN Improving Patient
Safety Portal
------------------------------------------------------------------------
Histopathology results reported The receiving transplant program's
post-procurement patient safety contact
------------------------------------------------------------------------
Relevant information
------------------------------------------------------------------------
All final culture information for The receiving transplant program's
any culture results that were patient safety contact
reported according to these
requirements
------------------------------------------------------------------------
Other psycho-social history, The receiving transplant program's
medical history, autopsy, testing, patient safety contact
and laboratory findings
identifying infectious conditions
that may adversely affect a
potential transplant recipient
------------------------------------------------------------------------
15.4.B Host OPO Requirements for Reporting Post-Procurement Discovery
of Recipient Disease or Malignancy
If the host OPO is notified that an organ recipient is suspected to
have, is confirmed positive for, or dies from a potential transmissible
disease, infection, or malignancy and there is substantial concern that
it could be from the transplanted organ, then the host OPO must do all
the following:
1. Communicate the suspected donor's and affected organ recipient's
test results and diagnosis that may be relevant to acute patient care,
as soon as possible but no more than 24 hours after receipt, to any
transplant program patient safety contacts and tissue banks that
received organs, vessels, or tissue from the donor. This includes any
test results that were not available at the time of procurement or that
were performed after procurement. The host OPO must document that this
information is shared with all receiving transplant programs and tissue
banks.
2. Report the event to the OPTN Improving Patient Safety Portal as soon
as possible but no more than 24 hours after notification or receipt of
recipient test results or diagnosis.
15.5.B Transplant Program Requirements for Reporting Post-Transplant
Discovery of Recipient Disease or Malignancy
When an organ recipient is suspected to have, is confirmed positive
for, or has died from a potential transmissible disease, infection, or
malignancy and there is substantial concern that it could be from the
transplanted organ, then the transplant program must do all of the
following:
1. Notify host OPO or living donor recovery hospital that procured the
organ without waiting for all medical documentation that may eventually
become available. The transplant program must notify the host OPO or
living donor recovery hospital by phone and provide documentation as
soon as possible but no more than 24 hours after learning of the event.
2. Report the event through the OPTN Improving Patient Safety Portal as
soon as possible but no more than 24 hours after learning of the event.
3. Provide additional related information or specimens if requested.
15.6.A Living Donor Recovery Hospital Requirements for Reporting Post-
Donation Discovery of Living Donor Disease or Malignancy
If a living donor recovery hospital learns new information about a
living donor during the first two years post donation that indicates
risk of potential transmission of disease or malignancy, then the
living donor recovery hospital must do all of the following:
1. Disclose to the living donor that the potential disease transmission
or malignancy will be reported to the receiving transplant program and
the OPTN Improving Patient Safety Portal.
2. Notify the receiving transplant program.
3. Report the potential transmission through the OPTN Improving Patient
Safety Portal as soon as possible but no more than 7 days after receipt
of the new information.
MPSC Determination:
At its meeting on July 18, 2018, the MPSC accepted the proposal with
two changes:
1. All members will begin with a ``clean slate,'' i.e., any instances
of late reports that have occurred prior to implementation of this
process change are not counted towards the member's FTNC conditions
considerations.
2. The FTNC condition will be maintained for three years. Because the
MPSC reviews a member's compliance history going back three years,
members thought a similar time frame should be applied here.
No other changes were recommended. With the above two changes added
into the proposal, the MPSC voted 33-0-0 to accept and implement this
change.
______
Member Quality Site Survey
Process Proposal
MPSC Meeting
July 18, 2018
Staff Summary
Item for Consideration:
At the July 2018 MPSC meeting, the MPSC will consider changes to the
process by which the MPSC reviews member site survey reports. The
proposed process revisions will decrease the MPSC's case review
workload and will better identify for the MPSC review members that have
ongoing compliance issues. The process change will also reduce the
amount of time members must wait to learn the outcome of their survey
and the amount of time between the initial survey to and follow-up
surveys.
Background:
The site survey ``scorecard'' is a tool used to determine which site
surveys can be placed straight on a MPSC consent agenda to close with
no action and which site surveys must be posted for MPSC reviewers to
determine an appropriate action. The chart below summarizes the current
``scorecard'' thresholds for different survey types:
_______________________________________________________________________
HR KI LI LU Transplant 95% Clinical Score Threshold
Programs 90% Administrative Score Threshold
Posted for reviewers if member's score is
below either threshold
------------------------------------------------------------------------
IN PA Programs No scorecard, posted for reviewers if
survey has any errors
------------------------------------------------------------------------
Living Donor Component of KI No scorecard, posted for reviewers if
and LI Program survey has any errors
------------------------------------------------------------------------
OPOs Clinical scorecard only; posted for
reviewers if survey has any errors.
------------------------------------------------------------------------
Problems with the current scorecard and MPSC site survey review process
include the following:
Members rely on their ``score'' as a determination of their
overall effectiveness. For example, members under outcomes review may
cite their ``100% clinical compliance score.''
Changes to the scorecard are difficult to make. Because each
policy is weighted within the scorecard, adding or changing a policy to
the survey process requires re-evaluating the weight assigned to every
other policy.
Surveys without an established scorecard and threshold must be
posted for MPSC review. This results in the MPSC reviewing surveys with
a small number of errors that the member has already corrected.
The MPSC reviewers typically must decide whether to close the
review with no action or request a follow-up desk review of certain
policies. Feedback received from MPSC reviewers in the past has
suggested that they are often happy to defer to staff recommendations
on whether to close the review or conduct a follow-up survey.
Proposed Process Change:
The proposed process would completely eliminate the current scorecard
approach for determining which cases are posted for MPSC review.
Instead, Member Quality staff will use a Survey Evaluation Tool (SET)
to determine whether a survey can be closed with no follow-up, whether
a follow-up focused desk review of certain policies is needed, or
whether the survey should be sent to MPSC reviewers to determine the
appropriate action.
Survey Evaluation Tool:
All policies reviewed will be placed into a category based on the
potential risk to patient safety. OPOs will have four categories while
transplant programs, including living donor, will have three categories
based on assigned risk. Each category will have a threshold for
compliance as described in the charts below.
Survey Evaluation Tool--OPO
------------------------------------------------------------------------
Examples of Policies in this Required Compliance
Category Rate
------------------------------------------------------------------------
Tier I Policy 2.6.B--A2 and A2B 100%
Requirements
------------------------------------------------------------------------
Tier II Policy 2.4 requires 90%
documentation of communicating
factors associated with an
increased risk for disease
transmission
------------------------------------------------------------------------
Tier III Policy 2.8 requires OPOs to have 80%
a urinalysis within 24 hours of
cross clamp
------------------------------------------------------------------------
Tier IV Policy 18.1 requires accuracy of No follow-up
data submitted on DDRs
------------------------------------------------------------------------
Survey Evaluation Tool--Transplant Programs
(including Living Donor)
------------------------------------------------------------------------
Examples of Policies in this Required Compliance
Category Rate
------------------------------------------------------------------------
Tier I Policy 5.8.B--Pre-Transplant 90%
Verification Upon Organ Receipt
Policy 14.4.A--Living Donor
Medical Evaluation Requirements
------------------------------------------------------------------------
Tier II Policy 3.9--Removing Candidates 80%
from the Waiting List
Policy 14.3--LD Informed Consent
Requirements
------------------------------------------------------------------------
Tier III Policy 3.2--Notifying Patients No follow-up
of Their Options
Policy 18.1--Data Submission
Requirements Accuracy
------------------------------------------------------------------------
Members continue to be asked to submit a corrective action plan for
noncompliance with any policy in any tier.
If an OPO member does not meet the required compliance threshold for a
policy in Tiers I, II and III, UNOS staff will automatically conduct a
follow-up desk review of that policy. Transplant programs that do not
meet the required compliance threshold for a policy in Tiers I and II
will automatically have a follow-up desk review of that policy within
six or twelve months, depending on the program's transplant volume. If
a member meets all the required compliance thresholds, UNOS staff will
automatically close the review with no action, without posting the case
for MPSC review.
UNOS staff will post for MPSC review the results of any follow-up
focused desk review where the member continued to not meet the required
compliance threshold.
Benefits of the proposed process include:
A reduction in cases posted for MPSC review. For example, staff
anticipate the MPSC will review approximately 18 fewer heart program
surveys and 20 fewer liver program surveys each year under this rule,
which will free up time the MPSC can use for other purposes.
Continued ability to post any unusual or concerning cases for
MPSC review. Currently, staff will send a case for MPSC review based on
concerns regarding patient safety or any unusual findings, regardless
of whether the case meets the established scorecard threshold. Staff
will continue to prioritize posting for MPSC review any such survey
report, regardless of the program's compliance rate with given
policies.
Ability to easily adapt the survey evaluation tool to policies.
For example, if site survey adds a newly implemented policy to the list
of policies reviewed during a survey, site survey will only need to
determine which tier to assign the policy; adding or removing a policy
from the site survey process will not impact the assigned tier or
compliance rate for any other policy.
Emphasis on member's improvement rather than strict adherence to
compliance. Members who have errors on their initial survey but
demonstrate improvement in their follow-up survey will automatically be
released from monitoring.
Data Modeling:
Data modeling comparing review via the SET with prior MPSC review show
the outcome is the same or slightly more conservative than the outcomes
determined by MPSC reviewers, as shown in the chart below.
------------------------------------------------------------------------
Same outcome in
current and More follow-up Fewer follow-up
Survey Type proposed desk reviews in desk reviews in
processes proposed process proposed process
------------------------------------------------------------------------
HR KI LI LU IN PA 305 reviews 45 reviews 5 reviews
------------------------------------------------------------------------
Living Donor KI 33 reviews 17 reviews 3 reviews
and LI
------------------------------------------------------------------------
OPO 19 reviews 9 reviews 3 reviews
------------------------------------------------------------------------
Data modeling also indicates there will be a significant reduction in
MPSC workload, as described in the table below.
------------------------------------------------------------------------
Number Number
Reviewed by Requiring
Survey Type Date Range Surveys MPSC Under MPSC Review
Performed Current Under New
Process Process
------------------------------------------------------------------------
Heart March 2017-March 74 22 4
2018
------------------------------------------------------------------------
Liver March 2017--March 53 22 2
2018
------------------------------------------------------------------------
Recommendation
The Policy Compliance Subcommittee (PCSC) of the MPSC heard a report
from site survey staff on this proposed process change during the
PCSC's June 25 conference call and unanimously recommended that the
MPSC vote to support the proposed concept. The MPSC will be asked to
vote on this concept as a part of the PCSC consent agenda during the
MPSC meeting on July 18, 2018.
MPSC STAFF SUMMARY
Possible Revision to Operational Rule
No inquiry 2 meeting cycles from release in outcomes cases
February 26, 2018
Item for Consideration: During the February 26, 2018 PAIS meeting,
staff presented possible options for revision of the operational rule
regarding postponement of new MPSC outcomes inquiry. The PAIS
recommended that the operational rule be revised to make a program
ineligible to receive a new inquiry for 2 SRTR reporting cycles which
results in a time period of ineligibility which is more consistent
regardless of when the program is released. The PAIS approved this
recommendation by a vote of 15 for, 0 against and 1 abstention.
Summary: Under the current operational rule, the MPSC will not send an
inquiry to a program for 2 meeting cycles following release from review
for lower than expected post-transplant outcomes. In July 2017, the
PAIS/MPSC endorsed the elimination of the data request for updated
Spring SRTR reports for use at the October Subcommittee/MPSC meeting.
UNOS staff have noticed that the elimination of this October report has
resulted in an inconsistent result when applying the 2 meeting cycle
operational rule:
------------------------------------------------------------------------
Inquiry if
Release 2 meeting still Results
date cycles flagged
------------------------------------------------------------------------
March 2018 July 2018, March 2019 Skip if flagged in July 2018
October 2018 SRTR report and send inquiry if
flagged in January 2019 SRTR
report--1 year from release
------------------------------------------------------------------------
July 2018 October 2018, July 2019 Skip if flagged in January 2019
March 2019 SRTR report and send inquiry if
flagged in July 2019 SRTR
report--1 year from release
------------------------------------------------------------------------
October March 2019, March 2020 Do not receive SRTR reports in
2018 July 2019 (3 October 2019 so skip January
meeting 2019 and July 2019 SRTR reports
cycles) and receive inquiry if flagged
in January 2020 SRTR reports--1
year and 5 months from release
------------------------------------------------------------------------
The MPSC adopted this operational rule to accommodate the fact that
there is a 1 year lag in the SRTR reporting of one-year post-transplant
outcomes but the MPSC reviews current data and events when a program is
under review. For example, the MPSC will have reviewed synopsis of
events and improvement efforts through April 30, 2018 for a program
that is released in July 2018. In addition to the 2 meeting cycle
operational rule, the MPSC does not send an inquiry if there have been
no new events at the program since the program's release from review.
If the MPSC was to change the operational rule to use the SRTR
reporting periods as the deciding factor for when a new inquiry would
be sent, the following would be the effect for skipping 1 reporting
cycle or 2 reporting cycles: Two SRTR reporting cycles:
------------------------------------------------------------------------
2 SRTR Inquiry if
Release reporting still
date cycles flagged
------------------------------------------------------------------------
March 2018 July 2018, July 2019 Eligible for new inquiry 1 year,
January 2019 4 months after release
------------------------------------------------------------------------
July 2018 January 2019, March 2020 Eligible for new inquiry 1 year,
July 2019 8 months after release
------------------------------------------------------------------------
October January 2019, March 2020 Eligible for new inquiry 1 year,
2018 July 2019 5 months after release
------------------------------------------------------------------------
One SRTR reporting cycle:
------------------------------------------------------------------------
1 SRTR Inquiry if
Release reporting still
date cycle flagged
------------------------------------------------------------------------
March 2018 July 2018 March 2019 Eligible for new inquiry 1 year
after release
------------------------------------------------------------------------
July 2018 January 2019 July 2019 Eligible for new inquiry 1 year
after release
------------------------------------------------------------------------
October January 2019 July 2019 Eligible for new inquiry 9
2018 months after release
------------------------------------------------------------------------
Questions for PAIS/MPSC:
1. Should the current operational rule postponing new inquiry for 2
meeting cycles be revised to be based on SRTR reporting cycles?
2. If answer to question 1 is yes, should the new inquiry be postponed
for 1 SRTR reporting cycle or 2 SRTR reporting cycles?
If revisions to the rule are approved, the new rule will be effective
immediately.
3. Following the decision on the operational rule, the PAIS/MPSC will
need to vote on whether to send inquiries to the following programs
that were released in March 2018, are flagged in the SRTR reports from
January 2019 and have had additional events since release:
03953N LU pediatric component; identified for lower than
expected graft and patient survival
21440N KI adult component, identified for lower than expected
graft survival
41540N KI pediatric component, identified for lower than
expected patient survival
Relevant OPTN Bylaw or Policy:
OPTN Bylaws, Appendix D
Section D.11 Additional Transplant Program Requirements
A. Transplant Program Performance
Appendix D.12.A does not apply to VCA transplants.
The MPSC will conduct reviews of transplant program performance to
identify underperforming transplant programs and require the
implementation of quality assessment and performance improvement
measures. One measure of transplant program performance is triggered
through a review of the one-year graft and patient survival rates. The
MPSC utilizes performance metrics produced by the Scientific Registry
of Transplant Recipients (SRTR) as the principal tool to identify
transplant programs that have lower than expected outcomes.
For programs performing 10 or more transplants in a 2.5 year period,
the MPSC will review a transplant program if it has a higher hazard
ratio of mortality or graft failure than would be expected for that
transplant program. The criteria used to identify programs with a
hazard ratio that is higher than expected will include either of the
following:
1. The probability is greater than 75% that the hazard ratio is greater
than 1.2.
2. The probability is greater than 10% that the hazard ratio is greater
than 2.5.
For programs performing 9 or fewer transplants in a 2.5-year period,
the MPSC will review a transplant program if the program has one or
more events in a 2.5-year cohort.
The MPSC review will be to determine if the higher hazard ratio or
events can be explained by patient mix or some other unique clinical
aspect of the transplant program. If a program's performance cannot be
explained by patient mix or some other unique clinical aspect of the
transplant program, the program, in cooperation with the MPSC, will
adopt and promptly implement a plan for quality improvement. The
member's failure to adopt and promptly implement a plan for quality
improvement will be considered a noncompliance with OPTN Obligations
and may result in an OPTN action according to Appendix L: Reviews and
Actions.
As part of this process, the MPSC may conduct a peer visit to the
program at the member's expense. The MPSC may also require, at its
discretion, that the member participate in an informal discussion. The
informal discussion will be conducted according to Appendix L: Reviews
and Actions.
The MPSC may recommend that a member inactivate a program, or a
component of a program, or withdraw its designated transplant program
status based on patient safety concerns arising from review of the
program's graft and patient survival. The MPSC must offer the member an
informal discussion before recommending that the program inactivate or
withdraw its designated transplant program status. A program's failure
to inactivate or withdraw its designated transplant program status when
the MPSC recommends it do so will be considered a noncompliance with
OPTN Obligations and may result in an OPTN action according to Appendix
L: Reviews and Actions.
Excerpt from 2/27/2019 MPSC Confidential Meeting Minutes
1. Clinical Experience Pathway--2- to 5-year requirement
Prior to review of the above described key personnel change application
discussion, UNOS staff presented information about the requirement in
the clinical experience pathways for all organs that the primary
transplant surgeon perform a certain number of transplants or the
primary transplant physician care for a certain number of transplant
patients over a 2- to 5-year period. The language contained in the
bylaws is vague and could lead to an inconsistent application or
unintended application of the requirement. It is unclear whether the
requisite number of surgeries or patient care must take place
throughout the entire period. The Committee discussed various scenarios
and two interpretation options under the bylaws. The Committee
expressed support for an interpretation that would require a proposed
transplant surgeon or transplant physician demonstrate that they did
the requisite number of transplants or cared for the requisite number
of transplant patients over a 2-year period in which the surgeon or
physician was employed and on-site at a designated transplant
program(s). The transplants/patients used to satisfy the volume
requirement do not have to span the entire two year period as long as
the individual was employed and on-site at designated transplant
programs for a consecutive 2-year period.
______
MPSC STAFF SUMMARY
Proposed Operational Rule
Adding Application Rejections to the Consent Agenda
February 26, 2020
Item for Consideration:
During the February 2020 meeting, staff will present a proposed
operational rule regarding adding application rejections to the consent
agenda. The MPSC will be asked to vote to approve the rule.
Summary:
Currently, only applications where all subcommittee voters agree to
approve are included on the Membership consent agenda. When the
subcommittee votes to reject an application, the application is brought
for discussion with the full committee. This has led to the MPSC having
discussions to reject applications that do not meet the OPTN Bylaws,
which the MPSC has no option to approve. To eliminate this discussion,
which takes the MPSC's time but does not allow for the MPSC to take a
different action than the subcommittee recommendation, staff propose
that, when a subcommittee unanimously agrees on a rejection, that
decision be placed on the Membership consent agenda. This change would
be consistent with the way that Performance and Compliance create their
agendas. For those cases, if the subcommittee agrees on an action, it
goes on the consent agenda.
Staff will continue to review the application and prepare a staff
summary. The summary will indicate whether the completed application
meets the OPTN Bylaw requirements. The cases will still be posted for a
subcommittee of reviewers so that they can confirm the staff assessment
of the application.
Proposed rule:
If all reviewers agree to reject an application, the rejection will be
placed on the consent agenda for the full MPSC to approve.
If approved, the rule will be effective immediately and used in
creating the next consent agenda.
Example:
A member submits an application for a Primary Surgeon who does not have
logs for the appropriate number of procurements. The member provides a
letter that states that he performed the procurements, but does not
have the record information. Staff review the documentation and post it
for reviewers, noting that the documentation submitted does not meet
the OPTN Bylaw requirements. The subcommittee votes in Committee
Management to reject the application, so staff puts the rejection on
the consent agenda for the next full committee meeting.
______
MPSC STAFF SUMMARY
Proposed Process Change
Adding Self-Reported Cases to the Consent Agenda
April 22, 2021
Item for Consideration:
During the April 2021 meeting, staff will propose a change to the
existing operational rule regarding closing issues that members self-
report with no action. The change would allow self-reports to be added
to the consent agenda for closure, rather than being posted for
reviewers. The MPSC will be asked to vote to approve the rule.
Summary:
During its December 2019 meeting, the MPSC approved an operational rule
regarding closing issues that members self-report with no action. The
MPSC changed the recommended action for self-reported compliance cases
where there seems to be an appropriate response through a root cause
analysis (RCA) and corrective action plan (CAP), no likelihood of
recurrence, and no ongoing patient safety issues from a Notice of
Noncompliance to closing the issue with no action. The MPSC intended
this change to help support a plan to encourage self-reports and shift
community perception of the committee from solely focused on compliance
toward a focus on process improvement. Originally, reviewers still
examined all of these cases to confirm that the proposed action was
appropriate.
During the COVID-19 pandemic, staff and the MPSC agreed to a process
change that allowed self-reports with an appropriate RCA and CAP, no
concerns about recurrence, and no associated compliance history to be
placed on the consent agenda.
Cases reviewed:
------------------------------------------------------------------------
Straight to Posted for
Issue Total Consent Reviewers Outcomes
------------------------------------------------------------------------
Hemodilution 4 4 0 All closed
------------------------------------------------------------------------
HLA errors 3 2 1 All closed
------------------------------------------------------------------------
Packaging and 16 7 9 13 closed, 3
Labeling, Notice of
Laterality Noncompliance
Errors
------------------------------------------------------------------------
Wait-list 4 3 1 All closed
errors
------------------------------------------------------------------------
Data entry 2 1 1 Both closed
errors
------------------------------------------------------------------------
Vessel errors 1 1 0 Closed
------------------------------------------------------------------------
OPO 3 1 2 2 closed, 1
Responsibilit Notice of
ies Noncompliance
------------------------------------------------------------------------
Total 33 self- 19 14 29 closed, 3
reported Notice of
cases Noncompliance
------------------------------------------------------------------------
Reasons posted for reviewers:
------------------------------------------------------------------------
Issue July 2020 October 2020 February 2021
------------------------------------------------------------------------
Weak RCA/CAP 1 HLA error case 1 case--2 KI
were
accidentally
discarded, went
to discussion
------------------------------------------------------------------------
Patient safety 1 KI program 1 case--HR
issue/member failed to place surgeon left OR
under review 35 KI candidates without
on wait list on allowing
time, 1 data packaging
entry error
------------------------------------------------------------------------
Recent Hx of 3 packaging and 1 KI laterality 1 hemodilution
similar event labeling cases error case and case, 4
1 packaging and packaging and
labeling case labeling cases,
one went to
discussion
because of
history
------------------------------------------------------------------------
As you can see, staff have posted 14 case for MPSC review. Of those 14,
10 were also closed with no action, and four received a Notice of
Noncompliance. Based on this information, the MPSC is asked to
officially approve that self-reported compliance cases where there
seems to be an appropriate response through an RCA and CAP, no
likelihood of recurrence, and no ongoing patient safety issues be added
to the consent agenda with a recommendation to close the issue with no
action.
All cases will still be reviewed for whether the RCA and CAP are
appropriate, the member has a pattern of noncompliance, or the
circumstances of the issue call for a stronger action. Any cases with
concerns about these items will be posted for reviewers. As always, any
cases with strong patient safety concerns will be posted for MPSC
reviewers.
Proposed Rule:
The MPSC will close self-reported policy issues with no action on a
consent agenda, unless patient safety concerns, member history,
inadequate response, or other circumstances indicate another action.
If approved, the rule will be effective immediately.
______
MPSC STAFF SUMMARY
Proposed Operational Rule
Use of Survey Evaluation Tool on Desk Reviews
April 22, 2021
Item for Consideration:
During the April 2021 meeting, staff will present a proposed
operational rule regarding continuing to evaluate desk reviews with the
Survey Evaluation Tool (SET) and adding them to the consent agenda. The
MPSC will be asked to vote to approve the rule.
Summary:
Since July 2018 Member Quality staff use a Survey Evaluation Tool (SET)
to determine whether a survey can be closed with no follow-up, whether
a focused desk review of certain policies is needed, or whether the
survey should be sent to MPSC reviewers to determine the appropriate
action. The tool separates policies reviewed into categories based on
the potential risk to patient safety.
If a member does not meet the required compliance thresholds staff
automatically conduct a desk review of that policy after six months. If
a member meets all the required compliance thresholds, staff
automatically close the review with no action, without posting the case
for MPSC review. Prior to the COVID-19 pandemic, staff posted the
results of any focused desk review where the member continued to not
meet the required compliance threshold for MPSC review, as well as any
surveys with concerns that the MPSC needs to address.
During the pandemic, staff began assessing both routine surveys and the
resulting desk reviews with the SET, and adding the recommendation from
the desk review to the MPSC consent agenda. The table below shows that
site survey cases for the MPSC have decreased dramatically since the
implementation of the SET (February 2019). It also shows that the
number of surveys recommended for closing versus having a desk review
has not changed drastically using the SET for 2020. For July 2019--
February 2020, 80 surveys closed and 44 had a desk review. After the
process change May 2020--February 2021, 57 surveys closed and 34 had a
desk review.
------------------------------------------------------------------------
Closed Desk Review
------------------------------------------------------------------------
February 2019 150 53
------------------------------------------------------------------------
July 2019 24 31
------------------------------------------------------------------------
November 2019 28 4
------------------------------------------------------------------------
February 2020 28 9
------------------------------------------------------------------------
May 2020 14 4
------------------------------------------------------------------------
July 2020 19 6
------------------------------------------------------------------------
October 2020 6 4
------------------------------------------------------------------------
February 2021 18 20
------------------------------------------------------------------------
If the operational rules is approved, going forward the MPSC will
review only a member's second desk review. In all cases, any surveys
with serious concerns about patient safety, compliance, or corrective
action plans can be sent to the MPSC for review despite the SET
recommendation.
Proposed rule:
Staff will continue to evaluate routine site surveys with the SET and
close or conduct a desk review as recommended by the tool. Staff will
also evaluate the first desk review with the SET and add that
recommendation to the MPSC consent agenda. The MPSC will review any
second desk review results.
If approved, the rule will be effective immediately.
______
MPSC STAFF SUMMARY
Proposed Process Change
Updates to Allocation Operational Rules
April 22, 2021
Item for Consideration:
During the April 2021 meeting, staff will propose several changes to
the existing operational rules for MPSC review of allocation
deviations. The MPSC will be asked to vote to approve the changes to
the rules.
Summary:
Member Quality staff review the match runs for all deceased donor organ
allocations that result in a transplant. Each month, the Allocation
Analysts identify approximately 450-500 transplants with deviations
from the match run. The analysts inquire with members and forward
potential policy violations to the MPSC. Possible violations include
instances when an OPO skips or bypasses patients on the wait list
(``allocation out of sequence''), a transplant program accepts an organ
offer for one patient but transplants another patient on the match run
(``actual versus intended''), or a transplant program transplants a
patient not on a match run. During the COVID pandemic, analysts have
concentrated on making sure that they have adequate information about
each allocation and have only referred the most egregious or clear
policy violations to the Committee for review. As the analysts begin to
return to a more normal review process, policy changes have led to the
MPSC needing to review several of its current operational rules. After
the MPSC moves back into normal monitoring of allocations, staff will
continue to evaluate data for additional changes to these operational
rules.
Analysts send the MPSC one summary per year for each member. The
summary allows the MPSC to review any potentially concerning patterns
of behavior over time. The MPSC has closed almost all allocation
deviations with no action; most members attempt to follow the match run
as much as possible but deviate from the match run to avoid organ
wastage. To streamline the review process, the MPSC developed
operational rules to automatically close cases with no action when it
is likely that allocation deviation was necessary to avoid organ
wastage.
Currently, the MPSC does not review allocations when:
An OPO expedites placement of any organ from a Hepatitis C
positive donor.
An OPO expedites placement of any organ from a Hepatitis B core
positive donor.
An OPO expedites placement of any organ from a donor more than
70 years old.
A program transplants any organ into a patient other than the
original intended recipient and the Host OPO granted the transplant
program local back up.
A program transplants a kidney patient out of sequence due to
medical urgency as permitted by Policy 8.
A program transplants a kidney recipient who does not appear on
the match run as described in Policy 5.4.E.
An OPO expedites placement of any organ except kidneys from a
DCD donor.
An OPO expedites placement of an extra-renal organ turned down
in the Operating Room.
Kidney and Pancreas Allocation Changes
1. March 15, 2021 changes to kidney and pancreas allocation
included a change to Policy 5.9 (Released Organs) which now states
``The transplant program must transplant all accepted, deceased donor
organs into the original intended recipient or release the deceased
donor organs back to and immediately notify the host OPO or the OPTN
for further distribution. If a transplant program released an organ, it
must explain to the OPTN the reason for refusing the organ for that
candidate. The host OPO or OPTN must then allocate the organ to other
candidates according to the organ-specific policies. The host OPO may
contact the OPTN for assistance allocating the organs. The host OPO may
delegate the responsibility to the OPO serving the candidate transplant
program's DSA, except in the cases of released kidneys, pancreata, and
islets.'' (emphasis added)
Therefore, the idea of local backup involving the importing OPO
running a match and reallocating organs is no longer permitted for
kidneys and pancreata. While there may still be instances where the
host OPO chooses to offer the organ to the same hospital for a
different patient, it seems appropriate that the MPSC review these
instances, especially while the policy is new. Therefore, the MPSC is
asked to remove kidney and pancreas from the operational rule stating
``a program transplants any organ into a patient other than the
original intended recipient and the Host OPO granted the transplant
program local back up.''
2. Changes to Policy 8.5.A.i (Medically Urgent Status for Adult
and Pediatric Candidates) have added medically urgent candidates as an
allocation classification, and the offers for medical urgency are no
longer dependent on each individual DSA approval. Therefore, the MPSC
is asked to remove the operational rule ``a program transplants a
kidney patient out of sequence due to medical urgency as permitted by
Policy 8.5.A.i (formerly 8.2.A).''
Liver Expedited Placement Policy Change
Policy 9.10 (Expedited Placement of Livers) recently went into effect,
which provides OPOs with conditions under which they are permitted to
make expedited liver offers and a process for those allocations. These
conditions include the turndown of a liver offer after the donor has
entered the operating room. Staff will confirm that the OPO allocates
the liver appropriately using the new policy. Therefore, the MPSC is
asked to remove liver from the operational rule ``an OPO expedites
placement of an extra-renal organ turned down in the Operating Room.''
Conclusion
For any and all of these rules, staff can make details of any case
automatically closed with no action available at any time. In addition,
staff can provide aggregate data on reasons for closing cases for any
allocation review projects. During their reviews, even with these
rules, MPSC members often find that the OPOs appropriately expedited
placement to avoid organ wastage.
Based on this analysis, the MPSC is asked to officially approve the
rules as amended below.
Proposed Rules Summary:
------------------------------------------------------------------------
Rule Applicable Organs
------------------------------------------------------------------------
Hep C positive All
------------------------------------------------------------------------
Hep B Core positive All
------------------------------------------------------------------------
Over 70 years old All
------------------------------------------------------------------------
Transplanted a different recipient Heart, Intestine, Liver, Lung
with local backup
------------------------------------------------------------------------
Kidney recipient not on match but Kidney
follows 5.4.E
------------------------------------------------------------------------
DCD Donor Heart, Intestine, Liver, Lung,
Pancreas
------------------------------------------------------------------------
Turndown in OR Heart, Intestine, Lung, Pancreas
------------------------------------------------------------------------
The MPSC will adjust the review of kidney, pancreas, and liver
allocations based on the recent policy changes.
If approved, the rule changes will be effective immediately.
______
MPSC STAFF SUMMARY
Proposed Operational Rule
Lower Respiratory SARS-CoV-2 Testing for Lung Donors
May 25, 2021 MPSC Meeting
Item for Consideration:
During the May full MPSC meeting, staff will present a proposed
operational rule regarding real-time monitoring of the emergency policy
approved 4/26/21 that requires lower respiratory SARS-CoV-2 testing on
all lung donors. The MPSC will be asked to vote to approve the rule.
Summary:
This is a new policy that was proposed by the DTAC and it was taken to
the Executive Committee for emergency approval, to be implemented
within 30 days of approval. It will go through the summer Public
Comment cycle, while in effect, and then ultimately to the BOD in
December, pending with changes or as is. Site Survey will monitor OPOs'
compliance with this policy in real-time, by use of a weekly report
provided from the UNOS Research department. If it is found that an OPO
has not reported the test results in DonorNet and/or not uploaded the
results to the Attachments tab of DonorNet, then Site Survey will send
an inquiry email to the OPO to investigate. If it is found that the
member did not perform the test, Site Survey will ask the OPO to
provide an explanation and a plan for future potential lung donors.
Site Survey proposes to ``close'' the first identified event for each
OPO (same process as the operational rule for Wait-list Inactivity
notification letters), without forwarding to the MPSC for review, and
will communicate language to the member that any subsequent event would
then be forwarded on for committee review (as well as the first event).
Proposed rule: ``Site Survey staff will request members to provide an
explanation and develop a plan for future potential lung donors after
the first event of identified noncompliance with the Lower Respiratory
SARS-CoV-2 Testing requirement in Policy 2.9 and will not forward the
matter to the MPSC for review. If staff identifies a second event of
noncompliance in a subsequent weekly review, staff will ask the member
to provide an explanation as well as a corrective action plan and then
staff will provide all events' documentation to the MPSC for review.''
If approved, the rule will be effective immediately upon implementation
of the policy on May 27, 2021.
Of note: The weekly report from the Research department will provide a
list of donors where lower respiratory specimen results were not
reported in DonorNet prior to the lung recipient's removal from Wait
list.
Example:
OPO ABCD recovers lungs from donor A on 5/31/21. As of the run time of
the weekly report from Research on Friday 6/4/21, OPO ABCD has not
entered lower respiratory specimen test results in DonorNet. Site
Survey views the Attachments tab of DonorNet on 6/4/21 and confirms
that OPO ABCD has not uploaded a source document of the test. On the
afternoon of 6/4/21, Site Survey sends an Inquiry email to OPO ABCD to
ask if the test was completed and if so, for the OPO to provide the
test results to Site Survey and upload the source document to DonorNet.
Site Survey requests an answer by COB 6/7/21. OPO ABCD responds that
the test was not completed. Site Survey then requests an explanation
and a plan for future potential lung donors by COB Thursday 6/10/21.
Site Survey sends by email a Closure Letter to OPO ABCD noting the
noncompliance. Site Survey logs this first event of noncompliance into
an Excel tracker. OPO ABCD recovers lungs from donor B on 6/30/21. As
of the run time of the weekly report from Research on Friday 7/2/21,
OPO ABCD did enter lower respiratory specimen test results in DonorNet,
in compliance with Policy. OPO ABCD recovers lungs from donor C on 7/
31/21. As of the run time of the weekly report from Research on Friday
8/6/21, OPO ABCD had not entered lower respiratory specimen test
results in DonorNet. Site Survey views the Attachments tab of DonorNet
on 8/6/21 and confirms that OPO ABCD has not uploaded a source document
of the test. On the afternoon of 8/6/21, Site Survey sends an Inquiry
email to OPO ABCD to ask if the test was completed and if so, for the
OPO to provide the test results to Site Survey and upload the source
document to DonorNet. Site Survey requests an answer by COB 8/9/21. OPO
ABCD responds that the test was not completed. Site Survey then
requests an explanation and corrective action plan by COB Thursday 8/
12/21. Site Survey sends by email a formal Closure Letter to OPO ABCD
noting the noncompliance and informing the member that the events of
donors A and C will be forwarded to the MPSC. Site Survey logs this
second event of noncompliance into an Excel tracker. Site Survey
provides a case packet to the COAs prior to the next MPSC meeting, for
presentation and review by the MPSC. The MPSC will provide a final
resolution.
Relevant OPTN Bylaw or Policy:
New requirement: OPTN Policy 2.9, ``3. Infectious disease testing for
all potential deceased lung donors using an FDA licensed, approved,
cleared, or emergency use authorized lower respiratory specimen test
for SARS-CoV-2 (COVID-19) by nucleic acid test (NAT)
Lower respiratory specimen test results for SARS-CoV-2 by nucleic acid
test (NAT) must be available prior to transplant.''
Also relevant (current policy, no change)--OPTN Policy 2.2 #14
``Ensuring that documentation for all of the following deceased donor
information is submitted to the OPTN upon receipt: . . . c. Infectious
disease results source documentation. . . .''
Supporting Documents:
See proposal and policy notice on OPTN site.
______
MPSC STAFF SUMMARY
Proposed Operational Rule
Sending Performance Inquiries to Newly Identified Members
Item for Consideration:
The Performance Monitoring Enhancement Subcommittee is asked to
consider a proposed operational rule regarding the timing of sending
inquiries to members newly identified for performance review. The
Subcommittee will be asked to recommend that the MPSC approve the rule.
Summary:
Currently, staff receive the SRTR performance data twice a year, prior
to the MPSC's February and July meetings. When the data arrives, staff
determine which members are newly identified for review. Staff
automatically then add a row to the upcoming meeting's consent agenda
with a proposed action of ``Send Initial Inquiry.'' Members do not
receive their initial inquiry letter until after the MPSC approves the
consent agenda.
Proposed operational rule: The MPSC approves sending an initial inquiry
for members newly identified for outcomes review when the data is
available automatically, without a committee vote.
Benefits of this proposal are:
Newly identified members will receive their inquiry earlier,
which may allow both more time for their response and more time for
MPSC review before the next meeting.
The rule is consistent with the process used for inquiries in
other MPSC case types.
Shorter performance consent agendas and reduction of potential
errors.
If questions arise about whether to send an inquiry to a particular
program, staff will have the option to place the item on discussion for
MPSC consideration and decision.
If approved, the rule will be effective with the release of the Spring
2022 PSR in July.
______
United Network for Organ Sharing (UNOS)
700 North 4th Street
Richmond, VA 23219
tel: 804-782-4800
fax: 804-782-4816
https://unos.org/
August 17, 2022
The Honorable Ron Wyden, Chairman
The Honorable Charles Grassley
U.S. Senate Finance Committee
Washington, DC 20150
Dear Chairman Wyden and Senator Grassley,
United Network for Organ Sharing (UNOS) offers the following additional
information to the Senate Finance Committee following the testimony of
Mr. Brian Shepard, CEO, on August 3, 2022, concerning the U.S. organ
donation and transplantation system. UNOS shares the Committee's desire
to see a successful transplant for every patient in need. We ask that
the Committee please include this letter and the attached documents in
the record.
As Mr. Shepard testified, UNOS is and has always been committed to
improving the U.S. organ donation and transplantation system. We heard
the concerns shared by members of the Committee and will work in
collaboration with Congress, our federal partners, and community
members, to further improve the national system and save more lives. We
have a demonstrated record of continuous improvement, and in
partnership with Health Resources and Services Administration (HRSA)
and the broader transplant community, we have played a key role in nine
consecutive years of increases in the number of deceased donor
transplants. In 2021, we saw record breaking numbers of kidney, liver,
and heart transplants.
This sustained record of growth, which continued throughout a global
pandemic, shows that the system is dedicated to serving patients
through unprecedented challenges. The best course for our nation's
transplant system is to continue building on this momentum and to
identify and execute on new opportunities for continued improvement.
We would like to take this opportunity to reiterate our commitment to
continuous improvement in four key areas in particular:
State of the art technology: UNOS has always provided reliable,
effective, secure technology services to support the organ donation and
transplant community. The system UNOS built and operates to support the
OPTN has 99.99% up time, is regularly audited by HRSA, and exceeds
performance and security standards established by the federal
government. Just within the last two weeks, UNOS has achieved high
scores on two separate government reviews, and HRSA is currently
preparing for a full audit that will begin in a few weeks.
As with all developing technology, we are never satisfied with the
performance of the system, however, and we bring the leading technology
providers in the country together to make the system stronger. UNOS
partners with Nutanix to host the OPTN systems in the cloud. UNOS has
engaged Accenture to help apply human-centered design principles to
modernize the user experience of the OPTN system. UNOS uses Apigee to
support Application Program Interfaces (APIs) for electronic data
sharing, and more than 200 hospitals and OPOs provide data to UNOS
through APIs.
Attached to this submission are a copy of the IT presentation made
to committee staff earlier this year and a letter to the HRSA
administrator reiterating our commitment to government review of OPTN
IT systems.
Organ transportation: UNOS agrees with the consensus at the
hearing that any organ lost in transit, damaged or arriving otherwise
unable to be transplanted is a tragedy--both for the generous donor and
the patient waiting.
UNOS heard a desire from the community to improve the visibility
of tracking unaccompanied organs as an opportunity to improve
efficiency. UNOS has and offers a tracking solution, one of several on
the market. Just last week, the 5,000th organ carrying a UNOS-provided
tracker was shipped and transplanted. As mentioned during the hearing,
we are also currently piloting an organ travel mobile app that will
enable OPOs to more quickly determine the very best travel plan for an
organ in transit, based on a variety of factors.
UNOS is engaged with major commercial airline providers to design
improved organ handling processes that comply with TSA regulations
while safely and reliably delivering the organ. UNOS would be pleased
to work with the Committee in making improvements to federal
restrictions on organ handling, such as returning organs to the
passenger cabin or cockpit, where they once were allowed to travel.
Organ Discards: The hearing included discussions of the decade-
long rise in the number of kidney discards. UNOS agrees that there are
organs recovered by OPOs that could be acceptable for transplant yet go
unutilized. The OPTN has undertaken a number of initiatives designed to
empower transplant programs with relevant and timely information,
providing data, tools and analytics to help centers get to ``yes''
faster, as noted by the NASEM study.
UNOS recently deployed data-driven predictive analytics to help
clinicians decide whether to accept organ offers. A new offer filters
tool built by UNOS helps target organ offers to the candidates most
likely to accept them, improving system efficiency and ultimately
increasing the number of transplants. Similarly, the Center Acceptance
and Refusal Evaluation (CARE) tool allows centers to see all of the
outcomes for offers they accept, as well as those they refuse. The OPTN
Image Sharing project offers surgeons access to high resolution images
of a donor organ, enabling teams to make more informed acceptance
decisions up front, and reduce the likelihood of having to reallocate
an organ last minute. Further, the OPTN's Membership and Professional
Standards Committee (MPSC) has recently implemented additional
transplant center metrics to include Organ Offer Acceptance Rate
Ratios, a risk-adjusted calculation with an intent to both ensure
organs suitable and safe for transplantation are allocated to the
appropriate recipients on the waiting list based upon established
policy and to improve transparency of the offer system to patients and
providers.
OPTN member performance improvement and peer review: At times,
it seemed that questioners at the hearing conflated the two
complementary but distinct roles that the OPTN and CMS play in
oversight of the national transplant system. By statute, regulation,
and contract the OPTN, through its Membership and Professional
Standards Committee (MPSC), is designed to provide a collaborative
quality improvement process. In contrast, CMS has authority to impose
sanctions, including payment and decertification.
As Mr. Shepard testified, full and frank participation in our peer
review process is what we believe leads to understanding and
improvement following adverse events. Confidential peer review is a
quality improvement practice implemented across healthcare disciplines
following the Institute of Medicine's seminal report, To Err Is Human
(2000). The IOM recommended a two-pronged system, one that included
both confidential peer review for near misses and lesser events, and
stricter sanctions for serious events. We are committed to working with
the Committee and with HRSA and CMS at ensuring that the two-pronged
system is working correctly and cooperatively, and that the types of
events to be reviewed by each part of the system are properly defined.
However, we strongly believe that abandoning confidential peer review
entirely would have a detrimental effect on honest disclosure, and
ultimately on patient safety.
UNOS has a long and successful record of facilitating transplants in
the United States, and we are proud to be a part of the most successful
organ donation and transplant community in the world. It is our daily
mission to continue to improve the donation and transplant system.
We welcome the support of the Senate Finance Committee in implementing
improvements to the system, and continuing to pursue our shared goal of
saving lives through organ donation.
Sincerely
Jerry McCauley, M.D., MPH
President, UNOS Board of Directors
Chief, Division of Nephrology
Medical Director, Transplantation Services
Vice Chairman, Health Equity, Diversity and Inclusion
Thomas Jefferson University Hospitals
Philadelphia, PA
______
United Network for Organ Sharing (UNOS)
700 North 4th Street
Richmond, VA 23219
tel: 804-782-4800
fax: 804-782-4816
https://unos.org/
August 2, 2022
The Hon. Carole Johnson, Administrator
Health Resources and Services Administration
U.S. Department of Health and Human Services
Rockville, MD 20857
Dear Administrator Johnson,
United Network for Organ Sharing (UNOS) is proud to have served as the
Organ Procurement and Transplantation Network (OPTN) since 1984. In
partnership with HRSA, we are nearing a decade of continued growth in
the number of organ transplants and we are proud that our partnership
with HRSA has yielded the highly equitable and efficient system we know
today. We continue to make improvements every day for the benefit of
the patients we serve.
UNOS has recently been provided with a document that has since been
leaked to the media purporting to be a ``draft'' United States Digital
Service (USDS) report on the OPTN IT system. We have never received an
official copy of this draft report, despite a FOIA request to the U.S.
Office of Management and Budget (OMB). Unfortunately, the report
contains significant factual errors and demonstrably false
misstatements about the OPTN IT infrastructure. We understand HRSA may
have seen a copy of this report, and so we wanted to extend this
invitation to you to discuss these claims to clarify and correct its
numerous inaccuracies.
By way of background, the draft USDS report appears to be based
entirely on a ninety-minute presentation by UNOS on December 10, 2020,
pursuant to a request from HRSA during its 2019 Market Research for the
Modernization National Resource Allocation System, as well as UNOS's
responses to a set of follow-up questions submitted by HRSA. The USDS
neither engaged with nor sought further information from UNOS during
the development of this report, nor were we provided a chance to
comment on the report or identify and correct any inaccurate
information.
In contrast, the HRSA team has consistently reviewed the performance
and security of the OPTN IT system in great detail throughout our
performance of the OPTN contracts. HRSA reviews all OPTN contractual
requirements for compliance annually, as well as on a periodic basis
throughout each year, and UNOS consistently meets or exceeds its
contractual obligations. Specifically, UNOS submits to HRSA results of
the cybersecurity penetration testing conducted by a 3rd party on a
semi-annual basis. Further, HRSA security audits are conducted annually
to ensure the quality and security of the OPTN system. Just today, UNOS
received another 100% score on the HRSA Office of Information
Technology's Capital Planning and Investment Control (CPIC) dashboard.
With that background, UNOS offers the following selected clarifications
to the certain statements contained in the draft USDS report:
UNOS utilizes an industry best practice, cloud-based approach
incorporating both private and public cloud service providers. There
are no components hosted on-premises.
UNOS has maintained an IT system up time of 99.99% (outside of
scheduled maintenance) for more than 10 years.
More than 200 transplant hospitals and OPOs are leveraging UNet
system APIs for reporting or querying data, and in the past year alone,
the system processed nearly one million API transactions for members,
with no additional manual data entry required.
UNOS shares segments of real code with HRSA as part of both our
ongoing application security program and the government's annual audit.
UNOS has documented version control and the ability to replicate
historical matches based on the policies in effect at the time.
We note that this represents only a selection of the statements in the
draft report about which we have factual concerns.
Further, we are also concerned that the draft report mischaracterizes
what we view as UNOS' productive, cooperative relationship with HRSA
and ignores HRSA's above-referenced robust audit and oversight
functions. As you know, the relationship described in the USDS report
bears no resemblance to the working partnership we have with the HRSA
team, a partnership that has produced positive results for patients
since its inception.
You already have access to your team's routine annual audit information
about the reliable, safe IT system that UNOS operates, but we stand
ready to provide any additional briefings or information you request or
to host you and/or your team for additional onsite meetings so that you
can further understand our systems and processes.
We appreciate your consideration of our concerns about the inaccuracies
in the leaked draft report. It is our sincere hope that these
assurances, in combination with HRSA's own records, addresses any
concerns the draft report may have raised for you. We look forward to
continuing our work together on the critical mission of our Nation's
transplant system.
Sincerely,
Jerry McCauley, M.D., MPH
President, UNOS Board of Directors
CC: Cheryl Dammons, Associate Administrator, HRSA
Adriane Burton, Chief Information Officer, HRSA
______
United Network for Organ Sharing (UNOS)
700 North 4th Street
Richmond, VA 23219
tel: 804-782-4800
fax: 804-782-4816
https://unos.org/
March 2, 2022
The Hon. Ron Wyden, Chairman
The Hon. Charles Grassley
U.S. Senate
Committee on Finance
Washington, DC 20510
Dear Chairman Wyden and Senator Grassley,
We appreciated the opportunity to brief your staff regarding the issues
raised in your January 31, 2022, letter concerning UNOS' IT security
and technology infrastructure and practices. We are pleased to provide
the following additional information and actions taken since our
February 17, 2022 meeting, in addition to the presentation materials
and requested root cause analysis submitted to HRSA on February 26,
2021.
Penetration Testing
Senate staff inquired about the role of external entities in conducting
penetration testing. Below are clarifications about our most recent
tests.
A third-party commercial company conducted the 2021 tests.
Penetration test was a web application test with and without
credentials. Testing was conducted in our ``production equivalent''
environment.
The HHS Office of Inspector General (OIG) and
HRSA accepted this test in lieu of performing their own
penetration test for the 2021 Audit
No vulnerabilities were identified allowing
escalation of privilege or ability for lateral movement
As promised, we are providing the results and
remediations from the 2021 penetration test:
0 Critical
3 High: All closed immediately
6 Medium: 5 Closed, 1 pending software update
available in June 2022
3 Low: 1 Closed, 2 pending closure with code
roll-out May 2022
A HRSA-selected vendor, Synack, will conduct the 2022 test. It
will be a crowd-sourced penetration test. The test will be in non-
credentialed and credentialed format.
UNOS Relationship with Cybersecurity and Infrastructure Security
Agency (CISA)
Senate staff recommended UNOS seek out free cybersecurity resources and
services, such as the EINSTEIN sensor, offered by CISA to private
sector organizations operating ``critical infrastructure'' for the
nation. At this time, the OPTN system is categorized by HHS as a
``high-value asset'' and is ineligible for all services provided to
infrastructures with this more elevated designation.
We appreciate, however, the suggestion to secure cybersecurity hygiene
scans from CISA and have taken steps to request this important service.
UNOS established a relationship with CISA in 2015 and at that time
registered for and participated in the Government Telecommunications
Service (GETS), Wireless Priority Service (WPS), and Telecommunications
Service Priority (TSP) programs. We have since sponsored numerous OPOs
in support of their participation in the program.
Security Clearances and Classified Warnings
In response to a staff suggestion for gaining Top Secret
clearance for pertinent UNOS staff so that UNOS may receive classified
briefings from the U.S. government on security threats, a formal
request to HRSA has been made to determine the requirements for Secret
or Top-Secret clearances and sponsorship and is under review within
HHS. To date, Secret and Top-Secret designations have not been required
nor sponsored by HHS for the OPTN. UNOS currently receives unclassified
email alerts from the FBI, HRSA, and CISA.
UNOS meets the contractual obligation as stated in the Position
Sensitivity Designations requirements within the current OPTN contract,
which states: ``All contractor (and/or any subcontractor) employees
must obtain a background investigation commensurate with their position
sensitivity designation that complies with Parts 1400 and 731 of Title
5, Code of Federal Regulations (CFR).''
Code Scanning and Review
UNOS scans code throughout the software development lifecycle
using Veracode technology.
Snippets of code have been and will continue to be made
available to HRSA for verification and closure of findings as needed.
Over the past several months, HRSA and UNOS have been working to
establish a process for reviewing code. We estimate that HRSA will
begin code reviews in Q2 of 2022.
Vulnerability Management
Infrastructure vulnerability scanning is performed weekly using
Tenable, and all results are provided to HRSA.
HRSA is provided access upon request and on a regular schedule
to perform web applications scanning, using NetSparker, against a
production equivalent environment.
Offsite Backup Storage
Offsite backup storage practices have been in place since the
OPTN system's inception in 1999 and continue in the present.
2010 Modernization Project
As a follow-up to your question regarding the 2010 system
modernization project:
A project called Chrysalis was terminated in 2012
after concluding that it would not go far enough to modernize
and evolve the OPTN technology.
Following that decision, UNOS determined that the
path forward needs to be centered on digital transformation of
the OPTN System, embracing and practicing the Agile
methodology, test automation, open-source frameworks,
Application Programming Interfaces (APIs), mobile capabilities,
elevated security practices, and cloud computing. As a result
of this direction and culture, we have been able to --
React faster to the needs of the transplant
community.
Establish and maintain a consistent feedback
loop with the users of OPTN system.
Integrate cloud-based data analytics and machine
learning capabilities.
Implement a variety of open-source frameworks to
deliver value.
Enable members to benefit from our seamless
integration with EHRs and EMRs.
Empower members with secure mobile capabilities
to perform work whenever and wherever.
Reduce the threat landscape by implementing zero
trust principles in conjunction with a defense-in-depth
strategy.
Maintain high quality of software, leveraging
24x7 automated testing.
Deliver on the OPTN Board of Directors
commitments.
Retain and attract engineering talent.
February 2021 Service Outage
To clarify our response in our meeting, the February 2021 one-
hour service outage occurred as the result of a failure within a high-
availability redundant pair of internal firewalls, not a manual human
error. The human error occurred during the service restoration effort.
As requested during the meeting, the root cause analysis previously
provided to HRSA is included as part of this response. Since this
incident, further automation has been added to service restoration
procedures to eliminate the need for human intervention.
Please note the graphic depicted in the provided RCA reflects
the OPTN system architecture as of February 2021, while we were in
transition to the current state architecture. The OPTN system
architecture today reflects what was presented to the staff during our
call. It has additional built-in redundancies and security components,
advanced use of public and private cloud, and automation.
Please do not hesitate to contact me if you have additional questions
or require further clarifications.
Sincerely,
Brian Shepard, CEO
Attachments (2): UNOS IT Security Presentation for Senate Finance (17
February 2022); UNet Root Cause Analysis (6 February 2021)
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Areas of Focus
System modernization and reliability
Sufficient backup systems
Cloud utilization
Security of the system from cyberattacks
Basic features and security systems
Ensuring that security flaws do not lead to preventable deaths
Prevention of service interruptions due to ransomware attack,
technical failure or inefficiency causing delays
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Appendix
UNOS Information Security Team
More than 112 years of combined IT and Information Security
Experience
Holds 27 industry recognized certifications including:
Certified Ethical Hacker (CEH)
Certified Cloud Security Professional (CCSP)
Certified Detection Analyst (CDA)
Certified Incident Handler (CIH)
Certified Information Systems Security Professional (CISSP)
Certified Penetration Tester (GPEN)
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Incident: Periodic UNetSM Access Impact.
Date and Duration of Incident: 2021-02-06 8:10PM EST-11:00 PM EST.
Incident Summary
Starting around 2021-02-06 8:15PM EST, users began to experience
periodic latency and errors in UNet functions.
Root Cause
East Region 1 (ER1) Computing Environment experienced a Network
Equipment failure.
Detailed Description
UNet users experienced periodic latency or errors as a result of ER1
Networking Equipment failure.
Between 08:10pm and 08:15PM EST, one node of a clustered pair of
internal Cisco firewalls experienced an interface failure which
cascaded to the other firewall node, resulting in a total failure of
the internal firewall cluster.
This failure, in turn, caused interruption to internal network traffic
in ER1. Cisco technical support confirmed that the issue was caused by
a defect in the Cisco firewall's firmware.
Issue resolution actions consisted of transitioning impacted workloads
from ER1 to ER2 computing environment, as well as taking the ER1
internal firewall cluster offline and bypassing internal network
traffic. Confirmed no impact to matching function or patients.
Additional Information
Throughout the incident some workloads running in ER1 remained there.
Periodically, between 08:25 and 09:25PM EST, ER1 was not accessible to
UNet users. Procedural errors made in the process of transitioning some
workloads from ER1 to ER2 contributed to this incident. All other steps
taken (manual and automated) during this incident were accomplished
without any errors.
The equipment in question has not been put back in service.
Since the incident, ER1 has been and continues to be fully operational.
All normal workloads/ activities have been and are functioning there.
Action steps taken during incident:
_______________________________________________________________________
08:12PM EST Initial ThousandEyes.com alerts received
------------------------------------------------------------------------
08:25PM Organ Center (OC) receiving Members Calls
------------------------------------------------------------------------
IT On-call responding engineer informs On-call manager
and begins to evaluate the issue
------------------------------------------------------------------------
08:33PM Conference Bridge initiated
------------------------------------------------------------------------
08:56PM ER1 Networking Equipment failure identified as
triggering event
------------------------------------------------------------------------
Systems Engineer enroute to ER1
------------------------------------------------------------------------
09:10PM Decision is made to move some UNet functions to ER2.
Leverage external Transition Plan (TP) in
Attainium.net
------------------------------------------------------------------------
Additional Systems Engineers are brought into the
Conference Bridge to assist
------------------------------------------------------------------------
09:23PM TP procedures to ER2 are initiated
------------------------------------------------------------------------
09:40PM TP procedures to ER2 are completed
Reviewing periodic ThousandEyes.com alerts reported in
operational logs
------------------------------------------------------------------------
09:45PM UNet functions to add candidate or register donor are
functional
------------------------------------------------------------------------
10:01PM Some functions transitioned from ER1 to ER2 generating
periodic alerts
------------------------------------------------------------------------
10:22PM Issues in executing TP procedures to ER2 identified on
the Conference Bridge: (1) External Plan not up to
date; (2) Human data entry errors
------------------------------------------------------------------------
10:30PM Corrective Actions identified to address issues in TP
procedures
------------------------------------------------------------------------
10:58PM UNet functions accessible both internally and
externally
------------------------------------------------------------------------
Corrective Action:
We have completed our detailed investigation and compiled our
corrective actions to prevent future incidents of this kind:
All procedural documentation will be updated in Attainium.net
first then synchronized with on premises copy. Attainium.net has no
dependency to internal infrastructure. (Completed 2/8/21).
Transition Plan (TP) procedures training will be updated to
accommodate all scenarios. Staff retraining has commenced, and will be
required for all new team members. Training will be ongoing as
procedures are updated, and a quarterly review of all procedure
documentation will be conducted.
Continue with additional automation (scripting) to further
reduce manual TP tasks, avoiding potential for human error and
resulting in faster transitions.
(2/28/21)
Continue with West Region turn-on project (see below). Ensure
Transition Plan is updated accordingly to incorporate Nutanix advanced
management capabilities and staff are trained. (April 2021)
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Provide continuous updates to HRSA (2/9 and 2/11/21) and
NOOC (2/19/21) on UNet availability to maintain confidence in the
system
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
__
Questions Submitted for the Record to Brian Shepard
Questions Submitted by Hon. Ron Wyden
Question. Black Americans are disproportionately impacted by the
organ shortage. According to the 2022 OPTN kidney update, 28.5 percent
of kidney registrations on the wait list are Black. This is essentially
double their percentage in the population (2020 U.S. census data shows
that 14.2 percent of the U.S. population is Black or identifies as
Black). Additionally, minorities have much higher kidney disease burden
than their Caucasian counterparts. The 1-year monitoring report for the
new OPTN kidney allocation policy notes that transplant rates for
minorities are approaching/similar to Caucasians. However, to be
equitable, Black Americans would need to be transplanted at much higher
rates than their Caucasian counterparts given this disproportionality
of Black wait-list registrants.
Given the disproportionately large percentage of Black Americans on
the waiting list, what kidney transplant rate for this community would
the system need to achieve to reach equity for Black Americans? How has
UNOS calculated this? How has this community's transplant rate changed
over time?
Has UNOS calculated the equitable rates for other minorities? If
so, please provide these rates, how each was calculated, and how they
changed over time.
Answer. We agree that increasing equity in donation and transplant,
especially among historically marginalized communities, is of paramount
importance. Organ Procurement and Transplantation Network (OPTN)
policies play a key role in addressing these inequities, and the data
show that important gains in access for Black and other racial and
ethnic minority wait-listed patients have accelerated since December
2014, when the OPTN Kidney Allocation System (KAS) was implemented.
Following that policy change, we saw a dramatic expansion in the number
of Black patients with long wait times on dialysis who were able to
receive transplants. Six years later, despite the pandemic, 2020
deceased donor kidney transplant rates were similar for White and Black
patients.
As the question notes, a new kidney policy was implemented in March
2021, and the 1-year monitoring report showed sharp increases in kidney
transplant rates: 16-percent increase overall; 23-percent increase for
Black patients; and 36-percent increase for patients with 3 or more
years of dialysis time at listing.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Since 2015, as shown in table 1, the discrepancy between the
percentage of kidney transplants going to ethnic minorities in relation
to the percentage of the kidney waiting list comprising ethnic
minorities has been shrinking. This is seen most dramatically in the
Black candidate population. As of December. 31, 2015, 34 percent of
kidney waiting list registrations were Black, and 28 percent of 2015
deceased donor kidney transplants went to Black recipients. By
December. 31, 2021, 32 percent of registrations on the kidney waiting
list were Black, and 29 percent of 2021 deceased donor kidney
transplants went to Black recipients.
The Hispanic candidate population has seen similar increases in
equity; the percentage of candidates waiting for a transplant who are
Hispanic and the percentage of transplants going to Hispanic candidates
are now nearly on par, as of 2021. These improvements follow changes to
OPTN policies relating to human leukocyte antigen (HLA) matching and
typing as well as increased priority for highly sensitized patients.
The percent of transplants going to Asian recipients has declined
slightly relative to their waiting list presence, while the discrepancy
between percent transplanted and percent waiting has remained stable
over time for all other ethnic minorities.
While these gains are important, we agree that they are but one
component of the effort to eliminate inequities in access to the
transplant wait list. The community has long called for enhanced data
collection to better understand the socioeconomic factors that restrict
access to the transplant wait list as well as to the care that is often
required pre-listing, enabling the community to answer important
questions like 1a above and many others. Further, while understanding
the national disease burden is a key step toward addressing inequities
in access to transplant, it is also crucially important to understand
how many patients with end-stage organ failure are unable to seek
transplant due to comorbidities or other clinical factors. Both factors
are unknown.
While OPTN regulatory authority is limited to organ donors and
wait-listed patients, the OPTN has still sought to contribute to
understanding the barriers that exist to accessing the wait list. For
example, in 2021, the OPTN Data Advisory Committee (DAC) proposed a
project, currently under review with the Health Resources and Services
Administration (HRSA), to collect pre-wait-list patient referral and
evaluation data and to work with partners to study and improve
equitable access to the wait list. The OPTN also requested and received
additional funding from HRSA to study the feasibility and utility of
linking existing external social determinants of health (SDOH) datasets
with the OPTN dataset. That study led to the creation of two research
studies that helped the OPTN understand the role of SDOH in determining
wait-list outcomes among transplant candidates. As a result of these
studies, the OPTN is currently working with committees to find ways to
incorporate SDOH data into policy monitoring and evaluation. Finally,
the OPTN recently supported an amendment by HRSA to the OPTN Systems of
Records Notice, which added a new routine use to allow HRSA or its
contractors to disclose OPTN records ``to physicians or other health-
care professionals providing clinical treatment to such individuals,
for clinical purposes.''\1\ This will allow the OPTN to share candidate
information with physicians, such as nephrologists, and health-care
professionals, such as dialysis providers, to assist in the evaluation
and wait-listing process for their current patients who may be
potential candidates for kidney transplant.
---------------------------------------------------------------------------
\1\ OPTN Systems of Record Notice, 87 Fed. Reg. 46967 (August 1,
2022). https://www.federalregister.gov/documents/2022/08/01/2022-16344/
privacy-act-of-1974-system-of-records.
Question. According to UNOS 990s, in the year ending September 30,
2020, the organization brought in $4 million more in OPTN revenue than
it spent on expenses. In the year ending September 30, 2019, the
organization had $5.6 million more in OPTN revenue than expenses. Since
at least FY 2019, UNOS has had a financial management policy that it
could use revenues from OPTN contract fees that exceed reimbursable
costs for its general expenditures, and as of the year ending September
30, 2021, UNOS total assets are reported to be $97.7 million not
including property and equipment. What role did UNOS have in approving
---------------------------------------------------------------------------
this policy and for how long has it been in place?
Please describe how the UNOS policy of using excess revenues from
fees for general expenditures came about and how long it has been in
place.
Who ultimately determined that UNOS could utilize OPTN fee revenues
in this manner? UNOS management? The UNOS Board? HRSA?
Answer. UNOS has no such policy in place. While UNOS as a private
corporation may have revenues exceeding its expenses, any excess OPTN
Registration Fee revenue may not be used by UNOS for any purpose other
than for allowable costs under the OPTN contract and only when such
allowable costs are approved by the HRSA Contracting Officer. In order
to support the committee's understanding of our financial processes and
policies, however, we offer the below clarifying information.
The Form 990s referenced above are for UNOS, a private nonprofit
Virginia membership corporation. The OPTN is not yet a distinct private
nonprofit entity and accordingly, its financial position is presented
in consolidated financial statements with UNOS. In audited financial
statements, OPTN assets are listed as ``restricted cash'' and
``restricted investments'' within those consolidated financial
statements. As detailed in financial records provided to the Senate
Finance Committee and available online, OPTN Registration Fees may only
be used for allowable OPTN contract expenses, and only when a monthly
voucher is approved by the OPTN Contracting Officer's Representative at
HRSA. At the end of each fiscal year, OPTN Registration Fee revenue in
excess of allowable contract costs remains in the OPTN operating
account, and the amount may be carried forward to the next OPTN fiscal
year budget and included in the OPTN budget calculations. The annual
OPTN budget is developed by the OPTN Finance Committee and approved by
the OPTN Board of Directors with oversight by U.S. Department of Health
and Human Services (HHS) staff and ultimate approval by the HHS
Secretary. From time to time, OPTN operating account funds are invested
in a separate restricted OPTN reserve fund account.
To illustrate the funds transfer process, for the month of June,
UNOS would pay all of its expenses during the month from UNOS'
operating account. On behalf of the OPTN, UNOS continuously invoices,
collects, and holds in a separate OPTN operating account all OPTN
registration fee revenue received from OPTN member transplant hospitals
who add a candidate to the OPTN candidate waiting list. At the end of
June, UNOS prepares a voucher and submits it to the HRSA Contracting
Officer, accounting for all allowable OPTN contract expenses that UNOS
incurred during the month of June. HRSA reviews the voucher, and once
approved, UNOS transfers funds from the OPTN operating account to the
UNOS operating account to reimburse UNOS for expenses that UNOS has
already incurred and paid. This process occurs every month.
In pre-hearing interviews, Finance Committee staff specifically
asked about Note 4 in UNOS's most recent financial audit, which is
readily available online.\2\ The American Association of International
Certified Professional Accountants' (AICPA) Financial Accounting
Standards Board established a requirement that nonprofit organizations
must disclose publicly the amount of liquid resources available to
cover 12 months of expenses, in order for readers of the financial
statements to more accurately assess the organization's financial
stability.\3\ Note 4 of the UNOS financial audit details the amount of
assets that are available to pay organizational expenses in the next
12-month period.
---------------------------------------------------------------------------
\2\ 2021 UNOS Audited Financial Statement. https://unos.org/wp-
content/uploads/2021-Audited-Financial-Statement.pdf.
\3\ Accounting Standards Update (ASU) 2016-14, Not-for-Profit
Entities (Topic 958): Presentation of Financial Statements of Not-for-
Profit Entities, available at https://www.fasb.org/page/
PageContent?pageId=/projects/recentlycompleted/statements-
notforprofit.html&isstaticpage=true (accessed October 11, 2022).
An auditor completing the type of information contained in Note 4
evaluates whether there are limitations or restrictions on a nonprofit
organization's cash or cash equivalents that would make those assets
unavailable for general expenditures that will arise in the next 12
months. General expenditures are not defined but are understood to mean
those costs associated with the ordinary course of business. Cash or
cash equivalents are restricted if, for example, a donor places
limitations on the purpose for which a cash donation can be used, or
---------------------------------------------------------------------------
the time period during which it must be used.
It is also important to read Note 4 in conjunction with the
preceding Notes in the report. In particular, Note 1 describes that
UNOS ``functions as the sole national network whose mission is to
improve the effectiveness of the United States organ procurement and
transplantation system and to provide for the fair and equitable
distribution of all donated organs. To carry out this mission, the
Organization maintains a computerized database to identify potential
transplant recipients and to provide for the systematic matching of
donated organs with such recipients.''
Thus, in Note 4, ``when collection of OPTN registration fees exceed
the reimbursable costs incurred at a given point in time by the
Organization,'' the Organization ``has determined that the use of the
restricted cash and investments amounts will be for mission-related
activities within 1 year and, accordingly, these amounts are included
in financial assets available to meet general expenditures within 1
year.'' The mission being those OPTN activities described in Note 1.
To reiterate, excess OPTN registration fee revenues are used only
for allowable OPTN contract purposes and will remain in the OPTN
operating account until authorized to pay allowable contract costs, or
transferred to the OPTN reserve fund, as appropriate.
Question. One of the baseline requirements for Federal contracting,
Medicare, and Medicaid costs is that they must be reasonable and
necessary.
How does OPTN/UNOS define both ``reasonable'' and ``necessary'' for
itself and other parties in the OPTN?
Answer. The OPTN and UNOS Board of Directors Finance Committees are
composed of members of the donation and transplant community, along
with non-voting advisors and, on the OPTN Finance Committee,
representatives from HRSA. These Committees develop the annual OPTN and
UNOS budgets and related fees before seeking approval from the Board of
Directors.
The OPTN final rule requires the OPTN, annually, to establish the
OPTN registration fee for patients registered on the wait list, and
requires that the fee shall be determined by the OPTN and calculated to
cover the ``reasonable costs'' of operating the OPTN, with approval
from the Secretary:
An OPTN member shall pay a registration fee to the OPTN for
each transplant candidate it places on the waiting list. The
amount of such fee shall be calculated to cover (together with
contract funds awarded by the Secretary) the reasonable costs
of operating the OPTN and shall be determined by the OPTN with
the approval of the Secretary. No less often than annually, and
whether or not a change is proposed, the OPTN shall submit to
the Secretary a statement of its proposed registration fee,
together with such supporting information as the Secretary
finds necessary to determine the reasonableness or adequacy of
the fee schedule and projected revenues. This submission is due
at least 3 months before the beginning of the OPTN's fiscal
year. The Secretary will approve, modify, or disapprove the
amount of the fee.\4\
---------------------------------------------------------------------------
\4\ 42 CFR Sec. Sec. 121.5(c).
The budget development process applies these ``reasonable cost''
principles as is inherent in the budgeting process for public and
private institutions. The OPTN Finance Committee considers multiple
factors when determining what the ``reasonable costs'' of operating the
OPTN will be for the upcoming fiscal year. With respect to the OPTN
contract, revenue will consist of the estimated number of candidates
added to the waiting list multiplied by the approved OPTN Registration
Fee, and the contracted amount for the Federal appropriation. The
expense portion of the budget includes a detailed analysis of several
factors including but not limited to: the strategic and operational
goals of the OPTN; the estimated personnel costs to deliver the
requirements of the OPTN contract; the technology roadmap; and the
estimated number of policy projects the OPTN is anticipating and
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developing.
The OPTN Finance Committee propose a budget to address these goals,
and the board of directors approves the proposed budget. Ultimately,
the Secretary of HHS must approve the OPTN budget and associated OPTN
Registration Fee.
Neither UNOS nor the OPTN bill Medicare, Medicaid, or any Federal
or State public health insurance program for services.
Question. In the August 3rd hearing, you stated that UNOS lacks
strong enforcement levers to hold OPOs accountable. Specifically, you
stated that, ``The statute does not give UNOS any authority to offer
sanctions . . . the certification, decertification and payment
authorities belong to entirely to CMS.'' However, the OPTN final rule
gives UNOS the ability to refer an OPO to the Secretary of HHS for
decertification. In the 40 plus years of holding the OPTN contract,
UNOS has only referred an OPO to the Secretary once.
Why has UNOS only used this enforcement authority one time? Does
UNOS feel this appropriate reflects the overall performance of OPOs
during its tenure as the OPTN?
Answer. Oversight, rigorous performance measures, and continuous
improvement are essential parts of the Nation's organ donation and
transplantation system. The OPTN maintains a robust system for
monitoring member compliance with ``OPTN Obligations.'' OPTN
Obligations are defined in the OPTN Bylaws as ``. . . all the
applicable provisions of the National Organ Transplant Act (NOTA), OPTN
Final Rule, OPTN Charter, OPTN Bylaws, and OPTN Policies.'' Pursuant to
42 CFR Sec. 121.10(b), the OPTN conducts ongoing and periodic reviews
of each member OPO for compliance with these obligations.\5\
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\5\ OPTN Compliance and Evaluation. https://
optn.transplant.hrsa.gov/policies-bylaws/compliance-and-evaluation/.
The final rule defines the scope of the OPTN's role in monitoring
members, and that role was specifically designed by HHS to focus on
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member support and quality improvement.
The OPTN board-approved charge for the Membership and Professional
Standards Committee (MPSC) requires that the MPSC monitor OPTN member
compliance with OPTN membership criteria, OPTN bylaws and policies, and
the OPTN final rule. Through a robust peer and effective peer review
process, the MPSC analyzes events that are identified as presenting a
risk to patient safety, public health or the integrity of the OPTN. The
MPSC also evaluates and supports OPTN members by providing feedback on
and making recommendations to improve members' performance, compliance
and quality systems. The MPSC also identifies opportunities to educate
the community about improving patient safety through effective
practices.
When the MPSC considers members under review, the committee's
discussion centers primarily on how the member can improve its
performance, if corrective action planning or quality improvement
planning is necessary, and what benchmarks the member can provide the
MPSC to ensure they are correcting and improving. The MPSC is made up
of experienced donation and transplant professionals who are in the
best position to identify programs who can benefit from coaching and
help them improve. The MPSC takes action or makes recommendations for
further action to the OPTN board of directors as needed.
Based on law, precedent, policy, and longstanding effective
practices for quality improvement in health care, the OPTN's role is to
support its members in driving their improvement. Both the final rule
and the OPTN contract require the OPTN to employ a peer review process
and provide and facilitate confidential coaching of effective
practices, in contrast to the regulatory and financial oversight rules
that CMS provides. Sanctions are indeed a tool, but actions such as
decertification reside outside of the OPTN's mandated purview. Only the
Secretary of HHS is empowered to remove a member from the OPTN, and the
Secretary is not bound by the OPTN's recommendation, even in those
instances in which a member is referred to them. If a referred member
is not decertified, they remain a member of the OPTN. In all cases, the
OPTN's focus remains on member improvement. As noted in our response to
Senator Wyden, the MPSC will discuss specific potential improvements to
the process at its October 2022 meeting.
UNOS supports enhanced communications with CMS in particular, as
well as a more formal communication process between CMS and the OPTN.
In that process, UNOS believes communication must flow both ways. UNOS
would also be pleased to discuss with Congress, CMS, HRSA and HHS any
ongoing concerns about this process, to provide additional information
about how the review and member improvement approach works. We
understand the committee's interest in promoting the sharing of
valuable incident data within the OPTN and with Federal regulators. We
believe it is critical that any mechanisms for increased sharing
continue to protect patient privacy and to promote candid self-
disclosure when incidents do occur.
Question. During the August 3rd hearing you stated that the OPTN
``peer review process has significant persuasive authority, but all the
payment authority and all the certification/decertification authority
[for OPOs] live at CMS.''
Does UNOS routinely provide CMS with critical information on each
OPO's history of performance, policy compliance, and safe practice or
lack thereof, so that CMS may adequately enforce these payment and
decertification authorities?
If yes, please describe the mechanisms in place for UNOS to share
this information on a routine basis.
At the hearing, you alluded to HRSA's role in communicating this
type of information to CMS. Does UNOS routinely provide HRSA with
critical information on each OPO's history of performance, policy
compliance, and safe practice or lack thereof, so that HRSA may report
this information to CMS?
We understand from your testimony that HRSA participates in MPSC
discussions, but how does UNOS ensure HRSA is fully informed when less
than half of the OPO patient safety cases reported to UNOS in recent
years were referred to the MPSC?
Are OPOs and transplant centers required to report safety events to
UNOS? If so, please describe the requirements.
Is UNOS aware of failures to report safety events by any OPOs or
transplant centers? If so, what were the consequences of these
failures?
Answer. As the OPTN contractor, we have always welcomed a
substantive conversation about how best to share information with the
Federal Government in this process to ensure that all parties remain
informed. While we routinely provide HRSA information on member
performance, we do not routinely provide CMS with the same information.
Whether HRSA shares information with CMS is beyond our knowledge, as we
have traditionally been required to limit sharing of information only
to HRSA. However, we will be pleased to provide CMS with information if
directed and permitted by the OPTN Contracting Officer's Representative
(COR).
Engagement with HRSA and CMS: The OPTN board and committee
structure as required by NOTA, the final rule, and the OPTN contract is
designed to ensure HRSA is engaged and included at all levels of
governance. HRSA representatives serve as non-voting members of all
OPTN committees, as well as on the OPTN board of directors.
Additionally, HRSA representatives are present for all closed sessions
of the MPSC. If HRSA requests information from the OPTN, even
information protected by confidential medical peer review, the OPTN is
obligated to provide that information. The OPTN does not have
discretion over what HRSA does with any of this information after it is
provided and does not have insight over what HRSA provides to CMS.
We believe it is important that both HRSA and CMS fully understand
the issues the MPSC addresses in its peer review and monitoring
processes. Expanding communication to include direct engagement between
CMS and the OPTN is likely important to have more coordinated oversight
of the system and of OPOs in particular.
As mentioned above, HRSA is intimately involved in the OPTN's
compliance processes, and is informed of all cases sent to the MPSC. In
addition to being a part of the MPSC and the OPTN board of directors,
HRSA attends weekly MPSC leadership calls, during which HRSA and MPSC
leadership are apprised of any ongoing issues. HRSA has access to all
MPSC meeting agendas and materials, consistent with contract
requirements. If staff are not clear about whether a case should be
referred to the MPSC, staff will brief the MPSC leadership, including
HRSA, so that MPSC leadership can make an informed determination. Staff
also provide the MPSC with a retrospective report of the issues
reported in the previous year and provide a similar report to HRSA as
required in the OPTN contract. Even if a case is not reported to the
MPSC, it may nevertheless be reported to HRSA if it meets certain
agreed upon criteria, or other criteria agreed upon in the OPTN
contract.
Additionally, pursuant to the OPTN contract, UNOS staff annually
provide HRSA a monitoring report, which includes aggregate information
about the monitoring activities of both the MPSC and UNOS Member
Quality. The report provides data on efforts to monitor members and
improve member performance and compliance.
Reporting Patient Safety Events: Promoting patient safety is
central to the integrity of the donation and transplant system. OPTN
members are both required and encouraged to report safety events, and a
dedicated Patient Safety Portal is available for members to report
issues. However, the OPTN has been intentional about not explicitly
defining a ``patient safety event'' in OPTN policy in order to avoid
the risk of members potentially not reporting concerning events that
might fall outside a strict definition.
The OPTN contract requires UNOS to ``encourage OPTN member self-
reporting of potential patient safety issues'' but does not provide an
explicit definition for patient safety, save for a reference to types
of patient safety events described in the August 5, 2011 letter from
former HRSA Administrator Mary Wakefield (``the Wakefield letter'') to
then-OPTN board president Dr. John Lake.
As an example of the emphasis on patient safety, regardless of
definition, UNOS exceeds what is required in terms of providing
expedited notice to HRSA should any event meet the criteria outlined in
the Wakefield letter list of events; UNOS routinely provides notice
about other events that appear to be patient safety events despite not
being included on this list. This ensures that the broadest possible
scope of events reaches the MPSC for expert review and reasoned
deliberation to determine if an incident poses a risk to patient health
or public safety.
There are a number of OPTN policies that require submission
regarding specific kinds of patient safety events. Those policies
include, but are not limited to:\6\
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\6\ OPTN Policies. https://optn.transplant.hrsa.gov/policies-
bylaws/policies/.
15.5 Transplant Program Requirements for Communicating Post
Transplant Discovery of Disease or Malignancy.
15.6 Living Donor Recovery Hospital Requirements for
Reporting Post-
Donation Discovery of Disease or Malignancy.
16.2 Packaging and Labeling Responsibilities.
18.5 Reporting of Living Donor Events.
Additionally, when OPTN members use the Patient Safety Portal to
file a report, the portal itself outlines the types of events that OPTN
members should report, including: ``situations or activities that could
have affected patient safety. These situations may be related to
patient safety, organ placement/availability, communications, clinical
information accuracy, or risk of disease transmission that was
prevented. Situations that may not directly impact safety,
availability, or utilization but cause concern from a transplantation,
donation and/or quality perspective may also be reported.''
The OPTN becomes aware of patient safety events when events are
reported directly or otherwise discovered by the OPTN. If a member does
not report a patient safety event to the OPTN as outlined in OPTN
policies, that would qualify as a separate OPTN policy violation and
would be addressed on a case-by-case basis by the MPSC. Any
noncompliance is serious, and we are committed to engaging in
substantive conversations to address additional concerns the committee
may have about the MPSC's processes, and welcome opportunities to work
collaboratively to strengthen the rigorous, widely-used, and regulation
and contract-mandated confidential peer review process.
Question. Is UNOS able to calculate how many organs are matched
with a wait-list patient but ultimately not transplanted? If so, please
provide this number for each organ type in each of the last 5 years. To
the extent possible, please provide the reason the organ was not
ultimately transplanted.
Answer. Increasing the number of transplants by improving organ
utilization is a key strategic goal of the OPTN. The OPTN classifies
organ ``discards,'' or organs recovered for transplant but not
transplanted, as an organ that is recovered for the purpose of
transplant and ultimately not transplanted. The reasons for an organ
not being transplanted are provided to the OPTN by the recovering OPO,
and are categorized below:
1. Each transplant team who received the organ offer declined the
offer until there were no remaining wait-listed patients who matched
with the available organ.
2. There were biopsy findings that would make transplant unsafe.
3. There were poor organ function or organ disease that would make
transplant unsafe.
4. There were anatomic abnormalities that would make transplant
unsafe.
5. There were other unspecified medical reasons.
In most cases it is only kidneys, pancreata, and organs which will
be used for research purposes that travel without an accompanying team
of physicians. Livers, hearts, and lungs are generally not recovered
until the offer has been accepted by the candidate's transplant team;
the organ is then recovered by the candidate's transplant team who
maintain physical possession of the organ until the transplant surgery.
The following 2 tables provide the rate of ``discarded'' organs by
year/organ and the reasons for ``discard.''
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Question. For over 40 years, UNOS has remained the only
organization to manage the OPTN. As the sole operator, UNOS is
accountable for the outcomes that have occurred during their
management.
How does UNOS plan to address concerns raised by members during the
committee's August 3rd hearing, as well as concerns raised in the
committee's report?
What is UNOS doing, or planning to do, to improve its performance
in its role as the OPTN? Please provide these plans for improvement, as
well as when and how UNOS plans to accomplish them.
Answer. The strength of the U.S. donation and transplant system
lies in the hundreds of volunteer committee members who are integral to
the policy development process. This governance system includes two
patient and donor affairs representatives on all policy development
committees, and one quarter of the national board of directors is
composed of such representatives. As a whole, OPTN committees are made
up of experienced medical professionals, recipients, donors and donor
family members, and all are focused on honoring the gift of life by
increasing transplant. These stakeholders come together to create
policies after extensive collaboration, which also involves
incorporating input received during a rigorous public comment process.
The OPTN contractor is tasked with facilitating this process.
We agree that the OPTN contractor and all parties involved in the
organ donation and transplant system should be held to extremely high
standards and be held accountable for their performance. UNOS is proud
to be part of a system celebrating 9 consecutive years of growth in the
number of deceased donor transplants, 11 consecutive years of growth in
deceased donation, and record numbers of kidney, heart, and liver
transplants in 2021--a year in which the U.S. exceeded 40,000
transplants for the first time.\7\ In this system, tireless and
dedicated donation and transplant professionals continued to go above
and beyond to serve patients, despite a global pandemic. Of course,
though these are remarkable achievements, they are only made possible
thanks to the generosity of organ donors and their families nationwide.
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\7\ All-time records again set in 2021 for organ transplants, organ
donation from deceased donors. Organ Procurement and Transplantation
Network. https://optn.transplant.hrsa.gov/news/all-time-records-again-
set-in-2021-for-organ-transplants-organ-donation-from-deceased-donors/.
January 11, 2022.
It is incumbent upon us as the OPTN contractor to honor these gifts
of life not only by fulfilling the obligations of NOTA and the OPTN
contract to develop policies that ensure organs are allocated safely,
equitably and efficiently to the Nation's sickest patients, but also to
contribute to the growth and development of the system by proactively
offering system-wide, evidence-based and patient-focused policy
solutions at all levels of governance. Accordingly, the OPTN board of
directors adopts a new strategic plan every 3 years to guide the work
of the OPTN and its committees.\8\ The strategic plan maintains a
balance between setting high level community goals and allowing
committees the flexibility to design specific policy projects. The plan
for 2021-2024 is built around four primary goals. The most important is
Goal 1: Increasing the Number of Transplants, to which one third of the
OPTN's committee project resources are allocated. The other three goals
are Provide Equity in Access to Transplants, Promote Living Donor and
Transplant Recipient Safety, and Improve Wait-listed Candidate, Living
Donor, and Transplant Recipient Outcomes. Each goal is accompanied by a
suite of performance metrics, which is presented as an annual report to
the Board by the OPTN Executive Director. HRSA also receives this
report as a deliverable in the OPTN contract.
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\8\ 2021-2024 OPTN Strategic Plan. https://
optn.transplant.hrsa.gov/about/strategic-plan/.
In addition, the OPTN maintains a publicly accessible OPTN metrics
dashboard online, which displays key system performance indicators
related to donation, transplantation, wait-list details, patient and
graft survival, and transplant and mortality rates.\9\ The OPTN also
publishes the Equity in Access Dashboard, which shows how the OPTN
monitors trends related to equitable access to deceased donor
transplants among active waiting list candidates in the U.S. through an
Access to Transplant (ATS) score. The ATS follows the National
Institute on Minority Health and Health Disparities' Minority Health
and Health Disparities Framework, which lays out potential conditions
that can influence a person's health outcomes.\10\
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\9\ OPTN Metrics Dashboard. https://insights.unos.org/OPTN-
metrics/.
\10\ OPTN Equity in Access Dashboard. https://insights.unos.org/
equity-in-access/.
As indicated in her inaugural message to the entire organ donation
and transplant community, interim CEO Maureen McBride, Ph.D., said UNOS
will remain responsive to feedback received from the public, the
Federal Government, Congress, and other stakeholders.\11\ Dr. McBride
will seek engagement and support from the board of directors and
community as a whole in developing responsive improvements that
continue to accelerate system growth, increase patient and public
engagement, and seek to address challenges that face the system within
and outside the scope of the OPTN contract. Dr. McBride has identified
key areas of focus, including:
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\11\ UNOS names interim CEO. https://unos.org/news/unos-names-new-
interim-ceo/. October 1, 2022.
1. Engage patients, donors and their families to reimagine public
engagement, information and resources: In partnership with an external
vendor, Accenture Federal Services, a consulting firm and expert in
human-centered design, UNOS launched a research project to better
understand what specific information, tools and resources patients need
the most to support them in their journey. To date, UNOS and Accenture
have conducted more than 50 interviews with a broad spectrum of
patients, caregivers, living donors and transplant coordinators to
better understand their perspectives. The results of these interviews,
which will include members of the OPTN Patient Affairs Committee, will
serve as a foundation for operational, policymaking, and strategic
changes to UNOS and the OPTN in service of a more patient-focused
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organization.
2. Organ tracking and transportation: We share your concern about
organ transportation and agree that one organ lost is one too many.
Both UNOS and the OPTN have supported system-wide improvements in this
area, from the launch of UNOS's own organ tracking service to the
recently board-approved enhancements to OPTN data collection related to
organ logistics and allocation.\12\ Pending OMB approval, the data
collection is expected to begin in May 2023. OPTN committees are
currently building upon this work, exploring the development of common,
community-wide guidance outlining the importance of organ tracking data
and effective practices, as well as possible pathways within the
authority of the OPTN for enhancing organ tracking system-wide. UNOS is
also developing a technology product to help OPOs identify the most
expeditious transportation options for organs given the dynamic
challenges in the allocation system.
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\12\ ``Notice of OPTN data collection changes: Data collection to
evaluate organ logistics and allocation.'' https://
optn.transplant.hrsa.gov/media/5accb1s3/policy-notice_osc_data-
collection.
pdf.
3. Enhancements to the MPSC peer review process: At its October
2022 meeting, the MPSC plans to review and reaffirm its operational
rules and discuss the current construct of peer review as a mechanism
for its reviews. The committee also plans to assess potential
improvements to the way it shares information with the broader
community, as well as other OPTN committees, for the benefit of the
system and, ultimately, patients. Several recent system enhancements
focused on increasing patient safety were a direct result of the MPSC
peer review process. The MPSC is also driven to connect community
members with peer mentors in order to improve the system and
disseminate effective practices. Continuing to broadly disseminate MPSC
learnings and improvement structures may inform future OPTN
policymaking, lead to additional technology enhancements and spur
future collaborative improvement initiatives. The OPTN Board will
review and discuss the MPSC's recommendations at its December 2022
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meeting.
4. Seek support from HHS to expand data collection throughout the
transplant journey: Referral to a transplant program for a medical
eligibility evaluation is the initial step to receiving a transplant,
but patient referral information is siloed and not available in a
systematic fashion. The barriers in these initial steps in the
transplant process may be exacerbated by a number of social
determinants of health. The OPTN will seek support from the Secretary
to expand data collection of patient referral information as a next
step to evaluating and enhancing equity in access to the transplant
wait list.
5. Changes to UNOS senior leadership: On October 1st, Dr. McBride
announced a restructured senior leadership team. Her new team includes
key positions that renew a focus on streamlining operations to ensure
UNOS is providing an equitable and inclusive environment for the
volunteer workforce, the donation and transplant community, and the
patients it serves; ensuring UNOS is the best possible steward of the
resources it manages, promoting excellence and efficiency; and taking a
holistic, data-based approach to how it drives strategy across the
organization.
6. Separating the OPTN and UNOS boards: UNOS board leadership
finalized a work plan to formally separate the OPTN and UNOS boards in
September 2022, developed after ongoing discussions that began in 2021.
UNOS will work with HRSA to take the necessary legal, contractual and
operational steps to implement the plan.
7. Serve as a ``convener'' for system-wide initiatives and
improvements: UNOS will continue to partner with other key stakeholder
groups and leaders in the fields of medicine, technology and data on
strategic initiatives that contribute to the advancement of the field
of organ donation and transplant. For example, UNOS hosts an annual
conference for transplant administrators annually, sponsors a
professional education forum, and hosts meetings with key stakeholders
in the community. To this end, UNOS also will seek to expand
relationships with patient advocacy groups and other public health
organizations. Together, UNOS and its partners will identify and
advocate for evidence-based, patient-centered, systems improvement
policy solutions.
______
Questions Submitted by Hon. Chuck Grassley
Question. The U.S. Digital Service (USDS) found UNOS's information
technology (IT) systems outdated and voiced concerns that it operates
on local data centers, rather than the cloud, and relies on manual data
entry, resulting in user error and unacceptable downtime. USDS
recommended that the Federal government take action to create a better
organ transplant system including that the Organ Procurement and
Transplantation Network (OPTN) IT contract be bid separately because
UNOS has ``denied nearly 100 Federal requests to audit source code.''
Why has UNOS denied Federal requests to audit its source code?
How can Congress--or patients--trust UNOS to oversee its IT systems
when reports show that it is fragile and antiquated?
Has UNOS provided a demonstration of its IT system for the Health
Resources and Services Administration (HRSA) or discussed its IT
modernization efforts with them? If not, why not?
Will you commit that UNOS will have this discussion with HRSA or
other Federal agencies?
If the technology component of the OPTN contract is awarded to a
different vendor, will UNOS commit to working with the Federal
government to ensure a smooth transition for transplant patients?
Answer. UNOS appreciates the opportunity to address this concern
and clarify any lingering misconceptions. The entirety of the report,
as provided by a member of the media earlier this year, appears to be
based on a 90-minute presentation by UNOS on December 10, 2020,
pursuant to a request from HRSA during its 2019 Market Research for the
Modernization National Resource Allocation System, as well as UNOS's
responses to a set of follow-up questions submitted by HRSA.
The USDS has never conducted a review of our systems, and to date,
they have not reached out to UNOS directly regarding the results of
their report. UNOS continues to welcome the opportunity to review our
systems with the USDS and discuss our architecture, code base and
infrastructure. In an August 2, 2022, letter to the HRSA Administrator,
UNOS reiterated our willingness to undergo any additional review deemed
necessary. UNOS was and continues to be eager to engage directly with
USDS in the interest of continually improving our technology systems
and infrastructure.\13\
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\13\ Letter to HRSA Administrator. https://unos.org/wp-content/
uploads/20220802_UNOS-McCauley-Letter-to-HRSA-Administrator.pdf.
HRSA conducts an annual audit of our entire IT infrastructure, and
consistently reviews the performance and security of the OPTN system in
detail, as required by the OPTN contract. Their 2022 audit of our
systems is currently underway. HRSA also reviews all OPTN contractual
requirements for compliance annually, as well as on a periodic basis
throughout each year. UNOS consistently meets or exceeds all
contractual obligations. Semiannual tests are also conducted on OPTN IT
systems by a verified third party. UNOS has also just shared with HRSA
the results of the most recent cybersecurity penetration testing
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conducted by a third party in August.
The topics discussed have included the IT 3-year strategic plans,
API strategy and updates, new concepts requested by the transplant
community, information security, business continuity and disaster
recovery, cloud transformation, test automation, establishment, and
updates on the organ allocation assurance program, collaboration/
innovation events at various transplant conferences and numerous
others. Multiple times every year, and outside of annual audits, UNOS
has discussed a modernization strategy and updates on efforts for the
IT system with HRSA and the OPTN board of directors. Since 2016, this
has been a standing agenda item at every technology committee meeting
and annually at the OPTN board meeting. These discussions are
memorialized in OPTN Network Operations and Oversight Committee (NOOC)
meeting summaries published on the OPTN website.\14\
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\14\ OPTN Network Operations and Oversight Committee (NOOC) meeting
summaries. https://optn.transplant.hrsa.gov/about/committees/network-
operations-oversight-committee-board-of-directors/.
On February 9, 2017, HRSA staff (including the program office,
information technology and procurement) conducted an onsite, all-day
visit where various UNet functions were demonstrated, and where an IT
modernization strategy and progress were presented. More recently, our
IT system was demonstrated to HRSA at the December 2020 HRSA Market Day
presentation and again in September 2022, during the kickoff of the
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annual HRSA audit.
Since April 2019, the start of the current OPTN contract, and at
every subsequent contract year kickoff meeting with HRSA, UNOS IT has
presented technology modernization accomplishments for the prior year,
as well as plans for the current contract year. These meetings are with
the HRSA OPTN Contracting Officer's Representative (COR) and other HRSA
staff.
UNOS's technology systems are uniquely designed to support complex
allocation policies; they are flexible, modular and integrated within
the policy development framework, so as policies and clinical
requirements evolve, our systems can quickly evolve and change with
them. Additionally, our technology experts have deep experience and
understanding of transplant allocation algorithms, business rules and
logic, making for a seamless transition from policy to technology. A
dedicated IT liaison is assigned to each policy-making committee and
regularly attends committee and leadership meetings to ensure the
committee understands how the system works, and how intended changes to
policies might impact data collection and workflows. As part of the
interdepartmental team supporting committees, the IT liaison
participates in policy development from the idea stage, through public
comment, and board approval, refining business requirements and
ensuring that the policies can be supported with scalable technology
solutions that meet policy intent. IT's engagement with the solution
development allows a variety of technology options to be shared with
the committee as new policies are developed. Weekly meetings among
support staff and with committee leadership ensure alignment between
policy and system implementation at each stage.
However, UNOS is never satisfied with the status quo. That is why
we remain committed to constantly improving our IT systems and
responding to shifts in the technology and cybersecurity landscape to
make our systems as safe, secure, efficient, and responsive to our
members' needs as possible.
Since 2019, UNOS has maintained a cross-departmental team that is
focused on creating public cloud patterns that can scale our ideas and
core infrastructure for the capabilities found in the public cloud.
While building this expertise, we have partnered with the Microsoft
Tech for Social Impact team to align our vision with a reality we can
bring to the transplant community.
In 2021, UNOS completed a transformation to a multi-regional hybrid
cloud environment built using Nutanix cloud infrastructure and
Microsoft Azure public cloud. In line with a cloud-first approach for
all new functionality, UNOS has implemented new cloud-native real-time
capabilities in Predictive Analytics decision support for organ offer
acceptance, while actively executing a roadmap to move existing core
infrastructure to the public cloud. Building microservices is critical
to driving a seamless experience for a scalable solution that is built
both by UNOS teams and vendors in the community. As of January 2022,
UNOS has built hundreds of microservices as well as APIs with key
integrations with vendors through our developer portal that is
supported by Google Cloud's API management platform, Apigee.
One of the greatest challenges remains community adoption. Building
and providing members with APIs does not guarantee that transplant
hospitals, organ procurement organizations and histocompatibility
laboratories will use them. Decisions to adopt APIs are at times driven
by cost considerations between OPTN members and their Electronic Health
Records (EHRs, such as Epic, CareDX, TransplantConnect, etc.) who
integrate with our APIs. There are also cases when the OPTN members
decide not to leverage APIs because of previously implemented
automation, where the information they submit to OPTN is created
automatically within their EHR versus being entered manually. This
automation was built years ago in collaboration between UNOS and the
EHRs servicing OPTN members.
UNOS believes that APIs are still the path forward for seamless
data exchange between systems and have staff who work directly with
OPTN members and their software vendors (EHRs) to promote awareness and
adoption of our APIs. To build on that investment, UNOS is partnering
with Accenture Federal, a consulting firm and tech leader, to expand
and extend our API strategy to increase API adoption. This strategy is
focused on working with OPTN Member organizations to help them
understand what APIs they have access to but are not yet leveraging,
assisting them with implementation and testing, and driving process
improvements to further streamline future adoption.
There are opportunities to continue to improve the usability of
UNet applications to save users time and streamline customer
experience. To accomplish this, we also are working with our strategic
partner Accenture Federal, given their expertise in digital
transformation for Federal agencies using human-centered design, to
redesign the user interface and workflows within UNet applications. Our
goal is to make it more convenient, easier and faster for transplant
coordinators to manage patients in the national transplant system.
UNOS welcomes the opportunity to have focused and open discussions
about how we can continue to improve the information technology systems
that support the national transplant system. It bears repeating that we
invite the USDS and HRSA to participate in meaningful conversations
about our systems and improvements, and UNOS welcomes any additional
feedback they can provide.
Based on the data, annual HRSA audits, demonstrations, third-party
reviews and the fact that the system has remained safe for 36 years
despite over 3 million hacking attempts each day, Congress and patients
can trust the technology that powers the Nation's transplant system,
which remains safe, secure and efficient.
Question. During the committee's August 3, 2020 hearing, you
testified that UNOS's IT system was ``paid for in part by taxpayers.''
How much of UNOS's IT system was paid for by taxpayers?
How much of UNOS's IT system was paid for by OPTN members?
Answer. The National Organ Transplant Act (NOTA), 42 U.S.C. 273 et.
seq. requires that the OPTN operate a national system to allocate
organs using computer systems, and thus the costs of operating the OPTN
include the costs of operating a national system using computer
technology to allocate organs, including updates to reflect changes in
organ allocation policies, data collection, security, privacy,
reliability, improvements and architecture. The OPTN contract requires
the OPTN contractor to provide computer systems and software to meet
the statutory obligations of the OPTN, as well as meet extensive
Federal requirements for security, operability, privacy, and
reliability.
Within the UNOS budget, which is separate and distinct from the
OPTN budget, approximately 8-10 percent of UNOS revenues come from
Federal appropriations. Because UNOS does not directly bill Medicare,
Medicaid, or any other public insurance program or system, UNOS cannot
provide insight into the reimbursements hospitals and transplant
centers receive from public or private insurance. UNOS bills the
hospital directly and in turn is reimbursed by the hospital directly.
Approximately 85-90 percent of the OPTN budget is from a one-time
fee transplant hospitals pay per patient registered on the wait list.
Question. During the committee's August 3, 2022 hearing, you
acknowledged that over 3,000,000 attempts are made each day to hack
into UNOS's IT system. Does UNOS report these hacking attempts to the
Cybersecurity and Infrastructure Security Agency (CISA)? If so, what
types of information does UNOS share with CISA, and how often?
Answer. CISA conducts cyber hygiene scans of our external-facing
network weekly for vulnerabilities. Our scanning efforts with CISA
began this year, resulting in one ``low'' priority finding to date. We
subscribe to their alert program and are provided alerts for active
attacks and vulnerabilities. We also receive Indicators of Compromise
(IOCs) from them. We would report any impactful cybersecurity incidents
to CISA.
Question. On April 27, 2022, UNOS acknowledged that it failed to
report 35,000 deaths among patients on the waiting list. According to
UNOS, ``process improvement and automation'' allowed it to verify this
figure. This is deeply concerning and illustrates how the quality of
information provided by UNOS complicates policymakers' understanding of
how to improve outcomes for patients.
Please explain what new ``process improvement and automation'' have
allowed UNOS to report 35,000 additional deaths on the waiting list.
What caused the failure to identify to and report the additional
deaths? Is the failure attributed to UNOS technology, and/or other
factors?
Can UNOS provide a breakdown of the 35,000 additional deaths based
on patient attributes such as race, religion, age, sex, veteran status,
rural status, or physical or mental disability? If not, why not?
How many new or amended OPTN policies have relied on UNOS's faulty
data?
How many times did UNOS cite incorrect patient death data in
communications with policymakers and administrators in the executive or
legislative branches?
Answer. We appreciate the opportunity to clarify this issue for the
committee.
Prior to 2013, UNOS, as the OPTN contractor, had routine access to
the full and publicly available Social Security Death Master File. That
information supplemented the deaths reported to the OPTN by member
institutions. As of 2013, however, that file has not been publicly
available.
A new agreement between HRSA and CMS was established that allowed
the OPTN to continue having access to death data, on the condition that
the OPTN must verify each of the deaths with an external source prior
to release in the publicly available OPTN dataset. As part of this
workflow between 2013 and 2022, a multi-tiered process was used for
this verification, which included a manual review of obituaries online.
This process consumed significant resources each month, and the OPTN,
in collaboration with HRSA, limited the process to verifying those
deaths most likely to impact data analyses used for policy development
and monitoring of member performance.
As part of our continuous improvement efforts, UNOS evaluated
several technology and software solutions to automate the manual
searching of obituaries. UNOS partnered with a vendor in 2021 whose
technology was able to scan vastly more obituaries and match those
deaths to become part of the publicly available OPTN dataset.
The first complete scan with this new software verified 35,087
deaths that had been previously unreported to the OPTN, and that dated
back several decades. Following the data use agreement between HRSA and
CMS, those data were then incorporated into the publicly available OPTN
data set in the spring of 2022.
It is important to note that of these 35,087 deaths, roughly 23,000
were of transplanted patients who died at some point after their
transplant (which in many instances could be years later). Fewer than
100 were of patients who were active on the waiting list at the time of
their death, and roughly 12,000 were patients who died at some point
after they had been removed from the wait list. Transplant programs
remove patients from the wait list for a variety of reasons including
the patient being too sick to transplant, their condition improves,
they refuse a transplant, transplant programs are unable to contact
them, or other reasons. In this verification process used by the OPTN,
the reasons for death are unknown or unreported and could be for
reasons unrelated to transplantation.
Religion and/or physical or mental disability are not part of OPTN
policies and are not collected by the OPTN. Data regarding veteran
status is not specifically collected; however, the primary source of
payment is reported by transplant programs, and the Department of
Veterans Affairs is one of the possible selections.
Below is a breakdown of the recently verified 35,087 patient deaths
by race/
ethnicity, age (at listing or transplant), education status at time of
listing, primary source of payment (at listing or transplant).
------------------------------------------------------------------------
Number of Percent of
Patient Deaths Patient Deaths
------------------------------------------------------------------------
Total Individuals 35,087 100.0%
------------------------------------------------------------------------
Race/Ethnicity
------------------------------------------------------------------------
White, Non-Hispanic 20,282 57.8%
------------------------------------------------------------------------
Black, Non-Hispanic 8,425 24.0%
------------------------------------------------------------------------
Hispanic/Latino 4,590 13.1%
------------------------------------------------------------------------
Asian, Non-Hispanic 1,209 3.4%
------------------------------------------------------------------------
American Indian/Alaska Native, Non- 349 1.0%
Hispanic
------------------------------------------------------------------------
Native Hawaiian/other Pacific 131 0.4%
Islander, Non-PHispanic
------------------------------------------------------------------------
Multiracial, Non-Hispanic 96 0.3%
------------------------------------------------------------------------
Unknown 5 0.0%
------------------------------------------------------------------------
Age at Transplant/Listing *
------------------------------------------------------------------------
< 1 1 0.0%
------------------------------------------------------------------------
1-5 35 0.1%
------------------------------------------------------------------------
6-10 74 0.2%
------------------------------------------------------------------------
11-17 249 0.7%
------------------------------------------------------------------------
18-34 3,097 8.8%
------------------------------------------------------------------------
35-49 9,424 26.89%
------------------------------------------------------------------------
50-64 15,860 45.2%
------------------------------------------------------------------------
65+ 6,347 18.1%
------------------------------------------------------------------------
Education Level at Listing **
------------------------------------------------------------------------
Not Reported 2,948 8.4%
------------------------------------------------------------------------
None 138 0.4%
------------------------------------------------------------------------
Grade School (0-8) 1,821 5.2%
------------------------------------------------------------------------
High School (9-12) or GED 13,284 37.9%
------------------------------------------------------------------------
Attended College/Technical School 6,804 19.4%
------------------------------------------------------------------------
Associate/Bachelor Degree 3,984 11.4%
------------------------------------------------------------------------
Post-College Graduate Degree 1,700 4.8%
------------------------------------------------------------------------
N/A (< 5 years old) 32 0.1%
------------------------------------------------------------------------
Unknown 4,376 12.5%
------------------------------------------------------------------------
Primary Source of Payment at
Transplant/ Listing *, **
------------------------------------------------------------------------
Not Reported 2,418 6.9%
------------------------------------------------------------------------
Private Insurance 13,704 39.1%
------------------------------------------------------------------------
Public Insurance--Medicaid 1,780 5.1%
------------------------------------------------------------------------
Public Insurance--Medicare FFS (Fee 8,236 23.5%
for Service)
------------------------------------------------------------------------
Public Insurance--Medicare & Choice 3,925 11.2%
------------------------------------------------------------------------
Public Insurance--CHIP (Children's 3 0.0%
Health Insurance Program)
------------------------------------------------------------------------
Public Insurance--Department of VA 334 1.0%
------------------------------------------------------------------------
Public Insurance--Other government 145 0.4%
------------------------------------------------------------------------
Self 62 0.2%
------------------------------------------------------------------------
Donation 3 0.0%
------------------------------------------------------------------------
Free Care 35 0.1%
------------------------------------------------------------------------
Pending 57 0.2%
------------------------------------------------------------------------
Foreign Government 2 0.0%
------------------------------------------------------------------------
Public Insurance--Medicare (further 4,169 11.9%
detail not collected)
------------------------------------------------------------------------
U.S./State Government Agency 214 0.6%
------------------------------------------------------------------------
* For recipients with a transplant, age at transplant and source of
payment at transplant were used. Age at listing and source of payment
reported at listing were used for all other patients.
** Education at listing and primary source of payment were not collected
throughout the entire period of OPTN data collection and therefore are
not available for all patients.
Question. In 2018, UNOS made significant changes to heart
transplant selection criteria in order to reduce wait-list times, among
other reasons. I understand that some in the heart transplant community
are beginning to raise questions about the impact these changes have
had on physician practice patterns.
Is UNOS monitoring long-term changes in both clinical outcomes and
quality of life for these post-transplant? If not, does UNOS intend to
study the impact on these patients? If not, why not?
Is UNOS open to making any appropriate adjustments to the system to
help improve patient outcomes and quality of life while maintaining
shorter wait times? If not, why not?
Answer. Policy development does not end with implementation. A key
aspect of the community-driven OPTN policy process is how it monitors
both the short- and long-term outcomes and impacts of policy changes on
patients and the system. Following the implementation of any policy,
the OPTN begins monitoring the impact, looking for opportunities to
potentially improve the policy, for any unintended consequences, and
results that may require additional actions by OPTN committees and the
board. The review process for any policy is agreed upon beforehand by
committee leadership and is documented in the proposal that is
ultimately reviewed and approved by the OPTN board of directors. Staff,
committees and the board continue to analyze whether the policy is
meeting stated goals. Additionally, UNOS researchers present their
ongoing analysis to the sponsoring committee and interested external
stakeholders. The committees' reviews of this analysis may result in
new ideas to improve the policy and by extension, the overall
transplant system. In this way, the policy development process comes
full circle, resulting in continued innovations and improvements.
As it specifically relates to the 2018 heart policy change, the
OPTN Heart Committee has reviewed monitoring reports gauging the
ongoing impact of this policy at 1 year, 18 months, 2 years and 3 years
post-implementation of the heart allocation policy changes. As noted in
each report, a number of key metrics are monitored, including patients
added to the heart wait list by medical urgency, patients waiting for a
heart transplant by medical urgency, deaths on the wait list, post-
transplant survival, the total number of transplants, the time it takes
for a transplant hospital to accept offers, distance the heart travels
between the donor and the recipient, utilization rates, and many other
metrics.\15\ Where relevant, these metrics are then stratified by age,
region, and urgency status to arrive at a fuller, more accurate picture
of the policy's ongoing impact.
---------------------------------------------------------------------------
\15\ OPTN Heart and Lung Resources: Heart Monitoring Reports.
https://optn.transplant.hrsa.
gov/professionals/by-organ/heart-lung/.
The 3-year report reviewed by the committee on October 10, 2022 is
responsive to specific questions raised by the Heart Committee based on
its review of past data, as well as the collective clinical experiences
of its members who have been practicing under the new policy.\16\ For
example, based on previous findings and recent scholarly analyses, the
Heart Committee has since emphasized the need to better understand
wait-list mortalities associated with the individual criteria found in
the adult heart medical urgency statuses 2, 3 and 4. The Heart
Committee believes these data will provide a better idea of the medical
urgency of patients who are being transplanted at each status and help
to identify additional opportunities to assist any populations in need
of improved access under the revised policy.
---------------------------------------------------------------------------
\16\ Schellinger, E.; Bradbrook, K.; Lindblad, K. ``Three-Year
Monitoring of the Heart Allocation Proposal to Modify the Heart
Allocation System Prepared for the OPTN Heart Committee.'' October 11,
2022. https://optn.transplant.hrsa.gov/professionals/by-organ/heart-
lung/.
Consistent, rigorous, data-driven monitoring and responsive policy
changes are essential to continuously improving the national system and
---------------------------------------------------------------------------
ensuring the best outcomes for patients.
Question. In 2018, HRSA issued a request for proposal (RFP) for the
operation of the OPTN. The RFP included conditions that required the
contractor to submit a plan to ensure that the OPTN board of directors
be separate from the contractor's board of directors. UNOS filed a
protest with the Government Accountability Office, arguing that HRSA
``does not have the authority under NOTA to direct the OPTN to have a
board of directors that is separate from the entity that is awarded a
contract to operate the OPTN.'' GAO rejected UNOS's argument and found
``nothing in [the National Organ Transplant Act] prohibits the agency
from issuing a solicitation that treats the UNOS and the OPTN as
separate entities.''
Has UNOS taken steps to separate the UNOS and OPTN board of
directors? If not, why not?
How does the current board structure prevent conflicts of interest?
Answer. Yes, UNOS has taken these steps, and began the effort to
separate the UNOS board and OPTN board in earnest in Spring 2021.
More recently, the UNOS board of directors leadership affirmed this
plan, passing a resolution in August 2022 charging staff ``to explore
the separation of the boards to develop a viable framework for separate
boards that provides clarity on roles and responsibilities, fiscal
matters, and operational interactions between the OPTN board, HRSA, and
UNOS. Staff are authorized to retain such experts as appropriate and
will provide a report to the committee for its review within 30 days.''
Currently, the existing OPTN contract with HRSA requires that the
UNOS board of directors also serve as the OPTN board of directors.
Thus, separation of the boards will require approval by HRSA, as it
would require a significant modification to the OPTN contract.
Regarding conflicts of interest, the OPTN bylaws include specific
provisions to address and avoid conflicts of interest for both board
and committee membership. Additionally, the OPTN board has approved a
plan to augment its current policies regarding potential conflicts of
interest. Activities of the OPTN are clearly described and separate
from UNOS's. The OPTN board of directors receives an annual orientation
regarding its obligations to the OPTN, which includes a presentation
from HRSA staff. In addition, members of the OPTN board sign an
attestation document acknowledging their obligation to the OPTN
separate from any obligations to any other organization, including to
UNOS.
As previously stated, efforts are currently underway to officially
establish two separate boards, a process UNOS began over a year ago and
which we believe will help address concerns about conflicts of interest
and will provide another layer of transparency and accountability.
Question. Please identify the OPTN policy that prohibits organ
procurement organizations (OPO) from discriminating against donor
patients or their families based on attributes such as race, religion,
age, sex, veteran status, rural status, or physical or mental
disability?
Answer. OPTN policies do not allow for the segregation of patients
or donors by distinguishing characteristics such as disability, race,
religion, sex, age, veteran status or rural location.
OPTN Policy 2.2: OPO Responsibilities, includes the following
provision:
``The host OPO is responsible for all of the following . . .
6. Establishing and then implementing a plan to address organ
donation for diverse cultures and ethnic populations.''
OPTN Policy 5.4.A: Nondiscrimination in Organ Allocation, states
the following:
``A candidate's citizenship or residency status in the
United States must not be considered when allocating deceased
donor organs to candidates for transplantation. Allocation of
deceased donor organs must not be influenced positively or
negatively by political influence, national origin, ethnicity,
sex, religion, or financial status.''
Question. In May 2012, the former director of the Alabama Organ
Center was sentenced to 13 months in prison in his role in a scheme to
take kickbacks from a funeral home that did business with the organ
center. Has UNOS ever addressed Medicare fraud and misuse of Medicare
dollars among OPOs by implementing OPTN policies and procedures? If so,
please identify the OPTN policy that addresses Medicare fraud among
OPOs. How does UNOS monitor and enforce compliance?
Answer. Because Federal law does not provide the OPTN with the
authority to investigate Medicare fraud or misuse of public monies,
this issue is not within the scope of the OPTN's authority. CMS has
direct access to OPO cost reporting and information relating to the
OPO's business practices. Under the current regulatory and oversight
construct, the OPTN would not have this information. Federal law and
regulation for the OPTN primarily directs the OPTN to assist OPOs in
organ placement and develop organ allocation and clinical data
collection policies.
In this particular case from Alabama, we understand that the scheme
related to tissue recovery from deceased donors, which is regulated by
the Food and Drug Administration (FDA), and not the OPTN or HRSA.
Because of this separation of oversight responsibilities, the OPTN does
not collect data on payment or tissue recovery/allocation.
Question. Studies show that, on average, kidney transplant
candidates receive 16 organ offers while on the transplant wait list.
However, studies also show that a large number of these offers are
declined on their behalf by transplant hospitals, contributing to the
shortage of available organs in the United States. It's critical that
the OPTN be transparent with patients and their families when these
decisions are made so that we improve trust in the OPTN.
Does UNOS have a system to alert patients when organ offers are
rejected by transplant centers on their behalf? If not, why not?
Members of UNOS's Patient Affairs Committee (PAC) told committee
staff that they discussed this issue with UNOS, but that UNOS did not
listen to their concerns. If UNOS's PAC raised this issue, why hasn't
it been addressed?
How will you alleviate concerns raised by PAC members that UNOS
does not listen to their advice or counsel?
Answer. UNOS agrees that the continued rise in the number of organs
recovered for transplant that are ultimately not transplanted requires
a multi-pronged, systemic approach to address this issue, as noted in a
February 2022 report from the National Academies of Science,
Engineering, and Medicine (NASEM).\17\ In this report recommendation,
``Key Area for Improvement for Transplant Centers: Organ Offer
Acceptance,'' the authors review in detail many of the factors that may
contribute to this trend. The NASEM report also notes two OPTN tools,
enhanced ``refusal codes'' and ``offer filters'' as having the
potential to increase system efficiency and contribute to a hospital's
understanding of its own acceptance practices with improved data. UNOS
agrees that patients, not just hospitals, need more information in key
areas.
---------------------------------------------------------------------------
\17\ National Academies of Sciences, Engineering, and Medicine.
2022. ``Realizing the promise of equity in the organ transplantation
system.'' Washington, DC: The National Academies Press. https://
doi.org/10.17226/26364.
---------------------------------------------------------------------------
shared decision-making
UNOS does not currently have a mechanism to alert patients when
organ offers are declined on their behalf by their transplant teams.
UNOS, however, supports and encourages clear communication between
transplant teams and the patients they serve, and is in the discovery
phase of developing a tool that members could use to help patients
understand why they have refused organ offers.
UNOS is also currently conducting a research study with Accenture
Federal Services, a consulting firm and expert in human centered
design, to understand patient information needs throughout the
transplant journey. More than 50 patients, caregivers, living donors
and transplant professionals representing pre- and post-transplant,
representing all organ types and geographic areas, along with members
of the PAC, are being interviewed as part of the study. Findings will
inform actions the OPTN can take to better meet patient's information
needs and ensure equity in access to transplant.
UNOS agrees with recommendations in the NASEM report that
empowering patients with information about their care leads to more
positive transplant outcomes and is committed to pursuing tools and
technology that will facilitate greater shared decision-making.
patient engagement
As of October 1st, UNOS has an interim CEO who is prioritizing
listening to and determining how to better engage with patients. The
patient, donor and family perspective are an essential component of
both OPTN and UNOS governance and the interim CEO attended the in-
person Public Affairs Committee (PAC) meeting in September. In the
coming months, UNOS will seek new ways to ensure the patient voice is
heard and acted upon. The UNOS leadership team will engage the board of
directors, the PAC and members of the donation and transplant community
in identifying concrete solutions for addressing this concern.
UNOS has evolved support of the PAC over the past several years and
made multiple operational changes to improve patient engagement both
within our volunteer network and beyond, including:
During the development of the current strategic plan, the
PAC provided numerous and specific comments intended to improve
patient engagement. Almost all of those comments were adopted
and included in the plan. Following adoption of the strategic
plan, several changes have occurred to follow up on that
commitment:
An increase in the number of patient and
donor affairs representatives to ensure a minimum of
two on all policy development committees (the OPTN
final rule at 42 CFR Sec. 121.3(a)(4)(i) requires at
least one transplant candidate, transplant recipient,
organ donor or family member), with staggered terms so
that new patient representatives will have the support
of another representative that has experience on the
committee moving forward.
Creation of a standard to include a
patient representative on each of the regional
nominating committees that nominate regional
representatives to serve on the OPTN board of
directors.
Strengthened the patient voice by recruiting experienced PAC
alumni to serve on other committees and the board of directors.
Developed a two-step process for soliciting patient feedback
on OPTN policy proposals, so that PAC members receive education
and background on a topic first, and are asked for more
detailed feedback on subsequent meeting, building on previous
efforts to ensure and empower patients to provide informed,
actionable feedback.
Created focused, plain language prompts and a glossary of
terms for proposals out for public comment, so patients and the
general public are more empowered to influence policy
development.
Released new, patient-specific on-demand education modules
on UNOSConnect, UNOS's learning management system, designed to
inform patient volunteers on the donation and transplantation
system.\18\
---------------------------------------------------------------------------
\18\ UNOSConnect. https://unos.org/resources/education/.
---------------------------------------------------------------------------
Promoted attendance and participation by patient
representatives at OPTN Regional Meetings:
Highlighted and welcomed PAC regional
representative at the beginning of each meeting (Winter
cycle 2022).
Held prep sessions for PAC
representatives prior to Summer 2022 regional meetings
and provided opportunity for them to introduce
themselves and their connection to transplant at the
meetings.
Offered and committed to maintaining
virtual attendance options for regional meetings to
allow for increased patient accessibility.
Created and distributed a customized
``what to expect'' meeting guide to all registered
patient and donor family attendees in advance of the
meeting with contact information for questions/
suggestions.
Noted an increase in almost all regions
with patients providing their feedback during the
regional meeting, providing valuable perspectives to
the transplant community in attendance.
Building on these accomplishments will require taking a holistic
look at what information UNOS and the OPTN can provide to support
patient empowerment. From their time on the wait list to their life
post-transplant, treating patients as informed partners in their own
care is a critical, system-wide goal.
Question. Section 5.4.A of OPTN policy mandates that ``[a]llocation
of deceased donor organs must not be influenced positively or
negatively by political influence, national origin, ethnicity, sex,
religion, or financial status.'' However, recent research demonstrates
that some transplant centers factor in financial resources in wait-list
determinations, causing otherwise eligible transplant candidates to be
determined ineligible for transplantation based on socioeconomic
status.
Is this behavior a violation of section 5.4.A of OPTN policy?
How does UNOS ensure that its members do not consider political
influence, national origin, ethnicity, religion or financial status
when making the initial wait-list decision?
Answer. It is important to distinguish between the allocation of
deceased donors to transplant candidates who are on the waiting list,
and access of potential transplant candidates to be placed on the
waiting list. OPTN policies, including organ allocation algorithms, are
programmed into the computer systems that allocate organs. The OPTN
monitors every organ transplant to ensure that the organ allocation
``match run'' is followed, or that deviations from the ``match run''
are adequately explained by objective criteria. The question cites
research that some transplant hospitals may deny patients access to the
waiting list based on the financial resources of the patient, which is
not addressed by OPTN Policy 5.4.A. Decisions on whether to add a
patient to the OPTN waiting list are complex medical and social
decisions made by a team of health-care providers at each transplant
hospital.
To ensure that every transplant has the best chance for success and
to prevent futile transplants, NOTA requires that patients demonstrate
critical success factors for transplant, including availability of a
full-time caregiver, transportation to the transplant center during the
recovery period, and financially related matters among other things.
Transplant teams conduct full psycho-social evaluations of every
potential transplant patient as part of their decision to add them to
the waiting list.
Question. UNOS's new organ allocation policy appears to have added
significant chaos to the transplantation system. What is the OPTN doing
to alleviate this chaos that is adversely impacting patients before
making additional changes that require even greater travel distances--
and more cold ischemic time--for organs? How can Congress--or
patients--trust UNOS to effectively quarterback this system when
investigative reports show it fails at even the basics of organ
transportation, regularly losing track of organs in transit?
Answer. The data does not support the above assertions. In fact,
similar arguments have been raised by certain plaintiffs in litigation
in an attempt to block implementation of the national liver and kidney
allocation policies. However, the GAO found no fault in their
development, and the courts have upheld the OPTN's adoption of these
policies.\19\
---------------------------------------------------------------------------
\19\ ``Organ Transplants: Changes in Allocation Policies for
Donated Livers and Lungs.'' U.S. Government Accountability Office.
October 16, 2020. https://www.gao.gov/products/gao-21-70.
Since the implementation of new allocation policies in recent
years, we have seen national increases in transplants for all major
organs. In fact, the three organ types most commonly transplanted
(kidneys, livers and hearts) all set records in 2021, despite a global
pandemic. Liver transplant totals have set annual records for the past
9 years, and heart transplants have set a new record each of the past
---------------------------------------------------------------------------
10 years.
Specifically for kidney and liver, OPTN monitoring reports for
recent changes to allocation policies for both organs have shown that
these policies are fulfilling the obligations of NOTA by ensuring
donated organs are shared as broadly as possible to reach the sickest
patients first, regardless of where a patient is listed. These
community- and data-driven allocation policies and ongoing efforts to
further improve the system have resulted in more transplants and more
lives saved; policies that have increased equity, expanded access and
met the dual goals of ensuring that changes to cold ischemic time have
no impact on the health of the organ (minimal increases were shown to
be clinically insignificant) while also prioritizing the sickest
patients first. Looking at this data and the policies that helped drive
these outcomes, Congress as well as patients and their families can
trust the Nation's organ donation and transplant system.
All organ allocation policy monitoring reports are available on the
OPTN website for the public's review at https://
optn.transplant.hrsa.gov/professionals/by-organ/.
______
Questions Submitted by Hon. John Barrasso
Question. This committee has obviously been hard at work trying to
identify shortcomings in the organ procurement and transplantation
system over the past couple years. Also within the past couple years,
the Trump administration proposed and the Biden administration
finalized the OPO final rule. This rule established new performance
metrics for OPOs as well as helped promote more frequent oversight and
competition among OPOs.
Are there other regulatory or legislative actions Congress or the
administration should take to ensure the OPTN is performing to its
maximum potential for patients and providers?
Answer. UNOS is pleased to offer the following items for your
consideration:
1. Invest in innovations that may offer improved OPO regulatory
oversight and increase organ donation: In order to improve regulatory
oversight and identify underperforming OPOs, UNOS recommends automating
donor referrals to collect data that will accurately measure true donor
potential.\20\ At least six OPOs with service areas across 15 States
have partnered with donor hospitals to replace current manual data
entry with automated donor referral, leveraging existing technology on
the market to automatically alert an OPO of a potential donor in a
hospital ICU.\21\, \22\, \23\ One study's
analysis on three pilot hospitals in Texas found that electronic
referral was associated with a 45-percent increase in referrals, an 83-
percent increase in approaches for donor family authorization, a 73-
percent increase in donor family authorizations, and a 92-percent
increase in organ donors.\24\ A national investment into this
innovation could not only save more lives by increasing the number of
donor referrals, but also provide a more granular, independently
reported and clinically accurate data set that would enable the OPTN
and CMS to best assess performance.
---------------------------------------------------------------------------
\20\ ``5 ways to improve the U.S. organ donation and transplant
system: Automate real-time donor referral.'' Accessed October 10, 2022.
https://unos.org/news/media-resources/5-ways/automate-real-time-donor-
referral/.
\21\ Niles, Patricia; Hewlett, Jonathan; Piano, John; Liu, Wade.
``Automated Electronic Referrals Are Changing Donation.''
Transplantation: September 2020--Volume 104--Issue S3--p. S259 doi:
10.1097/01.tp.0000699788.52410.58.
\22\ Glazier, A.; Moss, M.; Martin, L. (2021). ``Electronic Health
Records Can Improve the Organ Donation Process.'' Retrieved January 20,
2022, from https://hbr.org/2021/12/electronic-health-records-can-
improve-the-organ-donation-process.
\23\ ``Cleveland Clinic, Lifebanc and Transplant Connect Develop
Automated Donor Referral Process.'' April 30, 2021. https://
newsroom.clevelandclinic.org/2021/04/30/cleveland-clinic-lifebanc-and-
transplant-connect-develop-automated-donor-referral-process/. Accessed
January 20, 2021.
\24\ Levan, Macey L.; Trahan, Chad; Klitenic, Samantha B.; Hewlett,
Jonathan; Strout, Tyler; Levan, Michael A.; Vanterpool, Karen B.,
Ph.D., MPH; Segev, Dorry L., M.D., Ph.D.; Adams, Bradley L.; Massie,
Allan B., Ph.D.; Niles, Patricia, BS, RN. ``Short Report: Evaluating
the Effects of Automated Donor Referral Technology on Deceased Donor
Referrals.'' Transplantation Direct: August 2022--Volume 8--Issue 8.
2. Encourage HHS to enable the OPTN to collect data on inequities
in access to pre-wait-list care and referral: Substantial research has
documented inequities in access to the national wait list, and
substantial variation across transplant programs with respect to
transplant access.\25\, \26\ However, what is unknown is the
extent to which these inequities in access to transplantation are due
to patient characteristics or to transplant program characteristics.
OPTN data collection begins at the time a patient is wait-listed for
transplantation. The transplant community, including clinicians,\27\
community members,\28\ and researchers,\29\ has repeatedly called for
pre-wait-list data collection to address this important problem, but no
national data exist to identify patients who have end-stage organ
failure and are appropriate candidates for transplantation. Authorizing
the OPTN to collect this data would allow for better system evaluation
and performance improvements. The OPTN Data Advisory Committee (DAC)'s
request to HRSA to collect and study these elements is currently
pending.
---------------------------------------------------------------------------
\25\ Ashby, V.B., J.D.; Kalbfleisch, R.A.; Wolfe, M.J. Lin; F.K.
Port; A.B. Leichtman. ``Geographic Variability in Access to Primary
Kidney Transplantation in the United States, 1996-2005.'' American
Journal of Transplantation 7, no. s1 (2007): 1412-23. https://doi.org/
10.1111/j.1600-6143.2007.01785.x.
\26\ King, Kristen L.; Syed Ali Husain; Zhezhen Jin; Corey Brennan;
Sumit Mohan. ``Trends in Disparities in Preemptive Kidney
Transplantation in the United States.'' Clinical Journal of the
American Society of Nephrology 14, no. 10 (2019): 1500-1511. https://
doi.org/10.2215/cjn.03140319.
\27\ Sehgal, Ashwini R. ``Should Transplant Referral Be a Clinical
Performance Measure?'' Journal of the American Society of Nephrology
28, no. 3 (2016): 721-23. https://doi.org/10.1681/asn.2016111169.
\28\ Fowler, Kevin John. ``Accountability of Dialysis Facilities in
Transplant Referral.'' Clinical Journal of the American Society of
Nephrology 13, no. 2 (2018): 193-94. https://doi.org/10.2215/
cjn.13741217. 2018;13(2):193-194.
\29\ Patzer, Rachel E.; Laura McPherson. ``Variation in Kidney
Transplant Referral: How Much More Evidence Do We Need To Justify Data
Collection on Early Transplant Steps?'' Journal of the American Society
of Nephrology 30, no. 9 (2019): 1554-56. https://doi.org/10.1681/
asn.2019070674.
3. Support information sharing between the OPTN and CMS: As
previously mentioned, CMS and the OPTN can mutually benefit from
increased information sharing to aid in their respective roles in the
system. UNOS continues to support the development of such a process in
a way that enhances and improves holistic oversight and improvement for
---------------------------------------------------------------------------
the system.
______
Questions Submitted by Hon. Benjamin L. Cardin
organ transportation
Question. Since 2010, what penalties have OPOs or transportation
companies received when an organ has been lost or damaged in transit
such that it has to be subsequently discarded?
What is the exact number of organs lost, delayed, and/or damaged?
Of those, what is the exact number of the resulting loss of prospective
transplants, and how many patients died waiting for a new organ? Please
provide a methodology to support your answer in a manner that is
reproducible.
Does UNOS collect or have access to data regarding the number and
percentage of organs that are transported with real time tracking
(i.e., GPS) and organs transported with temperature tracking? If so,
please provide that information you have from the last 5 years.
Given the overrepresentation of Black Americans waiting on a
kidney, do transportation problems that seem to disproportionately
impact kidneys impact the disparity we observe?
Answer. Any transplant opportunity lost due to transportation
errors is one too many. As the committee is aware, organs are currently
tracked by the OPTN's TransNetSM system, made mandatory by OPTN Board
action in 2017, requiring the use of color-coded external, internal and
vessel labels when shipping or transporting organs outside the donor
hospital.\30\
---------------------------------------------------------------------------
\30\ OPTN organ transport. https://optn.transplant.hrsa.gov/
professionals/by-topic/organ-transport/.
Nonetheless, UNOS agrees that improving data collection and
transportation tracking would benefit the system and supports an
increase in data collection in this area to identify any appropriate,
---------------------------------------------------------------------------
data-driven interventions that would support any improvements needed.
Should Congress wish to establish a central authority to track all
organs unaccompanied by a transplant team (primarily kidneys) in
transit across all transportation and logistics vendors, we submit the
following for your consideration to support the development of
potential policy solutions.
At present, the only authority the OPTN has under both
Federal law and regulation relates to its member institutions.
The OPTN cannot make requirements or lodge penalties of
transportation companies because they are not OPTN members and
would not qualify as one per the OPTN final rule (42 CFR Sec.
121.3(b)(1)).
Additional Federal appropriation may be required to develop
and implement the technology required to track organs in
transit across multiple commercial, non-clinical vendors and
airlines, depending on the level of granularity of data and
whether ``real time'' tracking is desired.
Any policy solutions should clearly define a ``reportable''
transportation-
related delay or damage, including how to determine if a
specific incident played a role in the non-use of an organ or a
transplant failure, or what individuals, organizations, private
entities, businesses, etc. to hold ultimately accountable and
under what authority.
We strongly believe the donation and transplant community, and
especially patient and donor affairs representatives, should be engaged
to develop requirements for such a solution, in addition to all other
key stakeholders, to ensure all necessary considerations are
identified. The OPTN would be pleased to provide a review of the
previous Operations and Safety Committee, OPO Committee and MPSC's
discussions on this topic to date should the committee desire.
As mentioned during the hearing, UNOS is taking action to address
some of these challenges. In 2019, UNOS began developing an organ
tracking solution to offer to OPOs. Since the product launched in June
2021, and as of September 22, 2022, 5,628 shipments have been tracked,
accounting for roughly 8 percent of all packaged organs during that
time period. Clients on average track 30 percent of all their packaged
organs. Some OPOs don't track organs such as hearts, lungs and livers
because they are traditionally accompanied by the procuring surgeon.
Other OPOs only track kidneys and/or livers that use commercial air
and/or are exported from their service area.
Based on currently available data, it is difficult to assess the
impact that transportation might have on transplant disparities.
Please see additional transportation information in the responses
to Senator Wyden's seventh question and Senator Young's first question.
technology
Question. You testified that UNOS's IT system has a 99.99-percent
uptime, and according to a report from the USDS entitled ``Lives Are At
Stake,'' UNOS told the Federal Government that it had ``experienced
99.79 percent uptime since 1999.'' Since January 1, 2022, UNOS began
reporting uptime excluding scheduled maintenance.
Please provide documentation of UNOS uptime including scheduled
maintenance time.
Why is UNOS now excluding planned maintenance from its uptime
calculation?
Are there any contract requirements for downtime related to planned
maintenance?
Is there a definition of planned maintenance in the service-level
agreement?
Answer. Both during the oral testimony and in the written
testimony, we have affirmed the fact that UNOS has consistently met or
exceeded OPTN contract requirements across the board, including for
system uptime.
The new uptime requirement, as referenced in your question, was
adopted following a study requested by HRSA and conducted by the OPTN's
Network Operations Oversight Committee (NOOC) to determine a
``clinically acceptable'' level of availability of the OPTN matching
function. As detailed in a June 2022 report to the board, based on the
committee's findings and supported by Gartner research into health-care
applications on a national scale, the NOOC recommended that the OPTN
maintain a 99.9-percent matching function uptime, not including planned
maintenance.\31\ The committee noted that any potential delay in organ
matching as a result of downtime is managed at the donor level so that
patient safety is protected, and organ offers are not missed.
---------------------------------------------------------------------------
\31\ ''Clinically acceptable availability of the OPTN matching
function.'' OPTN Network Operations Oversight Committee report to the
board. June 26, 2022.
As shown in the UNet Availability Summary below, the early years
(2000-2005) of our systems' existence were challenging as new features
and functions were being added. During 2005, core stability and
scalability improvements were made and since 2006, the system has been
consistently reliable and available. Additional high-availability
improvements have been implemented between 2016 and 2022, including
---------------------------------------------------------------------------
migration to multi-regional hybrid cloud.
Nonetheless, as shown below, UNOS has consistently exceeded 99.9
percent availability.
UNet Availability Summary
------------------------------------------------------------------------
Total
Uptime/ Planned Availability
Year Availability % (Maintenance) (Planned +
Availability % Unplanned) %
------------------------------------------------------------------------
2000 99.09% 98.90% 97.99%
------------------------------------------------------------------------
2001 99.68% 99.51% 99.19%
------------------------------------------------------------------------
2002 99.89% 99.90% 99.79%
------------------------------------------------------------------------
2003 99.96% 99.95% 99.90%
------------------------------------------------------------------------
2004 99.98% 99.89% 99.87%
------------------------------------------------------------------------
2005 99.93% 99.95% 99.88%
------------------------------------------------------------------------
TOTAL 2000-2005 99.76% 99.68% 99.44%
------------------------------------------------------------------------
Significant scalability improvements made after 2005
------------------------------------------------------------------------
2006 100.00% 99.93% 99.92%
------------------------------------------------------------------------
2007 99.98% 99.94% 99.92%
------------------------------------------------------------------------
2008 99.99% 99.98% 99.97%
------------------------------------------------------------------------
2009 99.98% 99.95% 99.94%
------------------------------------------------------------------------
2010 99.97% 99.95% 99.92%
------------------------------------------------------------------------
2011 99.99% 99.97% 99.96%
------------------------------------------------------------------------
2012 99.92% 99.98% 99.90%
------------------------------------------------------------------------
2013 100.00% 99.93% 99.93%
------------------------------------------------------------------------
2014 100.00% 99.91% 99.91%
------------------------------------------------------------------------
2015 100.00% 99.95% 99.95%
------------------------------------------------------------------------
2016 99.99% 99.97% 99.96%
------------------------------------------------------------------------
2017 100.00% 99.95% 99.95%
------------------------------------------------------------------------
2018 99.98% 99.96% 99.94%
------------------------------------------------------------------------
2019 100.00% 99.94% 99.94%
------------------------------------------------------------------------
2020 99.99% 99.92% 99.91%
------------------------------------------------------------------------
2021 99.99% 99.93% 99.92%
------------------------------------------------------------------------
2022 (thru August) 99.99% 99.90% 99.89%
------------------------------------------------------------------------
TOTAL since 2006 99.99% 99.95% 99.93%
------------------------------------------------------------------------
Planned maintenance is defined in the SLA as time when UNet is
purposefully taken offline to perform regular system maintenance or to
deploy organ allocation policy changes. To minimize impact to users,
UNOS performs planned maintenance at low-usage times and with advance
communication to users.
In January 2022, after the recommendation by the NOOC, HRSA agreed
to increase the Matching Function Service Level Agreement (SLA) from
99.5 percent uptime to 99.9 percent, excluding planned maintenance.
This new SLA provides a more accurate picture of system stability by
removing planned events from the measure, while also decreasing the
contractually permitted amount of unplanned downtime from 0.5 percent
to 0.1 percent. Further, it was determined that where practical,
planned maintenance periods should not exceed 30 minutes per event.
Question. You testified that UNOS is ``subject to 3 million
attempts a day to hack the patient database.''
How many hack attempts is UNOS receiving if you exclude attacks
that are just routinely defended against using standard, commodity
anti-virus, firewall software?
How many of those are targeted specifically and uniquely at UNOS,
rather than just being the result of broad vulnerability scans of the
Internet by attackers?
Answer. UNOS takes the position that all attacks have the potential
to be targeted and we have implemented automation capabilities to block
or respond to the wide threat landscape. Based on extensive and
continuous system monitoring and alerting, there are attacks that are
raised to levels of greater concern and are investigated by UNOS's
Information Security team. Over the last year, almost 300 events were
elevated for additional investigation, with zero impactful incidents.
The sources of these attacks are as follows:
------------------------------------------------------------------------
Threat or vulnerability (CY 2021) Quantity
------------------------------------------------------------------------
Websites blocked for malicious or inappropriate 3,813,576
content
------------------------------------------------------------------------
Inbound email blocks for inappropriate content or spam 444,600
------------------------------------------------------------------------
Emails quarantined based on confirmed security 33,806
concerns
------------------------------------------------------------------------
Crowdstrike--End-Point Detection 592
------------------------------------------------------------------------
Refused connections 1,204,258,768
------------------------------------------------------------------------
Events requiring follow-up by Information Security 286
------------------------------------------------------------------------
Impactful incidents 0
------------------------------------------------------------------------
data
Question. Given testimony during the hearing that UNOS has
retaliated by withholding data access from researchers it disfavors,
will UNOS commit to transparently sharing with all qualified
researchers a full and complete reporting of the number of patients
referred by hospitals to each OPO by month since 2010?
Answer. NOTA, the OPTN final rule, and the OPTN contract outline
the criteria that members of the general public and researchers must
meet to receive different types of data (i.e., identifiable data,
limited datasets, etc.). The more identifiable the data, the more
rigorous are the criteria for receiving access to such data.
UNOS, as the OPTN contractor, has always fulfilled all requests in
compliance with these requirements. Further, Task 3.7 in the OPTN
contract, quoted below, requires the OPTN contractor to report to HRSA
when certain requests cannot be fulfilled.
Task 3.7: The contractor agrees to meet the following data
disclosure standards (except sub-task 3.7.2, when it concerns
requests from the Secretary of HHS): some data requests involve
data that may be withheld under the terms of the Privacy Act of
1974 (5 U.S.C. 552a), the Trade Secrets Act (18 U.S.C. 1905),
the Freedom of Information Act (FOIA) (5 U.S.C. 552), or other
applicable laws. For example, any
personally-identified or personally identifiable data will be
maintained according to the OPTN/SRTR/HRSA Data System of
Records, HHS/HRSA/HSB/DoT, No. 09-15-0055, including data
maintained electronically, must be disclosed consistent with
the Privacy Act and the Systems Routine Uses, outlined in the
applicable System of Records Notice (73 Fed. Reg. 19519, as
amended). The contractor will provide a log of these requests
and releases with level of effort for each request to the COR
in the quarterly report.
The contractor shall notify the COR in the quarterly report if,
in its view: (1) the data are not collected and/or verified;
(2) release of the data violates the Privacy Act or applicable
laws; or (3) the data and information are otherwise exempted
from disclosure under the FOIA, when applicable.
The OPTN collects aggregate-level data on the number of referrals
by hospital to each OPO by month. That data is submitted by the OPOs
and is part of the OPTN dataset that we would provide to any researcher
requesting it. UNOS, as the OPTN contractor, does not withhold data
access from researchers for OPTN data. We don't know the specifics
around the context that generated this question, but UNOS would be
happy to talk with any researchers to get them the OPTN data they seek.
Question. In April 2022, UNOS acknowledged that it failed to report
35,000 deaths among patients on the waiting list. In 2019 alone, nearly
one in four pre-transplant patient deaths were missed or mislabeled in
UNOS data. Low-quality data provided by UNOS impedes researchers and
Congress from understanding how to improve patient care.
How many new or amended OPTN policies have relied on UNOS's faulty
data?
How many times did UNOS cite incorrect patient death data in
communications with the Senate Finance Committee or its members?
Answer. Please see response to Senator Grassley's fourth question.
Question. Given one of your emails, which was included in the
record at the Senate Finance Committee hearing, described UNOS's peer-
review process as ``Like putting your kids' artwork up at home. You
value it because of how it was created rather than whether it's well
done.''
When and in how many instances has UNOS communicated to the Federal
governing that UNOS's peer-review process was deficient?
If UNOS made such communications, please provide any supporting
written communications from UNOS to the Federal Government.
Answer. The segment of the email as cited was a personal ad hoc
reaction to a discussion taking place in the moment. It does not
reflect an evidence-based conclusion that the OPTN peer review process
is substantially flawed, nor was it intended as a specific, action-
oriented recommendation for a change to the process.
Confidential medical peer review is critical to achieve
improvements to the entire transplantation network and even more
broadly, foundational to quality assessment throughout the health-care
system and beyond.
Question. In 2022, UNOS approved the implementation of ``bypass
filters,'' allowing transplant centers to preemptively indicate donor
characteristics that they are unwilling to consider for patients on
their wait list. Currently, these filters are not shared with patients,
who may be unaware if they are listed at a transplant center where they
will not meet criteria to receive an organ. Bypassed organ offers are
not currently included in the denominator of SRTR reported organ offer
acceptance rates, further obfuscating choices for patients.
Did UNOS consult with the data advisory committee or SRTR review
committee before implementing these bypass filters?
How is information regarding the use of bypass filters being shared
with patients?
Is UNOS monitoring how the use of these filters will adversely
impact the probability of transplantation for patients at a given
transplant center?
Has UNOS done any analysis to determine how bypass filters may
impact organ discards, organ offer acceptance rates, or disparities by
age, race/ethnicity, and geography in patients receiving a transplant?
Will UNOS commit to providing transparency to the public,
especially to patients, regarding which bypass filters are being used
by which transplant programs, and how these filters may impact the
ability of wait-listed patients to obtain a transplant?
Answer. The OPTN implemented the Offer Filters tool as a system
enhancement based on the organ donation and transplant community's
feedback and collaboration. The goal of Offer Filters is to increase
kidney utilization by helping transplant hospitals automate ``refusal''
of organ offers that they know they will not accept in accordance with
their existing acceptance criteria, allowing the OPO to find an
accepting center more quickly, especially for hard to place organs. In
other words, Offer Filters screens offers that centers were already
manually declining for their patients. Offer Filters significantly
reduces the delays that could occur as a result of the former manual
process.
By analyzing hospitals' kidney acceptance trends, Offer Filters
reduces the time between offer and acceptance, bringing kidneys to
patients faster and reducing non-utilization of organs (``discards'').
The Transplant Coordinators Committee formed a work group to give
feedback on the development of the Offer Filters project. In 2019, 29
kidney programs participated in the Offer Filters pilot. In 2020, UNOS
conducted a second pilot with 34 more kidney programs. The results of
these two pilots were used to refine the requirements for the national
rollout of Offer Filters in 2022.
UNOS is committed to providing transparency to the public and to
patients about all facets of its operations. UNOS recognizes the
potential benefit to patients of using the Offer Filters tool for
shared decision-making and will explore options for doing so.
Increasing the use of Offer Filters by transplant hospitals is
currently under consideration by the OPTN Operations and Safety
Committee (OSC). This summer, the committee released a concept paper to
seek community and public feedback. The committee is considering
proposing a policy change in this area, which could come with additions
to the monitoring plan.\32\ The current monitoring plan tracks 15
metrics at a national and program level. Changes in transplant volume
are among these metrics tracked, as well as national and program-level
rates of non-utilized organs.
---------------------------------------------------------------------------
\32\ ``Optimizing Usage of Kidney Offer Filters.'' OPTN Operations
and Safety Committee. December 20, 2021. https://
optn.transplant.hrsa.gov/policies-bylaws/public-comment/optimizing-
usage-of-kidney-offer-filters/.
______
Question Submitted by Hon. Robert P. Casey, Jr.
Question. The Finance Committee's investigation and witness
testimony documented repeated instances of transportation errors
leading to organs being damaged beyond use. However, the investigation
found that transportation errors are rarely referred to the MPSC--of 53
transportation-related complaints, just 6 percent went to the MPSC for
review. Accordingly, the Finance Committee recommended (1) increasing
transparency and accountability for chain of custody and transportation
of organs procured for transplant by providing for public reporting, as
appropriate, on the status of organs in transport; and (2) increasing
accountability for organs lost, damaged, or delayed in transport by
requiring oversight and corrective action for such incidents.
What actions will UNOS take to implement these recommendations?
Answer. As shared in answer to question 7 of Senator Wyden, the
OPTN agrees with the committee that increasing transparency and
accountability for the transportation of organs would be an important
system-wide improvement. The majority of organs that travel
unaccompanied by surgical teams are kidneys, which are the most
transplanted organ and thus impact the greatest number of patients on
the waiting list.
The actions UNOS is taking to implement the committee's
recommendations include discussions underway among the members of the
OSC about ways to increase our understanding of the breadth and depth
of transportation errors in the system. Discussion within both the OPO
and OSC committees has acknowledged the complexity of implementing
nationwide organ tracking and begun to review possible pathways to
address the issue within the scope of the OPTN's authority.
UNOS provided data to the committee in a July 11, 2022, letter that
offers some insight into the scale of transportation issues reported to
the MPSC. The letter provided a more detailed accounting of data
discussed in a UNOS Member Quality staff interview.
Over a 5-year period, there were 37 transportation-related cases
out of 1,479 total OPO-related cases, or 2.5 percent of cases. Of those
37 unique cases over the same 5-year period, 14 were classified as
involving commercial air transportation, 7 were classified as involving
private or chartered air transportation, and 16 were classified as
involving ground transportation. Of these 37 cases, 13 organs (or 0.88
percent of cases) over 5 years were ultimately unable to be
transplanted for reasons that may or may not be related to the
transportation error. During this same time period, 151,531 organs were
transplanted.
While the OPTN is required to admit designated OPOs as members of
the OPTN, not all organizations involved in the chain of custody for
transporting organs are members of the OPTN. For example, commercial
airlines, other common carriers, commercial shippers, and courier
companies are not members of the OPTN, yet OPOs rely on these
organizations to ship organs thousands of times a year. Please see
question 20 of Senator Cardin for more detail on this issue.
______
Question Submitted by Hon. Tim Scott
care disparities
Question. Your unsealed emails reveal your belief that, in the
transplant system which you have managed for a decade, ``Only people
who have means can get transplants.''
Why, despite this awful care disparity which you yourself
acknowledge, has UNOS spent its considerable resources lobbying against
reforms, like the previous administration's Executive Order on
Advancing American Kidney Health, that have been universally championed
by patient groups?
Answer. This quote from a personal email of former UNOS CEO Brian
Shepard has been routinely mischaracterized by plaintiffs in an ongoing
lawsuit seeking to prevent more equitable distribution of livers. In
the email, Mr. Shepard acknowledges the challenges of achieving equity
in the U.S. health-care system, where access to insurance coverage or
personal resources are so critical to accessing treatment. The
transplant system is impacted by the flaws and challenges of the
greater health-care system. UNOS would be pleased to work with the
committee or individual Senators on initiatives that would expand
access to health care, including organ transplantation.
UNOS routinely offered its support for important reforms, like the
Executive Order on Advancing American Kidney Health, which issued
ambitious and laudable goals for all actors in the system. In addition,
while UNOS also strongly and routinely agreed with the need for
improvements to OPO regulation, we were joined by many members of the
community in cautioning against some of the technical aspects of the
now-implemented rule that will harm patients if not addressed, such as
mass decertification of OPOs without a transition plan in place.\33\
UNOS and its partners also offered evidence-based, collaborative
alternative solutions to achieve these goals.
---------------------------------------------------------------------------
\33\ AST, ASTS and UNOS letter to CMS Acting Administrator Richter.
https://unos.org/wp-content/uploads/UNOSGR-202210304-AST-ASTS-UNOS-
Joint-Comment-CMS-3380-F2-OPO-Medicare-Conditions-for-Coverage-
March2021.pdf. March 4, 2021.
______
Questions Submitted by Hon. Elizabeth Warren
Question. You testified that ``the system has been paid for in part
by taxpayers; approximately 10 percent of the budget of this contract
is taxpayer funded, the rest of that is paid by hospitals when they
list patients.'' Your answer spoke only to contract funding from HRSA,
and entirely ignored Medicare dollars that have funded the system, as
well as taxpayer dollars from Medicaid, Children's Health Insurance
Program (CHIP), and the Department of Veterans Affairs (VA).
What percentage of the OPTN patient registration fees are
ultimately reimbursed by all taxpayer funded sources? Please breakdown
by source including Medicare, Medicaid, CHIP, and the VA.
What percentage of UNOS fees are ultimately reimbursed by all
public sources, despite the fact that the UNOS fees are voluntary and
not required to add a patient to the waiting list? Please breakdown by
source including Medicare, Medicaid, CHIP, and the VA.
Answer. The OPTN final rule, 42 CFR 121.5(c) requires OPTN members
to pay a registration fee to the OPTN for each transplant candidate it
places on the waiting list. UNOS bills hospitals directly whenever a
transplant center places a patient on the national transplant waiting
list and requires the OPTN registration fee established by the OPTN
board of directors, and approved by the Secretary, to cover the
reasonable costs of operating the OPTN. Reimbursement is received from
hospitals directly. Therefore, UNOS has no visibility to how public or
private insurance programs are billed by the hospital. UNOS does not
have information concerning hospitals' financial models, costs of care,
or payor reimbursements.
Question. In October 2020, the Senate Finance Committee wrote to
the Secretary of HHS with a concern about ``double billing'' from OPTN/
UNOS.
Currently, to list the exact same patient on the organ waiting
list, how much in fees does OPTN/UNOS charge to Medicare?
Answer. Federal regulation requires transplant hospitals to pay a
fee to the OPTN to add a candidate to the organ transplant waiting
list.\34\ Neither the OPTN nor UNOS bill Medicare, Medicaid, or any
other insurance provider for costs it incurs.
---------------------------------------------------------------------------
\34\ 42 CFR Sec. 121.5(c). ``An OPTN member shall pay a
registration fee to the OPTN for each transplant candidate it places on
the waiting list. The amount of such fee shall be calculated to cover
(together with contract funds awarded by the Secretary) the reasonable
costs of operating the OPTN and shall be determined by the OPTN with
the approval of the Secretary.''
Authorized by Federal regulation and approved annually by the OPTN
board of directors and the Secretary of HHS, the OPTN assesses a one-
time registration fee (currently $868), billable to a transplant
hospital at the time it registers a candidate for a transplant.
Pursuant to section 121.5(c) of the final rule, the OPTN establishes
the fee based on the reasonable costs of operating the OPTN, and HRSA
approves that fee. The OPTN does not know the source of funding that
OPTN members use to pay the OPTN registration fee. UNOS is a Virginia
nonprofit membership corporation founded by the transplant community in
1984. UNOS members also pay a fee to UNOS, $100 per patient added to
the waiting list in FY23, to fund UNOS operations and for the services
that UNOS provides to the donation and transplant community and to its
members. It is important to note that these are separate fees for
different services to transplant hospitals; payment of the UNOS fee is
not required for a transplant hospital to add a patient to the OPTN
---------------------------------------------------------------------------
waiting list.
UNOS has no visibility to how public or private insurance programs
are billed by the hospital. UNOS does not have information concerning
hospitals' financial models, costs of care, or payor reimbursements. To
supplement this response, please see our response to your first
question.
Question. How much in fees does OPTN/UNOS charge to other public
sources including Medicaid, CHIP, and the VA, including via hospital
fees for which government payers reimburse?
Answer. See above answer.
Question. For each of the last 10 years (2012 to present):
What have been (a) per patient and (b) total OPTN fees received by
UNOS as the OPTN?
What percentage of that total has been paid by Medicare?
What percentage of that total has been paid by other public sources
including Medicaid, CHIP, and the VA, including via hospital fees for
which government payers reimburse?
OPTN Fees
------------------------------------------------------------------------
Fiscal OPTN Fees Per
Year Candidate Fees Collected
------------------------------------------------------------------------
2012 $603 $41,259,959
------------------------------------------------------------------------
2013 $651 $43,682,960
------------------------------------------------------------------------
2014 $810 $55,946,345
------------------------------------------------------------------------
2015 $793 $57,081,282
------------------------------------------------------------------------
2016 $812 $57,125,866
------------------------------------------------------------------------
2017 $834 $59,310,720
------------------------------------------------------------------------
2018 $834 $61,812,887
------------------------------------------------------------------------
2019 $794 $65,479,021
------------------------------------------------------------------------
2020 $748 $59,082,927
------------------------------------------------------------------------
2021 $748 $60,461,138
------------------------------------------------------------------------
2022 $868 $66,270,399
(August
YTD)
------------------------------------------------------------------------
The OPTN final rule, 42 CFR 121.5(c) requires OPTN members to pay a
registration fee to the OPTN for each transplant candidate it places on
the waiting list. UNOS, serving as the OPTN contractor, bills hospitals
whenever a transplant center places a patient on the national
transplant waiting list. As such, UNOS does not have visibility into
hospitals' financial models, costs of care, or payor reimbursements,
and does not know the source of funding that OPTN members use to pay
the OPTN Registration fee.
Question. For each of the last 10 years (2012 to present):
What have been (a) per patient and (b) total UNOS fees received by
UNOS as the OPTN?
What percentage of that total has been paid by Medicare?
What percentage of that total has been paid by other public sources
including Medicaid, CHIP, and the VA, including via hospital fees for
which government payers reimburse?
Answer. The OPTN Registration Fee and the UNOS fee are for distinct
and separate services. The OPTN Registration Fees, as outlined above,
are required to be paid by OPTN members for the reasonable costs of
operating the OPTN, outlined in the OPTN contract and below. The UNOS
fee is collected from UNOS members and pays for services outlined
below.
UNOS Fees
------------------------------------------------------------------------
Fiscal
Year UNOS Fees Fees Collected
------------------------------------------------------------------------
2012 $122 $4,788,048
------------------------------------------------------------------------
2013 $125 $5,131,425
------------------------------------------------------------------------
2014 $147 $5,454,592
------------------------------------------------------------------------
2015 $164 $6,410,040
------------------------------------------------------------------------
2016 $145 $6,763,625
------------------------------------------------------------------------
2017 $145 $7,980,220
------------------------------------------------------------------------
2018 $145 $8,414,851
------------------------------------------------------------------------
2019 $158 $9,657,618
------------------------------------------------------------------------
2020 $178 $8,909,304
------------------------------------------------------------------------
2021 $178 $10,845,896
------------------------------------------------------------------------
2022 $122 $7,063,800
(YTD
August)
------------------------------------------------------------------------
UNOS does not have visibility into hospitals' financial models,
costs of care, or payor reimbursements, and does not know the source of
funding that UNOS members use to pay the UNOS Fee.
Question. On what activities are OPTN fees spent?
Answer. The OPTN registration fees and budget must be calculated to
meet the ``reasonable costs of operating the OPTN'' and are approved
annually by the HHS Secretary pursuant to 42 CFR Sec. 121.5(c). Those
costs will include sufficient resources to perform the following OPTN
contract tasks:
(1) Administering the OPTN contract through a project management
plan; providing daily, weekly, quarterly, and annual updates to HRSA
and other external audience; proposing the annual OPTN registration fee
schedule and associated annual budget; providing HRSA monthly reports
tracking revenue and expenditures associated with the OPTN contract;
and maintaining various secure web-based platforms, including a
platform for submitting contract deliverables to HRSA, and a document
management platform to allow OPTN governance group members to share
documents.
(2) Supporting the OPTN board of directors (BOD) and executive
committee, and OPTN BOD operating committees by: supporting an annual
OPTN BOD composition review and recruiting plan; reviewing the OPTN
charter; supporting the appointment of the OPTN executive director;
supporting the operating committees and policy development committees;
strategic planning to guide OPTN activity; providing ongoing education
on OPTN legal and regulatory requirements; providing opportunities for
public access to OPTN governance activities; and other administrative
and logistical support and subject matter expertise.
(3) Supporting the OPTN policy process and policy development
committees and expert groups to address critical OPTN policy issues by:
developing, revising, and maintaining OPTN bylaws, policies, standards,
and guidelines for the operation of the OPTN; recruiting volunteers to
serve on the OPTN policy development committees; documenting the OPTN
policy development process; tracking policy development process
metrics; reviewing the OPTN regional process; and hosting consensus
conferences to solicit input from the transplant community and public
on matters related to OPTN bylaws, policies, or operations.
(4) Providing an OPTN electronic matching of donor organs to
transplant candidates 24 hours per day, every day; ensuring real-time
access to the electronic matching function for allocating deceased
donor organs; developing innovative applications to enhance the
matching functions; operating the OPTN Kidney Paired Donation Pilot
Project (KPDPP); electronically managing all OPTN patient review board
processes; and maintaining allocation decision rules.
(5) Operating the Organ Center to facilitate organ placement by
providing technical assistance to OPTN members 24 hours/day, 7 days/
week.
(6) Monitoring OPTN member compliance and performance, quality
improvement, and sanctioning, by: maintaining documentation describing
the OPTN monitoring, performance improvement, and enforcement
requirements; measuring the effectiveness of the processes used to
identify compliance, encourage improvement, and determine sanctions;
providing HRSA with an annual OPTN monitoring activity report on all
OPTN members; reviewing and periodically reassessing OPTN membership
applications, including submitting OPTN membership application forms
for OMB clearance; developing new models for monitoring and improving
OPTN membership performance through collaborative performance
improvement structures; reporting to HRSA information about member
performance that poses significant risk to patient health or public
safety; and conducting special reviews of OPTN members as requested by
the Secretary.
(7) Collecting official OPTN data to support the operations of
the OPTN and maintaining a data repository of all official OPTN data,
which according to contract must be collected after submitting
clearance packages for Office of Management and Budget (OMB) approval,
collecting all official OPTN data through direct electronic transfer;
integrating standard clinical data ontologies into OPTN data collection
and operation of the OPTN, identifying and supplementing official OPTN
data with information from external data sources, and collecting
official OPTN data through survey methods.
(8) Providing access to official OPTN data by: making standard
analysis data sets and other data sets available to the scientific
community and the public for research and analysis purposes; responding
to data requests from HRSA and other components within the Federal
Government; responding to data requests from OPTN members and providing
online access to OPTN-branded online data reports to members to improve
system performance; and responding to data requests from the general
public.
(9) Coordinating OPTN policy development and analytic needs with
the Scientific Registry for Transplant Recipients (SRTR) contractor
through a formal written agreement for data transfer, and by
coordinating activities and meetings with the SRTR contractor to
discuss OPTN data issues, planning and participating in joint meetings
with the SRTR contractor, and collaborating with the SRTR contractor on
the development of the OPTN/SRTR Annual Data Report.
(10) Maintaining and improving the OPTN website to be a
comprehensive source of OPTN-related information for the public and the
transplant community, which also must be securely configured.
(11) Communicating about all activities of the OPTN with OPTN
members, transplant professionals, transplant patients, living organ
donors, donor families, media, and the general public by: developing a
communications plan and a branding plan; developing OPTN educational
materials for patients, the public, and transplant professionals; and
informing HRSA and the SRTR of media inquiries.
(12) Providing an OPTN patient services line to provide 24-hour
toll-free information with English and Spanish capabilities.
(13) Providing written updates and summaries on OPTN activity to
HRSA as required for reports to Congress or other official reports.
(14) Managing and maintaining OPTN records to retain functionality
and integrity throughout the full records lifecycle, subject to the
Privacy Act of 1974, including maintaining records identified in the
OPTN System of Records Notice.
(15) Executing special studies on topics identified by HRSA.
(16) Meeting security and privacy requirements and safeguarding
information and information systems by meeting Federal standards for
protection, confidentiality, and nondisclosure of sensitive
information; encryption of computing devices and information; complying
with Federal Rules of Behavior, notifying HRSA of, and responding to,
security incidents and privacy breaches; continuous monitoring of
information security; permitting government access for security
assessments; and adhering to security requirements for cloud services.
Federal appropriations constitute approximately 8-10 percent of the
resources used to meet the obligations of the OPTN contract.
Question. On what activities are UNOS fees spent?
Answer. UNOS is a nonprofit nonstock membership corporation founded
by the transplant community in 1984 to serve as the national
transplantation network. With the tremendous growth in transplantation
and to meet the broad responsibilities of the OPTN contract, UNOS has
since grown to 450 diverse professional staff. The UNOS fee is one of
the revenue sources for UNOS and those revenues are maintained in UNOS
operating accounts where the fees are commingled with revenues from
other sources including charitable donations, unrelated business
income, and most significantly, costs reimbursed to the contractor
under the OPTN contract. The UNOS fee makes it possible to provide
enhanced services not required by Federal contract that respond to the
community's needs and continuously improve the national transplant
system. Examples of these UNOS enhancements include, but are not
limited to:
Data tools and analysis to help member institutions analyze
and improve performance and patient outcomes.
Innovative technology and research to improve the efficiency
of organ offers, placement and transportation.
Educational offerings and collaborative events to help
transplant professionals grow their knowledge and skills.
General and administrative expenses are also covered by the UNOS
fee, which include maintaining the infrastructure essential to serve as
the OPTN contractor and which costs are not directly reimbursable under
the OPTN contract.
The structure of a separate UNOS fee to provide enhanced services
to the transplant community not covered by the OPTN fee represents an
ongoing effective
public-private solution to a public health challenge. Managed in the
private sphere but overseen in the public, the U.S. organ donation and
transplant system has demonstrated growth year over year that has led
to nearly a million lives saved through transplant, more than any other
country in the world.
Question. Are UNOS fees used to pay for activities disallowed under
the Federal Acquisitions Regulations (e.g., lobbying expenses)?
Answer. UNOS's private funds are used for UNOS efforts, including
our government relations work. Lobbying expenses are not an allowable
cost for reimbursement under the Federal Acquisition Regulations and
are never billed to the OPTN contract in compliance with HHSAR 352.203-
70: Anti-Lobbying, which is incorporated into the OPTN contract.
Question. Are any OPTN fees used to support OPTN/UNOS technology?
Answer. The National Organ Transplant Act (NOTA), 42 U.S.C. 273 et.
seq. requires that the OPTN operate a national system to allocate
organs using computer systems. Thus, the costs of operating the OPTN
include the costs of operating a national system using computer
technology to allocate organs, including updates to reflect changes in
organ allocation policies, data collection, security, privacy,
reliability, improvements and architecture. The OPTN contract requires
the OPTN contractor to provide computer systems and software to meet
the statutory obligations of the OPTN, as well as meet extensive
Federal requirements for security, operability, privacy, and
reliability. UNOS utilizes registration fees paid to the OPTN by
transplant hospitals and appropriated funds paid to the contractor by
HRSA to meet its technology obligations under the OPTN contract.
Question. Are any UNOS fees used to support OPTN/UNOS technology?
Answer. The OPTN contract requires the contractor to provide a
computer system to meet all of the obligations of the OPTN organ
matching and data collections functions for all organ types, while also
meeting the extensive security and privacy requirements of the OPTN
contract. The contractor's computer system must be in operation
exceeding 99.9-percent availability, while being continuously updated
by changes to organ allocation policies/algorithms approved by the OPTN
board of directors. The government has never provided software or
hardware to the OPTN contractor to meet these contract requirements.
UNOS pays its operating expenses and makes investments in
technology from its operating account. The UNOS operating account
receives funds from different sources but primarily from reimbursement
of allowable costs under the OPTN contract, revenues from UNOS members
paying the UNOS fee, charitable contributions, and unrelated business
income. UNOS expenses are paid from its operating account, which
include salaries and benefits for all staff; general and administrative
costs; and property, plant and equipment. Since UNOS was formed in 1984
by the transplant community, UNOS Information Technology staff
developed, maintain and enhance UNOS software that it uses to power the
OPTN and meet the obligations of the OPTN contract.
See Senator Cardin's first question.
Question. Please distinguish what aspects of the OPTN/UNOS IT
system (e.g., hardware, platforms such as UNet, DonorNet, and TransNet,
and code used to facilitate matching) were paid for using UNOS fees;
which were paid for using OPTN fees; and which were paid for using
appropriated funds awarded through the contract.
Answer. See question above.
Question. Please provide the amount spent on OPTN/UNOS IT from each
of these three sources of funding for each year under the current
contract for the operation of the OPTN.
Answer. Please see the below report of expenditures on the IT-
related tasks under the current OPTN contract, which commenced with a
partial year on April 1, 2019:
----------------------------------------------------------------------------------------------------------------
Task 5-- Task 20--
Task 4--OPTN Collect Task 9--OPTN Security and
Electronic Official OPTN Website Privacy Total
Matching Data Requirements
----------------------------------------------------------------------------------------------------------------
Year 1 FY 2019 (Apr- $12,114,912 $1,727,410 $106,806 $953,039 $14,902,167
Sep)
----------------------------------------------------------------------------------------------------------------
Year 2 FY 2020 $26,567,255 $4,896,707 $264,113 $2,693,269 $34,421,345
----------------------------------------------------------------------------------------------------------------
Year 3 FY 2021 $26,216,727 $4,977,437 $323,871 $2,378,211 $33,896,246
----------------------------------------------------------------------------------------------------------------
Year 4 FY 2022 (Aug. $26,210,887 $4,828,467 $231,152 $2,972,366 $34,242,872
YTD)
----------------------------------------------------------------------------------------------------------------
Total $91,109,780 $16,430,022 $925,942 $8,996,885 $117,462,629
----------------------------------------------------------------------------------------------------------------
Question. In light of your misleading answer about taxpayer funding
of the OPTN system and technology (since both HRSA funding and Medicare
funding are from the taxpayer, as are funds from the other government
sources such as the VA), how do you justify that the taxpayer should
have to pay to buy back OPTN/UNOS technology in the event of HRSA
electing different OPTN contractors?
Answer. With the passage of NOTA in 1984, Congress determined that
the organ transplant network should reside in the private sector with
appropriate oversight by the Federal Government. The OPTN contract
requires the contractor to provide a computer system to meet the
obligations of the OPTN organ matching and data collections functions
for all organ types, while also meeting the extensive security and
privacy requirements of the OPTN contract. The contractor's computer
system must be in operation exceeding 99.9-percent availability, while
being continuously updated by changes to organ allocation policies/
algorithms approved by the OPTN board of directors. The government has
never provided software or hardware to the OPTN contractor to meet
these contract requirements. Through a cost-sharing contract, the
government has exercised its discretion to utilize a contractor-owned,
contractor-operated (COCO) system to meet the requirements of NOTA and
the OPTN contract.
Question. Given that taxpayers have paid for this technology, how
do you justify that UNOS refused to allow the USDS to inspect its code,
making UNOS the first and only of nearly 100 agencies/contractors to
rebuke such a request from USDS?
Answer. We appreciate the opportunity to address these concerns and
believe it is important to establish the factual foundation for our
response. As discussed above in more detail, since 1984, UNOS has
developed and maintained its software that it uses to provide the
services required by the OPTN contract and power the OPTN's statutory
functions. The government has not provided software or hardware to the
OPTN contractor and instead opted for a model where the OPTN contractor
utilizes contractor-owned systems to meet the OPTN requirements
specified by the government. UNOS has used a variety of funding sources
to develop its software and it is inaccurate to state that taxpayers
have paid for the UNOS-owned software and systems. For more
information, please see our response immediately above.
We appreciate the opportunity to clarify that UNOS never received a
request from the USDS to review our code. UNOS would have welcomed
then--and still welcomes now--a meeting with USDS to have a focused
review of our code, coding practices, code repositories, and other
relevant information that could facilitate a more accurate
understanding of our systems.
UNOS reiterated its willingness to undergo any additional review
deemed necessary in an August 2, 2022, letter to the HRSA
Administrator, so that we can discuss the significant factual errors
about the OPTN IT infrastructure contained within the USDS report.\35\
We would be pleased to have the opportunity to further clarify the
facts for Congress, HHS and the USDS alike.
---------------------------------------------------------------------------
\35\ McCauley, Jerry, M.D., MPH. Letter to HRSA Administrator
Carole Johnson. August 2, 2022. https://unos.org/wp-content/uploads/
20220802_UNOS-McCauley-Letter-to-HRSA-Administrator.pdf.
The HRSA team has consistently reviewed the performance and
security of the OPTN IT system in great detail throughout our
performance of the OPTN contracts, and their annual audit of our
systems is currently underway. HRSA reviews all OPTN contractual
requirements for compliance annually, as well as on a periodic basis
throughout each year, and UNOS consistently meets or exceeds its
---------------------------------------------------------------------------
contractual obligations.
Question. In response to The Washington Post article on UNOS's
``refusal to turn over the full code,'' you stated that this was to
``safeguard patient data''; as there should not be any patient data in
the code itself, it is concerning that UNOS does not understand basic
terminology. Can you clarify?
Answer. There is no patient data in our code. That being said,
allowing broad access to any part of the system, regardless of whether
it contains patient data, would introduce significant risk to system
security. That's why UNOS works closely with HRSA to ensure access is
given only to those with appropriate clearance. UNOS does, however,
offer the opportunity for an on-site and fully secured review of the
code.
We are pleased to share the full statement provided by UNOS to The
Washington Post below as clarification.
USDS has never made a formal request to come onsite to review
the code. As we've mentioned before, we would welcome USDS to
visit UNOS, where we will provide an overview of our software,
review matching function code, our coding practices, and how
the code is managed and tested.
HRSA conducts annual audits of our system. We provide excerpts
of code at their request if they identify areas of improvement
during an audit. We also provide HRSA both before and after
sections of code to show that the audit-identified improvements
have been made.
Additionally, the OPTN contract requires that we regularly
provide HRSA with extensive documentation, which includes
decision logic used to implement the organ allocation policies.
This documentation is updated any time organ allocation
policies change and is used by our software engineers when
making any updates.
While the source code remains UNOS's intellectual property, we
have still offered HRSA the opportunity to do an on-site review
of our code repositories, but as of this writing, they have not
taken us up on this offer.
We have struck an important balance: providing HRSA and other
auditors the access they need to ensure the system's security
while limiting wider access in order to safeguard patient data
and protect UNOS' intellectual property.
Question. In light of concerns expressed by the Senate Finance
Committee about the state of OPTN/UNOS technology, including but not
limited to concerns identified by the USDS's report ``Lives Are at
Stake,'' please provide your total compensation for 2021 and 2022; the
total expenditures for lobbying, marketing, and public relations for
2021 and 2022; and the expenditures for hardware and software
maintenance in 2021 and 2022.
Answer. As reported on IRS form 990, total chief executive officer
compensation for fiscal year 2021 was $734,490. The 2022 990 has not
been prepared, but the chief executive officer compensation as of the
September 30th pay stub was $627,634.
------------------------------------------------------------------------
FY 2021 FY 2022--Aug. YTD
------------------------------------------------------------------------
Lobbying, Marketing, PR (UNOS $296,129 $476,796
expenses)
------------------------------------------------------------------------
Hardware and software maintenance $25,584,244 $25,498,223
(OPTN and UNOS)
------------------------------------------------------------------------
______
Questions Submitted by Hon. Todd Young
Question. Once an Organ Procurement Organization (OPO) is
designated as on probation or not in good standing, how does UNOS
evaluate when and how an OPO should be removed from probation or
restored to good standing?
What corrective actions must occur for the OPO to get back in
``good'' standing?
Answer. The overall process is described in Appendix L to the OPTN
bylaws. In general, the MPSC actively monitors the member's activity
and documents progress toward process improvement. After the member has
addressed the area(s) of concern and communicated to the MPSC's
satisfaction the actions they have taken to meet performance standards,
it will recommend to the OPTN board of directors that the designation
be removed.
In the case of Member Not in Good Standing (MNIGS), the institution
must remain in that status for a minimum of 9 months. It is also an
option that the board may move the institution from MNIGS to probation
for an additional period of time. Similarly, a member institution
placed on probation must remain in that status for a minimum of 9
months before there is any consideration that it may regain full
standing.
The corrective actions required for a member to demonstrate
improvement and regain full member standing are specific to the
issue(s) under review. The MPSC provides the member with notice of the
areas where the member must document improvement, often with a specific
set of milestones or metrics by which improvement will be assessed.
Question. In November 2020, CMS issued a final rule changing the
methodology used to evaluate OPO performance. Based on 2018 data, CMS
estimated that 22 of the 57 OPOs would fail the new outcome measures
and be decertified. As the entity overseeing policy compliance, what
steps is UNOS taking to improve OPO performance given the new
performance measures?
Answer. The OPTN continues to believe that the best way to hold
OPOs accountable for their performance is to develop an accurate, clear
metric with a rationale that has been adequately justified. It is
important to note CMS's metric is a comparative one, and each review
period will always identify OPOs not in the top 25 percent as
``failing'' regardless of how many OPOs are in operation. Further, a
comparative metric alone does not provide sufficient information on how
well an OPO performs.
UNOS is committed to improving performance for OPOs and for the
system as a whole. In addition to the OPTN MPSC's routine peer-review-
based performance improvement work, already described in detail for the
committee throughout the investigation as well as described on the OPTN
website, the OPTN also provides other pathways for all member
improvement. They include:
Collaborative improvement (CI) projects designed to spread
change in a targeted area of focus, involving transparent peer-
to-peer sharing of successes and challenges in a collaborative
environment. In an OPTN collaborative, members are part of a
network with a common aim. With CI, effective donation and
transplant practices can be gathered, shared and implemented by
others for broad, collective impact.
Individual member-focused improvement (IMFI) that involves
working closely with an OPTN performance improvement support
team and tailoring a project plan to meet specific quality
improvement goals. IMFI also supports donation and transplant
members by facilitating peer mentorship sessions with
experienced leaders in relevant fields and delivering other
services that can vary according to need.
More detail about these programs is available at https://
optn.transplant.
hrsa.gov/professionals/improvement/.
The continued, accelerated growth in organ donation and transplant
sustained over many years indicates that the U.S. system overall is
strong. Notably, the volume of deceased organ donors has been steadily
rising after a plateau of approximately 8,000 donors annually from
2006-2013. In 2021, nearly 14,000 deceased donors were recovered, the
11th straight year of growth.
While it is a commonly held misconception that the national opioid
epidemic is the sole source of this growth, the data do not support
this assertion. The number of donors from other natural causes, other
injuries, and cardiovascular events has also continued to rise. The
percentages of total deceased donors dying of drug intoxication, which
includes but is not limited to opioid intoxication, was approximately
13 percent from 2016-2019, and then increased to 16 percent in 2020;
this remained stable in 2021.
Regardless of the manner of death of an organ donor, OPOs and
transplant hospitals have continued to increase performance for the
last nine consecutive years in the number of deceased donor organs
transplanted. Our community is grateful for the lifesaving gifts we've
received from so many generous donors.
Question. What attention has UNOS given to the significant annual
increase in organ discards? What plan does UNOS have to address and
improve the organ discard rate?
Answer. While the decision whether to accept an organ for
transplant belongs in the hands of transplant clinicians and their
patients, UNOS and the OPTN have consistently provided system-wide
tools, data and strategies to increase organ utilization across
multiple modalities. A select few are below.
policy monitoring
All OPTN committees closely monitor the non-utilization
(``discard'') rate in organ allocation policy evaluation reports and
have adjusted policies where possible to reduce their incidence. A
recent example of this includes the 2018 implementation of allocation
policies for dual and en bloc kidney offers, when data showed that
these more complex organ offers were recovered but accepted at lower
rates.
data tools
The kidney Offer Filters tool, discussed in detail in the NASEM
report as an effective tool to decrease the time between offer and
transplant, has shown a preliminary positive impact on the rate of
kidneys recovered but not transplanted. Preliminary data following the
national rollout of Offer Filters on January 27, 2022, show an
approximate 5 percent decrease in the number of organs recovered for
transplant but not transplanted. The OPTN Operations and Safety
Committee sought public comment on ways to optimize the use of offer
filters this fall.\36\
---------------------------------------------------------------------------
\36\ ``Optimizing usage of kidney offer filters concept paper.''
OPTN Operations and Safety Committee. Fall 2022 public comment. https:/
/optn.transplant.hrsa.gov/policies-bylaws/public-comment/optimizing-
usage-of-kidney-offer-filters/. Accessed October 11, 2022.
Transplant programs may utilize the Center Acceptance and Refusal
Evaluation (CARE) report tool. The tool allows programs to see all of
the outcomes for organ offers they accept as well as all of those they
refuse. The CARE report is designed to help transplant centers adopt
best practices and reduce the non-utilization rate by understanding
their organ acceptance behavior and enhancing their ability to analyze
acceptance patterns. The tool provides a visualization of organ
rejection organ acceptance for specific types of donors as well as
transplant-specific and aggregate outcomes so centers can learn what
happened to the organs they turned down.
performance metrics
The MPSC Performance Metrics proposal, which was recently approved
by the OPTN board of directors and which has begun to be implemented
this summer, focuses on both pre-transplant as well as post-transplant
patient data. With less emphasis placed just on post-transplant
outcomes, acceptance behaviors are expected to change, which also may
encourage more programs to transplant more complex organs that are
otherwise refused.
refusal codes
In June 2021, the OPTN board approved a project to update OPTN
``reasons for refusal'' of organ offers made to patients. These revised
codes were implemented in December 2021. Revising the list of refusal
codes supports increased efficiency of the OPTN through better
understanding of refusal behaviors, providing more robust data to
develop improved allocation strategies to reduce cold ischemic time,
reduce the number of non-utilized organs, and increase the number of
transplants.\37\
---------------------------------------------------------------------------
\37\ OPTN project to update refusal codes. https://
optn.transplant.hrsa.gov/policies-bylaws/a-closer-look/project-to-
update-refusal-codes/. Accessed October 11, 2022.
---------------------------------------------------------------------------
allocation policy
In advance of the transition to the Continuous Distribution organ
allocation framework beginning with lung in early 2023, the Utilization
Considerations of Kidney and Pancreas Continuous Distribution Workgroup
is studying the operational aspects of kidney and pancreas allocation
that encourage optimization of kidney and pancreas utilization. The
workgroup has a practical focus on utility and efficiency, and is
composed of representatives from the OPO, Operations and Safety,
Transplant Coordinator, Data Advisory, Kidney, and Pancreas committees,
who provide experienced clinical and practical allocation perspectives.
This workgroup is charged with developing recommendations for
transitioning current utilization and efficiency optimization tools and
ensuring that these tools function effectively in a Continuous
Distribution framework.
Question. Please share the number of organs lost and/or delayed and
the resulting loss of prospective transplants that occurred over the
past year.
The data provided in response to this question is necessarily
limited to only the small subset of organ transportation arrangements
that were facilitated by the UNOS Organ Center, because the OPTN does
not collect transportation data on a national, systematic basis.
It is important to note that transportation arrangements
facilitated by the UNOS Organ Center are based on the transportation
vendors and methods (driving, commercial aircraft, etc.) selected by
the OPOs and transplant hospitals involved in the shipment. UNOS staff
serve as a communication hub to connect those vendors with the senders
and receivers of the shipments throughout the process. The vast
majority of organ transportation arrangements are facilitated directly
by the recovering organ procurement organization, and not by UNOS. As
noted in a Kaiser Health News article, ``Matters involving the
transportation methods used by organ procurement organizations (OPOs)
are arranged directly between OPOs and transplant centers.''\38\
---------------------------------------------------------------------------
\38\ JoNel Aleccia, ``How Lifesaving Organs for Transplant Go
Missing in Transit,'' Kaiser Health News (February 10, 2020), available
at https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/ (accessed on February 26, 2020).
Between October 1, 2021. and September 30, 2022, the Organ Center
assisted with providing deceased donor organ transportation
arrangements for 1,727 of 35,319 deceased donor transplants (4.9
percent) performed in this same time period. Out of the 1,727 organ
shipments, 70 had a 2-hour or more delay from the original estimated
time of arrival, and 13 were transplanted at an alternate transplant
hospital. Thirty-five organ shipments were not ultimately transplanted,
but it is important to note that it is not possible to draw any
absolute conclusions about the association between an incident that may
have occurred in transit and the ultimate outcome of the transplant.
There are many reasons why a transplant hospital may not ultimately
---------------------------------------------------------------------------
transplant an organ it accepted for a recipient, including:
Too much cold ischemic time (which may or may not be due to
a transportation issue).
The anatomy or appearance of the organ upon arrival (which
may or may not be due to a transportation issue).
A change in the health of the recipient that may make them
unsuitable for the scheduled transplant.
The same reasons can also be true for organs without any
``transportation issues.'' For all the same reasons (cold ischemic
time, anatomy of the organ, health of the recipient) and many others
not listed, the transplant surgery may still not occur.
Please see additional information about transportation in responses
to Senator Wyden's seventh question and Senator Cardin's first
question.
Question. Are there penalties or repercussions for OPOs or
transportation companies if an organ is lost and subsequently
discarded?
Answer. As provided by Federal law and regulation and the terms of
the OPTN contract, the OPTN will review OPTN member institutions for
compliance with OPTN obligations. ``Transportation companies''
including commercial airlines and couriers, are not members of the OPTN
and therefore, the OPTN has no oversight or ability to impose penalties
on those companies.
For OPOs, the OPTN has authority to investigate issues of potential
OPTN policy noncompliance or issues involving patient safety. Of the
OPTN adverse member actions resulting in either Probation or Member Not
in Good Standing (MNIGS), none to date has specifically involved a
sentinel event related to organ transportation. Such an issue, however,
might be subject to OPTN review if the event or issue directly relates
to OPTN Obligations or, in the opinion of peer reviewers, is a threat
to patient safety.
Question. What process improvements has UNOS put in place to
minimize lost organs?
Answer. UNOS developed its own organ tracking solution, in addition
to the variety of organ tracking tools already available on the market.
Because of this, UNOS has access to data for the OPO clients who use
our tracking service, but not for all organs being transported. Since
the product launched in June 2021, and as of September 2022, 5,628
shipments have been tracked, recently accounting for an average of 8
percent of all packaged organs. Clients on average track 30 percent of
all their packaged organs. OPOs don't typically track organs such as
hearts, lungs and livers because they are traditionally accompanied by
the transplanting surgeon (accounting for 40 percent of all packaged
organs). Other OPOs only track kidneys and/or livers that use
commercial air and/or are exported from their service area. Currently,
OPOs can choose the tracking system that best suits their needs.
Please see additional information about transportation in responses
to Senator Wyden's seventh question and Senator Cardin's first
question.
Question. In 2017, I asked UNOS for information about an OPO which
it had recently placed as a ``member not in good standing'' as a result
of patient safety endangerment issues. UNOS's response to me at the
time, which was personally signed by Mr. Shepard, was that UNOS could
not share any of the documents I requested, but that UNOS ``provides
appropriate and highly effective oversight.'' Then, when Senators
Grassley, Wyden, Cardin and I launched an investigation into these
patient safety failures, UNOS changed its messaging to state that it
actually does not consider itself responsible for OPO oversight at all.
How can Congress be assured there is ``appropriate and highly
effective oversight'' when UNOS is unwilling to provide any
documentation showing oversight is actually taking place--and when
pushed, changes tactics to point fingers or deny UNOS's role in the
oversight process?
Answer. Oversight of OPOs is shared between the Centers for
Medicare and Medicaid Services (CMS) and the OPTN. The OPTN is charged
with monitoring OPTN members, including OPOs, for compliance with OPTN
Obligations as defined in the OPTN bylaws. These obligations include
NOTA, the OPTN final rule, and OPTN policies and bylaws. Federal
regulation,\39\ the OPTN contract, and OPTN bylaws also require the
OPTN to maintain a peer review process to promote quality assurance and
performance improvement for all OPTN members, and this is the
appropriate and intended role for the OPTN particularly with respect to
OPOs where the OPTN's enforcement options are particularly limited. For
example, the OPTN has no discretion whether to admit an OPO as a member
of the OPTN nor does it have the authority to expel an OPO from OPTN
membership.\40\ The OPTN has requirements that OPOs must meet, and
reviews OPOs for compliance with those obligations. When an OPO is
found to be noncompliant with an OPTN obligation, the MPSC works
collaboratively with the OPO to correct deficiencies, implement
corrective actions, and improve the quality of services it provides.
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\39\ 42 CFR Sec. 121.10(b)(1)(i).
\40\ ``The OPTN shall admit and retain as members the following:
(i) All organ procurement organizations;'' 42 CFR Sec. 121.3(b)(1)(i)
(emphasis added).
The Centers for Medicare and Medicaid Services (CMS) has the most
complete and extensive Federal regulatory oversight over OPOs. This
includes granting licensure to operate and designation to serve as an
OPO, and approving financial reimbursement. To the extent that the OPTN
has oversight authority, as provided by Federal law and regulation and
the OPTN contract, the OPTN addresses member compliance with OPTN
obligations and, in the opinion of peer reviewers, issues which may
affect patient safety and the quality of services it provides. This is
by necessity a more limited scope, and with different enforcement
mechanisms. OPTN ``oversight'' is not duplicative but rather,
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complements CMS's oversight authority.
Question. Will UNOS commit to sharing needed documents with
appropriate oversight agencies to ensure thorough review and evaluation
of adverse events in order to save lives and improve the organ donation
and transplant system?
Answer. Yes. In an effort to support the committee's investigation,
UNOS suggested several pathways for the committee to obtain the data it
needs to conduct its work. These included offers to meet with
investigative staff in person to review documentation, providing
detailed but deidentified case information, and a suggestion that
Congress request the Secretary for the information, because we are
required to provide the Secretary with any information the Secretary
requests. We would suggest these mechanisms for future requests as
well.
UNOS is an organization that brings together all components of the
nationwide organ transplantation community and has a compelling
interest in preserving the sanctity of its highly effective peer review
process. The medical peer review privilege between the OPTN and OPTN
members is a reciprocal privilege; that is, both parties to the peer
review process have an obligation to the other party to maintain the
confidentiality of the communications and materials shared throughout
the process. These mutual assurances of confidentiality ensure the
candor and openness that is essential to an effective peer review
process as envisioned in the Institute of Medicine Report, ``To Err is
Human: Building a Safer Health System.''\41\ Statements made and
information provided by an OPTN member to the OPTN contractor and vice
versa during any interview, hearing, investigation, or inquiry with the
MPSC, as a peer review body, are made during the course of its
confidential peer review process and with the understanding that these
statements and information would also be protected from discovery under
the medical peer review privilege. The OPTN bylaws provide assurances
to OPTN members that information provided during compliance activities
will remain confidential pursuant to medical peer review \42\ and
further exposes the OPTN contractor and its staff to personal liability
for violating this peer review privilege.\43\ In light of the OPTN's
obligation to provide a peer review system and the widely recognized
benefits of confidential medical peer review, UNOS provides aggregate
data on system-wide compliance activities that demonstrate the OPTN
provides appropriate and highly effective oversight when OPTN members
are found to be non-compliant with OPTN obligations.
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\41\ Washington (DC): National Academies Press (US); 2000.
Available at: https://pubmed.ncbi.nlm.nih.gov/25077248/ accessed
October 11, 2022.
\42\ OPTN Bylaws Article A.1 (A)(5)(B). ``Any act, communication,
report, recommendation or disclosure, with respect to any applicant or
member made in good faith and at the request of the OPTN contractor and
its representatives, anywhere and at any time, for the purposes
described in (a) above are privileged to the fullest extent permitted
by law as part of the OPTN medical peer review. The medical peer review
privilege extends to any third parties who either supply or are
supplied information and are authorized to receive, release or act upon
the same.''
\43\ Id. at (c). ``The immunity and release from liability provided
in this section shall not apply to acts of willful misconduct by the
OPTN contractor and its representatives.''
HRSA presently provides oversight of the OPTN on behalf of the HHS
Secretary. The OPTN is required by regulation to provide the Secretary
any information that may be requested by the Secretary (42 CFR
121.11(b)(iii)). The OPTN has always met this requirement and will
continue to provide the Secretary any information that the Secretary
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prescribes.
Question. Organ Procurement Organizations (OPOs) are constrained
from placing their own kidneys with national transplant centers and
instead forced to wait for the Organ Procurement Transplantation
Network system to place them. According to the Report of National
Kidney Foundation Consensus Conference to Decrease Kidney Discards
published in Clinical Transplantation, October 2018, the overall
placement rate for high Kidney Donor Profile Index (KDPI) kidneys
allocated through the Organ Center is 28 percent, which those with KDPI
of 80+ have a placement rate of less than 15 percent. OPOs who work to
place kidneys themselves, have much higher placement rates. Why are
OPOs penalized for placing the kidneys themselves?
Answer. The ``Report of National Kidney Foundation Consensus
Conference to Decrease Kidney Discards'' published in Clinical
Transplantation, October 2018, does not cite an overall placement rate
for high KDPI kidneys or those with a KDPI of 80+ allocated through the
Organ Center.
It's important to note that when this report was written, kidneys
allocation was different than it is currently. Kidneys at that time
were offered first within the OPO's Donation Service Area (DSA), then
regionally, and finally to the Nation. Once all potential candidates at
transplant programs within the OPO's DSA and region had received and
refused kidney offers, OPTN policy required the OPO to contact the
Organ Center for assistance allocating the kidney. An OPO's placement
rate of high KDPI kidneys at the local DSA and regional classifications
is not comparable to the Organ Center's placement rate at the national
classifications. The higher quality organs will be accepted and
transplanted prior to offers at the national level. Kidneys that have
been declined by the local DSA and region often have more extended cold
ischemic times, abnormal biopsy/laboratory findings, and/or anatomical
issues, making Organ Center nation placement attempts significantly
more challenging.
Kidney allocation changed in 2021, and kidneys are now offered to
transplant hospitals located within 250 nautical miles (NM) of the
donor hospital and then to centers located over 250NM away from the
donor hospital. OPTN policy requires the OPO to contact the Organ
Center for assistance allocating a kidney once all centers within the
250NM classifications have declined. The same issues apply to these
placements; higher quality kidneys are more likely to be placed within
the higher ranked 250NM classifications, leaving the allocation of the
harder to place kidneys to the Organ Center. Therefore, just as in the
prior policy, placement rates between the OPO and the Organ Center are
not comparable.
OPOs and the Organ Center use the same kidney match for placement.
Successful kidney placement has three major components: (1) quality of
the donor and organ, (2) distance/logistical constraints, and (3)
transplant program and transplant candidate requirements. If the OPO is
following the rank order of the match, then holding all else equal,
placement rates should be the same at the national classifications
regardless of the entity that is making the offers. UNOS staff do not
prohibit nor penalize OPOs that make national kidney offers. However,
if made aware of a case, staff will educate them on the OPTN policy and
the potential deviation.
The OPTN has pursued many projects from the 2018 NKF Consensus
Conference recommendations. Below are just a few.
Recommendation: ``Create expedited placement pathway to directly
offer organs at risk of discard to small subset of centers that opt in
to accepting these organs.'' ``Center must sustain high rates of
acceptance to receive offers.''
In 2019, the Organ Center implemented a data-driven yearlong Kidney
Accelerated Placement (KAP) project, which was very similar to the
recommendation from the NKF Consensus Conference. During the KAP
project, hard-to-place kidneys were offered to transplant programs that
had a history of accepting them. The acceptance to transplant rate was
slightly higher under KAP (72.7 percent versus 71.2 percent), although
not significant. More information about the project can be found at:
https://onlinelibrary.wiley.com/doi/epdf/10.1111/
ajt.16859.
Recommendation: ``Understanding the role of kidney biopsies in the
evaluation of organ quality and impact on allocation/acceptance.''
In June 2022 two policies related to biopsies were passed by the
OPTN board of directors. The policies establish minimum kidney donor
criteria requiring a biopsy and standardize the reporting and data
collection of kidney biopsies. In addition to improving allocation
efficiencies, these two policies will allow for further research around
the impact kidney biopsies have on acceptance and transplantation
rates. More information about those policies can be found at:
https://optn.transplant.hrsa.gov/policies-bylaws/public-
comment/standardize-kidney-biopsy-reporting-and-data-collection/.
https://optn.transplant.hrsa.gov/policies-bylaws/public-
comment/establish-minimum-kidney-donor-criteria-to-require-biopsy/.
Recommendation: ``Strengthen local OPO-transplant center
cooperative QAPI efforts to reduce discard.''
The OPTN created a collaborative improvement framework where
members could share best practices and ideas for improvement. The
primary aim of the Collaborative Innovation and Improvement Network
(COIIN) was increasing transplantation with a particular focus on
moderate to high Kidney Donor Profile Index (KDPI) kidneys. Favorable
results were seen in both cohorts, and findings show that an increase
in transplant rate and greater utilization of moderate to high KDPI
organs were realized in many participating centers.\44\
---------------------------------------------------------------------------
\44\ Wey, A., Foutz, J., Gustafson, S.K., Carrico, R.J.,
Sisaithong, K., Tosoc-Haskell, H., McBride, M., Klassen, D., Salkowski,
N., Kasiske, B.L., Israni, A.K., Snyder, J.J. ``The Collaborative
Innovation and Improvement Network (COIIN): Effect on donor yield,
wait-list mortality, transplant rates, and offer acceptance.'' Am J
Transplant. 2020 Apr;20(4):1076-1086. https://pubmed.ncbi.nlm.nih.gov/
31612617/.
Recommendation: ``Develop and test measures of transplant center
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organ acceptance to help inform organ allocation.''
In 2021, the reason for refusal of an organ list was updated.\45\
Revising the list of refusal codes supports increased efficiency of the
OPTN through better understanding of refusal behaviors. Offering
members more options for reporting why an offered organ is refused
provides more robust data to develop improved allocation strategies to
reduce cold ischemic time and number of non-utilized organs well as
increase the number of transplants.
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\45\ Project to update refusal codes. OPTN Data Advisory Committee.
Nd. https://optn.transplant.hrsa.gov/policies-bylaws/a-closer-look/
project-to-update-refusal-codes/.
Question. Why is UNOS so far behind in creating Application
Programming Interface (API) software that electronically transmit data
between hospitals/OPOs/transplant centers to UNOS without having to
manually enter data into other databases first? What APIs currently
exist? What is the process for their use? How many are entities in the
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system are using APIs?
UNOS launched the UNet application in 1999 with tools for users to
transmit data electronically to avoid manual entry. As part of ongoing
modernization, UNOS started a formal API program in 2016. Since that
time, UNOS development and implementation of APIs has advanced and is
increasing.
As of September 2022, 243 hospitals and OPOs use APIs to transmit
or receive data. Our external APIs empower OPTN members to
electronically:
Manage donor data
Demographics
Vitals
Medical and social history
Clinical lab values
Infectious disease testing results
Diagnostic test results
Urinalysis
Blood gases
Culture results
Medications and fluids
Human Leukocyte Antigens (HLA)
Kidney preservation data
File attachments (for images and source
documentation)
Manage candidate data
Demographics
Unacceptable antigens
Liver labs
Lung labs and functional status
Offer acceptances
Report organ-specific data on patients and donors at key
transplant milestones
Transplant Candidate Registration (TCR)
Transplant Recipient Registration (TRR)
Transplant Immunosuppression Data (IMR)
Transplant Recipient Follow-Up (TRF)
Transplant Immunosuppression Data during
Follow-Up (IMF)
Deceased Donor Registration (DDR)
Living Donor Registration (LDR)
Living Donor Follow-Up (LDF)
Calculate key transplantation scores
Calculated Panel Reactive Antibody Score
(CPRA)
Model for End-Stage Liver Disease Score
(MELD)
Pediatric End-Stage Liver Disease Score
(PELD)
Lung Allocation Score (LAS)
Report deceased donor referrals
Retrieve donor hospital data
Retrieve public reporting data
UNOS coordinates with OPTN members and EHR vendors prior, during,
and after our own API development. This includes conducting community
research to identify API development targets that OPTN members and
their EHR vendors want to integrate with, maintaining regular
communication and hosting town hall events with the community to
describe upcoming offerings and changes to existing APIs, and
collaborating with vendors and members throughout their
implementations.
In addition to providing direct user assistance, we maintain a
developer portal with detailed API documentation through our Google
Cloud API Management platform, Apigee. We inform stakeholders of
upcoming changes months in advance, provide them with specification
details prior to implementation, and offer direct support throughout
their own work.
Furthermore, we maintain our Beta Portal, an external facing, non-
production OPTN System (UNet) environment that enables vendors and
members to build and test their own systems against upcoming changes.
Changes to existing APIs are deployed to Beta Portal 6-8 weeks prior to
moving to production. UNOS regularly monitors Beta Portal activity to
identify challenges developers are encountering. We also adapt our API
roadmap to minimize the frequency an API experiences significant
changes. These measures appropriately throttle our own development to
provide stability for our customers (OPTN members end users) while
still improving our technology.
The U.S. health-care system's unique complexity and fragmentation
presents both a greater need for integration and a higher barrier to
it, and that is reflected in current API adoption. UNOS recognizes that
building APIs does not guarantee that transplant hospitals, organ
procurement organizations and histocompatibility laboratories will use
them. Decisions to adopt APIs go through software vendors as well as
OPTN members' leadership, IT teams, and clinicians. These parties act
in alignment with their own interests and constraints, and may choose
to rely on historical solutions. Transplantation remains a small sector
of health care, and in this respect, lagging API adoption and continued
reliance on historical solutions are to be expected.
Nevertheless, UNOS is not a passive observer in this space. While
OPTN members have not been mandated to use APIs, UNOS has taken
measures to lead the community forward through the deprecation of
previously developed solutions and standards. This includes the recent
sunset of a tool to import candidates' unacceptable antigen data, which
increased use of the corresponding API from 16 centers in January 2022
to 91 centers in September 2022. Similarly, UNOS is enforcing updates
to API authentication protocols in 2022, ensuring that OPTN members
consistently adhere to the most current cybersecurity standards for
integration. In these cases, UNOS balances community readiness and
value to the OPTN to set appropriate deadlines, similar to Congress and
HHS's journey to retire ICD-9 from 2008 to 2015.
To further drive adoption, the UNOS API program has begun ramping
up proactive engagement efforts with OPTN members. Staff are conducting
direct outreach to OPTN members and EHR Vendors for API implementation
based on their needs and their EHR vendors' capabilities, to assist
with implementation and testing, and to drive continuous improvement
for future API development, rollout, and updates. UNOS is also
partnering with Accenture Federal, a consulting firm and tech leader,
to expand and extend our API strategy to increase API adoption with
plans to assist OPTN members with any implementation or testing needs,
and driving process improvements to further streamline future adoption.
Question. What have you committed to investing in OPTN systems to
bring them into the 21st century? What is your action plan, timeline
and allocation of resources to do so?
Answer. Some of the key technology trends in the 21st century are
Microservices, APIs, Cloud, Mobile, Big Data/Machine Learning and
leveraging Agile methodology to build software.
In addition to implementing OPTN policy projects, since 2014, UNOS
has leveraged these industry themes and never lost sight that the most
important factor of successfully using technology is to focus on the
customer.
With that in mind, to date we have invested in iterative modular
development and automated testing while building an API platform, using
Google Cloud's Apigee, that we can use to share data securely using RFC
standards. We focused on modularizing our software through
microservices. These web-based microservices are a foundation for all
development as we build new solutions, seamlessly share data with
external systems, and transform our production systems used by OPTN
members to save lives. The illustration and summaries below depict some
of the modernization efforts accomplished since 2016. In addition, the
projects listed below the timeline are other OPTN Board of Directors or
Member requested projects implemented during that time.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
technology highlights since 2016
In 2016, in addition to launching our APIs and Microservices
efforts, UNOS developed and released reporting and analytics
capabilities to help improve the quality, scope, and timeliness of
organ offers for transplant centers and OPOs. Leveraging Big Data
concepts, Hortonworks Connected Data Platforms, 100-percent open-source
ApacheTM Hadoop and Tableau, transplant centers were given
automated, detailed, and visually rich reports on all organ offers they
received and the outcome if it was transplanted.
In 2017, UNOS developed a matching function test automation suite
to conduct ongoing software testing to reduce project implementation
time. This suite continues to be updated with every OPTN policy change
or customer requested functionality enhancement. This was built on the
open-source framework Selenium and gives us the robust capabilities to
leverage coding to test all critical features.
In 2018, UNOS implemented and integrated with Salesforce.com
leveraging their industry leading Software as a Service (SaaS) Customer
Relationship Membership (CRM) platform to manage the OPTN Membership.
Also in 2018, a new reimagined and modernized version of the OPO
mobile experience was released. This product was developed with
critical input and prioritization by the OPO community and incorporated
numerous existing and newly developed microservices.
We continued this journey in 2019, when we created a cross-
departmental team that is focused on creating public cloud patterns
that can scale our ideas and core infrastructure for the capabilities
found in the public cloud. In parallel, we developed a new Security
Administration application. The new application increased capabilities
for OPTN site security administrators, leveraged microservices and
features an immersive, modern user experience.
In 2020, UNOS implemented an integrated Clinical Image Sharing
solution via integration with an industry leader, Ambra Health. This
intuitive, feature rich DICOM viewer enables OPOs to upload organ donor
clinical studies and allows transplant professionals to make more
informed decisions.
Also in 2020, UNOS launched a new mobile, web-responsive experience
for transplant hospitals to interact with DonorNet utilizing
microservices. We collaborated closely with many transplant
coordinators, administrators, and surgeons throughout the country using
human-centered design techniques to create and test designs. This new
design and experience enabled them to evaluate and respond to offers
regardless of where they are at any time of day.
In 2021, we completed a transformation to a multi-regional hybrid
cloud environment built using Nutanix cloud infrastructure and
Microsoft Azure public cloud. Aligned with our cloud-first approach for
all new functionality, we have implemented new cloud-native real-time
capabilities in Predictive Analytics decision support for organ offer
acceptance, while actively executing a roadmap to move existing core
infrastructure to the public cloud.
To protect the organ matching system and patient data to which we
are entrusted, over the last several years we made significant
investments in security capabilities aligned with defense-in-depth and
zero trust principles. Among these are robust authentication
capabilities, application code vulnerability scanning, security log
aggregation, correlation and visualization, industry leading endpoint
detection and response, and distributed denial of service (DDoS)
protection.
resources allocated
Since 2016, UNOS has invested more than 200,000 hours of resources
into ongoing technology modernization efforts; we understand the
importance of enhancing and securing the technology the OPTN members
use to save lives.
UNOS routinely documents and updates the OPTN Network Operations
Oversight Committee (NOOC) and HRSA on improvement plans. Please see
roadmap below, shared with the NOOC and HRSA, for planned improvements
to the system.
The illustration below depicts continued improvements and
innovation areas we envision and aim to implement over the next several
years.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
UNOS leverages microservices (internal-facing APIs) as part of
its continued technology transformation into a modern microservices
architecture. A number of internal system components already make heavy
use of internal APIs, free of external dependencies, allowing UNOS to
rapidly expand its footprint in this area. Through these efforts, we
continue to mature our technology systems and practices.
partnering with leaders in technology innovation
A significant component of our strategy is leveraging or
integrating leading technologies in areas beneficial to the transplant
ecosystem. That is the reason UNOS has advanced the OPTN system with
solutions utilizing open-source frameworks that include: Angular;
Swift; Kotlin; and NodeJS.
This is extended with integrations offered by key Cloud SaaS
providers: Twilio; Salesforce; Ambra; and Azure.
UNOS understands and has prioritized the use of open-source
frameworks and created partnerships with dozens of recognized
technology leaders to advance the capabilities of the OPTN system.
During the transformation of our technology, we have partnered with
the Microsoft Tech for Social Impact team to align our vision with a
reality we can bring to the transplant community. This partnership has
also helped us make connections with other countries, share our
learnings and assist them in using the public cloud for solving their
problems.
Question. Why does it take 2-plus years to process a policy change
at the OPTN, even when it is non-controversial and there is agreement
on the needed change?
Answer. The OPTN must balance its requirements under the law, which
includes involving multiple stakeholders during the policy development
process and during public comment. Public comment, a critical aspect of
the policy development process is required by NOTA (42 U.S.C.
Sec. 274(b)(2)(B)) and the OPTN final rule (42 CFR Sec. 121.4(b)(1)).
The time to process large allocation proposals has fallen over the
last decade. For example, the revised kidney allocation system took
over 9 years and liver distribution over 6 years. In contrast, the
development of lung continuous distribution, which included an overhaul
of the entire framework of the allocation system and member tools, took
less than 3 years to develop.
Continuous advances in the science and practice of organ
transplantation require ongoing refinement of policy that involves
experts in the field as well as the public and the larger donation and
transplant community. To ensure the best possible solutions for
patients awaiting transplantation and for the donors whose precious
gifts make that possible, the policy development process is:\46\
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\46\ OPTN Policy Development Process. https://
optn.transplant.hrsa.gov/policies-bylaws/policy-development/
#policyProcess.
Inclusive--encouraging participation by interested persons,
organizations and the general public.
Responsive--assessing and modifying policies to remain
current with the field.
Equitable--helping to ensure that all patients have an equal
chance of receiving a suitable organ.
Evidence based--making decisions based on extensive and
valid scientific data and analysis.
The hundreds of volunteers who serve on OPTN committees that
develop policy comprise highly experienced medical professionals,
patients, and donor families. UNOS values the feedback of the whole
community and strives to achieve consensus, which contributes to the
time it takes to develop a policy.
Question. During the hearing, you referenced a rubric for matters
referred to the Membership and Professional Standards Committee (MPSC)?
Please provide the rubric.
Answer. The rubric, part of the MPSC's operational rules, is
provided as part of this submission.
Question. What are you doing to ensure OPOs and donor hospital and
transplant centers are aligned in their work? And what accountability
measures do you have in place for transplant centers to align their
efforts with those of OPOs?
Answer. UNOS brings together all stakeholders in the community to
drive continuous improvement and increase transplant.
Our field is uniquely interdependent. Making the system more
equitable and efficient requires regulatory agencies, OPOs, transplant
centers and the approximately 6,000 donor hospitals in the U.S. to
efficiently and effectively align their work toward our common goal of
saving and enhancing lives. Many people, often in different parts of
the country, collaborate at all hours of the day or night. This occurs
nowhere else in medicine, and it requires our constant vigilance and
care to assure that it is done well and that all facets of the system
are accountable for its success.
Recent efforts by UNOS to better align work across the organ
donation and transplant system and ensure the highest level of
accountability include:
A new performance monitoring system for transplant
hospitals.
Collaborative Improvement (CI) and Individual Member Focused
Improvement (IMFI) projects that bring together transplant
programs, OPOs and HRSA on quality improvement initiatives.\47\
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\47\ OPTN Collaborative Improvement. https://
optn.transplant.hrsa.gov/professionals/improvement/collaborative-
improvement/.
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The incorporation of predictive analytics into the organ
offer experience for adult deceased donor kidneys that is
intended to impact acceptance behavior and increase organ
utilization.
Every day, our community's collective efforts to provide
exceptional clinical care, assure equitable organ allocation policies,
and innovate to continuously improve move the system forward and save
even more lives.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
The last place anybody wants to hear about gross mismanagement and
incompetence is in the business of saving lives. That's precisely and
unfortunately what the Finance Committee meets to discuss today.
This morning's hearing is an update on an investigation Senator
Grassley and I, along with Senator Cardin and Senator Young, have been
conducting for more than 2\1/2\ years. It examines the network of
dozens of organizations that manage organ transplants, and particularly
the group that oversees and coordinates them, the United Network for
Organ Sharing, or UNOS. We have reviewed 100,000 UNOS documents
totaling more than a half-million pages.
Before I get to specific findings, I want to frame what we've
learned as simply as possible. Far too many Americans are dying
needlessly because UNOS and many of the transplant organizations it
oversees are failing and seem uninterested in improving.
These issues involve an alphabet soup of acronyms and
organizations, so I'll start out with a bit of background. A 1984 law
created the first computerized system to match sick patients with the
organs they needed. It was named the Organ Procurement and
Transplantation Network. Somebody needed to manage that system for the
entire country, so the government sought to contract an organization to
run it. UNOS was the only bidder for that first contract in 1986. The
contract has come up for bid seven other times. UNOS has won all seven.
Today the network UNOS oversees is made up of nearly 400 members,
including 252 transplant centers and 57 regional organizations known as
organ procurement organizations, or OPOs. Each OPO has a defined
geographic service area. A family sitting in a hospital room thinking
about donating a loved-one's organ doesn't have a choice of OPOs.
Those are the important terms to remember. When a kidney donated in
Corvallis needs to get to a patient in Portland, that's where an OPO
comes in. UNOS oversees the OPOs. As our investigation shows, UNOS does
it very poorly.
Serious errors in the procurement and transplant system are
shockingly common. Between 2010 and 2020, more than 1,100 complaints
were filed by patients and families, staff, transplant centers, and
others. The nature of those complaints runs the gamut. For example, in
a number of cases OPOs had failed to complete critical, mandatory tests
for things like blood types, disease, and infection.
Our investigation found one patient died after being transplanted
with lungs that a South Carolina OPO marked with the wrong blood type.
Similar blood-type errors happened elsewhere, and patients developed
serious illness. Some had to have organs removed after transplant.
Another patient was told he would likely die within 3 years after
an OPO in Ohio supplied him with a heart from a donor who had died of a
malignant brain tumor. UNOS did not pursue any disciplinary action.
In a case from Florida, another patient contracted cancer from
transplanted organs, and the OPO sat on the evidence for months.
In total, our investigation found that between 2008 and 2015, 249
transplant recipients developed a disease from transplanted organs.
More than a quarter of them died.
Delivering organs has been another source of life-threatening
errors. We found 53 such complaints between 2010 and 2020, as well as
evidence that those were just the tip of the iceberg. In some cases,
couriers missed a flight. In others, the organs were abandoned at
airports. Some organs were never picked up. Many of these failures
resulted in organs being discarded.
It's reasonable to assume that many more errors are going
unreported. Why? Because filing official complaints with UNOS appears
to accomplish zero productive oversight or reform. Organ transplant
professionals repeatedly told the Finance Committee that the UNOS
complaint process was a ``black hole.'' Complaints went in, UNOS went
quiet.
In interviews with the committee, UNOS leaders have dragged their
feet, dodged tough questions, and shifted responsibility onto others.
Investigations and disciplinary measures rarely amount to more than a
slap on the wrist. Only one time--just once--has UNOS recommended that
an OPO lose certification.
The bottom line is that the failures we've uncovered cost lives.
Thousands of organs donated each year wind up discarded, including one
in four kidneys. Yet according to Federal data, roughly 6,000 Americans
die every year while waiting for an organ transplant.
This kind of mismanagement has a disproportionate impact on
minority Americans. African Americans, for example, have a greater need
for kidney transplants than those from other demographic groups.
The Centers for Medicare and Medicaid Services recently issued new
standards for OPO performance, and more than a third of OPOs are
failing to meet them. Fixing what's broken could substantially increase
the supply of lifesaving organs available for transplant.
Finally, another area of the committee's investigation has examined
the IT used by UNOS to run the transplant network. This system is
outdated, mismanaged, and insecure. Using such decrepit tech to run the
transplant network puts lives in danger and puts sensitive data at
risk, and there is no apparent solution in sight. In a report issued
last year titled ``Lives Are at Stake,'' the U.S. Digital Service
flatly concluded that UNOS did not have the technical capability to
modernize the system.
I'll close on this. If you looked at the staff at UNOS and many of
the Nation's OPOs, I'd wager the vast majority are hardworking people
doing their best to save lives. The glaring issues uncovered in our
investigation stem from leadership failures.
Our investigation is ongoing. It's clear this system needs reform
badly. We're going to continue digging into issues at UNOS and the
OPOs, as well as the policies that need changing at the Federal level.
This is not a partisan subject. Everybody wants this system to work
with as few errors as possible. Senators Grassley, Cardin, Young, and I
are going to keep at it.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
__
Communications
----------
Letter Submitted by Jaison M. Abraham
Hello, Honorable Senator(s),
For the record, I believe it is extremely unfair to blame United
Network for Organ Sharing (UNOS) and OPOs for bad performance and poor
outcomes. The allocation system may not be perfect but has evolved over
the years. It will always be a continuous process to decrease
disparities and better serve patients. Transplant Centers should also
be held accountable. Programs that failed to evolve their practices are
struggling more. The Senate committee selected AdventHealth, a non-
academic center with one of the lowest organ offer acceptance rates and
lowest 1M, and lowest 1Y outcomes in its Kidney and Liver Transplant
programs, to provide witness testimony in its investigation. Though I
do not believe the Senate intended to select a low-performing center to
represent the transplant community--it did. I urge the Senate committee
to look at a broader cross-section of the transplant community for
better representation at future hearings.
The U.S. Transplant system is the most developed and successful in the
world. Transparency is one of its strengths. As transplant
administrators, we appreciate the efforts of the senate to improve the
transplant system and are hopeful that the inquiry will elevate
processes and improve care for the patients cared for by all of the
centers.
Respectfully,
Jaison Abraham, MBA, LSSBB
Director of Transplant Programs
UF Health Shands
Office: 352-594-5288
Web: https://ufhealth.org/transplant-center/
______
American Society of Nephrology
1401 H Street, NW, Suite 900
Washington, DC 20005
On behalf of the 37 million Americans living with kidney diseases,
thank you for your efforts to improve the United States transplant
system. ASN seeks to transform transplant care and applauds the Senate
Finance Committee for investigating shortcomings of the Organ
Procurement Transplantation Network (OPTN).
``ASN believes a strong and equitable transplant system is essential to
meet the needs of the more than 800,000 Americans living with kidney
failure. While a kidney transplant is the optimal therapy for most
people living with kidney failure, transplantation remains out of reach
for too many people. ASN is deeply concerned with reports of technology
failures from the OPTN contractor that are contributing to the immense
organ discard rate and shortage of kidneys for transplantation. ASN
reaffirms our call for the OPTN contract to be modernized. The more
than 21,000 kidney health professionals who comprise ASN are committed
to creating a world without kidney diseases, including by transforming
transplant care. ASN commends the Senate Finance Committee for
continuing to drive improvements in transplantation and stands in
partnership to ensure all Americans who could benefit have access to
this critical therapy,'' said ASN President Elect Michelle A.
Josephson, M.D., FASN in a press statement.
Of the more than 100,000 people currently on the transplant waiting
list, there are nearly 90,000 people currently waiting to receive a
kidney, the largest subset of any organ. Devastatingly, a national
organ shortage means that 13 people die every day while on the kidney
transplant wait list.
ASN believes that transformations are needed across the transplant
system in order to meet the growing need for kidney transplantation,
including at the level of the OPTN. This statement focuses on 4 policy
recommendations that address challenges related to the OPTN, including:
Modernize the OPTN contract by separating the IT infrastructure
into a distinct contract.
Address barriers to transplant access that promote or exacerbate
inequities, including the use of race in the organ quality metric that
guides allocation Kidney Donor Profile Index (KPDI).
Streamline oversight of the U.S. transplant system by
establishing an office of organ transplantation.
Elevate transplant patients as partners in care, including by
improving transparency regarding organ offers.
Modernize the OPTN Contract by Separating the IT Infrastructure Into a
Distinct Contract
The OPTN is a quasi-governmental government agency responsible for
establishing organ transplant and allocation policy, conducting
oversight and enforcement of transplant programs and Organ Procurement
Organizations (OPOs), and maintaining an IT infrastructure to support
transplantation. The OPTN contract has been held by a single not-for-
profit organization, the United Network for Organ Sharing (UNOS) since
the contract was created in 1986.
UNOS maintains an IT infrastructure, which UNOS claims to be
proprietary despite being developed under a federal contract with tax
dollars and user fees, to support wait-listing, organ allocation,
sharing of donor information and data capture for regulatory oversight.
As revealed by The Washington Post, stakeholders in government have
expressed repeated concerns over UNOS continued use of antiquated
systems for data capture and collection with no validation tools or
interoperability features. The stakeholders, including the White House
U.S. Digital Service, noted deep issues with transparency when reviewed
by the service as well as major security vulnerabilities. Efforts to
modernize these systems have been slow and ineffective, with changes in
policy such as new organ allocation schemes taking as long as a year or
more to implement.
Further, data are collected from different parts of the transplant
system at the expense and labor of transplant centers and OPO staff,
and then returned back to transplant centers and OPOs in the form of
well curated dashboards (for a fee for national datasets), while some
free reporting tools exist, they are often clunky and lack the depth of
information provided in paid reporting tools. Despite being established
through taxpayer- and user-fee-supported funding, The Washington Post
reports that UNOS claims ownership of the system and would charge the
American taxpayer $55 million to purchase the current IT system should
it ever lose the contract.
This arrangement is unique as other important responsibilities in
transplantation, such as the statistical and analytical support
provided by the Scientific Registry of Transplant Recipients (SRTR),
are structured as an independent contract. It is no surprise that
stakeholders ranging from the White House U.S. Digital Service to a
bipartisan group of HHS technology officers to the National Academies
of Science and Medicine have all called for the IT infrastructure
responsibilities of OPTN to be separated into an independent and
competitive contract. Separating the IT infrastructure portion of the
OPTN contract would align with other federal contracting protocols,
increase competition, and drive innovation.
Address Barriers to Transplant Access That Promote or Exacerbate
Inequity, Including the Use of Race in the Organ
Quality Metric That Guides Allocation, Kidney Donor
Profile Index (KPDI)
Kidney transplantation is the optimal therapy for most people living
with kidney failure, yet kidney transplantation is not equally
accessible for all Americans. For example, Black patients are less
likely to be identified as transplant candidates, referred for
evaluation to receive a pre-emptive transplant, and to complete the
transplant evaluation. Black patients are also less likely to have the
preferred living donor and less likely to be placed on the waiting
list, while also being more likely to receive lower quality kidneys
regardless of the age of the patient and length on the kidney wait
list, and have poorer transplant graft survival for a multitude of
reasons that may include difficulties in access to care--a cyclical and
compounding struggle that is nearly impossible to defeat without real
identification and solution to racism.
Many of the policies needed to establish equity in transplant require
cooperation between multiple stakeholders in the private sector and
across different government agencies. However, one improvement is
squarely in the purview of the OPTN contractor: removing the use of
race in metrics related to organ allocation.
Race does not have any physiological relationship with the function of
a patient's kidney, yet clinical decision support tools such as the
estimated Glomerular Filtration Rate equation (eGFR) have included race
adjustor variables, systemically overestimating the kidney function of
Black patients and leading to reduced access to transplantation. On
June 27, 2022, OPTN finalized a policy to remove race as a variable
from eGFR, following the recommendation of the American Society of
Nephrology and National Kidney Foundation and citing concerns that the
variable was leading to a 16% overestimation of kidney function among
Black patients.
Despite this welcome decision, OPTN is still allowing a race adjustment
in the Kidney Donor Profile Index (KDPI), with no public plans to cease
their use. The KDPI estimates the relative risk of post-transplant
kidney graft failure of organs obtained from a deceased donor. The KDPI
includes a race variable, automatically assigning lower quality to
kidneys obtained from Black donors independent of biological factors,
arbitrarily reducing the supply of donated kidneys and effectively
turning away the gift of life from Black donors. Analyses from SRTR
have demonstrated that removing a race variable does not alter the
equation's predictability of graft failure or patient survival. Race
variables should be removed from tools assessing biological factors,
including the organ quality metric that guides kidney allocation, the
Kidney Donor Profile Index.
Streamline Oversight of the U.S. Transplant System by Establishing an
Office of Organ Transplantation
Oversight of the U.S. transplant system is currently divided between
the Centers for Medicare and Medicaid Services (CMS), who oversee
transplant programs, and the Health Resources and Services
Administration (HRSA), who oversee OPTN and OPO contractors. This split
responsibility leads to gaps in oversight, confusion in navigating the
transplant system, and a regulatory framework that does not elevate
patients to be true partners in care.
One glaring example of this confusion is the use of financial means
testing to evaluate a transplant recipient's eligibility to receive a
transplant. In 2020, Congress passed the Comprehensive
Immunosuppressive Drug Coverage Act, effectively ending the need for
kidney transplant recipients to pay for immunosuppressive drugs out of
pocket and a commonly used justification for financial screening.
Both transplant programs, regulated by CMS under the Conditions for
Coverage, and the OPTN contractor, regulated by HRSA under the OPTN
final rule mandate that patient selection (CMS) and organ allocation
(HRSA) must ensure fair and non-discriminatory distribution of organs,
yet financial criteria are still used to screen low-SES people from
access to transplantation, even if the patient is otherwise healthy and
a good transplant candidate.
Establishing a unified office of organ transplantation at HHS would
enable transplant policy to be built around people in need of a
transplant as opposed to being built around regulatory silos. Broadly,
transplant policy should be aligned with the primary goal of increasing
access to kidney transplantation to the maximum number of patients with
kidney failure while improving longer term post-transplant outcomes
(particularly among our younger recipients) and quality of life
(particularly among older recipients where long-term survival may not
be the paramount goal).
Currently, regulations across kidney care, including for dialysis
facilities, transplant centers, and OPTN are not aligned and do not
recognize the role of all in facilitating a smooth transition of care
for patients. As a result, there are silos of care that occur in the
nephrology clinic, dialysis unit, and the transplant center that
increase challenges faced by patients in achieving optimal patient
care. Establishing a single office of organ and transplant policy would
better encourage patient-centered regulation instead of the current
framework which focuses almost exclusively on short-term patient
outcomes. This shift would improve communications across silos of care
(dialysis units, referring nephrologists, and transplant centers),
encourage transplant centers to provide increased and timely access to
evaluation and related testing, and encourage greater communication
about wait-listed candidates among transplant centers and current care
teams. Unifying oversight of the transplant system under a single
office would ensure that patients' interests do not become lost in gaps
of oversight.
Elevate Transplant Patients as Partners in Care, Including by
Improving Transparency Regarding Organ Offers
ASN believes that patients should be informed partners in their care,
and most patients want more rather than less information about their
care. Unfortunately, the current transplant system does not emphasize
this principle: most patients are currently unaware of organ offers
that are declined on their behalf by their care team. This is
particularly concerning given research has shown that 85% of all
kidneys are declined at least once, and that the 10,000 people who die
per year on the transplant wait list receive a median of 16 organ
offers while waiting for an organ.
While real-time notifications of organ offers are likely not feasible,
practical, or desirable, asynchronous communication of these offers are
a potential option for improving patient engagement and elevating
patients as partners in their care. IT systems could be developed to
facilitate local EHR communications and increase transparency and
communication between people waiting for a transplant and the
transplant care team. and
For example, informing patients at regular intervals (every three or
six months) could help by improving communication between patients,
transplant center and dialysis providers about patient preferences and
priorities, and by helping patients appreciate the tradeoff between
increased selectivity for organs and wait times for those organs.
Finally, it would be of considerable benefit for transplant centers to
have effective tools to assess the implications of turning down an
offer, just as much as patients need tools to assess the implications
of accepting a higher-risk kidney compared to remaining on the
transplant wait list. Above all, patients should be provided the
opportunity to be true partners in their care, and transparency should
be fostered in the transplant system to elevate patients to be informed
decision makers wherever possible.
Conclusion
Again, thank you for addressing this high area of need in the
transplant system. ASN stands ready to help address these challenges
and transform transplant care into an accessible therapy for all
Americans. Should you have any questions about this statement, please
do not hesitate to contact Zach Kribs, ASN Manager of Congressional
Affairs at [email protected] or 202-618-6991.
Sincerely,
Michelle A. Josephson, M.D., FASN
President-Elect
Roslyn B. Mannon, M.D., FASN
Chair, Policy and Advocacy Committee
______
Association of Organ Procurement Organizations
8300 Greensboro Drive, #L1-620
McLean, VA 22102
(703) 556-4242
https://aopo.org/
On August 3, 2022, the Senate Finance Committee held a hearing and
released a report \1\ entitled: ``A System in Need of Repair:
Addressing Organizational Failures in the U.S. Organ Procurement and
Transplantation Network.'' The Association of Organ Procurement
Organizations (AOPO) shares the Committee's goal of creating and
maintaining a more equitable and efficient system.
---------------------------------------------------------------------------
\1\ https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Memo.pdf.
The year 2021 marked the eleventh record year in a row for deceased
organ donors and the ninth consecutive year of increases in the number
of organ transplants nationwide.\2\ We are actively working to ensure
this upward trend continues. As part of that effort, we are committed
to improvement and seek feedback from impacted individuals,
communities, and other stakeholders.
---------------------------------------------------------------------------
\2\ OPTN Press: ``All-time records again set in 2021 for organ
transplants, organ donation from deceased donors,'' https://
optn.transplant.hrsa.gov/news/all-time-records-again-set-in-2021-for-
organ-transplants-organ-donation-from-deceased-donors/.
AOPO agrees that by investing in new, promising technologies, aligning
policies and metrics towards shared, system-wide goals, and
establishing mutual accountability for participants in the organ
donation and transplantation process, we can improve the efficiency and
equality of our system and ultimately save more lives. To move forward,
the Committee should endorse the findings from the National Academies
of Sciences, Engineering, and Medicine (NASEM)\3\ report which assesses
where the system currently stands, delineates the role each stakeholder
plays, and charts a path to a more equitable donation and
transplantation system. We agree that continued improvements are
necessary to advance care for patients.
---------------------------------------------------------------------------
\3\ NASEM Publication: ``Realizing the Promise of Equity in the
Organ Transplantation System,'' https://www.nationalacademies.org/our-
work/a-fairer-and-more-equitable-cost-effective-and-transparent-system-
of-donor-organ-procurement-allocation-and-distribution.
---------------------------------------------------------------------------
Organ Acceptance Rates and Non-Utilization
The under-use of viable organs, leading to an increase in organ waste,
is an urgent issue that all donation and transplant stakeholders must
solve as it is a major contributing factor to the nationwide wait list
exceeding 100,000 patients. According to research cited in the NASEM
report, a person who dies on the wait list has, on average, been
offered 16 organs. Unfortunately, transplant center acceptance rates
are low, and one fundamental way to advance equity is by increasing
acceptance rates for organs from older and more medically complex
donors.
OPOs are currently engaging in groundbreaking technologies, pushing the
boundaries of what is possible. For example, lung perfusion technology
can potentially rehabilitate and transplant up to two-thirds of lungs
that would otherwise be unusable.\4\ However, transplant programs are
directly responsible for the patients in their care, and they decide
whether to utilize organs that OPOs make available. In addition,
transplant programs are evaluated based on survival rates that
discourage them from taking on ``riskier'' patients or transplants.
---------------------------------------------------------------------------
\4\ UNOS Press: ``Companies at the Forefront of Organ Perfusion
Technology,'' https://unos.org/news/insights/game-changers-at-the-
forefront-of-organ-perfusion-technology/.
At the hearing, specific cases of kidneys were discussed where the
witness described declining an organ based on an assessment of its
condition upon arrival. However, it should be noted that not all of
these organs were discarded. In fact, one of the kidneys the witness
rejected was re-allocated and successfully transplanted into a patient
---------------------------------------------------------------------------
at another transplant program.
This example highlights the significant role that the variability in
clinical practice by transplant center plays in organ acceptance
practices. In fact, UNOS will now evaluate transplant centers by their
acceptance rates and make that information available to the public. The
acceptance rates are also affected not just by the donor's clinical
factors but also by when the donor organ was recovered. The NASEM
report cites research supporting the ``weekend effect'' as a reason for
non-utilization, stating:
There has been compelling research on the ``weekend effect''
for kidneys and livers. In SRTR data from 2000 to 2013, and
compared with weekday kidneys, organs procured on weekends are
significantly more likely not to be used . . . even after
adjusting for organ quality. Program structure and staffing,
particularly during weekends and in smaller programs, affects
kidney use and ultimately affects a patient's chances of
receiving a transplant. This is unacceptable for a lifesaving
surgical procedure such as transplantation.\5\
---------------------------------------------------------------------------
\5\ NASEM Report: ``Realizing the Promise of Equity in the Organ
Transplantation System'' (pages 6-24), https://
www.nationalacademies.org/our-work/a-fairer-and-more-equitable-cost-
effective-and-transparent-system-of-donor-organ-procurement-allocation-
and-distribution.
High and increasing non-utilization of available organs is a
significant problem involving all components of the donation and
transplantation system. Between 2018 and 2020, the number of donor
kidneys not transplanted increased by 34%,\6\ partly due to low
acceptance rates and high variability in acceptance practices across
transplant programs. AOPO supports implementing a robust system to
document the cause of every organ which is not utilized and the
implementation of strategies to increase organ acceptance and minimize
organ waste. For example, advancements in and the usage of screening
tools could reduce the number of patients offered an organ with a known
deferral, expediting the matching process and lowering the number of
discards.
---------------------------------------------------------------------------
\6\ AOPO Report: ``50,000 Annual Organ Transplants in 2026 Goal,''
based on OPTN data as of February 17, 2021, https://aopo.org/wp-
content/uploads/2022/03/AOPO50K-Campaign-Overview-03-29-2022.pdf.
---------------------------------------------------------------------------
System Efficiency and Performance
The United States has the most effective system in the world for
maximizing donation and transplantation. In the last 5 years, OPOs have
increased the number of deceased organ donors by 35% and increased the
number of recovered organs by 27%.\7\ Although we are proud of the
increase in the number of available organs for transplantation, there
is more work to be done. AOPO concurs that improvements are necessary
to advance care and equity for patients.
---------------------------------------------------------------------------
\7\ AOPO Infographic: ``U.S. Organ Donation and Transplantation
Highlights,'' based on OPTN data as of January 30, 2022, https://
aopo.org/wp-content/uploads/2022-US-Donation-Highlights-Infographic-
1.pdf.
AOPO does note that the Senate Finance Committee report references the
non-peer-reviewed Bridgespan report, which claims that more than 28,000
additional organs could be transplanted each year. AOPO submits that
this is not validated and is conditioned upon certain circumstances
which will not occur, including a 100% donation rate and 100%
utilization of donated organs. Some organs are simply not safe for
---------------------------------------------------------------------------
transplant.
The Senate Finance Committee report also attributes increased donation
and transplantation rates in recent years to increased suicides and
opioid-related deaths. The study cited to support this claim is based
on a dataset that includes all donors who had at any time in their life
used an illegal drug or were reported as a one-time drug user by a
family member. While the opioid epidemic impacted donation, it is far
from the only factor. Much more significant are advancements such as
donation after circulatory determination of death (DCDD), which has
increased an unprecedented 123% over the last five years, and organ
preservation technologies extending the time between organ recovery and
transplantation.
AOPO supports meaningful performance measurement that holds all system
stakeholders accountable for reaching our shared mission of saving as
many lives as possible. We are working with our member OPOs to meet the
new performance metrics established by the Center for Medicare and
Medicaid Services (CMS). In fact, several OPOs identified as having
issues within the Senate Finance report have become top performing OPOs
with a ``Tier 1'' status according to CMS's latest release of data.\8\
---------------------------------------------------------------------------
\8\ CMS Quality, Certification, and Oversight Reports (QCOR): ``OPO
Public Performance Report,'' https://view.officeapps.live.com/op/
view.aspx?src=https%3A%2F%2Fqcor.cms.gov%2Fdocu
ments%2F2021%2520OPO%2520Aggregate%2520Performance%2520Report.xlsx&wdOri
gin=
BROWSELINK.
The report states that 22 out of 57 OPOs would fail the new outcome
measures and be decertified. It is critical to understand that the new
methodology used in evaluating OPO performance is a comparative measure
defining the bar to ``pass'' as the top 25th percentile. Therefore, by
design, the metrics can result in OPOs assigned to ``Tier 2'' and
``Tier 3'' categories being subject to possible decertification or
competition, regardless of continued improved performance over the
certification cycle.
Organ Evaluation
The Senate Finance Committee report shares that 249 recipients
experienced disease transmission following an organ transplant or an
error in blood typing, and 70 recipients died due to failures in the
donation and transplantation system. Any death resulting from an error
is tragic, and the system must ensure that when errors occur, they are
reviewed and understood, and steps are taken to prevent them in the
future.
Despite systems in place to prevent mistakes and best practices in
place to identify the risk of transmission, the risk of disease
transmission following an organ transplant is extremely low but will
never be zero. The numbers reported by the Committee represent .03% of
the 231,180 organs transplanted over the indicated seven-year
period.\9\ The numbers show that nearly 99.9% of transplants resulted
in successful outcomes and did not result in illness or death due to
infected organs. The minimal risk must be understood in the context of
the extremely high risk of death from organ failure for patients not
being transplanted.
---------------------------------------------------------------------------
\9\ Based on OPTN data as of August 8, 2022, https://
optn.transplant.hrsa.gov/data/.
Overall, organ transplantation is safe and the best treatment for organ
failure. Patient safety is always of utmost importance to the OPO
professionals working every day to save lives. All medical procedures
have associated risks and complications, and OPOs work to prevent such
adverse outcomes. OPOs conduct multiple tests for every organ donor to
identify the potential for disease transmission and other safety
issues. Many of these tests are guided by transplant centers when
considering an organ for their patient to assess organ viability and
---------------------------------------------------------------------------
donor match suitability.
The Organ Procurement and Transplantation Network (OPTN)/United Network
of Organ Sharing (UNOS) requires a medical record review and donor risk
assessment interview with the potential donor's next of kin to obtain a
five-year history of illness and other social determinants of health.
OPTN/UNOS also requires physicians to perform a visual examination and,
if warranted, a biopsy of potential donor organs to identify risks. As
an extra step to rule out undiagnosed cancers and other diseases, OPOs
are actively working to routinely administer CT scans on patients that
pose a known possible risk.
As part of organ evaluation, OPOs and hospital partners are also
required to identify the potential donors' blood type to prevent organ
rejection in the recipient. Some potential donors have experienced
severe trauma requiring blood transfusions which can, in rare
instances, impact the blood typing results. Therefore, OPOs and
hospitals tasked with donor management and assessment must take extra
precautions if the blood type test is unclear or has shown varying
results. Following blood typing errors in recent years, new policies
were implemented to prevent such incidences.
Organ Transportation
With mere hours to transplant life-saving organs after recovery, proper
transportation is essential to the organ donation and transplantation
process. OPOs are tasked with determining the safest and quickest way
to transport donor organs. While even one organ lost or damaged in
transport is too many, the transit incidents covered in this report are
extremely rare,\10\ and something OPOs have actively implemented
mechanisms to avoid.
---------------------------------------------------------------------------
\10\ During the hearing, it was stated that OPOs are 15 times more
likely to lose, damage, or delay an organ in transport than a
commercial airline does with passenger luggage. This appears to be
based on a misunderstanding of a February 2020 Kaiser Health News
article that examined shipments handled by UNOS. As the article
correctly points out, UNOS only manages transportation for a small
fraction of annual transplants. Regardless of the validity of the
analysis concerning UNOS, our OPO members have not experienced adverse
transportation incidents of the magnitude claimed.
Post-9/11-rules prohibit OPO staff from taking organs through airport
security and directly to an awaiting aircraft, which created a barrier
to efficient commercial transport. In response, many individual OPOs
use private aircraft, when possible, to avoid delays from restrictive
commercial air travel schedules. OPOs also partner with charter,
courier, and delivery companies to expedite the ground transportation
of organs. Undoubtedly, additional tools from the OPTN to support
transportation and track organs in transit will facilitate overall
system efficiency and effectiveness. Federal Aviation Agency (FAA)
regulations standardizing how airlines handle organ shipments would
---------------------------------------------------------------------------
also improve efficiency and reduce travel-related delays.
It is noteworthy that in the interim, and as referenced during the
hearing, OPOs are collaborating with companies offering organ tracking
technology, which has helped improve transportation logistics and
efficiencies between the donor hospital and transplant center. OPOs are
also using TransNet, a barcode system, to automate the organ packaging
and labeling process, ensuring that organs are transported to the
correct recipient. When OPOs experience transportation issues, details
are promptly documented and reported to OPTN/UNOS.
In Conclusion
As the Committee is aware, the recent NASEM report includes several
detailed recommendations focused on establishing a more effective and
equitable system.\11\ The recommendations align with AOPO's goal to
achieve 50,000 annual organ transplants in 2026 by expanding
collaboration with stakeholders, reducing health inequities, increasing
organ utilization, and driving innovation and research. We welcome the
opportunity to meet with Committee members and staff to discuss the
report's recommendations and collaborate to identify changes to
policies, practices, and programs that will help ensure the nation's
organ procurement and transplantation system meets the needs of all
patients.
---------------------------------------------------------------------------
\11\ NASEM Report: ``Realizing the Promise of Equity in the Organ
Transplantation System,'' https://www.nationalacademies.org/our-work/a-
fairer-and-more-equitable-cost-effective-and-transparent-system-of-
donor-organ-procurement-allocation-and-distribution.
We stand ready to work with our fellow stakeholders, Congress, and the
Biden Administration to pursue the day when every donation opportunity
---------------------------------------------------------------------------
results in lives saved.
______
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, MD 20853
[email protected]
Statement of Michael Bindner
Chairman Wyden and Ranking Member Crapo, thank you for the opportunity
to address this issue.
At first blush, the consideration of this issue by the Committee is
puzzling until one draws the connection between Medicare and organ
transplants, including establishing universal healthcare and funding
it. Please see the following attachments, as well as the second part of
this submission, for discussion of these topics.
Other than its impact on Medicare and affordable care, we are leery of
any congressional involvement in this issue. Ideally, it is based on
science and best regulated by medical professionals. Even without
intervention, putting pressure on the system is ill-advised. With
political pressure often comes pressure from donors. The beauty of the
current process is that the ability to pay is not part of it. Of
course, if there are abuses on this front in the current system, they
should be looked into and dealt with by the Congress and this
Committee.
Even with the best of motives, adjusting the process (even if flawed)
does not resolve the issues facing organ transplantation. There are
simply not enough organ donors and the system, which relies on
voluntary donation for its legitimacy, would not be helped with
economic incentives--especially as these would be more attractive to
the poor. This borders on abuse. Not only do we exploit them in life,
incentives would continue this exploitation in death.
Ultimately, the solution is better science. This is where government
involvement can help and where issues of fiscal equity come in. Any
treatment must be provided to all, regardless of the ability to pay.
While the private sector may be helpful in developing treatments,
government funded research would help the process and assure equity.
A promising solution is the use of retargeted stem cells, either grown
on cartilage or injected into the sick organ. Both would render
donation and its possibility of rejection to the realm of temporary
solutions, as would artificial organs.
Research in this process can always be sped up with more government
money for NIH. To make sure everyone can benefit from advancements,
such as using 3D printing to create cartilage on which to grow stem
cells both outside and inside the body, research and actual organ
generation can be publicly funded. Public organ manufacture, because of
its expense in every case, is likely better than relying on for profit
medicine.
As we have stated before, most recently in March of this year, but also
in 2019 and 2020, orphan drug research and manufacture should be owned
and managed by the federal government. The same path can be taken for
the development of cloned organs. If the government owned the process,
profiteering would be minimized. To facilitate cooperation and speed
the process, creation of a quasi-governmental enterprise would be
useful. It would combine NIH, NSF, FDA. To repeat our previous comments
on drug pricing:
A main problem with high cost drugs, especially orphan drugs,
is the high development costs and the cost of small batch
manufacturing. This could drive the need to raise drug prices
for mature drugs in order to subsidize the orphans, although
some hikes are undertaken because no one can stop them. The
solution for this is for NIH and the FDA to own the rights to
orphan drugs and to contract out research and development costs
as it does basic research, as well as testing and production.
Hospitals and doctors would still make reasonable profit, but
the government would eat the risk and sometimes reap the
rewards. NIH/FDA might even break even in the long term,
especially if large volume drugs which were developed with
government grants must pay back a share of basic research costs
and the attached profits, as well as regulatory cost.
Another way to assure equity in the growth and distribution of cloned
organs, health care reform is essential. Again, to repeat our comments
from March:
Universal coverage, starting with a public option under the
Affordable Care Act, with eventual evolution to some type of
single-payer system is inevitable. Unless we start building
negotiation into the system now, we will give the drug
companies a reason to oppose reform later.
A public option will only pass if pre-existing condition
reforms are abolished with public option enrollment being
automatic upon rejection. The public option must be subsidized,
replacing Medicaid for the disabled and those not requiring
long-term nursing care. Long-term care should be removed from
states and replaced with a new federal Medicare Part E.
The profit motive, with the need to constantly increase profits
to attract Wall Street investment or keep stock prices growing,
will lead to an ever increasing number of people who will be
considered uninsurable, thus relying on the public option.
Most health-care systems will provide services to both
comprehensive insurance beneficiaries, the retired, the
disabled and those with the public option. In other words,
Medicare for All is our future, with the only exception being
firms abandoning the system and providing their own doctors
while making arrangements with local hospitals and
specialists--essentially creating local HMOs.
The major issue here is funding, although more efficiency will
reduce prices. Costs are already minimized by the for-profit
and by governmental medical care (which often uses for profit
networks). To repeat, with a shout THE ISSUE IS PRICE, NOT
COST!
Thank you again for the opportunity to add our comments to the debate.
Please contact us if we can be of any assistance or contribute direct
testimony.
Attachment--Hearing on Pathways to Universal Health Coverage, June 12,
2019
There are three methods to get to single-payer: a public option,
Medicare for All and single-payer with an option for cooperative
employers.
The first to set up a public option and end protections for pre-
existing conditions and mandates. The public option would then cover
all families who are rejected for either pre-existing conditions or the
inability to pay. In essence, this is an expansion of Medicaid to
everyone with a pre-existing condition. As such, it would be funded
through increased taxation, which will be addressed below. A variation
is the expansion of the Uniformed Public Health Service to treat such
individuals and their families.
The public option is inherently unstable over the long term. The profit
motive will ultimately make the exclusion pool grow until private
insurance would no longer be justified, leading again to Single Payer
if the race to cut customers leads to no one left in private insurance
who is actually sick. This eventually becomes Medicare for All, but
with easier passage and sudden adoption as private health plans are
either banned or become bankrupt.
The second option is Medicare for All, which I described in an
attachment to June 18th and 19th's comments and previously in hearings
held May 8, 2019 (Finance) and May 8, 2018 (Ways and Means). Medicare
for All is essentially Medicaid for All without the smell of welfare
and with providers reimbursed at Medicare levels, with the difference
funded by tax revenue.
Medicare for All is a really good slogan, at least to mobilize the
base. One would think it would attract the support of even the Tea
Partiers who held up signs saying, ``don't let the government touch my
Medicare!'' Alas, it has not. This has been a conversation on the left
and it has not gotten beyond shouting slogans either. We need to decide
what we want and whether it really is Medicare for All. If we want to
go to any doctor we wish, pay nothing and have no premiums, then that
is not Medicare.
There are essentially two Medicares, a high option and a low one. One
option has Part A at no cost (funded by the Hospital Insurance Payroll
Tax and part of Obamacare's high unearned income tax as well as the
general fund), Medicare Part B, with a 20% copay and a $135 per month
premium and Medicare Part D, which has both premiums and copays and is
run through private providers. Parts A and B also are contracted out to
insurance companies for case management. Much of this is now managed
care, as is Medicare Advantage (Part C).
Medicaid lingers in the background and the foreground. It covers the
disabled in their first two years (and probably while they are seeking
disability and unable to work). It covers non-workers and the working
poor (who are too poor for Obamacare) and it covers seniors and the
disabled who are confined to a long-term care facility and who have run
out their assets. It also has the long-term portion which should be
federalized, but for the poor, it takes the form of an HMO, but with no
premiums and zero copays.
Obamacare has premiums with income-based supports (one of those facts
the Republicans hate) and copays. It may have a high option, like the
Federal Employee Health Benefits Program (which also covers Congress)
on which it is modeled, a standard option that puts you into an HMO.
The HMO drug copays for Obamacare are higher than for Medicare Part C,
but the office visit prices are exactly the same.
What does it mean, then, to want Medicare for All? If it means we want
everyone who can afford it to get Medicare Advantage Coverage, we
already have that. It is Obamacare. The reality is that Senator Sanders
wants to reduce Medicare copays and premiums to Medicaid levels and
then slowly reduce eligibility levels until everyone is covered. Of
course, this will still likely give us HMO coverage for everyone except
the very rich, unless he adds a high-option PPO or reimbursable plan.
Either Medicare for All or a real single payer would require a very
large payroll tax (and would eliminate the HI tax) or an employer paid
subtraction value-added tax (so it would not appear on receipts nor
would it be zero rated at the border, since there would be no evading
it), which we discuss below, because the Health Care Reform debate is
ultimately a tax reform debate. Too much money is at stake for it to be
otherwise, although we may do just as well to call Obamacare Medicare
for All and leave it alone.
The third option is an exclusion for employers, especially employee-
owned and cooperative firms, who provide medical care directly to their
employees without third party insurance, with the employer making HMO-
like arrangements with local hospitals and medical practices for
inpatient and specialist care.
Employer-based taxes, such as a subtraction VAT or payroll tax, will
provide an incentive to avoid these taxes by providing such care.
Employers who fund catastrophic care or operate nursing care facilities
would get an even higher benefit, with the proviso that any care so
provided be superior to the care available through Medicaid or Medicare
for All. Making employers responsible for most costs and for all cost
savings allows them to use some market power to get lower rates.
This proposal is probably the most promising way to arrest health care
costs from their current upward spiral--as employers who would be
financially responsible for this care through taxes would have a real
incentive to limit spending in a way that individual taxpayers simply
do not have the means or incentive to exercise. The employee-ownership
must ultimately expand to most of the economy as an alternative to
capitalism, which is also unstable as income concentration becomes
obvious to all.
Attachment--Tax Reform, Center for Fiscal Equity, December 7, 2021
Subtraction Value-Added Tax (S-VAT). These are employer paid Net
Business Receipts Taxes. S-VAT is a vehicle for tax benefits, including
Health insurance or direct care, including veterans' health care
for non-
battlefield injuries and long-term care.
Employer paid educational costs in lieu of taxes are provided as
either
employee-directed contributions to the public or private unionized
school of their choice or direct tuition payments for employee children
or for workers (including ESL and remedial skills). Wages will be paid
to students to meet opportunity costs.
Most importantly, a refundable child tax credit at median income
levels (with inflation adjustments) distributed with pay.
Subsistence level benefits force the poor into servile labor. Wages and
benefits must be high enough to provide justice and human dignity. This
allows the ending of state administered subsidy programs and
discourages abortions, and as such enactment must be scored as a must
pass in voting rankings by pro-life organizations (and feminist
organizations as well). To assure child subsidies are distributed, S-
VAT will not be border adjustable.
The S-VAT is also used for personal accounts in Social Security,
provided that these accounts are insured through an insurance fund for
all such accounts, that accounts go toward employee-ownership rather
than for a subsidy for the investment industry. Both employers and
employees must consent to a shift to these accounts, which will occur
if corporate democracy in existing ESOPs is given a thorough test. So
far it has not. S-VAT funded retirement accounts will be equal-dollar
credited for every worker. They also have the advantage of drawing on
both payroll and profit, making it less regressive.
A multi-tier S-VAT could replace income surtaxes in the same range.
Some will use corporations to avoid these taxes, but that corporation
would then pay all invoice and subtraction VAT payments (which would
distribute tax benefits. Distributions from such corporations will be
considered salary, not dividends.
Tax Reform Summary
3. Employers distribute the child tax credit with wages as an offset
to their quarterly tax filing (ending annual filings).
4. Employers collect and pay lower tier income taxes, starting at
$100,000 at 7.2%, with an increase to 14.4% for all salary payments
over $150,000 going up 7.2% for every $50,000 up to $250,000.
5. Shift payment of HI, DI, SM (ACA) payroll taxes to employers,
remove caps on employer payroll taxes and credit them to workers on an
equal dollar basis.
6. Employer paid taxes could as easily be called a subtraction VAT,
abolishing corporate income taxes. These should not be zero rated at
the border.
7. Expand current state/federal intergovernmental subtraction VAT to a
full GST with limited exclusions (food would be taxed) and add a
federal portion, which would also be collected by the states. Make
these taxes zero rated at the border. Rate should be 19.5% and replace
employer OASI contributions. Credit workers on an equal dollar basis.
______
Guidehouse, Inc.
1676 International Drive, Suite 800
McLean, VA 22102
guidehouse.com
Guidehouse appreciates the opportunity to submit a statement for the
record to the Senate Finance Committee (the ``Committee'') on this
critical public health issue. Guidehouse is a leading global provider
of healthcare consulting services to the public sector, including the
U.S. federal government, 40 U.S. state governments, and commercial
markets providing broad capabilities in management, technology, and
risk consulting. As a result of the services we provide across the
entire health ecosystem, we are in a unique position to provide
perspective across the various policies, governance, stakeholders, and
technology influencing the OPTN. Our statement for the record includes
two sections. The first section details our view on challenges and
recommendations facing the OPTN with a focus on ``Rebuilding Trust
Through Policy and Governance Reform, Stakeholder Engagement, and
Communications to Improve Quality'' and ``IT Modernization: Digital
Twin Study and Impact with Performance Metrics.'' In the second section
we detail our background, experience and previous related engagements
to establish our qualifications in the tasks necessary to modernize the
OPTN. We applaud the bipartisan support and ongoing examination by this
Committee in its efforts to reform the OPTN to provide equity,
transparency, and quality of care to save lives in an efficient and
timely manner.
OPTN Challenges and Recommendations:
Health Resources and Services Administration's (HRSA) released two
Requests for Information, issued April 8, 2020, and April 8, 2022, but
later modified and re-
released on May 5, 2022, identifying required services to modernize and
maintain the OPTN. Recommendations from the NASEM 2022 Report
``Realizing the Promise of Equity in the Organ Donation Process,''
provided additional detail and prescriptive feedback for the OPTN.
Based on this awareness of OPTN programming, Guidehouse provides the
following lessons learned from implementing programs similar in scale
and complexity for OPTN reform and modernization:
OPTN Operational Transformation: Rebuilding Trust Through Policy and
Governance Reform, Stakeholder Engagement, and
Communications to Improve Quality
Modernizing the OPTN requires rebuilding stakeholder trust through
outcome focused policy and governance reform. We recommend HRSA and the
OPTN to access a similar network of multi-discipline thinking and
established partnerships for the OPTN to support national reform. We,
along with additional partners, manage coalitions of the nation's
existing medical research institutions and professional networks,
including representation from Historically Black Colleges and
Universities and other Minority Serving Institutions, can guide OPTN's
health equity policy agendas and priorities. Part of this effort may
include restructuring the OPTN Board, reassessing organ distribution
criteria, and integrating quality control and evidence-based best
practices with oversight management policies. The OPTN and government
programs can leverage this expertise across health and medicine, gain
access to unique and existing data resources, and realize valuable
opportunities to collaborate with communities, including those
underserved by current organ donation and transplant systems. Patient
and provider engagement strategies must consider early on how cultural
nuances influence communications outcomes, participation,
implementation, and evaluation methods. Our Guidehouse and partnership
programs engage racially and ethnically diverse stakeholders and keep
them involved throughout the process. This is critical for the future
of the OPTN network and helps to quickly identify and eliminate
cultural biases. It is also an approach that helps minimize or avoid
conflict of interest and rebuild trust with underserved communities.
Challenges: 20% discarded or unused; limited availability especially
with underserved and minority communities, rural areas and Midwest
states; status on the waiting list is a mystery.
Solutions: Increase targeted education with cultural appropriateness
and community champions; create transparency with data and access to
waiting list status; onboard patient advocates with hospital care
transplant teams; maintain a Patient Advocacy Coalition and network of
donors, recipients, and families; create additional opportunities to
register as a donor besides the DMV (driver's license) including
options with paired donations/living donors for kidneys through primary
care providers.
In our experience assisting executive leadership teams launch system-
wide, patient focused modernization initiatives in large health systems
we have collected several lessons learned that are relevant to the
OPTN. Accountability and transparency regarding tough decisions is
necessary for optimizing change, building skills and redesigning
processes that sustain success while focusing on measurable results and
outcomes to address issues in real time. For the OPTN, we can apply
these lessons learned from commercial industry best practices to align
a redesign process with performance incentive models that drive
accountability with the organ procurement organizations (OPOs). We also
recommend partnerships, as recommended by the NASEM report, with the
National Quality Forum and the National Academy of Public
Administration to integrate oversight and monitoring standards with
certified and contracted OPOs.
Increasing culturally appropriate and audience-segmented communication
and education about organ donation and transplants is critical. The
transplant process is less familiar and can be stressful to even the
most informed patients. Having a better understanding through all
phases of the process, especially from the patient journey perspective
or the living donor perspective may encourage more donor registrations
and accessibility to organs. Communication strategies need to be
patient-centric and relevant to cultures and communities, especially
with underserved communities and subpopulations. Using a ``human-
centered design'' approach will engage patients who have already been
through the process of donating or receiving an organ to inform new
patients and families what they need to know prior to their journey.
This approach can also highlight where challenges or bottlenecks in the
process typically occur and where additional support may be needed.
Stakeholder engagement is also imperative when reforming the nation's
OPTN. It is particularly important to maximize this engagement by
diversifying partnerships and enlisting nontraditional organizations
that can inspire community organizations among underserved populations
to help recruit new organ donors. We have experienced success enlisting
organizations to support clinical trial recruitment while building
future workforces. Our vision for OPTN is to fully immerse the
stakeholder voice into the OPTN Board through the formation and
management of a virtual ``roundtable'' with ongoing feedback for the
transplantation community through patient feedback and monitoring to
provide quality improvement, influence and increase organ procurement,
and represent diversity and inclusion across all OPOs.
IT Modernization: Digital Twin Study and Impact with Performance
Metrics
Modernization of complex data collection systems in the 21st century
requires the ability to model, represent, and evaluate inputs and
outcomes of interdependent systems while interacting with the system's
variables, dependencies, and connections. Led by Guidehouse's Chief
Innovation Officer, Dr. Rod Fontecilla, Guidehouse understands that a
real-time understanding of a complex network of people, places,
policies, processes, and data is the first and most critical step
towards achieving true data transparency and insight into the
performance and quality metrics of that network and its individual
components.
A unique concept Guidehouse proposes for HRSA and the OPTN is the
``digital twin'' virtual representation of physical entities such as
devices, people, processes, or systems that use computer simulation,
machine learning, reasoning, and real-time data to help organizations
make model-driven decisions related to detection, prevention,
prediction, and optimization.
Digital twins are more easily adaptable than their physical
counterparts, as organizations can modify digital assets and assess the
results without incurring the time or monetary costs needed to adjust
physical assets. Digital twin architectures use data from the assets
being modeled and from related systems, to provide a method of storing
and providing access to that data, and track and organize that data so
that it stays in sync with real-world data about the asset and other
digital twins. Industries use digital twins to track assets, such as
products, throughout their lifecycles. For example, a hospital might
use a digital twin based on its emergency room attributes to simulate
and evaluate their readiness (e.g., resources, infrastructure,
processes) under different scenarios (e.g., infectious disease pandemic
response, emergency due to civil unrest, or natural disasters etc.), to
explore changes and predict outcome (i.e., improved readiness) prior to
making changes.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The digital twin concept was first introduced in 2002 for use in
large manufacturing applications such as defense and aerospace
engineering. Today's digital twins are accessible to any enterprise due
to the scalable, cost-effective computing capabilities of the cloud.
The level of maturity has driven commercial toolkits with cloud
providers now offered at a price point that allows a broader set of use
cases to use digital twins for enterprise applications. A digital
twin's performance is driven by the effective use of cloud-based
technologies for compute and storage, as well as the ability to ensure
that the data is representative of live data in the field, so that data
scientists and SMEs can more rapidly derive algorithms that ensure the
simulations are operationally relevant.
Challenges: Conflict of Interest with the current OPTN Board and UNOS
participation; lack of Quality Improvement monitoring.
Solutions: OPTN Board to be comprised of elected and credentialed
members with backgrounds in medical research, bioinformatics,
epidemiology, patient safety, transplant expertise; no engagement from
the awarded contractor; equal representation from minority serving
institutions and geographic diverse OPOs; use of evidence-based
research and OPO performance metrics for decision-making; transparency
of all OPTN Board communications and decisions.
Guidehouse proposes creating a digital twin of the OPTN to unite
elements of the operational network environment (e.g., organ donor-
specific, organ recipient-specific, processes related to procurement/
logistics etc.) to inform HRSA performance metrics and impact of
potential policy or process changes without changing the physical
configuration of OPTN itself. Digital twins can incorporate relevant
data, such as logistics, supply chain, physical and human resources,
donor registration policy, recipient registration/wait-list practices,
data collection and sharing, and social determinants of health. We
propose a phased approach to simulate the behavior and future
performance, as well as deliver real-time synchronization for data
access, visualization, and dynamic decision making.
Background on Guidehouse
Guidehouse \1\ is comprised of public and commercial health executives,
strategists, actuaries, Ph.D.s, regulators, physicians, nurses,
technologists, programmers, and consultants with direct experience
modernizing IT systems and managing business operations for large scale
health systems, including several of the U.S.'s largest transplant
centers and the largest health system, Veteran's Affairs. We also
provide expertise with finance and payer/insurance models, business
process improvement, clinical transformation, and strategy for health
equity and governance infrastructure that integrates transparency and
performance metrics reporting. Examples of our related work to the OPTN
include:
---------------------------------------------------------------------------
\1\ https://guidehouse.com/capabilities/industries/healthcare.
Subject Matter Expertise: Edward Abraham, M.D., is a partner and
executive physician leading and transforming academic medical centers,
including healthcare delivery, finances, research, and educational
programs. Most recently, he served as Executive Vice President for
Health Affairs of the University of Miami and CEO of the University of
Miami Health System, an academic medical center with more than $2.5
billion/year in revenues, 1,300 physicians, and 10,000 employees. He
led the oversight of the Miami Transplant Institute, which has
performed more organ transplants than any other center in the country.
He served as Dean of two medical schools (University of Miami and Wake
Forest School of Medicine), leading strategic planning initiatives
including those around organ transplantation.
Public Sector Transplantation and Veterans: Guidehouse manages
the VA's Office of Integrated Veteran Care, a national program that
integrates healthcare services from the private sector for veterans for
acute and chronic diseases where transplantation may be an option.
Guidehouse supports VA in assisting with implementing the new Live
Donor benefit and the Chimeric Antigen Receptor (CAR) T-cell therapy,
coordinating with VA Medical Centers, VA Transplant Centers, community
specialists, and the OPTN.
Commercial Sector Transplantation and Business Process
Improvement: St. Louis University Hospital engaged Guidehouse to
evaluate and prepare responses to transplant contracts associated with
payers. We developed a price transparency tool based on the provider
files to create a comparative database of reimbursement by payer, plan,
facility, geography, and service code. By integrating social
determinants of health indicators, market share information, and
hospital statistics, we detected trends in reimbursement for
transplants.
Medicare Claims with End-Stage Renal Disease (ESRD): We support
contract work with the Centers for Medicare and Medicaid Innovation
Center Business Services Group to identify, test, and evaluate new ways
to improve care for Medicare beneficiaries with the Comprehensive ESRD
Care model. This includes managing participant compliance and
assessment of data collection and analysis of payment and service
delivery.
IT Infrastructure Modernization and Support: Guidehouse provides
a full suite of enterprise IT services for a large, national defense
contract including project management; application administration;
application operations and maintenance support; cloud services planning
and implementation; infrastructure management; ITSM implementation; and
security operations, with 99.99+% availability. With 150+ full-time
employees, including engineering, operations, and support personnel,
the team securely designs, develops, and deploys all technical services
for over 60 applications used by 150,000+ international users via
5,000+ hardware devices and serviced by 2000+ servers. Key
modernization efforts have included server technology refresh, network
upgrades, security compliant private cloud implementation, and
converting the existing operating environment from traditional server-
based infrastructure to a virtualized server environment with real-time
back-ups and redundancy. These efforts, and other supported program
initiatives, have led to multi-million-dollar savings on an annual
basis.
Modernizing IT for a Federal Health Research Agency: This agency
required collations, analysis, and storage of large-scale datasets
while using a wide range of digital tools for complex research
processes. Guidehouse assessed the existing operating model and
collaborated with the federal IT staff to develop a strategic roadmap
to support the adoption of cloud technology, proactively mitigated
risks, and defined critical processes to optimize IT operations and
provide higher quality IT services for the agency. Our team also
provided a change management strategy and training to support the
maintenance of the new solutions.
Conclusion
We believe HRSA can reform and modernize the OPTN through a combined
clinical and operational program transformation. This effort should
focus on two major areas. First, rebuilding trust in the OPTN system by
implementing a human centered approach to modernizing policy,
governance, stakeholder engagement, and communications; and, second,
accelerating technology implementations by using digital twins and
performance metrics. Modernizing OPTN is essential for enhancing
quality, optimizing distribution channels, and ensuring access for all
patients involved with the OPTN. Thank you again for this opportunity
to submit a statement for the record to the Committee on this critical
public health issue.
For any further discussion or to answer any questions, please contact
Steve Reynolds, Partner, Guidehouse Health, at (703) 258-2083 or
[email protected].
______
Letter Submitted by Suzanne Hughes
My kidney transplant date: June 15, 2022.
Summary: Received organ with inactive TB and active syphilis discovered
post-transplant
I had been on the kidney transplant list since August 2020, and I
received the call at 10:30 p.m. on June 14, 2022 that a kidney had
become available, and I would need to take a flight the next morning
for the transplant if I accepted this kidney. Per the call with the
transplant nurse Cathy who is out of VA Portland (I am a U.S. Army vet,
served 7 years in regular army and 2 years in reserves), the kidney was
rated a 45 on the KDPI scale, which is a fairly good score. I was
notified that the donor was positive for Hep C, but I knew the VA
Portland had a good record of preventing transmission of Hep C post-
transplant, and that I would be monitored. Since there were no other
issues with the kidney and I am a difficult person to match with (I was
told my body would reject 99 out of 100 kidneys), I accepted, and
received the transplant on June 15, 2022 out of the Portland VA
Hospital.
About 2 days post-transplant, I was visited by an infectious disease
doctor, who told me that although most tests are completed prior to
transplant, not all tests are back in time for the surgery. I was then
told that in addition to Hep C, the transplanted kidney also was
positive for TB, meaning the patient at one time had TB but it was not
active TB at the time of the owner's passing. But in addition, the
kidney also had active syphilis. My dismay and shock of learning about
this was immense, even though every doctor assured me that it really
wasn't a big deal, take the meds and move on. Obviously, I have not yet
moved on.
Part of my career involves project management and research, and I
approached my transplant the same way. I researched and read a lot of
info prior to my transplant, and I had learned that nationwide the
chance of me receiving an organ with an STD was 0.05%. So after
receiving an organ with Hep C (known) and then also learning it had TB
and syphilis, I was disillusioned with the organ transplant process. I
still feel like I am waiting for another shoe to drop, even though the
doctors assure me that all is well, and I should be grateful. One
question a doctor did ask me is if I would have accepted the organ had
I known about all of the issues with the organ, and I said I would not.
I wish I had been provided a choice with all facts up front.
Currently I am being monitored and treated with meds to prevent Hep C,
monitored for TB, and I have been tested and remain negative for
syphilis. The treatment I received for syphilis is 3 LARGE intra-
muscular injections in the rear end, and the shots are spread over 3
weeks. I cannot express how painful these shots are, and they result in
a welt the size of a dollar coin that lasts 7 to 10 days. Now imagine
you have a 12 inch incision on your belly from the transplant, and
welts on both sides of your rear end, which means sleep was close to
impossible due to the inability to find a comfortable position and
pain.
I write to you in the hope that this does not happen to anyone else in
the future. I was shocked to read some of the details on your
investigation, and I think complications are either not being reported
or are able to be cloaked under the privacy of organ donation. I
certainly don't recall in my research seeing some of the stories that
you uncovered. In addition to the above, I also had two other
complications although not related to the donated kidney. One was leg
numbness resulting in needing a walker to walk for one month, and I
also developed bilateral DVTs most likely due to my limited mobility.
Although this is not related to UNOS, I am hoping the hospital does
list this as a complications so patients in the future have this info.
I thank you for allowing me to add my experience with the committee,
and I hope for higher standards and oversight.
Best Regards,
Suzanne Hughes
______
Hypertrophic Cardiomyopathy Association
66 Ford Rd., Suite 213B
Denville, NJ 07834
P: 973-983-7429
F: 973-983-7870
https://4hcm.org/
August 16, 2022
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Dear Chairman Wyden, Ranking Member Crapo, and Members of the
Committee,
The Hypertrophic Cardiomyopathy Association (HCMA) respectfully submits
this Statement for the Record in response to the Senate Finance
Committee hearing on Wednesday, August 3, 2022, ``A System in Need of
Repair: Addressing Organizational Failures of the U.S.'s Organ
Procurement and Transplantation Network.'' We commend the Committee for
escalating the importance of the nation's organ donor and transplant
system and its desire to improve upon the existing system to maximize
the rate of organ donation in the country and maximize the rate of
successful procurement and transplant of vital human organs.
HCMA was established in 1996 to serve the hypertrophic cardiomyopathy
(HCM) spectrum disorder community. HCM is a genetic heart muscle
disorder affecting one in 200 worldwide and presents with highly
variable symptoms such as shortness of breath, chronic fatigue, life-
threatening dysrhythmias, and the mental health challenges of living
with a chronic illness. Approximately 5% require heart transplant. In a
study published in 2010 in the United Network for Organ Sharing (UNOS)
database, 1% of all heart transplants were given to HCM patients1.
Today that number has grown to nearly 5% of all heart transplants,
thanks partly to better disease management and timely listing for
transplants. The age of transplant ranges from infants to those in
their 70s. Kidney, lung, or liver transplants may also be necessary for
these individuals.
On a personal note, I received a heart transplant at the age of 47 on
February 2, 2017 due to complications associated with HCM and my
sister, also afflicted with HCM, died of sudden cardiac death in 1995
and was a kidney and liver donor.
The current subject of this committee's investigation is of paramount
importance to the HCM community and all stakeholders. In January 2016,
I participated in a meeting held by UNOS on changes to the organ
procurement process for donors and listing status for patients awaiting
transplants. During this meeting, I inquired about UNOS' experience
with what appeared to be inconsistencies among UNOS regions in the
listing of an HCM patient in need of a heart transplant. HCMA provided
guidance for listing HCM patients for heart transplant that were
incorporated in 2018 to minimize inconsistencies in listing HCM
patients for heart transplant.
HCMA wishes to alert the committee of a grave consequence of the lack
of screening for HCM among potential heart donors. We know of at least
two occasions when heart transplant recipients received hearts with
hypertrophic cardiomyopathy. I am aware of another case in which a
woman died from what was classified as tonsillitis complications.
Later, her sister was found to have a diagnosis of hypertrophic
cardiomyopathy. Upon communication with the OPO, it was confirmed that
the individual had anatomy consistent with hypertrophic cardiomyopathy
at her death. Yet, her heart valves were donated, and her family was
never informed of the underlying disease process.
As a transplant recipient, a donor family, and an advocate on behalf of
a community whose very lives rely on the safe, timely, and appropriate
use of transplant medicine, I call on the committee to take appropriate
action to ensure the highest standards are met when lives are on the
line.
HCMA recommends the Organ Procurement and Transplantation Network
(OPTN) be competitively awarded and the contractor be required to have
in place an adverse reporting system that will capture these potential
problems and others arising from the unknown consequences of donation.
These reports must be transparent and timely.
HCMA recommends that governance of the OPTN, through government
oversight and contractor performance, be conducted with utmost
transparency and representation from all stakeholders in the organ
donation and transplantation field. This includes donor families and
recipients, both actual and those waiting. Government oversight of
these actions is critical to the success of a robust, safe, fair, and
sustainable system. Technology and systems used in the organ
procurement process must be consistent, efficient, and not overly
redundant.
Finally, HCMA encourages the committee to consider legislation that
would adopt ``opt-out'' organ donor policies in the National Organ
Transplant Act as in place in European nations.
Thank you for your time and attention and please contact me at
[email protected] should you have additional questions or I can be of
assistance.
Sincerely,
Lisa Salberg
CEO and Founder
______
Ischemic Injured Organs and Limbs Foundation
2000 Kraft Drive, Suite 1208
Blacksburg, VA 24060
August 3, 2022
Hon. Ronald Wyden
Chairman
Hon. Michael Crapo
Ranking Member
U.S. Senate
Committee on Finance
Ladies and Gentlemen,
I requested to appear before the Senate Finance Committee to present a
different perspective of what needs to be done to eliminate the organ
shortage and the security that is demanded to protect the personal
identities of the organ donors, the donor families, and the transplant
recipients. However, I became aware of this meeting on Monday, August
1, 2022. I will agree with this committee that UNOS has not been clear
and open about the security of the current computerized system. UNOS,
along with the OPOs, has also been very arrogant to the general public
with an attitude that we know more than the general public about
improving the organ donation rates in the United States. However, CMS
is just as guilty when they have been contacted multiple times with
ideas addressing how to increasing the number of viable organs for
transplant. CMS's return comment to me was we control this monopoly and
will not allow alternative OPOs to recover organs that go to the grave
with trauma victims. HHS, along with the Division of Transplantation,
are also just as guilty for refusing to listen to proposals that would
exceed the new requirements for an OPO to be recertified. The Senate
and the House of Representatives are also accountable because they
control the budgets of these federal agencies. Jim Casey, the founder
of UPS, stated, ``you expect what you inspect.'' Have either the Senate
or the House committees responsible for overseeing UNOS and the OPOs
inspected what they have done since the Transplant Act of 1984 was
approved? Since July 2020, I have been contacting the staff members of
Senators Cardin, Van Hollen, Warner, Kaine, and Peters; as well as the
House of Representatives' Raskin, Kildee, and Griffith. Their staff
members have been kind and polite looking at our research numbers and
were supposed to pass on the data to our elected officials but not one
elected official has requested an appointment to see my data. Only
Congressman Griffith has shown interest in our research data, and has
met with my colleagues and myself at our Blacksburg, Virginia lab and
his office twice in DC.
While attending the Ohio State University, majoring in perfusion, I was
a work-study student in the dialysis and transplant programs performing
preventative maintenance on the equipment. When I graduated in 1983, I
worked full-time for the transplant program in the transplant research
lab and the University based OPO. As I became more experienced in
transplants, I learned to preserve kidneys on perfusion equipment,
obtained organ consent, and assisted in organ recoveries. When there
were no donor activities, I honed my skills in the transplant research
lab; working on various projects from self-sealing dialysis grafts,
xenotransplants, liver preservation systems, kidney preservation
systems, and algorithms predicting kidney viability. 1993 moving to
Washington DC to develop a Non-Heart-Beating trauma donor program, and
in 1996 presented our data that led to a Federal law to preserve organs
inside the cardiac dead trauma victim while the next-of-kin was located
and gave permission for organ donation. 2000 established the Baltimore
regional organ preservation lab for Johns Hopkins and the University of
Maryland transplant programs and developed a new kidney preservation
system. 2005 I went to the Army-Navy Transplant program to establish a
limb preservation system for amputated arms and legs. To test the limb
preservation hypothesis, I received Congressionally Directed grant
W81XWH1120212, ``Development of Room Temperature Human Organ & Tissue
Preservation Technology.'' This grant set up the Army-Navy Transplant
research lab in Bangkok, Thailand. 2016 I started collaborating with
Dr. John Robertson to develop a more efficient cardio-emulating organ
preservation systems for hearts, lungs, livers, kidneys, pancreas,
small bowel, and amputated arms and legs. The system produces a cardiac
QRS complex and the pressure Dicrotic notch waveforms. Raman
Spectroscopy to monitor the preservation solution's chemistries,
Infrared Imaging to provide a clear picture of the organ's vascular
structure, and a filtration system that removes bacteria preventing
infections, and reduces the need for antibiotics. In May 2022, the
final prototype of the Robertson Cardio-
Emulating heart, kidney, pancreas, small bowel, arm and leg systems are
ready for the final system build-out. The room temperature preservation
has been redeveloped to address the long ischemia time without oxygen,
reduce the organ's metabolism, scavenger the cytokines and chemokines
that are released due to the lack of oxygen, and vasodilate the
vascular structure of the organs and preserve the organs for at least
24 hours.
In May 2021, the Ischemic Injured Organ and Limb (IIOL) Foundation was
invited to participate in the first long-range FAA-authorized drone
organ transportation project. We used a large kidney preservation
system with 3D printed kidneys at the Ohio State Medical Center. Using
a small Drone, we transported a box that contained blood and tissues
specimens for cross-matching the organ donor and the transplant
recipient from the OSU Medical Center to OSU airport. I drove the
kidneys from the hospital to Don Scott airfield, where the kidney
preservation system and the tissue typing material had arrived. They
both were placed onto a remote-controlled helicopter to transport 30
miles northwest to a satellite hospital in Marysville, Ohio. Once at
the Marysville airport, the kidneys and the tissue typing material were
transferred to the Ohio State self-driving van for the 2 miles trip to
the hospital. While drones were transporting the organs and tissue
typing material, we were tracking them on our phone app, keeping track
of the perfusion parameters and the location of the drones o an
encrypted secure computerized program.
Background:
Dr. Robertson and I were part of a collaborative team UNOS put together
to submit a research project to the Chan Zuckerberg Initiative, which
was not funded. However, we have been working with UNOS and the other
collaborative universities to fund a more advanced transplant project.
That will increase the number of transplants in the United States and
address the past discriminatory practices of minorities and
socioeconomically deprived individuals who are not eligible for the
current transplant waiting list. Organs are in short supply, and the
need for organ transplants will only increase over the next few years,
primarily due to projected increases in the number of individuals with
organ failure and chronic disease. Today more than 100,000 individuals
are waiting for an organ transplant. Still, the number of patients on
the National Organ Transplant Wait List does not encompass the entirety
of organ failure prevalence across the United States. Approximately
800,000 Americans have an end-stage renal disease (ESRD), 6.2 million
have heart failure, 5.5 million have end-stage liver disease (ESLD),
and 16.4 million have Chronic Obstructive Pulmonary Disease (COPD). CDC
estimates that over 3.1 million Americans are ineligible to be placed
on the National Organ Transplant Waiting list. It is projected by 2030,
over five million people in the US will require renal replacement
therapy. We envision a future where there is no waiting list, and there
is a lifesaving transplant for everyone in need. What science and
technologies can be leveraged to address this anticipated surge in
demand for kidneys and other transplantable organs? The organ
transplant ecosystem must integrate living, brain dead, and cardiac
dead human donors with the emergence of xenotransplantation and new
technologies to manufacture organs and repair tissues in donated
organs.
A more significant emphasis must be placed on the recovery,
resuscitation, and validation of cardiac dead human organ donors. There
are five different cardiac dead classifications: dead on arrival, those
who succumb shortly after arrival at the hospital, those who are not
brain dead but have no chance of survival and the family removes them
from life support, brain dead patients who progress to cardiac death,
and the patient that has either a cardiac arrest or respiratory arrest
in a hospital with unsuccessful resuscitation attempt and pronounced
cardiac dead. Since 2012 the Healthcare Cost and Utilization Project
reported 661,000 annual hospital cardiac deaths. The American College
of Surgeons trauma data has shown since 2010, and there have been an
average of 200,000 cardiac deaths annually in the United States. The
U.S. House of Representatives in the health and welfare subcommittee
reported (February 2022), that since the beginning of the COVID
pandemic, an average of 100,000 yearly opioid cardiac deaths along with
an untold increased number of suicides.
The DMV Region consists of the states of Maryland, Virginia, and the
District of Columbia. There are eleven adult and five pediatric Level I
Trauma Centers, eleven adult Level II Trauma Centers, and nine adult
Level III Trauma Centers in the DMV region. Because of the need to
properly train staff at each Rapid Organ Recovery (ROR) unit, it was
determined to establish ROR units at the six most active trauma centers
in the DMV region. As more personnel are trained, ROR units will be
expanded to the remaining trauma centers in the study region. Personnel
may be assigned to two or more trauma centers in the rural areas of the
DMV region.
ROR unit consists of Family Advocates (FA), Physician Assistants (PA),
and Organ Recovery Technicians (ORT). FAs will be responsible for
locating the next of kin, preserving forensic evidence, and obtaining
organ donation consent. PAs will place the cannulas in the trauma
victims and resuscitate the organs while waiting for authorization from
the next of kin, assist with recovering the organs, and oversee the
medical practices under the medical director's supervision. ORTs will
operate the Rapid Organ Resuscitation system, correct and initiate
resuscitation of abdominal and thoracic organs during consent, preserve
the organs during recovery, and place the organs on individual organ
resuscitation systems.
Training of the various ROR staff functions will consist of didactic
and hands-on training. FAs will receive a minimum of six to eight weeks
of training in forensic evidence identification, handling forensic
evidence, identifying and locating the next of kin, obtaining organ
donation consent, and identifying cardiac and brain dead organ donors.
PAs will receive about four weeks of training in identifying and
cannulating femoral arteries and veins in cadavers. PAs will also
receive training in the chemical composition of the organ resuscitation
solution and how to operate the various organ resuscitation systems,
along with assisting in the recovery of the donated organs. ORTs will
receive the most in-depth training for two to three years, receiving a
Bachelor of Science degree before being eligible for certification.
ORTs will learn transplant history, abdominal and thoracic organs
anatomy and physiology, donor chemistry, monitoring the organs on the
different organ resuscitation systems, transporting organs, Homeland
Security and Transportation Security Administration rules and
regulations for transporting organs on commercial airlines, and
microbiology. We intend to initially train as many ORTs and get them
hands-on experience in the animal lab as the Cardio-Emulating equipment
is being prepared for FDA animal and human clinical trials.
Pilot Study Preliminary Data:
The following tables show the potential number of cardiac dead deaths
in the DMV Region. Table 1 shows the potential number of brain dead
organ donors and the potential number of cardiac deceased organ donors.
Table 1 shows the number of deaths reported by each hospital to the
state's vital statistics department. Data from the Healthcare Cost and
Utilization Project states that brain deaths were approximately 2% of
the total cardiac deaths recorded annually in the United States.
Table 1 Mean Death Rates DMV Region Past 5 Years
------------------------------------------------------------------------
Hospital City State Brain Dead Cardiac Dead
------------------------------------------------------------------------
Level I
------------------------------------------------------------------------
Shock Trauma UMMS Baltimore MD 30 1,200
------------------------------------------------------------------------
Johns Hopkins Adult/ Baltimore MD 15 500
Pediatric
------------------------------------------------------------------------
Washington Hospital Washington DC 15 575
Center/Children's
------------------------------------------------------------------------
George Washington Washington DC 15 525
------------------------------------------------------------------------
Howard University Washington DC 10 375
Hospital
------------------------------------------------------------------------
Chipenham Richmond VA 12 400
------------------------------------------------------------------------
INOVA Fairfax Fairfax VA 20 600
------------------------------------------------------------------------
Children's Hospital Norfolk VA 8 100
Kings Daughter
------------------------------------------------------------------------
Sentara Norfolk Norfolk VA 15 525
------------------------------------------------------------------------
Carillion Roanoke Roanoke VA 10 375
Adult/Pediatric
------------------------------------------------------------------------
VCU MC Adult/ Richmond VA 17 550
Pediatric
------------------------------------------------------------------------
UVA MC Charlottesv VA 16 400
ille
------------------------------------------------------------------------
Level I Total 183 6,125
------------------------------------------------------------------------
Level II
------------------------------------------------------------------------
Hopkins Bayview Baltimore MD 12 400
------------------------------------------------------------------------
UMMS Capital Regional Largo MD 20 500
------------------------------------------------------------------------
Sinai Hospital Baltimore MD 9 200
------------------------------------------------------------------------
Hopkins Suburban Bethesda MD 10 275
Hospital
------------------------------------------------------------------------
Henrico Doctors Richmond VA 8 175
------------------------------------------------------------------------
Lynchburg General Lynchburg VA 6 100
------------------------------------------------------------------------
Mary Washington Fredericksb VA 6 125
urg
------------------------------------------------------------------------
Reston Hospital Reston VA 4 225
Center
------------------------------------------------------------------------
Riverside Medical Newport VA 5 175
Center News
------------------------------------------------------------------------
Virginia Hospital Arlington VA 7 225
Center
------------------------------------------------------------------------
Winchester Medical Winchester VA 4 100
Center
------------------------------------------------------------------------
Level II Total 91 2,500
------------------------------------------------------------------------
Level III
------------------------------------------------------------------------
Merritus Medical Hagerstown MD 4 125
Center
------------------------------------------------------------------------
UPMC Western Maryland Cumberland MD 4 100
------------------------------------------------------------------------
Tidal Health Salisbury MD 7 150
Peninsula Hospital
------------------------------------------------------------------------
New River Valley Christiansb VA 6 125
Medical Center urg
------------------------------------------------------------------------
Lewis Gale-Montgomery Blacksburg VA 4 100
Hospital
------------------------------------------------------------------------
Loudoun Hospital Leesburg VA 4 125
------------------------------------------------------------------------
Southside Regional Petersburg VA 3 75
Medical Center
------------------------------------------------------------------------
Virginia Beach Virginia VA 3 75
General Beach
------------------------------------------------------------------------
Sentara Northern Woodbridge VA 3 80
Virginia MC
------------------------------------------------------------------------
Level III Total 38 955
------------------------------------------------------------------------
Grand Total 9,580
------------------------------------------------------------------------
Table 2 compares the Standard Acquisition Fee for the Brain Dead OPO
versus the projected Cardiac Dead Standard Acquisition Cost. The
Standard Acquisition Fee consists of evaluating the potential organ
donor, recovering the organs, preserving the organs, transporting the
organs to the transplanting hospital, personnel, office rent and
utilities, various insurances, and other ancillary office costs. The
Brain Dead OPO Standard Acquisition was taken from the ``Milliman
Research Report 2020 U.S. Organ and Tissue Transplants: Cost Estimates,
Discussion, and Emerging Issues.'' The Cardiac Dead Standard
Acquisition Fees are from the projected cost of the preservation
systems, preservation solution, transportation, hospital recovery,
personnel, office rent and utilities, various insurances, and other
ancillary office costs.
Table 2 Comparison of the Standard Acquisition Cost for BD OPO Versus CD OPO
----------------------------------------------------------------------------------------------------------------
Difference (BD
Organ BD SAC CD Pilot SAC Savings)
----------------------------------------------------------------------------------------------------------------
Heart $131,500.00 $59,500.00 $72,000.00
----------------------------------------------------------------------------------------------------------------
Single Lung $110,100.00 $65,000.00 $45,100.00
----------------------------------------------------------------------------------------------------------------
Double Lung $127,700.00 $68,000.00 $59,700.00
----------------------------------------------------------------------------------------------------------------
Liver $104,200.00 $65,000.00 $39,200.00
----------------------------------------------------------------------------------------------------------------
Kidney $113,900.00 $58,500.00 $55,400.00
----------------------------------------------------------------------------------------------------------------
Pancreas $113,900.00 $61,000.00 $50,800.00
----------------------------------------------------------------------------------------------------------------
Total $699,200.00 $377,000.00 $322,200.00
----------------------------------------------------------------------------------------------------------------
Collaborative Team Approach:
A solution to the organ shortage is at hand, but only if we work
together. This collaborative, diverse team of regional university
partners will work for the creation of a Bio Hub focused on enhancing
and expanding the existing organ transplant ecosystem. This endeavor
will bring together powerhouses across the transplant community with a
regional focus centered within the region. The collaborative team
consists of the United Network for Organ Sharing (UNOS), Virginia Tech,
University of Virginia, Virginia Commonwealth University, Old Dominion
University, and Wake Forest University. This collaborative group
presents unique scientific and scholarly strengths across every facet
of organ and composite tissue transplants.
UNOS: is a private, non-profit organization that serves as the United
States organ transplant system (Organ Procurement and Transplantation
Network [OPTN]). UNOS collaborates internationally with transplant
organizations in Canada, the United Kingdom, Europe, France, and
Australia.
Virginia Tech (VT): brings decades of experience designing and
fabricating organ preservation systems for abdominal, thoracic, and
amputated limbs. VT's focus has been on resuscitation of ischemic
injured organs and limbs utilizing predictive analytics, sensing
technologies, and algorithms to predict organ viability. VT's expertise
in multimodal machine learning, medical imaging, data quality,
visualization, and data fusion, augmented reality and geospatial
systems make them a strong partner in the group's efforts to enhance
and expand the existing organ transplant ecosystem, especially in
cardiac dead organ donors, with a seamless transition to new
technologies maximizing equitable patient access and outcomes. The VT
team combines the expertise of organ preservation and transplantation
engineers with specialists in multimodal predictive data analytics,
augmented and virtual reality-based visualization systems, and
transplantation ``hardware'' prototyping.
University of Virginia (UVA): is one of the oldest transplant programs
in the United States, focusing on transplantation research, ischemic-
reperfusion injury, engineering, and applied science, translational
medicine, social and decisional analytics, system science and advanced
computing, mathematical and biocomplexity, visual and decision
informatics, and engineering in medicine. UVA's transplant research lab
offers cutting technology and innovative methods to explore novel
opportunities to eliminate end-stage organ diseases, optimize donor
organ health, and dramatically improve transplant patients' outcomes.
Virginia Commonwealth University (VCU): Is one of the country's most
extensive liver and kidney transplant programs, with expertise in
reducing minorities and socioeconomic disparity, and unique protocols
to utilize Hepatitis C, HIV, and COVID donor organs in successful
transplants. VCU's transplant laboratory uses molecular biology and
cell culture models in standard and extended criteria donors and
cardiac dead donors for therapeutic interventions.
The Virginia Modeling, Analysis, and Simulation Center (VMASC) is an
enterprise center of Old Dominion University (ODU): the advanced
analytics, geospatial analytics, machine learning, and artificial
intelligence methods analyze data collections from the community and
stakeholder-led efforts, environmental assessments, and curating of
social, environmental and medical information to determine various
outcomes from the collected and analyzed data.
Wake Forest Institute of Regenerative Medicine (WFIRM): is pioneering
regenerative medicine technologies to improve human health. These
technologies aim to enhance the human body's intrinsic regenerative
ability to repair after damage, rendering marginal organs
transplantable and enabling the manufacturing of body parts that will
replace functionally impaired organs and tissues. WFIRM scientists are
currently working to create organs and tissues, developing therapeutic
cell treatments for over 30 areas of the body. WFIRM is the
coordinating site for the Armed Forces Institute of Regenerative
Medicine II, with 35 participating institutions throughout the United
States. WFIRM recently received a significant award from the Defense
Threat Reduction Agency for their ``Body on a Chip'' project to develop
a miniaturized system for human organs that mimics the body's responses
to harmful agents and develop potential therapies.
Air Space Link: Northern Virginia company building small drones and
contracts with the FAA for routing drone flights in the United States.
Has developed small drone technology to transport blood and specimens
for transplant histocompatibility and serology testing. Air Space
Link's expertise will allow for developing and implementing drone
transport of organs and tissues and obtaining FAA certification.
MOOG Aerospace, a Division of MOOG Incorporated: is located on the
Virginia Tech campus. Large drones up to helicopter-size remote-
controlled aircraft to transport the deceased body to an organ recovery
center or transport multiple organs from a donor hospital to a regional
organ preservation lab.
Revivicor: is a biotechnology company that has developed a unique line
of pigs that are compatible with humans to increase the supply of
organs for human transplants Revivicor provided the pig heart for the
first Xenograft, pig to human, transplant in January 2022. Revivicor
brings expertise in developing xeno-transplantable organs for humans
that cannot be matched with a deceased organ donor.
Space Link: is a secure communication network located in Northern
Virginia utilizing Medium Earth Orbit (MEO) satellites. Collaborating
with Space Link will allow for more rapid communication between
regional organ preservation labs, UNOS, the organ center, organ
recovery teams, and the transplanting teams. This system will ensure
that personal data will be transmitted with clear and concise
information about the recovered organs to the transplanting team. Space
Link solves the security problem, and the data is encrypted, so there
will be no Personal Information, Privacy Issues, or HIPPA violations
when sharing data between multiple locations, thus allowing for more
placement and delivery of organs around the United States.
From Bench to Bedside:
In the first two years of funding, this collaborative research between
the university programs will develop algorithms to evaluate the organs
before transplantation. Share secure computerized organ perfusion data
so multiple transplant centers can simultaneously evaluate organs.
Expeditiously distribute the organs to the appropriate transplant
recipient. Collect and analyze pre and post-transplant data and predict
the survival length of the transplanted organs. In order to implement
the findings, a central location, either the VT campus in Crystal City
or Falls Church, is the most central location for the trauma centers
and the transplanting hospitals involved in the DMV pilot study. The
Cardiac Dead Pilot program in the DMV Region will use the 1996 Federal
to recover and resuscitate organs from all Maastricht cardiac dead
classification. If the hypothesis proves true at the end of the DMV
cardiac dead pilot program, we will expand the cardiac dead trauma
victims program nationwide. By having a nationwide Cardiac Dead OPO
complementing the Brain Dead OPOs, we anticipate in five years a
minimum of 50,000 Cardiac Dead organ donors and 12,000 to 15,000 yearly
Brain Dead organ donors, providing a potential of 300,000 to 400,000
yearly organ transplants. As the programs become more acceptable, we
believe there will be over 200,000 Cardiac Dead organ donors and close
to 35,000 to 40,000 Brain Dead organ donors annually. Thus, allowing
Revivicor to continue its research and obtain FDA clearance to
transplant xenoallographs into individuals who cannot receive a human
organ transplant because of rare antibodies that do not match an organ
donor.
Table 3 Potential of Cardiac Dead Organ Donors Pin the DMV Pilots Study
------------------------------------------------------------------------
Hospital Yr. 1 Yr. 2 Yr. 3 Yr. 4 Yr. 5
------------------------------------------------------------------------
Level I
------------------------------------------------------------------------
Shock Trauma 120 180 180 180 180
------------------------------------------------------------------------
Johns Hopkins Adult/Pediatric 0 60 60 60 60
------------------------------------------------------------------------
George Washington 0 60 60 60 60
------------------------------------------------------------------------
Washington Hospital Center/ 60 60 60 60 60
Children's
------------------------------------------------------------------------
Howard University 0 36 60 60 60
------------------------------------------------------------------------
Chipenham 0 0 36 48 60
------------------------------------------------------------------------
INOVA Fairfax 60 120 120 156 156
------------------------------------------------------------------------
Children's Hospital Kings 0 36 36 60 60
Daughter
------------------------------------------------------------------------
Sentara Norfolk General 0 60 84 84 120
------------------------------------------------------------------------
Carillion Roanoke 0 36 60 60 60
------------------------------------------------------------------------
Virginia Commonwealth Adults/ 60 60 84 84 84
Pediatrics
------------------------------------------------------------------------
University of Virginia Adult/ 60 60 84 84 84
Pediatric
------------------------------------------------------------------------
Total 360 768 924 996 1,044
------------------------------------------------------------------------
Level II
------------------------------------------------------------------------
Bay View 0 48 48 60 72
------------------------------------------------------------------------
UMMS Capital Regional Medical 60 60 72 72 84
Center
------------------------------------------------------------------------
Sinai Hospital Baltimore 0 36 48 48 60
------------------------------------------------------------------------
Suburban 0 60 60 72 84
------------------------------------------------------------------------
Henrico Doctors Hospital 0 0 36 48 60
------------------------------------------------------------------------
Lynchburg General 0 36 48 60 72
------------------------------------------------------------------------
Mary Washington Hospital 0 0 36 48 60
------------------------------------------------------------------------
Reston Hospital Center 0 0 36 48 60
------------------------------------------------------------------------
Riverside Medical Center 0 0 36 48 60
------------------------------------------------------------------------
Virginia Hospital Center 0 0 36 48 48
------------------------------------------------------------------------
Winchester Medical Center 0 0 36 48 48
------------------------------------------------------------------------
Total 60 240 492 600 720
------------------------------------------------------------------------
Level III
------------------------------------------------------------------------
Merritus Medical Center 0 0 36 48 60
------------------------------------------------------------------------
UPMC Western Maryland 0 0 36 48 48
------------------------------------------------------------------------
Tidal Health Peninsula Hospital 0 0 0 36 36
------------------------------------------------------------------------
New River Valley Medical Center 0 36 36 48 48
------------------------------------------------------------------------
Lewis Gale-Montgomery Hospital 0 36 36 48 48
------------------------------------------------------------------------
Loudon Hospital 0 0 36 48 48
------------------------------------------------------------------------
Southside Regional Medical 0 0 36 36 48
Center
------------------------------------------------------------------------
Virginia Beach General Hospital 0 0 36 36 48
------------------------------------------------------------------------
Sentara Northern Virginia 0 0 36 48 48
Medical Center
------------------------------------------------------------------------
Total 0 72 288 396 432
------------------------------------------------------------------------
Grand Total 420 1,080 1,704 1,992 2,196
------------------------------------------------------------------------
Development and Utilization of Drone Technology:
The DMV region is one of the worst areas for traffic delays in the
United States. A small drone is needed to transport blood and organs
from the donor hospital to regional histology and serology labs.
Transporting the specimens to the proper laboratories more
expeditiously will allow the lab results to be obtained sooner, thus
decreasing the time to start the organ placement. Once the donor and
the recipients are identified for each organ, especially if recipients
are determined before the organ recovery procedure is initiated, the
organs need to be resuscitated and prepared for transportation to the
regional preservation lab. Because of the potential of eight organs
being recovered from one donor and transported to the regional
preservation lab, larger drones will be required to transport the
organs. As more Cardiac Dead Organ Donors become standard practice, the
need to have a regional recovery center added to the regional organ
preservation lab will expedite organ recoveries and placement. Having
both the recovery center and the preservation lab located up to 250
radial miles from the trauma centers would require larger drones for
the more extended transportation of donors and organs.
Secure Communications for all Transplant Parties:
One of the biggest complaints from transplant surgeons concerning the
recovery teams is the lack of clear communication. The Bio Hub proposal
will address this significant problem that leads to many discarded
organs because of long preservations time and unclear documentation of
recovered organs outside the transplant team's home region between the
organ recovery team and the organ transplanting teams. Utilizing the
Bio Hub collaborators, computer science engineers, and scientists to
develop a secure communication link to share real-time data. There
needs to be a partner organization to transmit and share real-time data
securely. The addition of Space Link (an MEO satellite provider) allows
for UNOS, the regional organ preservation labs, and the transplanting
hospitals to share real-time data about the recovered organs with each
team member. Another major problem with the current organ center's
sharing policy is the wasted time placing the cadaveric organs because
transplant programs do not trust the existing data transmitted to the
potential recipient hospitals. By simultaneously utilizing real-time
encrypted donor information to all potential recipient hospitals so the
transplant programs can decide whether to accept the organs. Then
creating a cue for which recipients will receive the organs can be done
more expeditiously than in the current system. This same system will
have pre-signed consents for all potential recipients accepting Cardiac
Dead organs for a transplant. The potential transplant recipients will
have all their blood work, health exams, and vaccines maintained at a
current status or be placed in an inactive status until the transplant
centers have the potential recipient missing data brought current.
Using secured, rapidly transmitted data at Terabyte speed will make the
data system more user-friendly and efficient. Allowing for the
transportation of organs around the United States to the closest match
donors and recipients is an exciting benefit of this proposal.
As Dr. Robertson and myself work with UNOS to set up the collaboration
between the multiple universities to address the concerns of this
Senatorial Committee, we have seen the UNOS staff members' awareness of
past mistakes and an interest in becoming more accountable for their
past actions. I believe submitting this Statement for the Records will
hold UNOS responsible to the Senate and the House of Representatives
during this five-year proposal. I look forward to presenting a more in-
depth presentation of our data for this proposal to the Senate Finance
Committee and addressing your questions. I also ask for your support in
funding this proposal through the American CARES Act 2.0 and hold us
accountable for the annual milestones for this funded project.
Respectfully,
Frederick A. Gage
Director
______
Letter Submitted by Michael G. Ison, M.D., MS et al.
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Bldg.
Washington, DC 20510-6200
Organ transplantation provides the opportunity for improved life for
patients with end-stage organ disease. Recently, there has been
attention to adverse outcomes of the organ procurement and
transplantation processes in the United States. While these reports may
be viewed as alarming, it is critical to place them within the context
of the overall risk of end-organ disease and transplantation. As prior
chairs of the Disease Transmission Advisory Committee (DTAC) of the
Organ Procurement and Transplantation Network (OPTN), a volunteer
position, we have a unique understanding of many of the relevant
issues. We write as practicing physicians, engaged in the care of
transplant recipients and involved in the transplant community.
Recent media attention and Senate hearings have highlighted
transmission of disease from the organ donor in 249 people of whom 70
have died. While these numbers may seem high and the details of
specific cases may seem shocking, they must be placed within the
context of the absolute number of transplants performed annually. End-
stage organ disease has significant risk of death and illness; more
than 50% of people with advanced liver disease die within 3 months of
diagnosis. From 2008 through mid-2015, the period that the Senate
reported on, 174,338 individuals underwent transplantation, placing the
rate of unexpected disease transmissions at 0.14%. During this same
time, the deaths attributed to disease transmission only account for
0.09% of the 74,253 total deaths that occurred in patients transplanted
during this period. Importantly, the types of diseases transmitted as
well as the rates of disease transmission and death are nearly
identical to those reported by other countries that track donor deaths
such as France where transplantation oversight is managed by a
government agency, Agence de la Biomedecine. The fact that results
under the UNOS oversight of organ vigilance and donor screening are
similar to those under the French system suggests that these outcomes
are part of the known risks associated with transplantation.
The OPTN DTAC was established to develop an organ vigilance system in
the United States. The group represents a unique collaboration between
the various transplant communities, including transplant center and
organ procurement professionals, and key government agencies, including
HRSA and the Centers for Disease Control and Prevention (CDC). Since
its inception, the DTAC has strived to be transparent, sharing key
findings through regular presentations and publication of current data.
The program's success has made it the model emulated as other countries
sought to establish similar programs.
This organ vigilance work has helped keep transplant patients safe,
maintaining a low rate of disease transmission whilst fostering an
increase in transplant volume amidst the challenges of a pandemic. UNOS
has encouraged DTAC to be nimble, updating testing parameters for organ
donors based on continuous assessments of patient experience. We have
seen similar updating in other committees of the OPTN, where the need
to be proactive remains a high priority. The pandemic is an especially
good example of how this constant process of reassessment allows for
the maximal safe use of donors. Data on testing and disease
transmission risk have been reviewed and guidelines updated throughout
the pandemic. As a result, transplantation in the US not only returned
to pre-pandemic rates but grew to record numbers despite the ongoing
impact of SARS-CoV-2.
Organ transplantation is incredibly complex and limitations exist as to
what can be known about any donor within the time available between a
donor becoming eligible to donate and organs being placed into their
grateful recipients. Optimal donor assessments must always balance
risks with benefits to ensure maximal use of potential donated organs.
The landmark Institute of Medicine article ``To Err is human''
recognized that rather than assigning blame, processes need to be
developed to prevent errors or minimize harm. Similarly, through
lessons learned as part of organ vigilance programs, we continue to
strive to improve our systems and processes. Unexpected disease
transmissions and other adverse events will always occur no matter what
system is in place, but putting these into context is critical.
Thankfully they occur rarely and when recognized, systems implemented
by UNOS, refine the processes further in a non-blaming fashion to
improve survival of all transplant recipients. While every system
requires continuous quality improvement, the implication that the
current system has failed to promote patient safety as relates to
disease transmission--or that an alternative administrative structure
or contractor would result in a safer system--is not supported by our
experience.
Michael G. Ison, M.D., MS
Northwestern University Feinberg School of Medicine, Chicago, Illinois
340 E North Water St., Unit 2210, Chicago, IL 60611
Emily Blumberg, M.D.
Perelman School of Medicine at University of Pennsylvania,
Philadelphia, Pennsylvania
3400 Spruce St., 3 Silverstein Suite E, Philadelphia, PA 19104
Michael Green, M.D.
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
3705 5th Avenue, Pittsburgh, PA 15213
Dan Kaul, M.D.
University of Michigan Medical School, Ann Arbor, Michigan
3116 Taubman Center, Ann Arbor, MI 48109
Marian Michaels, M.D.
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
3705 5th Avenue, Pittsburgh, PA 15213
Cameron Wolfe, M.D.
Duke University School of Medicine, Durham, North Carolina
Hanes House, Room 150, Trent Drive, Durham, NC 27710
______
Mississippi Organ Recovery Agency
4400 Lakeland Drive
Flowood, MS 39232
PH 601-933-1000
FAX 601-933-1006
https://msora.org/
August 17, 2022
U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200
Re: Mississippi Organ Recovery Agency's Statement for the
Record on Senate Finance Committee Hearing of August 3, 2022,
entitled ``A System in Need of Repair: Addressing
Organizational Failures of the U.S.'s Organ Procurement and
Transplantation Network''
Dear Members of the Senate Committee on Finance,
On behalf of the Mississippi Organ Recovery Agency (MSOP), I thank
the Committee for its dedication to improving the organ procurement and
transplantation system. During the above-referenced hearing (Hearing)
on August 3, 2022, the Committee represented that the goal of the
hearing was to create a more equitable and efficient organ donation and
transplant system. We greatly appreciate the Committee's willingness to
work to engage with the stakeholders to improve the system to ensure as
humanly as possible that every organ is given the best chance to save a
life.
In conjunction with the Hearing, the Committee released a memo
entitled ``Staff Memo on Organizational Failures of The United States
Organ Procurement'' (Memo) along with exhibits. Page 11 of the Memo
references a ``Courier Case'' involving Mississippi Organ Recovery
Agency (MSOP), and states that ``[o]n February 25, 2017, two incidents
were reported to UNOS where the courier service requested by the OPO
did not arrive in time to get the organs to their flight.'' Appendix F
to the Memo provides additional documentation related to the events. I
write to provide information to clarify the situation identified.
With regard to the incidents on February 25, 2017, it is important
to clarify that MSOP facilitated the donation of the right, but not the
left kidney. The right kidney was offered by MSOP and accepted by AZMC.
According to the courier, when the courier arrived at our local
airport, the commercial airline company agent refused to accept the
kidney for the flight to Phoenix via Dallas. Also, according to
courier, even though the right kidney arrived within the parameters of
acceptance for acceptance for the flight, the airline agent refused to
put it on the flight. The courier immediately notified the UNOS Organ
Center. UNOS, in collaboration with the courier company, then
identified another commercial airline company to fly the kidney to
AZMC, AZMC declined the kidney due to the later arrival time on the new
flight, even though the new flight departed only fifteen (15) minutes
later than the original flight. The right kidney was then quickly
accepted by the transplant center that had also accepted the left
kidney. Both the right and left kidneys were then placed on the same
flight to the new transplant center on a different commercial airline
company flight. Both kidneys arrived in a safe and timely manner to the
transplant center that accepted both kidneys. However, according to the
accepting transplant center, on arrival and after further evaluation,
unfortunately the effects of the donor's history of hypertension and
diabetes had damaged the kidneys to the point they were not
transplantable.
In spite of the transportation challenges in this case, MSOP worked
diligently with the courier and UNOS to ensure that the organ was
quickly placed with another transplant center and transported
expeditiously. In spite of these efforts, ultimately, the discard in
this case was within the discretion of the transplant center.
MSOP recognizes the urgent need to address organ discards and
supports the statement made by AOPO on August 4:
AOPO encourages a robust system to trace the cause of every
organ discard to better determine the reasons for organ
declines by transplant centers and develop strategies to
minimize organ waste and increase organ acceptance. With the
discard rate trending upward this year, this is an urgent issue
that all donation and transplant stakeholders must solve for
all the patients on the waiting list.
More broadly, MSOP also agrees with and strongly supports Senator
Wyden's statement that the system should work with as few errors as
possible. However, in order to effectively reduce or eliminate those
errors and meaningfully transform the system, the policies and
practices of all donation and transplant partners should be considered.
As Senator Wyden acknowledged in his opening statement, UNOS oversees
nearly 400 members, including 252 transplant centers and 57 OPOs. The
focus of the Hearing was on the ``failures'' of the government Organ
Procurement Transplant Network (OPTN) contractor, UNOS, and Organ
Procurement Organizations. Notably absent from this discussion is any
reference to transplant centers or their policies. OPOs and transplant
programs are equally integral to the system. If the system is to be
comprehensively reformed, all partners' policies must be considered.
In addition to OPOs and transplant centers, the above-referenced
incident highlights the numerous partners, whether members of UNOS or
otherwise, whose practices affect the ultimate outcome of a successful
organ recovery and transplantation. In addition to this event, others
of the ``Transportation Failures'' referenced in the Memo appear to
have been completely outside of the control of UNOS, the organ
procurement organization, or the transplant program. MSOP suggests that
policies should be developed to ensure that all partners, including
transportation partners, maximize protection of these precious life-
saving gifts.
The Mississippi Organ Recovery Agency has been and always will be
striving to be the best possible organ procurement organization in the
United States of America. We welcome any meaningful and comprehensive
improvements to the system to ensure that ALL stakeholders are held
accountable.
Sincerely,
M. Kevin Stump
President/CEO
______
National Down Syndrome Society
1155 15th Street, NW, Suite 540
Washington, DC 20005
800-221-4602
www.ndss.org
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510 6200
Dear Chairman Wyden and Ranking Member Crapo:
On behalf of the Down syndrome community, we wish to thank you for
holding a hearing on addressing the organizational failures of the
United States' organ procurement and transplantation network. We look
forward to working together to address this critical issue,
particularly as it affects individuals with intellectual and
developmental disabilities. As you consider improvements to the system,
we urge you to recognize that the lives of individuals with
disabilities have equal value to the lives of people without
disabilities, so they deserve equal access to organ transplants. We ask
that you advance meaningful solutions to address systemic
discrimination against individuals with disabilities found at all
levels of the organ procurement and transplantation network.
Organ transplants are a key part of our nation's health care system.
They save lives every day. Unfortunately, people with disabilities have
consistently been denied organ transplants in the United States based
on unfounded assumptions on their quality of life and ability to comply
with post-operative care. This is in direct violation of the Americans
with Disabilities Act, Section 504 of the Rehabilitation Act of 1973,
and Section 1557 of the Affordable Care Act, which prohibit
discrimination on the basis of disability.
Despite these existing overarching protections, real-world
discrimination persists. The National Council on Disability (NCD)
recently reviewed applicable federal and state laws, the disability-
related policies of various organ transplant centers, and policies of
the Organ Procurement and Transplantation Network and issued a report
in September 2019.\1\ The report found that people with disabilities
are frequently denied access to organ transplants based on written and
unwritten policies excluding people with disabilities as organ
transplant candidates, even in the nine states that, at the time, had
state laws in place prohibiting such practice. Furthermore, some
medical professionals even refused to evaluate a patient's medical
suitability for organ transplant because of their disability.
---------------------------------------------------------------------------
\1\ National Council on Disability. (2019). Organ transplant
discrimination against people with disabilities. Retrieved from https:/
/ncd.gov/sites/default/files/NCD_Organ_Transplant_508.
pdf.
In our community, the threat of discrimination in organ transplantation
presents a real-world danger. About 50% of all people born with Down
syndrome have congenital heart disease, which often requires heart
surgery and, if unsuccessful, can lead to the need for transplantation.
Last year, NDSS learned of Zion Sarmiento, a baby born in June with
Down syndrome in Florida. Zion had a congenital heart defect and
underwent multiple surgeries, but ultimately, he needed a transplant to
survive. Despite Florida having passed a state-law prohibition of
disability discrimination in organ transplantation, effective July 1,
2020,\2\ Zion was unable to access a transplant and tragically passed
away in October. He was less than four months old.
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\2\ Florida CS/HB 1179 (2020), https://www.myfloridahouse.gov/
Sections/Bills/billsdetail.aspx?BillId=69420.
While progress has been made since NCD issued their report, including
the passage of laws in 34 states,\3\ this patchwork does not adequately
ensure individuals with disabilities are protected because the organ
transplant ecosystem, as a whole, is firmly interstate. We therefore
strongly urge the Committee to support consideration and passage of the
Charlotte Woodward Organ Transplant Discrimination Prevention Act (S.
3301), which would prohibit discrimination against people with
disabilities who need organ transplants, upholding, clarifying, and
building upon rights established in the Americans with Disabilities Act
of 1990, Sec. 504 of the Rehabilitation Act of 1973, and Sec. 1557 of
the Affordable Care Act. This commonsense legislation is bipartisan in
both chambers (with H.R. 1235) and has no fiscal impact.
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\3\ National Down Syndrome Society. (2022). Organ transplant
discrimination state laws. Retrieved from https://www.ndss.org/
advocacy#p_health.
NDSS is eager to partner with you as the Committee explores and
develops meaningful policies to improve the nation's organ transplant
ecosystem, including protecting the civil rights of individuals with
disabilities. For more information, please contact Bartholomew N.
---------------------------------------------------------------------------
Devon, senior director of public policy, at [email protected].
Sincerely,
Kandi Pickard
President and CEO
The National Down Syndrome Society (NDSS) is the leading human rights
organization for all individuals with Down syndrome. NDSS envisions a
world in which all people with Down syndrome have the opportunity to
enhance their quality of life, realize their life aspirations, and
become valued members of welcoming communities.
______
National Kidney Foundation
30 East 33rd Street
New York, NY 10016
Statement of Sharon Pearce, Senior Vice President, Government Relations
The National Kidney Foundation (NKF) respectfully submits our statement
for the record on behalf of the 37 million individuals in the United
States, 1 in 7 adults, estimated to have chronic kidney disease
(CKD).\1\ The prevalence of kidney failure is expected to increase
dramatically, possibly exceeding one million people who may need access
to the transplant wait list by 2030.\2\ There are not enough deceased
or living donor organs to meet current or future needs creating a
public health emergency that needs immediate attention. Although 24,669
people received a kidney transplant in 2021, far too many are still
waiting. Many never access the transplant wait list or learn that a
transplant is an option. There are over 100,000 individuals on the
transplant wait list, and more than 90,000 are waiting for a kidney.
---------------------------------------------------------------------------
\1\ Centers for Disease Control and Prevention. Chronic Kidney
Disease in the United States, 2021. Centers for Disease Control and
Prevention; 2021.
\2\ McCullough K.P., Morgenstern H., Saran R., Herman W.H.,
Robinson B.M. Projecting ESRD Incidence and Prevalence in the United
States through 2030. J Am Soc Nephrol. 2019 Jan;30(1):127-135. DOI:
10.1681/ASN.2018050531. Epub 2018 Dec 17. PMID: 30559143; PMCID:
PMC6317596.
NKF is fiercely committed to holding the transplant system accountable
for the ethical stewardship of organs as a precious, life-saving
resource. NKF's transplant policy agenda seeks to implement policy
changes, payment reforms, legislative solutions, quality measurement,
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and oversight activities that:
Maximize the number of kidneys procured and transplanted;
Minimize the number of kidneys discarded;
Enhance the transplant process to become more transparent and
patient-centric; and
Drive continuous performance improvement across the transplant
system.
The United Network for Organ Sharing (UNOS) has been the sole
contractor of the Organ Procurement and Transplantation Network (OPTN)
contract--without competition--since 1986. In its nearly 40 years of
providing oversight of the organ donation and transplant system, UNOS
has witnessed the continuous growth of the wait list, which comprises
almost 106,000 organ failure patients currently waiting for a kidney
transplant.\3\ UNOS is acutely aware that supply is not meeting demand.
The OPTN goals should include transparency, equity, and efficacy of
organ donation and transplantation practices.
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\3\ National data--OPTN (hrsa.gov).
A vital responsibility of UNOS is to provide oversight to the nation's
organ procurement organizations (OPO). As revealed in recent
congressional investigations, life-threatening inefficiencies and
inequities in the transplant system are directly related to OPO
underperformance. OPOs are the only transplant stakeholders with the
privilege and responsibility of recovering organs from deceased donors
for transplant. The lack of oversight is a catastrophic disservice to
patients. Transplant centers and OPOs are left to their own devices and
tools to sort out logistics of organ and patient transportation leading
to inefficiency, wasted expense and directly leading to increased
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discards.
We have made many recommendations to the Centers for Medicare and
Medicaid Services (CMS), Health Resources and Services Administration
(HRSA), Organ Procurement and Transplantation Network (OPTN), and
Scientific Registry for Transplant Recipients (SRTR) on strategies to
improve the organ donation and transplant system, which are summarized
below.
1. Improving Organ Procurement and Increasing Organ Donation
Immediate data transparency: OPOs collect organ donation data that is
currently inaccessible to the public. As an entity whose sole purpose
is to serve the public, it is a disservice to patients needing
transplantation, organ donors, and donor families who make the selfless
decision to donate their loved one's organs. The following metrics (at
a minimum), currently captured by all OPOs, should be made publicly
available for quality assurance, performance improvement, and
stratified by gender, race, ethnicity, age, zip code for health equity
purposes:
Number of organ referrals.
Number of braindead donors.
Number of donation after cardiac (DCD) donors.
Missed organ referrals.
Conversion rate.
Approach rate.
Consent rate.
Percentage of first-person consent.
Regulatory consequences for OPOs failing to respond timely to donor
hospitals to evaluate potential organ donors: When donor hospitals make
a referral for a patient who is not automatically clinically ruled out
as an organ donor, the OPTN contractor should require OPOs to make
every effort to elicit a timely onsite response for an evaluation.
Regulatory consequences for missed organ referrals: Donor hospitals
should face repercussions for missed referrals of potential organ
donors. When a hospital fails to notify an OPO of a potential organ
donor, critically ill patients continue to wait for a life-saving organ
transplant. Further, families lose the opportunity to continue the
legacy of their loved ones through the selfless gift of organ donation,
and the wishes of the person who has designated their desire to donate
their organs are unfairly forfeited.
Staffing to reflect the DSA (Donor Service Area) community: The OPTN
contractor must call for OPOs to recruit, hire, and train staff
representing the diverse racial, ethnic, and cultural communities they
serve. Diversity, equity, and inclusion should be reflected across all
departments within the OPO, including executive leadership, OPO
professional staff, the clinical teams that interface with donor
hospitals, and the teams that work with potential donor families.
Transportation: Organ transportation delays and inefficiencies have
life-threatening consequences for waiting patients. It is unacceptable
that donated organs are discarded due to transportation pitfalls after
donors and donor families have made the selfless decision to donate
organs. Examining challenges in the transportation system and
identifying policies, best practices, and strategies to mitigate cold
ischemia time that results in organ discards is imperative.\4\
---------------------------------------------------------------------------
\4\ Cooper M., Formica R., Friedewald J., et al. Report of National
Kidney Foundation Consensus Conference to Decrease Kidney Discards.
Clin Transplant. 2019;33(1):e13419. doi:10.1111/ctr.13419.
Consent training: Reducing disparities and ensuring that each donor and
their families are respectfully considered and supported during the
donation process must be a standard upheld by all OPOs.\5\ OPO staff
must be adequately trained and equipped to approach families of all
races, ethnicities, socioeconomic backgrounds, and religious beliefs
for organ donation. OPOs should be held accountable for instituting
donor family communication best practices, especially around
recognizing and eliminating implicit bias, ensuring racial equity, and
delivering trauma-informed care.
---------------------------------------------------------------------------
\5\ Guadagnoli E., McNamara P., Evanisko M.J., Beasley C.,
Callender C.O., Poretsky A. (1999). The influence of race on
approaching families for organ donation and their decision to donate.
American Journal of Public Health, 89(2), 244-247. https://doi.org/
10.2105/ajph.
89.2.244.
Donor management and patient safety: The OPTN contractor must assess
and improve the clinical knowledge of OPO staff to maximize organ
recruitment and transplantation. This includes perfusing organs and
donation outcomes after cardiac death (DCD) and braindead (BD) donors
and organs. Patient safety during organ recovery and transplantation
must never be compromised, and documentation of adverse events should
undoubtedly be documented, reported, and reviewed to determine the
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cause and need for remedy.
2. Reducing Deceased Donor Kidney Discards
In partnership with CMS, HRSA, and other stakeholders, the OPTN
contractor should implement regulatory changes, payment policy
adjustments, and quality improvement initiatives to incentivize OPO and
transplant center practices that could reduce discards as recommended
by NKF's 2017 Discard Consensus Conference:\6\ Such recommendations
include:
---------------------------------------------------------------------------
\6\ Cooper M., Formica R., Friedewald J., et al. Report of National
Kidney Foundation Consensus Conference to Decrease Kidney Discards.
Clin Transplant. 2019;33(1):e13419. doi:10.
1111/ctr.13419
Begin the organ allocation process earlier in the donor evaluation
phase.
Improve communication between OPO and transplant surgeons--The
Kidney Allocation System relies on an electronic communication
platform, DonorNet, that limits verbal communication between the OPO
and transplant center. The exclusive use of DonorNet without
collaborative conversations between the OPO and transplant center
contributes to decreased organ utilization.
Accelerate virtual crossmatching and send early prospective
crossmatch samples.
Require frequent QAPI meetings with OPOs and transplant centers to
review and analyze data and investigate root causes for low organ
transplant rates.
Secure ``local backups'' to mitigate the possibility of a kidney
discard.
Increased patient-centricity around organ offers may reduce kidney
discards.
The OPTN contractor should consider creating an algorithm that
recommends which patient group receives specific organ offers (ex.,
determine which patient group would benefit most from a particular
organ offer to mitigate ``list diving'' and reduce organ discards).
Risk aversion in the transplant system is a significant contributor to
kidney discard and devastating for patients depending on a life-saving
kidney transplant. NKF has urged CMS to develop new reimbursement
mechanisms that incentivize transplant centers to list high-risk
patients, accept less-than-perfect organs for transplant, and adopt
innovative therapies and technologies. New transplant center
performance measures should be designed to reduce risk-aversion.
Patients have an essential role in improving risk aversion and reducing
discards by making their wishes clear to their care teams. Patients are
often less risk-averse than their surgeons and centers. As they spend
more time on the wait list, they may accept an imperfect organ that
still confers clinical value compared to dialysis. Transplant centers,
nephrologists, and dialysis facilities must regularly consult patients
to assess and refine their transplant goals. Increasing utilization is
closely linked to reimbursement, transparency, and improved organ
acceptance practices. However, it begins with a patient-centered
approach to understanding the wait-
listed patient's goals and preferences. Transplant programs should also
promote shared decision-making with inactive wait-list patients.
Place urgent attention on the role of organ transportation in organ
discards: Changes in the allocation system have resulted in more organs
being transported across the nation than ever before. Dependence on
commercial flights presents several challenges for transplantation that
contribute to avoidable discards. Organ recovery usually occurs in the
late hours when donor hospital operating rooms are less busy and when
there are fewer commercial flights. Every hour a recovered organ waits
to be transplanted, cold ischemia time (CIT) increases, decreasing the
likelihood of transplantation. Federal regulations no longer allow
organs to fly in the cockpit with the pilot, only as cargo, which
exacerbates CIT. Kidneys with too much CIT are discarded and represent
a potential life lost on the wait list. Deceased kidneys are a scarce
resource; inefficiencies in air travel should never be a reason for
organ discard.
3. Making the Transplant Process and Experience More Transparent and
Patient-Centered
Patients on the wait list receive many organ offers; however, the
transplant center often declines organ offers on behalf of their
patients without their knowledge or consent. Increasing organ
utilization is closely linked to reimbursement, transparency, and
improved organ acceptance practices. However, it begins with a
patient-centered approach to understanding the wait-listed patient's
goals and preferences. Transplant programs should never lose sight of
promoting shared decision-making with patients. Patient-centricity
should be a priority for every regulatory agency that oversees the
organ donation and transplant system, as patients should always have
the option to be active participants in shared decision-making with
their healthcare team.
There is a need for organ donation and transplant stakeholders to
implement additional patient-centric process measures, including bi-
annual reports to patients on organs offered and declined on their
behalf and annual conversations between patients and their care team
regarding patient preferences and tolerances for accepting or rejecting
imperfect organs. In addition, if, through this process of shared
decision-making, transplant programs and candidates discover either
donor or recipient characteristics that would result in universal organ
decline, we encourage transplant programs to utilize the organ filters
now better optimized to minimize allocation of unacceptable offers
resulting in increased cold ischemia time and slowing identification of
the appropriate recipient and potential organ discard.
4. Improving System Performace
Harmonizing regulatory agency oversight: NKF supports policies that
remove silos, improve operations, drive system-level performance, and
increase equity. CMS, UNOS, HRSA, SRTR, and the Joint Commission share
oversight of the organ donation and transplantation system. This
fragmented oversight contributes to communication, process, and
alignment gaps. NKF advocates for one HHS-level office that would
provide overall management of the transplant ecosystem to mitigate
deficiencies that result from a lack of cohesion and accountability. It
is of the utmost importance that performance standards among the
regulatory agencies that oversee organ donation and transplantation are
aligned in both process and implementation. Misaligned measures only
muddle behavior rather than direct it towards shared goals.
Modernizing the technology infrastructure: NKF supports two separate
contracts for the Information Technology (IT) Infrastructure and one
for other OPTN priorities. The current IT architecture is outdated and
fraught with inefficiencies that impair organ donation and
transplantation, such as OPO and transplant center communication, wait-
list management, and organ allocation. Patients face life-threatening
consequences because the UNOS technology is not sophisticated enough
for efficient organ distribution. For example, nearly one in five
kidneys is offered to a deceased person still on the wait list because
the transplant center is unaware that the patient has died, and
deceased candidates receive a median of 4 organ offers before being
removed from the wait list.\7\
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\7\ Husain S.A., Winterhalter F.S., Mohan S. Kidney transplant
offers to deceased candidates. Am J Transplant. 2018 Nov;18(11):2836-
2837.
The OPTN contractor should not own any technology associated with the
organ donation and transplantation process. Separating the two
contracts allows OPTN to leverage significant improvements in
information technology and mitigate the risk of disruption to the
---------------------------------------------------------------------------
donation and transplant process.
Mandating transparency: Data transparency of organ donor hospitals,
OPOs, and transplant centers must be prioritized to improve organ
allocation processes. The lack of data transparency creates significant
barriers to care and inequities for the entire population that could
benefit from transplantation. Data collected from OPOs and transplant
centers are outdated, inadequately audited, incomplete, and self-
reported, making it impossible to develop modern quality measures,
specifically for steps in the pre-transplant process. Patients need
real-time data, or as close to real-time as possible, to make informed
decisions about transplantation. The current delay in data does not
accurately portray the current state of organ donation and
transplantation.
NKF was deeply troubled by OPTN's announcement about adding 35,000
verified deaths to the standard analytical files. This adjustment
illustrates the failure of the current system to capture data from a
range of sources and cross-reference it to ensure maximum efficiency.
Further, OPTN's announcement lacked urgency or even recognition of the
gravity of data inconsistencies and their implications for
transplantation-related research. This incident reinforces the critical
need for transparency and the need to separate the IT contract from
other OPTN requirements to ensure that patients and the system benefit
from the cutting-edge technologies that can eliminate these
inconsistencies and inefficiencies. HRSA must also determine how death
data is collected and verified with the OPTN contractor and CMS to
mitigate an error of this magnitude in the future.
Enhanced wait-list management: The transplant wait list is poorly
maintained because of inconsistent communication between transplant
centers, dialysis facilities, and patients or caregivers due to the
current antiquated IT architecture. Patients on the wait list are
frequently unaware of their wait-list status--active or inactive--and
receive little or no information from the transplant centers. This
absence of communication among patients, their dialysis facilities, and
transplant centers represents a failure of the OPTN to improve
communication between various stakeholders in transplantation,
resulting in inefficient allocation and the perpetuation of silos of
care.
Health equity: Prejudice and implicit bias are common elements of OPO
practice. Beliefs that people of color will not donate perpetuate
patterns where hospitals are less likely to refer prospective donors to
the OPO. In studies, Black/African American families have declined
donation because of insufficient time to process and discuss important
issues and a lack of sensitivity and empathy during the approach
process.\8\ Research has also found that OPOs are more likely to
approach White families over Black/African American families.\9\ NKF
strongly opposes race-based adjustments to the OPO metrics and suggests
that OPOs adopt best practices to overcome bias and prejudice on the
ability of families to donate their loved one's organs. For example,
hiring staff that represents the communities they serve and
implementing frequent training on cultural sensitivity, diversity, and
inclusion to improve conversations with non-White populations about
donation.
---------------------------------------------------------------------------
\8\ Siminoff L.A., Alolod G.P., Gardiner H.M., Hasz R.D., Mulvania
P.A., Wilson-Genderson M. A Comparison of the Content and Quality of
Organ Donation Discussions with African American Families Who Authorize
and Refuse Donation. J Racial Ethn Health Disparities. 2021;8(2):485-
493. doi:10.1007/s40615-020-00806-7.
\9\ Guadagnoli E., McNamara P., Evanisko M.J., Beasley C.,
Callender C.O., Poretsky A. The influence of race on approaching
families for organ donation and their decision to donate. Am J Public
Health. 1999;89(2):244-247. doi:10.2105/AJPH.89.2.244.
A kidney transplant is the optimal treatment for end-stage renal
disease. Still, Black/African American people are disadvantaged at
every step of the transplant process and have poorer graft
outcomes.\10\ Organ failure patients desperately need an equitable
transplant ecosystem. Justice, fairness, equity, and transparency are
values our organ donation and transplant system need, and patients
deserve. Federal agencies that oversee the organ donation and
transplant system must uphold these values to influence public
confidence in our organ donation and transplant system. Regardless of
demographic characteristics or socioeconomic status, every person
should have the right to access the national transplant wait list.
---------------------------------------------------------------------------
\10\ Norton JM, Moxey-Mims MM, Eggers PW, et al. Social
Determinants of Racial Disparities in CKD. J Am Soc Nephrol.
2016;27(9):2576-2595. doi:10.1681/ASN.2016010027.
---------------------------------------------------------------------------
5. Amplifying the Patient Voice
As a patient advocacy organization, NKF is proud to uplift the voices
of the patients we have the honor to represent. Improvement of the
organ donation and transplantation system should not occur without
patients learning what they need and want for the success of their
transplant journey. When presented with the opportunity to comment on
how to improve the current transplant system, we received the following
responses from patients:
Improve communication--``Ensure that transplant centers have adequate
resources and staff to support their patients with consistent and
effective communication. Patients deserve to know when they are listed
for transplant and the actions they can take to maintain optimal health
on the wait list. Centers must alert patients of their wait-list status
when they become listed and made inactive or delisted. Physicians,
Advanced Practice Providers, Nurses, Transplant Coordinators, Social
Workers, and other transplant center staff that interface with patients
should adequately and compassionately share the reasons for an inactive
status with patients and why they have been delisted.''
Include the patient as part of the care team--``Clear and timely
communication between the transplant team and patients can promote
shared decision-making should be afforded to each patient. Transplant
centers have complained about patient compliance; if transplant centers
want improved cooperation from patients, they should prioritize shared
decision-making.''
Promote cultural sensitivity--``Clinical and non-clinical transplant
center staff must practice cultural sensitivity and inclusivity to
decrease patients' risk of falling through the cracks due to language
barriers and cultural misunderstandings. Transplant centers need
appropriate communication strategies and mechanisms to relay messages
with non-English speaking patients to prevent patient isolation and
poor outcomes.''
Address patients' mental and emotional well-being--``Organ failure is
scary. Dialysis creates added stress and anxiety. Dialysis patients
face various challenges--healthcare complications, lethargy (too tired
to participate in common daily activities), lack of social support, and
depression, to name a few. Patients experience a general fear when
faced with organ failure and the prospect of their mortality. Organ
donation and transplant surgery are overwhelming to think about.
Transplant centers could assuage these feelings by communicating with
their patients in as close to real-time as possible about what to
expect during the process (not just once, but reminders throughout
would be helpful).''
Conclusion
The National Kidney Foundation has been fighting kidney disease for
over 55 years and works tirelessly to improve outcomes for kidney
patients and patients at risk by emphasizing prevention, early
detection, and CKD management to slow or stop the progression of kidney
disease. We are also committed to increasing access to kidney
transplantation and improving patient choice of high-quality, patient-
centered options to treat kidney failure. Kidney care is fraught with
disparities. We will continue to advocate for policies that prevent
barriers, biases, and prejudices that prevent all patients from
receiving the care they rightly deserve.
We welcome any questions about our recommendations and to improve the
American organ donation and transplant system. Please contact Morgan
Reid, Director of Transplant Policy and Strategy
([email protected]), or Lauren Drew, Director of Congressional
Relations ([email protected]).
Thank you for your consideration.
______
Organ Donation Consortium
975 F Street, NW, Suite 400-A
Washington, DC 20004
[email protected]
August 5, 2022
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Bldg.
Washington, DC 20510-6200
Chairman Wyden, Ranking Member Crapo, and Members of the Committee:
The Organ Donation Consortium (the ``ODC''), comprised of five of the
nation's leading organ procurement organizations (``OPOs'') and
collectively representing almost 38 million Americans, applauds the
work of the U.S. Senate Committee on Finance (the ``Committee'')
addressing organizational failures of the U.S. Organ Procurement and
Transplantation Network (``OPTN''), including severely lacking
technology and its impact on our ability to save lives through organ
donation and transplantation. We formed the ODC in part to address such
failures and gaps left by many in the donation and transplantation
ecosystem. Our strategic focus is fully aligned with the Committee's
work as well as with many of the key recommendations, particularly
those concerning health equity, organ utilization and the modernization
and integration of state-of-the-art heath information systems, found in
the report of the NASEM Committee on a Fairer and More Equitable, Cost-
Effective, and Transparent System of Donor Organ Procurement,
Allocation, and Distribution.
The ODC's strategic focus is on technological innovations and
integrations, cross-sector stakeholder collaboration, and transparent
accountability. With the open integration of systems among all
stakeholders--donor hospitals, OPOs, and transplant centers, as well as
the OPTN--we have set out to save more lives through donation and
transplantation while:
Eliminating health disparities in donation and transplantation;
Increasing the number of organs made available for transplant;
Eliminating the unnecessary discard of transplantable organs;
Reducing inefficiencies and errors in the donation process;
Improving quality through the donation process;
Reducing the time it takes to shepherd a life-saving organ from
donor to recipient;
Reducing costs in the donation system; and
Providing a framework for the consistent and reliable collection
of data for performance measurement of all stakeholders that make organ
donation and transplantation possible.
No one is above scrutiny in these matters, including OPOs, hospital
systems, transplant centers, and those overseeing this work, including
the OPTN, and the ODC stands ready to assist in the development of
further reforms and technological innovations to achieve significant
improvements in organ donation and transplantation for all Americans.
Sincerely,
Janice F. Whaley Diane Brockmeier
President and CEO President and CEO
Donor Network West Mid-America Transplant
San Ramon, California St. Louis, Missouri
Kelly Ranum Ginny McBride
President and CEO Executive Director
Louisiana Organ Procurement Agency Our Legacy
Covington, Louisiana Orlando, Florida
Bradley L. Adams
President
Southwest Transplant Alliance
Dallas, Texas
______
Organ Procurement and Transplantation Network
Patients Affairs Committee
August 2, 2022
Dear Members of the Senate Finance Committee,
As the leaders of the OPTN Patients Affairs Committee (PAC), we are
reaching out to share our experiences on the committee that we believe
indicate a systemic failure of UNOS to serve patients as the OPTN. This
is all the more urgent in light of investigative reporting from The
Washington Post.\1\
---------------------------------------------------------------------------
\1\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
Antiquated technology and an apathetic culture cause patients to
languish with incomplete and often incorrect information, and leave
people to die every day on the list. OPTN PAC members have raised these
points often with UNOS leadership, and have seen our calls for reform
ignored. We have been aghast at the absolute failure of UNOS to operate
the practice and business of transplant, and to acknowledge--much less
effectively serve--patients who are waiting and dying on the organ wait
---------------------------------------------------------------------------
list.
On July 28th, in preparation for the upcoming August 3rd Senate Finance
Committee hearing into UNOS, PAC leaders received an email from UNOS
CEO, Brain Shepard, referring to your investigation, in which he makes
four assertions that UNOS has shared with the Committee.
We wish to correct the record for your urgent consideration.
Shepard: ``Our IT system remains safe, secure and routinely meets and
surpasses federal standards.''
The Washington Post reported ``The system for getting donated kidneys,
livers and hearts to desperately ill patients relies on out-of-date
technology that has crashed for hours at a time and has never been
audited by federal officials for security weaknesses or other serious
flaws.''
We hope the Committee asks UNOS how many patients have died due to the
inability to match organs during downtime, as well as other
technological inefficiencies such as data error due to manual entry, as
well as how many patient life-years have been lost due to delays in
organ transportation. That said, given the lack of transparency in the
UNOS tech system, it is difficult to imagine anyone at UNOS could
answer this question with any confidence.
Shepard: ``We have worked together as a community to improve the
transport of organs with innovative, evidence-based products.''
The UNOS transportation record on organs is woefully--and fatally--
inadequate, as outlined by investigative reporting from Kaiser Health
News \2\--as well as cases brought before the Senate Finance Committee.
Put simply, UNOS operates as an antiquated, closed system that keeps
out external innovators that could help patients with better tools and
services.
---------------------------------------------------------------------------
\2\ https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/.
Shepard: ``Our committees and staff are proud to work collaboratively
---------------------------------------------------------------------------
with all members to serve as partners in improvement.''
PAC members have often sought--and not received--clarity on how patient
input is used. When PAC takes clear positions (such as the need to
fast-track proposed changes to using eGFR results to list people of
color), UNOS has refused to act. Compare this to a recent UNOS fast
track process that addressed a hardware defect in a mechanical heart
that went through in less than a month. Black patients deserved this
kind of speedy remedy when eGFR was proven to have racial bias. We also
note Washington Post \3\ reporting that UNOS's policy making processes
have been so divisive that they have ``spark[ed] open conflict'' among
OPTN members.
---------------------------------------------------------------------------
\3\ https://www.washingtonpost.com/national/health-science/liver-
transplant-rules-spark-open-conflict-among-transplant-centers/2019/05/
16/91b37f84-781c-11e9-bd25-c989555e7766_story.
html.
Shepard: ``The system we are all so honored to be a part of just
surpassed 41,000 transplants in 2021, while continuing to expand
---------------------------------------------------------------------------
equitable access to transplant.''
UNOS obscures its underperforming record behind recent increases in
organ donation rates that have resulted from tragic spikes in opioid
overdoses, gun deaths, and car accidents, including as second-order
effects of the COVID pandemic, not from UNOS's own performance. See the
former U.S. Chief Data Scientist making this point in MedPage,\4\ and
research in the Journal of the American Medical Association \5\ finding
that, after controlling for public health trends and scientific
advancements which have increased the size of the donor pool, organ
donation rates have not even kept pace with population growth.\6\
---------------------------------------------------------------------------
\4\ https://www.medpagetoday.com/opinion/second-opinions/98363.
\5\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
\6\ https://bloomworks.digital/organdonationreform/assets/PDF/
donation-increase.pdf.
The alarming revelations in The Washington Post (antiquated technology;
covering for failures of organ procurement organizations; and lack of
cooperation with the government, even devolving to UNOS having
``threatened to walk away'') lead us to believe that UNOS has proven
---------------------------------------------------------------------------
itself incapable of functioning as the OPTN.
We ask that you ensure that the federal government makes the fast-
approaching contracting OPTN cycle competitive for the first time since
the original OPTN contract was awarded in 1986, opening critical
functions up to best-in-class innovators across the country; and we
implore you to ensure that UNOS does not hold patients hostage in the
process.
We urge you to continue with your oversight and institute urgent
reforms that will literally result in lives saved.
Signed,
Garrett Erdle
Chair, OPTN PAC
Living Kidney Donor, Alexandria, VA
Molly J. McCarthy
Vice Chair, OPTN PAC
3-time Kidney Transplant Recipient, Redmond, WA
Chris Yanakos
Former Member of OPTN PAC
Living Liver Donor, Caregiver and Donor Family Member, Pittsburgh, PA
Steve Weitzen
Region 2 Representative, OPTN PAC
Heart Recipient, Randolph, NJ
Calvin Henry
Region 3 Representative, OPTN PAC
Lung Recipient, Dacula, GA
Lorrinda Gray-Davis
Region 4 Representative, OPTN PAC
Liver Recipient, Yukon, OK
Julie Spear
Region 8 Representative, OPTN PAC
Donor Family Member, Boulder, CO
Eric Tanis
Region 10 Representative, OPTN PAC
Liver Recipient, Gary, IN
______
Paragonix Technologies, Inc.
222 Third Street
Cambridge, MA 02142
https://paragonixtechnologies.com/
August 16, 2022
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Dear Chairman Wyden, Ranking Member Crapo, and Members of the
Committee,
Paragonix Technologies, Inc. (``Paragonix'') respectfully submits this
Statement for the Record in response to the Senate Finance Committee
hearing on Wednesday, August 3, 2022, A System in Need of Repair:
Addressing Organizational Failures of the U.S.'s Organ Procurement and
Transplantation Network. We commend the Committee for escalating the
importance of the nation's organ donor and transplant system, and its
desire to improve upon the existing system to maximize the rate of
organ donation in the country and maximize the rate of successful
procurement and transplant of vital human organs.
Paragonix Technologies, Inc. is a medical device company headquartered
in Cambridge, MA, that designs, produces, and markets organ
transportation devices that preserve human organs intended for
transplant during the journey between the donor procurement facility
and the transplant recipient center. Paragonix is a leader in providing
FDA-cleared devices for the transportation and preservation of all
solid organs: heart, liver, lung, kidney, and pancreas. Since its
commercial launch in 2020, Paragonix devices have preserved over 2,200
donor organs.
We also recognize the benefits of the Recommendations provided by the
Senate Finance Committee following the Hearing on August 3, 2022. In
particular, we would like to offer support and solutions towards
improvements in the methods, tracking and data reporting of organ
transportation systems, highlighted as one of the most pressing
concerns voiced at the Hearing. We refer to the following specific
recommendation:
VIII.
Recommendations:
Increase transparency and accountability for chain of custody and
transportation of organs procured for transplant by providing for
public reporting, as appropriate, on the status of organs in
transport.''
(https://www.finance.senate.gov/imo/media/doc/UNOS%20Hearing%20Confiden
tial%20Memo%20(FOR%20RELEASE).pdf)
Improvements in the Method, Tracking, and Data Reporting of Organ
Transportation Systems
For nearly 5 decades, the most common form of organ preservation (i.e.,
storage during transport between donor and recipient) has been ice-cold
storage in simple non-medical grade, non-regulated containers (e.g.,
plastic coolers, cardboard boxes, food storage tubs, etc). This method
is fraught with complications and potential hazards and lacks any
regulatory oversight consistent with updated methods and needs.
This is an extremely outdated approach to the storage of organs during
transport, yet remains embedded in current OPTN Policy (sections
16.3.E.i. and 16.3.E.iii):
An outer container of corrugated plastic or corrugated
cardboard, with at least 200 pounds burst strength, that is
coated with a water-resistant substance.'' (OPTN Policy,
Section 16.3.E.i) . . . ``If a member of the organ recovery
team is accompanying the organ to the potential transplant
recipient's transplant hospital, the organs and tissue typing
material may be transported in a cooler. A cooler may be reused
only if it is properly cleaned and sanitized and all labels
from previous donor organs are removed.'' (OPTN Policy, section
16.3.E.iii)
These policies describe a method of cold storage using coolers or
disposable cardboard boxes filled with ice to cool the organ and
thereby reduce the metabolic demand of the organ. This ice-based method
has been ensconced in the transplant field to the point it thwarts
innovation and progress. It also is not reflective of the technological
advancements and clinical advantages of mechanical preservation
systems.
Admittedly, this ice-based method provides an inexpensive approach to
organ preservation; however, it poses serious risks to the patient and
is difficult, nearly impossible, to standardize. In short, the ice-
based method of transporting organs is outdated, potentially harmful,
and does not reflect current methods of storage recognized and cleared
by the FDA.
A multitude of potential harms have been noted, including: (a) freezing
injury of organs as a result of organs becoming frozen due to an ice-
based method of preservation, (b) uneven cooling of the organ tissue
and violations of FDA-regulated temperature requirements of
preservation solutions, (c) lack of standardization due to a
variability in composite, type, and strength of packaging materials;
(d) the inability to know the biocompatibility of the material that
touches the organ; (e) potential tissue injury due to erratic movements
or vibrations during manual handling; and (f) the lack of knowledge of
the real-time changes in temperature during transport, one of the most
important parameters in organ preservation that directly impacts organ
function post-transplant.
With these limitations in mind, Paragonix makes the following
recommendations regarding transporting organs for transplantation:
(A) OPTN Policies should require, and organ procurement and transplant
programs should adopt, the use of FDA-cleared and regulated
preservation systems.
In contrast to non-regulated containers used during organ transport
(e.g., plastic food containers), FDA-regulated devices require rigorous
review and validation prior to gaining market clearance for use in a
healthcare setting. This includes design verification, electronic
safety review, thermal qualifications, ship testing (for clinical use
conditions), sterile validations, sterile barrier qualifications,
biocompatibility testing, etc. None of these requirements are made of
retail, commercially purchased storage containers, posing unknown risks
to patients. For example, retail coolers used for transporting organs
are not required to demonstrate they are safe for physical contact with
human organs, nor are they validated to maintain a consistent,
documented temperature.
The 2020 Consensus Statement of the International Society of Heart and
Lung Transplantation states, ``[T]here are some new technologies for
packaging . . . that prevent direct contact of the ice with the
``myocardium [which] may cause freezing . . . and is undesirable
because freezing and thawing cause irreversible cellular damage.'' In
short, transplant professionals recognize the advantages possible in
newer technologies, such as mechanical preservation systems that offer
temperature control.
Using our own technology, Paragonix has shown the clinical and economic
value of mechanical and controlled preservation of organs over
uncontrolled cold storage on ice through studies conducted with data
from the GUARDIAN registries (NCT04141605, NCT04930289 for lung,
NCT05082077 for liver). In particular, the GUARDIAN Heart registry
collects and evaluates various clinical effectiveness parameters in
patients with transplanted donor organs that were preserved and
transported within the Paragonix SherpaPak' Transport
Systems and those that were transported using simple ice storage. Data
collected by 17 transplant centers for approximately 800 patients was
presented at the International Society for Heart and Lung
Transplantation in April of 2022 (Leacche et al.). In a propensity-
score analysis, the authors showed improvements in the function of
donor hearts post-transplant using controlled mechanical preservation
when compared to simple ice storage in several important areas,
including statistically significant:
I. fewer complications within 24 hours post-op of the
transplant, as evidenced by a 72% reduction in severe primary graft
dysfunction,
II. improved post operative care as evidenced by a 39% reduction
in post-
transplant mechanical circulatory support, 66% reduction of the use of
intra-aortic balloon pumps, and a 60% reduction in ECMO or temporary
VAD requirement, and
III. improved long-term benefits, as evidenced by a 68% mortality
reduction at 1 year.
These clinical findings were noted even at extended total ischemic
times (i.e., long transport times).
GUARDIAN registry data has also been analyzed to evaluate post-
operative cost differences from improvements in clinical outcomes and
their associated reductions in clinical interventions, with a total
average savings of tens of thousands of dollars per patient when a
Paragonix system was used to transport a donor heart.
In summary, the requirement to use an FDA-regulated preservation system
will ensure that the most current approaches using technology that is
validated specifically for safe use in organ transplantation is
consistently utilized across all organ procurement and transplant
programs. Paragonix recommends that those organ procurement
organizations (OPOs) and transplant programs that currently do not
utilize an FDA-regulated mechanical preservation system develop a plan
to adopt this method of organ transport by 2024.
(B) OPTN Policies should require, and organ procurement and transplant
programs should adopt, the use of FDA-cleared and regulated
preservation systems that continuously collect data on the
temperature of the preservation solutions used during transport
of the organ and have such data incorporated into the donor
record.
The lowering of an organ's metabolic demand during transport using
hypothermic storage is another critically important concept in organ
preservation. Again, however, current OPTN policies do not require
temperature data to be collected or reported.
The lack of temperature data makes it difficult to ascertain organ
viability. Rapid temperature decreases to below freezing temperatures
have been observed in multi-center clinical studies as well as
preclinical studies that show average organ temperatures during ice
cooler transportation below 2 +C and below 0 +C (Horch et al.,
Transplant Proceed 2002; Hendry et al., J Thorac and Cardiovasc Surg
1989; Michel et al. Ann Transplant 2014; Michel et al. Ann Transplant
2015; Ingemansson et al., Ann Thorac Surg 1996; Mankad et al., J Thorac
and Cardiovasc Surg 1992; Keon et al., Ann Thorac Surg 1988). Organs
such as the liver, lung, and kidney frequently are exposed to prolonged
(several hours) temperatures at freezing, below, or just above
freezing. The consequences of frozen preservation solutions, and of
exposing a donor organ to temperatures at or below freezing, poses
undue harm and injury to the organ and potentially leads poor patient
outcomes.
Even in Dr. Locke's insightful testimony in the August 3 hearing, she
highlighted the issue of receiving frozen kidneys. In her written
testimony, she writes of receiving a kidney ``as hard as a rock, like
an ice cube you could put in your drink,'' where she was forced to
discard the selfless gift of a donor and inform the potential recipient
they would have to remain on the wait list.
Although this data is currently not collected on a routine basis, the
FDA recognizes the importance of temperature regulation in its review
and approval of all preservation solutions used during transport. For
example, the Belzer UW' Cold Storage Solution, used to
``flush'' the organ's vasculature and provide cold storage of kidney,
liver, and pancreas organs, has an Indication for Use (IFU) that reads:
Belzer UW' Cold Storage Solution must be cooled to 2+ to 6
+C (36+ to 43 +F) prior to use . . . Administration of Belzer
UW' Cold Storage Solution, at the recommended temperature,
will effectively cool the organ and lower its metabolic requirements.
Similar IFUs for other solutions state: ``do not freeze'' and ``do not
use if frozen.'' Thus, it is well recognized that temperature control
is a key necessity in organ transportation systems, and should be
continuously monitored and recorded.
(C) OPTN Policies should require OPTN members to develop written
protocols for recording temperatures during transport,
including corrective actions for deviations from recommended
temperature ranges.
Paragonix recommends that OPOs and transplant centers develop written
protocols and/or regulations to collect data regarding the temperature
of preservation solutions. Additionally, Paragonix recommends the
placement of corrective actions should the monitored temperature be
observed lower or higher than required by the labeling of the FDA-
cleared preservation solution. Transport temperature data would be easy
to obtain, does not require any laboratory testing or interpretation of
findings, and is consistent with the growing use of innovative
mechanical technologies used in organ transport. There would be no
inherent additional burden on the OPO or transplant program to collect
this data. This data can be analyzed to review the likelihood of
temperature control during the transportation of organs and its impact
on post-transplant organ function.
(D) OPTN policies should be developed to require the tracking of organs
during transport.
Of considerable concern, the inability to track an organ with any
confidence during its transport between donor and recipient was voiced
repeatedly at the Senate Finance Committee Hearing on August 3, 2022.
Sadly, many noted the comparison to a consumer's use of DoorDash, ``who
knows where my food is,'' and the lack of similar tracking abilities in
something as critical as organ transportation.
Paragonix wishes to call attention to the newer technologies that can
easily and aptly track organs during transport with confidence and
accuracy. In developing its own tracking system, the Paragonix App
allows users of the Paragonix organ preservation systems to (1) utilize
Bluetooth technology for pairing with Paragonix organ preservation
systems for real-time monitoring and data collection; (2) monitor GPS
tracking so organs are not misplaced or lost; (3) log key clinical
events in real-time to minimize communication between coordinator and
transplant hospital; and (4) rely on HIPAA compliant communications
platforms to keep all parties informed in real-time. This type of
technology simplifies an enormous amount of work, time, and resources
traditionally expended by personnel. It eliminates outdated, subpar
methods of tracking organs, streamlines the process more efficiently
across the country, ensures a consistent and readily available
``picture'' of the organ during transport, and minimizes the risk of an
organ being lost.
Tracking systems that provide similar advantages should be routinely
used by OPOs and transplant centers and, if not standardized, at a
minimum include a baseline number of capabilities that eliminates the
chance that organs will be lost or misplaced during transport.
(E) OPTN Policies should require, and organ procurement and transplant
programs should adopt, the collection of ``ischemic time'' data
during organ transport.
The transplant community has historically placed considerable emphasis
on the donor organ's ``ischemic time''--the time between the cross-
clamp of blood flow to the donor organ and the in situ reperfusion in
the recipient. Organ allocation policies have been based, in part, on
unique ischemic times for each organ type; however, the actual time the
organ spends within an organ preservation device is not documented.
OPTN policies should require data collection and reporting of
``ischemic time'' during organ preservation and transport. This data
should be part of the donor record.
In closing, Paragonix appreciates the opportunity to provide this
Statement for the Record to be officially entered into the Senate
Finance Committee's record. It is deeply concerning that challenges
exist in the transportation of human organs for transplant that can be
readily eliminated by improvements in transportation protocols that are
reviewed and regulated by the FDA and accessible to all within the
field.
Please contact me at [email protected] with any additional
questions regarding our concerns and recommendations.
Respectfully,
Lisa Anderson, Ph.D.
President and CEO
______
Science in Donation and Transplant
791 Alexander Rd.
Princeton, NJ 08540
August 16, 2022
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Chairman Wyden and Ranking Member Crapo,
Thank you for this opportunity to respond to the issues raised
during the August 3, 2022 presentation concerning the United States'
Organ Procurement and Transplantation Network before the Senate Finance
Committee. Our organization, Science in Donation and Transplant
(SID&T), shares the commitment of the physicians, patient advocates and
donation professionals who labor daily to make the miracle of
transplant work. This commitment includes the study of ways to improve
the nation's system of altruistic organ donation and transplant, a
system which is, already and without question, the best opt-in system
in the world. SID&T understands that the foundation of a system based
on altruism is public trust. We are concerned that certain actions of
the Senate Finance Committee, and the process of one-sided vituperative
attack, risks damaging this trust, and that this attack is not designed
to further the goals of system improvement, but rather engenders
mistrust and threatens the peer-reviewed scientific evidence based
quality-enhancing processes.
Congress recently charged the National Academies of Sciences,
Engineering, and Medicine (NASEM) to examine and recommend improvements
to research, policies, and activities related to deceased donor organ
procurement, allocation, and distribution.\1\ The congressional
language requested that the report include recommendations to update
the Organ Procurement and Transplantation Network's (OPTN's) policies
and processes. NASEM took up this challenge and issued its report
earlier this year, making targeted recommendations for further study,
not only of the OPTN, but of the OPOs and transplant centers and
physicians that make the miracle of transplant a reality. The Senate
Finance Committee hearing, the report for which was drafted before the
hearing was even held, added nothing to the worthwhile and serious
project of NASEM to save more lives, more equitably. Instead, it
damaged efforts to ascertain quality in an irresponsible effort to
diminish the public's trust in a system, which while imperfect, is in
need of support, not constant, privately orchestrated attack. If there
was an interest served by this hearing, it was not the public's
interest, or the interest of even a single patient on the waiting list.
---------------------------------------------------------------------------
\1\ Realizing the Promise of Equity in the Organ Transplantation
System (The National Academies of Sciences, Engineering, and Medicine
Consensus Study Report, 2022), https://nap.nationalacademies.org/
catalog/26364/realizing-the-promise-of-equity-in-the-organ-
transplantation-system.
The purpose of the ``hearing'' (which to be fair was more of a
public flogging), was for Chairman Wyden and Senator Grassley to voice
their concerns about the government contractor serving as the nations'
Organ Procurement and Transplantation Network (OPTN). United Network
for Organ Sharing (``UNOS'') is the private nonprofit entity that has
been designated to serve as the Network for the last thirty-eight
years. Federal oversight of UNOS' organ transplant policies is
conducted by the Health Resources and Services Administration
(``HRSA''), an agency within HHS (see 42 U.S.C. Sec. 274c). The
``hearing'', apparently intended as an expose of gross failures,
instead demonstrated the wisdom of Congress in 1984 when it put the
complex issues of organ donation and transplantation policy in the
hands of a non-profit representative member organization, made up of
---------------------------------------------------------------------------
experts, and not into the political sphere.
Experts in healthcare, such as peer-selected UNOS leadership know
how to review, evaluate, and assess factual claims. They also know how
to utilize data on frequency, severity and trends. Most importantly,
they know how to conduct reviews of facts in a manner best calculated
to obtain those facts, design better outcomes, and protect the
confidentiality of the patients involved. The Senate Finance
Committee's process and report flouted all of these standards and
practices, decimating its own statutory construct for a peer review
system in order to spew a few out-of-context sound bites designed not
to improve quality, but presumably to score media headline points.
Having already gnawed one leg of the table, by flogging the network of
non-profit OPOs, the second leg has now been chewed to a nub. According
to the Committee, the next leg will be the Executive Branch. We will
see if transplant centers and hospitals, as the fourth leg, will also
be cut off, leaving no institution left for the public to rely on to
ethically obtain organs from the altruistic deceased and their
families, and equitably share them nationally. The only solution
proposed to correct the ``failures'' of the world's most successful
system seems to be closure and de facto replacement by new, preferably
technology-based entities, and the entry of large for-profits into
Americans' most intimate moments.
While there are real problems to be addressed, by serious and
knowledgeable policy makers, the Senate Finance Committee seems to
prefer overlooking the remarkably few errors over several years, the
significant gains in organ donation and transplant, and ways for
improving the existing donor transplant infrastructure. The report on
which the hearing was based was released to the press, the non-UNOS
participants and others prior to the hearing, but was withheld from
UNOS, its membership, and the public until after the spectacle,
eliminating any opportunity to correct errors, provide context or
correct misleading contents. This process underscored the nature of the
hearing as an effort to sling mud, rather than to gather or examine
facts.
Rather than discuss the recommendations of the Congressionally
mandated and financed NASEM report, including the need for a lengthy
and fact-based examination of the OPTN's IT capability, the Senate
Finance Committee instead shared stories concerning medical errors
investigated by UNOS, without context, comparison or recommendation
about how another, different process would have changed any of the
incidents. While SID&T believes that any error is too many, we support
the process of peer review and corrective action that is the bedrock of
all healthcare quality efforts. UNOS' role is not to ``close poor
performers'', but rather to investigate and remediate the causes of
errors, in order to prevent them. While UNOS can recommend to HRSA that
action be taken against an OPO or transplant center, its statutory role
is not primarily punitive, but rather policy-making and prophylactic.
Public stoning, like the Senate Finance Committee meeting, has never
fixed a process error. By punitively revealing materials that were
openly shared in a peer review process, and sharing more than the
minimum necessary facts about these materials, Congress undermines the
peer review process created by the National Organ Transplant Act
created; a process that has saved more lives than any other nation's
donation and transplant system.
The OPTN is a membership organization that was established to be
``operated by the transplant community [. . .] with oversight by HHS.''
It is governed by a Board of Directors that is made up of
representatives from transplant centers, physicians, organ candidates,
donors, and recipients, along with organ procurement organizations
(``OPOs''), voluntary health associations, and members of the general
public. Members include OPOs, transplant hospitals, and other
institutions or individuals with an interest in organ donation. Each of
the witnesses paraded before the Finance Committee admitted to being
UNOS members, and each of them was unquestionably granted an equal
voice in policy decisions and processes. What the Committee failed to
share with the public is that most of the individuals testifying are
also engaged in litigation against UNOS, due to policy disagreements
between their private hospitals, and UNOS' representative members.\2\
---------------------------------------------------------------------------
\2\ See e.g., Adventist Health Sys./Sunbelt, Inc. v. United States
Dep't of Health and Hum. Servs., No. 320CV00101SMRSBJ, 2021 WL 973455,
at *20 (S.D. Iowa Mar. 12, 2021), aff'd, 17 F.4th 793 (8th Cir. 2021)
in which both Mr. Friedman's employer (Adventist) and Dr. Locke's
hospital (University of Alabama) sought to enjoin national organ
allocation policy, and where the Court ruled ``This case demonstrates
exactly why judicial review of agency action--particularly that based
on scientific expertise, complex data modeling, and detailed
statistical analysis--should be made in a slow, deliberate, and
cautious manner. Plaintiffs raise genuine policy disagreements [but]
they do not reach the high threshold required to block the enactment of
a federal regulation. [. . .] The short time frame under which the
Court is asked to rule on Plaintiffs' claims weigh strongly against [.
. .] second-guessing the technical expertise of a scientific body.''
Where the courts were leery of second-guessing technical expertise, the
Senate Finance Committee had no apparent problem with allowing one side
of a policy dispute to rail against the other without the burden of
evidentiary rules or the ability to cross-examine. See also, Callahan
v. United States Dep't of Health and Hum. Servs. Through Azar, 434 F.
Supp. 3d 1319, 1327 (N.D. Ga. 2020) in which a hospital affiliated with
Ms. Brockmeir's OPO sought unsuccessfully to enjoin the nationwide
implementation of UNOS and DHHS' policy for allocating donated livers.
SID&T does not have a comment on the wisdom or equity of the policy
position that UNOS' membership and HRSA approved, a policy
determination that has thus far been sanctioned by the courts, but we
note that presenting members engaged in active litigation against the
nation's plan to equitably allocate organs as being representative of
the transplant community as a whole was at least disingenuous, and
could be seen as disqualifying in any real ``hearing''. These witnesses
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had conflicts of interest that, at least, needed to be disclosed.
The risks of political actors engaging themselves in issues of
complex policy and healthcare systems without objective guidance were
on full display during the hearing. For example:
1. Although UNOS, a private non-profit entity, is currently the
contract holder for the nation's OPTN system, they will presumably be
in a competitive bidding posture against other private entities in the
near future. This hearing taints the process of public contracting by
injecting political pressure into what should be a fair bidding process
based on legal processes and measurable deliverables.
2. The Committee spouted facts and figures without context or
analysis, as though numbers have an independent magical meaning. When
discussing healthcare outcomes, stating that 70 deaths occurred is
profoundly misleading without the context of the number of successful
transplants over those seven years, which in this case is over 230,000.
It is also meaningless without the context of medical error rates in
general.\3\ Any health care outcomes reviewer would acknowledge that
the numbers compare extremely favorably to overall death rates due to
medical error (0.03% for deaths due to donation and transplant system
errors, compared to 9.5% for medical error rates overall). If the point
of the hearing was fact-finding, or general concern, as opposed to
lobbying for a new private contractor, this point would have been
shared.
---------------------------------------------------------------------------
\3\ According to a study by Martin Makary of Johns Hopkins, 9.5
percent of all deaths each year in the U.S. stem from a medical error.
Thus, as unacceptable as a single death due to error in transplant
system processes is, the rate of deaths due to transplant error is
indicative of high quality, not failure. See Medical error--the third
leading cause of death in the U.S., BMJ 2016;353:i2139, https://
doi.org/10.1136/bmj.i2139 (Published May 3, 2016).
---------------------------------------------------------------------------
3. The Senators, both in the report and in Committee, devoted much
time to stating that of the complaints submitted, too few were
forwarded to HRSA for decertification. Again, this presumes that
referral for decertification is the best or most appropriate response
to a complaint, rather than review, investigation, peer review, root
cause analysis and monitored effective corrective action. It also
assumes that all complaints are within UNOS' scope of action, and
meritorious. Again, without context, such facts are meaningless, worth
less than anecdotes. Health care quality does not arise from the
recounting of stories, it arises from close analysis of the cause of
mishaps, and full-throated participation from the professionals
involved, including doctors, nurses, OPO professionals and others. UNOS
promises that those who participate in fact-sharing will be protected,
because this is how quality is done in America.
Perhaps the worst thing accomplished by the Senate Finance
Committee in its presentation was the assault on health care quality by
its unnecessary violation of basic tenets of peer review and quality.
The Senate requested, and eventually obtained, the peer review
privileged material entrusted to UNOS under federal law. In managing
the OPTN, UNOS has established a Membership and Professional Standards
Committee (MPSC) that, among other things, conducts quality assurance
and peer review of OPTN members, and reviews events that are identified
as a risk to patient safety, public health, or the integrity of the
OPTN. Participation in the quality assurance and peer review process is
mandatory for continued membership in the OPTN. In reporting the
results of its ``investigation'', the Senate Finance Committee bared
these sensitive materials to the public eye in a manner and scope that
served no public purpose; there was not a single point made or scored
that could not have been made without revealing sensitive data.
The purpose of peer review protection is to ensure the very
transparency that the Committee states that it is trying to achieve,
and that Congress mandated as it passed such laws as the UNOS enabling
statute and the Healthcare Quality Act. With a single publication, the
Finance Committee broke the trust of the hundreds of witnesses and
evaluators who have participated in UNOS' standards' committees over
the years, and damaged the ability of this organization or any other
quality review organization in the future to do its job. As any health
care provider can tell you, revealing such information as patient age,
gender, diagnosis and date of death, all identifying factors which
could easily lead to public identification of donors or recipients
violates both law and basic privacy. This breach served no public
purpose except to cast aspersions on some but not all of the
participants in the chain of events leading to possible medical errors.
Again, without the full story, expert involvement and explanation, the
citation of these ten incidents serves no purpose but to re-state cases
which have already undergone complete review and disposition. Every
medical professional would agree that medical errors happen, and that
improvements in process are always possible. Reiterating this
conclusion in this hearing and report does nothing to further quality,
transparency or trust. It is merely sensationalizing the very real
tragedies of the patients who were injured, while adding nothing to the
journey toward quality.
Furthermore, the line of questioning related to access and equity
was simply hypocritical because a number of the Senators doing the
questioning had long since written letters to the Department of Health
and Human Services asking to expedite Trump Administration regulations
that will decertify OPOs and leave system vacuums in the organ donation
and transplant ecosystem, particularly among high risk populations.
We all have a shared desire to improve organ donation outcomes
through a more accountable, more equitable, and more productive organ
transplantation system. The NASEM report has provided us with the tools
to achieve these goals for all the patients and families who need the
system to work to its full potential. We owe it to them to heed the
consensus advice of our scientific community. We look forward to
working with you to follow the science and build the stronger, fairer
transplantation system that America deserves.
Sincerely,
Anthony Pizzutillo
Chair
______
Letter Submitted by Amy Silverstein
Living with a transplanted heart for 34 years has allowed me to
experience firsthand the history of the organ transplant system in all
its aspects, almost since the inception of the UNOS contract.
Over these decades, I've dug deep into the workings of transplant from
the inside out, giving back to the community by serving as an elected
patient representative on the UNOS board (and executive committee) for
six years, as well as an appointed patient rep on committees of
professional transplant organizations--the American Society of
Transplantation (AST), the American Society of Histocompatibility and
Immunogenetics (ASHI), and the Scientific Registry of Transplant
Recipients (SRTR). I have also written articles for transplant medical
journals, as well as two transplant-centered books that have been
published by major publishers. Given my substantial and uniquely
lengthy experience in transplantation, I feel a responsibility to share
my insights with the Committee in the wake of yesterday's
groundbreaking hearing.
What it's Like on the Waiting List
My transplant peer and friend Cal Henry did a wonderful job answering
your questions on this issue. I'd like to offer some additional food
for thought.Here's what it's like on the heart wait list.
I was a 24-year-old, second-year law student at NYU School of Law when,
from out of nowhere, I developed heart failure. The doctors said it was
a virus and all would resolve in about 6 months. But 6 months later, I
was rushed by ambulance to Columbia Presbyterian Hospital in New York
City, having had an episode of ventricular fibrillation that nearly
ended my life. I spent the next 2.5 months at Columbia, waiting for a
donor heart. I was told that in order to get to the top of the heart
waiting list (where it's most possible to get a donor heart), patients
generally need to have a 2-week life expectancy. I was in that
precarious zone. I was that sick. And yet, I waited 2.5 months for a
donor heart, hospitalized and dying.
The defibrillator cart careened into my room with gruesome regularity.
A swarm of physicians had the terrible task of trying to prevent my
heart from giving out. One morning, I flatlined--lost breath and pulse
for a good long time. I woke to the sound of crying nurses, one of whom
kept calling my name through tears, ``Amy! Amy!''
Being on the heart transplant waiting list is an experience no one
should ever have--watching and feeling one's own death. I experienced
my heart dying increasingly by the day. I lost my ability to get out of
bed (even to go to the bathroom) because it would set off another
deadly arrhythmia attack. I lost my breath: my lungs became like two
balloons poked with holes. At 24, I came to know death as much as any
living person can.
And most affectingly, to this day, I carried and carry the trauma that
comes with waiting desperately at the top of the heart transplant
waiting list.
To think that there was inefficiency, ill management, greed, mumbo
jumbo transportation glitches, and other slipups in the organ donation/
procurement system that might have elongated the intense illness and
trauma I experienced on the waiting list--is horrifying. To think that
I might have had my chest burned by defibrillator paddles for
additional days or weeks due to systematic failures--I shudder. And I
know many heart recipients who have been or are currently in as
desperate a position as I was: they shudder, too.
Please keep wait-listed heart patients in mind when getting tough on
UNOS and OPOs.
The Gratitude Problem
But of course, there is a happy ending to my wait-list story: I
received a heart. And this part of the transplantation is, I believe, a
major factor in why and how UNOS, OPO's (and other system aspects of
transplantation) have been able to perpetuate their failures so well
and for so long. I think of it as ``the gratitude problem''. It is a
phenomenon in transplant that did not come up at the hearing, but was a
constant underpinning, nonetheless.
Every transplant saves a life. Every transplant moves a patient from
organ failure to organ function. Every transplant delivers a patient
from death's door to life's promise. It's wonderful.
I can tell you--you lie down on the operating table, and you cannot
catch your breath, and you wake up hours later with pink cheeks and
toes (both had been gray from oxygen deprivation), an appetite (which
had disappeared), and an incredible sense of being full of air and
light. The death is gone. You are full of life. And enormous gratitude
and awe for the donor whose pulse has now become your own. A pulse that
saved you. Two weeks later, you're hiking. Six weeks later, I was
jogging.
And you're told by everyone you know: It's a miracle! And you find
yourself saying all the time: I'm so grateful!
Miracle and grateful become your transplant mantras.
There's a problem with this.
Transplant is not a miracle. It is the result of science and medicine.
And there is nothing miraculous about the life expectancy post heart
transplant: after my transplant in 1988, I was told if I was luckiest
lucky, I might eke out 10 years with my transplanted heart (the
statistics are still pretty much the same, 34 years later). And I soon
found out that the transplant medicines have serious side effects that
impair everyday life--and they also cause secondary diseases like
diabetes, high blood pressure and cancer. Worst of all, it became clear
that these immunosuppressive medicines, for all their side effects and
drawbacks, do not work to protect transplanted organs long term.
I bet you didn't know this, senators.
Transplant is a wonderful medical intervention. But it is no miracle.
Everyone I know who received a transplant around the time I had mine in
1988 is long gone. And I know donor families who are bereft because the
donated organs of their loved ones lasted only a few years. Patients
and donors alike are aware that transplant is no miracle. And yet
society expects us to speak the miracle mantra at every turn.
This makes for a silent, non-complaining transplant community of
patients. How dare we criticize UNOS or OPO's when we are living
miracles? How dare we voice our frustrations about antiquated
transplant medications and the gross underfunding of transplant
research by the NIH and FDA when it's a miracle that we are alive?
If there is anything miraculous about transplantation, it's this: organ
donation. That families or others can rise above their incredible grief
to donate an organ or organs at the most terrible moment of their lives
is, I believe, a miracle in humanism.
And this, too, acts as a silencer of patients' complaints: it would be
ungrateful to say something is wrong with the way transplant works--
administratively, clinically, medically.
Have you ever heard a transplant patient say transplant life is
incredibly hard? Debilitating? Frustrating? Heartbreaking? Cancerous?
Deadly? Or that complacency in transplant research/science has
maintained the status quo with the same antiquated, dangerous
transplant medicines just where they've been for the last 34 years, and
the lack of FDA and NIH funding has stymied progress?
Before yesterday's hearing, had you ever heard a transplant recipient
say the transplant system is a mess or that they deserve better than
the current system?
I rest my case.
Transparency
The hearing raised issues about UNOS' Membership and Professional
Standards Committee (MPSC) with regard to citing and censuring troubled
or failing OPOs. I'd like to point out another issue with the MPSC.
MPSC is tasked with managing low performing or failing transplant
centers as well. Last year, the head of the MPSC rallied my committee
at the AST in hopes that we might post a comment in the public record
in support of some changes to MPSC rules. My committee was not
satisfied with the changes. Namely, it was apparent that patients still
would have no way of knowing if their transplant center was in serious
or even dangerous violation of transplant center safety rules. It
seemed to me notable that when we go to restaurants, we see the safety
grade posted in the window (which allows us to gauge whether to, say,
have the seafood salad), but we know nothing about our transplant
centers. In many areas, there are several transplant centers to choose
from; patients, thus, need information to transparency to make an
informed decision about where to entrust their survival.
The MPSC chairman responded to my comment by saying ``Some things have
to stay behind the curtain.'' When I pushed and asked why, he said
something like, ``Patients don't need to know how the sausage is
made.''
I told him that I am alive for 34 years post-transplant precisely
because I have made it my business to know exactly how the sausage is
made--and to make my sausage choices very carefully. To which he
replied that the information found on the SRTR should suffice. But see,
it doesn't.
There is no way for patients to know if the transplant center they're
choosing for their care is failing or in serious violation of
transplant regulations.
Transparency is crucial to transplant health and well-being. But,
again, patients don't dare ask for it. They're miracles, after all. And
they are expected to be nothing but grateful. They have the seafood
salad they're served and hope for the best.
Thank You, Senate Finance Committee
I watched yesterday's hearing while texting with a transplant friend--a
kidney recipient who has had 3 kidney transplants over the last 31
years (again transplant does not last long). We shoveled popcorn into
our mouths and drank root beer, and we shared with each other our
feelings: aghast, excited, sad, thankful.
We have been waiting a long time for what we call ``truth in
transplant.'' The ``miracle and gratitude'' mantras attached to
transplantation have put a veil over the whole system. It takes courage
and grit to stand up to it (as the speakers yesterday attested to). My
transplant friend and I have had to shore up ours to speak up about the
various issues I've mentioned in this long comment. We've been rebuffed
and rebuked at times. We've also made some inroads.
As we see it, UNOS/OPOs is a crucial start of the process of seeking,
revealing, and attending to ``truth in transplant.''
We hope to live long lives with good quality. We hope to help all
patients do the same. To honor our donors, we must help these donor
organs live on and on. Thank you for your part in addressing the
systemic aspects of our quest.
Amy Silverstein
______
Starzl Network for Excellence in Pediatric Transplantation
4401 Penn Avenue
Faculty Pavilion, 6th Floor
Pittsburgh, PA 15224
https://starzlnetwork.org/
August 16, 2022
Chairman Ron Wyden
Ranking Member Mike Crapo
U.S. Senate Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
RE: Statement of University of Pittsburgh Medical Center (UPMC) in
response to August 3, 2022, Full Committee Hearing, ``A System in Need
of Repair: Addressing Organizational Failures of the U.S.'s Organ
Procurement and Transplantation Network''
Dear Chairman Wyden and Ranking Member Crapo:
We are writing on behalf of the families and pediatric transplant
providers of the Starzl Network for Excellence in Pediatric
Transplantation www.starzlnetwork.org.
The Starzl Network is a consortium of leading pediatric liver
transplant centers across the United States--including centers in
California, Colorado, Florida, Georgia, Illinois, New York, Ohio,
Pennsylvania, Texas, Virginia, and Washington State. The Network
closely integrates the patient and family voice along with transplant
professionals and other collaborators to increase transparency, develop
and share best practice, and improve outcomes for children undergoing
transplantation.\1\ The Network recognizes that delivering the best
care possible is an urgent task and adopting policies which align with
and enable such practice will benefit the whole of the transplant
community. Thus, we applaud the Committee for highlighting the voices
of transplant patients and their families in their recent hearing.
Incorporating the priorities and experiences of patients and families
who entrust their lives to this system is critical to understanding--
and improving it.
---------------------------------------------------------------------------
\1\ Perito E.R., Squires J.E., Bray D., et al. A Learning Health
System for Pediatric Liver Transplant: The Starzl Network for
Excellence in Pediatric Transplantation. J Pediatr Gastroenterol Nutr.
March 1, 2021;72(3):417-424. doi:10.1097/MPG.0000000000002974.
Network members have reviewed the testimony and wish to add several
---------------------------------------------------------------------------
areas of additional focus:
We appreciate the committee's focus on inequalities faced by
marginalized populations and those mentioned in the hearing--African
Americans and persons living in rural communities--were rightly
emphasized. However, disparity in care delivery is an unfortunate
reality for many other vulnerable populations and we welcome the
opportunity to specifically discuss why children deserve special
protection and priority in any efforts to improve the national system
of organ allocation.
Among pediatric patients listed for liver transplant in the U.S. today,
1 in 10 infants and 1 in 20 children die while awaiting a suitable
organ. This is an unacceptable reality. Particularly since in those
children that do receive a liver transplant--either a deceased donor
allocated through UNOS or a living donor--the vast majority survive and
thrive well into adulthood.
And while improvements can surely be applied to the current system, we
do strongly support the management of organ allocation by a single,
nationally organized, non-profit institution. Should the U.S. organ
allocation system be overseen by a for-profit entity, we are extremely
concerned that disadvantaged populations such as children, which
represent only 2% of the transplant wait list, would be further
deprioritized and undervalued.
Saving the lives of children awaiting liver transplant requires that
they have reliable access to offers of the rare organs that are right
for them. Here, the Committees focus on decreasing organ discard rates
presents another opportunity. To ensure that every child awaiting
transplant has access to the best possible care, we believe it is
critical that offers to vulnerable, under-represented populations--like
children--are not bypassed in favor of expedited placement from organ
procurement organizations (OPO) to adult transplant centers.
Having a well-coordinated, technologically efficient, and up-to-date
national transplant system is critical for getting children to life-
saving liver transplants. If OPTN functions are divided amongst
multiple contractors, it is imperative that there is an oversight body
to ensure that the work of all contractors is carefully aligned and
collaborative. For the pediatric liver transplant community, having
centralized data collection on ALL children awaiting transplant has
been critical to identifying those at highest risk of waiting list
death--and to designing policies that will prioritize and protect those
at-risk children.
Among other technological initiatives, we urge the prioritization of an
application programing interface (API) serving the integration,
coordination, and centralization of streaming data among the community
of stakeholders around the OPTN, including verified 3rd party IT
support systems, custom interfaces, and electronic health record
systems. Deeper, two-way integration of the OPTN data with verified
stakeholder systems create a fertile environment for innovation that is
both ancillary and complementary to the primary functions of the OPTN
technology ecosystem.
Notably, modification of the current system is possible and recent
policy changes have enabled modest improvements in access to care. With
contemporary adaptations, more than 60% of children now receive livers
that are ``shared nationally;'' meaning that the organ travels to the
child who needs it most. Since this change, more timely transplants
have occurred, and fewer children have died awaiting an acceptable
organ offer.
Unfortunately, other policy initiatives, such as prioritizing the
splitting of donor allografts so that a child and an adult can benefit
from one liver, have not been implemented. A ``split-first'' liver
allocation policy has proven efficacious in Europe resulting in
increased access to transplant for kids while maintaining access for
adults. Evidence suggests that outcomes are equivalent for both adult
and pediatric split-liver recipients. The Network would welcome the
opportunity to provide additional data and documentation on this topic
and firmly believe legislation that would mandate improved organ
utilization using split liver transplantation is a move that could
efficiently improve wait-list outcomes for both adults and children.
We also recommend optimization of the policy review and implementation
process. Currently, most policy changes from proposal to Board approval
may take 18-24 months and then still await programming or
implementation challenges. Efforts for improvement should focus on
ensuring stakeholder engagement, public review, and expert input while
still allowing for more rapid implementation of life saving policies.
Finally, to help children access the liver donors they need, OPOs must
have the training and resources to work with families of pediatric
donors, to appropriately manage pediatric donors, and to help deliver
the ``gift of life'' from those children and families to transplant
centers that can use them for children.
In the Starzl Network, our mission is to unite big data, technology,
patient advocacy, and transplant thought leaders to deliver the best
possible care and develop new, scalable solutions to pediatric
transplantation's most challenging problems. We believe the OPTN, and
the U.S. transplant system, can and should provide this same support to
all organ transplant candidates.
Respectfully submitted on behalf of the Starzl Network,
George Mazariegos, Chair
James E Squires, Co-Chair
______
Tennessee Donor Services
566 Mainstream Drive
Nashville, TN 37203
(O) 615-564-3642
(F) 615-564-3911
Website: tds.dcids.org
I am writing to CORRECT THE RECORD as it pertains to Dr. Jayme Locke's
testimony on August 3, 2022. She described 4 kidneys that, for various
reasons, she declined to transplant. The subject of my response is the
one noted to have had a ``botched biopsy'' pictured in image 4 of her
written testimony (https://www.
finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Finalv2.
pdf). She was seemingly unaware the kidney was successfully
transplanted elsewhere. When we got word it was being declined for the
specific reason, we were essentially 100% confident it was
transplantable. Given the importance of every hour of being outside the
body with no blood flow that Dr. Locke accurately described, we
retrieved it from her hospital over a 3-hour drive away, while
simultaneously attempting to reallocate it. Fortunately, another
transplant center approximately 4 hours away accepted and successfully
transplanted this kidney. As of August 5, 2022, the recipient was doing
``great'' according to that center and had a creatinine = 1.16, which
signifies excellent kidney function, 3 months post-transplant. Since
her testimony was based on specific anecdotes and not aggregate data, I
felt it necessary to correct the one anecdote I knew to be wrong.
Dr. Locke and her colleagues at UAB need to be recognized for their
superior kidney offer acceptance ratios (OARs). UAB has been a leader
in kidney transplantation in that regard for decades. If every kidney
transplant program in the U.S. emulated their offer acceptance
behavior, morbidity and mortality from end-stage renal disease would be
far less in this country. They are within 250 nautical miles of much of
our donation service area, which means their patients are likely to
heavily populate the match runs on many of our donors. As such, their
OAR undoubtedly benefits our organ transplantation rate, which is a
very important metric for us as an organ procurement organization.
Again, their acceptance practice is laudable.
In addition to the kidney described in her testimony, which was clearly
transplantable, we had another kidney declined earlier this year by
them for the same reason. Unfortunately, it was declined too many hours
after removal from the donor for us to reallocate it, and it was
discarded. We retrieved it for surgical review and unequivocally
concluded it was transplantable. This was a 37 year-old kidney donor
with normal kidney function and a normal biopsy, so it would have
likely gotten someone off dialysis for many years. So, despite being an
exemplary program in most respects, even model programs like hers
contribute to our tragically high kidney discard rate, which now is
approximately 30%. We respectfully reached out to her asking her to re-
examine their practice of assessing transplantability of biopsied
kidneys and to clarify how we can do a biopsy that they don't deem a
kidney non-transplantable. We want to help her help her waitlisted
patients. They deserve for us to be on the same page.
While it is not appropriate to make system changes based on anecdotes,
each of these anecdotes have many similar sister-anecdotes, which means
we have a worsening problem. The ones detailed here and ones Dr. Locke
eloquently testified to each equate to a life saved or lost, depending
on whether the system functions optimally. They also illustrate the
fact that all persons and steps in the process must function optimally;
failure by any person/step can derail the entire endeavor and
contributes to the problems of organ discard and wait-list mortality.
Moreover, each failure robs the donor and their family of an important
component of their legacy and/or emotional healing; the importance of
this cannot be overstated.
I have been in the organ donation/transplantation profession for over
25 years and have seen first-hand the amazing work that has resulted
from it. I have also witnessed the amazing progress made. Wait-list
mortality, however, remains unacceptably and unnecessarily high. It is
not overdramatic to say that each death represents a failure of our
current system, processes, and society.
All in the system--CMS, UNOS/OPTN, OPOs, donor hospitals, transplant
centers--are responsible for addressing failures, and all must be held
accountable to serve our mission to candidates on the wait list and to
donors and donor families. Meaningful accountability is lacking. We
all, including and especially you, are in a position to improve it; so,
thank you for your attention to this life-and-death matter.
If you have any questions regarding my thoughts or desire further
information from me, please reach out anytime.
Sincerely,
Marty T. Sellers, M.D., MPH
Organ recovery surgeon
Tennessee Donor Services
Former transplant surgeon
University of Alabama at Birmingham
University of Pennsylvania
University of Pittsburgh
Piedmont Atlanta Hospital
Emory University
Medical Advisor
Association of Organ Procurement Organizations
______
Transplant Families
24654 N. Lake Pleasant Pkwy #103-187
Peoria, AZ 85383
August 12, 2022
The Honorable Ron Wyden
Chairman
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510
The Honorable Mike Crapo
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo:
We are writing to you today as a coalition of community-based
organizations with a vested interest in pediatric transplantation. Each
of us has either watched our child slowly succumb to organ failure, not
knowing if they would live or die, or we have supported someone who has
been through this process. We, caregivers, have watched our childrens'
transplant teams work extremely hard to list our children on the
national organ waiting list, and, thereafter, they have provided
around-the-clock care and a shoulder to cry on in our most helpless of
hours. We have celebrated with our transplant teams when algorithm
matching is successful, and our child is offered a second chance at
life. We are especially thankful when a donor family makes a
heartbreaking and selfless choice to allow that second chance at life
for our loved ones. Many of these things were discussed in your hearing
on August 3rd, 2022. We commend the Committee on their commitment to
continuous improvement for a system that saves the lives of so many.
However, we couldn't help but notice that the most vulnerable
recipients were left out of consideration. We are writing to you to
consider pediatric patients in future proceedings regarding the Organ
Procurement and Transplantation System (OPTN) and its contractor,
United Network for Organ Sharing (UNOS).
We believe the current system needs improvement, as it is not
representative of people who live with organ failure: patients and
caregivers. Often the voices of one of the most marginalized groups of
organ failure are underrepresented throughout the system: children.
Time and time again, past policies created around organ procurement,
such as multi-organ transplants, have harmed pediatric patients. In
this example, multi-organ transplants take priority over those children
waiting for kidney transplant.\1\ Children need fair access to the
national system, and all involved need specialized training to work
with donor families who are losing a child and recipient families who
receive the gift of life. We all agree the list is too long, and organ
discard rates need to decrease, but not at the expense of children who
may be passed over in favor of adult transplant centers.
---------------------------------------------------------------------------
\1\ Organ Procurement and Transplant Network. [Ethical implications
of multi-organ transplants]. [https://optn.transplant.hrsa.gov/
policies-bylaws/public-comment/ethical-implications-of-multi-organ-
transplants/]. Accessed [August 2022].
---------------------------------------------------------------------------
A few items to consider are:
1. Incorporating the patient and family's voice in the OPTN's work
is critical! There should be appropriate representation on Committees,
in the discussion of policy priorities, and in considering patient-
centered outcomes and metrics--these advocates need to have adequate
training and support from the organization. They should not have to be
employed by a hospital, OPO, or the like to be considered. Sometimes
the best advocates that will give an objective point of view do not
work within the transplant system.
2. There was important attention in the Committee's Report and in
the hearing to that of minority groups, like African-Americans, which
are at risk for limited access to transplant and poorer outcomes. We
applaud the Committee for bringing attention to this and would like to
add that races other than white often make up over half of all
pediatric transplants, according to the SRTR donation and transplant
analytics page.\2\ Many of these are Hispanic families with no access
to Spanish patient education.
---------------------------------------------------------------------------
\2\ Scientific Registry of Transplant Recipients. [Donation and
Transplantation Analytics]. [https://www.srtr.org/tools/donation-and-
transplantation-analytics/]. Accessed [August 2022].
---------------------------------------------------------------------------
3. Currently, there are just 2,100 children on the U.S. wait list
for solid organ transplant--this is less than 2% of the total wait list
(1 in 100 on the kidney wait list, 1 in 20 for liver, 1 in 10 for
heart, 1 in 50 for lung). But every one of those children is on the
organ transplant wait list because they have a risk of dying without
transplant--and every one of them is likely to survive and thrive into
adulthood IF they get a transplant.
a. There was NO mention in the report, accompanying
documents, or the hearing itself about children on the
transplant wait list--another vulnerable population
that is critical to prioritize and protect.
b. In terms of the amount of patient years they have
lived, children are underrepresented in policy-making
but almost always see the full impact of policies, good
or bad.
4. A well-coordinated national transplant system is imperative for
these children. Because children are small, they have fewer options for
suitable donors. Well-organized, efficient, regional, and national
sharing of organs is thus critical for children and pediatric
transplant centers to obtain the right organ for every child.
5. Ensuring that OPOs have the training and resources needed to
approach families of pediatric donors--and to manage pediatric donors
and connect them to transplant centers that can utilize them
effectively for children--is an important need. There is little known
about OPO performance specifically as relates to pediatric donors.
6. In considering OPO strategies for decreasing organ discard
rates, it is imperative to ensure that potential offers to marginalized
populations--like children--are not skipped over in favor of expedited
placement along well-trodden paths from OPOs to adult transplant
centers. To save the lives of children on the transplant wait list,
they need to have broad, trustworthy access to offers of organs that
are right for them. This is specified in the ``Maximin'' principle as
spelled out in the Ethical principles of pediatric organ updated
November 2014 on the OPTN website.\3\
---------------------------------------------------------------------------
\3\ Organ Procurement and Transplant Network. [Ethical implications
of multi-organ transplants]. [https://optn.transplant.hrsa.gov/
policies-bylaws/public-comment/ethical-implications-of-multi-organ-
transplants/]. Accessed [August 2022].
Finally, we would like to address a few line items based on the
recommendations outlined in the Staff Memo on Organizational Failures
of the United States Organ Procurement.\4\
---------------------------------------------------------------------------
\4\ United States Senate Committee on Finance (August 3, 2022)
Staff Memo on Organizational Failures of the United States Organ
Procurement [https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Confidential%20Memo%20(FOR%20RELEASE).pdf].
While we encourage competition to improve any system,
specifically opening the contract to for-profit entities as the first
line item concerns patients and families as this will most certainly
drive costs up for organ transplant, pre- and post-care. As we have
seen in other for-profit areas, these costs are always shifted to the
consumer (or patient in this case), who already shoulders significant
costs when it comes to life-saving transplants. We hope that the
Committee will please take this into consideration.
The second line item stating that policy can be enacted by
several contractors is also concerning. Having centralized organ
allocation (i.e., a ``clearinghouse function'') is almost necessary in
order to keep seamless exchange to and from OPOs and transplant
hospitals. In other countries that have separate organ allocation
systems (that would mimic the several contractor's scenario), there
aren't easy or automated ways to share life-saving resources. Our
current data allocation system works well. It is the discards and
transport that is one of the most concerning items, along with access
to the wait list. We hope the solution that you are alluding to in item
4 is actually a centralized data store and allocation with potential
contractors involved at another point besides decisioning and would
like clarification between points 2 and 4.
All of the other suggestions we strongly support and are willing
to give specifics as to why.
Thank you for your compassion, time, and effort during these hearings.
It is clear that the Committee shares a desire for positive change
within our organ allocation system. We write to you in hopes that these
changes will always include and consider those it affects the most: the
donor and recipient patients and their families.
Sincerely,
Melissa McQueen
Parent to heart transplant recipient Dylan (14, transplanted 8 months
old)
Executive Director/Founder Transplant Families
Member, OPTN/UNOS Board of Directors
Member, OPTN/UNOS IT Advisory Committee/Network Ops and Oversight
Committee
Former Member, OPTN Data Advisory Committee
Former Member, OPTN Pediatric Committee
Families in Action Council Co-Chair, Advanced Cardiac Therapies
Improving Outcomes Network (ACTION)
PARTNER Project Lead--PCORI project facilitated by Starzl Network and
Transplant Families
Jennifer Lau
Parent to liver transplant recipient Nathan (10, transplanted 9 months
old)
Board Vice President, Transplant Families
Member, OPTN Pediatric Committee
Co-Founder/President BARE Inc.
Chair, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
PARTNER Project Lead--PCORI project facilitated by Starzl Network and
Transplant Families
PFV Member, Starzl Network
Stacy Hillenburg
Parent to pediatric heart transplant recipient (10 years old, 2 months
old at transplant)
Board Secretary, Transplant Families
Jill L. Brown, MPA
Parent and Living Donor to kidney transplant recipient Kylee (12,
transplanted at 3 years old)
Executive Director of NW Kidney Kids
Board Treasurer, Transplant Families
Riki Graves, MHA
Parent to heart transplant recipient, Juliana (8, transplanted at 17
days old)
Board Member, Transplant Families
Quality Initiatives Committee Member, Pediatric Heart Transplant
Society
Families in Action Council Member, Advanced Cardiac Therapies Improving
Outcomes Network (ACTION)
Joseph Hillenburg
Parent to pediatric heart transplant recipient (10 years old, 2 months
old at transplant)
Strategy Advisor, Transplant Families
Member, Scientific Committee, Pediatric Heart Transplant Society
Member, Families in Action (FACT), Advanced Cardiac Therapies Improving
Outcomes Network (ACTION)
Member, American Society of Transplantation Transplant Community
Advisory Committee
Member, Donate Life America Volunteer Committee
Former Member, OPTN/UNOS Board of Directors
Former Member, OPTN/UNOS IT Advisory Committee/Network Ops and
Oversight Committee
Former Member, OPTN Patient Affairs Committee
Former Member, OPTN Pediatric Committee
Ansara Piebenga
Parent to kidney/liver transplant recipient, Lauren (16, transplanted
at 16 months old)
Board Member, Transplant Families
Member, Improving Renal Outcomes Collaborative (IROC)'s Community
Engagement Workgroup
Ambassador and Volunteer, National Kidney Foundation
Sarah Vargas
Parent to pediatric two-time liver transplant recipient, Rosie (8, 9
months and 4 years of age)
Board Member, Transplant Families
PFV and Executive Steering Committee, Starzl Network
Erin Babin, LCSW
Parent to liver transplant recipient Elise (10, transplanted at 17
months)
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Anna Beeman
Parent to liver transplant recipient, Will (4, 6 months old at
transplant)
CEO of Liver Mommas and Families, Inc.
Christopher Beeman
Parent to liver transplant recipient, Will (4, 6 months old at
transplant)
Board Member, BARE, Inc.
Bonnie Bolin, RN, BSN
Mother to heart transplant recipient Raylan (2, transplanted at 3
months old)
Advanced Cardiac Therapies Improving Outcomes Network (ACTION)
Committee Member
Hospital Services Coordinator for Southwest Transplant Alliance
Jessica Callear
Parent to liver transplant recipient Hazel (6, transplanted 10 months
old)
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Hilary Camille
Parent to heart transplant recipient Shiloh (11, heart transplant at 2
years old)
Certified Grief and Trauma Coach
Advocate and Co-Administrator of Pediatric Heart Transplant Caregiver
Group, representing nearly 2,000 caregivers nationwide
Amanda Morcheles Goldstein
Parent to pediatric kidney transplant recipient (Lily, transplanted in
2016, 11 years old)
Co-Chair of the Improving Renal Outcome Collaborative's (IROC)
Community Engagement Workgroup
Serina Guerrero
Parent to heart transplant recipient Amaya (9, transplanted at 8 months
old)
Advocate and Co-Administrator of Pediatric Heart Transplant Caregiver
Group, representing nearly 2,000 caregivers nationwide
Jasmine Hollingsworth
Parent to liver transplant recipient, Kai (14, 4 months old at
transplant)
Founder/Executive Director of Liver Mommas and Families, Inc.
Amanda Kammes
Parent to current liver wait-list child, William (12)
Board Member BARE, Inc.
Sherrie Logan, BSc, BA
Parent to liver transplant recipient, Ashley (15, 2 years old at
transplant)
Co-Founder of Ashley's Angels (Third party fundraising initiative in
support of The Hospital for Sick Children)
Executive Committee Member Starzl Network
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Kimberly Matthews
Parent to liver transplant recipient, Isaac (18, transplanted at 5
months)
Member, Patient and Family Engaged Partners of SPLIT ( Society of
Pediatric Liver Transplantation)
Stephanie Mullett
Parent to pediatric liver transplant recipient (4, 10 months old at
transplant)
Program Administrator, Alagille Syndrome Alliance
CHOC Representative for PFV, Starzl Network
Brittany Munn
Parent to liver transplant recipient Caleb (8, transplanted at 6 months
old)
Board Member, BARE Inc.
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Jennifer Rodriguez
Parent of pediatric kidney transplant recipient Emily (3.5 years post-
transplant)
IROC Community Engagement Workgroup Member
Jordan Sarbaugh
Parent to liver transplant recipient Hudson (5, transplanted 9 months
old)
Co-Founder, VP BARE Inc.
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Krupa Shah
Parent of liver transplant recipient Jaisal (11, transplanted 15 months
old)
Member Parent and Family Voice, Starzl Network
Stephanie Skrede
Parent to liver transplant recipient Sophia (9, transplanted at 9\1/2\
months old)
Board Member, BARE Inc.
Vanessa Smith
Living Liver Donor
Parent to liver transplant recipient Rylie (15, transplanted at 10
months)
Member, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Jennifer White
Parent to liver transplant recipient Joshua (24, transplanted 14 years
old)
Co-Chair, Patient and Family Engaged Partners of SPLIT (Society of
Pediatric Liver Transplantation)
Tawanna Williams, CPC
Parent to heart transplant recipient Avery Grace (6, 2 years old at
transplant)
Diversity, Equity, and Inclusion Consultant
Certified Professional Coach
National Board Member/Medical Advisory Council
The Children's Heart Foundation
Parent and Advisory Board Member
Additional Ventures
Cheryl Witty
Parent to pediatric kidney transplant recipient Kimberly (transplanted
at 12 years old)
Co-Founder, Children's Transplant Initiative
Ross Witty
Parent and living kidney donor to daughter Kimberly (transplanted at 12
years old)
President/CEO, Co-Founder, Children's Transplant Initiative
Leslie Wyers
Parent to TWO pediatric kidney transplant recipients (Logan,
transplanted 10 years ago, and Kylie, transplanted 8 years ago)
Living Donor
Co-Chair of Improving Renal Outcome Collaborative's (IROC) Community
Engagement Workgroup
President NephHope Foundation
Past UNOS Patient Affairs Committee member
Kathleen Yago
Parent to heart transplant recipient Hana (7, transplanted at 21 months
old)
Member, Families in Action (FACT), Advanced Cardiac Therapies Improving
Outcomes Network (ACTION)
Family Advisory Council Member, Stanford Medicine Children's Health at
Lucile Packard Children's Hospital
Susan Zohner
Parent to pediatric heart transplant recipient (10 years old, 4 months
old at transplant)
Deborah Morrissey Pham
Parent to pediatric heart transplant recipient Madelyn (18,
transplanted at 7 weeks old)
Madelyn Pham (18)
Pediatric heart transplant recipient at 7 weeks of age
Diana D. Kendall
Executive Director
Transplants for Children
Rick Lofgren
President and CEO of the Children's Organ Transplant Association (COTA)
Representing more than 2,000 pediatric transplant families across the
country since 1986
Carolyn Salvador
Chief Executive Officer, Enduring Hearts
Diann Begley R.N., BSN
Program Administrator, Enduring Hearts
Lisa Yue
President and Founder
Children's Cardiomyopathy Foundation
______
Letter Submitted by a Transplant Surgeon
August 10, 2022
To whom it may concern;
I am a transplant surgeon at Thomas Jefferson University Hospital. I
have worked in transplantation for slightly more than 22 years. I am a
current OPTN/UNOS board member. My comments are based on my viewing of
the entire hearing. I have not had the time to review the accompanying
documents. I have gotten to know Brian Shepard during the time I have
served on the UNOS board and have found him to be an effective leader
who is unflappable and professional. Of course, he is not perfect and I
am sure that in the 10 years that he has been the CEO of UNOS, there
have been a few things that he wished he had done differently. All in
all, his leadership has been highly effective and 41K transplants while
the country is still struggling with a pandemic is testament to his
focused leadership. I found the hearing to be disheartening as someone
who has worked tirelessly in my profession. There was a gross over
simplification of the problems faced and a is characterization of who
are the heroes and who are the ``villains.'' Seeing an individual,
Brian Shepard who I know to be a force of good being vilified by
several U.S. Senators, was mockery of good governance and the fact that
it was bipartisan did nothing to lessen the blow. Fortunately, my State
Senator, Senator Casey, stood out as being reserved in judgement. There
were no real solutions proposed during this hearing. Dividing UNOS and
OPTN leadership perhaps might improve things, but I humbly submit it
would do little and on the whole the mission of UNOS and the OPTN are
largely quite aligned.
I would hope the Senators consider the following: (1) There has been a
profound push within the OPTN/UNOS leadership to encourage
diversification of the committee membership to ensure that all voices
are heard in making policy. Having a greater voice for patient and
donor representatives, has been a significant part of this push. These
moves have championed by UNOS leaders like Brian Shepard and Dr. Mathew
Cooper. (2) Geographic disparity with regards to deceased donor kidney
transplant access has been a great inequity within the U.S. and is in
violation of the final rule from 2000. OPTN policies have been placed
into effect to deal with this inequity which have caused strains on the
transplant system. Dealing with this inequity does require greater
deceased donor kidney travel and with travel comes risk. (3)
Sensational stories of deceased donor kidneys being incorrectly
surgically procured; incorrectly package leading to the organ being
frozen; mishandled during transport; or even run over by likely a poor
chain of custody for the organ are not the real story of the problems
that plague the system. That does not mean that they do not need to be
addressed, but these are not the real numbers behind kidney discards.
(4) Deceased donor kidney discards are a real problem and I know the
Senators recognize this. Many deceased donor kidneys do come with
sizeable risks including donor derived disease which was discussed
during the hearing.
I humbly submit my comments as a transplant surgeon and as citizen of
this country. I found the approach of several Senators to be overly
opinionated and devoid of balance that I expect of our country's
leaders.
______
University of Pittsburgh Medical Center
U.S. Steel Tower
Suite 6200
600 Grant Street
Pittsburgh, PA 15219
August 16, 2022
Hon. Ron Wyden
Chairman
Hon. Mike Crapo
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Dear Chairman Wyden and Ranking Member Crapo:
UPMC appreciates the Committee's diligence in reviewing and
spotlighting shortcomings in the nation's organ procurement, allocation
and transplantation systems.
Since 1981, UPMC Transplant Services has performed more than 20,000
organ transplant surgery procedures, including liver, kidney, pancreas,
small bowel, liver/small bowel, heart/lung, double lung, single lung
and multiple-organ transplants. UPMC is home to some of the world's
foremost transplant experts and has a long history of developing new
anit-rejection therapies, allowing organ recipients to enjoy better
health. Our program is also distinguished by its commitment to
discussing living donation with each patient who will benefit. Our
living-donor liver and kidney transplant programs have helped many
patients receive the gift of life through living donation.
Executive Summary
As a leader in transplantation, we share many of the concerns
raised by the Committee, and write today to include our perspectives
with respect to additional opportunities not addressed during the
hearing that United Network for Organ Sharing (UNOS) can implement to
drive system innovation and improvement and that can ultimately reduce
or eliminate wait-list mortality. First, UNOS' policies unnecessarily
deny children the most optimal care by failing to fully endorse and
support deceased donor liver transplant (DDLT) splitting, a practice
common in other countries that has effectively reduced wait-list
mortality elsewhere.\1\ Second, UNOS' policies do nothing to improve
adult and pediatric wait-list mortality by failing to promote and
implement living donor liver transplant (LDLT) options. Third, UNOS has
for years displayed a lack of sincere effort, and in some instances a
total breakdown in communication, in responding to UPMC and other
living donor allied groups in seeking to better educate the public
about the benefits of living donor transplants.\2\
---------------------------------------------------------------------------
\1\ For example, the United Kingdom's intent-to-split study policy
resulted in [a] dramatic reduction of wait-list mortality and was
accomplished with deceased donor liver transplant (DDLT) variant split
grafts. Sixty-five percent of pediatric liver transplants were
performed as split deceased donor grafts with excellent outcomes . . .
[and] most significantly, pediatric wait-list mortality was eliminated
during the last 4 years of the study period. Battula N.R., Platto, M.,
Anbarasab R., Perera M.T.P.R., Ong E., Roll G.R., et al. Intention to
split policy: A successful strategy in a combined pediatric and adult
liver transplant center. Ann Surg. 2017;265:1009-15.
\2\ See Addendum I, Index of Communications with UNOS on
Educational Initiatives Since 2018.
UNOS is slow to embrace these and other innovations in
transplantation. In UPMC's experience, it is very difficult to raise
pediatric voices within UNOS' committee structure, in particular, and
even more challenging to implement policy change in general. UNOS'
policy review process is lengthy and all too often years elapse between
peer-reviewed recommendations and policy implementation, increasing
mortality risk for adults and tragically, to even greater degrees, for
children.\3\ With respect to pending liver transplants alone,
approximately 20 percent of adults die while waiting, and in some
centers, up to 10 percent of children perish or get to sick for
transplant while waiting for transplant therapies.
---------------------------------------------------------------------------
\3\ The U.S. transplant community does regularly assess the impact
of policy change, although these assessments may take too much time and
often do not distinguish between pediatric and adult outcomes, limiting
their ability to drive efficient cycles of continuous improvement.
Mazariegos G.V., Soltys K.A., Perito E.R.; Editorial, Waitlist
mortality in pediatric liver transplantation: The Goal is Zero. Liver
Transpl 2022;00:1-2.
This mortality trend is unacceptable and could be substantially
improved or eliminated with robust support for DDLT splitting, with
substantial LDLT program implementation, and for other novel
transplantation innovations. Currently at UPMC, LDLTs comprise 65
percent of our total number of liver transplants (contrasted with the
national average of 6 percent), resulting in substantial increases in
transplant rates and reductions in wait-list mortality.
Innovations in Pediatric Liver Allocation
Deceased donor livers remain a limited resource, in the U.S. and
elsewhere. In the U.S., mortality of pediatric patients on liver
transplant waiting lists persists despite improved care for patients
and directed efforts to increase pediatric priority in liver
allocation. Organ allocation systems, like those managed by UNOS in the
U.S., play a primary role in determining wait time and likelihood of
transplantation on the pediatric waiting list. As long as wait-list
mortality persists, a need exists to use all available methods,
especially technical variant grafts that should drive increased
utilization of split-liver transplantation, which U.S. and
international data now suggest equivalent outcomes for both adult and
pediatric split recipients.\4\ However, under UNOS oversight, voluntary
splitting of livers to 2 recipients is rare in the U.S. and essentially
only occurs when the organ is first allocated to a pediatric
recipient.\5\
---------------------------------------------------------------------------
\4\ Hsu E.K., Mazariegos G.V., Global Lessons in Graft Type and
Pediatric Liver Allocation: A Path Toward Improving Outcomes and
Eliminating Wait-List Mortality, Liver Transpl 23:86-95 2017.
\5\ Id. at 89.
More generally, UNOS, in implementing the Institute of Medicine's
recommendations on Congress' Final Rule \6\ with respect to liver
allocation in 2002, adopted the Model for End-Stage Liver Disease
(MELD) and Pediatric End-Stage Liver Disease (PELD) scoring system,
which UNOS recognized did not accurately reflect the true mortality
risk of every pediatric patient on the waiting list. And so UNOS
created standardized exceptions that were designed to elevate the
priority score in those children who met certain criteria, and
additional nonstandard case-by-case exceptions reviewed by UNOS
Regional Review Boards.
---------------------------------------------------------------------------
\6\ The Final Rule mandated that an objective wait list of patients
be established. 63 Fed. Reg. 16296-16338 (1998).
By 2005, UPMC and others in the pediatric liver transplant
community observed an increasing dependence on standard PELD exception
requests for allocation.\7\ Further examination of the nonstandard
(case-by-case) exception requests found a five-fold increase,\8\ with
variation in approval rates from 65 percent (Region 5) to 100 percent
(Region 6).\9\ The case-by-case exceptions were associated with better
outcomes and lower mortality in children, but UPMC was then and remains
today concerned that such significant regional and racial variation in
case-by-case or nonstandard exception rates, with those of caucasian
identity and private insurance being more likely to benefit,\10\
creates an unfair imbalance in the system that UNOS should address in a
more consistent manner, ideally in a uniform fashion rather than a
provider-directed, case-by-case one, which would reduce both regional
and racial disparity.
---------------------------------------------------------------------------
\7\ Shneider B.L., Suchy F.J., Emre S., National and regional
analysis of exceptions to the Pediatric End-Stage Liver Disease scoring
system (2003-2004), Liver Transpl 2006;12:40-45.
\8\ Braun H.J., Perito, E.R., Dodge J.L., Rhee S., Roberts J.P.,
Nonstandard exception requests impact outcomes for pediatric liver
transplant candidates, Am. J Transplant 2016;16:3181-3191.
\9\ Id.
\10\ Hsu E.K., Shaffer M., Bradford M., Mayer-Hamblett N., Horslen
S., Heterogeneity and disparities in the use of exception scores in
pediatric liver allocation. Am. J Transplant 2015;15:436-444.
More broadly, UNOS' attempt at redistricting to resolve regional
disparity concerns like those discussed supra have shown little
significant impact upon pediatric allocation and transplantation
rates.\11\
---------------------------------------------------------------------------
\11\ Gentry S.E., Massie A.B., Cheek S.W., Lentine K.L., Chow E.H,.
Wickliffe C.E., et al. Addressing Geographic Disparities in liver
transplantation through redistricting. Am. J Transplant 2013;13:2052-
2058.
With the exception of the U.S., many other countries have
prioritized liver allocation in a definitive manner without detriment
to adult liver access. Revisiting splitting criteria is critical. UNOS
policy 9.8.A allows for regional splitting when the adult is the index
patient, but the policy has not resulted in a significant increase in
split grafts benefitting children. This lack of change in split
utilization in the U.S. suggests that pediatric prioritization will be
essential to improve split application.\12\ UNOS can and should
repurpose resources and policies to prioritize pediatric access to life
saving therapy, primarily by emphasizing the importance of split-graft
utilization.
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\12\ See supra FN 3 and 1, respectively.
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Innovations in Adult Liver and Kidney Allocation
UPMC believes that the Committee's investigation and hearing offer
a critical opportunity to raise awareness to what we strongly believe
is a key part of the solution to organ shortages, and, by extension,
long patient wait lists: living donation. We hope this letter augments
the Committee's work in acknowledging that certain diseases, like
diabetes, chronic kidney disease and end-stage liver and renal diseases
are on the rise and will drive an even greater need for kidney and
liver transplantation in the coming years.
It is our hope that UNOS establishes a substantial commitment to
broader education and public awareness about living donation for kidney
and liver transplantation, in addition to split-graft liver transplant
procedures like those discussed supra.
So far, UNOS has not shown this level of interest or commitment. In
fact, as UPMC has pressed UNOS for greater promotion of living donor
options, including the publication and dissemination of materials and
data to the public that make the case for living donation, UNOS has,
for the most part, stood down.
Either because of ambivalence or because of bureaucratic red tape,
UNOS' failure to move in the direction of advancing living donor
transplantation forced UPMC to act on its own.\13\ Understanding the
great need for public awareness and acceptance of living donor liver
transplantation, UPMC invested in and launched its own national
awareness campaign in 2018 to educate the public about the option.\14\
Our own results with LDLT clearly demonstrate the successes of
educational campaigns to promote living donation and beneficial effects
on patient outcomes. UPMC has partnered with other non-profit and
transplant-related organizations to help continue to promote awareness
and education of this life-saving procedure, and of the benefits of
living donation overall. We believe UNOS can, and should, join us.
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\13\ A description of UPMC's efforts to coordinate with and
convince UNOS of the benefits of novel transplant options since 2018,
like living donation, is attached as Addendum I.
\14\ See generally https://www.upmc.com/services/transplant/liver/
living-donor.
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Conclusion
As the Committee continues to examine possible structural
alternatives to the current UNOS-governed organ procurement and
allocation system, we strongly advocate that greater attention be given
to LDLT, split liver and novel transplant procedures that can increase
organ availability and reduce wait-list mortality. We are pleased to
submit this response to the Committee's hearing and stand ready to
further expand on our points and references described herein at your
convenience. Thank you for your ongoing attention to this matter.
Sincerely,
Abhinav Humar, M.D.
Clinical Director of the Thomas E. Starzl Transplantation Institute
Chief, Division of Transplantation in the Department of Surgery at UPMC
George Mazariegos, M.D.
Chief Pediatric Transplantation, UPMC Children's Hospital of Pittsburgh
Professor of Surgery and Critical Care, University of Pittsburgh School
of Medicine
ADDENDUM I
INDEX OF COMMUNICATIONS WITH UNOS
ON EDUCATIONAL INITIATIVES SINCE 2018
Fall 2018. UPMC submitted topics for a co-branded consumer webinar to
UNOS communications officials. UPMC met with UNOS designees and UPMC
was advised to provide content for review before UNOS would commit to
the webinar. UPMC developed content and submitted it but never received
return acknowledgement from UNOS on topics including (1) current status
of living donor liver transplantation in the U.S.; (2) shifting the
paradigm toward living donor liver transplant; and (3) novel
indications for living donor liver transplant.
Winter 2019. UPMC submitted copy to UNOS for a co-branded consumer-
directed brochure on living donor liver options. UPMC met with UNOS
officials and were advised that the project would be held pending a
rebuild of the UNOS website. UPMC did not receive any further contact.
Summer 2019. UPMC, Donate Life America, American Liver Foundation and
WedMD participated in an educational summit in Washington, DC to
educate the public about the shortage of deceased-donor livers
available for transplantation and living donation as an option to
reduce wait-list deaths. Brian Shepherd represented UNOS on a panel of
experts.
Summer 2020. UPMC submitted three patient stories and photographs for
the newly rebuilt UNOS website. The patient stories were only
temporarily posted publicly.
March 2022. UPMC convened a phone call with Brian Shepherd to
introduce a new idea for updating the multi-listing brochure that all
transplant centers are required to give waitlisted patients to include
information about living donation. UNOS agreed this could be part of
the brochure update but advised that it would be assigned to a work
group of the UNOS Patient Committee and could take up to a year to
complete because of the levels of review involved. UPMC followed up in
late May and received no response from UNOS. As an alternative, UPMC
has been working with contacts at Donate Life America to reach members
of the UNOS Patient Committee directly to facilitate approval and
publication of the new information about living donation. Success of
those efforts is to be determined.
______
Vanderbilt University Medical Center
1161 21st Avenue South
D-4316 Medical Center North
Nashville, TN 37232-2730
tel 615-322-2363
fax 615-343-5365
[email protected]
August 16, 2022
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Wyden, Ranking Member Crapo, Senator Grassley, and
Members of the Senate Finance Committee:
As the largest heart transplant center, largest donor hospital and one
of the largest overall transplant centers in the United States,
Vanderbilt University Medical Center (VUMC) would like to express its
gratitude to the Senate Finance Committee for holding an important and
compelling oversight hearing on the Organ Procurement and
Transplantation Network (OPTN). The hearing and related Committee
investigation highlighted numerous failings of the current OPTN
contractor, the United Network for Organ Sharing (UNOS), running this
central component of the nation's transplant system.
Members of the Vanderbilt Transplant Center have served on the Board of
Directors of OPTN/UNOS, have testified before Congress on related
subject matter,\1\ and held numerous national leadership positions in
transplantation over a period of more than 30 years. Based on this
experience, we strongly endorse the conclusions reached by the
Committee in its investigative findings, namely that there is
widespread and consequential failure by UNOS in managing the OPTN
contract. These failings most certainly have led to patient harm and
death, demanding prompt action by the Department of Health and Human
Services (HHS) to ensure stewards of the U.S. transplant donation and
allocation system immediately address deficiencies and improve service
for prospective transplant patients.
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\1\ Testimony of Seth Karp, M.D. before the U.S. House Committee on
Oversight and Reform, ``The Urgent Need to Reform the Organ
Transplantation System to Secure More Organs for Waiting, Ailing, and
Dying Patients'', May 4, 2021. Online at https://oversight.house.gov/
legislation/hearings/the-urgent-need-to-reform-the-organ-
transplantation-system-to-secure-more.
Although the problems are widespread, we believe significant
improvement can be made by addressing the following issues identified
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by the Committee:
(1) Lack of effective oversight of Organ Procurement Organizations
(OPOs):
Assessment: Many in the governance and leadership of UNOS are
also leaders of OPOs. Although the Final Rule Sec. 121.10 instructs the
OPTN to design appropriate plans and procedures to review the
performance of each member OPO, this is simply not occurring. In fact,
multiple Board Members are actively involved in blocking oversight of
OPO performance. Twenty years of high-quality research suggests the
number of donors in the U.S. should be 2-3 times the number of actual
donors, and that poor OPO performance is a principal cause of this gap
between what is, and what could be, the number of organs available for
transplant.
Recommendation: OPO performance oversight must be immediately
removed from the purview of UNOS. We applaud the new CMS guidelines
(CALC metric) for assessing OPO performance but stress the need for
active enforcement by HHS to ensure the intended goal of improving OPO
performance is being achieved. All stakeholders, including OPOs,
transplant centers and the OPTN must be held to account when we fail
patients.
(2) Obsolete technology:
Assessment: As the hearing elucidated in great detail, UNOS
technology is failing with respect to logistics, safety, usability,
reliability and efficiency. As Members of the Committee described, UNOS
lacks the core competency to improve the system.
Recommendation: A new contract should be issued after an open
bidding process for the OPTN commences. HHS should take necessary steps
to assure that HHS or another appropriate Federal oversight agency has
permanent rights of use and further development in the current
technology and software platforms used by UNOS, as well as those that
may be developed in the future by any new organization retained to
serve as the OPTN contractor.
(3) UNOS is a bad faith actor:
Assessment: Although the majority of members of UNOS are
motivated by a desire to serve the transplant community, the leadership
of UNOS subverts this energy to serve the interests and objectives of
UNOS, whether or not those interests ultimately will serve transplant
candidates well. When UNOS senior leadership reports to Congress that
only 10% of the UNOS budget is taxpayer funded and ignores the
significant contributions by the Medicare program (and in some cases
Medicaid) through payment of organ acquisition fees, it undermines the
transplant community's trust of the OPTN. When UNOS lobbies HRSA to
require anyone competing for the OPTN contract to have extensive
experience in running the OPTN, it eliminates competition and
perpetuates the same poor performance. When UNOS refuses to separate
the Boards of UNOS and the OPTN, it ensures that the OPTN cannot
separately hold UNOS to account for deficits in its operating
performance, and thus prevents HHS from regulating the OPTN contractor
effectively. When multiple members of the community are subject to
reprisals for speaking out against UNOS policy, as detailed by Dr.
Jayme Locke, an environment of fear and intimidation is created.
Recommendation: HHS and HRSA should immediately bid out the
OPTN contract and prevent any current or recent board member of UNOS
from taking on a leadership position in whatever organization may be
awarded the contract. In addition, HHS and HRSA should assure that the
boards of the OPTN and any new contractor retained to operate the OPTN
are separate and distinct, and that a majority of members of the OPTN
Board are independent from, and do not serve in the leadership or
governance of, any organization selected to serve as the OPTN
contractor.
In our view, these aims can only fully be achieved by HHS awarding a
new contractor that is fully committed to improving upon the status
quo. VUMC and the Vanderbilt Transplant Center stand ready to be a
resource to policymakers as you seek additional oversight and
accountability, and as you push for meaningful reforms of the OPTN.
Thank you for your commitment to this critical issue.
Sincerely,
Seth J. Karp, M.D.
Professor and Chair, Section of Surgical Sciences
Surgeon-in-Chief, Vanderbilt University Medical Center
Director, Vanderbilt Transplant Center
[all]