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Congress Questions VA on Tissue Used in Surgeries

Packaged human tissue seized from a Ukraine recovery facility minibus in February was labeled as having come from Germany. The mislabeling raises concerns about the origin and quality of tissue ultimately used in surgical procedures.

An investigation by a Congressional subcommittee has found that a number of Department of Veterans Affairs doctors with the ability to select where they buy bone- and tissue-based products used for surgeries also serve on the boards of at least one of the major suppliers of biologics.

The claim was made on Wednesday by Rep. Mike Coffman, R-Colo., who chairs the House Veterans Affairs Oversight and Investigations subcommittee.

"Our investigation [also] reveals that problems include VA's failure to adequately vet biological implant vendors to make sure 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," Coffman said.

Philip Matkovsky, assistant deputy undersecretary for health and administrative operations at the VA, was not directly questioned about the alleged conflicts of interest and made no reference to it in his own remarks.

But Matkovsky did offer a defense of the VA, saying it has no evidence that vendors from which it has bought biologics were not registered with the FDA. While the VA relies on FDA oversight of tissue vendors, VA policies do not require that its own employees check a vendors' FDA registration status for most purchases, according to the General Accountability Office.

VA's procurement process for biologics, which it has categorized as a prosthetic, has been under fire from lawmakers for several years. Military.com reported May 2012 that the department was overspending on biologics by millions of dollars each year by giving its purchasing agents pretty much a free hand on procurements. Buyers were able to go outside the Federal Supply Schedule of contractors.

Under pressure from Congress, the VA has been tightening up the purchasing system.

Late last year, Matkovsky told lawmakers on Wednesday, the VA pulled purchasing warrants from staff that were not contracting officers -- which is where the wasteful spending was occurring.

Meanwhile, he said VA is continuing to find better ways to source, manage and control biologics and is also developing a set of new national contracts for their procurement.

"We fully expect our new procurement packages to establish more stringent quality standards than previous schedule contracts," Matkovsky said. "We anticipate the solicitation phase of these new procurement actions to be initiated prior to the end of FY 2014."

A bill now being drafted, the "Biological Implant Tracking and Veteran Safety Act of 2014," will require the VA to adopt a standard identification system for biological implants and tissue or bone grafts. This will enable the VA to track a tissue- or bone-based product from the donor to the veteran patient. The so-called Unique Device Identifier can be used to track and trace the biological product, including in the event there is an alert or recall announced for it.

Additionally, the bill will now require the VA to buy biologics from suppliers and distributors accredited by a recognized organization.

The provision was included in the bill after testimony last month by Frank Wilton, chief operating officer for the American Association of Tissue Banks -- the only such national organization.

Wilton, who was back before a House Veterans Affairs subcommittee on Wednesday, said that "with this change the VHA will be joining the ranks of leading medical centers of excellence which currently require that all tissue be sourced from AATB accredited tissue banks."

Wilton said in March that the leading private and public medical centers across the country already require that sellers and distributors of the biological products be accredited by AATB.  Wilton said AATB currently accredits more than 125 tissue banks and approximately 850 individual members. All told, he said, the banks recover tissue from more than 30,000 donors annually, which eventually is used in more than a million tissue transplants.

-- Bryant Jordan can be reached at bryant.jordan@monster.com

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