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87–675 2015

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 

( 

Available via the World Wide Web: http://www.fdsys.gov 


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COMMITTEE ON VETERANS’ AFFAIRS 

JEFF MILLER, Florida, Chairman 

DOUG LAMBORN, Colorado 

GUS M. BILIRAKIS, Florida, Vice-Chairman 

DAVID P. ROE, Tennessee 

BILL FLORES, Texas 

JEFF DENHAM, California 

JON RUNYAN, New Jersey 

DAN BENISHEK, Michigan 

TIM HUELSKAMP, Kansas 

MIKE COFFMAN, Colorado 

BRAD R. WENSTRUP, Ohio 

PAUL COOK, California 

JACKIE WALORSKI, Indiana 

DAVID JOLLY, Florida 

MICHAEL H. MICHAUD, Maine, Ranking 

Minority Member 

CORRINE BROWN, Florida 

MARK TAKANO, California 

JULIA BROWNLEY, California 

DINA TITUS, Nevada 

ANN KIRKPATRICK, Arizona 

RAUL RUIZ, California 

GLORIA NEGRETE MCLEOD, California 

ANN M. KUSTER, New Hampshire 

BETO O’ROURKE, Texas 

TIMOTHY J. WALZ, Minnesota 

JON TOWERS, Staff Director 

NANCY DOLAN, Democratic Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION 

MIKE COFFMAN, Colorado, Chairman 

DOUG LAMBORN, Colorado 

DAVID P. ROE, Tennessee 

TIM HUELSKAMP, Kansas 

DAN BENISHEK, Michigan 

JACKIE WALORSKI, Indiana 

ANN KIRKPATRICK, Arizona, Ranking 

Member 

MARK TAKANO, California 

ANN M. KUSTER, New Hampshire 

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 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. 


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C O N T E N T S 

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 


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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 


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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. 


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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. 


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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. 


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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 


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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 


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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. 


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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. 


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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 


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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— 


VACREP180 with DISTILLER
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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? 


VACREP180 with DISTILLER
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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 nonFDA 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 nonFDA 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 


VACREP180 with DISTILLER
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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. 


VACREP180 with DISTILLER
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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 


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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. 


VACREP180 with DISTILLER
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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? 


VACREP180 with DISTILLER
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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 


VACREP180 with DISTILLER
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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 


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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 


VACREP180 with DISTILLER
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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 


VACREP180 with DISTILLER
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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 beVerDate Aug 31 2005 09:36 Aug 27, 2015 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 Y:\87-675.TXT PAT

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cause 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. 


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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 


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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 


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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. 


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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. 


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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. 


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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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