Lawmakers ‘Shocked’ by Surgical Implant Vendor Role in Patient Care

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By Sandra Basu

WASHINGTON — Lawmakers expressed alarm at a government report that vendor representatives were involved directly in the application of skin grafts at a VA medical center and demanded more oversight of the use, tracking and procurement of surgical implants.

“It is frankly shocking to me that this actually happened,” Rep. Dan Benishek, MD, (R-MI) said in response to testimony about a recent Government Accountability Office (GAO) report that not only found problems with surgical implant acquisitions but also cited vendor involvement with patient care as recently as last August.

“I don’t see any reason to ever have a vendor having any hands-on with a patient,” added Rep. David Roe, MD, (R-TN).

The hearing was in response to a GAO investigation finding that four VAMCs — chosen for investigation because they were geographically dispersed and had large patient volumes — did not always follow VHA requirements for documenting open-market purchases of surgical implants to ensure that a “fair and reasonable price” was paid.

The GAO report noted that spending on such items had increased to about $563 million in fiscal year 2012.

“VA and VHA must pay much better attention to patient safety concerning surgical implants,” said House Veterans’ Affairs Subcommittee on Oversight and Investigations Chairman Rep. Mike Coffman (R-CO).

The GAO also confirmed a committee investigation finding that surgical implant vendor representatives had participated in direct patient care at a VAMC.

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“We were able to affirm that, in some instances, vendors were participating in direct patient care at one of the three VAMCs we investigated, as recently as August 2013,” according to an appendix to written testimony offered by GAO Healthcare Director Randall Williamson. “At the two other VAMCs we were unable to affirm these allegations. Specifically, several clinicians at the one VAMC stated that vendor representatives applied skin grafts to patients or assisted Department of Veterans Affairs clinicians with the application of skin grafts on multiple occasions,”

The GAO did not provide any conjecture as to why this occurred but noted that a physician assistant told investigators that the vendor might have participated in direct care because the VAMC lacked clinical staff to provide such assistance. A physician who was present during the skin grafts told GAO that he did not know the official vendor policy at the VAMC, according to the report.

National Vendor Policy

Williamson told lawmakers that, to address this issue, GAO recommends that VHA develop national policy to better clearly define the role of surgical implant vendors in patient care. While VA only permits vendors to provide technical assistance during a surgical implant procedure, the GAO report explained that it also found that VHA policy governing vendor access is “broad in nature” and requires each VAMC to develop its own procedures.

“Absent definitive national guidelines, VAMCs acting alone may develop different and inconsistent guidelines in control over vendors, which is actually what we found at the three locations we investigated,” Williamson told lawmakers.

Meanwhile, Philip Matkovsky, VA Assistant Deputy Undersecretary for Health for Administrative Operations, told lawmakers that an overarching policy regarding the role of vendors is being developed.

“National policy will set the frame, local policies will derive from that, and training will be associated with those policies,” he said.

Matkovsky explained that the “presence of vendors in the operating room is a common practice in healthcare.” He told lawmakers that current VHA policy requires that physicians obtain the patient’s signature on a consent form before surgery. That form, he said, explains that “under certain circumstances the presence of a vendor is important to the success of the procedure.” He added that, while vendors may provide technical advice, they are not allowed to physically participate in a procedure.

As for GAO’s finding of vendor representatives providing direct patient care at a VAMC, Thomas Lynch, MD, VA Assistant Deputy Undersecretary for Health Clinical Operations, said that all of the details are not clear but that it appears the incident happened outside of the surgical suite, not as reported by the GAO.

“It happened outside the operating room. It happened during the course of a dressing change. It was not a skin graft. It was a skin substitute … It did not involve a physician. We believe it involved a midlevel provider,” Lynch explained.

Lynch noted that, “regardless of where it occurred, and regardless of the circumstances …, it should not have occurred.” The VA Office of the Medical Inspector has been asked to look into the matter, he said.

Prosthetics Procurement

During the hearing, VA officials also provided information about other reforms to its surgical implant program. Matkovsky told lawmakers that VHA is updating and finalizing its policy for prosthetics procurement. Once published, this new directive will provide comprehensive and clear guidance to VA medical center staff on how to appropriately order prosthetic appliances, including surgical implants and biologics, he explained.

He also said VHA has made “significant changes” in the past three years in the way it obtains surgical implants by having warranted contracting officers handle purchases of surgical implants and prosthetic appliances valued greater than $3,000.

Responding to GAO charges that the VHA is limited in its ability to identify and locate patients who have received implants, Matkovsky explained that VHA has a comprehensive recall process for surgical implants and that, at the facility level, all surgical implants are required to be tracked.

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