[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]




       VA & HUMAN TISSUE: IMPROVEMENTS NEEDED FOR VETERANS SAFETY

=======================================================================

                                HEARING

                               before the

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION

                                 of the

                     COMMITTEE ON VETERANS' AFFAIRS
                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                        WEDNESDAY APRIL 2, 2014

                               __________

                           Serial No. 113-62

                               __________

       Printed for the use of the Committee on Veterans' Affairs

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                     COMMITTEE ON VETERANS' AFFAIRS

                     JEFF MILLER, Florida, Chairman

DOUG LAMBORN, Colorado               MICHAEL H. MICHAUD, Maine, Ranking 
GUS M. BILIRAKIS, Florida, Vice-         Minority Member
    Chairman                         CORRINE BROWN, Florida
DAVID P. ROE, Tennessee              MARK TAKANO, California
BILL FLORES, Texas                   JULIA BROWNLEY, California
JEFF DENHAM, California              DINA TITUS, Nevada
JON RUNYAN, New Jersey               ANN KIRKPATRICK, Arizona
DAN BENISHEK, Michigan               RAUL RUIZ, California
TIM HUELSKAMP, Kansas                GLORIA NEGRETE McLEOD, California
MIKE COFFMAN, Colorado               ANN M. KUSTER, New Hampshire
BRAD R. WENSTRUP, Ohio               BETO O'ROURKE, Texas
PAUL COOK, California                TIMOTHY J. WALZ, Minnesota
JACKIE WALORSKI, Indiana
DAVID JOLLY, Florida
                       Jon Towers, Staff Director
                 Nancy Dolan, Democratic Staff Director

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION

                    MIKE COFFMAN, Colorado, Chairman

DOUG LAMBORN, Colorado               ANN KIRKPATRICK, Arizona, Ranking 
DAVID P. ROE, Tennessee                  Member
TIM HUELSKAMP, Kansas                MARK TAKANO, California
DAN BENISHEK, Michigan               ANN M. KUSTER, New Hampshire
JACKIE WALORSKI, Indiana             BETO O'ROURKE, Texas
                                     TIMOTHY J. WALZ, Minnesota

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
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                            C O N T E N T S

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                                                                   Page

                        Wednesday, April 2, 2014

VA & Human Tissue: Improvements Needed for Veterans Safety.......     1

                           OPENING STATEMENTS

Hon. Mike Coffman, Chairman......................................     1
Hon. Tim Walz....................................................     3

                               WITNESSES

Mr. Philip Matkovsky, Assistant Deputy Under Secretary for Health 
  for Administrative Operations, VHA, Department of Veterans 
  Affairs........................................................     4
    Prepared Statement...........................................    29

    Accompanied by:

        Dr. William Gunnar, M.D., National Director of Surgery, 
            Veterans Health Administration, Department of 
            Veterans Affairs
    And
        Dr. Michael Icardi, M.D., National Director of Pathology 
            and Laboratory Medicine Services, VHA, Department of 
            Veterans Affairs
Ms. Marcia Crosse, Director, Health Care U.S. Government 
  Accountability Office..........................................    17
    Prepared Statement...........................................    33
Mr. Frank Wilton, Chief Executive Officer, American Association 
  of Tissue Banks................................................    24
    Prepared Statement...........................................    51

                        QUESTIONS FOR THE RECORD

Questions From: Chairman Mike Coffman............................    55

 
       VA & HUMAN TISSUE: IMPROVEMENTS NEEDED FOR VETERANS SAFETY

                              ----------                              


                        Wednesday, April 2, 2014

             U.S. House of Representatives,
                    Committee on Veterans' Affairs,
      Subcommittee on Oversight and Investigations,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to notice, at 10:13 a.m., in 
Room 334, Cannon House Office Building, Hon. Mike Coffman 
[chairman of the subcommittee] presiding.
    Present:  Representatives Coffman, Lamborn, Roe, Huelskamp, 
Benishek, Walz.

           OPENING STATEMENT OF CHAIRMAN MIKE COFFMAN

    Mr. Coffman. Good morning. This hearing will come to order.
    I want to welcome everyone to today's hearing titled VA & 
Human Tissue: Improvements Needed for Veterans Safety. This 
hearing focuses on VA's continuing problems with the tracking 
and management of biological implants which include skin 
grafts, bone grafts, heart valves, tendons, and other products 
that use human tissue.
    In a previous hearing in January, this subcommittee 
examined continuing issues regarding prosthetic procurement, in 
particular VA's over-reliance on open market purchases that are 
potentially the most expensive procurement method and may pose 
the greatest risk to patient safety.
    VA contends that waivers are necessary to accommodate 
clinician preference for products with which they are familiar. 
However, our investigation of this billion dollar industry 
shows that there may be ulterior motives.
    In this regard, over 57 percent of biological implants are 
procured by VA as open market purchases, and we have found that 
several VA clinicians serve on the board of directors of at 
least one of the major suppliers to VA of biological implants 
on the open market.
    VA's failures regarding biological implants go well beyond 
possible conflicts of interest in procurement practices. Our 
investigation reveals that the problems include VA's failure to 
adequately vet biological implant vendors to make sure that 
they are registered with the Food and Drug Administration and 
that they are utilizing best practices such as those 
established by the American Association of Tissue Banks.
    Even more concerning is that VA lacks any ability to 
identify the sourcing of the material used in biological 
implants and track it from donor to recipient. The lack of such 
a track and trace system poses very serious and unnecessary 
risks to patient safety.
    Although it is very difficult to attribute adverse events 
to tissue product contamination, one recent example of a 
contaminated transplant shows the ramifications. According to a 
report in the Journal of the American Medical Association, the 
kidneys of an air force recruit from North Carolina who died 
from a rabies infection in July 2013 were transplanted into a 
Maryland veteran who later died from complications with rabies.
    Illegal trafficking of human tissue jeopardizes the supply 
chain of biological implants. A 2012 report from the 
International Consortium of Investigative Journalists indicates 
that trafficking of human tissue crosses international 
boundaries.
    One of the most egregious examples of such trafficking 
within the United States is the case of a dentist in Brooklyn 
who lost his license due to drug addiction and who then created 
a massive scheme to plunder tissue from funeral homes including 
from people who had died of cancer, HIV, and infectious 
diseases. He would pay undertakers, falsify required records, 
and then he would sell the tissue under the business name 
Biomedical Tissue Services.
    Significantly at least one of the alleged customers is a 
current supplier to VA and has received repeated citations from 
the FDA for cross-contamination issues. Apparently VA took no 
action to address this major safety violation with that company 
even after receiving a biological implant from the vendor.
    GAO and the VA's Office of the Inspector General have 
documented weak inventory controls that make it difficult if 
not impossible for VA to identify the patients and to whom they 
were implanted.
    In its written statement, GAO found that VA uses informal 
tracking systems that are not standardized or shared across 
departments and that even when used are prone to error because 
they rely on manual data entry.
    In its statement for a previous related hearing in January, 
GAO found that for some clinical specialties including 
gastroenterology, interventional radiology, and pulmonary, 
identifying information on implants was not tracked in any 
system.
    Given the incomplete and inaccurate data regarding 
inventory control, serious doubts are raised about VA's ability 
to identify patients in the event of contamination or a product 
recall.
    It is troubling to consider, but in an investigation in 
March of 2012, VA's Office of the Inspector General found 
expired products remaining on VA's inventory shelves. 
Fortunately, the FDA has developed a unique device 
identification system that if deployed by VA would facilitate 
reliable tracking and tracing of biological implants.
    I urge VA to implement this system and to develop an 
automated inventory control system that is compatible with the 
unique identifiers. VA needs to make VHA the premier health 
care delivery system it aspires to be.
    It should lead the Nation in the adoption of FDA's unique 
device identification system for all types of biological 
implants even before FDA's implementation deadlines.
    The six million veterans served annually by VHA deserve the 
highest standards of patient care in the Nation.
    With that, I recognize Ranking Member Walz for his opening 
statement.

               OPENING STATEMENT OF HON. TIM WALZ

    Mr. Walz. Well, thank you, Mr. Chairman, and thank you for 
your continued care of our Nation's veterans and willingness to 
make sure we do our job of oversight.
    But I would also like to thank Ranking Member Kirkpatrick 
for her work on this and for the opportunity to allow me to be 
here today.
    We are here to talk about VA's surgical and biological 
human tissue implant purchases and the ability of VA to safely 
track these. I am looking forward to exploring the progress 
that VA is making in maintaining accountability of implants and 
what impediments, if any, stand in the way of VA instituting a 
system-wide policy to verify vendor VA registration.
    Last year, nearly 60,000 tissue products were used at VA 
medical centers. Ensuring that these are safe and reliable 
needs the full attention of the VA and of this subcommittee. 
Tissue implants can provide amazing relief to the suffering of 
our veterans, but as with all these technological wonders, 
there are risks that the chairman mentioned.
    In January, we held a hearing to investigate VA's 
procurement of surgical implants. There were a number of 
shortcomings noted by the GAO including a lack of an automated 
mechanism for tracking.
    I look forward today to hearing about the progress VA is 
making in this effort and what further steps are required not 
only in the area of human tissue but in the larger area of 
surgical implants and prosthetics. Implementing a system-wide 
implant tracking system utilizing bar code technology for blood 
products are important steps to ensuring patient safety.
    I note that the VA has established a working group to look 
into improving management of biological implants. I would like 
to hear today whether VA can move faster to develop a single 
comprehensive tracking inventory management system for all 
biological implants.
    Finally, I look forward to hearing what system VA has in 
place so that implants can be tracked and appropriate action 
taken if the FDA issues a recall. In addition, I look forward 
to hearing how VA will ensure vendors are registered with the 
FDA.
    Last week, we held a legislative hearing on a draft bill, 
Biological Implant Tracking and Veterans Safety Act of 2014, 
addressing some of the concerns of Congress and expanding the 
implant tracking requirements.
    Unfortunately, VA was unable to testify on the draft at 
that time. I look forward to hearing your thoughts today.
    Mr. Chairman, I want to thank you again for your work on 
oversight. And with that, I yield back.
    Mr. Coffman. Thank you, Mr. Walz.
    I ask that all Members waive their opening remarks as per 
this committee's customs.
    With that, I invite the first panel to the witness table. 
On this panel, we will hear from Mr. Philip Matkovsky, 
assistant deputy under secretary for Health for Administrative 
Operations, Veterans Health Administration.
    He is accompanied by Dr. William Gunnar, National Director 
of Surgery for the Veterans Health Administration, and Dr. 
Michael Icardi, National Director of Pathology and Laboratory 
Medicine Services for the Veterans Health Administration.
    Please come to the table.
    Mr. Matkovsky, your complete written statement will be made 
part of the hearing record and you are now recognized for five 
minutes.

STATEMENT OF PHILIP MATKOVSKY, ASSISTANT DEPUTY UNDER SECRETARY 
   FOR HEALTH FOR ADMINISTRATIVE OPERATIONS, VETERANS HEALTH 
ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY 
 WILLIAM GUNNAR, NATIONAL DIRECTOR OF SURGERY, VETERANS HEALTH 
ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS; MICHAEL ICARDI, 
    NATIONAL DIRECTOR OF PATHOLOGY AND LABORATORY MEDICINE 
    SERVICES, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF 
                        VETERANS AFFAIRS

    Mr. Matkovsky. Mr. Chairman, Ranking Member Walz, and 
Members of the committee, thank you for the opportunity to 
appear before you this morning to discuss the Department of 
Veterans Affairs' sourcing, procurement, tracking, and 
oversight of its biological implant purchases including implant 
tissue.
    I am joined today by Dr. William Gunnar, national director 
of Surgery, and Dr. Michael Icardi, national director of 
Pathology and Laboratory Medicine Services.
    Over the last eight to ten years, utilization of biological 
implants including implant tissue has grown significantly 
resulting in the doubling of dollar value of the biomaterials 
market since 2004.
    However, the field of biological implants continues to 
rapidly evolve with new advancements in tissue fabrication, 
nomenclature standardization, and industry governance.
    In procurement, VHA recently completed its transition of 
procurement duties from prosthetics purchasing agents. This 
transition resulted in the removal of warrants from staff who 
are not contracting officers and procurements above the micro 
purchase that are now performed by our contracting officers 
with warrants.
    While Title 38, Section 8123 grants broad authorities to 
the secretary of VA for the procurement of prosthetics 
appliances, we have now integrated our prosthetics purchasing 
authority with FAR and VA acquisition regulation provisions.
    In this integration, the 8123 is primarily employed as a 
statutory basis for a FAR part 6 justification. This is for 
other than full and open competition.
    What this means in practice is that if a clinician who has 
been trained on a particular product has felt comfortable with 
that product, then they can be assured that a government 
procurement official will not restrict them from selecting and 
using a product with which they feel competent for their 
patients.
    This application of our prosthetics authority enables 
clinicians to make choices based on their medical determination 
of what is best for our patients.
    In complicated systems, it is always possible to improve 
our management and tracking controls. We have made significant 
progress often setting industry standards in tracking 
medications, blood products, and implants. However, we do 
acknowledge we can improve our tracking and inventory 
management of biological implants including tissue.
    In 2013, the Food and Drug Administration published a final 
rule requiring most medical devices distributed in the U.S. 
carry a unique device identifier or UDI and that information 
concerning each covered device be submitted to the global 
unique identification database.
    The rule does contain a staggered compliance date. With the 
advent of this new identifier, systems should be able to track 
a specific item and associate it with the manufacturer. This 
will improve adverse event tracking and will further enable 
greater automation and product recalls.
    However, I do need to be clear. This rule does not yet 
apply to biological and tissue implants. VHA will be 
participating with the FDA this summer in the formulation of 
this policy and applying it to biologics and tissue implants.
    With the more recent developments in the biological 
implants industry and in reaction to external audits and 
reviews as well as this committee's oversight, VHA has 
established a work team to identify improvements to our 
sourcing, management, and control of biologics.
    This work team is expected to complete its review and 
recommendations in the third quarter of fiscal 2014. We will 
review their product and then begin the process of establishing 
a standard protocol across each of our medical centers.
    Similarly we have charged a work team to develop a set of 
new national contracts for biological implants. This work team 
is in the phase of procurement that we call the development of 
requirements. The team is comprised of clinician leaders as 
well as logistics and prosthetics specialists.
    We expect our procurement packages to establish stringent 
quality standards not available on previous federal supply 
schedule contracts.
    My personal performance contract contains the expectation 
that this solicitation phase for this new procurement action 
will be initiated prior to the end of fiscal 2014.
    In conclusion, our mission in VHA is the delivery of 
timely, quality, patient-centered care. Our systems must apply 
controls where appropriate to further this mission.
    We acknowledge we must seek to find and implement 
improvements to our management, tracking, and control of 
biologics items. We are committed to making necessary changes 
to our policies, practices, and systems to improve.
    We must, however, ensure our procurement system achieves 
and complies with all federal laws and regulations, but that it 
also achieves a balance. It must enable our physicians whom we 
trust with the most critical decisions to apply clinical 
discretion when needed to provide veterans with individualized 
health care.
    Mr. Chairman, this concludes my testimony. I appreciate 
this committee's continued interest in and care of the health 
and welfare of America's veterans. At this time, my colleagues 
and I are prepared to answer your questions, sir.

    [The prepared statement of Philip Matkovsky appears in the 
Appendix]

    Mr. Coffman. And thank you for your testimony.
    Dr. Matkovsky, there are at least ten VA doctors on the 
board of directors for the Musculoskeletal Transplant 
Foundation of which VA has purchased over $1 million in 
biological implants over the past 15 months.
    Is this relationship a conflict of interest?
    Mr. Matkovsky. Mr. Chairman, thank you for your question.
    All of our employees are required to declare by our ethics 
policy any conflicts of interest. As a matter of fact, in each 
of our clinical committee meetings, they are required to 
announce any conflicts of interest.
    We researched some of these assertions. We went back and 
identified each of the clinicians and we did not find in our 
review any involvement in the procurement decisions associated 
with the MTF organization.
    I would add that the Musculoskeletal Transplant Foundation 
is a nonprofit organization which I do believe is an AATB 
accredited tissue bank.
    Mr. Coffman. Thank you.
    I think that the entity you just referred to did $4 billion 
of business last year.
    The criminal conflict of interest statute in 18 United 
States Code, Section 208 prohibits a federal employee from 
participating personally and substantially in a particular 
official duty that will have a direct and predictable effect on 
the employee's own financial interest.
    Do the VA clinicians who sit on the board of biological 
implant vendors violate this statute?
    Mr. Matkovsky. I do not believe they did, sir. They are 
required by policy to notify their management of any conflict 
of interest, any boards they may sit on. And if they are 
involved in a procurement decision that may be associated with 
a firm with which they might be associated externally, they are 
to recuse themselves from that transaction.
    We did not find an instance where they were involved in 
that procurement decision.
    Mr. Coffman. Mr. Matkovsky, according to your memo dated 
May 23rd, 2012, surgical implants are required to be bought on 
the FSS or federal supply schedule unless a waiver is obtained 
from the director of the National Acquisition Center.
    Is a waiver obtained from the director for every surgical 
implant purchased on the open market?
    Mr. Matkovsky. In many cases, the biological implants that 
are acquired are below the micro purchase threshold. Since 
those are not going to be affected by a procurement 
organization or contracting officer, many of those do not have 
a waiver.
    I will point out that in, I believe it was fiscal 2013, 
there were 21 waivers. That may not sound like a large number, 
but that is a waiver for a contract that would be a local 
contract that would cover many purchases.
    We have actually requested that our contracting officers 
increase their scrutiny to ensure that anything that we are 
acquiring that does not conform to the VAAR, this is the VAAR 
hierarchy, that we have waivers for that. We are able to 
monitor that now much better in the procurement organization.
    Mr. Coffman. My understanding, it is something like 97 
percent of the purchases are micro purchases?
    Mr. Matkovsky. I think in the biologics area, it is about 
95 percent.
    Mr. Coffman. It just seems to me, I mean, that there is an 
intentional effort to negate the rule by virtue of doing the 
smaller purchases.
    Mr. Matkovsky. Well, you know, with all due respect, sir, I 
do not know that that is necessarily the case. In many cases, 
these are acquired in time for a surgical procedure. So a 
surgeon may be going into a procedure and will acquire that 
item.
    A dermal graft may be a micro purchase, but in some cases, 
some of our dermal grafts have to be stored at negative 43 
degrees Fahrenheit and, you know, the storage requirement for 
that would negate us having it around for quite a while.
    So you will acquire it in time for the procedure and we are 
not keeping a significant stock of these items. So you will see 
smaller purchase items.
    Having said that, I want to be clear. We do want to have a 
clinically cleared national contract available for us that 
includes certification and accreditation and then promulgate 
that contract for broad use.
    Mr. Coffman. Mr. Walz.
    Mr. Walz. Thank you, Mr. Chairman.
    In your testimony, sir, you said VA is developing implant 
tracking in cardiology and surgery and wants a single 
comprehensive tracking system.
    What is the time frame on getting to that single 
comprehensive tracking system?
    Mr. Matkovsky. Some of that will depend, Congressman Walz, 
on our analysis. We have a group that is meeting face to face 
next week. We do expect the recommendations in the third 
quarter.
    Some of what we are going to have to do is going to require 
an interface to VistA, CPRS. Those interfaces to VistA will 
have to be an IT funded requirement. As we went through our IT 
requirements exercise for fiscal year 2015, implant tracking 
and alerting was one of our higher priority items to get 
funded.
    But there will be some requirement on IT funding to be able 
to deliver the completed system. I will tell you that as we 
looked across what we are doing in some of our networks today, 
there are commercial systems that are bar code enabled systems 
that would allow us to better track both in the OR setting and 
in the outpatient setting.
    That may be possible. It may be possible for us to acquire 
that with medical resources which might expedite that portion 
of it. The connect to VistA, though, would require an IT fix.
    Mr. Walz. Well, I am probably not telling you anything new, 
but coming here with IT funding request is going to be met--I 
am not sure. I will let my colleagues use the words they will 
use on that, but this is a difficult one because of the roads 
we have been down.
    So I ask you to make sure that we have evaluated that 
thoroughly because more requests for more IT when we still do 
not have seamless transition between DoD, that is a tough sell. 
I hear what you are saying, though.
    Other than the part played by the National Center for 
Patient Safety, VA has taken a somewhat decentralized approach 
to tracking.
    My question to you is, and I started to research this, I 
represent the district that has the Mayo Clinic, how would an 
organization like that do this as opposed to the VA, if you can 
give me your insights on how that works, if you know?
    Mr. Matkovsky. I am going to defer to some of my colleagues 
here. And in response, we will answer two questions. I think 
one of them is our recall process and then the question might 
be, you know, our tracking in blood and the extension of the 
blood tracking that we do today, we have, frankly, been doing 
that for decades down to the patient level. And I will ask Dr. 
Icardi to weigh in.
    We have a three-step process for recalls. The first 
question is, do we have this item in our inventory? Is it 
something we have acquired? And on a recall, the first action 
is to pull from inventory.
    Then there is a clinical decision to determine whether or 
not there is clinical significance for a patient directly and 
then lastly the patient involvement and close out with the 
patient which may involve tracking. It may involve removal of 
an implant, for instance, a hip.
    But let me ask Dr. Icardi to walk us through a little bit 
of what we have done in the blood bank since 2006.
    Dr. Icardi. Since 2006, we have had the VBECS system up 
which allows us to go through and track all of our blood 
products and combined with what the FDA and CDC does. That 
allows you to track a blood product from when it is initially 
collected all the way till its final disposition.
    Mr. Walz. That is how a large private sector would do the 
same way?
    Dr. Icardi. Yes.
    Mr. Walz. Best practice that way?
    Dr. Icardi. Yes.
    Mr. Walz. Okay. Okay. The next one I have, and this one I 
am still trying to wrap my mind around, in the GAO report, it 
states that there is a possibility that VA has utilized tissue 
implants from vendors that have not registered with the FDA.
    My question is twofold again. How is that happening, how 
does it happen, and do you believe that it is happening outside 
the VA also? Is this a system-wide problem in health care 
delivery because this one seems pretty staggering to me that 
that would be allowed to happen? So, please.
    Mr. Matkovsky. Quite frankly, I am not quite sure the 
nature of that finding. I think that the nature of that finding 
would be that in review of the recorded purchasing transactions 
that some of them, they would indicate that the record keeping 
might indicate that it is not an FDA. I do not have any 
indication to confirm that, quite frankly.
    Do I think it is a broader issue across the health care 
industry, I cannot opine.
    Mr. Walz. So what you are saying is they may have been or 
they should have been registered, we just do not have the 
paperwork to prove that they were registered?
    Mr. Matkovsky. No. I think it is just a matter of record 
keeping, ensuring that what we have in our national prosthetics 
patient database is the valid recording. And if it contains 
information that may be subject to human error, then there is 
some question as to whether or not that would be----
    Mr. Walz. Does it concern you that that might be the case?
    Mr. Matkovsky. Well, I think we want to have a standard 
national contract that we know has clinical input into it, 
quite frankly. So, yes.
    Mr. Walz. Okay. With that, I yield back. Thank you, Mr. 
Chairman.
    Mr. Coffman. Dr. Roe.
    Dr. Roe. Thank you all for being here today.
    And let me just go over a few things. And first of all, 
these biologics and as I have looked into this, and obviously 
they had been tremendous for patients. There is no question 
about that.
    I think one of the concerns we had and certainly in my 
State of Tennessee is when we had an outbreak of some 
contaminated epidurals medication that caused some people to 
die. It was contaminated with a fungus and we were able to 
trace that right back to its source, stop that and not use that 
source.
    The way I understand this from the GAO report and the part 
that I read is that when you buy, some of the vendors that you 
buy from have not been FDA approved; is that correct?
    Mr. Matkovsky. I think that is in the report, I believe, 
yes, sir.
    Dr. Roe. That is not what I asked. I said is it correct?
    Mr. Matkovsky. I do not know that it is correct, sir.
    Dr. Roe. Okay. So you do not know for sure that it is or is 
not. Okay.
    Mr. Matkovsky. Correct.
    Dr. Roe. Fair enough. And when these are placed, do you 
tell the patients that they are getting a biologic? Do they 
understand?
    And let me explain where I am coming from. Because the 
patients expect us, the system to make sure what goes in them 
is safe, they expect us to have done our due diligence.
    And if you look at tissue, allograph tissue, it can come 
from foreign sources and some of those sources, and I have done 
a little bit of research on that, one story from the Ukraine 
and they had bins of tissue that was contaminated.
    And what patients do not understand is this has to be 
retrieved under certain conditions. And there have to be people 
who are excluded who have cancer, who have any infectious 
disease. Certainly the case that the chairman brought up with 
rabies obviously should never have been. That is a different 
system, tracking system of organ transplantation as opposed to 
allograph transplantation.
    But patients have that right and if that happened, if a 
patient was contaminated by, let's say, hepatitis C, hepatitis 
B, does the VA have a system that could track those patients 
down?
    Mr. Matkovsky. We do. It is important to note as we----
    Dr. Roe. You are saying to me now that even though some 
hospitals do not have a system that is tracking it, the VA 
could track that from its source of origin to that individual 
patient? You all have that system in place? That is good if you 
do.
    Mr. Matkovsky. I will walk through the scenarios that we 
have that I can state definitively, Congressman Roe.
    Since roughly 2008, there have been 13 recalls for 
biologics that have triggered a National Center for Patient 
Safety action within the VA. Six of those we had in our 
inventory.
    I am going to ask Dr. Gunnar to walk us through a little 
bit about that recall process, but it is important to note that 
in six of those that we had, we had in one of our medical 
centers some inventory.
    There is then a clinical determination as to whether or not 
we need to notify the patient, and I am going to ask Dr. Gunnar 
to elaborate on that. But in those recall instances, we have 
been able to track the inventory, facility, and then take 
clinical action.
    Dr. Roe. Just a commentary before he does. I would 
absolutely think you ought to notify the patients. I mean, that 
is the most affected person. And I think out there now, if I am 
a patient that got a new anterior cruciate ligament and I found 
out later that the source was contaminated, I think it would at 
least be fair to tell that person so they could be tested.
    And we have been down this road before with contaminated 
colonoscopes and other things. This is not new.
    Mr. Matkovsky. In a couple of these cases, the recall 
itself was rescinded.
    Dr. Gunnar. I can assure you, Congressman Roe, that in 
those situations, we would--there is policy, VHA policy 
regarding disclosure of adverse events and National Center of 
Patient Safety would work with the program offices as well as 
the facilities and the providers to identify the individuals 
who received that implant and make sure that the correct 
clinical action occurs.
    Dr. Roe. But what I am hearing from you all is is that 
there is a system to do that now, so----
    Dr. Gunnar. Correct. There is a system in place to do that 
now. What we do not have is that single button and I think that 
is what this other--what the bill supposes that we would have a 
bar coding system, that we would be able to go to one source 
and push the button and the list would come up. And, 
unfortunately, we do not have that source.
    Dr. Roe. Okay. There is another issue that does not affect 
the VA, but the FDA, and that is, and this is a little 
bothersome, this is not anything to do with you all at all, but 
when they approve a tissue bank, sometimes they do not go back 
for years to ever examine that tissue bank.
    And that is a little worrisome because the patients expect 
us and the surgeon who uses material that he or she is used to 
using--I get that. I mean, we got our little toys we like to 
use. But we expect that that particular piece of tissue that we 
get is safe when we get it. I mean, we are assuming that the 
people who procure that for us have done the due diligence to 
make sure that when we do transplant that into a patient, that 
that patient is getting a safe graft.
    And I guess the other thing I will ask, Dr. Gunnar, you, 
does the staff inform patients that they are getting an 
allograph? I know I always did, but it is not required, I do 
not think.
    Dr. Gunnar. It is actually by policy required in our time-
out process. So the implant is actually--you have to--before 
the patients--the procedure even starts, you have to assure 
that the implant is there, that it is not----
    Dr. Roe. No, no, that is not what I mean. I mean, does the 
patient know they are getting an allograph?
    Dr. Gunnar. Yes, in the informed consent process.
    Dr. Roe. And I am sorry I ran over just a second here, but 
the other one is is how do you for expired tissue, and that is 
obviously very important, that the GAO found still sitting on 
the shelves, why did that happen?
    Dr. Gunnar. Well, I believe that was some time ago and Mr. 
Matkovsky can comment about how the inventory was managed 
following that. But what I can tell you is that there has now 
been the policy that ensures correct surgery and invasive 
procedures requires that there be a read back of the expiration 
date on any biologic that is going to be implanted.
    Dr. Roe. Well, do you think any expired tissue has been 
implanted into anybody?
    Dr. Gunnar. I am sorry.
    Dr. Roe. Tissue expired----
    Dr. Gunnar. Yes.
    Dr. Roe [continuing]. Got to the operating room, got 
implanted into a patient, has that happened?
    Dr. Gunnar. To my knowledge, that has not happened, but I 
think there is a culture of safety that is developed in the VA 
that is associated with a national policy that would provide 
assurances that that would not occur.
    Dr. Roe. Well, it could if that tissue was still sitting 
there on the shelf.
    Anyway, I yield back.
    Mr. Matkovsky. I would simply indicate, though, I mean, I 
think the discussion of the tracking and alerting mechanism, we 
do need that. We need a mechanism to better manage the 
inventory and facility. I would concur.
    Mr. Coffman. Dr. Huelskamp.
    Dr. Huelskamp. Thank you, Mr. Chairman. Appreciate the 
chance to discuss this issue today.
    First I want to turn to Mr. Matkovsky. The National Center 
for Patient Safety, that is internal to the VA; is that 
correct?
    Mr. Matkovsky. That is correct, sir.
    Dr. Huelskamp. And as I read and review the GAO report, 
they presume that all the recall notices and such coming out of 
that NCPS are sufficient and conclusive of what needs to be 
recalled. Is that your understanding?
    Mr. Matkovsky. We believe so, yes, sir.
    Dr. Huelskamp. How different is that from other systems 
that impact this particular industry and how is it different 
than what is in the industry? Again, this is only internal to 
the VA and the GAO assumes every recall that was necessary was 
identified by NCPS.
    Mr. Matkovsky. I think NCPS is actually an aggressive 
organization inside. I think it has a very forward leaning 
stance. It works with programs. I think our scale is different 
than other entities in the private sector. But other than that, 
I think it functions in much the same way as a recall entity 
would in the private sector.
    But it is a very strong coordinative entity that can 
trigger a recall either from an internal source or from an 
external source, works with the program office be it surgery or 
blood, pulls data where we can at the national level and then 
can issue a recall notice down to the facility and follow it 
through to its completion.
    Dr. Huelskamp. Does this work together with the FDA?
    Mr. Matkovsky. If the FDA issues a recall, yes, sir, it 
would. So it would trigger an FDA recall, would trigger a 
patient safety alert for us.
    Dr. Huelskamp. When you do that with non-FDA vendors, how 
do you work with those if, again, they are not registered with 
the FDA and they are not approved by the FDA, but you are using 
their products?
    Mr. Matkovsky. If there is a recall action, we would be 
notified and then we would initiate the recall action for that 
item. I am sorry. I am not sure I understand.
    Dr. Huelskamp. I do not understand why you are working with 
non-FDA vendors. Could you describe why you are working with 
non-FDA vendors in this particular arena?
    Mr. Matkovsky. I do not know that we are working with non-
FDA vendors, sir.
    Dr. Huelskamp. Didn't the GAO report identify that?
    Mr. Matkovsky. I think they indicated that given record 
keeping issues that----
    Dr. Huelskamp. You have no idea if you are working with 
non-FDA vendors; is that correct?
    Mr. Matkovsky. I do not believe that is correct, sir.
    Dr. Huelskamp. You said you do not have the paperwork to 
determine that you always work with FDA vendors.
    Mr. Matkovsky. No. I think the GAO comment was that we 
could not assure given our record system that we work----
    Dr. Huelskamp. And you are assuring me today you are not 
working with any non-FDA vendors?
    Mr. Matkovsky. I can take that for the record and research.
    Dr. Huelskamp. Yes or no?
    Mr. Matkovsky. I will take it for the record, sir.
    Dr. Huelskamp. So you cannot assure us today you are not 
working with non-FDA vendors? That is the GAO report. That is 
what they are saying. You do not have the paperwork to identify 
that? I am just trying to get the basis of that. So you are 
taking that system which you do not have the paperwork for, 
that is also the basis for which the GAO indicates you are 
following your own internal standards for a recall? Are there 
recalls that take place elsewhere in this country that the NCPS 
did not feel proper to have a recall within----
    Mr. Matkovsky. In many cases, we will have a recall that is 
not triggered by the FDA. Our own internal organization may 
trigger more recalls than would be triggered outside.
    Dr. Huelskamp. My question is, is there a recall that 
elsewhere in this particular industry that the NCPS chose not 
to precipitate within the VA system?
    Mr. Matkovsky. I do not know. I do not know of any.
    Dr. Huelskamp. Could you provide any proof of that for 
later reference? I would appreciate knowing.
    Mr. Matkovsky. I would also go back and I will research the 
data down to the granular data to look at every vendor we have 
purchased from.
    Dr. Huelskamp. Okay. Well, I appreciate that because that 
is core from the GAO report because there is not the data there 
to answer the question to say, hey, yes, we are only working--
is there a reason you would work with a non-FDA vendor?
    Mr. Matkovsky. There is none, sir.
    Dr. Huelskamp. There is none whatsoever?
    Mr. Matkovsky. I think the other thing that is also getting 
lost in some of this, the GAO is performing an audit function 
against the data we can provide. It is a time limited audit. We 
are going off of data we can provide.
    There is an accreditation function that occurs in each one 
of our facilities. Each of our facilities is a Joint Commission 
accredited entity that has its own processes reviewed by the--
--
    Dr. Huelskamp. And I understand that, but you are using the 
VA's National Center for Patient Safety as the basis for making 
these decisions. That is all internal to the VA. My concern is 
an external source on that.
    Lastly, you made some reference in your oral testimony, it 
is not in your written testimony, about personal performance 
contract. Could you describe that a little further?
    Mr. Matkovsky. I will, sir. Following our hearing on 
January 15th, I went back and modified my performance contract 
and added in there that we would have a clinically cleared 
national biologics contract by the end of--sorry--the 
requirements set by the end of this fiscal year. So we would go 
into the solicitation process. So I have modified my 
performance contract to be personally accountable.
    Dr. Huelskamp. Okay.
    Mr. Matkovsky. I think it is important.
    Dr. Huelskamp. You modify your own contract with the 
Federal Government?
    Mr. Matkovsky. We all have a performance agreement, so I 
inserted into my performance agreement working with my boss at 
the time. She and I had a discussion when I came back from this 
hearing and I thought that I needed to ensure that I was 
personally accountable to make sure we did this.
    Dr. Huelskamp. Can we receive a copy of that personal 
performance----
    Mr. Matkovsky. Absolutely, sir.
    Dr. Huelskamp. That is the first time I heard about that 
and the first time I have heard anybody say they altered their 
own personal performance contract. So did you get a bonus last 
year and that is----
    Mr. Matkovsky. I think mine is still in deliberation, sir. 
I think it is a performance award and I think it is still in 
deliberation.
    Dr. Huelskamp. Is it based on your old written contract or 
it is based on your new one? Do you----
    Mr. Matkovsky. My new one will take effect for the period 
of fiscal 2014. At the conclusion of fiscal 2014, if I am 
unable to actually deliver a requirements package for 
biologics, it will affect my personal performance, yes.
    Dr. Huelskamp. So you do not know if you got a bonus for 
fiscal year 2013 from six months ago?
    Mr. Matkovsky. I do not, sir.
    Dr. Huelskamp. When will they tell you as an employee?
    Mr. Matkovsky. I do not know.
    Dr. Huelskamp. Who makes that decision?
    Mr. Matkovsky. I also do not know. I am not sure I want to.
    Dr. Huelskamp. You have a contract. You do not know who 
makes the determination on the bonus?
    Mr. Matkovsky. Things happen.
    Dr. Huelskamp. Actually, they do not happen.
    Mr. Matkovsky. Well----
    Dr. Huelskamp. Sir, I have a hard time believing you do not 
know who is making a decision on whether you get a bonus or 
not.
    Mr. Matkovsky. I believe the secretary makes the decision--
--
    Dr. Huelskamp. Okay.
    Mr. Matkovsky [continuing]. And reviews it.
    Dr. Huelskamp. So the secretary makes the decision. He has 
waited six months and has not told you yet; is that correct?
    Mr. Matkovsky. That is correct.
    Dr. Huelskamp. Thank you. I yield back.
    Mr. Coffman. Dr. Benishek.
    Dr. Benishek. Thank you, Mr. Chairman.
    I thank you all for being here this morning.
    Dr. Gunnar, are you involved in the process of fixing this? 
I mean, Mr. Matkovsky has said how they do not quite have the 
plan yet or do not have an accurate method of tracking all this 
stuff right to the patient, I guess at the macro level really 
because I think in each hospital, they sort of track it.
    But are you involved in that process? I mean, it looks like 
you are the director of Surgery for the VA. So I always like to 
have the doctor involved with, you know, a lot of this stuff. 
So I just want to know if you are involved in that.
    Dr. Gunnar. So I am involved in the surgical world and was 
instrumental in modifying the VistA surgery package back in 
2011 to actually add implant information at the time in the OR. 
The VistA surgery package is not used for out of operating room 
procedures.
    And the majority of biologics, to take it back to the 
subject of this hearing, are actually applied in the outpatient 
arena. I think for that reason, we have testified that 
conceptually we want to align this with the blood bank concept 
of bar coding and being able to----
    Dr. Benishek. So, Dr. Icardi, then would you have----
    Dr. Gunnar. In the world of biologics----
    Dr. Benishek. You have not really been involved in that 
process?
    Dr. Gunnar. But I am involved.
    Dr. Benishek. Yeah.
    Dr. Gunnar. Yes, absolutely.
    Dr. Benishek. Well, it sounds like you said that you were 
involved in the stuff that went to the OR but not involved in 
the stuff that did not get to the OR, so is that correct? It is 
more like a blood banking issue and then the blood banking 
people are more in charge of that sort of thing then? Is that 
what you are saying?
    Dr. Gunnar. Congressman, this is, and I appreciate the 
question, this is the work group that is established will come 
to a decision in the third quarter of this year.
    Dr. Benishek. Well, the point I am trying to get at, Dr. 
Gunnar, is that, you know, I get very uncomfortable. You know, 
I am a general surgeon, too, and I get uncomfortable when 
people who are not physicians are making decisions that affect 
patients. I think as physicians, our primary concern is for the 
patient, at least mine always was.
    Now, you have that whole team working behind you when you 
are in the operating room and you want to be sure that they are 
all doing their job. And, you know, I understand that you 
cannot oversee that piece of material from the beginning to the 
end yourself. And I would like to see that physicians are at 
least in charge over the process or involved in the discussion, 
so----
    Dr. Gunnar. Dr. Icardi, to answer your question 
specifically, Dr. Icardi and I and other clinicians, program 
offices within central office are engaged in this work group 
and are participating as leaders as this work group moves 
forward.
    Dr. Benishek. Well, Dr. Icardi, let me ask you then. What 
input have you provided for this process of, you know, making 
sure that the VA has an accurate identification process for 
biologics?
    Dr. Icardi. Well, as you know, biologics, they break into 
two sides. There is the blood side and then there is the tissue 
side. And so in the blood bank, we handle mainly blood. And so 
where we have been involved----
    Dr. Benishek. Okay. Well, it sounds as if you are kind of 
backing away from the tissue side and you are talking about 
just blood. So if it is not Dr. Gunnar and it is not you with 
the tissue, then where is the doctor who follows the tissue?
    Mr. Matkovsky. Be very clear here. Both of these gentlemen 
to my left and my right are involved in this team. This will be 
a clinically led team. The recommendation will be informed by 
our clinicians. Our ultimate decision is to the process owner.
    Dr. Benishek. Well, no, I understand that. It is just that 
Dr. Icardi answered me and then he kind of was backing away 
from the tissue issue. I am trying to find out, you know, who 
is the doctor involved in planning for the tissue. And 
apparently--am I incorrect? Are you involved in planning for 
the tissue, how that all works? You said, no, I am involved 
with the blood.
    Dr. Icardi. Nationally we are involved with the blood. On 
the local level, there are some blood banks which are involved 
with tissue. And as GAO noted, it does vary from facility to 
facility.
    Dr. Benishek. So who is the doctor that is leading the 
charge on making sure the tissue is well cared for from 
beginning to implantation?
    Dr. Icardi. Well, Dr. Gunnar has----
    Dr. Benishek. All right. Well, I guess my time is up, but I 
appreciate that you are here this morning. Thank you.
    Mr. Matkovsky. If I may, just one clarification for Dr. 
Benishek. Thank you.
    Surgery is involved in this process definition. We have 
gone out. We have canvassed. We have surveyed all of our 
medical centers. We have looked at what practices we have. And 
some of our practices have the local blood bank actually 
managing the tissue. We have a really strong practice that has 
been in place for decades. We have established processes, 
established clinical directives with clinical leadership.
    Our expectation is----
    Dr. Benishek. I understand you are saying all that, Mr. 
Matkovsky, but, you know, you brought two physicians here with 
you. I asked each of them how are you involved in the process. 
And Dr. Gunnar said, well, I am in the OR. He limited his 
answer immediately and then so did Dr. Icardi limit his answer 
immediately.
    So I am wondering who is the physician who is directing, 
you know, the processing of tissue. And it is not either one of 
these. Is there someone else? You know what I mean? So that is 
the problem that I have with what happened here this morning.
    Mr. Matkovsky. Okay.
    Dr. Benishek. Very well.
    Mr. Coffman. We will go into a second round of questions. 
One question I have, do you, the GAO report discussed the death 
of a veteran. So it says according to a report--oh, I am sorry, 
this is in the Journal of the American Medical Association. The 
kidneys of an Air Force recruit from North Carolina who died 
from a rabies infection in July, 2013 were transplanted into a 
Maryland veteran who later died from complications with rabies. 
Are you acknowledging or denying that that event occurred? 
Okay. Okay. I understand that that might have occurred at 
Walter Reed, so.
    Mr. Matkovsky. I do not, I cannot comment on it.
    Mr. Coffman. Okay. Let me go into why has the Veterans 
Implant Tracking System, a vital tool necessary for patient 
safety, been allowed to stall?
    Mr. Matkovsky. I do not know that it was allowed to stall, 
Mr. Chairman. I think it went, finished software development, 
then it went into testing. I believe, Dr. Gunnar, at the end of 
fiscal year 2013 it went into testing and some critical defects 
were identified and then I believe that it sort of got caught 
up in the IT funding question.
    Mr. Coffman. According to GAO's testimony, VHA has no 
oversight ensuring VAMCs check their inventory for and alert 
affected patients for recall products. Why is no oversight 
conducted to ensure this safety measure is carried out?
    Mr. Matkovsky. You know, from 2008 to the end of 2013 there 
were 13 recalls that were triggered and notified to the VA. Of 
those, six of them were identified as having an effect on our 
inventory. So you know, the statement that we have, no 
mechanism, I do not know that that is entirely accurate because 
we are able to identify in those six cases for those recalls 
that we had inventory supply or had inventory supply at some 
time and initiated a local recall process.
    It is correct, however, I want to be clear, that managing 
the inventory and having greater granular control can be 
improved with a better tracking system.
    Mr. Coffman. According to GAO, VA does not ensure that 
biological implant vendors are registered with the FDA. Is not 
a simple verification important for patient safety?
    Mr. Matkovsky. Yes. In so many words, it is.
    Mr. Coffman. Very well. Mr. Walz.
    Mr. Walz. No further questions.
    Mr. Coffman. No further questions? Dr. Roe? No further 
questions. Dr. Huelskamp, no further questions. Well very well, 
thank you very much, panel, for your testimony.
    On our second panel we will hear from Ms. Marcia Crosse, 
Director of Healthcare for the Government Accountability 
Office. Your complete written statement will be made part of 
the hearing record. Ms. Crosse, you are now recognized for five 
minutes.

                 STATEMENT OF MS. MARCIA CROSSE

    Ms. Crosse. Thank you. Chairman Coffman and members of the 
committee, I am pleased to be here to discuss our work on the 
safety of tissue products used at the Veterans Health 
Administration. In fiscal year 2013 approximately 59,000 tissue 
products were used to provide care to veterans at VA medical 
centers. The tissue products most commonly used by VHA are bone 
and skin grafts.
    While tissue products may provide valuable methods to 
sustain and improve quality of life, there are also risks that 
they can transmit a communicable disease from a donor to a 
recipient, potentially resulting in complications. The Food and 
Drug Administration, FDA, is responsible for regulating the 
manufacture of tissue products. These products are generally 
regulated under FDA's human tissue regulations, or under FDA's 
medical device regulations. Establishments that manufacture 
tissue products must register annually with FDA and must follow 
applicable regulations, including reporting certain adverse 
events and following good manufacturing practices.
    Although VA relies on FDA to ensure the quality of its 
tissue vendors, VA policies do not require that a vendor's FDA 
registration status, an important component of federal 
oversight, be checked for most purchases. VHA officials told us 
that for open market purchases the agency does not require 
purchasing staff and contracting officers to check the FDA 
registration status of tissue product vendors. Open market 
purchases account for 57 percent of the tissue products that 
are procured with purchases made from several hundred different 
vendors.
    For the remaining purchases made under fewer than a dozen 
federal supply schedule contracts, VA does check vendors' 
registration status for tissue products regulated as medical 
devices. However, there is no policy requiring staff to check a 
vendor's registration status for products regulated under FDA's 
human tissue regulations.
    It is important to note that VHA has not found evidence 
that it has received contaminated tissue products. It is often 
not possible to definitively attribute post-surgical infections 
to a tissue product and it is not uncommon for such infections 
to occur even in the absence of tissue use. In the past five 
years VA has notified its medical centers of 13 recalls for 
tissue products and these recalls were generally issued because 
of the possibility of contamination, not because of known 
contamination.
    When a recall does occur VHA's ability to identify and 
track recalled tissue products in its inventories may be 
limited by poor inventory management practices. The medical 
centers are required to search their inventories for any 
recalled products that have not been used. But GAO and the VA 
OIG have previously reported concerns with the completeness and 
accuracy of VHA's inventory data and have made recommendations 
for improvement.
    Further, while VA medical centers are also responsible for 
accurately identifying all recalled tissue products that have 
been used, identifying implanted tissues may be a challenging 
task for the medical centers to accomplish. Officials stated 
that it is difficult to search for information on tissue 
products that have been implanted in the operating room in part 
because there is no automated search capability. We also found 
that VHA conducts no oversight to ensure that these checks of 
patient records are performed.
    VA is taking steps that may improve its ability to track 
tissue products. For example, VA officials told us that the 
agency is continuing development of a Veterans Implant Tracking 
and Alert System, VITAS, which was created to track and 
retrieve identifying information on surgical implants, 
including tissue products. In addition, the agency told us that 
it established a working group to determine the feasibility of 
utilizing scanning and tracking technology to automatically 
upload tissue information into patients' medical records.
    In summary, VA's recent actions may improve VHA's ability 
to identify tissue products both in inventories and used to 
treat veterans. Mr. Chairman, this completes my prepared 
statement. I would be happy to respond to any questions that 
you or members of the subcommittee may have.

    [The prepared statement of Marcia Crosse appears in the 
Appendix]

    Mr. Coffman. Thank you, Ms. Marcia Crosse. I have got a few 
questions. Some tissue products have already been implanted, 
injected, or applied by the time a recall occurs. How does VHA 
ensure that veterans who have been the recipient of such 
products are identified and notified?
    Ms. Crosse. VHA officials have told us that it is very 
difficult for them to identify the patients who have received 
those products. For the tissue products that are implanted in 
an operating room, VA staff required to enter identifying 
information about the source and lot number of that product 
into the patient's record. But it is manually entered and it is 
not searchable except by pulling up a text field. So someone 
must actually go through each patient record to determine if a 
relevant product implanted. For the outpatient clinics it is 
even less clear how the information could be tracked.
    Mr. Coffman. Are the steps VA medical centers take to 
notify patients of a product recall sufficient to enable prompt 
identification?
    Ms. Crosse. It is not clear. As I said, it is not clear 
that contaminated tissues have actually been implanted into 
patients in VA medical facilities. There have been a small 
number of recalls. I would like to clarify that among those 13 
recalls, for six of them VA identified the product at 27 
different facilities. The remaining seven recalls were sent out 
because there was a belief that the VA had purchased these 
products. They did not find any. Whether that meant they had 
already been used or had expired, we do not know. Regarding the 
steps to actually identify patients, I am not aware that there 
have been any notifications given to patients that they have 
received a contaminated tissue. VA has told us they are not 
aware of any cases of such contamination occurring.
    Mr. Coffman. Ms. Crosse, what is the problem with VA 
medical centers operating room staff entering implant serial 
and model numbers into medical records by hand?
    Ms. Crosse. You have the potential for error, just simple 
transcription error by, someone having to type something in. In 
addition it is not entered into something that is automatically 
searchable. It is in a field where you actually have to go back 
in and read it and compare it to the product that you would be 
looking for. It is not something like a bar code that is 
automatically read into the record.
    Mr. Coffman. Okay, thank you very much. Mr. Walz?
    Mr. Walz. Well thank you, Mr. Chairman. Thanks, Ms. Crosse. 
Is VA's purchasing and tracking of biological implants the same 
as private industry?
    Ms. Crosse. We have not looked at private industry. Some of 
the same problems exist. There is a new system that is coming 
online for those tissue products that are regulated as medical 
devices, the unique device identifier system that is going to 
be used by facilities throughout the country, VA or private. 
There is not a similar system in place for identification for 
biologics that are regulated as tissue products. I think each 
individual facility has been and will continue to be making its 
own decisions about what kind of system they have to track.
    Mr. Walz. Maybe Mr. Wilton can help me with that. The 
reason I keep bringing this up, and I think one of my 
colleagues mentioned it, we need these facilities to be the 
best. When my folks at Mayo Clinic tell me that the cardiology 
at Mayo, Minneapolis, is the best in the world, that is a good 
thing. That is the way it should be. I keep bringing this back 
up because it is important holistically as we approach medical 
reform to understand what the private sector is doing, where 
they are doing it better and where they are doing it less. And 
I understand this committee's scope of responsibility as the VA 
and we are exercising that.
    I bring this in to see if we can learn from each other and 
I know we do that often. And it seems like this would be one of 
those issues where that would be pertinent information, so we 
are not operating in a vacuum.
    My next one is how will you, and maybe it is not you, maybe 
it is in conjunction with the IG to follow up on your report, 
how will you follow up regarding the recommendations you made 
in the 2014 report here?
    Ms. Crosse. GAO does follow up routinely. We follow up at 
least annually with the agency to determine what actions have 
been taken to make changes in accordance with the 
recommendations that we have made. We publish an annual report 
giving the status of recommendations that is available on GAO's 
website. We also track recommendations for at least five years.
    Mr. Walz. Will our veterans be safer if they follow your 
recommendations?
    Ms. Crosse. We believe that those recommendations are 
grounded in the need for actual changes to occur. That it will 
improve the care that is given to veterans if these changes are 
made in VHA's inventory management practices.
    Mr. Walz. And I for one, I do appreciate, and I think Dr. 
Huelskamp was hitting on something important, and I was curious 
too about his questions on how this worked. I do think it is 
admirable that there is going to be a connection to whether 
these things are followed through with, whether this report is 
implemented, to someone that we can address. So I want to 
highlight that, though. But he did bring up an interesting 
point, is who is going to make that ultimate decision? That 
would be an important thing. Now you said the Secretary. But I 
do like this, that all of us in conjunction here, because the 
ultimate goals is accountability for veteran safety. And so now 
your report, and they are working with it, and they are adding 
back, and if the private sector can add anything which we will 
hear from our next panel, so that is our goal. So I am 
appreciative of that. And with that, I will yield back the 
remainder of my time.
    Mr. Coffman. Thank you, Mr. Walz. And just a very quick 
point, I think, that in the private entities as you mentioned, 
Mr. Walz, I think that families if there is a lapse in patient 
safety have recourse through the court system where our 
veterans rely on us. Dr. Roe?
    Dr. Roe. Thank you. And just to dovetail on what Mr. Walz 
was saying, I really appreciated Mr. Matkovsky, that is the 
first time since I have been here in five-and-a-half years that 
someone has said the buck stops here. And I appreciate that. 
And that fact that you are going to put yourself at some 
financial risk if you do not get this done, the criteria done 
and so forth, not completely implemented, I understand that, by 
the end of the year. So thank you for that.
    Ms. Crosse, a couple of things that just looking here, and 
the more I delve into this the more I realize it is not just 
the VA, this is a systemwide, perhaps we will hear from our 
third panel what is going on in the private sector. But it is a 
little disconcerting that the FDA would approve a tissue bank 
and then not go back and look at it for several years to see if 
they are up to standard or doing what they are supposed to. I 
think that is something that started my wheels turning a little 
bit. That your report pointed out to me a deficiency not just 
in VA. They cannot help what the FDA does. So maybe we need to 
take another step toward that direction. Would you agree with 
that?
    Ms. Crosse. The FDA has a risk-based system that they use 
for tissue products. They also have a risk-based system that 
they use for making determinations about inspecting medical 
device establishments and drug manufacturers. The data that it 
provided to us indicated that it had inspected about a quarter 
of the tissue banking facilities that were registered with it 
in the last fiscal year. About 600 inspections had been done 
out of about 2,500 or 2,600 registered establishments. That 
actually is in line with or perhaps somewhat higher than the 
inspections they are performing for medical device 
establishments and for drug manufacturers. We previously put 
out a series of reports on this topic and FDA has begun to 
shift its inspections because it was generally inspecting drug 
manufacturers domestically and not abroad. And so it has been 
shifting where it is targeting its inspections and trying to 
target on those that are manufacturing the riskiest products. I 
cannot speak to whether it is an appropriate frequency, but 
that is the frequency FDA is inspecting with the resources it 
has.
    Dr. Roe. Well I think the thing when you see FDA approved, 
and they have a great reputation, the FDA does, for looking 
after safety. And quite frankly what we have heard today is 
that these, so that our viewers out there understand, that for 
the most part this is very, very safe and very beneficial. But 
there are holes in there that we need to plug up and make sure. 
Because if you are a patient, one patient, I mean that young 
veteran, I guess active duty, who got a kidney transplant, that 
was 100 percent for him that he got rabies and died because of 
that mistake that was made. So as a physician, we have got to 
be right every time. And the folks that are providing, or as 
every time that we can. And the systems that are providing this 
material for us, they have to be right on nearly 100 percent 
perfect. And obviously errors could be made. But 57 percent of 
341 different vendors the VA used that made these small 
purchases that were not, as I understand it, we did not check 
the FDA. And open sources, I heard you say they did not check 
the FDA status. So that means a lot of those never got checked. 
We just made an assumption it was safe.
    Ms. Crosse. We do not know if VA checked.
    Dr. Roe. Do not know, okay.
    Ms. Crosse. And I think that is a concern. There is no 
policy that requires that a check be made. Unlike the federal 
supply schedule purchases, where actually part of that process 
requires that VA check the FDA registration status for 
establishments making products that are regulated as medical 
devices, there is no requirement for the small purchases that 
are made, the open market purchases. Similarly, even for the 
federal supply schedule purchases there is no required check in 
place to ascertain the registration status for the products 
that are regulated as tissues as opposed to those regulated as 
devices.
    Dr. Roe. And I think the other thing is just because 
something is FDA approved does not mean it is 100 percent safe. 
And because it had not been, does not mean it is not either. I 
think that is because the clinical outcomes of most of these 
59,000 people, and they have had no reported cases, I guess, 
unless the tracking is----
    Ms. Crosse. There have been adverse events reported to FDA. 
When FDA has conducted investigations it has positively 
confirmed two donors from whom contaminated tissues were 
recovered and that were sent out to facilities. But neither of 
those instances involved VHA facilities for the confirmed 
cases. There are recalls. Adverse events are required to be 
reported to FDA. There are instances in which there is at least 
the possibility of contamination and FDA wants to have those 
products recovered from inventory and patients checked. We know 
that there is a process at VA for recovering from inventory. We 
are not sure what is happening in terms of checking patient 
records.
    Dr. Roe. And just as I finish, Mr. Chairman, you know it 
looks like as you pointed out, and human error, and the bar 
code, that that technology is available. I mean, Harris Teeter 
knows when I walk in and buy a box of cereal what I bought, and 
they send me a coupon three weeks later for fifty cents off. So 
it should be fairly easy to do that. But that is not new 
technology, it has been around forever. And it would create a 
line downstream to find out where this came from, where the 
source was, and you could track it much easier. I think that 
would simplify it tremendously. I yield back.
    Mr. Coffman. Dr. Huelskamp.
    Dr. Huelskamp. Thank you, Mr. Chairman. Ms. Crosse, the 
question from Mr. Walz was about what is happening in the 
private sector, how this occurs, and you did not have 
experience on that, had not compared that. Are you able to 
compare that to other sectors? The federal government? The DoD 
has an enormous system. Do they use non-FDA approved items? Do 
they purchase off the schedule? Can you shed any light on 
comparison there?
    Ms. Crosse. I am afraid our review did not focus on what 
was happening in other federal health care facilities. We only 
were looking at what was happening at the VA.
    Dr. Huelskamp. Okay. And I appreciate that. I understand 
the limits on that. You did look at the VA's OIG study in March 
of 2012?
    Ms. Crosse. Yes.
    Dr. Huelskamp. Where it indicated that informal tracking 
systems, I am not sure how well informal tracking systems work, 
and if you are trying to look at a recall, you are trying to 
look at adverse effects, they cannot even track the product on 
the shelves much less the patients. I mean, so if I asked the 
question, as you saw earlier, it is, well, we do not know. We 
actually do not know what we do not know. Is that an accurate 
assessment of an informal tracking system that no one knows for 
sure what is there and it is just a best guess?
    Ms. Crosse. According to the IG's report, different 
facilities had their own individual systems in place for 
tracking. There was not a centralized system. It could not be 
accessed by VHA systems. But as I understand it, that is part 
of the changes that are being put in place that Dr. Gunnar 
spoke to, specifically for those products that are implanted in 
operating rooms. I am not sure what is being done for the 
outpatient facilities.
    Dr. Huelskamp. And you reviewed the report. Do you know if 
this has been implemented? Or how far along they are in fixing 
this informal tracking system which is the basis for saying 
that no adverse events have been reported on the use of these 
tissues?
    Ms. Crosse. Our understanding is that the comprehensive 
inventory management system is part of what was discussed 
earlier and the last update we had was that it is supposed to 
begin to come online in 2015.
    Dr. Huelskamp. Okay, so it is still not there. So one other 
question I would ask of the VA I would like followed up on is 
populating the NCPS system. Or NCPS, in your opinion is that 
sufficient? Can you describe for the committee how it is 
determined that you do a recall? Again, I presume actually if 
the FDA had a recall that did not mean that VA actually 
initiated a recall either. They were not always the same. Can 
you describe that a little bit more, about an internal VA 
system that everything is hinging on in terms of this report?
    Ms. Crosse. The NCPS system is used to try to track 
recalled products that may still be in inventory. There is a 
centralized system that allows NCPS to go out, that covers the 
VAMCs, and that would allow NCPS to determine whether or not 
those products had been procured at different facilities so 
that they could then have the facility go and remove that 
product from the shelf. There have been some concerns about the 
accuracy of all the information that is in that system but 
nevertheless that at least provides a centralized source. The 
gap I think occurs because VHA does not have oversight of what 
has happened for the tissues that have been used and that may 
be covered by that recall. That is where the VAMCs are 
individually responsible for checking individual patient 
records to make a determination of whether or not someone 
received an implanted product that had been recalled and 
whether notification to that patient is warranted.
    Dr. Huelskamp. And you do also note that although the NCPS 
tracks and responds to recalls, at least partially I would say, 
they do not track warning letters. Can you describe a little 
bit more why those are ignored by the system?
    Ms. Crosse. VA told us that the information in warning 
letters is really not that helpful for them because the warning 
letters that FDA puts out are really focused on changes that a 
company needs to make in order to be in compliance with FDA 
requirements and would not necessarily result in products 
having been distributed that were contaminated or otherwise 
needed to be subject to a recall. There have only been a small 
number of warning letters to tissue establishments in the last 
several years. But the VA officials indicated they did not 
believe that that would provide them with actionable 
information.
    Dr. Huelskamp. Even though in one case the FDA issued a 
warning letter to a vendor and the VHA did not know about that, 
and obviously did not respond to that because they only respond 
to recalls. Ms. Crosse, I appreciate the report and I would 
suggest in the future, and like Mr. Walz indicated, you know, 
comparison to what is going on in the private sector. But I 
also would like to see as well, I mean, comparison to the DoD. 
Because the NCPS does use DoD information. I am not for sure 
how that works here. But it seems to be not in any formal 
manner. But in your report you do mention in a footnote, you 
talked to visiting officials, you talked to FDA, DoD, and 
tissue vendors, and I am not sure if there is any formal 
process for doing that.
    But last, really quickly, the non-FDA issue----
    Ms. Crosse. Yes.
    Dr. Huelskamp [continuing]. And we do not know what we do 
not know, and we could not prove that. The recalls, obviously 
if FDA is going to have a recall, it is not going to apply to 
non-FDA vendors in this case. And I am not sure how you track 
that, or you can indicate you tried?
    Ms. Crosse. Most recalls are actually not directed by FDA. 
Most of the recalls that occur are voluntary recalls that are 
initiated by the vendor themselves. There have only been one or 
two instances where FDA has actually mandated that a recall 
occur. That is not uncommon across the board for all types of 
medical products. Most recalls are voluntary.
    Dr. Huelskamp. I appreciate it. I yield back, Mr. Chairman.
    Mr. Coffman. Our thanks to Ms. Crosse. You are now excused.
    I now invite the final witness to the table. On our third 
panel we will hear from Mr. Frank Wilton, Chief Executive 
Officer of the American Association of Tissue Banks. Your 
complete written statement will be made part of the hearing 
record. Mr. Wilton, you are now recognized for five minutes.

                 STATEMENT OF MR. FRANK WILTON

    Mr. Wilton. Chairman Coffman, Mr. Walz, and distinguished 
members, the American Association of Tissue Banks, or AATB, 
would not be here today if it was not for the U.S. military. 
The very first tissue bank in the U.S. was the United States 
Navy Tissue Bank, which was established in 1949 by Dr. George 
Hyatt. In 1976, Dr. Hyatt and his colleagues helped found the 
American Association of Tissue Banks. Recognizing the 
increasing use of human tissue for transplant, these 
individuals saw the need for a national organization to develop 
standards, promote ethics, and increase donations.
    Beyond the historical significance, AATB accredited tissue 
banks continue to focus on the needs of veterans. As you know, 
many military personnel serving in Operation Iraqi Freedom and 
Operation Enduring Freedom have received severe burn injuries 
due to the use of IEDs. If necessary, donor skin may be used as 
a life saving dressing. AATB accredited tissue banks have 
helped ensure that veterans have access to these life saving 
dressings, as well as other biological implants necessary to 
relieve pain, restore mobility, restore sight, and save limbs.
    With that in mind, thank you for the additional opportunity 
to come before you today in support of the ``Biological Implant 
Tracking and Veteran Safety Act of 2014.'' This critical 
legislation directs the Secretary of Veterans Affairs to adopt 
a standard identification system for use in the procurement of 
biological implants by the Department of Veterans Affairs. By 
building upon the success of the implementation of the unique 
device identifier, or UDI, this legislation will ensure that 
biological implants used within the Department can be 
appropriately tracked from a human tissue donor all the way to 
the recipient. This critical capability for track and trace 
efforts will enhance patient safety, expedite product recalls 
when necessary, assist with inventory management and improve 
overall efficiencies.
    This legislation takes a bold step to expand UDI to all 
tissue products. In addition to human tissue devices which are 
already covered by the UDI, the legislation adds another 
product category: certain biological implants or, as termed by 
the Food and Drug Administration, 361 human cells, tissues, and 
cellular tissue-based products, or HCT/Ps. While many of the 
biological implants do have company specific bar coding 
information, by requiring a standardized format for those bar 
codes as outlined in this legislation, it will be easier for 
the Department of Veterans Affairs medical facilities to 
utilize universal bar coding conventions and to realize the 
full benefit of a unique identification system. Finally, by 
applying a system which has been developed for devices to 
biological implants such a solution should also be applicable 
to other health care settings and other health care systems 
such as the Department of Defense health care system and the 
private sector.
    While I understand the committee's skepticism in requesting 
that the VHA attempt a VITAS-like enterprise in this 
legislation after failing to do so before, I would note that a 
lot has changed since 2008 when the VHA first envisioned VITAS. 
First, there is now a UDI benchmark which allows those 
developing the necessary software for data capture to move from 
a design incorporating dozens of bar code technologies to only 
three. In addition the VHA is not alone in trying to develop a 
system for integrating UDI like information directly into the 
medical record. For instance, the Office of the National 
Coordinator for Health Information Technology is currently 
focused on the ways in which the UDI can be better 
operationalized to ensure its adoption into key standards. As 
part of those efforts ONC is initially focusing on 
implantables, the very focus of the legislation we are 
discussing today. Therefore the VHA will not be attempting to 
establish such a system alone, but can partner with other 
governmental agencies to ensure its success.
    For those of you unfamiliar with my organization, the 
American Association of Tissue Banks is a professional, not for 
profit scientific and educational organization. It is the only 
national tissue banking organization in the United States and 
its membership totals more than 125 accredited banks and 
approximately 850 individual members. These banks recover 
tissue from more than 30,000 donors and distribute in excess of 
two million allografts for more than one million tissue 
transplants performed annually in the U.S.
    Finally when I last discussed this legislation before the 
committee I noted my concern that the draft legislation lacked 
a requirement that biological implants purchased by the VHA be 
subject to appropriate accreditation standards. It is my 
understanding that those concerns have been addressed in the 
latest version of the legislation by requiring accreditation by 
AATB or a similar accreditation organization. Thus with this 
change the VHA will be joining the ranks of leading medical 
centers of excellence which currently require all tissue to be 
sourced from AATB accredited tissue banks.
    AATB strongly supports this legislation and urges the 
committee to favorably report it out of committee. This ends my 
prepared remarks and I would be happy to answer any questions.
    [The prepared statement of Frank Wilton appears in the 
Appendix]
    Mr. Coffman. Thank you, Mr. Wilton. Mr. Wilton, is it 
common for biological implant vendors to receive FDA warning 
letters?
    Mr. Wilton. No. In fact it is fairly rare, Mr. Chairman. We 
went back and looked back to fiscal year 2000, and there were 
43 recalls that were issued within that roughly 15-year period. 
To put it in perspective the FDA, looking at all the different 
areas it has jurisdiction over, issued 45 in January of this 
year alone. However, it is a very serious thing that our banks 
take with the utmost concern.
    Mr. Coffman. Mr. Wilton, what is the benefit of the UDI or 
a standardized identification system for VHA?
    Mr. Wilton. As I remarked, in my comments, Mr. Chairman, it 
is largely due to tracking and tracing so we can track it from 
the donor all the way to the recipient. I think from the VHA's 
perspective it will be helpful for inventory management, be 
useful if there is in fact a recall and overall improve 
efficiency within the VHA system.
    Mr. Coffman. What are some concerns with the use of tissue 
distribution intermediaries?
    Mr. Wilton. Sure. TDIs are sort of on the back end of the 
system, if you will. We went back and looked at FDA 
registration data and as best we can tell only about 16 percent 
of the TDIs are in fact accredited by AATB. So the question 
becomes, are they maintaining the standards they need to in 
order to make sure that the tissue is stored appropriately and 
it is distributed appropriately? So the short answer is, we do 
not know for sure. Only the ones that we accredit can we speak 
for.
    Mr. Coffman. Mr. Walz.
    Mr. Walz. Thank you, Mr. Chairman. Thank you, Mr. Wilton. 
Just two quick ones here for you. From your approach on this, 
and you have been hearing some questions as you have been here, 
how does the VA look compared to those other centers of 
excellence you are looking at in terms of where they are going 
in this?
    Mr. Wilton. Yes, I think this is a terrific effort. And as 
I said in my testimony, we hope that once this is implemented 
it can get beyond the VHA to DoD and to the private sector. I 
think the big change is our tissue banks track and trace all 
their tissue but there are a lot of different bar code systems. 
With the FDA's guidance there will now be three, and I think it 
will be much easier for the VHA to implement those systems and 
then hopefully go much beyond that.
    Mr. Walz. And that will hold true both in the private 
sector also for them to follow that?
    Mr. Wilton. Yes. Yes, sir.
    Mr. Walz. So this will help, will this help lead and push 
into that?
    Mr. Wilton. Absolutely. I think it is a terrific step for 
the VHA to take the leadership role in this, and we are happy 
to work with them.
    Mr. Walz. That is great. And from today's testimony, what 
did you hear that most concerns you, if there is something you 
could hear amongst this testimony? Just trying to educate us 
and understand some of----
    Mr. Wilton. Sure. I mean, again, the good news is, the FDA 
registration issue is one that clearly concerns the committee. 
AATB accredited tissue banks are registered with the FDA. You 
had some concerns about the frequency of inspections. When you 
are accredited by AATB, we inspect each one, and there is a 
three-year period where we reinspect. So between the FDA and 
AATB, there are many more inspections. And we just think that 
our veterans deserve the best, and we feel strongly that AATB 
accredited tissue banks provide the best.
    Mr. Walz. Okay. Because what you are hearing, and I hear 
when it got explained further, we are always going to err on 
the side of cautiousness towards our veterans. So when we hear 
that there is a possibility I think my colleague was bringing 
up a good point. I understand it is not proving the negative 
type of situation. He was just asking, you cannot in all, 100 
percent confidence, tell us this is happening. That concerns 
us. So I think it is important for us to understand what those 
steps are and how they are there and how we make that clear as 
we go back and assure our constituents that they are protected. 
And so with that, I yield back.
    Mr. Coffman. Thank you, Mr. Walz. Dr. Huelskamp.
    Dr. Huelskamp. Thank you, Mr. Chairman. Mr. Wilton, your 
association, is that the entirety of the industry? Or are there 
some other competing associations?
    Mr. Wilton. I am not aware of any others.
    Dr. Huelskamp. Okay.
    Mr. Wilton. And in doing the analysis we feel that about 92 
percent of all the tissue that is recovered and processed in 
this country is done through AATB accredited tissue banks.
    Dr. Huelskamp. Mm-hmm. And the other eight percent, is that 
through another accredited organization? Or----
    Mr. Wilton. I am not aware of another organization.
    Dr. Huelskamp. Okay. What happens in that eight percent, 
then? Can you describe that? No one knows, is that----
    Mr. Wilton. I think you are correct, sir. No one knows.
    Dr. Huelskamp. Okay. Okay. In your experience, I asked a 
question of both the previous panels. Are you able to compare 
the VA, compared to say the DoD, or other federal agencies? And 
can you describe that comparison, what it looks like for the 
committee?
    Mr. Wilton. I think there are challenges in all health care 
settings once the tissue actually gets to the consignee, the 
hospital or the doctor. I think it is a universal problem. And 
as I said earlier, I think it is terrific that the VHA is 
considering taking a leadership role in this.
    Dr. Huelskamp. So does the DoD track this? Do they have an 
informal tracking system? Do they have a formal tracking 
system----
    Mr. Wilton. My understanding----
    Dr. Huelskamp [continuing]. Next largest system?
    Mr. Wilton. Yes, my understanding is they do it the same 
way that the VHA does.
    Dr. Huelskamp. Which is----
    Mr. Wilton. Again, it is a manual process, not a bar coding 
process. So having it in an automated sense I think would make 
great strides for both DoD and----
    Dr. Huelskamp. Do you believe is it standardized and manual 
or----
    Mr. Wilton. As I alluded to, there are going to be three 
different systems that the FDA has approved to track and trace. 
And I think the VHA and DoD will be able to adopt them, and our 
members will obviously provide those as well.
    Dr. Huelskamp. And my concern was not so much necessarily 
with the manual aspect of that. It is the fact that in the VA 
it was not standardized.
    Mr. Wilton. My understanding is it is not, sir.
    Dr. Huelskamp. Yes. And it was informal, which means it is 
not formal. But is the DoD, in your opinion is it informal as 
well----
    Mr. Wilton. My understanding is that they operate on a 
similar fashion.
    Dr. Huelskamp. Okay. Well that is particularly troubling. 
So if there is a recall, how does the DoD handle that?
    Mr. Wilton. I am not aware of that, sir.
    Dr. Huelskamp. You are not aware? So I presume you have 
members that work with the DoD? I would appreciate some follow 
up on that from your, how they handle that----
    Mr. Wilton. We would be happy----
    Dr. Huelskamp [continuing]. I know we are talking about the 
VA. But if we are going to talk about that you think the VA 
system that they are talking about implementing would be the 
best, that raises a concern with me as well. Mr. Chairman, I 
yield back. Thank you.
    Mr. Coffman. Thank you. Dr. Roe. Mr. Wilton, thank you so 
much for your testimony. You are now excused.
    At this time I would like to give VA, if they would like to 
respond to any of the comments in the prior two panels? Okay, 
seeing none, today we have had a chance to hear about many 
problems occurring with VA sourcing, procurement, and tracking 
of biological implants. From the testimony provided and 
questions asked today, I am alarmed at the great risk of harm 
our veterans face when they receive a biological implant from 
the VA. As such this hearing was necessary to accomplish a 
number of items: to identify the reasoning for VA's 
questionable procurement and tracking practices involving 
biological implants; to require VA officials to explain their 
inadequate response to these obvious deficiencies; and to 
determine what steps are being taken to correct these issues 
and improve the care provided to our veterans.
    I ask unanimous consent that all members have five 
legislative days to revise and extend their remarks and include 
extraneous material. Without objection, so ordered.
    I would like to once again thank all of our witnesses and 
audience members for joining in today's conversation. With 
that, this hearing is adjourned.
    [Whereupon, at 11:41 a.m., the subcommittee was adjourned.]
    
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