A Department of Veterans Affairs official on Wednesday denied claims made by government investigators that representatives for companies doing business with the VA assisted in medical procedures at a VA medical facility.
Dr. Thomas Lynch, assistant deputy under secretary for health clinical operations, said the VA was able to determine that a vendor assisted in the changing of a dressing for a skin graft, but it did not occur in the operating room.
"Regardless of where it occurred, or the circumstances, it should not have occurred," Lynch told members of the House Veterans Affairs subcommittee on oversight and investigations. "I think this was an outlier, but we have to make sure it doesn't happen again."
The incident was revealed in a report by the Government Accountability Office, Congress' watchdog, which looked into such allegations at three VA medical centers. The GAO report said that vendors of biological implants actually took part in medical procedures at the hospitals -- unidentified in the report -- in some cases because the facility "lacked available clinical staff to provide the assistance."
Randall B. Williamson, director for health care at GAO, testified to lawmakers that the vendors with skin grafts and also observed implant procedures in the operating room.The VA's Office of the Inspector General has taken up the allegations made in the GAO report and is conducting its own investigation.
VA hospitals allow vendor reps in the operating room to observe or consult under certain conditions, but the patient must grant consent in advance. To allow the vendor in without patient consent would violate the veteran's privacy, Rep. Mike Coffman, R-Colo., subcommittee chairman said.
Lynch said that if the IG turns up evidence of any breach in the law "people will be held accountable."
The GAO report, which looked at four medical centers between February 2013 and January 2014, also hit the VA in two other areas dealing with biologics, including such things as artificial hips and pacemakers.
One is a continuing problem with failing to record tracking information -- lot and serial numbers -- of implants into a patient's medical records. This makes it difficult to track which product has been implanted into particular patients if there is an alert or recall. The VA's IG raised the same issue in 2007 and again in 2012.
A plan initiated in 2008 to track implants was suspended in September 2012 because of data-reliability problems stemming from inaccurate or missing entries in the prosthetics purchasing system and interoperability issues between the tracking system and the Veterans Health Administration.
Some lawmakers pressed VA officials on why barcode information is not recorded on any device going into a veteran, so it can be tracked. Officials said VA does not have that capability.
The VA said it currently addresses this issue by recording specific device information into a patient's medical records. For word of specific alerts or recalls, it depends on the National Center for Patient Safety.
The VA also insisted during the hearing that has made significant progress in reforming its system for procuring biological implants, which it had reportedly been paying millions more for because VA purchasing officials were often not using Federal Supply Schedule contracts.
In 2012, following reports that VA purchasing officials were buying products often without securing competitive bids, the VA pulled more than 1,100 warrants that authorized non-contracting staff to procure implants for VA facilities
Philip Matkovskey, assistant deputy under secretary for health for admin operations, said VA is updating and finalizing a new policy on prosthetic purchases, including implants that will provide more comprehensive and clear guidance to its buyers.
The GAO, in its report, said none of the four medical centers it looked at complied with VA requirements governing procurement of implants.
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