This is the accessible text file for GAO report number GAO-14-463T 
entitled 'Veterans' Health Care: Oversight of Tissue Product Safety' 
which was released on April 2, 2014. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as 
part of a longer term project to improve GAO products' accessibility. 
Every attempt has been made to maintain the structural and data 
integrity of the original printed product. Accessibility features, 
such as text descriptions of tables, consecutively numbered footnotes 
placed at the end of the file, and the text of agency comment letters, 
are provided but may not exactly duplicate the presentation or format 
of the printed version. The portable document format (PDF) file is an 
exact electronic replica of the printed version. We welcome your 
feedback. Please E-mail your comments regarding the contents or 
accessibility features of this document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

United States Government Accountability Office: 
GAO: 

Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Veterans' Affairs, House of Representatives: 

For Release on Delivery: 
Expected at 10:00 a.m. EDT: 
Wednesday, April 2, 2014: 

Veterans' Health Care: 

Oversight of Tissue Product Safety: 

Statement of Marcia Crosse: 
Director, Health Care: 

GAO-14-463T: 

GAO Highlights: 

Highlights of GAO-14-463T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Veterans' Affairs, House of 
Representatives. 

Why GAO Did This Study: 

In fiscal year 2013, approximately 59,000 tissue products were used to 
provide care to veterans at VAMCs; bone and skin grafts were the most 
common. While tissue products can repair the body and improve function 
and feeling, there is also the risk that communicable diseases can be 
transmitted from the donor to the recipients, potentially resulting in 
severe complications. FDA is responsible for regulating the 
manufacture of tissue products to help ensure the safety of such 
products marketed in the United States. For purchasing purposes, VHA 
considers tissue products to be a type of surgical implant and a 
prosthetic—items that support or replace a body part or function. 

At recent hearings of this subcommittee, concerns were raised about 
VA's oversight of surgical implant purchases and its ability to 
identify veterans who received an implant that is being recalled by 
the manufacturer or FDA. This testimony addresses (1) whether VHA 
received tissue products that may have been contaminated and (2) VHA's 
safeguards to prevent the receipt and use of contaminated tissues, 
including VHA's ability to ensure the quality of its vendors and to 
respond to recalls of tissue products. GAO reviewed FDA and VHA data 
on recalls and adverse reactions related to tissue products and VHA 
purchasing data. GAO also interviewed VA, VA OIG, and FDA officials on 
tissue product safety requirements and oversight actions. GAO focused 
on the policies and procedures at the VA and VHA level. 

What GAO Found: 

Data from the Veteran's Health Administration (VHA), within the 
Department of Veterans Affairs (VA), do not show evidence of VHA 
receiving contaminated tissue products, although, it is difficult to 
link adverse events in recipients to such products. VA's National 
Center for Patient Safety (NCPS), which began operation in 1999, has 
not issued any patient safety alerts—mandates for action to address 
actual or potential threats to life or health—or advisories—guidance 
to address issues such as equipment design and product failure—related 
to tissue products potentially received by VA medical centers (VAMC) 
in the last 10 years. NCPS issues patient safety alerts and advisories 
for recalls that require specific clinical actions to ensure patient 
safety. Since NCPS began issuing and recording data on recalls in 
November 2008, NCPS has notified VAMCs of 13 recalls for tissue 
products from vendors from which VHA could have received affected 
products—none of these recalls have resulted in patient safety alerts 
or advisories. For 6 of the recalls, 27 VAMCs reported to NCPS that 
they had identified and removed the recalled products from their 
inventories. For the other 7 recalls, none of the VAMCs had the 
affected tissue products in their inventories. The13 recalls were not 
issued for known tissue product contamination. Instead, most were 
initiated because of the possibility of contamination, such as 
compromise of product sterility and incomplete donor records. Further, 
VHA officials told us that their analysis of VHA data found no 
evidence of reported adverse events among VHA patients that were 
caused by contaminated tissue products. According to officials from 
the Food and Drug Administration (FDA), post-surgical infections often 
occur, even in the absence of tissue use, and it is often not possible 
to definitively attribute such infections to a tissue product. 

VHA's identification of recalled tissue products may be limited, 
although recent actions by the agency may help. VA and VHA rely on FDA 
to ensure the quality of tissue vendors—who are generally required to 
register with FDA—but VA and VHA policies do not require that a 
vendor's FDA registration status be checked for most purchases. In 
addition, VHA's ability to track recalled tissue products in its 
inventories may be limited by poor inventory management practices. 
After receiving a recall notice, VAMCs are required to search their 
inventories for recalled products; however, GAO and VA Office of 
Inspector General (OIG) have previously reported concerns with the 
completeness and accuracy of VHA's inventory data and have made 
recommendations to improve VHA's ability to accurately identify all 
recalled products in VAMCs inventories. VA is in the process of 
responding to these recommendations. Further, while VAMCs are 
responsible for checking for and accurately identifying all implanted, 
applied, or injected tissue products subject to a recall, GAO found 
that VA and VHA conduct no oversight to ensure this is done and rely 
on VAMCs, which may have limited ability to conduct this check. For 
example, VHA officials stated that it is difficult to search for 
information on implanted tissue products, in part, because there is no 
automated search capability. VA is taking steps that may enhance its 
ability to identify tissue products after they have been used. 

VA and FDA reviewed facts GAO developed in preparing this testimony. 
VA and FDA provided technical comments, which were incorporated as 
appropriate. 

View [hyperlink, http://www.gao.gov/products/GAO-14-463T]. For more 
information, contact Marcia Crosse at (202) 512-7114 or 
CrosseM@gao.gov. 

[End of section] 

Chairman Coffman, Ranking Member Kirkpatrick, and Members of the 
Subcommittee: 

I am pleased to be here to discuss our work on the safety of tissue 
products used at the Veterans Health Administration (VHA), within the 
Department of Veterans Affairs (VA). Tissue products can be used to 
repair parts of the body, improve function and feeling, and restore 
appearance. In fiscal year 2013, approximately 59,000 tissue products 
were used to provide care to veterans at VA medical centers (VAMC). 
[Footnote 1] Some of the more commonly used tissue products by VHA are 
bone and skin grafts.[Footnote 2] Some tissue products, such as bone 
or tendon, may be permanently implanted into veterans in the operating 
room. Others, that are temporary in nature because they degrade over 
time or are absorbed into the body, may be applied or injected in 
outpatient clinics. These include skin grafts used in wound care and 
collagen injections. 

While tissue products provide valuable methods to sustain and improve 
quality of life, there are also risks that they can transmit 
communicable disease from the donor to the recipient, potentially 
resulting in severe complications.[Footnote 3] Transmissible pathogens 
can include viruses, bacteria, parasites, and fungi. The Food and Drug 
Administration (FDA), an agency within the Department of Health and 
Human Services, is responsible for regulating the manufacture of 
tissue products to help ensure that these products are safe and to 
prevent disease transmission. 

VHA, which oversees all VAMCs, considers tissue products to be a type 
of surgical implant for purchasing purposes.[Footnote 4] VHA defines 
these as prosthetics, which include all items that support or replace 
a body part or function. At recent hearings before this subcommittee, 
concerns were raised about VA's oversight of surgical implant 
purchases and the agency's ability to identify veterans who received 
an implant that is being recalled by the manufacturer or FDA. My 
remarks today will address the following two areas: (1) whether VHA 
received tissue products that may have been contaminated and (2) VHA's 
safeguards to prevent the receipt and use of contaminated tissue 
products, including VHA's ability to ensure the quality of its vendors 
and to respond to recalls of tissue products. 

My remarks today are based on information we collected through 
reviewing agency documents and interviews with VA, VHA, and FDA 
officials. Specifically, to examine evidence related to possible 
receipt of contaminated tissue products, we reviewed VHA's analyses of 
purchasing data from its National Prosthetics Purchasing Database 
(NPPD) and NPPD data on tissue products used for treatment of 
veterans. We also reviewed VHA's and FDA's analyses of data on recalls 
and reported adverse events related to tissue products, including 
outcomes of these events. To determine the actions VHA takes to 
prevent the use of contaminated tissue products, we interviewed VA and 
VHA officials and reviewed documentation on VA's processes and 
requirements related to tissue product safety. For example, we 
reviewed certain aspects of VHA's oversight of and purchasing from 
tissue product vendors, such as whether VHA requires its vendors to 
have an active registration with FDA. We also reviewed VHA's tracking 
of, and response to, manufacturer recalls of tissue products. In 
addition, we interviewed officials from the VA's Office of Inspector 
General (OIG) regarding its related work on this topic. Our work 
focused on the policies and procedures at the VA and VHA level. Our 
work did not focus on VAMCs, though VAMCs may have their own policies 
and procedures, such as those related to purchasing and responding to 
recalls. 

To assess the reliability of the data used to prepare this statement, 
we gathered information from VHA and FDA on their data collection 
methods, including controls used to help ensure the data recorded is 
accurate and complete. We recently reported that NPPD data has some 
inconsistencies and errors that are attributable to data entry errors 
and omissions.[Footnote 5] In our work for this statement, we also 
found data errors in NPPD data on VHA's tissue product vendors, such 
as missing or incorrect values. These errors could affect the accuracy 
of VHA's reports of its tissue product purchases made through 
contracts with vendors and purchases made on the open market.[Footnote 
6] However, NPPD data represent the best information available and are 
the data VHA relies on to determine the vendors it uses and to manage 
its purchasing. As a result, we found that these data were 
sufficiently reliable for our use in preparing this statement. 

We conducted this performance audit from January 2014 to April 2014 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

We shared the information we used to prepare this statement with VA 
and FDA. After reviewing this information, VA and FDA provided us with 
technical comments, which we incorporated as appropriate. 

Background: 

VHA operates one of the largest health care delivery systems in the 
United States, providing care to more than 6 million veterans 
annually. Its health care system includes 151 VAMCs nationwide that 
offer a variety of outpatient and inpatient services, ranging from 
routine examinations to complex surgical procedures. VHA also provides 
outpatient care at more than 800 community-based outpatient clinics. 

Like other health care providers, VHA relies on FDA to regulate the 
manufacture of tissue products to help ensure the safety of such 
products marketed in the United States. Depending upon whether the 
tissue product is derived from a human tissue or an animal tissue, 
different FDA regulations apply. 

* Human tissue products: FDA generally regulates human tissue products 
under a regulation specific to human cells, tissues, and cellular and 
tissue-based products.[Footnote 7] Establishments that manufacture 
human tissue products must register annually with FDA and submit a 
list of each type of human tissue product manufactured.[Footnote 8] 
FDA regulations include requirements for human tissue establishments 
to screen and test potential tissue donors for relevant communicable 
disease agents and diseases, report certain adverse events involving a 
communicable disease, and follow current good tissue practice 
requirements.[Footnote 9] Some human tissue establishments may also 
manufacture products regulated as drugs, devices, or biological 
products that would be subject to additional regulatory requirements 
including premarket review, and the adverse event reporting 
requirements specific to those products.[Footnote 10] FDA conducts 
inspections of foreign and domestic human tissue establishments to 
ensure they are in compliance with applicable regulations.[Footnote 11] 

* Animal tissue products: FDA generally regulates tissue products 
derived from animals under its medical device regulations.[Footnote 
12] Similar to human tissue establishments, device establishments must 
register annually with FDA and submit a list of each product 
manufactured, report certain adverse events that may have been caused 
or affected by use of one of its devices, and follow current good 
manufacturing practice requirements.[Footnote 13] FDA inspects certain 
foreign and domestic device establishments to ensure they meet 
required manufacturing standards.[Footnote 14] Similar to human tissue 
products regulated as devices, animal products regulated as devices 
also must meet certain premarket review requirements.[Footnote 15] 

VHA Data Do Not Show Evidence of Contaminated Tissue Products, 
Although Attributing Adverse Events to Tissue Product Contamination Is 
Difficult: 

While there have been thousands of tissue products used at VAMCs, VHA 
data do not show evidence of VHA receiving contaminated tissue 
products. However, it is difficult to attribute adverse events to 
tissue product contamination. VA's National Center for Patient Safety 
(NCPS) issues patient safety alerts, patient safety advisories, and 
recalls to notify VAMCs of possible receipt of unsafe or defective 
medical products, including tissue products. NCPS, which began 
operation in 1999, has not issued any patient safety alerts--mandates 
for action to address actual or potential threats to life or health--
or advisories--guidance to address issues such as equipment design and 
product failure--related to tissue products in the last 10 years, 
according to NCPS officials.[Footnote 16] NCPS issues patient safety 
alerts or advisories for recalls that require specific clinical 
actions to ensure patient safety. Since NCPS began issuing and 
recording data on recalls in November 2008, it has notified VAMCs of 
13 recalls through September 2013 for tissue products from vendors 
from which VHA could have received the affected products--none of 
these recalls have resulted in patient safety alerts or advisories. 
[Footnote 17] Each of these recalls could represent the recall of just 
one product, multiple products, or all products processed within a 
specific date range from a particular vendor. After NCPS issues 
recalls, it receives reports from VAMCs on whether recalled products 
were identified in their inventories--VAMCs do not report to NCPS if 
any products were used. Of the 13 recalls, 6 resulted in 27 VAMCs 
reporting back to NCPS that they had identified and removed the 
recalled products from their inventories. For the other 7 recalls, no 
VAMCs indicated that they had the affected products in their 
inventories. None of the 13 recalls were issued for known tissue 
product contamination. Instead, most were initiated because of the 
possibility of contamination for reasons such as compromise of product 
sterility, tissue recovered from donors with risk factors for 
communicable diseases, incomplete donor records, or manufacturers 
suspected to have deviated from FDA's current good manufacturing 
practices.[Footnote 18] 

Further, VHA officials told us that their analysis of VHA data found 
no evidence of reported adverse events among VHA patients that were 
caused by contaminated tissue products. Specifically, NCPS officials 
stated that they searched the NCPS Patient Safety Information System 
database, commonly known as "SPOT," which did not yield any evidence 
of proven adverse events being caused by tissue product contamination. 
SPOT contains root cause analysis reviews (investigations conducted by 
VAMCs to evaluate the system or process causes of reported adverse 
events) and patient safety incident reports (patient safety-related 
adverse events reported to NCPS).[Footnote 19] Collectively, NCPS 
officials stated that their search of SPOT encompassed nearly 1 
million records over more than 11 years. 

Nonetheless, it is also important to note that it is difficult to 
determine whether adverse events are caused by contaminated tissue 
products. FDA officials told us that it is often not possible to 
definitively attribute post-surgical infections to a tissue product, 
despite thorough investigations of reported adverse events. FDA noted 
that there may be multiple possible causes of an adverse event, given 
the several potential sources of infection (e.g., the patient, the 
clinical setting, or the medical product itself). FDA also pointed out 
that infections following surgical procedures often occur, even in the 
absence of tissue use. Adverse events specifically caused by 
contaminated tissue appear to be rare nationwide. Of the approximately 
850 reported adverse events potentially related to human tissue 
products received by FDA between January 1, 2006, and June 30, 2013, 
FDA informed us of 2 cases where infection could reasonably be 
attributed to the tissue product.[Footnote 20] 

VA Does Not Ensure Vendors are Registered with FDA; VHA's 
Identification of Recalled Tissue Products May Be Limited, Although 
Recent Actions May Help: 

VA relies on FDA's oversight of tissue vendors, but VA and VHA 
policies do not require that staff check tissue vendors' FDA 
registration status for most purchases. VHA's ability to track 
recalled tissue products may be limited by poor inventory management 
practices. We and VA OIG previously have reported similar concerns 
with VHA's inventory management practices and have made 
recommendations to improve VHA's ability to accurately identify all 
recalled products in VAMCs' inventories. Although VAMCs are 
responsible for checking for all implanted, applied, or injected 
tissue products subject to a recall, VA and VHA have no oversight to 
ensure this is done. VAMCs' ability to conduct this check may be 
limited, but VA has taken steps that may enhance its ability to 
identify tissue products after they have been used. 

VA Relies on FDA Oversight of Tissue Vendors but Does Not Ensure Its 
Vendors Are Registered with FDA: 

The VA and VHA policies we reviewed suggest that VA and VHA do not 
require staff to check tissue vendors' FDA registration status for 
most types of purchases, despite VHA's reliance on FDA's oversight of 
tissue establishments to ensure the quality of the tissue products the 
agency receives. In addition, VA does not conduct additional oversight 
of its own.[Footnote 21] Registration is important to ensure that 
tissue establishments are subject to proper federal oversight. This 
oversight includes, for example, FDA inspections to determine 
compliance with regulatory requirements pertaining to tissue product 
safety, such as testing and screening donors for communicable 
diseases. It is important to note that, according to officials, VA's 
vendors could include some distributors who are not required to 
register with FDA because they never take physical possession of 
tissue products. VHA has no policies requiring purchasing staff to 
check whether these distributors are supplying tissue products from 
registered tissue establishments. When discussing their purchasing 
requirements, VA and VHA officials told us that: 

* The majority--51 percent--of tissue product purchases were open-
market purchases below the Federal Acquisition Regulations (FAR) micro-
purchase threshold of $3,000 in fiscal year 2013; pursuant to VHA's 
purchasing processes, these purchases are made by local VAMC 
purchasing staff.[Footnote 22] VHA officials told us that the agency 
has no policies requiring VAMC purchasing staff to check whether 
tissue vendors are registered with the FDA when making these purchases. 

* VHA likewise does not require VAMC purchasing staff and contracting 
officers to check FDA registration status of the tissue product vendor 
for open-market purchases over $3,000. Such purchases are rare--just 6 
percent of VHA's fiscal year 2013 tissue product purchases were open-
market purchases over $3,000. 

* Finally, VHA can also purchase tissue products through national, 
regional, or local contracts, including national-committed use 
contracts and Federal Supply Schedule (FSS) contracts.[Footnote 23] Of 
VHA's fiscal year 2013 tissue product purchases, 40 percent were FSS 
purchases below $3,000 and 2 percent were FSS purchases greater than 
$3,000.[Footnote 24] VA officials stated that before issuing an FSS 
contract they check vendors' FDA registration status for medical 
devices and drugs, which may include some tissue products. However, 
there is no policy requiring staff to check a vendor's FDA 
registration status for other tissue products, such as those regulated 
under FDA's human tissue regulations. Purchases under other contracts, 
such as regional or local contracts are rare--less than 1 percent of 
purchases in fiscal year 2013--and VHA has no requirements to check a 
vendor's FDA registration status for these purchases. 

However, VHA officials stated that these data may undercount the 
number of purchases made under a contract, because NPPD does not 
require staff to enter contract information when recording purchases 
in the database. For VHA's tissue product purchases by purchase type 
see figure 1. 

Figure 1: Veterans Health Administration (VHA) Tissue Product 
Purchases in Fiscal Year 2013: 

[Refer to PDF for image: pie-chart] 

Purchases less than or equal to $3,000 made through the open market: 
51%; 
Purchases less than or equal to $3,000 made under an FSS contract[A]: 
40%; 
Purchases more than $3,000 made through the open market: 6%; 
Purchases more than $3,000 made under an FSS contract: 2%; 
All purchases under non-FSS contracts, such as regional or local 
contract purchases[B]: 1%. 

Source: GAO analysis of data provided by VHA from its National 
Prosthetics Purchasing Database (NPPD) for fiscal year 2013. 

Note: According to VHA, these data may undercount the number of 
purchases made under a contract, because NPPD does not require staff 
to enter contract information when recording purchases in the 
database. This was the best data available from VHA at the time we did 
our work. 

[A] Federal Supply Schedule (FSS) contracts are national level 
contracts negotiated by the Department of Veterans Affairs National 
Acquisitions Center. 

[B] This includes all purchases under non-FSS contracts--both those 
above and below $3000. 

[End of figure] 

VHA's Ability to Track Recalled Tissue Products May Be Limited by Poor 
Inventory Management Practices: 

In the event of a recall, NCPS informs VAMCs, which check their 
inventories for the recalled items; however, in the past we and VA OIG 
have reported concerns with VA's inventory management practices. 
[Footnote 25] According to VHA policy, VAMCs must have a program for 
responding to recalls that includes identifying numbers and locations 
of tissue products at the VAMCs. To ensure products are removed, VAMCs 
are required to report the results of these inventory searches to 
NCPS--which manages recalls for VHA and documents recalled products 
found in VAMC inventories in VHA's recall database. 

However, VAMC inventory searches may be limited by poor inventory 
management practices. For example, in May 2011, we reported that VA 
may lack complete information about expendable medical supplies and 
reusable medical equipment in its inventories.[Footnote 26] In the 
event of a manufacturer recall or patient safety alert for such items, 
VAMCs may be unable to use their inventory management systems to 
systematically determine whether the affected items are in their 
facilities. Instead, they may need to resort to a physical search, 
which could miss items, creating the risk that recalled products could 
be used in patient care. This is consistent with findings of our 
previous work related to VAMCs' poor inventory management practices. 
In our 2011 report, we recommended that VAMCs be required to enter 
information about all expendable medical supplies and reusable medical 
equipment into an appropriate inventory management system.[Footnote 
27] To address deficiencies we identified, VHA issued new requirements 
in 2011 for the management of medical supplies and equipment in VAMCs 
inventories. However, in 2013 we again reported that none of the VAMCs 
we reviewed had fully complied with all of VHA's new requirements for 
managing inventories, and that VAMC inventories were still incomplete. 
We additionally recommended that VAMCs ensure that medical supplies 
and equipment are tracked in the appropriate inventory management 
system and VA concurred with our recommendation and described specific 
actions that it plans to take to improve VMACs' compliance with VHA's 
new requirements for managing inventories, such as providing training 
to VAMC staff.[Footnote 28] If these recommendations are effectively 
implemented, it will help improve VA's overall inventory management 
practices. 

Similarly, in March 2012, VA OIG reported concerns that VHA's 
prosthetics inventory data--which includes tissue products--are 
incomplete and inaccurate.[Footnote 29] VA OIG officials reported that 
VAMCs should use an automated inventory system--the Prosthetics 
Inventory Package--to manage certain prosthetic inventories including 
tissue products.[Footnote 30] However, VA OIG told us that the few 
tissue products found at the VAMCs they inspected were tracked in 
inventory spreadsheets or logs, rather than through the Prosthetics 
Inventory Package. These informal tracking systems are maintained by 
clinical staff in the operating room and are therefore not 
standardized or shared across VAMCs. They are prone to error due to 
manual entry, thus making accurate identification of all recalled 
products and oversight of VAMCs' actions more challenging. In 
addition, when conducting the work for this statement, VA officials 
told us that NCPS would not notify VAMCs of recalls in certain 
situations; for example, if FDA reports that the recalled product is 
expired at the time of reporting and thus should no longer be in VHA's 
inventory. However, VA OIG also found that expired products often 
remain on VAMC's inventory shelves, which suggests that they may 
retain expired products that have been recalled. VA OIG recommended 
that VAMCs be required to conduct comprehensive physical inventories 
of stocked prosthetics supplies and adjust the Prosthetics Inventory 
Package to match inventory quantities. It also recommended that the 
Prosthetics Inventory Package be replaced with a comprehensive modern 
inventory system and a mechanism be established to identify surgical 
device implants stored in VAMC inventories. VA concurred with these 
recommendations. According to VA OIG, VA completed its physical 
inventory in June 2012 and plans to have a comprehensive inventory 
system in place in March 2015. VHA's development of a mechanism to 
identify surgical device implants in inventories is in process. 
[Footnote 31] 

Although NCPS tracks and responds to recalls, NCPS does not track 
warning letters, which notify vendors of violations found during 
inspections, including conditions that could lead to tissue 
contamination.[Footnote 32] VA officials stated that they do not track 
warning letters because they are intended to give vendors an 
opportunity to take voluntary corrective action before FDA initiates 
an enforcement action and do not necessarily provide information on 
specific tissue products. For example, in 2012, FDA issued a warning 
letter to a vendor used by VHA that outlined problematic inspection 
results including conditions that could result in accidental exposure 
of tissue products to communicable diseases. NCPS officials explained 
that they did not receive this FDA warning letter, and would not 
expect to, as there is no recall action indicated in these letters. 

Identification of Recalled Tissue Products Already Implanted, Applied, 
or Injected May Be Limited, but VA Is Taking Steps That May Improve 
Its Ability to Identify Such Products: 

VAMCs are responsible for checking for and accurately identifying all 
tissue products subject to a recall that have been implanted, applied, 
or injected. However, VA and VHA conduct no oversight to ensure this 
is done. While we did not review policies and procedures that may 
exist at individual VAMCs, our work suggests that VAMCs' ability to 
check for implanted, applied, or injected tissue products may be 
limited. NCPS officials told us that, unlike tissue products stored in 
VAMCs' inventories, NCPS is not responsible for managing and 
documenting recalls of tissue products that have been used and does 
not require VAMCs to report back the results of their search for these 
tissue products. Rather, according to officials, each VAMC is 
responsible for ensuring it tracks the recalled products to individual 
patients. However, there is no oversight at the VA or VHA level to 
make certain that VAMCs are indeed conducting this check. In addition, 
VHA officials stated that it is difficult to search for this 
information. For example, although VAMC operating room staff have been 
required to include the serial and model numbers of the tissue 
products used in the surgical patient records since 2011, VHA 
officials told us that there is no way to automatically search these 
data. Consequently, according to VHA officials, VAMCs generally rely 
on tissue product vendors to provide information on the medical 
facilities that have received recalled tissue products and staff must 
check individual patients' records to verify the vendor's information. 
Further, the quality of the data on tissue products recorded in the 
surgical patient records--which is entered manually by clinical staff--
has not been assessed. It also does not include information on tissue 
products used in outpatient settings, such as skin grafts--one of VA's 
more commonly used tissue products. VHA's National Prosthetics 
Purchasing Database--NPPD--contains the serial and model number of 
prosthetics used for individual patients, including tissue product 
implants; however, VHA officials told us that NPPD is not used to 
track patients with implants in the case of a recall, but is generally 
used for purchasing and accounting purposes. Additionally, we recently 
reported that NPPD data was often found to be incomplete or incorrect. 
[Footnote 33] 

VA is taking steps that may enhance its ability to identify implanted, 
applied, or injected tissue products at VAMCs. VHA began developing a 
system, the Veterans Implant Tracking and Alert System (VITAS), in 
2008. VITAS provides a means to track and retrieve identifying 
information--including the serial and lot number--of surgical implants 
placed in patients, including tissue products. VITAS's development was 
temporarily suspended due to data-reliability challenges stemming from 
inaccurate or missing entries in NPPD and interoperability challenges 
between VITAS and other VHA systems. However, VA officials told us 
that they plan to fund further development of VITAS in fiscal year 
2014. In addition, VHA officials told us that they have established a 
working group to determine the feasibility of utilizing scanning and 
tracking technology to automatically upload tissue product implant 
information into electronic patient medical records.[Footnote 34] 
Scanning a universal code on a tissue product can reduce errors in 
tracking implants; for example, those that occur when transcribing 
this information into patient records by hand. In addition, FDA issued 
a final rule on September 24, 2013, to establish a system to identify 
devices through distribution and use. The rule requires the label of 
medical devices to include a unique device identifier (UDI) in plain 
text and in a form that uses automatic identification and data capture 
technology, such as a bar code scanner. This rule applies to tissue 
products regulated under FDA's medical device regulations, and could 
help with the identification of these products both before and after 
they have been used.[Footnote 35] 

Chairman Coffman, Ranking Member Kirkpatrick, and Members of the 
Subcommittee, this completes my prepared statement. I would be pleased 
to respond to any questions that you may have. 

GAO Contact and Staff Acknowledgments: 

If you or your staff have any questions about this testimony, please 
contact me at (202) 512-7114 or crossem@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this statement. GAO staff who made key 
contributions to this statement include Geri Redican-Bigott, Assistant 
Director; Emily Binek; Deirdre Brown; Sandra George; and Cathleen 
Hamann. 

[End of section] 

Footnotes: 

[1] For purposes of this testimony we refer to VAMCs to include the 
associated outpatient clinics. 

[2] Other types of tissue products used by VHA include cartilage, 
collagen, connective tissues, heart valves, ocular tissues, and 
tendons. While tissue products can be derived from humans or animals, 
the majority of the tissue products used by VHA are derived from 
humans. Human tissue products that are derived from living or deceased 
donors are known as allografts. A patient's own tissue can also be 
used for a surgical reconstruction procedure--these are known as 
autografts. Our work did not include a review of VHA's use of 
autografts. 

[3] Some tissues may be more prone to communicable disease than 
others, depending on the tissue type and processing methods used to 
prepare them for implantation, application, or injection. 

[4] VHA codes tissue products as biological implants--a type of 
surgical implant--in its National Prosthetics Purchasing Database. 

[5] GAO, VA Surgical Implants: Purchase Requirements Were Not Always 
Followed at Selected Medical Centers and Oversight Needs Improvement, 
[hyperlink, http://www.gao.gov/products/GAO-14-146] (Washington, D.C.: 
Jan.13, 2014), 31. 

[6] VA negotiates national, regional, and local competitive contracts 
with vendors for all types of items--including tissue products. Items 
that are not purchased from these contracts are referred to as open-
market purchases. 

[7] 21 C.F.R. pt. 1271. In this statement we refer to these 
regulations as FDA's "human tissue regulations." Under FDA 
regulations, the manufacture of human tissue includes the recovery, 
processing, storage, labeling, packaging, or distribution of human 
tissue, and the screening or testing of the tissue donor. 21 C.F.R. § 
1271.3(e). 

[8] 21 C.F.R. § 1271.21(a), (b). Establishments subject to these 
requirements include a place of business under one management, at one 
general physical location, that engages in the manufacture of human 
cells, tissues, and cellular and tissue-based products. 21 C.F.R. § 
1271.3(b). 

[9] Current good tissue practices are intended to ensure that tissue 
products do not contain communicable disease agents, are not 
contaminated, and do not become contaminated. They include 
requirements related to tissue storage and distribution, labeling, 
record keeping, and tracking tissue products from the donor to the 
consignee. 21 C.F.R. § 1271.150. 

[10] 21 C.F.R. § 1271.1(b)(2). 

[11] FDA conducts inspections of human tissue establishments based on 
available resources and uses certain risk-based priorities when 
determining which establishments to inspect. In fiscal years 2012 and 
2013, FDA inspected 592 and 671 establishments regulated under its 
human tissue regulations, respectively. FDA officials stated that, due 
to data constraints, the agency could not determine if all 
establishments regulated under its human tissue regulations had an 
inspection. Human tissue establishments that are also regulated under 
FDA's drug, device, or biologics regulations are subject to inspection 
requirements under those provisions. 21 C.F.R. § 1271.390. 

[12] 21 C.F.R. pts. 800-898. Some tissue products derived from animals 
may be regulated as drugs or biological products. 21 C.F.R. pts. 200-
499, 600-680. 

[13] A device establishment is a place of business under one 
management at one general physical location at which a device is 
manufactured, assembled, or otherwise processed. 21 C.F.R. § 807.3(c). 

[14] FDA is required to inspect domestic establishments that 
manufacture devices that meet certain risk classifications every two 
years. 21 U.S.C. § 360(h). FDA is not required to inspect foreign 
establishments on a specific schedule. 

[15] In general, unless exempt by regulation, new devices are subject 
to premarket review either through the premarket notification process, 
to determine whether a new device is substantially equivalent to 
another legally marketed device, or the more stringent premarket 
approval process, which requires the manufacturer to supply evidence 
providing reasonable assurance that the device is safe and effective. 
21 U.S.C. §§ 360(k), 360e. On January 23, 2014, FDA issued draft 
guidance related specifically to medical devices containing materials 
derived from animal sources. FDA stated that although the use of 
animal derived-material in medical devices is well established, animal 
materials may carry a risk of transmitting communicable disease when 
improperly collected, stored, or manufactured. The draft guidance 
describes the information that should be documented at the 
manufacturing facility and included in any premarket submissions to 
FDA. 

[16] Patient safety alerts or advisories are classified as such based 
on the severity and frequency of the incident. 

[17] NCPS identified recalls related to tissue products through 
September 30, 2013. The products included in these 13 recalls were 
obtained from 11 different vendors. NCPS issues recall notifications 
through VHA's Alerts & Recalls intranet database to ensure that every 
applicable facility receives them and assigns facilities to review and 
take any designated actions, such as removing the product(s) from 
inventories. NCPS does not issue notices for all recalls. According to 
officials, reasons not to issue a recall notice include FDA reports 
that the recall is complete or terminated, the vendor reports that VHA 
did not receive the affected product(s), the product at the time of 
reporting is expired, or the product was not a remove-from-use (pull 
off the shelf) recall notification. 

[18] One of the 13 recalls was initiated for reasons other than 
potential contamination. 

[19] All root cause analyses are required to be reported to NCPS. 
According to NCPS, each VAMC can submit patient safety incident 
reports to NCPS using a web-based form that is standardized across 
VAMCs. However, officials cautioned that they rely on personnel in the 
field to recognize an event as a patient safety-related adverse event 
and enter it into the system. Since it is a voluntary reporting 
system, NCPS officials said they would not feel comfortable stating 
that every adverse event that has happened in all VAMCs is represented 
in the database. In addition, the level of detail in each report is 
often not enough to say why an event happened. Besides submitting 
patient safety incident reports to NCPS, each VAMC maintains its own 
incident reporting system, which is used by VAMC staff to report 
information on adverse events. Our review did not include those 
adverse events maintained in the individual VAMC's reporting systems. 

[20] The data included those products regulated solely under FDA's 
human tissue regulations with the exception of cell therapy products 
or reproductive tissue products, which are tissue products not 
generally used by VHA. These data did not include tissue products that 
are also regulated under FDA's drug, device, or biologics regulations 
and are, therefore, subject to those regulations' adverse event 
reporting requirements. 

[21] We reviewed VA and VHA-wide policies; our review did not include 
any policies that may exist at the VAMC-level. For example, VAMCs may 
have established their own VAMC-specific purchasing policies. 

[22] The Federal Acquisition Regulations (FAR) are government wide 
regulations that establish uniform policies and procedures used by all 
executive branch federal agencies for their acquisitions. Purchases 
above $3,000 are completed through a contracting process that involves 
the VAMC purchasing staff and Networking Contract Office staff. 

[23] These national level contracts are negotiated by VA's National 
Acquisitions Center. However, VHA currently has no national committed-
use contracts for biologic implants, although other surgical implants 
could be purchased through these contracts. National committed-use 
contracts typically establish a fixed price for several models of a 
certain type of surgical implant, which VHA must use throughout its 
healthcare system. Federal Supply Schedule (FSS) contracts are 
indefinite delivery and indefinite quantity contracts awarded to 
vendors for various types of surgical implants and include some 
biologic implants, such as skin grafts. 

[24] According to VA officials, there are 9 vendors with FSS contracts 
that could supply tissue products to VA. In January 2014, we 
recommended that VA develop a plan for evaluating the benefits of 
developing more national contracts--such as FFS contracts--with 
vendors of surgical implants, which could include vendors of tissue 
products. VA concurred with this recommendation and told us that it 
plans to develop a national contract procurement package for tissue 
products by the end of fiscal year 2014. See [hyperlink, 
http://www.gao.gov/products/GAO-14-146], 26-27, 35. 

[25] NCPS learns of recalls from designated officials at the regional 
and local level; other federal agencies, including FDA and the 
Department of Defense; and tissue vendors. According to VHA Directive 
2008-080, vendors are required to notify VHA of any recalls or 
important product safety issues. VHA is required to report to NCPS any 
problems identified by its subordinate chain that may necessitate a 
recall, such as voluntary recall notices received from tissue vendors 
and observed clinical problems with tissue products. VHA is also 
required to contact NCPS should it become aware of a recall or other 
product safety information from vendors. 

[26] GAO, VA Health Care: Weaknesses in Policies and Oversight 
Governing Medical Supplies and Equipment Pose Risks to Veterans' 
Safety, [hyperlink, http://www.gao.gov/products/GAO-11-391] 
(Washington, D.C.: May 3, 2011). 

[27] [hyperlink, http://www.gao.gov/products/GAO-11-391], 19. 

[28] GAO, Veterans Health Care: VHA Has Taken Steps to Address 
Deficiencies in Its Logistics Program, but Significant Concerns 
Remain, [hyperlink, http://www.gao.gov/products/GAO-13-336] 
(Washington, D.C.: Apr. 17, 2013), 7-8, 25. 

[29] The VA OIG report reviewed VHA's prosthetic inventory management 
practices. Department of Veterans Affairs, Office of the Inspector 
General, Office of Audits and Evaluations, Veterans Health 
Administration: Audit of Prosthetics Supply Inventory Management, 11-
00312-127 (Washington, D.C.: Mar. 30, 2012). 

[30] VA OIG 11-00312-127, 14. 

[31] VA OIG, 11-00312-127, 21-22. 

[32] FDA issues warning letters for violations of regulatory 
significance that may lead to enforcement action if not promptly and 
adequately corrected. 

[33] We reported in January 2014 that the lot number and serial number 
of items used in patients is not always entered into NPPD by 
purchasing and procurement staff, as required. In addition, this 
information must be entered manually, which has the potential to cause 
inaccuracies in information that is entered into NPPD. [hyperlink, 
http://www.gao.gov/products/GAO-14-146], 33. 

[34] Officials also cited another recent change noting that as of 
January 24, 2014, this tissue implant data from the medical records 
can be captured in VHA's Corporate Data Warehouse, which would allow 
these data to be extracted and searched at a national level. However, 
access to the data is permission-based, and while VHA officials said 
the data could be searched at a national level, there are currently no 
VHA policies in place for VHA or VAMC staff to search the database 
during a recall. 

[35] This rule does not apply to products subject only to FDA's human 
tissue regulations. These requirements will be phased in over a 7-year 
period; however, the labels and packages of implantable, life-
supporting, and life-sustaining devices must bear a UDI within 2 
years. 78 Fed. Reg. 58786 (Sept. 24, 2013). 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation, and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the 
performance and accountability of the federal government for the 
American people. GAO examines the use of public funds; evaluates 
federal programs and policies; and provides analyses, recommendations, 
and other assistance to help Congress make informed oversight, policy, 
and funding decisions. GAO's commitment to good government is 
reflected in its core values of accountability, integrity, and 
reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's website [hyperlink, http://www.gao.gov]. Each 
weekday afternoon, GAO posts on its website newly released reports, 
testimony, and correspondence. To have GAO e-mail you a list of newly 
posted products, go to [hyperlink, http://www.gao.gov] and select 
"E-mail Updates." 

Order by Phone: 

The price of each GAO publication reflects GAO's actual cost of 
production and distribution and depends on the number of pages in the 
publication and whether the publication is printed in color or black 
and white. Pricing and ordering information is posted on GAO's 
website, [hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card, 
MasterCard, Visa, check, or money order. Call for additional 
information. 

Connect with GAO: 

Connect with GAO on facebook, flickr, twitter, and YouTube.
Subscribe to our RSS Feeds or E mail Updates. Listen to our Podcasts.
Visit GAO on the web at [hyperlink, http://www.gao.gov]. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 
Website: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]; 
E-mail: fraudnet@gao.gov; 
Automated answering system: (800) 424-5454 or (202) 512-7470. 

Congressional Relations: 

Katherine Siggerud, Managing Director, siggerudk@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, DC 20548. 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, DC 20548. 

[End of document]