[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
VA & HUMAN TISSUE: IMPROVEMENTS NEEDED FOR VETERANS SAFETY
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HEARING
before the
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
WEDNESDAY APRIL 2, 2014
__________
Serial No. 113-62
__________
Printed for the use of the Committee on Veterans' Affairs
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.fdsys.gov
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COMMITTEE ON VETERANS' AFFAIRS
JEFF MILLER, Florida, Chairman
DOUG LAMBORN, Colorado MICHAEL H. MICHAUD, Maine, Ranking
GUS M. BILIRAKIS, Florida, Vice- Minority Member
Chairman CORRINE BROWN, Florida
DAVID P. ROE, Tennessee MARK TAKANO, California
BILL FLORES, Texas JULIA BROWNLEY, California
JEFF DENHAM, California DINA TITUS, Nevada
JON RUNYAN, New Jersey ANN KIRKPATRICK, Arizona
DAN BENISHEK, Michigan RAUL RUIZ, California
TIM HUELSKAMP, Kansas GLORIA NEGRETE McLEOD, California
MIKE COFFMAN, Colorado ANN M. KUSTER, New Hampshire
BRAD R. WENSTRUP, Ohio BETO O'ROURKE, Texas
PAUL COOK, California TIMOTHY J. WALZ, Minnesota
JACKIE WALORSKI, Indiana
DAVID JOLLY, Florida
Jon Towers, Staff Director
Nancy Dolan, Democratic Staff Director
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION
MIKE COFFMAN, Colorado, Chairman
DOUG LAMBORN, Colorado ANN KIRKPATRICK, Arizona, Ranking
DAVID P. ROE, Tennessee Member
TIM HUELSKAMP, Kansas MARK TAKANO, California
DAN BENISHEK, Michigan ANN M. KUSTER, New Hampshire
JACKIE WALORSKI, Indiana BETO O'ROURKE, Texas
TIMOTHY J. WALZ, Minnesota
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
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C O N T E N T S
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Page
Wednesday, April 2, 2014
VA & Human Tissue: Improvements Needed for Veterans Safety....... 1
OPENING STATEMENTS
Hon. Mike Coffman, Chairman...................................... 1
Hon. Tim Walz.................................................... 3
WITNESSES
Mr. Philip Matkovsky, Assistant Deputy Under Secretary for Health
for Administrative Operations, VHA, Department of Veterans
Affairs........................................................ 4
Prepared Statement........................................... 29
Accompanied by:
Dr. William Gunnar, M.D., National Director of Surgery,
Veterans Health Administration, Department of
Veterans Affairs
And
Dr. Michael Icardi, M.D., National Director of Pathology
and Laboratory Medicine Services, VHA, Department of
Veterans Affairs
Ms. Marcia Crosse, Director, Health Care U.S. Government
Accountability Office.......................................... 17
Prepared Statement........................................... 33
Mr. Frank Wilton, Chief Executive Officer, American Association
of Tissue Banks................................................ 24
Prepared Statement........................................... 51
QUESTIONS FOR THE RECORD
Questions From: Chairman Mike Coffman............................ 55
VA & HUMAN TISSUE: IMPROVEMENTS NEEDED FOR VETERANS SAFETY
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Wednesday, April 2, 2014
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Oversight and Investigations,
Washington, D.C.
The Subcommittee met, pursuant to notice, at 10:13 a.m., in
Room 334, Cannon House Office Building, Hon. Mike Coffman
[chairman of the subcommittee] presiding.
Present: Representatives Coffman, Lamborn, Roe, Huelskamp,
Benishek, Walz.
OPENING STATEMENT OF CHAIRMAN MIKE COFFMAN
Mr. Coffman. Good morning. This hearing will come to order.
I want to welcome everyone to today's hearing titled VA &
Human Tissue: Improvements Needed for Veterans Safety. This
hearing focuses on VA's continuing problems with the tracking
and management of biological implants which include skin
grafts, bone grafts, heart valves, tendons, and other products
that use human tissue.
In a previous hearing in January, this subcommittee
examined continuing issues regarding prosthetic procurement, in
particular VA's over-reliance on open market purchases that are
potentially the most expensive procurement method and may pose
the greatest risk to patient safety.
VA contends that waivers are necessary to accommodate
clinician preference for products with which they are familiar.
However, our investigation of this billion dollar industry
shows that there may be ulterior motives.
In this regard, over 57 percent of biological implants are
procured by VA as open market purchases, and we have found that
several VA clinicians serve on the board of directors of at
least one of the major suppliers to VA of biological implants
on the open market.
VA's failures regarding biological implants go well beyond
possible conflicts of interest in procurement practices. Our
investigation reveals that the problems include VA's failure to
adequately vet biological implant vendors to make sure that
they are registered with the Food and Drug Administration and
that they are utilizing best practices such as those
established by the American Association of Tissue Banks.
Even more concerning is that VA lacks any ability to
identify the sourcing of the material used in biological
implants and track it from donor to recipient. The lack of such
a track and trace system poses very serious and unnecessary
risks to patient safety.
Although it is very difficult to attribute adverse events
to tissue product contamination, one recent example of a
contaminated transplant shows the ramifications. According to a
report in the Journal of the American Medical Association, the
kidneys of an air force recruit from North Carolina who died
from a rabies infection in July 2013 were transplanted into a
Maryland veteran who later died from complications with rabies.
Illegal trafficking of human tissue jeopardizes the supply
chain of biological implants. A 2012 report from the
International Consortium of Investigative Journalists indicates
that trafficking of human tissue crosses international
boundaries.
One of the most egregious examples of such trafficking
within the United States is the case of a dentist in Brooklyn
who lost his license due to drug addiction and who then created
a massive scheme to plunder tissue from funeral homes including
from people who had died of cancer, HIV, and infectious
diseases. He would pay undertakers, falsify required records,
and then he would sell the tissue under the business name
Biomedical Tissue Services.
Significantly at least one of the alleged customers is a
current supplier to VA and has received repeated citations from
the FDA for cross-contamination issues. Apparently VA took no
action to address this major safety violation with that company
even after receiving a biological implant from the vendor.
GAO and the VA's Office of the Inspector General have
documented weak inventory controls that make it difficult if
not impossible for VA to identify the patients and to whom they
were implanted.
In its written statement, GAO found that VA uses informal
tracking systems that are not standardized or shared across
departments and that even when used are prone to error because
they rely on manual data entry.
In its statement for a previous related hearing in January,
GAO found that for some clinical specialties including
gastroenterology, interventional radiology, and pulmonary,
identifying information on implants was not tracked in any
system.
Given the incomplete and inaccurate data regarding
inventory control, serious doubts are raised about VA's ability
to identify patients in the event of contamination or a product
recall.
It is troubling to consider, but in an investigation in
March of 2012, VA's Office of the Inspector General found
expired products remaining on VA's inventory shelves.
Fortunately, the FDA has developed a unique device
identification system that if deployed by VA would facilitate
reliable tracking and tracing of biological implants.
I urge VA to implement this system and to develop an
automated inventory control system that is compatible with the
unique identifiers. VA needs to make VHA the premier health
care delivery system it aspires to be.
It should lead the Nation in the adoption of FDA's unique
device identification system for all types of biological
implants even before FDA's implementation deadlines.
The six million veterans served annually by VHA deserve the
highest standards of patient care in the Nation.
With that, I recognize Ranking Member Walz for his opening
statement.
OPENING STATEMENT OF HON. TIM WALZ
Mr. Walz. Well, thank you, Mr. Chairman, and thank you for
your continued care of our Nation's veterans and willingness to
make sure we do our job of oversight.
But I would also like to thank Ranking Member Kirkpatrick
for her work on this and for the opportunity to allow me to be
here today.
We are here to talk about VA's surgical and biological
human tissue implant purchases and the ability of VA to safely
track these. I am looking forward to exploring the progress
that VA is making in maintaining accountability of implants and
what impediments, if any, stand in the way of VA instituting a
system-wide policy to verify vendor VA registration.
Last year, nearly 60,000 tissue products were used at VA
medical centers. Ensuring that these are safe and reliable
needs the full attention of the VA and of this subcommittee.
Tissue implants can provide amazing relief to the suffering of
our veterans, but as with all these technological wonders,
there are risks that the chairman mentioned.
In January, we held a hearing to investigate VA's
procurement of surgical implants. There were a number of
shortcomings noted by the GAO including a lack of an automated
mechanism for tracking.
I look forward today to hearing about the progress VA is
making in this effort and what further steps are required not
only in the area of human tissue but in the larger area of
surgical implants and prosthetics. Implementing a system-wide
implant tracking system utilizing bar code technology for blood
products are important steps to ensuring patient safety.
I note that the VA has established a working group to look
into improving management of biological implants. I would like
to hear today whether VA can move faster to develop a single
comprehensive tracking inventory management system for all
biological implants.
Finally, I look forward to hearing what system VA has in
place so that implants can be tracked and appropriate action
taken if the FDA issues a recall. In addition, I look forward
to hearing how VA will ensure vendors are registered with the
FDA.
Last week, we held a legislative hearing on a draft bill,
Biological Implant Tracking and Veterans Safety Act of 2014,
addressing some of the concerns of Congress and expanding the
implant tracking requirements.
Unfortunately, VA was unable to testify on the draft at
that time. I look forward to hearing your thoughts today.
Mr. Chairman, I want to thank you again for your work on
oversight. And with that, I yield back.
Mr. Coffman. Thank you, Mr. Walz.
I ask that all Members waive their opening remarks as per
this committee's customs.
With that, I invite the first panel to the witness table.
On this panel, we will hear from Mr. Philip Matkovsky,
assistant deputy under secretary for Health for Administrative
Operations, Veterans Health Administration.
He is accompanied by Dr. William Gunnar, National Director
of Surgery for the Veterans Health Administration, and Dr.
Michael Icardi, National Director of Pathology and Laboratory
Medicine Services for the Veterans Health Administration.
Please come to the table.
Mr. Matkovsky, your complete written statement will be made
part of the hearing record and you are now recognized for five
minutes.
STATEMENT OF PHILIP MATKOVSKY, ASSISTANT DEPUTY UNDER SECRETARY
FOR HEALTH FOR ADMINISTRATIVE OPERATIONS, VETERANS HEALTH
ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY
WILLIAM GUNNAR, NATIONAL DIRECTOR OF SURGERY, VETERANS HEALTH
ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS; MICHAEL ICARDI,
NATIONAL DIRECTOR OF PATHOLOGY AND LABORATORY MEDICINE
SERVICES, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF
VETERANS AFFAIRS
Mr. Matkovsky. Mr. Chairman, Ranking Member Walz, and
Members of the committee, thank you for the opportunity to
appear before you this morning to discuss the Department of
Veterans Affairs' sourcing, procurement, tracking, and
oversight of its biological implant purchases including implant
tissue.
I am joined today by Dr. William Gunnar, national director
of Surgery, and Dr. Michael Icardi, national director of
Pathology and Laboratory Medicine Services.
Over the last eight to ten years, utilization of biological
implants including implant tissue has grown significantly
resulting in the doubling of dollar value of the biomaterials
market since 2004.
However, the field of biological implants continues to
rapidly evolve with new advancements in tissue fabrication,
nomenclature standardization, and industry governance.
In procurement, VHA recently completed its transition of
procurement duties from prosthetics purchasing agents. This
transition resulted in the removal of warrants from staff who
are not contracting officers and procurements above the micro
purchase that are now performed by our contracting officers
with warrants.
While Title 38, Section 8123 grants broad authorities to
the secretary of VA for the procurement of prosthetics
appliances, we have now integrated our prosthetics purchasing
authority with FAR and VA acquisition regulation provisions.
In this integration, the 8123 is primarily employed as a
statutory basis for a FAR part 6 justification. This is for
other than full and open competition.
What this means in practice is that if a clinician who has
been trained on a particular product has felt comfortable with
that product, then they can be assured that a government
procurement official will not restrict them from selecting and
using a product with which they feel competent for their
patients.
This application of our prosthetics authority enables
clinicians to make choices based on their medical determination
of what is best for our patients.
In complicated systems, it is always possible to improve
our management and tracking controls. We have made significant
progress often setting industry standards in tracking
medications, blood products, and implants. However, we do
acknowledge we can improve our tracking and inventory
management of biological implants including tissue.
In 2013, the Food and Drug Administration published a final
rule requiring most medical devices distributed in the U.S.
carry a unique device identifier or UDI and that information
concerning each covered device be submitted to the global
unique identification database.
The rule does contain a staggered compliance date. With the
advent of this new identifier, systems should be able to track
a specific item and associate it with the manufacturer. This
will improve adverse event tracking and will further enable
greater automation and product recalls.
However, I do need to be clear. This rule does not yet
apply to biological and tissue implants. VHA will be
participating with the FDA this summer in the formulation of
this policy and applying it to biologics and tissue implants.
With the more recent developments in the biological
implants industry and in reaction to external audits and
reviews as well as this committee's oversight, VHA has
established a work team to identify improvements to our
sourcing, management, and control of biologics.
This work team is expected to complete its review and
recommendations in the third quarter of fiscal 2014. We will
review their product and then begin the process of establishing
a standard protocol across each of our medical centers.
Similarly we have charged a work team to develop a set of
new national contracts for biological implants. This work team
is in the phase of procurement that we call the development of
requirements. The team is comprised of clinician leaders as
well as logistics and prosthetics specialists.
We expect our procurement packages to establish stringent
quality standards not available on previous federal supply
schedule contracts.
My personal performance contract contains the expectation
that this solicitation phase for this new procurement action
will be initiated prior to the end of fiscal 2014.
In conclusion, our mission in VHA is the delivery of
timely, quality, patient-centered care. Our systems must apply
controls where appropriate to further this mission.
We acknowledge we must seek to find and implement
improvements to our management, tracking, and control of
biologics items. We are committed to making necessary changes
to our policies, practices, and systems to improve.
We must, however, ensure our procurement system achieves
and complies with all federal laws and regulations, but that it
also achieves a balance. It must enable our physicians whom we
trust with the most critical decisions to apply clinical
discretion when needed to provide veterans with individualized
health care.
Mr. Chairman, this concludes my testimony. I appreciate
this committee's continued interest in and care of the health
and welfare of America's veterans. At this time, my colleagues
and I are prepared to answer your questions, sir.
[The prepared statement of Philip Matkovsky appears in the
Appendix]
Mr. Coffman. And thank you for your testimony.
Dr. Matkovsky, there are at least ten VA doctors on the
board of directors for the Musculoskeletal Transplant
Foundation of which VA has purchased over $1 million in
biological implants over the past 15 months.
Is this relationship a conflict of interest?
Mr. Matkovsky. Mr. Chairman, thank you for your question.
All of our employees are required to declare by our ethics
policy any conflicts of interest. As a matter of fact, in each
of our clinical committee meetings, they are required to
announce any conflicts of interest.
We researched some of these assertions. We went back and
identified each of the clinicians and we did not find in our
review any involvement in the procurement decisions associated
with the MTF organization.
I would add that the Musculoskeletal Transplant Foundation
is a nonprofit organization which I do believe is an AATB
accredited tissue bank.
Mr. Coffman. Thank you.
I think that the entity you just referred to did $4 billion
of business last year.
The criminal conflict of interest statute in 18 United
States Code, Section 208 prohibits a federal employee from
participating personally and substantially in a particular
official duty that will have a direct and predictable effect on
the employee's own financial interest.
Do the VA clinicians who sit on the board of biological
implant vendors violate this statute?
Mr. Matkovsky. I do not believe they did, sir. They are
required by policy to notify their management of any conflict
of interest, any boards they may sit on. And if they are
involved in a procurement decision that may be associated with
a firm with which they might be associated externally, they are
to recuse themselves from that transaction.
We did not find an instance where they were involved in
that procurement decision.
Mr. Coffman. Mr. Matkovsky, according to your memo dated
May 23rd, 2012, surgical implants are required to be bought on
the FSS or federal supply schedule unless a waiver is obtained
from the director of the National Acquisition Center.
Is a waiver obtained from the director for every surgical
implant purchased on the open market?
Mr. Matkovsky. In many cases, the biological implants that
are acquired are below the micro purchase threshold. Since
those are not going to be affected by a procurement
organization or contracting officer, many of those do not have
a waiver.
I will point out that in, I believe it was fiscal 2013,
there were 21 waivers. That may not sound like a large number,
but that is a waiver for a contract that would be a local
contract that would cover many purchases.
We have actually requested that our contracting officers
increase their scrutiny to ensure that anything that we are
acquiring that does not conform to the VAAR, this is the VAAR
hierarchy, that we have waivers for that. We are able to
monitor that now much better in the procurement organization.
Mr. Coffman. My understanding, it is something like 97
percent of the purchases are micro purchases?
Mr. Matkovsky. I think in the biologics area, it is about
95 percent.
Mr. Coffman. It just seems to me, I mean, that there is an
intentional effort to negate the rule by virtue of doing the
smaller purchases.
Mr. Matkovsky. Well, you know, with all due respect, sir, I
do not know that that is necessarily the case. In many cases,
these are acquired in time for a surgical procedure. So a
surgeon may be going into a procedure and will acquire that
item.
A dermal graft may be a micro purchase, but in some cases,
some of our dermal grafts have to be stored at negative 43
degrees Fahrenheit and, you know, the storage requirement for
that would negate us having it around for quite a while.
So you will acquire it in time for the procedure and we are
not keeping a significant stock of these items. So you will see
smaller purchase items.
Having said that, I want to be clear. We do want to have a
clinically cleared national contract available for us that
includes certification and accreditation and then promulgate
that contract for broad use.
Mr. Coffman. Mr. Walz.
Mr. Walz. Thank you, Mr. Chairman.
In your testimony, sir, you said VA is developing implant
tracking in cardiology and surgery and wants a single
comprehensive tracking system.
What is the time frame on getting to that single
comprehensive tracking system?
Mr. Matkovsky. Some of that will depend, Congressman Walz,
on our analysis. We have a group that is meeting face to face
next week. We do expect the recommendations in the third
quarter.
Some of what we are going to have to do is going to require
an interface to VistA, CPRS. Those interfaces to VistA will
have to be an IT funded requirement. As we went through our IT
requirements exercise for fiscal year 2015, implant tracking
and alerting was one of our higher priority items to get
funded.
But there will be some requirement on IT funding to be able
to deliver the completed system. I will tell you that as we
looked across what we are doing in some of our networks today,
there are commercial systems that are bar code enabled systems
that would allow us to better track both in the OR setting and
in the outpatient setting.
That may be possible. It may be possible for us to acquire
that with medical resources which might expedite that portion
of it. The connect to VistA, though, would require an IT fix.
Mr. Walz. Well, I am probably not telling you anything new,
but coming here with IT funding request is going to be met--I
am not sure. I will let my colleagues use the words they will
use on that, but this is a difficult one because of the roads
we have been down.
So I ask you to make sure that we have evaluated that
thoroughly because more requests for more IT when we still do
not have seamless transition between DoD, that is a tough sell.
I hear what you are saying, though.
Other than the part played by the National Center for
Patient Safety, VA has taken a somewhat decentralized approach
to tracking.
My question to you is, and I started to research this, I
represent the district that has the Mayo Clinic, how would an
organization like that do this as opposed to the VA, if you can
give me your insights on how that works, if you know?
Mr. Matkovsky. I am going to defer to some of my colleagues
here. And in response, we will answer two questions. I think
one of them is our recall process and then the question might
be, you know, our tracking in blood and the extension of the
blood tracking that we do today, we have, frankly, been doing
that for decades down to the patient level. And I will ask Dr.
Icardi to weigh in.
We have a three-step process for recalls. The first
question is, do we have this item in our inventory? Is it
something we have acquired? And on a recall, the first action
is to pull from inventory.
Then there is a clinical decision to determine whether or
not there is clinical significance for a patient directly and
then lastly the patient involvement and close out with the
patient which may involve tracking. It may involve removal of
an implant, for instance, a hip.
But let me ask Dr. Icardi to walk us through a little bit
of what we have done in the blood bank since 2006.
Dr. Icardi. Since 2006, we have had the VBECS system up
which allows us to go through and track all of our blood
products and combined with what the FDA and CDC does. That
allows you to track a blood product from when it is initially
collected all the way till its final disposition.
Mr. Walz. That is how a large private sector would do the
same way?
Dr. Icardi. Yes.
Mr. Walz. Best practice that way?
Dr. Icardi. Yes.
Mr. Walz. Okay. Okay. The next one I have, and this one I
am still trying to wrap my mind around, in the GAO report, it
states that there is a possibility that VA has utilized tissue
implants from vendors that have not registered with the FDA.
My question is twofold again. How is that happening, how
does it happen, and do you believe that it is happening outside
the VA also? Is this a system-wide problem in health care
delivery because this one seems pretty staggering to me that
that would be allowed to happen? So, please.
Mr. Matkovsky. Quite frankly, I am not quite sure the
nature of that finding. I think that the nature of that finding
would be that in review of the recorded purchasing transactions
that some of them, they would indicate that the record keeping
might indicate that it is not an FDA. I do not have any
indication to confirm that, quite frankly.
Do I think it is a broader issue across the health care
industry, I cannot opine.
Mr. Walz. So what you are saying is they may have been or
they should have been registered, we just do not have the
paperwork to prove that they were registered?
Mr. Matkovsky. No. I think it is just a matter of record
keeping, ensuring that what we have in our national prosthetics
patient database is the valid recording. And if it contains
information that may be subject to human error, then there is
some question as to whether or not that would be----
Mr. Walz. Does it concern you that that might be the case?
Mr. Matkovsky. Well, I think we want to have a standard
national contract that we know has clinical input into it,
quite frankly. So, yes.
Mr. Walz. Okay. With that, I yield back. Thank you, Mr.
Chairman.
Mr. Coffman. Dr. Roe.
Dr. Roe. Thank you all for being here today.
And let me just go over a few things. And first of all,
these biologics and as I have looked into this, and obviously
they had been tremendous for patients. There is no question
about that.
I think one of the concerns we had and certainly in my
State of Tennessee is when we had an outbreak of some
contaminated epidurals medication that caused some people to
die. It was contaminated with a fungus and we were able to
trace that right back to its source, stop that and not use that
source.
The way I understand this from the GAO report and the part
that I read is that when you buy, some of the vendors that you
buy from have not been FDA approved; is that correct?
Mr. Matkovsky. I think that is in the report, I believe,
yes, sir.
Dr. Roe. That is not what I asked. I said is it correct?
Mr. Matkovsky. I do not know that it is correct, sir.
Dr. Roe. Okay. So you do not know for sure that it is or is
not. Okay.
Mr. Matkovsky. Correct.
Dr. Roe. Fair enough. And when these are placed, do you
tell the patients that they are getting a biologic? Do they
understand?
And let me explain where I am coming from. Because the
patients expect us, the system to make sure what goes in them
is safe, they expect us to have done our due diligence.
And if you look at tissue, allograph tissue, it can come
from foreign sources and some of those sources, and I have done
a little bit of research on that, one story from the Ukraine
and they had bins of tissue that was contaminated.
And what patients do not understand is this has to be
retrieved under certain conditions. And there have to be people
who are excluded who have cancer, who have any infectious
disease. Certainly the case that the chairman brought up with
rabies obviously should never have been. That is a different
system, tracking system of organ transplantation as opposed to
allograph transplantation.
But patients have that right and if that happened, if a
patient was contaminated by, let's say, hepatitis C, hepatitis
B, does the VA have a system that could track those patients
down?
Mr. Matkovsky. We do. It is important to note as we----
Dr. Roe. You are saying to me now that even though some
hospitals do not have a system that is tracking it, the VA
could track that from its source of origin to that individual
patient? You all have that system in place? That is good if you
do.
Mr. Matkovsky. I will walk through the scenarios that we
have that I can state definitively, Congressman Roe.
Since roughly 2008, there have been 13 recalls for
biologics that have triggered a National Center for Patient
Safety action within the VA. Six of those we had in our
inventory.
I am going to ask Dr. Gunnar to walk us through a little
bit about that recall process, but it is important to note that
in six of those that we had, we had in one of our medical
centers some inventory.
There is then a clinical determination as to whether or not
we need to notify the patient, and I am going to ask Dr. Gunnar
to elaborate on that. But in those recall instances, we have
been able to track the inventory, facility, and then take
clinical action.
Dr. Roe. Just a commentary before he does. I would
absolutely think you ought to notify the patients. I mean, that
is the most affected person. And I think out there now, if I am
a patient that got a new anterior cruciate ligament and I found
out later that the source was contaminated, I think it would at
least be fair to tell that person so they could be tested.
And we have been down this road before with contaminated
colonoscopes and other things. This is not new.
Mr. Matkovsky. In a couple of these cases, the recall
itself was rescinded.
Dr. Gunnar. I can assure you, Congressman Roe, that in
those situations, we would--there is policy, VHA policy
regarding disclosure of adverse events and National Center of
Patient Safety would work with the program offices as well as
the facilities and the providers to identify the individuals
who received that implant and make sure that the correct
clinical action occurs.
Dr. Roe. But what I am hearing from you all is is that
there is a system to do that now, so----
Dr. Gunnar. Correct. There is a system in place to do that
now. What we do not have is that single button and I think that
is what this other--what the bill supposes that we would have a
bar coding system, that we would be able to go to one source
and push the button and the list would come up. And,
unfortunately, we do not have that source.
Dr. Roe. Okay. There is another issue that does not affect
the VA, but the FDA, and that is, and this is a little
bothersome, this is not anything to do with you all at all, but
when they approve a tissue bank, sometimes they do not go back
for years to ever examine that tissue bank.
And that is a little worrisome because the patients expect
us and the surgeon who uses material that he or she is used to
using--I get that. I mean, we got our little toys we like to
use. But we expect that that particular piece of tissue that we
get is safe when we get it. I mean, we are assuming that the
people who procure that for us have done the due diligence to
make sure that when we do transplant that into a patient, that
that patient is getting a safe graft.
And I guess the other thing I will ask, Dr. Gunnar, you,
does the staff inform patients that they are getting an
allograph? I know I always did, but it is not required, I do
not think.
Dr. Gunnar. It is actually by policy required in our time-
out process. So the implant is actually--you have to--before
the patients--the procedure even starts, you have to assure
that the implant is there, that it is not----
Dr. Roe. No, no, that is not what I mean. I mean, does the
patient know they are getting an allograph?
Dr. Gunnar. Yes, in the informed consent process.
Dr. Roe. And I am sorry I ran over just a second here, but
the other one is is how do you for expired tissue, and that is
obviously very important, that the GAO found still sitting on
the shelves, why did that happen?
Dr. Gunnar. Well, I believe that was some time ago and Mr.
Matkovsky can comment about how the inventory was managed
following that. But what I can tell you is that there has now
been the policy that ensures correct surgery and invasive
procedures requires that there be a read back of the expiration
date on any biologic that is going to be implanted.
Dr. Roe. Well, do you think any expired tissue has been
implanted into anybody?
Dr. Gunnar. I am sorry.
Dr. Roe. Tissue expired----
Dr. Gunnar. Yes.
Dr. Roe [continuing]. Got to the operating room, got
implanted into a patient, has that happened?
Dr. Gunnar. To my knowledge, that has not happened, but I
think there is a culture of safety that is developed in the VA
that is associated with a national policy that would provide
assurances that that would not occur.
Dr. Roe. Well, it could if that tissue was still sitting
there on the shelf.
Anyway, I yield back.
Mr. Matkovsky. I would simply indicate, though, I mean, I
think the discussion of the tracking and alerting mechanism, we
do need that. We need a mechanism to better manage the
inventory and facility. I would concur.
Mr. Coffman. Dr. Huelskamp.
Dr. Huelskamp. Thank you, Mr. Chairman. Appreciate the
chance to discuss this issue today.
First I want to turn to Mr. Matkovsky. The National Center
for Patient Safety, that is internal to the VA; is that
correct?
Mr. Matkovsky. That is correct, sir.
Dr. Huelskamp. And as I read and review the GAO report,
they presume that all the recall notices and such coming out of
that NCPS are sufficient and conclusive of what needs to be
recalled. Is that your understanding?
Mr. Matkovsky. We believe so, yes, sir.
Dr. Huelskamp. How different is that from other systems
that impact this particular industry and how is it different
than what is in the industry? Again, this is only internal to
the VA and the GAO assumes every recall that was necessary was
identified by NCPS.
Mr. Matkovsky. I think NCPS is actually an aggressive
organization inside. I think it has a very forward leaning
stance. It works with programs. I think our scale is different
than other entities in the private sector. But other than that,
I think it functions in much the same way as a recall entity
would in the private sector.
But it is a very strong coordinative entity that can
trigger a recall either from an internal source or from an
external source, works with the program office be it surgery or
blood, pulls data where we can at the national level and then
can issue a recall notice down to the facility and follow it
through to its completion.
Dr. Huelskamp. Does this work together with the FDA?
Mr. Matkovsky. If the FDA issues a recall, yes, sir, it
would. So it would trigger an FDA recall, would trigger a
patient safety alert for us.
Dr. Huelskamp. When you do that with non-FDA vendors, how
do you work with those if, again, they are not registered with
the FDA and they are not approved by the FDA, but you are using
their products?
Mr. Matkovsky. If there is a recall action, we would be
notified and then we would initiate the recall action for that
item. I am sorry. I am not sure I understand.
Dr. Huelskamp. I do not understand why you are working with
non-FDA vendors. Could you describe why you are working with
non-FDA vendors in this particular arena?
Mr. Matkovsky. I do not know that we are working with non-
FDA vendors, sir.
Dr. Huelskamp. Didn't the GAO report identify that?
Mr. Matkovsky. I think they indicated that given record
keeping issues that----
Dr. Huelskamp. You have no idea if you are working with
non-FDA vendors; is that correct?
Mr. Matkovsky. I do not believe that is correct, sir.
Dr. Huelskamp. You said you do not have the paperwork to
determine that you always work with FDA vendors.
Mr. Matkovsky. No. I think the GAO comment was that we
could not assure given our record system that we work----
Dr. Huelskamp. And you are assuring me today you are not
working with any non-FDA vendors?
Mr. Matkovsky. I can take that for the record and research.
Dr. Huelskamp. Yes or no?
Mr. Matkovsky. I will take it for the record, sir.
Dr. Huelskamp. So you cannot assure us today you are not
working with non-FDA vendors? That is the GAO report. That is
what they are saying. You do not have the paperwork to identify
that? I am just trying to get the basis of that. So you are
taking that system which you do not have the paperwork for,
that is also the basis for which the GAO indicates you are
following your own internal standards for a recall? Are there
recalls that take place elsewhere in this country that the NCPS
did not feel proper to have a recall within----
Mr. Matkovsky. In many cases, we will have a recall that is
not triggered by the FDA. Our own internal organization may
trigger more recalls than would be triggered outside.
Dr. Huelskamp. My question is, is there a recall that
elsewhere in this particular industry that the NCPS chose not
to precipitate within the VA system?
Mr. Matkovsky. I do not know. I do not know of any.
Dr. Huelskamp. Could you provide any proof of that for
later reference? I would appreciate knowing.
Mr. Matkovsky. I would also go back and I will research the
data down to the granular data to look at every vendor we have
purchased from.
Dr. Huelskamp. Okay. Well, I appreciate that because that
is core from the GAO report because there is not the data there
to answer the question to say, hey, yes, we are only working--
is there a reason you would work with a non-FDA vendor?
Mr. Matkovsky. There is none, sir.
Dr. Huelskamp. There is none whatsoever?
Mr. Matkovsky. I think the other thing that is also getting
lost in some of this, the GAO is performing an audit function
against the data we can provide. It is a time limited audit. We
are going off of data we can provide.
There is an accreditation function that occurs in each one
of our facilities. Each of our facilities is a Joint Commission
accredited entity that has its own processes reviewed by the--
--
Dr. Huelskamp. And I understand that, but you are using the
VA's National Center for Patient Safety as the basis for making
these decisions. That is all internal to the VA. My concern is
an external source on that.
Lastly, you made some reference in your oral testimony, it
is not in your written testimony, about personal performance
contract. Could you describe that a little further?
Mr. Matkovsky. I will, sir. Following our hearing on
January 15th, I went back and modified my performance contract
and added in there that we would have a clinically cleared
national biologics contract by the end of--sorry--the
requirements set by the end of this fiscal year. So we would go
into the solicitation process. So I have modified my
performance contract to be personally accountable.
Dr. Huelskamp. Okay.
Mr. Matkovsky. I think it is important.
Dr. Huelskamp. You modify your own contract with the
Federal Government?
Mr. Matkovsky. We all have a performance agreement, so I
inserted into my performance agreement working with my boss at
the time. She and I had a discussion when I came back from this
hearing and I thought that I needed to ensure that I was
personally accountable to make sure we did this.
Dr. Huelskamp. Can we receive a copy of that personal
performance----
Mr. Matkovsky. Absolutely, sir.
Dr. Huelskamp. That is the first time I heard about that
and the first time I have heard anybody say they altered their
own personal performance contract. So did you get a bonus last
year and that is----
Mr. Matkovsky. I think mine is still in deliberation, sir.
I think it is a performance award and I think it is still in
deliberation.
Dr. Huelskamp. Is it based on your old written contract or
it is based on your new one? Do you----
Mr. Matkovsky. My new one will take effect for the period
of fiscal 2014. At the conclusion of fiscal 2014, if I am
unable to actually deliver a requirements package for
biologics, it will affect my personal performance, yes.
Dr. Huelskamp. So you do not know if you got a bonus for
fiscal year 2013 from six months ago?
Mr. Matkovsky. I do not, sir.
Dr. Huelskamp. When will they tell you as an employee?
Mr. Matkovsky. I do not know.
Dr. Huelskamp. Who makes that decision?
Mr. Matkovsky. I also do not know. I am not sure I want to.
Dr. Huelskamp. You have a contract. You do not know who
makes the determination on the bonus?
Mr. Matkovsky. Things happen.
Dr. Huelskamp. Actually, they do not happen.
Mr. Matkovsky. Well----
Dr. Huelskamp. Sir, I have a hard time believing you do not
know who is making a decision on whether you get a bonus or
not.
Mr. Matkovsky. I believe the secretary makes the decision--
--
Dr. Huelskamp. Okay.
Mr. Matkovsky [continuing]. And reviews it.
Dr. Huelskamp. So the secretary makes the decision. He has
waited six months and has not told you yet; is that correct?
Mr. Matkovsky. That is correct.
Dr. Huelskamp. Thank you. I yield back.
Mr. Coffman. Dr. Benishek.
Dr. Benishek. Thank you, Mr. Chairman.
I thank you all for being here this morning.
Dr. Gunnar, are you involved in the process of fixing this?
I mean, Mr. Matkovsky has said how they do not quite have the
plan yet or do not have an accurate method of tracking all this
stuff right to the patient, I guess at the macro level really
because I think in each hospital, they sort of track it.
But are you involved in that process? I mean, it looks like
you are the director of Surgery for the VA. So I always like to
have the doctor involved with, you know, a lot of this stuff.
So I just want to know if you are involved in that.
Dr. Gunnar. So I am involved in the surgical world and was
instrumental in modifying the VistA surgery package back in
2011 to actually add implant information at the time in the OR.
The VistA surgery package is not used for out of operating room
procedures.
And the majority of biologics, to take it back to the
subject of this hearing, are actually applied in the outpatient
arena. I think for that reason, we have testified that
conceptually we want to align this with the blood bank concept
of bar coding and being able to----
Dr. Benishek. So, Dr. Icardi, then would you have----
Dr. Gunnar. In the world of biologics----
Dr. Benishek. You have not really been involved in that
process?
Dr. Gunnar. But I am involved.
Dr. Benishek. Yeah.
Dr. Gunnar. Yes, absolutely.
Dr. Benishek. Well, it sounds like you said that you were
involved in the stuff that went to the OR but not involved in
the stuff that did not get to the OR, so is that correct? It is
more like a blood banking issue and then the blood banking
people are more in charge of that sort of thing then? Is that
what you are saying?
Dr. Gunnar. Congressman, this is, and I appreciate the
question, this is the work group that is established will come
to a decision in the third quarter of this year.
Dr. Benishek. Well, the point I am trying to get at, Dr.
Gunnar, is that, you know, I get very uncomfortable. You know,
I am a general surgeon, too, and I get uncomfortable when
people who are not physicians are making decisions that affect
patients. I think as physicians, our primary concern is for the
patient, at least mine always was.
Now, you have that whole team working behind you when you
are in the operating room and you want to be sure that they are
all doing their job. And, you know, I understand that you
cannot oversee that piece of material from the beginning to the
end yourself. And I would like to see that physicians are at
least in charge over the process or involved in the discussion,
so----
Dr. Gunnar. Dr. Icardi, to answer your question
specifically, Dr. Icardi and I and other clinicians, program
offices within central office are engaged in this work group
and are participating as leaders as this work group moves
forward.
Dr. Benishek. Well, Dr. Icardi, let me ask you then. What
input have you provided for this process of, you know, making
sure that the VA has an accurate identification process for
biologics?
Dr. Icardi. Well, as you know, biologics, they break into
two sides. There is the blood side and then there is the tissue
side. And so in the blood bank, we handle mainly blood. And so
where we have been involved----
Dr. Benishek. Okay. Well, it sounds as if you are kind of
backing away from the tissue side and you are talking about
just blood. So if it is not Dr. Gunnar and it is not you with
the tissue, then where is the doctor who follows the tissue?
Mr. Matkovsky. Be very clear here. Both of these gentlemen
to my left and my right are involved in this team. This will be
a clinically led team. The recommendation will be informed by
our clinicians. Our ultimate decision is to the process owner.
Dr. Benishek. Well, no, I understand that. It is just that
Dr. Icardi answered me and then he kind of was backing away
from the tissue issue. I am trying to find out, you know, who
is the doctor involved in planning for the tissue. And
apparently--am I incorrect? Are you involved in planning for
the tissue, how that all works? You said, no, I am involved
with the blood.
Dr. Icardi. Nationally we are involved with the blood. On
the local level, there are some blood banks which are involved
with tissue. And as GAO noted, it does vary from facility to
facility.
Dr. Benishek. So who is the doctor that is leading the
charge on making sure the tissue is well cared for from
beginning to implantation?
Dr. Icardi. Well, Dr. Gunnar has----
Dr. Benishek. All right. Well, I guess my time is up, but I
appreciate that you are here this morning. Thank you.
Mr. Matkovsky. If I may, just one clarification for Dr.
Benishek. Thank you.
Surgery is involved in this process definition. We have
gone out. We have canvassed. We have surveyed all of our
medical centers. We have looked at what practices we have. And
some of our practices have the local blood bank actually
managing the tissue. We have a really strong practice that has
been in place for decades. We have established processes,
established clinical directives with clinical leadership.
Our expectation is----
Dr. Benishek. I understand you are saying all that, Mr.
Matkovsky, but, you know, you brought two physicians here with
you. I asked each of them how are you involved in the process.
And Dr. Gunnar said, well, I am in the OR. He limited his
answer immediately and then so did Dr. Icardi limit his answer
immediately.
So I am wondering who is the physician who is directing,
you know, the processing of tissue. And it is not either one of
these. Is there someone else? You know what I mean? So that is
the problem that I have with what happened here this morning.
Mr. Matkovsky. Okay.
Dr. Benishek. Very well.
Mr. Coffman. We will go into a second round of questions.
One question I have, do you, the GAO report discussed the death
of a veteran. So it says according to a report--oh, I am sorry,
this is in the Journal of the American Medical Association. The
kidneys of an Air Force recruit from North Carolina who died
from a rabies infection in July, 2013 were transplanted into a
Maryland veteran who later died from complications with rabies.
Are you acknowledging or denying that that event occurred?
Okay. Okay. I understand that that might have occurred at
Walter Reed, so.
Mr. Matkovsky. I do not, I cannot comment on it.
Mr. Coffman. Okay. Let me go into why has the Veterans
Implant Tracking System, a vital tool necessary for patient
safety, been allowed to stall?
Mr. Matkovsky. I do not know that it was allowed to stall,
Mr. Chairman. I think it went, finished software development,
then it went into testing. I believe, Dr. Gunnar, at the end of
fiscal year 2013 it went into testing and some critical defects
were identified and then I believe that it sort of got caught
up in the IT funding question.
Mr. Coffman. According to GAO's testimony, VHA has no
oversight ensuring VAMCs check their inventory for and alert
affected patients for recall products. Why is no oversight
conducted to ensure this safety measure is carried out?
Mr. Matkovsky. You know, from 2008 to the end of 2013 there
were 13 recalls that were triggered and notified to the VA. Of
those, six of them were identified as having an effect on our
inventory. So you know, the statement that we have, no
mechanism, I do not know that that is entirely accurate because
we are able to identify in those six cases for those recalls
that we had inventory supply or had inventory supply at some
time and initiated a local recall process.
It is correct, however, I want to be clear, that managing
the inventory and having greater granular control can be
improved with a better tracking system.
Mr. Coffman. According to GAO, VA does not ensure that
biological implant vendors are registered with the FDA. Is not
a simple verification important for patient safety?
Mr. Matkovsky. Yes. In so many words, it is.
Mr. Coffman. Very well. Mr. Walz.
Mr. Walz. No further questions.
Mr. Coffman. No further questions? Dr. Roe? No further
questions. Dr. Huelskamp, no further questions. Well very well,
thank you very much, panel, for your testimony.
On our second panel we will hear from Ms. Marcia Crosse,
Director of Healthcare for the Government Accountability
Office. Your complete written statement will be made part of
the hearing record. Ms. Crosse, you are now recognized for five
minutes.
STATEMENT OF MS. MARCIA CROSSE
Ms. Crosse. Thank you. Chairman Coffman and members of the
committee, I am pleased to be here to discuss our work on the
safety of tissue products used at the Veterans Health
Administration. In fiscal year 2013 approximately 59,000 tissue
products were used to provide care to veterans at VA medical
centers. The tissue products most commonly used by VHA are bone
and skin grafts.
While tissue products may provide valuable methods to
sustain and improve quality of life, there are also risks that
they can transmit a communicable disease from a donor to a
recipient, potentially resulting in complications. The Food and
Drug Administration, FDA, is responsible for regulating the
manufacture of tissue products. These products are generally
regulated under FDA's human tissue regulations, or under FDA's
medical device regulations. Establishments that manufacture
tissue products must register annually with FDA and must follow
applicable regulations, including reporting certain adverse
events and following good manufacturing practices.
Although VA relies on FDA to ensure the quality of its
tissue vendors, VA policies do not require that a vendor's FDA
registration status, an important component of federal
oversight, be checked for most purchases. VHA officials told us
that for open market purchases the agency does not require
purchasing staff and contracting officers to check the FDA
registration status of tissue product vendors. Open market
purchases account for 57 percent of the tissue products that
are procured with purchases made from several hundred different
vendors.
For the remaining purchases made under fewer than a dozen
federal supply schedule contracts, VA does check vendors'
registration status for tissue products regulated as medical
devices. However, there is no policy requiring staff to check a
vendor's registration status for products regulated under FDA's
human tissue regulations.
It is important to note that VHA has not found evidence
that it has received contaminated tissue products. It is often
not possible to definitively attribute post-surgical infections
to a tissue product and it is not uncommon for such infections
to occur even in the absence of tissue use. In the past five
years VA has notified its medical centers of 13 recalls for
tissue products and these recalls were generally issued because
of the possibility of contamination, not because of known
contamination.
When a recall does occur VHA's ability to identify and
track recalled tissue products in its inventories may be
limited by poor inventory management practices. The medical
centers are required to search their inventories for any
recalled products that have not been used. But GAO and the VA
OIG have previously reported concerns with the completeness and
accuracy of VHA's inventory data and have made recommendations
for improvement.
Further, while VA medical centers are also responsible for
accurately identifying all recalled tissue products that have
been used, identifying implanted tissues may be a challenging
task for the medical centers to accomplish. Officials stated
that it is difficult to search for information on tissue
products that have been implanted in the operating room in part
because there is no automated search capability. We also found
that VHA conducts no oversight to ensure that these checks of
patient records are performed.
VA is taking steps that may improve its ability to track
tissue products. For example, VA officials told us that the
agency is continuing development of a Veterans Implant Tracking
and Alert System, VITAS, which was created to track and
retrieve identifying information on surgical implants,
including tissue products. In addition, the agency told us that
it established a working group to determine the feasibility of
utilizing scanning and tracking technology to automatically
upload tissue information into patients' medical records.
In summary, VA's recent actions may improve VHA's ability
to identify tissue products both in inventories and used to
treat veterans. Mr. Chairman, this completes my prepared
statement. I would be happy to respond to any questions that
you or members of the subcommittee may have.
[The prepared statement of Marcia Crosse appears in the
Appendix]
Mr. Coffman. Thank you, Ms. Marcia Crosse. I have got a few
questions. Some tissue products have already been implanted,
injected, or applied by the time a recall occurs. How does VHA
ensure that veterans who have been the recipient of such
products are identified and notified?
Ms. Crosse. VHA officials have told us that it is very
difficult for them to identify the patients who have received
those products. For the tissue products that are implanted in
an operating room, VA staff required to enter identifying
information about the source and lot number of that product
into the patient's record. But it is manually entered and it is
not searchable except by pulling up a text field. So someone
must actually go through each patient record to determine if a
relevant product implanted. For the outpatient clinics it is
even less clear how the information could be tracked.
Mr. Coffman. Are the steps VA medical centers take to
notify patients of a product recall sufficient to enable prompt
identification?
Ms. Crosse. It is not clear. As I said, it is not clear
that contaminated tissues have actually been implanted into
patients in VA medical facilities. There have been a small
number of recalls. I would like to clarify that among those 13
recalls, for six of them VA identified the product at 27
different facilities. The remaining seven recalls were sent out
because there was a belief that the VA had purchased these
products. They did not find any. Whether that meant they had
already been used or had expired, we do not know. Regarding the
steps to actually identify patients, I am not aware that there
have been any notifications given to patients that they have
received a contaminated tissue. VA has told us they are not
aware of any cases of such contamination occurring.
Mr. Coffman. Ms. Crosse, what is the problem with VA
medical centers operating room staff entering implant serial
and model numbers into medical records by hand?
Ms. Crosse. You have the potential for error, just simple
transcription error by, someone having to type something in. In
addition it is not entered into something that is automatically
searchable. It is in a field where you actually have to go back
in and read it and compare it to the product that you would be
looking for. It is not something like a bar code that is
automatically read into the record.
Mr. Coffman. Okay, thank you very much. Mr. Walz?
Mr. Walz. Well thank you, Mr. Chairman. Thanks, Ms. Crosse.
Is VA's purchasing and tracking of biological implants the same
as private industry?
Ms. Crosse. We have not looked at private industry. Some of
the same problems exist. There is a new system that is coming
online for those tissue products that are regulated as medical
devices, the unique device identifier system that is going to
be used by facilities throughout the country, VA or private.
There is not a similar system in place for identification for
biologics that are regulated as tissue products. I think each
individual facility has been and will continue to be making its
own decisions about what kind of system they have to track.
Mr. Walz. Maybe Mr. Wilton can help me with that. The
reason I keep bringing this up, and I think one of my
colleagues mentioned it, we need these facilities to be the
best. When my folks at Mayo Clinic tell me that the cardiology
at Mayo, Minneapolis, is the best in the world, that is a good
thing. That is the way it should be. I keep bringing this back
up because it is important holistically as we approach medical
reform to understand what the private sector is doing, where
they are doing it better and where they are doing it less. And
I understand this committee's scope of responsibility as the VA
and we are exercising that.
I bring this in to see if we can learn from each other and
I know we do that often. And it seems like this would be one of
those issues where that would be pertinent information, so we
are not operating in a vacuum.
My next one is how will you, and maybe it is not you, maybe
it is in conjunction with the IG to follow up on your report,
how will you follow up regarding the recommendations you made
in the 2014 report here?
Ms. Crosse. GAO does follow up routinely. We follow up at
least annually with the agency to determine what actions have
been taken to make changes in accordance with the
recommendations that we have made. We publish an annual report
giving the status of recommendations that is available on GAO's
website. We also track recommendations for at least five years.
Mr. Walz. Will our veterans be safer if they follow your
recommendations?
Ms. Crosse. We believe that those recommendations are
grounded in the need for actual changes to occur. That it will
improve the care that is given to veterans if these changes are
made in VHA's inventory management practices.
Mr. Walz. And I for one, I do appreciate, and I think Dr.
Huelskamp was hitting on something important, and I was curious
too about his questions on how this worked. I do think it is
admirable that there is going to be a connection to whether
these things are followed through with, whether this report is
implemented, to someone that we can address. So I want to
highlight that, though. But he did bring up an interesting
point, is who is going to make that ultimate decision? That
would be an important thing. Now you said the Secretary. But I
do like this, that all of us in conjunction here, because the
ultimate goals is accountability for veteran safety. And so now
your report, and they are working with it, and they are adding
back, and if the private sector can add anything which we will
hear from our next panel, so that is our goal. So I am
appreciative of that. And with that, I will yield back the
remainder of my time.
Mr. Coffman. Thank you, Mr. Walz. And just a very quick
point, I think, that in the private entities as you mentioned,
Mr. Walz, I think that families if there is a lapse in patient
safety have recourse through the court system where our
veterans rely on us. Dr. Roe?
Dr. Roe. Thank you. And just to dovetail on what Mr. Walz
was saying, I really appreciated Mr. Matkovsky, that is the
first time since I have been here in five-and-a-half years that
someone has said the buck stops here. And I appreciate that.
And that fact that you are going to put yourself at some
financial risk if you do not get this done, the criteria done
and so forth, not completely implemented, I understand that, by
the end of the year. So thank you for that.
Ms. Crosse, a couple of things that just looking here, and
the more I delve into this the more I realize it is not just
the VA, this is a systemwide, perhaps we will hear from our
third panel what is going on in the private sector. But it is a
little disconcerting that the FDA would approve a tissue bank
and then not go back and look at it for several years to see if
they are up to standard or doing what they are supposed to. I
think that is something that started my wheels turning a little
bit. That your report pointed out to me a deficiency not just
in VA. They cannot help what the FDA does. So maybe we need to
take another step toward that direction. Would you agree with
that?
Ms. Crosse. The FDA has a risk-based system that they use
for tissue products. They also have a risk-based system that
they use for making determinations about inspecting medical
device establishments and drug manufacturers. The data that it
provided to us indicated that it had inspected about a quarter
of the tissue banking facilities that were registered with it
in the last fiscal year. About 600 inspections had been done
out of about 2,500 or 2,600 registered establishments. That
actually is in line with or perhaps somewhat higher than the
inspections they are performing for medical device
establishments and for drug manufacturers. We previously put
out a series of reports on this topic and FDA has begun to
shift its inspections because it was generally inspecting drug
manufacturers domestically and not abroad. And so it has been
shifting where it is targeting its inspections and trying to
target on those that are manufacturing the riskiest products. I
cannot speak to whether it is an appropriate frequency, but
that is the frequency FDA is inspecting with the resources it
has.
Dr. Roe. Well I think the thing when you see FDA approved,
and they have a great reputation, the FDA does, for looking
after safety. And quite frankly what we have heard today is
that these, so that our viewers out there understand, that for
the most part this is very, very safe and very beneficial. But
there are holes in there that we need to plug up and make sure.
Because if you are a patient, one patient, I mean that young
veteran, I guess active duty, who got a kidney transplant, that
was 100 percent for him that he got rabies and died because of
that mistake that was made. So as a physician, we have got to
be right every time. And the folks that are providing, or as
every time that we can. And the systems that are providing this
material for us, they have to be right on nearly 100 percent
perfect. And obviously errors could be made. But 57 percent of
341 different vendors the VA used that made these small
purchases that were not, as I understand it, we did not check
the FDA. And open sources, I heard you say they did not check
the FDA status. So that means a lot of those never got checked.
We just made an assumption it was safe.
Ms. Crosse. We do not know if VA checked.
Dr. Roe. Do not know, okay.
Ms. Crosse. And I think that is a concern. There is no
policy that requires that a check be made. Unlike the federal
supply schedule purchases, where actually part of that process
requires that VA check the FDA registration status for
establishments making products that are regulated as medical
devices, there is no requirement for the small purchases that
are made, the open market purchases. Similarly, even for the
federal supply schedule purchases there is no required check in
place to ascertain the registration status for the products
that are regulated as tissues as opposed to those regulated as
devices.
Dr. Roe. And I think the other thing is just because
something is FDA approved does not mean it is 100 percent safe.
And because it had not been, does not mean it is not either. I
think that is because the clinical outcomes of most of these
59,000 people, and they have had no reported cases, I guess,
unless the tracking is----
Ms. Crosse. There have been adverse events reported to FDA.
When FDA has conducted investigations it has positively
confirmed two donors from whom contaminated tissues were
recovered and that were sent out to facilities. But neither of
those instances involved VHA facilities for the confirmed
cases. There are recalls. Adverse events are required to be
reported to FDA. There are instances in which there is at least
the possibility of contamination and FDA wants to have those
products recovered from inventory and patients checked. We know
that there is a process at VA for recovering from inventory. We
are not sure what is happening in terms of checking patient
records.
Dr. Roe. And just as I finish, Mr. Chairman, you know it
looks like as you pointed out, and human error, and the bar
code, that that technology is available. I mean, Harris Teeter
knows when I walk in and buy a box of cereal what I bought, and
they send me a coupon three weeks later for fifty cents off. So
it should be fairly easy to do that. But that is not new
technology, it has been around forever. And it would create a
line downstream to find out where this came from, where the
source was, and you could track it much easier. I think that
would simplify it tremendously. I yield back.
Mr. Coffman. Dr. Huelskamp.
Dr. Huelskamp. Thank you, Mr. Chairman. Ms. Crosse, the
question from Mr. Walz was about what is happening in the
private sector, how this occurs, and you did not have
experience on that, had not compared that. Are you able to
compare that to other sectors? The federal government? The DoD
has an enormous system. Do they use non-FDA approved items? Do
they purchase off the schedule? Can you shed any light on
comparison there?
Ms. Crosse. I am afraid our review did not focus on what
was happening in other federal health care facilities. We only
were looking at what was happening at the VA.
Dr. Huelskamp. Okay. And I appreciate that. I understand
the limits on that. You did look at the VA's OIG study in March
of 2012?
Ms. Crosse. Yes.
Dr. Huelskamp. Where it indicated that informal tracking
systems, I am not sure how well informal tracking systems work,
and if you are trying to look at a recall, you are trying to
look at adverse effects, they cannot even track the product on
the shelves much less the patients. I mean, so if I asked the
question, as you saw earlier, it is, well, we do not know. We
actually do not know what we do not know. Is that an accurate
assessment of an informal tracking system that no one knows for
sure what is there and it is just a best guess?
Ms. Crosse. According to the IG's report, different
facilities had their own individual systems in place for
tracking. There was not a centralized system. It could not be
accessed by VHA systems. But as I understand it, that is part
of the changes that are being put in place that Dr. Gunnar
spoke to, specifically for those products that are implanted in
operating rooms. I am not sure what is being done for the
outpatient facilities.
Dr. Huelskamp. And you reviewed the report. Do you know if
this has been implemented? Or how far along they are in fixing
this informal tracking system which is the basis for saying
that no adverse events have been reported on the use of these
tissues?
Ms. Crosse. Our understanding is that the comprehensive
inventory management system is part of what was discussed
earlier and the last update we had was that it is supposed to
begin to come online in 2015.
Dr. Huelskamp. Okay, so it is still not there. So one other
question I would ask of the VA I would like followed up on is
populating the NCPS system. Or NCPS, in your opinion is that
sufficient? Can you describe for the committee how it is
determined that you do a recall? Again, I presume actually if
the FDA had a recall that did not mean that VA actually
initiated a recall either. They were not always the same. Can
you describe that a little bit more, about an internal VA
system that everything is hinging on in terms of this report?
Ms. Crosse. The NCPS system is used to try to track
recalled products that may still be in inventory. There is a
centralized system that allows NCPS to go out, that covers the
VAMCs, and that would allow NCPS to determine whether or not
those products had been procured at different facilities so
that they could then have the facility go and remove that
product from the shelf. There have been some concerns about the
accuracy of all the information that is in that system but
nevertheless that at least provides a centralized source. The
gap I think occurs because VHA does not have oversight of what
has happened for the tissues that have been used and that may
be covered by that recall. That is where the VAMCs are
individually responsible for checking individual patient
records to make a determination of whether or not someone
received an implanted product that had been recalled and
whether notification to that patient is warranted.
Dr. Huelskamp. And you do also note that although the NCPS
tracks and responds to recalls, at least partially I would say,
they do not track warning letters. Can you describe a little
bit more why those are ignored by the system?
Ms. Crosse. VA told us that the information in warning
letters is really not that helpful for them because the warning
letters that FDA puts out are really focused on changes that a
company needs to make in order to be in compliance with FDA
requirements and would not necessarily result in products
having been distributed that were contaminated or otherwise
needed to be subject to a recall. There have only been a small
number of warning letters to tissue establishments in the last
several years. But the VA officials indicated they did not
believe that that would provide them with actionable
information.
Dr. Huelskamp. Even though in one case the FDA issued a
warning letter to a vendor and the VHA did not know about that,
and obviously did not respond to that because they only respond
to recalls. Ms. Crosse, I appreciate the report and I would
suggest in the future, and like Mr. Walz indicated, you know,
comparison to what is going on in the private sector. But I
also would like to see as well, I mean, comparison to the DoD.
Because the NCPS does use DoD information. I am not for sure
how that works here. But it seems to be not in any formal
manner. But in your report you do mention in a footnote, you
talked to visiting officials, you talked to FDA, DoD, and
tissue vendors, and I am not sure if there is any formal
process for doing that.
But last, really quickly, the non-FDA issue----
Ms. Crosse. Yes.
Dr. Huelskamp [continuing]. And we do not know what we do
not know, and we could not prove that. The recalls, obviously
if FDA is going to have a recall, it is not going to apply to
non-FDA vendors in this case. And I am not sure how you track
that, or you can indicate you tried?
Ms. Crosse. Most recalls are actually not directed by FDA.
Most of the recalls that occur are voluntary recalls that are
initiated by the vendor themselves. There have only been one or
two instances where FDA has actually mandated that a recall
occur. That is not uncommon across the board for all types of
medical products. Most recalls are voluntary.
Dr. Huelskamp. I appreciate it. I yield back, Mr. Chairman.
Mr. Coffman. Our thanks to Ms. Crosse. You are now excused.
I now invite the final witness to the table. On our third
panel we will hear from Mr. Frank Wilton, Chief Executive
Officer of the American Association of Tissue Banks. Your
complete written statement will be made part of the hearing
record. Mr. Wilton, you are now recognized for five minutes.
STATEMENT OF MR. FRANK WILTON
Mr. Wilton. Chairman Coffman, Mr. Walz, and distinguished
members, the American Association of Tissue Banks, or AATB,
would not be here today if it was not for the U.S. military.
The very first tissue bank in the U.S. was the United States
Navy Tissue Bank, which was established in 1949 by Dr. George
Hyatt. In 1976, Dr. Hyatt and his colleagues helped found the
American Association of Tissue Banks. Recognizing the
increasing use of human tissue for transplant, these
individuals saw the need for a national organization to develop
standards, promote ethics, and increase donations.
Beyond the historical significance, AATB accredited tissue
banks continue to focus on the needs of veterans. As you know,
many military personnel serving in Operation Iraqi Freedom and
Operation Enduring Freedom have received severe burn injuries
due to the use of IEDs. If necessary, donor skin may be used as
a life saving dressing. AATB accredited tissue banks have
helped ensure that veterans have access to these life saving
dressings, as well as other biological implants necessary to
relieve pain, restore mobility, restore sight, and save limbs.
With that in mind, thank you for the additional opportunity
to come before you today in support of the ``Biological Implant
Tracking and Veteran Safety Act of 2014.'' This critical
legislation directs the Secretary of Veterans Affairs to adopt
a standard identification system for use in the procurement of
biological implants by the Department of Veterans Affairs. By
building upon the success of the implementation of the unique
device identifier, or UDI, this legislation will ensure that
biological implants used within the Department can be
appropriately tracked from a human tissue donor all the way to
the recipient. This critical capability for track and trace
efforts will enhance patient safety, expedite product recalls
when necessary, assist with inventory management and improve
overall efficiencies.
This legislation takes a bold step to expand UDI to all
tissue products. In addition to human tissue devices which are
already covered by the UDI, the legislation adds another
product category: certain biological implants or, as termed by
the Food and Drug Administration, 361 human cells, tissues, and
cellular tissue-based products, or HCT/Ps. While many of the
biological implants do have company specific bar coding
information, by requiring a standardized format for those bar
codes as outlined in this legislation, it will be easier for
the Department of Veterans Affairs medical facilities to
utilize universal bar coding conventions and to realize the
full benefit of a unique identification system. Finally, by
applying a system which has been developed for devices to
biological implants such a solution should also be applicable
to other health care settings and other health care systems
such as the Department of Defense health care system and the
private sector.
While I understand the committee's skepticism in requesting
that the VHA attempt a VITAS-like enterprise in this
legislation after failing to do so before, I would note that a
lot has changed since 2008 when the VHA first envisioned VITAS.
First, there is now a UDI benchmark which allows those
developing the necessary software for data capture to move from
a design incorporating dozens of bar code technologies to only
three. In addition the VHA is not alone in trying to develop a
system for integrating UDI like information directly into the
medical record. For instance, the Office of the National
Coordinator for Health Information Technology is currently
focused on the ways in which the UDI can be better
operationalized to ensure its adoption into key standards. As
part of those efforts ONC is initially focusing on
implantables, the very focus of the legislation we are
discussing today. Therefore the VHA will not be attempting to
establish such a system alone, but can partner with other
governmental agencies to ensure its success.
For those of you unfamiliar with my organization, the
American Association of Tissue Banks is a professional, not for
profit scientific and educational organization. It is the only
national tissue banking organization in the United States and
its membership totals more than 125 accredited banks and
approximately 850 individual members. These banks recover
tissue from more than 30,000 donors and distribute in excess of
two million allografts for more than one million tissue
transplants performed annually in the U.S.
Finally when I last discussed this legislation before the
committee I noted my concern that the draft legislation lacked
a requirement that biological implants purchased by the VHA be
subject to appropriate accreditation standards. It is my
understanding that those concerns have been addressed in the
latest version of the legislation by requiring accreditation by
AATB or a similar accreditation organization. Thus with this
change the VHA will be joining the ranks of leading medical
centers of excellence which currently require all tissue to be
sourced from AATB accredited tissue banks.
AATB strongly supports this legislation and urges the
committee to favorably report it out of committee. This ends my
prepared remarks and I would be happy to answer any questions.
[The prepared statement of Frank Wilton appears in the
Appendix]
Mr. Coffman. Thank you, Mr. Wilton. Mr. Wilton, is it
common for biological implant vendors to receive FDA warning
letters?
Mr. Wilton. No. In fact it is fairly rare, Mr. Chairman. We
went back and looked back to fiscal year 2000, and there were
43 recalls that were issued within that roughly 15-year period.
To put it in perspective the FDA, looking at all the different
areas it has jurisdiction over, issued 45 in January of this
year alone. However, it is a very serious thing that our banks
take with the utmost concern.
Mr. Coffman. Mr. Wilton, what is the benefit of the UDI or
a standardized identification system for VHA?
Mr. Wilton. As I remarked, in my comments, Mr. Chairman, it
is largely due to tracking and tracing so we can track it from
the donor all the way to the recipient. I think from the VHA's
perspective it will be helpful for inventory management, be
useful if there is in fact a recall and overall improve
efficiency within the VHA system.
Mr. Coffman. What are some concerns with the use of tissue
distribution intermediaries?
Mr. Wilton. Sure. TDIs are sort of on the back end of the
system, if you will. We went back and looked at FDA
registration data and as best we can tell only about 16 percent
of the TDIs are in fact accredited by AATB. So the question
becomes, are they maintaining the standards they need to in
order to make sure that the tissue is stored appropriately and
it is distributed appropriately? So the short answer is, we do
not know for sure. Only the ones that we accredit can we speak
for.
Mr. Coffman. Mr. Walz.
Mr. Walz. Thank you, Mr. Chairman. Thank you, Mr. Wilton.
Just two quick ones here for you. From your approach on this,
and you have been hearing some questions as you have been here,
how does the VA look compared to those other centers of
excellence you are looking at in terms of where they are going
in this?
Mr. Wilton. Yes, I think this is a terrific effort. And as
I said in my testimony, we hope that once this is implemented
it can get beyond the VHA to DoD and to the private sector. I
think the big change is our tissue banks track and trace all
their tissue but there are a lot of different bar code systems.
With the FDA's guidance there will now be three, and I think it
will be much easier for the VHA to implement those systems and
then hopefully go much beyond that.
Mr. Walz. And that will hold true both in the private
sector also for them to follow that?
Mr. Wilton. Yes. Yes, sir.
Mr. Walz. So this will help, will this help lead and push
into that?
Mr. Wilton. Absolutely. I think it is a terrific step for
the VHA to take the leadership role in this, and we are happy
to work with them.
Mr. Walz. That is great. And from today's testimony, what
did you hear that most concerns you, if there is something you
could hear amongst this testimony? Just trying to educate us
and understand some of----
Mr. Wilton. Sure. I mean, again, the good news is, the FDA
registration issue is one that clearly concerns the committee.
AATB accredited tissue banks are registered with the FDA. You
had some concerns about the frequency of inspections. When you
are accredited by AATB, we inspect each one, and there is a
three-year period where we reinspect. So between the FDA and
AATB, there are many more inspections. And we just think that
our veterans deserve the best, and we feel strongly that AATB
accredited tissue banks provide the best.
Mr. Walz. Okay. Because what you are hearing, and I hear
when it got explained further, we are always going to err on
the side of cautiousness towards our veterans. So when we hear
that there is a possibility I think my colleague was bringing
up a good point. I understand it is not proving the negative
type of situation. He was just asking, you cannot in all, 100
percent confidence, tell us this is happening. That concerns
us. So I think it is important for us to understand what those
steps are and how they are there and how we make that clear as
we go back and assure our constituents that they are protected.
And so with that, I yield back.
Mr. Coffman. Thank you, Mr. Walz. Dr. Huelskamp.
Dr. Huelskamp. Thank you, Mr. Chairman. Mr. Wilton, your
association, is that the entirety of the industry? Or are there
some other competing associations?
Mr. Wilton. I am not aware of any others.
Dr. Huelskamp. Okay.
Mr. Wilton. And in doing the analysis we feel that about 92
percent of all the tissue that is recovered and processed in
this country is done through AATB accredited tissue banks.
Dr. Huelskamp. Mm-hmm. And the other eight percent, is that
through another accredited organization? Or----
Mr. Wilton. I am not aware of another organization.
Dr. Huelskamp. Okay. What happens in that eight percent,
then? Can you describe that? No one knows, is that----
Mr. Wilton. I think you are correct, sir. No one knows.
Dr. Huelskamp. Okay. Okay. In your experience, I asked a
question of both the previous panels. Are you able to compare
the VA, compared to say the DoD, or other federal agencies? And
can you describe that comparison, what it looks like for the
committee?
Mr. Wilton. I think there are challenges in all health care
settings once the tissue actually gets to the consignee, the
hospital or the doctor. I think it is a universal problem. And
as I said earlier, I think it is terrific that the VHA is
considering taking a leadership role in this.
Dr. Huelskamp. So does the DoD track this? Do they have an
informal tracking system? Do they have a formal tracking
system----
Mr. Wilton. My understanding----
Dr. Huelskamp [continuing]. Next largest system?
Mr. Wilton. Yes, my understanding is they do it the same
way that the VHA does.
Dr. Huelskamp. Which is----
Mr. Wilton. Again, it is a manual process, not a bar coding
process. So having it in an automated sense I think would make
great strides for both DoD and----
Dr. Huelskamp. Do you believe is it standardized and manual
or----
Mr. Wilton. As I alluded to, there are going to be three
different systems that the FDA has approved to track and trace.
And I think the VHA and DoD will be able to adopt them, and our
members will obviously provide those as well.
Dr. Huelskamp. And my concern was not so much necessarily
with the manual aspect of that. It is the fact that in the VA
it was not standardized.
Mr. Wilton. My understanding is it is not, sir.
Dr. Huelskamp. Yes. And it was informal, which means it is
not formal. But is the DoD, in your opinion is it informal as
well----
Mr. Wilton. My understanding is that they operate on a
similar fashion.
Dr. Huelskamp. Okay. Well that is particularly troubling.
So if there is a recall, how does the DoD handle that?
Mr. Wilton. I am not aware of that, sir.
Dr. Huelskamp. You are not aware? So I presume you have
members that work with the DoD? I would appreciate some follow
up on that from your, how they handle that----
Mr. Wilton. We would be happy----
Dr. Huelskamp [continuing]. I know we are talking about the
VA. But if we are going to talk about that you think the VA
system that they are talking about implementing would be the
best, that raises a concern with me as well. Mr. Chairman, I
yield back. Thank you.
Mr. Coffman. Thank you. Dr. Roe. Mr. Wilton, thank you so
much for your testimony. You are now excused.
At this time I would like to give VA, if they would like to
respond to any of the comments in the prior two panels? Okay,
seeing none, today we have had a chance to hear about many
problems occurring with VA sourcing, procurement, and tracking
of biological implants. From the testimony provided and
questions asked today, I am alarmed at the great risk of harm
our veterans face when they receive a biological implant from
the VA. As such this hearing was necessary to accomplish a
number of items: to identify the reasoning for VA's
questionable procurement and tracking practices involving
biological implants; to require VA officials to explain their
inadequate response to these obvious deficiencies; and to
determine what steps are being taken to correct these issues
and improve the care provided to our veterans.
I ask unanimous consent that all members have five
legislative days to revise and extend their remarks and include
extraneous material. Without objection, so ordered.
I would like to once again thank all of our witnesses and
audience members for joining in today's conversation. With
that, this hearing is adjourned.
[Whereupon, at 11:41 a.m., the subcommittee was adjourned.]
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