By Sandra Basu
WASHINGTON — VA policies do not require staff to check the Food and Drug Administration status of its tissue vendors for most types of purchases, even though FDA registration ensures the quality of the provider.
That was one of the conclusions of a Government Accountability Office (GAO) performance audit discussed at a recent congressional hearing. Overall, the GAO reported “poor inventory management practices by VA,” and noted that VA’s National Center for Patient Safety (NCPS), which began in 1999, has not issued any patient safety alerts or advisories related to tissue products potentially received by VAMCs in the last decade.
“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% of the tissue products procured with purchases made from several hundred vendors,” GAO Director for Heath Care Marcia Crosse told lawmakers.
While VA purchasers must check the FDA vendor registration status for tissue products regulated as medical devices, there is no policy requiring staff to check it for products regulated under FDA’s human tissue regulations, Cross explained. FDA registration ensures that vendors meet federal standards, such as screening donors for communicable diseases, she added.
Crosse’s comments came at a hearing before a House Veterans Affairs subcommittee on the oversight of VA tissue product safety. In FY 2013, approximately 59,000 tissue products were used to provide care to veterans at VAMCs, most commonly bone and skin grafts, according to GAO.
“The six million veterans served annually by VHA deserve the highest standards of patient care in the nation,” subcommittee chairman Rep. Mike Coffman, (R-CO) said at the onset of the hearing.
Crosse said that VHA told GAO that the agency’s data does not show evidence of VHA receiving contaminated tissue products from vendors. When post-surgical infections occur, however, it is not always possible to definitively link them with tissue products, she said.
Furthermore, when a recall for a product does happen, Crosse explained that VHA’s ability to identify and track recalled tissue products in its inventory is limited.
“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,” she said.
Crosse also told lawmakers that it may be difficult for medical centers to track whether a recalled tissue product has been used in patients, in part because there is no automated capability to do a search.
“So someone must go through each patient record to determine whether they had a relevant product implanted,” she explained.
Product information for surgically implanted tissue products are entered manually into medical records, leaving room for error, she pointed out, suggesting scanning a universal code could reduce errors in tracking implants.
Lawmakers agreed that barcode technology would allow product information to be automatically scanned without manual entry and could help simplify tracking products. Rep. David Roe (R-TN) pointed out that the technology is even used by grocery stores.
“Harris Teeter [grocery store] knows when I walk in and buy a box of cereal what I bought. … It should be fairly easy to do that. That’s not new technology,” he said.
Meanwhile, VA Assistant Deputy Undersecretary for Health Philip Matkovsky told lawmakers that improvements to tracking and management of tissue products are under way. He said that VA plans to deploy an automative tracking system for biological implants similar to the automation system it has been using for blood bank requirements.
The timeframe for the automation system will hinge on recommendations from a VHA work group established to identify improvements to management and control of biological implants, he said.
“We do expect their recommendations in the third quarter. Some of what we will have to do will require an interface to VistA CPRS (Computerized Patient Record System). Those interfaces to VistA will have to be an IT funded requirement,” he said.
In written testimony, Matkovsky also explained that a work team has been charged with developing a set of new national contracts for biological implants.
“We fully expect our new procurement packages to establish more stringent quality standards than previous schedule contracts,” he explained.
Also testifying was Frank Wilton, chief executive officer of the American Association of Tissue Banks, who told lawmakers that his organization supports a draft bill that directs the VA secretary to adopt a standard identification system for use in the procurement of biological implants by VA.
“This critical capability for ‘track and trace’ efforts will enhance patient safety, expedite product recalls when necessary, assist with inventory management, and improve efficiencies,” Wilton testified in a written statement.
A facility-specific survey found that 138 of 140 VA facilities reported shortages of medical officers, with psychiatry and primary care positions being the most frequently listed.
When Terrence O’Neil, MD, retired as chief of nephrology at the James H. Quillen VAMC in Johnson City in December 2016, he left in his wake decades of work treating kidney disease—nearly 35 years in the Air Force and DoD, plus 11 more at VA.