[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
VENDORS IN THE OR_VA'S FAILED
OVERSIGHT OF SURGICAL IMPLANTS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
WEDNESDAY, JANUARY 15, 2014
__________
Serial No. 113-49
__________
Printed for the use of the Committee on Veterans' Affairs
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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 MARK TAKANO, California
DAVID P. ROE, Tennessee JULIA BROWNLEY, California
BILL FLORES, Texas DINA TITUS, Nevada
JEFF DENHAM, California ANN KIRKPATRICK, Arizona
JON RUNYAN, New Jersey RAUL RUIZ, California
DAN BENISHEK, Michigan GLORIA NEGRETE McLEOD, California
TIM HUELSKAMP, Kansas ANN M. KUSTER, New Hampshire
MIKE COFFMAN, Colorado BETO O'ROURKE, Texas
BRAD R. WENSTRUP, Ohio TIMOTHY J. WALZ, Minnesota
PAUL COOK, California
JACKIE WALORSKI, Indiana
DAVID JOLLY, Florida
Jon Towers, Staff Director
Nancy Dolan, Democratic Staff Director
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
MIKE COFFMAN, Colorado, Chairman
DOUG LAMBORN, Colorado ANN KIRKPATRICK, Arizona, Ranking
DAVID P. ROE, Tennessee Minority Member
TIM HUELSKAMP, Kansas MARK TAKANO, California
DAN BENISHEK, Michigan ANN M. KUSTER, New Hampshire
JACKIE WALORSKI, Indiana BETO O'ROURKE, Texas
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
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
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Page
Wednesday, January 15, 2014
Vendors in the OR--VA's Failed Oversight of Surgical Implants 1
OPENING STATEMENTS
Hon. Mike Coffman, Chairman...................................... 1
Prepared Statement........................................... 38
Hon. Ann Kirkpatrick, Ranking Minority Member.................... 3
Prepared Statement........................................... 40
WITNESSES
Mr. Randall Williamson, Director, Health Care GAO................ 5
Prepared Statement........................................... 42
Accompanied by:
Mr. Wayne McElrath, Director, Forensic Audit and
Investigative Services GAO
Mr. Roscoe Butler, Assistant Director for Health Care National
Veterans Affairs and Rehabilitation Commission, The American
Legion......................................................... 6
Prepared Statement........................................... 54
Mr. Philip Matkovsky, Assistant Deputy Under Secretary for Health
for Administrative Operations Department of Veteran Affairs.... 22
Prepared Statement........................................... 59
Accompanied by:
Dr. Thomas Lynch, Assistant Deputy Under Secretary for Health
Clinical Operations Department of Veteran Affairs
MATERIALS SUBMITTED FOR THE RECORD
Questions for the Record......................................... 60
Questions and Responses for the Record........................... 62
Letter to Eric K. Shinseki from Chairman, Mike Coffman........... 68
VENDORS IN THE OR--VA'S FAILED OVERSIGHT OF SURGICAL IMPLANTS
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Wednesday, January 15, 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 10:02 a.m., in
Room 334, Cannon House Office Building, Hon. Mike Coffman
[chairman of the subcommittee] presiding.
Present: Representatives Coffman, Lamborn, Roe, Huelskamp,
Benishek, Walorski, Kirkpatrick, and Kuster.
OPENING STATEMENT OF THE CHAIRMAN MIKE COFFMAN
Mr. Coffman. Good morning. This hearing will come to order.
I want to welcome everyone to today's hearing titled, ``Vendors
in the OR--VA's Failed Oversight of Surgical Implants.'' This
hearing examines serious problems with the tracking and
handling of surgical implants within the VA and follows through
on procurement issues revealed in a previous hearing by this
subcommittee.
According to multiple sources VA medical centers have
allowed surgical implant vendors to participate in hands on
treatment administered to veterans. Based on my staff's initial
findings I asked GAO to investigate these allegations regarding
veteran healthcare and to determine what policies are currently
in place. GAO substantiated that several veterans had received
skin grafts that had been applied directly by skin graft
vendors. GAO found that VHA requires each medical facility to
develop its own policy on vendor access resulting in varying
degrees of specificity regarding their participation in patient
care.
These findings raise serious questions about the extent of
vendor involvement in patient care at VA facilities and the
lack of clear guidance regarding vendor access. VA's own
consent form as well as industry best practices state that
vendor representatives may be present to provide technical
advice but may not physically participate in the procedure.
However, GAO's investigation confirms that these policies are
being unevenly applied or unenforced. Clearly, national
guidance and oversight is necessary to protect veterans who
undergo surgical implant procedures.
There are also significant problems with how VA handles and
tracks surgical implants in veterans. Previous VA OIG audits
criticized the VHA for weak internal controls that jeopardize
VA's ability to identify and notify patients in the event of
FDA product recall. According to GAO's report released on
Monday these concerns remain and have not been remedied. For
some clinical specialties, including gastroenterology,
interventional radiology, and pulmonary, identifying
information on implants was not tracked in any system. It is
troubling to consider that for these specialties VHA was unable
to verify that the items purchased were actually implanted in
the patients for whom they were intended.
In 2008 VA began developing the Veterans Implant Tracking
and Alert System, VITAS, to track and retrieve identifying
information including the lot and serial number of surgical
implants placed in patients VHA-wide. Unfortunately according
to GAO this system's development was suspended at the end of
the fiscal year 2012 due to data reliability challenges and as
of December, 2013 development of VITAS has not resumed limiting
VHA's ability to identify and locate patients who have received
implants.
Additionally GAO's report shows that VA has failed to make
sufficient progress with prosthetic procurement reform. In a
May 30, 2012 hearing this subcommittee revealed that VA medical
centers and VHA regional network contract officers misused
waiving authority to spend nearly $3 billion on open market
purchases of prosthetics, including surgical implants, rather
than procure them through competitive contracts including those
with businesses on the federal supply schedule. As a result of
the hearing VA acknowledged that there are often several
options available for implants and that disadvantaged veteran
owned small businesses and others offering these products were
being unfairly excluded from consideration. VA indicated that
it would implement reforms so that noncompetitive and sole
source purchases would require justification on a case by case
basis.
GAO's report does contain some good news. VA has made some
progress with obtaining national committed use contracts for
non-biological implants, such as artificial joints, cardiac
pacemakers, heart valves, and coronary stints. Use of these
national committed use contracts is the most favored method of
procurement for implants under the Federal Acquisition
Regulations. However GAO also reported that no such contracts
have been negotiated for biological implants, such as skin and
bone grafts. Moreover contrary to a memorandum dated May 23,
2012 from Assistant Deputy Under Secretary Matkovsky GAO found
biological implants were rarely ordered from the federal supply
schedule at each VA medical center it visited. According to GAO
overuse of the waiver process continues. It reported that none
of the medical centers it visited procured surgical implants in
compliance with waiver requirements for open market purchases.
Finally it is most disappointing to note that while VA and
VHA now have procurement oversight components, GAO reported
that they have failed to impose corrective actions for these
deficiencies.
In conclusion, VA must continue to implement reforms so
that medical centers procure surgical implants that meet
patient needs while also ensuring best value. More importantly
VA and VHA must pay much better attention to patient safety
concerns regarding surgical implants. It is way past time for
VA to develop national policies that set forth the parameters
for vendor access to treatment facilities and that implement
sufficient oversight controls. Additionally proper tracking of
surgical implants is a problem that has been unresolved for far
too long and it must be remedied post haste.
[The prepared statement of Chairman Mike Coffman appears in
the Appendix]
With that, I now recognize Ranking Member Kirkpatrick for
her opening statement.
OPENING STATEMENT OF HON. ANN KIRKPATRICK, RANKING MINORITY
MEMBER
Mrs. Kirkpatrick. Thank you, Mr. Chairman. I really
appreciate having this hearing on the purchase and use of
surgical implants. As we know, it is common for the vendors of
medical devices to be in the operating room during surgery. But
it is very uncommon for them to scrub and to touch a patient.
So I am really interested in the testimony today and in whether
or not we need to actually, you know, beef up our policies on
this.
On Monday the Government Accountability Office released a
reported entitled, ``VA Surgical Implants--Purchase
Requirements were not Always Followed at Selected Medical
Centers and Oversight Needs to be Improved.'' So that is what
we are concerned about today. The GAO looked at four VA medical
centers and found that these hospitals did not always follow
VHA policy regarding documenting open market purchases of
surgical implants, including obtaining the necessary waivers to
purchase items not covered by a VA negotiated contract. Last
year VA instituted a new policy regarding purchases above the
Federal Acquisition Regulations, FAR, micro purchase threshold
of $3,000 and below the simplified acquisition threshold of
$150,000. Medical facility and regional office officials
attributed noncompliance mainly to insufficient VHA guidance
and VA staff's inexperience in completing the new requirements.
This is a familiar litany to members serving on this
subcommittee. It has been noted before that it does not matter
how good and thorough the policy and standards are if no one
follows them and there are seemingly no consequences for
noncompliance. This is what I would like to explore today, in
addition to looking at the specific allegations and looking at
ways to improve the process.
Surgical implants and the larger issue of medical
procurement provides us with the classic balancing act of
patient and provider choice on one hand, and efficiency and
savings on the other. These are not in my view mutually
exclusive concepts. But also there are ultimately very few easy
answers. Should there be a greater level of centralization on
procurement? Or should we provide greater local autonomy while
ensuring that the policies are followed? Indeed, how do we
ensure that VA employees are provided the tools to do their job
and help our veterans, but are also held accountable if they do
not comply with established policies?
On the issue of surgical implants, what policies and
structures are in place to ensure that VA staff is kept fully
up to date on advances in the field of surgical implants and
the availability of different options? While also ensuring that
VA's contracting efforts are directed toward items that are
clinically advantageous and necessary for patient care.
Our decisions regarding which items to include in a VA
negotiated committed use contract made from the top down or the
bottom up? And more importantly, are these decisions made
rigorously and systematically? How effective is the recently
instituted program executive office and does this effort have
the staffing level and financial resources to make a difference
and improve the process?
GAO reported that VHA spent approximately $563 million on
surgical implants in fiscal year 2012. That is an increase of
28 percent over the 2008 levels. I would like to hear from our
witnesses today regarding the factors that led to this
increase. It is not clear to me whether the increase is
primarily due to the practice of open market purchases or to an
increase in either the costs of surgical implants or an
increase in their use.
Patient care and safety is our number one concern. That is
why I am concerned over allegations that surgical implant
vendor representatives participated in direct patient care. I
want to ensure that the VA policies are fully followed in this
regard while also recognizing that at times vendor
representatives can have an important role in providing
technical assistance and education to VA care providers.
So let us begin the conversation on how best to fix the
problems before us today and work to improve the VA healthcare
system and the healthcare it provides to our veterans. Spending
taxpayer dollars wisely is essential but providing the
healthcare that veterans have earned and deserve is critical. I
look forward to hearing from our witnesses today and I yield
back. Thank you, Mr. Chairman.
[The prepared statement of Hon. Ann Kirkpatrick appears in
the Appendix]
Mr. Coffman. Thank you, Ranking Member Kirkpatrick. I ask
that all members waive their opening remarks as per this
committee's custom. With that I invite the first panel who are
now at the witness table. On this panel we will hear from Mr.
Randall Williamson, Director of the healthcare team at the
Government Accountability Office. He will be accompanied by Mr.
Wayne McElrath, Director of GAO's Forensic Audit and
Investigative Services Team. We will also hear from Mr. Roscoe
Butler, Assistant Director for Healthcare with the National
Veterans Affairs and Rehabilitation Commission at the American
Legion. Your complete written statements will be made part of
the hearing record. Mr. Williamson, you are now recognized for
five minutes.
STATEMENTS OF MR. RANDALL WILLIAMSON, DIRECTOR, HEALTH CARE,
GOVERNMENT ACCOUNTABILITY OFFICE; ACCOMPANIED BY MR. WAYNE
MCELRATH, DIRECTOR, FORENSIC AUDIT AND INVESTIGATIVE SERVICES,
GOVERNMENT ACCOUNTABILITY OFFICE; AND MR. ROSCOE BUTLER,
ASSISTANT DIRECTOR FOR HEALTH CARE, NATIONAL VETERANS AFFAIRS
AND REHABILITATION COMMISSION, THE AMERICAN LEGION
STATEMENT OF RANDALL WILLIAMSON
Mr. Williamson. Thank you. Good morning Mr. Chairman,
Ranking Member Kirkpatrick, and members of the subcommittee. I
am pleased to be here today to discuss GAO's recent report on
VA's purchasing of surgical implants. Surgical implants include
biological implants, such as skin and bone grafts, and non-
biological implants, such as cardiac pacemakers and artificial
joints. Today I will address three areas of our work. First,
VA's compliance with federal purchasing requirements and its
oversight of surgical implant purchasing; second, VA's ability
to identify veterans who have had surgical implants that are
recalled by the manufacturer or the Food and Drug
Administration; and third, allegations that surgical implant
vendor representatives participated in direct patient care at
VAMCs.
With me today is Wayne McElrath, who directed our
investigative work on vendor participation in surgical
procedures at three VAMCs.
Regarding VA's compliance with purchasing requirements, we
found through our work at selected VAMCs that VA's surgical
implant purchase requirements were not always followed. For
example, when surgical implants are purchased on the open
market and not through established VA and government negotiated
contracts where prices have been specifically established,
VAMCs are required to file a waiver justifying why the item is
being purchased on the open market. We found that in many cases
such waivers were not being obtained or had incomplete
documentation. We also found that in justifying open market
purchases of surgical implants over $3,000, VAMCs are not
always preparing a written determination that prices are fair
and reasonable and/or citing an appropriate rationale for sole
source award. We found that oversight over surgical implant
purchases was not robust and allowed these conditions to
persist at VAMCs.
Turning now to VA's ability to identify veterans who have
received recalled surgical implants, we found that VA is
limited in its ability to systematically identify and locate
all patients who receive surgical implants, which could be a
critical factor if an implant is recalled by the manufacturer
or the FDA because of safety concerns. For example, VA through
its own studies has found instances at numerous VAMCs where
data on lot and serial numbers for surgical implants were not
entered into VA's computerized system for tracking such
purchases. This limits the VAMC's ability to match veterans to
implants that they received. Absent the ability to accurately
track implants to veterans receiving them, VA may be putting
some veterans at risk in the event that surgical implants are
recalled.
In 2008 VA began developing a new tracking system to remedy
this problem. But VA's efforts to develop such a system are
currently stalled due to technical challenges and a lack of
funding.
Finally, our investigations of allegations received by the
subcommittee disclosed that in some instances a vendor
representative supplying surgical implants to one of the three
VAMCs we investigated was participating in direct patient care
at that facility. Specifically, at least as recently as August
2013, a vendor was assisting VA clinicians in applying skin
grafts or was himself applying skin grafts to several veterans.
Without proper precautions, allowing a vendor representative to
participate in direct patient care could compromise veteran
safety.
While VA allows vendors to provide technical assistance and
advice during procedures involving surgical implants, national
VA policies do not adequately define the degree that vendors
are allowed to participate in patient care. Rather, VA relies
on VAMCs themselves to develop their own procedures in this
regard. Absent definitive national guidelines VAMCs acting
alone may develop different and inconsistent guidelines and
controls over vendors, which is exactly what we found at the
three locations we investigated. For example, two VAMCs
required background screening for vendors accessing the
facilities, while the third VAMC did not. Also, at one VAMC,
written procedures covering vendor access and involvement in
clinical procedures expressly prohibits vendors from physically
performing any part of a clinical procedure, whereas written
procedures for the other two hospitals are silent in this
regard. Also we found instances where some VAMCs were not
following their own written procedures.
While the results of our findings cannot be generalized to
VA as a whole, they raise serious questions about the extent
that consistent procedures and controls exist with respect to
both vendor access to VA facilities and vendor involvement in
patient care at facilities nationwide. This concludes my
opening remarks.
[The prepared statement of Randall Williamson appears in
the Appendix]
Mr. Coffman. Thank you, Mr. Williamson. Mr. Butler, you are
now recognized for five minutes.
STATEMENT OF ROSCOE BUTLER
Mr. Butler. Chairman Coffman, Ranking Member Kirkpatrick,
and members of the subcommittee, on behalf of our National
Commander Dan Dellinger and the 2.4 million members of The
American Legion, I want to thank you for inviting our
organization here today to this hearing to address our concerns
with aspects of how VA implements their prosthetic and implant
medicine program.
As a member of The American Legion's System Worth Saving
Task Force, I have been privileged to travel to many VA
healthcare facilities and see firsthand how programs really
work in the field. In both my experience working for VA for
many years and in my travel on behalf of The American Legion, I
have seen that conditions in the field do not always match what
the folks inside the Beltway think they are. There are several
problems with VHA policies and implementation of implant
medicine healthcare. Most of these problems could be fixed with
clear written direction from central office and better
oversight and consequences to enforce compliance.
First, VA still has a problem tracking surgical implants
that places veterans at risk. An OIG audit from two years ago
identified that there are expired surgical devices on VA's
supply shelves. Further, GAO report and testimony today
indicated that VA has an inaccurate tracking capability in
recording the serial numbers of the implant surgical devices.
The grave concern of The American Legion is that in addition to
having expired products on the shelves veterans potentially
could be walking around today with expired surgical implants.
The American Legion urges Congress to require VA to implement
an automated tracking system that addresses vulnerabilities by,
one, initially recording the serial number of a surgical
implant device when procured and placed into VA's inventory;
two, record the expiration date; and three, that a record
tracking flag be put into place to alert VA staff when the
product is near its expiration date.
As there remain limitations to VA's current supply
inventory system and uncertainty surrounding the safety and
well-being of veterans currently with implantable devices, The
American Legion urges VA to verify that there are no veterans
with expired surgical implants and accelerate its timeline for
implementing a new prosthetic inventory system that includes
these recommendations.
Secondly, The American Legion remains concerned that VA
does not have an official policy on vendors in operating rooms.
While having vendors in the OR to provide technical advice may
be medically necessary, it needs to be made crystal clear that
veterans have consented and received full disclosure that
strictly adheres to a clear, delineated VA policy. VA has
admitted that they do not have a specific policy but indicated
the National Center for Ethics in Healthcare noted that the
presence of vendors in the operating room is a common practice
in U.S. healthcare. And when there are broadly accepted
professional ethics standards pertaining to a particular
practice VA does not particular reiterate those standards in VA
policy. Rather it was buried in VA's consent form under the
number 15, additional information, which states in part the
representative may provide technical advice but not participate
in the procedure. The foundation of VA policy should be based
on and consistent with statutory and regulatory authorities.
Third, The American Legion has concern about VA making a
regular practice of circumventing the supply schedule. The
federal supply schedule exists for a reason and the vendors on
the schedule have been carefully vetted. Many of them are
important contracts with veterans and/or small disabled
veteran-owned business owners. While The American Legion
recognizes and applauds the need to go off schedule in rare
circumstances for the medical interests of the patient, it is
becoming increasingly disturbing that off schedule purchases
seem to be more the norm than the exception.
Let us be clear: the medical health of the veteran is the
single most important factor in any decision about healthcare
in the system. System Worth Saving visits uncovered doctors who
choose to go off schedule to order stints for heart surgery
because they were uncomfortable with the durability of the
stints on the schedule. In that circumstance you would hope
that the doctors err on the side of the patient's safety 100
percent of the time. That said, if doctors are consistently
going off schedule then either the schedule needs to be
reformed or the process reformed. No system that is raised on
circumventing its own process can be considered in anyone's
best interest.
Again, thank you for the invitation to speak today and
keeping a close focus on ensuring veterans get the most out of
their healthcare system. We would be happy to answer any
questions you might have.
[The prepared statement of Mr. Roscoe Butler appears in the
Appendix]
Mr. Coffman. Thank you for your testimony. Mr. McElrath,
was GAO able to determine why vendor representatives were
allowed to provide potentially inappropriate patient care at
the VAMC where the allegations were substantiated?
Mr. McElrath. We were not able to identify one specific
reason. But some of the rationales that were given were lack of
staffing, the difficulty of placing grafts on patients without
having some assistance, and also a lack of knowledge relative
to the particular VAMC's policies and procedures.
Mr. Coffman. Mr. Williamson, based on your report please
elaborate on the challenges in trying to identify veterans who
may have received a recalled surgical implant?
Mr. Williamson. Well, currently VA has a prosthetic
purchasing system, which is used to track surgical implants and
match them with veterans. VA has done a study of that system
and found that lot and serial numbers were oftentimes were not
entered correctly, or not entered at all. And that really is a
detraction in trying to match veterans with implants.
Also, clinical services within VA have their own systems.
Oftentimes, VAMCs or clinical services themselves will design
systems. They may use spreadsheets, perhaps, kept on a
computer. The difficulty with those systems is they are not
standardized, and that information is not shared among VAMCs.
Have augmenting systems. VA is developing a new system called
the Veteran Implant Tracking and Alert System, VITAS. And that
system is designed to centralize tracking of implants.
The difficulty is it still relies on manual input, and the
chance of human error is still there. VITAS will have the same
kind of difficulty in the sense that it is inputted by people.
A way to get around that is to have a bar coding system where
you scan the bar code in, and it is put in automatically. And
that would solve the problem. VITAS is not going that route
right now.
Mr. Coffman. Okay.
Mr. Williamson. So those are the challenges.
Mr. Coffman. Thank you. Mr. Butler, did you find that VHA
had clear and consistent policy set forth to ensure a proper
and ethical procedure when vendors were present during surgery?
Mr. Butler. We asked VA if they could provide us a copy of
their policy and their response was that they did not have a
specific policy. However, the consent was included, the
authorization was included in their consent form. So that, this
concerns us that they are using guidance from the National
Office of Ethics but they themselves have not promulgated a
standard policy that can be applied consistently across the
board throughout VA, or VHA.
Mr. Coffman. Thank you. Ranking Member Kirkpatrick.
Mrs. Kirkpatrick. Thank you, Mr. Chairman. Mr. Williamson,
you probably do not know, but the committee knows, that I have
over 20 years experience in a hospital and I am really
interested in hearing from our physician members of the
committee about this. But it is highly unusual for a rep to
scrub in the OR. And in the instances that you mentioned, did
the reps scrub?
Mr. McElrath. The instance that we identified was the
application of biologics, or skin grafts. The interviews that
we conducted did not mention the words specifically ``scrubbing
in.'' But the wound care nurse and the vendor representative
actually performed the procedure.
Mrs. Kirkpatrick. So the nurse actually, the clinician
actually performed the procedure, not the rep?
Mr. McElrath. No. From the patient care record the wound
care nurse indicated that the vendor actually applied the skin
graft.
Mrs. Kirkpatrick. Okay, that is very disturbing. Can you
tell us what vendor that was?
Mr. McElrath. Out of respect for the investigative process
and the fact that we may be making a referral to the VA Office
of the Inspector General for further investigation, we would
respectfully request that we provide that information to your
committee staff after the hearing.
Mrs. Kirkpatrick. Thank you, please do. You know, looking
at the overall goal of cost saving and clinician choice, Mr.
Williamson, again I would like to know how effective is the
VHA's Program Executive Office? And do you have ideas for us
about how to strengthen and utilize that office?
Mr. Williamson. We did not look at that specific thing in
general. I know in the past the subcommittee was very concerned
about the use of Section 81-23 and whether that is being
overused. And that is certainly something we looked at in our
examination of the purchases, during our review. We see that
the use of 81-23 justification is going down. And used
prudently 81-23 is a good avenue for a physician or a clinician
to use to provide treatment, the best treatment that he or she
sees fit for a veteran. But we noted when we looked at the
justifications for sole source procurement that there is a much
greater use of emergent and compelling need as the basis of
sole source purchases as opposed to 81-23 saw a flip flop. The
81-23, box is not being checked anymore, but rather urgent and
compelling need is.
Mrs. Kirkpatrick. You know, and those of us who have
experience in healthcare know that the medical device industry
changes quickly. There are always new devices coming out. And
did you look at the training that the clinicians have in terms
of educating them on the best products, the best use? Did you
look at all about adequacy of training?
Mr. Williamson. Are you talking about the clinicians or the
vendors?
Mrs. Kirkpatrick. The clinicians, yes.
Mr. Williamson. We did not. We have in the past done some
fairly thorough studies of credentialing and privileging
systems that both VA and DoD have. We did not look at that
training during this review.
Mrs. Kirkpatrick. Mr. Butler, did you look at that at all?
Mr. Butler. We did not.
Mrs. Kirkpatrick. You did not. Okay. Mr. Chairman, I am
going to yield back. I really want to hear from our physicians
on the committee.
Mr. Coffman. Thank you, Ranking Member Kirkpatrick. Dr.
Huelskamp.
Dr. Huelskamp. Thank you, Mr. Chairman. I am a doctor but
not a physician, so there will be no confusion here. But I do
have some questions, particular of the GAO and I apologize for
my voice this morning. You made some mention to the issue of
urgency and perhaps timeliness as far as the purchases on the
open market versus those through the VA purchasing
requirements? Did you compare cost or quality, or any other
characteristics? I see you looked at a certain percentage of
those. I did not know if you had compared the outcomes and the
cost and such?
Mr. Williamson. Could you repeat the last part of the
question again?
Dr. Huelskamp. You mentioned you compared a few purchases,
about I believe six percent of a certain subset. Did you look
at the cost? Was it more or less expensive? Did you look at the
quality? Was there any timeliness? As far as comparing those
purchases in those two environments?
Mr. Williamson. Yes, we did not look at whether they got
the best price. What we did was rather to focus on the
documentation and see whether that existed. And in many cases,
it did not exist to our satisfaction.
Dr. Huelskamp. Okay. Yeah, and I did not see that in the
report. That is why I wanted to ask. The follow-up question
would be, what is the penalty for failing to comply with the
VHA purchasing requirements?
Mr. Williamson. Well agencies are also governed by the
Federal Acquisition Requirements. It is certainly something
that can cause a reprimand within the agency.
Dr. Huelskamp. Any evidence that there was any reprimand or
any penalties for failing to follow up?
Mr. Williamson. No. A lot of times when waivers are not
obtained, when the documentation is not obtained, it was not
followed up on by VA and there was no action plan by VA to
correct those kind of weaknesses.
Dr. Huelskamp. Sure. Okay. The next question would be I see
you are experience at working with the health systems in the
Department of Defense as well. Could you give a broad
comparison between VA and the DoD? Do they have these similar
problems, and are you familiar with that enough to answer?
Mr. Williamson. We have not looked at similar issues like
surgical implants in DoD, if that is what you are talking
about. No, we have not. We did look at how some large
healthcare systems like Kaiser in the private sector surgical
are purchasing implants under their contracts. And they are
much more aggressive than VA in trying to get items under
contract.
Dr. Huelskamp. Mm-hmm. But you did not look at the cost
comparison there?
Mr. Williamson. No.
Dr. Huelskamp. Okay. The last question will be for Mr.
Butler, and I am very concerned about the patient privacy and
the instances that were repeated here, and it is occurring. But
what are your suggestions? What should be able to be authorized
by a patient? If I understood correctly, you believe the
language that was used probably authorized the vendor to be in
the care situation. Is that your understanding of what----
Mr. Butler. No, it does not authorize, the language in
their consent form does not authorize the vendor to provide
hands-on care. It authorizes the vendor to provide technical
advice. But that is a contract between the vendor and the
patient, it is not a national policy. So we advocate that the
VA establish a national policy that articulates all of the
requirements for allowing vendors in the OR. And then use the
consent form as the agreement between the vendor and the
patient. We believe that if they have a national policy, as I
stated, the foundation of VA is predicated upon the statute,
the regulations, and the policy that VA adopts. And without a
policy there is no requirement that facilities operate in a
consistent manner or fashion.
Dr. Huelskamp. Well thank you, Mr. Butler. I agree as well.
And I yield back my time, Mr. Chairman.
Mr. Coffman. Dr. Benishek.
Dr. Benishek. Thank you, Mr. Chairman. I am a general
surgeon and I have been in the operating room, you know, lots
of times. I have never actually seen a vendor, you know, do a
case. So Mr. McElrath, can you, was this a couple instances of
some vendor putting on a skin graft? Is that what you are
saying? Is there any other episodes that you encountered that
the vendor was involved with a case? Or is it a couple----
Mr. McElrath. We found two cases where vendors were
actually involved but there were several instances over a
period of time. By speaking to clinicians that we interviewed
during the course of this investigation, we were able to
identify those records. If the clinicians had not input that
information directly into that patient record, all we would
have is witness testimonies. It made it easier for us to
corroborate their statements because they actually entered into
the patient record who placed the skin graft.
Dr. Benishek. Well, you know, it is frankly shocking to me
that this actually happened. You know, I am a little concerned
about, you know, standards that come from Washington to every
VA because all that stuff gets messed with. But it seems to me
that each hospital should have rules, like the Joint Commission
on Hospital Accreditation would not go for this. I mean, this
would not fulfill the accreditation needs of any hospital that
I know of. And, you know, I think that rule should be developed
at the hospital. They should be, you know, reasonable rules.
And I cannot believe that a, you know, something must have been
wrong. I mean, Mr. Williamson, you said that some of the
hospitals had no rules about----
Mr. Williamson. The three we looked at had written
procedures, but those procedures were inconsistent and they
left out some of the things that----
Dr. Benishek. Well in my experience, you know, which is in
the private sector mostly, but I have had some experience in
the VA system as well, you know, each hospital is required to
have a set of rules and procedures, you know, to be accredited
by the Joint Commission.
Mr. Williamson. Right.
Dr. Benishek. You know, which, you know, sets a standard
for not only the VA but for, you know, private sector hospitals
which I hope that the VA would be in the same boat. And the VA
that I worked at, you know, we were inspected. And this type of
stuff I think would fall out of an inspection, you know,
immediately if they were aware of it. What can we do? I guess
really the problem to me is accountability. I mean, nobody at
the, you know, the problem I come up with again and again in
this committee is that when errors like this are found, nobody
seems responsible. There is not one individual that you could
point to and say this is your responsibility and you need to be
reprimanded or change your ways, put it in your performance
review. Has any of that occurred in any of these circumstances
that you know of?
Mr. Williamson. You are talking about the vendor?
Dr. Benishek. Well, no. I am talking about the hospital
people that allowed this to happen. I mean, you know, you never
get to a person whose responsibility it was, then they could
identify, you know, report this place in their performance
review saying that, you know, they did not comply with the
rules of the hospital.
Mr. Williamson. Mm-hmm.
Dr. Benishek. And, you know, you may be subject to
termination, you may be subject to disciplinary action. The
accountability of the administration of the hospital or, you
know, the upper echelon is always of importance to me. Because
it seems to never happen where one person gets identified as
being a problem. And you know, a culture of lackadaisical
performance seems to be allowed a lot of the time within the
VA. So as far as you know, has anybody been disciplined or had
a report placed in their----
Mr. Williamson. No.
Dr. Benishek. Well we will ask the VA, too. But I just was
hoping that maybe you guys could. Let me also ask about this
vendor, or the purchase of materials. You know, as a surgeon I
want to work with the materials and the devices that I am
familiar with.
Mr. Williamson. Right.
Dr. Benishek. Okay? So sometimes I would be upset that the
VA, you know, really want to use this thing which I never
used----
Mr. Williamson. Mm-hmm.
Dr. Benishek.--and I am not comfortable with it. So I want
to have the implant or, you know, the device that I am
comfortable with and used to using. And I think that many
surgeons have that same, you know, preference.
Mr. Williamson. You are correct.
Dr. Benishek. But there is no reason why when you come to
the hospital and set up you can tell them all of what you are
going to use.
Mr. Williamson. Mm-hmm.
Dr. Benishek. And they should be able to set up a plan to
purchase that, you know, in a price advantageous. And I think
that is a problem. And I think that is a problem related to how
this is working here. Because the surgeon comes in, the VA will
not put it on their formulary for whatever reason, and the guy
says, ``Well I am not doing the case unless I get the stuff
that I am familiar with.'' So is there any evidence of that
happening?
Mr. Williamson. Well when we went to four different VA
hospitals across the country to look at this we interviewed 28
clinicians, and we asked them that very question. Why do you
choose surgical implants from the open market in many cases
when these are on contract? And it comes down to, number one,
the best interest of the patient. In other words, veterans
sometimes have unique needs and they have implants that best
suit their treatment needs. The other reason is like you say,
``what are you comfortable in using?'' ``What have you been
trained on in terms of the surgical implants?'' Also, other
reasons include the literature searches that they might have
access to in terms of the effectiveness of implants and
contacts with surgical implant vendors.
Dr. Benishek. Well that does not preclude the ability of
the VA to enter into contracts with people that provide a
myriad of different devices. I mean, there are lots of VAs
across the country. You know, there may be ten different
devices and, you know, a hundred different surgeons may use
each one of those differently.
Mr. Williamson. Right.
Dr. Benishek. So I do not see how that, that does not
preclude the ability for the VA to contract with multiple
providers for the same type of----
Mr. Williamson. Right.
Dr. Benishek [continuing]. Implant. And that does not seem
to happening.
Mr. Williamson. The key is for VA to get more items under
contract to get a good price.
Dr. Benishek. Right.
Mr. Williamson. And right now we only have nine types of
items under national committee use contracts that VA has with
vendors. And one of the things that we recommended was that VA
take a more aggressive posture in----
Dr. Benishek. There are only nine?
Mr. Williamson. There are only nine, all non-biological
implants.
Dr. Benishek. Out of the thousands of implants, different
types of implants available?
Mr. Williamson. Yes. They are the highest----
Dr. Benishek. That is a shocking number----
Mr. Williamson [continuing]. High volume and high cost
items.
Dr. Benishek [continuing]. Because that is a very small
number of the different implants that it happens.
Mr. Williamson. Right.
Dr. Benishek. That is a major deficiency that I think you
have identified here at a high level within the VA. Because
there should be a thousand different implants on the VA
formulary. You know----
Mr. Williamson. Now there are, in addition to the national
committed use contracts, there are the federal supply schedule
contracts. And there are a number of both biological and non-
biological surgical implants on the FSS. So there are other
lists to choose from. But the first choice would be the
national committed use contracts because those give VA the best
prices.
Dr. Benishek. My time is expired. Thank you.
Mr. Coffman. Congresswoman Walorski.
Mrs. Walorski. Thank you, Mr. Chairman. Mr. Williamson, I
just, the information is just shocking. And every time we sit
in these Oversight Committee hearings with these reports, which
I very much appreciate, it is just shocking I think to the
American taxpayers and to all of us who sit here who want to
provide the absolute finest services to our best and brightest
servicemen and women and to hear these kind of reports. And I
guess, you know, one question I have is it just is shocking to
me that there are national medical device tracking efforts
already. Would it not behoove the VA to look at something that
is already in place like the UDI if they obviously have not
been able to successfully track implants?
Mr. Williamson. I do not think there is any, I do not think
that it necessarily would provide the information VA needs on
surgical implants. I think that the trouble is there is no
centralized system right now. The prosthetics purchasing system
has some weaknesses, as I reiterated in my opening remarks. And
VA is trying to develop a centralized system in addition to a
number of systems that the surgical services are using on their
own. So there are two sets of books here.
Mrs. Walorski. Is there a bar code system set up----
Mr. Williamson. No.
Mrs. Walorski [continuing]. In the VA where those implants
are just bar coded before they----
Mr. Williamson. Not to my knowledge, no. That would take
away the human error and that would probably be the best
system. A system based on bar coding would be a better system.
Mrs. Walorski. And what about the FDA's UDI system? Or what
about the American Joint Replacement Registry, AJRR? Or
something as simple as just having some kind of a standardized
policy of a scanner where it is literally just scanned into a
system that tracks?
Mr. Williamson. Yes, that would be, something that could be
considered. Again, it is a scanning system. It alleviates----
Mrs. Walorski. But what happens when, what happens when,
you know, we see a recall of some specific device that has been
implanted and it has affected X amount of people? How do they
know if that is implanted in a veteran?
Mr. Williamson. Well, you have got to rely on your systems
that you have already in place and identify through serial
numbers, lot numbers, medical records, other kinds of things--
--
Mrs. Walorski. But when human error puts a wrong code or
wrong----
Mr. Williamson. I am not saying it is impossible because if
there was a recall there are existing ways to trace it.
Certainly going through the medical records. But that is a
long, laborious project. And it is also subject to human error.
Would somebody detect it as they are going through all that?
Mrs. Walorski. Thank you, Mr. Chairman. I yield back my
time.
Mr. Coffman. Thank you. Dr. Roe.
Dr. Roe. I thank the chairman for yielding and thank you
for this testimony. Let me just, having been involved in a lot
of devices and having an implantable device in my eye right
now, and I actually can read your name, something I could not
do before my device was implanted. I would like to go about how
the procedure, how this actually works in the private sector.
And Dr. Benishek alluded to it. Let us say a uterine ablation
or any other new procedure that comes out, as a surgeon you
have to go and be trained. There are standards in your hospital
that require a certain number of hours of training before you
can do that. And there may be some technical assistance in the
operating room if you are operating a piece of machinery or
whatever that you need a vendor there for.
Mr. Williamson. Mm-hmm.
Dr. Roe. I completely agree that the vendor has no place in
actually doing the procedure. You as the surgeon are trained to
do that procedure. And the technical advice are there are just
things that come up that happen during the procedure. So I
certainly understand the need for, and Ms. Kirkpatrick clearly
pointed it out, these changes are happening at light speed.
Now I would be very uneasy if I knew that this device in my
left eye could not be kept up with. If we did not know, that
there was some reason it could not be tracked. Because as you
know, and mostly in orthopaedic, that is where most of the
implants are, that sometimes these fail. And if you find a
behavior of failure throughout these you would like to be able
to track down the patients and tell them that, hey, this device
has some risk to you or could do this. Look out for these
symptoms. As a physician I would want to be able to inform my
patients that that happened.
So the way it worked in our hospital is when the new
procedure came out you had to have a certain amount of
training, be certified in that procedure, and then carry out
that procedure a number of times. And then many times I would
mentor other people, teach them how to do the procedure. And
the old saying in years gone by, see one, do one, teach one,
that has sort of gone by the wayside now.
You are absolutely right, a system, whether it is bar
coding, that is the simplest thing in the world. I mean,
Walmart can tell you how many bars of soap went out of Walmart
in Tennessee. You ought to be able to keep up with a lens
implant or a knee implant and find out who they are. That is
fair, technology is there, it is not new. So I think those
kinds of things are fairly simple. And I do not believe that we
have a problem here that can be easily solved with the systems
that are in place. And maybe it will require a new IT, I do not
know, Mr. Williamson, whether it will or will not, or whether
those current systems are available. But this is not new. I
mean, we have been doing this for 25 years. And we are going to
continue to do it. And especially as our population ages and
more and more implantable procedures are done. I mean, how many
people have you met now that cannot go through an airport
because they set off a metal detector they have had so many
devices implanted in them? And we have to have a way to track
those. Because not all of them are perfect, there is no
question about it. And the reason it is important to be able to
track those is because when you find out what those defects are
it gives the manufacturer and the engineers a chance to improve
those and make them better for future patients. So I mean, I
think, Ms. Kirkpatrick, I have learned, I know your background,
and I certainly believe what we have got here, and I agree with
Dr. Benishek, I am not sure we need a national policy. But each
hospital, that is fairly simple stuff. And I will yield to
anyone who wants to respond. Mr. Butler, I read your testimony
and agree with much of it. But again, this is not reinventing
the wheel.
Mr. Butler. If I may?
Dr. Roe. Yes, sir?
Mr. Butler. With regard to your comment about the national
policy, the local hospitals develop their local policies based
upon the national guidance from the central office. So if they
do not have national guidance from central office, their local
policies may be inconsistent from one facility to the next. So
there needs to be consistency across all the VA healthcare
system. And that consistency comes from the national guidance
provided by the program office out of DC.
Dr. Roe. I certainly, I cannot argue with that, some
consistency. The other thing that I think we get into is
surgeons. And I get this. You know, I like a certain type of
suture. Is it vicryl? Is it chromic? Is it whatever? Do I like
staples? Do I like this particular staple? I mean, those things
change so fast and there needs to be some consistency because
error rates go down when you have, there is no question, when
you have a policy and a procedure that you go through just like
taking an airplane off. We learned that in our operating room,
that the more consistent that you could do it and the more
frequently you did it the same way, the less errors there were.
But there ought to be some latitude because not everybody falls
under the bell-shaped curve, as Dr. Benishek clearly pointed
out. And what you are familiar and used well and had good
success with. So procuring that, and I understand if you have
got ten surgeons the procurement officer in a VA cannot procure
ten different types of suture for that when it really does not
make any difference on the long term outcomes and the data will
prove that. And this should be data driven and not just cost
driven. And I think unfortunately what happens a lot of times
these things are cost driven and not data driven.
I would yield back my time.
Mr. Coffman. Thank you, Dr. Roe. Mr. Lamborn from Colorado.
Mr. Lamborn. Thank you, Mr. Chairman. And I want to thank
you for having this important hearing and for your work on this
issue. So I appreciate that.
Mr. Williamson, your report noted that the fair and
reasonable price determination was not completed for a number
of open market purchases that you reviewed and not properly
documented in other cases. Does this mean that the VHA was
overpaying for surgical implant purchases from the open market?
Mr. Williamson. Not necessarily. We did not look at, the
cost itself. Rather we just looked at the documentation that
existed to support that. But it does certainly make it more
likely that the fair and reasonable price was not obtained.
Even when we looked and examined documentation when there was
an explanation, sometimes the explanation was not too good. For
example the language might say that it was based on prior
prices. And yet the prior prices were not delineated. So, it is
just a statement and nothing more. Another case we found for
example, was a case of a bone graft that was supposed to cost
$6,000 and the fair and reasonable price determination was
based on a price range of other bone grafts that ranged from
$3,000 to $20,000. And, on the basis of that range, the VA
staff person determined that the $6,000 bone graft was fair and
reasonable. That is probably not the precision that you would
want in determining the reasonableness of that $6,000 bone
graft. So even when the documentation was there, it was not
very good in many cases.
Mr. Lamborn. Okay, thank you. And Mr. Butler, I have a
question for you. In your testimony you indicated that the
American Legion is utilizing a System Worth Saving Task Force.
Can you please elaborate on the task force and what it found
regarding implant tracking?
Mr. Butler. Well in 2003 our Past National Commander Ron
Connelly, when he was the Commander, went out and visited over
60 VA healthcare facilities looking at the quality of care and
access within the VA healthcare system. As a result of that at
our national convention a resolution was adopted that the
System Worth Saving Task Force continue those site visits. So
every year the American Legion System Worth Saving Task Force
identifies a theme. This year our theme is a ten-year look back
at the VA healthcare where we are visiting 15 VA healthcare
facilities and we are looking at the access, the quality of
care that is provided to America's veterans.
So with regard to your question about what findings we
found as it relates to implants, we have not really focused,
that has not been the focus of our attention. But we are
beginning to, since this was a part of the hearing, as we go
out on our site visits we are beginning to ask those questions
in terms of procurement and so forth to see what systems and
what concerns veterans have. When we go out to a site visit we
have a town hall meeting with veterans and we bring those
veterans in so that they can tell us what are the concerns and
the issues they have. So we are asking veterans what concerns,
issues they might have so that we can when we meet with the
medical centers we can address those intelligently to find
what, to get their response to those issues. So as we are
continuing our site visits we are beginning to focus on those
questions.
Mr. Lamborn. Okay. I appreciate your work and the American
Legion's work on that. And Mr. Williamson, I have a follow up
question. Does ``open market'' mean the possibility that items
are not Trade Agreement Act compliant?
Mr. Williamson. Not necessarily. No, I do not think so on
that one. If I understand your question right.
Mr. Lamborn. Yeah, what I am trying to get at is there
potential that there are gray market products that the VA is
using?
Mr. Williamson. There is always that potential, although we
did not, notice that when we did our work.
Mr. Lamborn. Okay. I appreciate that. Mr. Chairman, I yield
back.
Mr. Coffman. Thank you, Mr. Lamborn. Mr. Williamson, what
are the implications of low compliance with waiver requirements
for purchasing surgical implants from the open market?
Mr. Williams. Two things come to mind here. One is an
accountability factor. The waiver requirements are there for a
reason, to make sure that people go through a thoughtful
process, that clinicians go through a thoughtful process when
they choose open market items. And that is one factor. The
other factor is that the information that VA can glean from a
waiver, has a connection to national contracts, establishing
more national contracts. For example, VA gets information on
high volume, high use items, through the waiver process, that
are being purchased on the open market. VA can use that data to
identify items that they should pursue under a national
contract. So that is a very important part of having good solid
waiver information.
Mr. Coffman. Okay. And Mr. Williamson, your report
identified shortcomings in VA and VHA oversight of surgical
implant purchasing. How do you think that oversight could be
improved?
Mr. Williamson. Well, one of the things that both VA and
VHA have done is to perform separate studies looking at
surgical implant purchasing they came up with basically a
number of the same findings that we did. The difficulty was
that when they identified areas of noncompliance and talked to
VAMCs about them it was more in an advisory capacity, a
disclosure category, as opposed to doing something about it.
And one would expect, and what we expect when we recommend
something to somebody, is that they come back with an action
plan or something of that nature to make sure it happens.
Mr. Coffman. And Mr. Williamson, you know, finally your
report discussed low compliance with waiver requirements for
purchasing surgical implants from the open market. Why were
facilities not fully compliant?
Mr. Williamson. There were a couple of reasons. As you
know, VA is implementing a new system for surgical implants and
purchases over $3,000. Over the last year or so it has been a
major effort with VAMCs across the country. People that we
asked in the VAMCs about why they did you not prepare waivers
or why are these not on file told us that the higher priority
was to get this new system in place. And that was one of the
reasons. Also as other members have alluded, to physicians who
practice in VA facilities often have outside practices. They
may be working at VA part-time. And so they are not always as
familiar with the waiver rules. And those are basically the two
reasons that we heard when we asked that question.
Mr. Coffman. Thank you, Mr. Williamson. Ranking Member
Kirkpatrick.
Mrs. Kirkpatrick. Thank you, Mr. Chairman. Dr. Roe, I agree
with you that we should try to solve this problem within the
existing policies that we have. However, Mr. Chairman and the
committee, if it is the consensus of the committee that we need
a new policy I think we need to be very careful that we protect
that local control. Because doctors, as you stated and Dr.
Benishek as well, we want our physicians to have the tools that
they are comfortable with because ultimately our goal is the
best patient care possible for our veterans. So I think we have
to be careful and keep that in mind and give our physicians,
men and women, the best tools that are available so that they
can deliver the best patient care.
That said I would like the panel's thought about this idea.
When a vendor's rep crosses the line and actually touches a
patient in the OR, would it not be more effective just to
terminate the contract with the vendor? Terminate the contract?
Mr. Williamson. That is certainly a possibility. And again,
if you really want to enforce the idea that vendors, have no
hands on treatment ability in VA hospitals, there have got to
be some fairly stringent requirements and penalties in place. I
can probably think of a number of things in terms of improving
the whole access process for vendors in VAMCs. It starts with
getting them to sign in at the police office when they arrive.
We found, for example, that at one facility we looked at the
log in the police office that vendors were supposed to complete
in had not had an entry since 2011. And we knew that vendors
had been in there many times. So there are a number of things
in the whole access process that need to be addressed, it is
not just in the operating room or during procedures it is the
whole access that needs to be changed.
Mrs. Kirkpatrick. And maybe the procurement process, making
sure that those contracts have some clause in there that if a
rep actually touches the patient their contract is terminated.
Mr. Butler, do you have any opinion on that?
Mr. Butler. Well, you know, there may be provisions already
in the contract that covers that. They have to look back at the
contracts and see specifically what the contract states. And I
would agree that if there are not any particular provisions
that allow that, that there needs to be something. Because that
is a violation of what the veteran consented. The veteran,
based upon the current consent form the veteran did not consent
for the vendor to participate in the surgery. So clearly that
is a violation of the agreement between the veteran and the
clinician.
Mrs. Kirkpatrick. Right. You know, and my interest is not,
you know, again, it is making sure we have got the best patient
care possible for our veterans. But let us do not make the
physician's job more difficult. You know, let us look at the
vendor who actually violated that consent form.
Back to the bar code and the tracking, Mr. Williamson, does
not the VA track medication by bar code already? I mean, is
there not a system----
Mr. Williamson. I believe so, but I am not sure of that.
Mrs. Kirkpatrick. Okay. Again, I think we should look at
what is working within the VA system. I am pretty sure they
track medications. I do not know why they cannot track medical
devices. Thank you, Mr. Chairman.
Mr. Coffman. Thank you, Ranking Member Kirkpatrick. Dr.
Benishek.
Dr. Benishek. Thank you, Mr. Chairman. I did not really
touch upon the other issue that we are talking about and that
is the tracking. Some of the other members did. But frankly I
just cannot believe that that does not happen either. I mean,
like Dr. Roe mentioned it has been going on in the private
sector for 25 years. And you know, you know, constantly with
every device that I know of comes with a sticker with a bar
code on it. And you put it in the chart, you know, so that it
is thoroughly documented, you know, what device is in which
patient. And I just cannot believe that this goes on. And it
brings me back to my same question I had, and that is the
accountability of when these errors occur. What can we do
better to identify, you know, the people who manage this system
and to make them accountable for these errors? Do any of you
have an idea about that?
Mr. Williamson. Well, keep in mind that people, are looking
at a surgical implant package and there are numbers all over
the package. Given that, there can be a very innocent
transposition of numbers. It is not something intentional, it
may not be done a lot, but it does happen and there are enough
cases happening that it leads one to have concern if a recall
occurs.
Dr. Benishek. Oh, I understand that errors can occur, you
know, among the OR scrub nurse, or the circulating nurse. But,
you know, that is uncommon. I mean, and I think, you know, a
procedure like with a sticker where there is not going to be a
transposition of numbers because you are going to be placing
the sticker that came with the device in the patient's chart--
--
Mr. Williamson. Right.
Dr. Benishek [continuing]. And in some kind of a hospital
tracking system and scanned into the computer, that happens all
the time. But making sure that that system is in place is
somebody's job. And that is what concerns me about, you know,
the VA in general, that nobody seems to be accountable for
things like this when we bring them up in these committees. I
mean, we have issues like this that come up with in the VA all
the time and we never get down to, you know, whose job it was
to do that? And, you know, are they being, getting the right
oversight?
Mr. Williamson. That is probably a good question for VA. I
would think that the IT people should be all over that. But
again, I think that is a question that you should address to
VA.
Dr. Benishek. Well I am going to let Dr. Roe talk as well.
Thank you.
Mr. Coffman. Thank you, Dr. Benishek. Ms. Walorski. Dr.
Roe.
Dr. Roe. I guess the question that I have now is we have
identified the problem. It is pretty simple, really. And the
question is what recommendations would you all have? And I
agree with Ranking Member Kirkpatrick. You want to make sure
that the job I have when I go in the operating room is as easy
as possible. I think some of the, Dr. Benishek, who is a
general surgeon, touching this about who is accountable is that
he knows who is accountable when they put the knife in his
hand, it is him.
Mr. Williamson. Right.
Dr. Roe. And he does not have to look anyplace but the
mirror. And with the VA system we continually try to find out
well whose job was it that was to prevent this? I think that is
a little bit of your frustration as I, and mine also. But I
guess very simply what recommendation would you all have for
us? This is a fairly simple problem to solve. And we do need
these folks. And Ms. Kirkpatrick may have hit on something. If
you cannot go back in the OR, that is the death penalty. I
mean, for a vendor that is the death penalty for them. And that
company cannot do that. And you do need, when you get these new
devices many of them are, procedures I mean, are highly
technical. And until you have a real sense of familiarity with
them, you know, everybody is going to do their first procedure
at some point in time, whether it is, it may be some variation
of what you have been doing. But when new techniques come out,
you are going to learn those techniques, but somebody has got
to be the first one. And you know, hopefully it goes well, and
you need assistance with that. So we do not want to stop that
certainly. But there is, I do not see any reason to ever have a
vendor having any hands on with a patient. I just cannot
conceive of a situation where you would need to do that. Can
you, Dan?
Dr. Benishek. No.
Dr. Roe. Okay, I do not either. And so let me yield to you
all. And give us two or three things that we need to do, and
let us get this done.
Mr. Williamson. Well with regard to that, a national policy
governing the hands on treatment of veterans I think, is
important, as Mr. Butler has said, a national policy or
national procedure as a template is needed for the VAMCs so
they are not all going out and doing their own thing. And as I
said in my opening remarks, we found variation and
inconsistency in that regard. Now, you have heard throughout
the questions and answers and in my opening remarks the word
``accountability.'' And accountability for oversight and
accountability for properly preparing a waiver and other
requirements that go into purchasing. That word is important
throughout any of the recommendations we make. There has got to
establish accountability people to do what they are supposed to
do. And it varies as far as where accountability lies.
Sometimes it is the clinician, sometimes it is the procurement
folks. In other cases, it is people in Washington, DC.
Dr. Roe. So the policies would be a reliable, repeatable
tracking system for any implantable device.
Mr. Williamson. Mm-hmm.
Dr. Roe. Fairly simple technology now, should be able to
take care of that easily. Number two, there should not be any
vendor contact with, direct patient care, I should say. To
advise you about how to use a particular piece of technical
equipment, that is what they are there for. To turn this device
this way, you have seen other surgeons do that. I certainly
have used them very successfully in the operating room. But no
direct patient contact. And then I think thirdly the
procurement is a little different issue because it does get
into, and I do see, like I said if you have got ten different
surgeons, and we all think we are absolutely right every time.
You know that. And that our way is the best way. And so I do
understand some standardization. But I think at least those two
things we could agree on today and implement those things and I
think would solve most of these problems.
Mr. Williamson. That makes sense.
Dr. Roe. Okay. I yield back.
Mr. Coffman. Thank you, Dr. Roe. Mr. Lamborn of Colorado.
Mr. Lamborn. Thank you. Just a quick comment, I have a
plant in my district and I toured it recently and they do
marvelous work creating these amazing implantable devices,
everything from little pins and screws to large bone grafts,
apparatuses, and things like that. And it is just amazing the
amount of work and engineering and experience that goes into
one of those. And I just think that they have been a wonderful
partner in working with the VA and the medical field at large
to improve the lives and the prognosis of patients who have all
kinds of, and veterans who have all kinds of medical
difficulties. So I just want to make sure that no one ends up
blaming them or in case the VA has procedures that need to be
improved. So let us not lose our focus. I mean, this is the VA
that we need to have in front of us. And we are really making
sure their procedures are up to speed and that the
accountability with the VA is what it should be. So I just
wanted to make that clarification. Mr. Chairman, I yield back.
Mr. Coffman. Thank you, Mr. Lamborn. And I want to thank
the panel so much for your testimony. And let us see, you are
now excused. I now invite the second panel to the witness
table. Our second panel, we will hear from Mr. Philip
Matkovsky, Assistant Deputy Under Secretary for Health for
Administrative Operations at the Veterans Health
Administration. He will be accompanied by Dr. Thomas Lynch,
Assistant Deputy Under Secretary for Health Clinical Operations
at the Veterans Health Administration. Your complete written
testimony will be made part of the hearing record. Mr.
Matkovsky, you are now recognized for five minutes.
STATEMENT OF MR. PHILIP MATKOVSKY, ASSISTANT DEPUTY UNDER
SECRETARY FOR HEALTH FOR ADMINISTRATIVE OPERATIONS, DEPARTMENT
OF VETERANS AFFAIRS; ACCOMPANIED BY DR. THOMAS LYNCH, ASSISTANT
DEPUTY UNDER SECRETARY FOR HEALTH CLINICAL OPERATIONS,
DEPARTMENT OF VETERANS AFFAIRS
STATEMENT OF PHILIP MATKOVSKY
Mr. Matkovsky. Mr. Chairman, Ranking Member Kirkpatrick,
and members of the committee, thank you for the opportunity to
appear before you this morning to discuss the Department of
Veterans Affairs' practices regarding the use, tracking, and
procurement of surgical implants at VA medical centers. I am
accompanied today by Dr. Thomas Lynch----
Mr. Coffman. Make sure that your microphone is on, could
you do that? Is it on?
Mr. Matkovsky. I believe it is. Perhaps it is not
functioning? Can you hear me now?
Mr. Coffman. The light is on now.
Mr. Matkovsky. All right. I am sorry about that.
Mr. Coffman. That is all right.
Mr. Matkovsky. I am accompanied today by Dr. Thomas Lynch,
Assistant Deputy Under Secretary for Health for Clinical
Operations. The Veterans Health Administration has made
significant changes in the last three years to the way we
procure surgical implants and prosthetic appliances for
veterans. These changes are intended to improve procurement,
performance, and accountability while ensuring effective
healthcare delivery for veterans. Beginning in fiscal year 2012
and concluding at the end of fiscal year 2013, we transitioned
purchasing of surgical implants and prosthetic appliances
valued at greater than $3,000 to warranted contracting officers
in our procurement organization. VHA's procurement--sorry about
that. Sorry about that again. VHA's procurement organization
hired and provided specialized training to contracting staff to
ensure procurements are properly executed consistent with both
clinical requirements and federal and VA policies and
regulations. We believe these changes strengthened our
procurement performance.
Throughout the transition our main focus was ensuring
orders were completed timely and in concert with clinicians'
prescriptions. With the transition now complete we continue to
monitor timeliness and accuracy and we are now auditing
procurement quality and increasing our use of negotiated
contracts for sourcing implants and prosthetic appliances. As a
result of the transition our acquisitions above micro purchase
limits are now recorded in ECMS, our contract managing system,
and the federal procurement data system.
Our quality audits of these procurements have led to
changes in procedures and ordering templates as well.
Continuous QA reviews will begin in this fiscal quarter to
provide detailed oversight of our ordering process. These
reviews will focus on sourcing practices and will be used to
improve our utilization of existing national contracts, improve
training, and identify further opportunities to place biologics
and implants on additional contracts. In fiscal year 2014 we
will evaluate establishment of competed additional national
contracts that will be directly informed by our clinical
leadership to ensure we are emphasizing clinical quality,
patient safety, and value.
VHA is currently updating and finalizing our policy for
prosthetics procurement. Once promulgated this new directive
will provide comprehensive and clear guidance to VA medical
center staff on how to order prosthetics.
We are still reviewing the recently released GAO report on
surgical implants. Prior to receiving the GAO report VA had
initiated a number of reforms to acquisition. Any further
opportunities identified by GAO to enhance our acquisition
procedures will be considered in our ongoing process.
The presence of vendors in the operating room is a common
practice in healthcare settings. There are broadly accepted
professional standards pertaining to the presence of vendors in
operating rooms from the American College of Surgeons and the
American Medical Association. Physicians use professional
judgment to determine when the presence of a vendor in the
clinical setting improves the safety and effectiveness of
patient care. Currently VA is working however to develop
overarching policy regarding the role of vendors. VHA Handbook
1004.02, entitled Improved Consent for Clinical Treatments and
Procedures, requires physicians obtain patient signature on a
consent form before undertaking specific procedures such as
surgery. This policy requires physicians to discuss the
contents of this form with patients. The form also states that
under certain circumstances the presence of a vendor is
important to the success of the procedure; that prior to the
procedure the vendor will sign an agreement to strictly adhere
to the privacy rules; that the vendor may provide technical
advice but will not physically participate in the procedures;
and that the vendor will be closely monitored by the VA
treatment team.
VHA additionally has a comprehensive recall process that is
triggered both by our own facilities as well as external
notices such as the FDA. This process is overseen by our
National Center for Patient Safety, which monitors all recall
actions requiring product removal from inventory and
coordination with patients. At the facility level all surgical
implants are required to be tracked. Further for certain
implantable devices such as pacemakers vendors are additionally
required to ensure medical device tracking to the patient level
so that individuals may be contacted in the event of a recall
or a problem with the device they received.
When a recall is initiated VHA follows a step by step
process that begins with removing affected products from our
inventory and that further ensures all mandated actions are
closed out to 100 percent complete. This process then moves to
identifying process, notifying patients, monitoring patients,
and in certain cases performing clinical follow up with
patients. When recalls do occur we also work with vendors to
ensure all VA patients involved have been identified.
Mr. Chairman, we appreciate your support and encouragement
in identifying and addressing issues regarding the procurement
of surgical implants at VA medical centers. My colleague Dr.
Lynch and I are prepared to respond to any questions you may
have.
[The prepared statement of Philip Matkovsky appears in the
Appendix]
Mr. Coffman. Thank you for your testimony. Dr. Lynch, was
VHA aware of vendor representatives providing direct patient
care at VAMCs?
Dr. Lynch. We were not aware until the GAO report was
issued.
Mr. Coffman. Okay. Mr. Matkovsky, what does VA see as an
appropriate role for vendor representatives in the procedure
area, be it in the OR, wound care clinic, or any other setting?
Mr. Matkovsky. We do not see it as providing direct patient
treatment. I would indicate that in this one case, after we
found out from the GAO report, we did refer this case to our
Office of Inspector General ourselves. Consultation, support,
particularly technical advice regarding new technical implants
is permissible. But direct patient engagement is not.
Mr. Coffman. Mr. Matkovsky, what percent of biologic
contracts are made on the federal supply schedule and the open
market?
Mr. Matkovsky. We looked at a couple of these, sir. One of
them looking at the below threshold, so contract actions below
$3,000, about 70 percent of those actions are on contract, so
national contracts, regional contracts. In addition for the
biologics, I believe there were about $75 million of
acquisitions in fiscal year 2013. We have not broken out
separately those that were on contract, not on contract. But I
believe in the first quarter of fiscal year 2014, our number is
roughly about 40 percent on national contract, sir.
Mr. Coffman. Okay. I would very much like you to provide
that break down to the committee within two weeks. Thank you.
Ranking Member Kirkpatrick.
Mrs. Kirkpatrick. Mr. Matkovsky, I appreciate that VA is
working on policies regarding vendors in the OR. I think the
concern of this committee is always what is the consequence of
violating a policy of the VA? What is your thought about
terminating the contract with the vendor whose rep actually
touches a patient?
Mr. Matkovsky. Not to be evasive, Congresswoman, but in
this case we would have to look at it. If they violated the
terms of a contract, then an appropriate action would be to
terminate their contract with the VA. But at a minimum they
would have performed something in violation of our policy. The
difference there would be if it is a quality product or a
product that we have on a committed use contract would we want
to terminate a contract nationally for the actions of one
vendor? But it is something we would want to monitor very
closely.
Mrs. Kirkpatrick. And I just want to reiterate the concern
of the committee is that a lack of consequences, good policies,
but a lack of consequence if the policy is breached. But let me
go on to the second point. The GAO report states that the
program executive office identifies items that are frequently
used and high cost. This implies that that is the only
mechanism for identifying items to be included in these
contracts. Is that in fact the case?
Mr. Matkovsky. That is not the only mechanism, it is one of
the mechanisms. And I have some numbers from our program
executive office. It really took effect in fiscal year 2013. By
the end of fiscal year 2013, I was directly involved in setting
some of the performance goals for that organization and had
tied my accountability directly to that success. By the end of
the fiscal year, in fiscal year 2013, there were roughly 110,
113 packages developed by that group, the total life cycle
value of those packages in excess of $2.1 billion estimated.
What they do is they look at our procurement spend in something
we called MEDPDB, the medical product database that we share
with DoD. And we look at the things we buy. And where we do not
have items on national contract we identify them as
opportunities. That is one mechanism. It is not the only
mechanism. Another mechanism we use as we transitioned away, I
just want to emphasize in a period of about 18 months, we
removed 1,100 contracting officer warrants from prosthetic
staff and transitioned that to procurement staff. We now have
about 378 prosthetics contracts at a regional and local level
that we did not have before. Those total in a value annual of
$323 million. So that is a mechanism that allows us to do
bottom up.
I believe you had made the comment about top down versus
bottom up. Where clinician preference is indicated and we can
find it in buying patterns, we had hoped that this transition
would allow us to identify those spend patterns as it moves
into contracting. And then contracting would establish local
and regional contracts, and then subsequently we would
establish national contracts. We are evaluating a biologics
contract. It is going to be a complex contract but that would
be a national committed use contract like we have with.
Mrs. Kirkpatrick. Could you--oh, excuse me.
Mr. Coffman. I am sorry, Mr. Matkovsky? Could you please
speak a little closer into the microphone? Thank you.
Mr. Matkovsky. Okay. Sorry.
Mrs. Kirkpatrick. And could you provide the committee with
the performance goals and metrics for that system?
Mr. Matkovsky. I will.
Mrs. Kirkpatrick. Last question is, you know, you heard Dr.
Roe say that the medical devices are changing at light speed.
And what is your system for testing new devices and then
introducing them to the VA system at large?
Mr. Matkovsky. I am going to defer to Dr. Lynch for some of
this. But part of our evaluation process that we run with the
program executive office, frankly the OAL National Acquisition
Center for a number of years, had helped VHA in some of this
work. We get product samples from the vendor community. So
clinicians who are a member of our selection team are literally
evaluating products as part of that process. That is different
than the federal supply schedule mechanism, which is a much
more top down approach. Not negating the value of either, but
it would be direct testing of the product offering on the part
of clinicians and then I will defer to Dr. Lynch for the
research and evaluation of new technologies.
Dr. Lynch. Let me just try and comment a little bit about
the introduction of new technology and the process. I think
Congressman Roe and Congressman Benishek discussed that
earlier. The VA does in fact have a very rigid process of
credentialing providers and introducing new products into the
VA. Physicians are expected to undergo specific training. This
is actually specified in our credentialing process. When they
actually begin to do the process, if appropriate, they will do
it under supervision for a period of time before they are
credentialed to perform it widely without supervision. So I
think we have a process that is very similar to that discussed
by Congressman Roe in terms of introducing new procedures and
assuring that there is competence on the part of the physician
to perform that procedure.
Mrs. Kirkpatrick. Thank you, and I yield back, Mr.
Chairman.
Mr. Coffman. Thank you, Ranking Member Kirkpatrick. Dr.
Benishek.
Dr. Benishek. Well that is a great statement there you
made, Dr. Lynch, about, you know, rigorous rules for
credentialing. But something is wrong, right? Because I mean,
some vendors were doing cases. So there is obviously these guys
were not credentialed to be doing cases in the OR. So there is
a failure there somewhere, right?
Dr. Lynch. Let me----
Dr. Benishek. You would agree that there has been a failure
if this actually occurred like has been described?
Dr. Lynch. I absolutely agree that a vendor should not be
touching a patient. The GAO did not share the specifics of this
case with us. We have done some background. We think we
understand what happened and where it happened. It did not
happen in the operating room. It happened outside of the
operating room. It happened during the course of a dressing
change. It was not a skin graft, it was a skin substitute, one
of the cryopreserved skin covers that are used for wound care.
And it did not involve a physician. We believe it involved a
mid-level provider. We have asked our Office of Medical
Inspector to go in and evaluate that. Regardless of where it
occurred and regardless of the circumstances let me be very
clear it should not have occurred. But we do not believe that
it occurred in the operating room at this time.
Dr. Benishek. I see. Okay. Well I do not have, I am not
privy to the details either. So I mean obviously we need to get
that done.
Dr. Lynch. But I just wanted to be very clear that this
does not appear to have been an event that occurred in the OR
while a patient was asleep or while a patient was under
anesthesia.
Dr. Benishek. All right. Well I guess those facts have yet
to come out. It is just that I want to touch again on the
accountability part. You know what I mean? How many people are
in your department, Mr. Lynch? I mean, you are the, or Dr.
Lynch? You are the Assistant Deputy Under Secretary for Health
Clinical Operations. So either, I mean, how many people do you
have working for you?
Dr. Lynch. Directly I have about 15. Indirectly because of
the 151 care centers that I oversee, approximately 400 people
working for us, sir.
Dr. Benishek. You know that to me is, I am trying to get
to, I mean I think we have identified the fact that there is
problems here that should not have happened. My issue is that,
and you have heard me say it if you listened to the previous
testimony, I have difficulty with the fact that we never seem
to identify a person who is responsible for the follow up. And
I am going to tout my legislation. You know, I have got this VA
Accountability Act which would actually make the VA identify
somebody within the VA who is responsible for something that
did not occur, for example, to an Inspector General report.
Okay? So that there is actual accountability by a manager if
they did not comply with a, you know, an IG report. So do you
ever write performance reviews on any of these people that work
for you?
Dr. Lynch. I write the performance reviews for the people
who report to me directly, yes sir.
Dr. Benishek. So every year then you write, everybody gets
a performance review written out?
Dr. Lynch. My direct reports. Not for everybody across VHA,
but----
Dr. Benishek. No, no, but I mean those 15 people that you
talked about?
Dr. Lynch. Yes. Yes.
Dr. Benishek. And those 15 people each have 15 people until
you get to the 150,000----
Dr. Lynch. Actually 400. I mispoke when I said 100,000 to
150,000.
Dr. Benishek [continuing]. You are talking about?
Dr. Lynch. Correct.
Dr. Benishek. From my position here it is tough to get, you
know, the bureaucracy initial number provided corrected in this
document of the size that you are talking about with 150,000
people somewhere below you in the chain of command, to get
those individuals' performance to improve. Because whenever we
ask for the name of the person who is responsible for fixing
this, we do not get the name of a person. We get, you know, a
vague answer. We can never get down to improving people's
performance within the bureaucracy. Do you understand what I am
kind of getting to?
Dr. Lynch. I understand your frustration. I think though
you have practiced medicine as I have, and I think you also
appreciate the complexity of medicine and the interaction
between individuals, processes, and policies that sometimes
make it difficult to separate accountability from the person
and the process. And I think that is the challenge that we
face. We need to identify people who need to have remediation
of some form. We also need to be able to identify where our
processes and our policies interfere with our people performing
good services.
Dr. Benishek. Have you ever written a review that
recommended remediation or performance improvement?
Dr. Lynch. I have put several individuals on a performance
improvement plan, yes sir.
Dr. Benishek. But nobody has ever lost their job, or been
transferred in that circumstance of those 15 people?
Dr. Lynch. I have not fired anybody or transferred anybody,
no sir.
Dr. Benishek. And how long have been in the position?
Dr. Lynch. I have been in this position for about a year.
Dr. Benishek. Okay.
Dr. Lynch. I have worked in the VA for about 35 years, sir.
Dr. Benishek. Well, you know, well I admire your service to
our veterans. I really have a problem with this and I hope that
the remainder of the staff, we got this VA Accountability Act
through the committee but I was hoping that you all will tell
our colleagues on the floor to consider voting for this VA
Accountability Act so we can improve the accountability of
people in the VA. I find it very frustrating, Dr. Lynch, about,
you know, how the performance is. I guess I am way over my
time, sorry.
Mr. Coffman. Mrs. Walorski of Indiana.
Mrs. Walorski. Thank you, Mr. Chairman. Mr. Matkovsky, we
have learned in the testimony from the previous panel and then
also just here each VA hospital has its own healthcare industry
representative credentialing program; We know that; and
requirements, often creating discrepancies in both the
requirements and the enforcement from hospital to hospital. And
you may have alluded to this in your opening remarks but I
could not hear you real well, where, could you give us an
update on where you are, where the VA is in establishing a
single standardized credentialing program for use across the
system? And I would direct your attention to what is being
considered right now in my state, the State of Indiana, with
the Indiana Hospital Association. It has the potential to
create more consistent enforcement and compliance. After that
GAO report, could you just give us an update? Where are you in
coming up with a centralized program?
Mr. Matkovsky. Sure. I would separate the credentialing and
privileging question with the vendor policy.
Mrs. Walorski. Mm-hmm.
Mr. Matkovsky. And quite frankly we agree with Mr.
Williamson and Mr. Butler that a national policy would help
here and that policy sets the guideline and then from that the
local policies would be derived. We have just begun so I cannot
give you a specific timeline. But at the direction of the Under
Secretary, he wants us to look at this and establish some form
of national guidance.
Mrs. Walorski. Okay. And then also, as Mr. Lamborn alluded
to, the VA is a very important customer, partner for the
medical device industry. Since the implementation of the
medical device tax a year ago has the VA seen any negative
impact in terms of VA patient access? Or access to existing or
any new technologies? And is there a concern going forward
about access or new technologies as it pertains to the cost of
the medical device tax?
Mr. Matkovsky. I do not know that I have the specifics on
that cost factor. Some of the costs would probably be built
into the actual provided price to us. But I do not have those
details. I can get those and come back. We have not seen any
negative effect at this point to access to medical devices?
Mrs. Walorski. Could you provide that to the committee?
Mr. Matkovsky. We will.
Mrs. Walorski. Thank you. Thank you, Mr. Chairman.
Mr. Coffman. Mr. Lamborn, Colorado.
Mr. Lamborn. Thank you, Mr. Chairman. And this question is
for either one of you. According to the GAO report that we just
heard from, and I quote, ``a physician who stated that vendor
representatives were present during the application of skin
grafts at this VA medical center told us that he did not know
what the official vendor policy was at the VA medical center,
and that he was not aware of a VA medical center policy that
addresses vendor roles.'' It sounds to me like the oversight by
VA is lacking when physicians have not been informed and made
aware of VA policy. What are you doing as an overseer within
the VA to make sure this never happens again.
Mr. Matkovsky. I think we can do this as a two-part. First
of all, we went back and looked at all of the medical centers
to verify that we have policy. We do have policy across the
board. In this instance this is an individual who, the one that
we are looking at, there was in fact a policy and it was a
violation of local policy. I would further, with Congresswoman
Walorski's comment in my response there, that we will be
looking at a national policy. Part of the benefit of a national
policy is that it has certain enforcement authority that gets
carried with that as well. So the national policy will set the
frame, local policies will derive from that, training will be
associated with those policies. I agree wholeheartedly with Mr.
Butler that that actually is a sound practice. That is what we
are doing at this point.
Mr. Lamborn. And doctor, do you have anything to add to
that?
Dr. Lynch. I would reinforce what Mr. Matkovsky said. I
would also emphasize that we have asked our Office of Medical
Inspector to go in to help us understand why the failure
occurred so that we can prevent it from happening again.
Mr. Lamborn. Thank you. And Mr. Chairman, I yield back.
Mr. Coffman. Thank you, Mr. Lamborn. Dr. Roe, Tennessee.
Dr. Roe. And Dr. Lynch, thank you for your 35 years of
medical service to our veterans. I think this is, at least I
hope that this situation is just an outlier that occurred. And
at least I am beginning to think that it is. I was reading, it
is very clear in the VA policy where VA hospitals are teaching
facilities, which is great, and trainees may participate in or
observe in treatment/procedures. In certain circumstances the
presence of a vendor representative or a company representative
is important to the success of the procedure. That is true.
Prior to the procedure the representative will sign an
agreement to strictly adhere to VA privacy rules. And obviously
that policy was not followed in this circumstance that Mr.
Lamborn talked about. The representative may provide technical
advice but will not physically participate in the procedure.
That is very clear. The representative will be closely
monitored by the VA treatment team. I mean, that is pretty
clear policy to me. That is not hard to understand.
Dr. Lynch. I think VA's position is very clear. I think the
AMA and the American College of Surgeons have reinforced that
position. And like Congressman Benishek, I have spent many
years in the operating room. I have never seen a vendor
representative scrub on a case. I have seen them there for
technical information. I have seen them there for calibration
of the device that is placed. I have never witnessed a vendor
representative scrub. I think this was an outlier. But I think
it emphasizes the importance of understanding why it occurred
so we can assure it does not happen again.
Dr. Roe. I 100 percent agree with that. And I think your
evaluation, Dr. Lynch, is correct. Secondly, the tracking
system I think is something that is not a major obstacle with
today's technology. It should be fairly simple. Could you
elaborate on that? Or would you elaborate on that?
Dr. Lynch. I can tell you what we are doing and what I
think are several best practices in VA right now. For any
implant that is placed in the operating room in a VA hospital
not only is there a sticker placed in the chart, as Congressman
Benishek recommended or noted, but that information is also
placed in the patient's electronic medical record by the
circulating nurse at the time of the procedure. So there is in
fact a redundant system. Not only do we have information in the
prosthetic database but, we have information in CPRS, the
patient information system.
Dr. Roe. If you had a, as you know some, a number of years
ago there was a new ceramic hip that fractured. One of my, he
did not think it was so funny and neither did his mother. He
put it in his own mother. I would have never done that. I would
not touch my mother with a ten-foot pole, but anyway he did.
And well she----
Dr. Lynch. Would she be too demanding for you, Congressman?
Dr. Roe. But anyway, it fractured and he had a way because
of the tracking system to be able to get this out and replace
it.
Dr. Lynch. We actually----
Dr. Roe. The system, do you have that available now? Is
that up and running and we just do not know about it?
Dr. Lynch. We have a process in place that is run through
our National Center for Patient Safety. Any recalls that are
issued are processed by the National Center for Patient Safety.
They have representatives at the VISN and facility level that
they contact when there is a recall. Two steps happen depending
upon the nature of the recall. The material is removed from the
shelf so it cannot be placed in a patient. And if it is,
necessary, we identify the patients through the prosthetics
database and the operative record and notify the patients of
the recall and what steps need to be taken to follow them with
that implant. In most cases, a hip or a pace maker, for
instance it is usually not removed but the patient is followed
more closely?
Dr. Roe. How long does that take?
Dr. Lynch. I cannot tell you----
Dr. Roe. And are, because I know the VA dropped the ball
big time on four or five years, I guess it was almost five
years ago we talked about the colonoscopies and identifying
patients, and the VA records. There was a huge dropped ball
there. Are we sure, do you have systems in place to be sure
that my lens implant does not, that is recalled, that I am
notified?
Dr. Lynch. I am comfortable that we have good systems,
Congressman. I cannot guarantee you that there might not be
exceptions. There are always exceptions in healthcare. But I am
confident that we have good systems. I also feel that we can
improve those systems. We can make them better by using some of
the technology that we have developed, as the ranking member
mentioned, in terms of bar coding for medication. We also bar
code for transfusions. We need to look at some of the newer
technology associated with RTLS and bar coding to see if we can
improve the efficiency of that system. But I am confident that
in the majority of cases we can identify the individual and
assure the provider and the patient that they have appropriate
information regarding the recall.
Dr. Roe. There have been some whopping failures that I have
observed since I have been there. One, if you will indulge me
just a minute, one final question. The procedures and
techniques, or new devices I should say, that are tested by our
VA physicians, are they being added to the federal supply
schedule or not? Or are they purchased on open market
purchases?
Mr. Matkovsky. Two answers to that. They would be more
likely to go into a national contract or a committed use
contract right now than an FSS. The FSS is somewhat vendor
driven so the vendor will come and get itself on the schedule
listing for the most part. But we have a team. I mentioned it
before. It is broken into a number of different domains, a
prosthetics domain, a surgery domain, nursing, you name it, and
looks at our spend pattern and then moves things into committed
use contracts through that process.
Dr. Roe. Okay. Thank you, and I yield back. I thank you for
indulging me.
Mr. Coffman. Thank you, Dr. Roe. Mr. Matkovsky, recently VA
unilaterally deleted biologics from VA's federal supply
schedule contracts, then did an immediate about face by putting
them back on the schedule. Was this related to the lawsuit
filed against VA on this issue?
Mr. Matkovsky. Mr. Chairman, I do not have information on
that. If I can take that one for the record?
Mr. Coffman. Very well. Dr. Lynch, vendors performing
operations on veterans is not only a serious breach of VA
protocol but also violates the veteran's privacy and thereby
HIPAA. In accordance with VA's table of penalties at a minimum
will VA be holding anyone accountable for these failures?
Dr. Lynch. Mr. Chairman, I cannot comment on that right
now. It is under investigation. I think we will have a better
idea of the nature of the accountability once we understand
what happened. But if appropriate, people will be held
accountable.
Mr. Coffman. Mr. Matkovsky, you issued a memorandum on May
23, 2012 underscoring VHA policy on the purchase of biologics
that for the last year and a half has been blatantly
disregarded by VHA employees. Are you concerned that your
guidance is completely ignored without any repercussions? Or
was the memo just a hollow attempt to say that you did
something to address this continued failure to follow the law
from our hearing in 2012?
Mr. Matkovsky. No sir, I do not believe it was a hollow
attempt. I thought we had started at the same time from May 23,
2012 to September 30, 2013. We removed all of the warrants from
our prosthetics staff to be able to purchase above the $3,000
level. That was a significant transition for us. Much of our
energy went into making sure we got that right. One of the big
concerns we had at the time, and when we testified at that
hearing, the hearing before that, and then the subsequent
hearing, my big concern frankly was the timeliness effect of
that transition. We would be transitioning the purchasing of a
prosthetic appliance with a vendor waiting on the other side of
the transaction. So to complete that most of our energy went
into that.
Now we are looking at the procurement compliance. Our
audits are looking at the appropriate determination of the
justification for other than full and open. If we are using
8123 incorrectly our audits will pick that up now. And we will
make sure we are compliant, sir.
Mr. Coffman. Ranking Member Kirkpatrick.
Mrs. Kirkpatrick. Dr. Lynch, Mr. Matkovsky. Thank you for
being here. I appreciate your efforts in crafting a national
policy. But I just want to remind you that my district in
Arizona is a huge rural district. It is bigger than the State
of Pennsylvania and covers over half the state. And it is
unique in that we do have a lot of rural veterans. We also have
25 percent of the population Native American. And you know, I
am always concerned about a one size fits all policy. And I
would just like to know how you are addressing the unique
challenges and needs of our rural veterans and our Native
American veterans.
Dr. Lynch. Let me take a first crack at that. We are a
little bit off topic because I think once we move into rural
areas we are not talking about surgical procedures, or probably
not even the involvement of vendors. But we are talking about
providing services to veterans. And I think the VA has taken
the lead in telehealth as a means for delivering care, what I
would term to be point of residence, where the patient is. And
I think we have made great strides in developing mechanisms by
which we can treat and interact with patients remotely and
provide rural veterans the same quality of service that
veterans are getting in our larger facilities. It began in
primary care. I think we are now able to deliver specialty care
services. We have the ability to use stethoscopes and other
remote monitoring equipment. So that I think we are being
concerned about the rural veteran.
I came from Omaha, Nebraska. Our area covered about 70,000
to 80,000 square miles of Western Iowa and Nebraska. We faced
some of the same challenges, and we found the use of telehealth
very effective in delivering that care. The VA is actually now
looking at newer models which will deliver care directly into
the patients' homes by connecting physician and patient across
the internet, so that they can interface directly in the home.
So I think we are concerned about the rural veteran. We are
concerned about the veteran that cannot make the trip to our
facilities. And I think we do have some tools to provide that
care.
Mrs. Kirkpatrick. Let me just say I applaud your efforts in
my district. You know one of my concerns is, though,
communication between the VA hospitals and those rural veterans
and Native American veterans. Especially if you have got a
device recall. So I just hope that you will keep that in the
forefront of your minds as you go through the development of
the policy.
My other question is really process. The GAO report
indicated that in 2011 the VHA established a program management
office for prosthetics to identify additional surgical implants
that could be made available through a national committed use
contract. However an official told the GAO that the office was
unable to focus on developing national committed use contracts
because of staffing constraints. So would you explain to the
committee how the office is supposed to function? Where in the
organization structure of VA is it located, VHA? Does it have
the necessary staffing and financial resources to make a
difference and improve the process? And do you believe this
office is capable of performing the duties you have assigned to
it?
Mr. Matkovsky. That office is located in VHA's corporate
office in what we call patient care services. The national
program director is on board. I think that program is running
very well. There is a really strong collaboration between
prosthetics now, logistics, and contracting. We attend
concurrent meetings every Friday afternoon where we are
reviewing the prosthetics order timeliness and accuracy. The
committed use contracts, I gave a number very quickly, but at
the below $3,000 threshold, these are the transactions that are
micropurchases typically done on a purchase card by prosthetics
staff, 70 percent of those transactions are against contracts,
in excess of the dollar value of those contracts. Those will
increase.
Mr. Chairman in further response to your comment about the
memo from 2012, we have seen an increase, although not where we
would like it to be, in the use of waivers. And we have to do a
better job communicating that requirement to the clinical
community. Also just to make sure people do not think of it as
a punitive action but as an informative action, to let us know
what else we need to get on contract.
I think it is actually a really functioning partnership at
this point and the leadership team is doing a great job.
Mrs. Kirkpatrick. Thank you. Thank you very much. I yield
back.
Mr. Coffman. Dr. Benishek.
Dr. Benishek. Thank you, Mr. Chairman. Dr. Lynch, I have
just a couple more questions about, I know you responded to Dr.
Roe's question about the tracking. And you know we were
informed about this VITAS system, the Veterans Implant Tracking
and Alert System, apparently, which was in the process of
development. I mean, can you elaborate on what that was? And
what is the mechanism, are you not using that? Or what is the
mechanism that you are using that you answered Dr. Roe's
question in the affirmative. How does that work?
Dr. Lynch. First of all, VITAS was an attempt to integrate
the systems we currently have to track implants. It was
developed and during initial implementation evaluation was not
found to be functioning properly. So at the moment we have
pulled VITAS back. We are relying on the National Center for
Patient Safety (NCPS), who tracks recalls. We are relying on
their interface with our networks and facilities. We have
recall coordinators at each of our facilities who work with the
National Center for Patient Safety to receive the recall,
assure that any shelf product is immediately removed. The NCPS
then works with subject matter experts in VA Central Office,
who will work with the facility and its databases to identify
any patients who may have had a particular implant placed so
that we can inform the patient and the provider and be sure
appropriate actions are being taken.
Dr. Benishek. Has this actually occurred under your tenure
there? Have you seen anything that happened that you are aware
of?
Dr. Lynch. It has occurred seamlessly. There have been I
think about 46 recalls over the past year that have been
mediated by the National Center for Patient Safety. I cannot
itemize those for you. Thirteen of those involved biologics.
They were all biologics that were placed in the OR so we should
have record of the implantation.
Dr. Benishek. So then that information goes to each
individual medical center and then they from their list of
patients figure out if they have done any of those implants? Is
that how it works?
Dr. Lynch. What they would do is go back and review the
appropriate record to see if any of those were implanted in a
patient and then link that implant to a patient, yes.
Dr. Benishek. So do you know how, does that take a long
time then? Or, I mean, is it done on computers? Is that----
Dr. Lynch. The search is done by computers, yes.
Dr. Benishek. All right.
Mr. Matkovsky. And it is also tracked on a web site. So you
know, an internal system. National Center for Patient Safety
will issue an alert. It goes to a patient safety officer at the
VISN who oversees the patient safety officer at the facility.
And depending on the criticality of the alert notice, there is
a requirement to have 100 percent compliance by a given date.
And that date is set by the criticality of the alert.
Dr. Lynch. And there is a requirement that the medical
center communicate with the National Center for Patient Safety
to indicate that the appropriate action has been taken.
Dr. Benishek. All right. Well I do not know, I just got
this answer here in response to your answer. Apparently there
was a source saying that the National Center for Patient Safety
does not track biologics.
Dr. Lynch. The National Center for Patient Safety does not
specifically track the product, the facility does. The National
Center for Patient Safety, however, does track the recall
notices for biologics and does pass them through to Central
Office, the Network, and the facility when appropriate.
Dr. Benishek. All right. Well I am just----
Dr. Lynch. In fact there were 13 recalls within I believe
the past year that did relate to biologics that were managed by
the National Center for Patient Safety.
Dr. Benishek. All right. Well that is contradictory to
somebody else's answer at a previous date, apparently. So----
Mr. Matkovsky. I think the distinction is that at the
National Center for Patient Safety they are not keeping the
list of the individual patient and the implant of that patient.
That is not NCPS's charge. It is their charge to link to the
FDR, find an incident from a medical center, and then trigger
the recall action, set the goal, measure compliance. The
tracking is done both in CPRS and in the prosthetics that will
track that. So there are policies that require us to record the
serial number and associate that with the individual patient.
Mr. Coffman. Right. And I think, and just to interject for
a second, I mean, what we have had is testimony and certainly
evidence in the GAO analysis is that you are not effectively
tracking this information and that is a problem for patient
safety. Dr. Benishek, please proceed.
Dr. Benishek. Actually I am pretty much out of time here,
so thank you.
Mr. Coffman. Mrs. Walorski, Indiana.
Mrs. Walorski. Thank you, Mr. Chairman. Mr. Matkovsky, I
just wanted to ask a follow up on the issue of the medical
device tax. The reason I am asking that question and the reason
I am concerned about it, and I have repeatedly asked the
question of the VA, is because we have had complaints in my
district, which is in Northern Indiana, of long waits for
medical devices, hips, knees. Veterans even asking if they can,
you know, why the VA cannot refer them to private hospitals,
refer them to somebody else, get them the treatment because of
enduring pain. And I posed the question to the VA way back in
April of last year, of saying, you know, what is this impact
going to be? Is there going to be an access issue? Which I have
never received an answer on. But from what I am hearing in my
district, in my district there is potentially an access issue.
And the other question I have was on this issue of funding.
And I reasked the question to the VA back in November on the
committee and somebody was here representing the VA and they
said they would get back to us and they never did. I have never
had an answer in 60 days. And the reason I am reposing the
question to you today, especially because you are here
testifying on this specific issue that we are talking about,
when can you give me, even if the VA's answer is that the
dollar value is minimal, all I want is the dollar figure the VA
assigns to the medical device impact. When can I get that
dollar figure that you guys are assessing to the medical device
impact? Can you tell me? Because my fear is that if I walk out
of here today and I do not have some kind of an agreement with
the VA today, I have waited 60 days, even put the request in
writing, and we still do not have an answer. When can you
provide me the answer?
Mr. Matkovsky. I would say roughly within 30 days. We do a
forecast out for the prosthetics spend that we perform. And we
are getting better at forecasting that amount. It is going to
be somewhat challenging. I mean, we will have to look at how
much the device tax costs and then do some extrapolation on
that. But I would say give us 30 days and----
Mrs. Walorski. So I guess my response to that is I have
given the VA 60 days, and no response both verbally and in
writing. Can you provide me with that information by the end of
the week? By tomorrow, 5:00?
Mr. Matkovsky. I want to do a good job and make sure we get
it done right----
Mrs. Walorski. But my concern is nobody has answered the
question. We have done everything here. And the complaints that
I am receiving from veterans who are waiting for these products
has to lead me to believe if there is an access problem in my
district is there also a dollar value problem with funds
available to the VA? And is there a economic impact? So my
concern is because of the fact that veterans are complaining,
and the pain that they are in in the meantime, and the issue of
asking to even go to private hospitals, to go elsewhere, ask me
if the VA will reassign them?
Mr. Matkovsky. I will personally commit to you that I will
make sure we get this answer to you. I would say 30 days. We
have some concurrence processes and other things that I need to
go through. So I cannot necessarily commit to those timelines.
But I will make sure we get it done.
Mrs. Walorski. Thank you. Thank you, Mr. Chairman.
Mr. Coffman. Our thanks to the panel. You are now excused.
Today we have had a chance to hear about many deficiencies
present in VA's handling, tracking, and procurement of surgical
implants. I am not convinced that VA has taken the appropriate
steps to correct these problems, especially considering how
many of them were addressed in similar hearings this
subcommittee held nearly two years ago. This lack of progress
on the part of VA is unacceptable. As such, this hearing was
necessary to accomplish a number of items. Number one, to
discover the extent of VA inappropriately allowing vendors to
participate in hands on surgical procedures. Two, to address
the absence of an operational tracking system that would VA to
determine what implants were administered to veterans in case
of an emergency. Three, to identify the reasoning and effects
of VA's failure to procure biological implants on the federal
supply schedule as well as its rampant and incorrect use of
waivers. Four, to require VA officials to explain their
inadequate response to these serious problems and determine
what steps if any are being taken to correct them.
I ask unanimous consent that all members have five
legislative days to revise and extend their remarks and include
extraneous material. Without objection, I would like to thank
again all of our witnesses and audience members for joining in
today's conversation. With that, this hearing is adjourned.
[Whereupon, at 12:03 p.m., the subcommittees were
adjourned.]
APPENDIX
Prepared Statement of Mike Coffman, Chairman
Oversight and Investigations
Remarks--Vendors in the OR--VA's Failed Oversight of Surgical Implants
January 15, 2014
Good morning. This hearing will come to order.
I want to welcome everyone to today's hearing titled,
``Vendors in the OR--VA's Failed Oversight of Surgical
Implants.''
This hearing examines serious problems with the tracking
and handling of surgical implants within the VA and follows
through on procurement issues revealed in a previous hearing by
this subcommittee.
According to multiple sources, VA medical centers have
allowed surgical implant vendors to participate in hands-on
treatment administered to veterans. Based on my staff's initial
findings, I asked GAO to investigate these allegations
regarding veteran health care and to determine what policies
are currently in place.
GAO substantiated that several veterans had received skin
grafts that had been applied directly by skin graft vendors.
GAO found that VHA requires each medical facility to develop
its own policy on vendor access, resulting in varying degrees
of specificity regarding their participation in patient care.
These findings raise serious questions about the extent of
vendor involvement in patient care at VA facilities and the
lack of clear guidance regarding vendor access. VA's own
consent form as well as industry best practices state that
vendor representatives may be present to provide technical
advice but may not physically participate in the procedure.
However, GAO's investigation confirms that these policies are
being unevenly applied or unenforced. Clearly, national
guidance and oversight is necessary to protect veterans who
undergo surgical implant procedures.
There are also significant problems with how VA handles and
tracks surgical implants in veterans. Previous VA OIG audits
criticized the VHA for weak internal controls that jeopardize
VA's ability to identify and notify patients in the event of
FDA product recall. According to GAO's report, released on
Monday, these concerns remain and have not been remedied. For
some clinical specialties, including gastroenterology,
interventional radiology, and pulmonary, identifying
information on implants was not tracked in any system. It is
troubling to consider that for these specialties, VHA was
unable to verify that the items purchased were actually
implanted in the patients for whom they were intended.
In 2008, VA began developing the Veterans Implant Tracking
and Alert System (VITAS) to track and retrieve identifying
information--including the lot and serial number--of surgical
implants placed in patients VHA-wide. Unfortunately, according
to GAO, this system's development was suspended at the end of
fiscal year 2012 due to data-reliability challenges, and as of
December 2013, development of VITAS has not resumed, limiting
VHA's ability to identify and locate patients who have received
implants.
Additionally, GAO's report shows that VA has failed to make
sufficient progress with prosthetic procurement reform. In a
May 30, 2012 hearing, this subcommittee revealed that VA
medical centers and VHA regional network contracting officers
misused waiver authority to spend nearly 3 billion dollars on
open market purchases of prosthetics, including surgical
implants, rather than procure them through competitive
contracts, including those with businesses on the Federal
Supply Schedule.
As a result of the hearing, VA acknowledged that there are
often several options available for implants and that
disadvantaged veteran owned small businesses and others
offering these products were being unfairly excluded from
consideration. VA indicated that it would implement reforms so
that non-competitive and sole source purchases would require
justification on a case by case basis.
GAO's report does contain some good news: VA has made some
progress with obtaining national committed use contracts for
non-biological implants, such as artificial joints, cardiac
pacemakers, heart valves, and coronary stents. Use of these
national committed use contracts is the most favored method of
procurement for implants under the Federal Acquisition
Regulations. However, GAO also reported that no such contracts
have been negotiated for biological implants such as skin and
bone grafts. Moreover, contrary to a memorandum, dated May 23,
2012, from Assistant Deputy Under Secretary Matkovsky, GAO
found biological implants were rarely ordered from the Federal
Supply Schedule at each VA medical center it visited. According
to GAO, over-use of the waiver process continues. It reported
that none of the medical centers it visited procure surgical
implants in compliance with waiver requirements for open market
purchases. Finally, it is most disappointing to note that while
VA and VHA now have procurement oversight components, GAO
reported that they have failed to impose corrective action for
these deficiencies.
In conclusion, VA must continue to implement reforms so
that medical centers procure surgical implants that meet
patient needs while also ensuring best value. More importantly,
VA and VHA must pay much better attention to patient safety
concerns regarding surgical implants. It is way past time for
VA to develop national policies that set forth the parameters
for vendor access to treatment facilities and that implement
sufficient oversight controls. Additionally, proper tracking of
surgical implants is a problem that has been unresolved for far
too long and it must be remedied post haste.
Prepared Statement of Ann Kirkpatrick, Ranking Minority Member
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS HEARING
Vendors in the OR--VA's Failed Oversight of Surgical Implants
January 15, 2014
Statement of Rep. Ann Kirkpatrick, Ranking Member,
Subcommittee on Oversight and Investigations
Thank you Mr. Chairman.
This morning, the Subcommittee on Oversight and
Investigations will be looking into VA practices regarding
purchasing surgical implants. In addition, the Subcommittee
will be looking into allegations that surgical implant vendor
representatives had participated in direct patient care.
On Monday, the Government Accountability Office (GAO)
released a report entitled VA Surgical Implants: Purchase
Requirements Were Not Always Followed at Selected Medical
Centers and Oversight Needs Improvement.
The GAO looked at four VA medical Centers and found that
these hospitals did not always follow VHA policy regarding
documenting open market purchases of surgical implants,
including obtaining the necessary waivers to purchase items not
covered by a VA-negotiated contract. Last year, VA instituted a
new policy regarding purchases above the Federal Acquisitions
Regulation's (FAR) micro-purchase threshold of $3,000 and below
the simplified acquisition threshold of $150,000. Medical
facility and regional office officials ``attributed
noncompliance mainly to insufficient VHA guidance and VA
staff's inexperience'' in completing the new requirements.
This is a familiar litany to members serving on this
subcommittee. It has been noted before that it does not matter
how good and thorough the policy and standards are if no one
follows them and there are seemingly no consequences for
noncompliance. And this is what I would like to explore today
in addition to looking at the specific allegations and looking
at ways to improve the process.
Surgical implants, and the larger issue of medical
procurement, provides us with a classic balancing act of
patient and provider choice on one hand, and efficiency and
savings on the other. These are not, in my view, mutually
exclusive concepts, but also, there are, ultimately, very few
easy answers.
Should there be a greater level of centralization on
procurement matters, or should we provide greater local
autonomy while ensuring that policies are followed? Indeed, how
do we ensure that VA employees are provided the tools to do
their jobs and help our veterans but are also held accountable
if they do not comply with established policies.
On the issue of surgical implants, what policies and
structures are in place to ensure that VA staff is kept fully-
up-to-date on advances in the field of surgical implants, and
the availability of different options, while also ensuring that
VA's contracting efforts are directed toward items that are
clinically advantageous and necessary for patient care. Are
decisions regarding which items to include in a VA-negotiated
committed-use contract made from the top down, or the bottom
up, and more importantly, are these decisions made rigorously
and systematically? How effective is the recently instituted
program executive office and does this effort have the staffing
level and financial resources to make a difference and improve
the process?
GAO reported that VHA spent approximately $563 million on
surgical implants in fiscal year 2012, an increase of 28
percent over fiscal year 2008 levels. I would like to hear from
our witnesses today regarding the factors that led to this
increase. It is not clear to me whether the increase is
primarily due to the practice of open market purchases, or to
an increase in either the costs of surgical implants or an
increase in their use.
Patient safety is our number one concern. That is why I am
concerned over allegations that surgical implant vendor
representatives participated in direct patient care. I want to
ensure that VA policies are fully followed in this regard while
also recognizing that at times vendor representatives can have
an important role in providing technical assistance and
education to VA care providers.
So let us begin the conversation on how best to fix the
problems before us today and work to improve the VA health care
system and the health care it provides to our veterans.
Spending taxpayer dollars wisely is essential, but providing
the health care that veterans have earned and deserve is
critical.
I look forward to hearing from our witnesses today, and I
yield back the balance of my time.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Prepared Statement of Philip Matkovsky
Mr. Chairman, Ranking Member Kirkpatrick, and members of
the Committee, thank you for the opportunity to appear before
you this morning to discuss the Department of Veterans Affairs'
(VA) practices regarding the use, tracking, and procurement of
surgical implants at VA medical centers.
The Veterans Health Administration (VHA) has made
significant changes in the last 3 years to the way it procures
surgical implants and prosthetics appliances for the benefit of
Veterans. These changes are intended to improve procurement
performance and accountability while ensuring effective health
care delivery for our Veterans. Beginning in Fiscal Year (FY)
2012 and concluding at the end of FY 2013, VHA transitioned the
purchase of surgical implants and prosthetics appliances valued
at greater than $3,000 to warranted contracting officers in the
VHA procurement organization. This change strengthened our
procurement performance for the acquisitions above the micro
purchase level. Over 1,100 warrants have been pulled back from
non-contracting officer prosthetics staff. VHA's procurement
organization has hired and provided specialized training to
contracting staff to ensure prosthetics procurements are
properly executed, both systematically and in accordance with
Federal and VA policies and regulations.
Throughout this transition period, VHA's procurement team's
main focus was ensuring that orders were completed timely and
in concert with clinicians' prescriptions. With the transition
now complete, VHA continues to closely monitor ordering
timeliness and accuracy while auditing procurement quality and
increasing its use of negotiated contracts for sourcing
surgical implants and prosthetic appliances. As a result of
this transition, our acquisitions above micro-purchase limits
are now recorded in our electronic contract management system
and the Federal Procurement Data System.
These audits for compliance and procurement quality have
led to changes in VHA procedures and ordering templates use in
our electronic contract management system. Further improvements
to our ordering processes will occur in the near term. Quality
assurance reviews will begin in this fiscal quarter to provide
continuous management oversight into ordering processes. These
quality reviews will focus on the sourcing practices and will
be used to improve our utilization of existing national
contracts and our ability to place biologics and implants on
national contracts. These efforts to establish national
contracts will be directly informed by our clinical leadership
to ensure we are emphasizing quality and value.
VHA is currently updating and finalizing its policy for
prosthetics procurement. Once published, this new directive
will provide more comprehensive and clear guidance to VA
medical center staff on how to appropriately order prosthetic
appliances to include surgical implants and biologics. VA is
still reviewing the recently released Government Accountability
Office (GAO) report titled, ``VA Surgical Implants: Purchase
Requirements Were Not Always Followed at Selected Medical
Centers and Oversight Needs Improvement.'' Prior to receiving
the GAO report, VA had initiated a number of reforms to its
acquisitions process. Any further opportunities identified by
GAO to enhance our prosthetics acquisition procedures will be
considered in our ongoing efforts.
The presence of vendors in the operating room is a common
practice in health care. There are broadly accepted
professional ethics standards pertaining to the presence of
vendors in operating rooms from the American College of
Surgeons and the American Medical Association. Physicians use
their professional judgment to determine when the presence of
vendors in clinical settings will improve the safety and
effectiveness of patient care. VHA Handbook 1004.01, entitled
Informed Consent for Clinical Treatments and Procedures,
requires that physicians obtain the patient's signature on VA
Form 10-431 before undertaking specific procedures such as
surgery. The policy also requires that physicians discuss the
contents of this form with patients. The form states that under
certain circumstances the presence of a vendor representative
is important to the success of the procedure, that prior to the
procedure the representative will sign an agreement to strictly
adhere to VA's privacy rules, that the representative may
provide technical advice but will not physically participate in
the procedure, and that the representative will be closely
monitored by the VA treatment team. 38 CFR 1.220. also provides
additional guidance related to vendors in clinical settings.
In VA, the consent form that is used for all treatments and
procedures (VA Form 10-0431a) that patients (or their
surrogate) must sign prior to undergoing operative procedures,
contains the following language:
``VA hospitals are teaching facilities, and trainees may
participate in or observe this treatment/procedure. In certain
circumstances, the presence of a vendor representative (company
representative) is important to the success of the procedure.
Prior to the procedure, the representative will sign an
agreement to strictly adhere to VA's privacy rules. The
representative may provide technical advice but will not
physically participate in the procedure. The representative
will be closely monitored by the VA treatment team.''
Conclusion
Mr. Chairman, we appreciate your support and encouragement
in identifying and addressing issues regarding the procurement
of surgical implants at VA medical centers. My colleague and I
are prepared to respond to any questions you may have.
Questions for the Record
QUESTIONS FROM SUBCOMMITTEE CHAIRMAN MIKE COFFMAN
Question: 1 Please provide a detailed statement with
citations to all guidance, including but not limited to
directives, handbooks, and/or regulations, regarding VA and/or
VHA policies on access by surgical implant vendor
representatives to clinical settings where implantation occurs?
Please also describe any changes that are planned in this
regard.
Question: 2 Please provide a detailed statement with
citations to all guidance, including but not limited to
directives, handbooks, and/or regulations, regarding VA and/or
VHA policies related to credentials and other qualifications
necessary for surgical implant vendor representative
participation in implant procedures. Please also describe any
changes that are planned.
Question: 3 Please describe in detail the oversight and
enforcement processes that are in place or are planned
regarding the agreed conditions of informed consent notices
signed by patient/veterans, including those with respect to
vendor presence.
Question: 4 In Mr. Matkovsky's written testimony, he refers
to 38 CFR Sec. 1.220, as guidance for vendors in clinical
settings but on its face, this regulation applies to
pharmaceuticals. Does VA and/or VHA interpret the regulation to
include surgical implants? If so, please explain. If not, then
please indicate whether VA and/or VHA plan to promulgate a
similar regulation for surgical implants.
Question: 5 Please describe in detail the steps VA and/or
VHA plan to take to include biological implants on Federal
Supply Schedule contracts and/or national committed use
contracts.
Question: 6 Please describe in detail the circumstances
under which VA unilaterally deleted biologics from VA's Federal
Supply Schedule contracts and then did an immediate about face
to put them back on schedule.
Question: 7 In a memorandum dated May 23, 2012, Mr.
Matkovsky indicated that biological implants should be
purchased on the Federal Supply Schedule. Please indicate
whether this directive has been followed and provide the
specific number of such purchases.
Question: 8 The GAO report states that VHA has a number of
policy documents and trainings under development that are
designed to improve compliance with the new purchasing process
for surgical implants over $3,000. Please give us an overview
of what these documents and trainings will entail and when you
expect them to be in place. Also, please describe what steps
VHA is taking to monitor the timeliness of orders and to make
the process more efficient.
Question: 9 Given that VA and/or VHA is making open market
purchases and not properly documenting them, how does VA ensure
that it is not violating the Competition in Contracting Act?
How will VA ensure compliance and hold employees accountable
for adherence to federal acquisition regulations related to
future open market purchases?
Question: 10 GAO found that VA and/or VHA have oversight
mechanisms in place regarding procurement of surgical implant
purchases but that corrective action to prevent recurrence of
poorly documented open market purchases is not pursued. What
plans does VA and/or VHA have for improvement in this regard?
Question: 11 Please describe the status of the Veterans
Implant Tracking and Alert System (VITAS) and VA and/or VHA
plans and timetables to implement the system. Also, please
describe how VA and/or VHA expect to overcome the data
reliability problems that in 2012 prevented VITAS from
succeeding?
Question: 12 Please describe the controls that VA and/or
VHA have in place or plan to implement to prevent implantation
of expired or contaminated surgical implants and enable the
identification of patients with such implants for recall
purposes.
Questions and Responses for the Record
QUESTIONS FROM SUBCOMMITTEE CHAIRMAN MIKE COFFMAN AND RESPONSES FROM VA
Question: 1 Please provide a detailed statement with
citations to all guidance, including but not limited to
directives, handbooks and/or regulations, regarding VA and/or
VHA policies on access by surgical implant vendor
representatives to clinical settings where implantation occurs?
Please also describe any changes that are planned in this
regard.
VA Response: VHA Handbook 1004.01, Informed Consent for
Clinical Treatment and Procedures (available at http://
www.ethics.va.gov/ETHICS/docs/policy/VHA--Handbook--1004-01--
Informed--Consent--Policy--20090814.pdf), requires the use of
the informed consent process and the use of the iMedConsentTM
software program (or VA Form 10-431a, Consent for Clinical
Treatment or Procedures when iMedConsentTM cannot be used) for
procedures performed in and out of the operating room (OR) by
any provider. Notably, VA's informed consent form specifically
informs the patient that vendor representatives may provide
technical advice but will not physically participate in the
procedures. However, the informed consent process does not
address vendors who are present in non-procedure areas.
National level policy regarding vendors is in development.
VA has issued informal guidance to VA health care
facilities in the form of two Privacy Fact Sheets titled,
``Vendor Representatives in Surgical Setting'' (dated December
2003) and ``Disclosing the Minimum Amount of Protected Health
Information (PHI) to Vendors Assisting with Implantable Devices
or Observing Surgery'' (dated September 2007). Both Fact Sheets
address access to PHI by surgical implant vendor
representatives in clinical settings. These Privacy Fact Sheets
are meant to provide VA health care facility Privacy Officers
with information on the legal requirements under the Privacy
Act and Health Insurance Portability and Accountability Act
(HIPAA) for disclosing or sharing PHI with surgical implant
vendor representatives.
Question 2: Please provide a detailed statement with
citations to all guidance, including but not limited to
directives, handbooks, and/or regulations, regarding VA and/or
VHA policies related to credentials and other qualifications
necessary for surgical implant vendor representative
participation in implant procedures. Please also describe any
changes that are planned.
VA Response: There are no national level VA or VHA policies
related to credentials and other qualifications necessary for
surgical implant vendor representative participation in implant
procedures. Consistent with professional ethics standards and
guidelines promulgated by professional medical societies, the
policy currently in development will clarify that vendor
representatives in VA are not allowed to engage in the practice
of surgery or medical decision making or to be involved in
direct patient contact during procedures; and that the role of
vendor representatives is only to provide technical advice and/
or to be involved in the remote calibration or adjustment of
medical devices to the surgeons and manufacturers'
specifications. The policy will further clarify requirements
that vendors must meet before they are allowed to be present in
clinical settings.
It is anticipated that the policy should be completed in
early 2015. In the interim, VA's iMedConsentTM form states that
vendor representatives may provide technical advice, but they
will not physically participate in the procedures.
Question 3: Please describe in detail the oversight and
enforcement processes that are in place or are planned
regarding the agreed conditions of informed consent notices
signed by patient/veterans, including those with respect to
vendor presence.
VA Response: VHA Handbook 1004.01 constitutes VHA national
policy on informed consent. It mandates the use of the
iMedConsentTM software program or VA Form 10-431a to document
the informed consent process. This policy applies to procedures
performed both inside and outside of the OR by a provider. The
oversight responsibility is assigned to the facility.
Question 4: In Mr. Matkovsky's written testimony, he refers
to 38 CFR Sec. 1.220, as guidance for vendors in clinical
settings but on its face, this regulation applies to
pharmaceuticals. Does VA and/or VHA interpret the regulation to
include surgical implants? If so, please explain. If not, then
please indicate whether VA and/or VHA plan to promulgate a
similar regulation for surgical implants.
VA Response: 38 Code of Federal Regulations (CFR) Sec.
1.220 provides guidance regarding pharmaceutical
representatives. VA has not interpreted the regulation to apply
to vendor representatives for surgical implants. As for changes
that are planned with regard to policy concerning surgical
implant vendor access, please refer to VA's response to
question #1 and #2 above.
Question 5: Please describe in detail the steps VA and/or
VHA plan to take to include biological implants on Federal
Supply Schedule contracts and/or national committed use
contracts.
VA Response: In the fall of 2012, the Office of
Acquisition, Logistics, and Construction's National Acquisition
Center (NAC) attempted to increase the number of biologic
sources under Federal Supply Schedule (FSS) Group 65 Part II
Section A (FSS 65IIA) Medical Equipment and Supplies. During
this process, a review of the FSS Agency Specific clause
AS1904, Regulatory Requirement Provisions (August 2000), which
includes CFR Part 800-1200 revealed that human cells, tissues
and cellular, and tissue-based products (i.e., allografts)
which as classified under 21 CFR 1271 were believed to be a
controlled-substance in lieu of a medical device. As such, it
was then determined allografts should be removed from all FSS
contracts awarded under 65IIA. During the week of May 31, 2013,
VA Contracting Officers notified all affected FSS 65IIA
contractors, via a bilaterally-generated modification, that all
allografts line items would be effectively removed from their
respective contracts by June 15, 2013. All FSS contractors were
given until June 6, 2013, to sign, date, and return the
bilateral modification. FSS contractors who did not comply by
June 6, 2013, received a unilaterally-executed modification
removing allograft products with an effective date of June 15,
2013.
After additional fact finding and consultation with VHA and
the Office of General Counsel, VA determined that the NAC
misinterpreted the language of AS1904 as it pertained to
allografts. As a result, effective June 21, 2013, the Deputy
Assistant Secretary for Acquisition and Logistics directed the
NAC to rescind its decision to remove allografts from VA's FSS
and restore all products previously offered by the schedule
holders.
Question 6: Please describe in detail the steps VA and/or
VHA plan to take to include biological implants on Federal
Supply Schedule contracts and then did an immediate about face
to put them back on schedule.
VA Response: VHA performed the following steps to include
biological implants on national committed use contracts:
1) Convened a VHA-led panel of experts on February 27,
2014, to support establishing appropriate national committed
use contracts for biological implants by; and
2) Developed and submitted complete requirements
documentation to the VA Strategic Acquisition Center (SAC) by
the end of fiscal year (FY) 2014 to support their follow
through for award of national committed use biological implant
contracts.
Question 7: In a memorandum dated May 23, 2012, Mr.
Matkovsky indicated that biological implants should be
purchased on the Federal Supply Schedule. Please indicate
whether this directive has been followed and provide the
specific number of purchases.
VA Response: The memorandum communicated requirements to
both procurement and non-procurement staff to adhere to
sourcing and waiver processes. The memorandum was not, however,
a directive. Following the release of the memorandum, VHA
undertook the full transition of procurements above the micro-
purchase threshold (of $3,000) as indicated below:
Waivers
The data below identify the number of waivers from FSS
orders processed through local contracts:
FY 2012: 10 Waivers approved
FY 2013: 21 Waivers approved
Through the first quarter of FY 2014, there are eight
waivers approved or under review. Waiver requests are typically
for multiple items on a local contract. VHA is identifying
improvements to further improve the level of adherence to
waiver processes. As VHA has transitioned procurements above
the micro-purchase threshold from prosthetics staff to
procurement staff, it will be more feasible to improve
adherence with internal VA policies.
Purchases From FSS Biologics Vendors
It is difficult to track specific biologics vendors due to
limitations in VA FSS tracking systems. The data below identify
general trends for purchases from FSS vendors.
FY 2013: Total: $23.2 Million
------------------------------------------------------------------------
Top 5 Federal Supply Schedule Vendors:
------------------------------------------------------------------------
Avkare......................................... $14.7 Million
Shire Regenerative............................. $4.5 Million
Academy Medical................................ $2.4 Million
Advanced Biohealing............................ $1.3 Million
Cotton Medical Group........................... $309,000
------------------------------------------------------------------------
Transition of Warrants: Beginning in FY 2012 and concluding
at the end of FY 2014, VHA removed procurement authority above
the micro-purchase from over 1,000 for facility prosthetics
staff. These duties were transitioned to approximately 200
warranted Contracting Officers.
Question 8: The GAO report states that VHA has a number of
policy documents and trainings under development that are
designed to improve compliance with the new purchasing process
for surgical implants over $3,000. Please give us an overview
of what these documents and trainings will entail and when you
expect them to be in place. Also, please describe what steps
VHA is taking to monitor the timeliness of orders and to make
the process more efficient.
VA Response: The VHA Procurement Policy Office has drafted
VHA Directive 1081, Procurement Process for Individual
Prosthetic Appliances, which establishes procedures for
procuring prosthetic appliances and sensory aids including
surgical implants over the $3,000 micro-purchase threshold.
This directive is undergoing VA's coordination, concurrence,
and approval process and has obtained almost all required
concurrences. The directive defines and standardizes the
processes and policies that VHA Acquisition workforce will
follow when procuring the specified items. The directive also
defines the circumstances under which Veteran Affairs
Acquisition Regulation (VAAR) and Federal Acquisition
Regulation (FAR) may be cited and other than full and open
competition procedures utilized. Once approved and published,
the directive will define the roles and responsibilities of the
acquisition team members and streamline the procurement process
to make it more efficient.
1. Issuing Consignment Agreements: A standard operating
procedure (SOP) is being developed that provides guidance to
the acquisition workforce for procuring implantable devices on
a consignment basis so that the medical centers will have
instant availability to the different type or model.
2. Monitoring Timeliness of Orders: VHA has developed a
dashboard that tracks the timeliness of prosthetic orders by
the Network Contracting Office. The tool tracks four events in
the procurement process so when delays happen, the cause can be
readily identified. These events include the following:
Consult to electronic Contract Management System
(eCMS) Planning Module--This captures the date of the patient
consult and the date a Network Contracting Office receives a
procurement request.
eCMS Planning Module to Graphical User Interface
Purchase Order (GUI PO)--This captures the date of receipt of a
procurement request by the Network Contracting Office and the
date funds are committed to support the contract award.
GUI PO to eCMS Award--This tracks the date that funds
are committed and the date the purchase order is awarded by the
Contracting Officer.
Consult to eCMS Award--This tracks the overall time
frame from the patient consult to the date the purchase orders
are awarded by the Contracting Officer.
The Network Contracting Office dashboard shows the average
amount of days for each of the above events. The dashboard is
robust and allows us to drill down by the types of products
purchased to identify what may be causing overall timeframes to
be less than optimal. Network Contracting Offices and Network
Prosthetics Departments each own part of the process, and there
are conference calls each week to discuss performance and
timeliness. Good performers will share best practices, and
performance outliers are required to describe the actions they
are taking to reduce timelines. VHA is successfully using this
dashboard to not only monitor timeliness but also work with
Network Prosthetics Representatives and Network Contracting
Officers to improve performance.
Question 9: Given that VA and/or VHA is making open market
purchases and not properly documenting them, how does VA ensure
that it is not violating the Competition in Contracting Act?
How will VA ensure compliance and hold employees accountable
for adherence to federal acquisition regulations related to
future open market purchases?
VA Response: VA takes several steps to ensure it is not
violating the Competition in Contracting Act. VHA clinicians
determine which surgical implants will best meet the clinical
needs of individual patients. This is not a decision made by
Contracting Officers. Many times, the manufacturer and size of
a particular implant is not known until the surgery is being
performed, and the surgeon observes the internal physical
characteristics of the patient. Title 38 United States Code
Sec. 8123, Procurement of Prosthetic Appliances, states, ``The
Secretary may procure prosthetic appliances and necessary
services required in the fitting, supplying, and training and
use of prosthetic appliances by purchase, manufacture,
contract, or in such other manner as the Secretary may
determine to be proper, without regard to any other provision
of law.'' VHA has provided justification templates to our
acquisition workforce and has an audit program to ensure
contract files have proper documentation. When a specific
product is not identified in the physician's consult,
competition is used by Procurement/Contracting Officers.
Effective October 1, 2013, VHA transitioned purchasing
authority for items greater than $3,000 to Contracting
Officers. This threshold is significant because it denotes the
micro-purchase limit. For these transactions, VHA performs
quality assurance reviews to assess compliance of our
procurement staff.
Question 10: GAO found that VA and/or VHA have oversight
mechanisms in place regarding procurement of surgical implant
purchases but that corrective action to prevent recurrence of
poorly documented open market purchases is not pursued. What
plans do VA and/or VHA have for improvement in this regard?
VA Response: VHA has provided justification and approval
templates to our acquisition workforce and has an audit program
to ensure contract files have proper documentation. The
transition of the procurement workload for open-market surgical
implant purchases from VA medical center prosthetics
departments to Network Contracting Offices was completed on
October 1, 2013. Although it is still early in the transition,
expectations are the existing guidance and oversight program
will produce improvements in the documentation of open-market
surgical implant purchases. The oversight program includes a
corrective action plan/improvement plan requirement.
Question 11: Please describe the status of the Veterans
Implant Tracking and Alert System (VITAS) and VA and/or VHA
plans and timetables to implement the system. Also, please
describe how VA and/or VHA expect to overcome the data
reliability problems that in 2012 prevented VITAS from
succeeding.
VA Response: VITAS is designed to track implants (e.g.,
coronary stents, dental, aortic valves, etc.) to include both
non-biologic and biologic implants. Biologics that are not
``implanted'' such as wound care products will not be tracked
by this software solution. VITAS, as designed, will draw on a
number of registries for source implant device data including,
but not limited to, the VistA Dental Package, Cardiovascular
Assessment, Reporting and Tracking (CART) System, and VistA
Surgery Package. VITAS software, as developed, was undergoing
Initial Operating Capability (IOC) testing when the developer
contract concluded prior to VITAS release and implementation.
If funded for completion, two challenges identified in IOC will
require resolution. The first challenge identifies the National
Prosthetics Patient Database (NPPD) as an unreliable resource
for implant tracking purpose. The proposed solution is to
replace the NPPD with the VistA Surgery Package as source data
for surgical implants placed in the operating room. The second
challenge relates to locating the patient for notification in
the event of a product recall. VITAS, as designed, queried the
VA Primary Care Management Module (PCMM) to provide a primary
care physician as the sole point of contact for recall
notification. This was identified in IOC testing as a potential
risk to timeliness of notification since PCMM is currently not
a comprehensive data source for Veterans receiving care and
treatment in VA. The solution is for VITAS to provide
notification to additional providers (e.g., surgeon,
cardiologist, and dentist) and VHA administrators (e.g.,
facility Chief of Staff) for patient notification in the event
of a product recall consistent with current VHA policy.
Question 12: Please describe the controls that VA and/or
VHA have in place or plan to implement to prevent implantation
of expired or contaminated surgical implants and enable the
identification of patients with such implants for recall
purposes.
VA Response: VHA Directive 1039, Ensuring Correct Surgery
and Invasive Procedures, mandates that ``time-outs'' must be
facilitated by a checklist and occur immediately prior to the
start of a procedure including verification that the correct
implant is available, if applicable. An additional step is
required immediately prior to implantation of the medical
device. The privileged provider performing the procedure must
confirm the correct implant with a team member, including a
``read-back'' of the relevant information. Documentation of the
correct medical implant must be placed in the patient's
electronic health record.
If a potentially contaminated surgical implant is recalled
by the manufacturer or the Food and Drug Administration, VA's
National Center for Patient Safety (NCPS) Product Recall Office
posts a recall notice with a timeline for removal actions to
affected VA facilities through the VHA Alerts and Recalls
intranet database.
Facility Recall Coordinator (FRC) in each facility receive
the recall notices from the Product Recall Office and work
daily to remove defective medical products and food through
assignments made to the Facility Designated Area Specialists
within each medical center. Through this process, established
by VHA Directive 2008.080, Recall of Defective Medical Devices
and Medical Products, Including Food and Food Products, VA
facilities remove potentially harmful products from inventory
in a timely and effective manner.
NCPS' Product Recall Office receives feedback confirmation
from each FRC that the facility did or did not have the
affected product in stock at the time of the recall and removed
any recalled product from inventory. This prevents potentially
contaminated surgical implants from being used. The Product
Recall Office monitors compliance to the recall process for
each facility.
January 24, 2014
The Honorable Eric K. Shinseki
Secretary, U.S. Department of Veterans Affairs
810 Vermont Avenue, NW, Washington, DC 20420,
Dear Mr. Secretary:
Please provide written responses to the attached questions
for record for the Oversight and Investigations Subcommittee
hearing entitled ``Vendors in the OR--VA's Failed Oversight of
Surgical Implants'' that took place on January 15, 2014.
In responding to these questions for the record, please
answer each question in order using single space formatting.
Please also restate each question in its entirety before each
answer. Your submission is expected by the close of business on
February 25, 2014, and should be sent to Ms. Bernadine Dotson
at [email protected].
If you have any questions, please call Mr. Eric Hannel,
Majority Staff Director of the Oversight & Investigations
Subcommittee, at 202-225-3527.
Sincerely,
Mike Coffman, Chairman
Subcommittee on Oversight & Investigations
[all]