Investigator Finds Flaws in HIV tests at VA CenterMarch 12, 2018 |
by Daniel Chang, Associated Press
MIAMI — At least eight military veterans who were tested for HIV at the Miami VA Medical Center received a different result when they were screened for a second time by an outside lab — a discrepancy discovered only after an employee at the Miami facility complained to outside agencies and the White House that local managers were ignoring his concerns, according to an independent federal investigator.
The Department of Veterans Affairs investigated the complaints and said it was unable to substantiate the employee’s claims after a four-day visit to the Miami VAMC in October 2016.
On Wednesday the U.S. Office of Special Counsel, an independent federal investigative agency, called the VA’s findings “unreasonable” and expressed “incredulity” that the Miami VAMC complied with new HIV testing policy only after the employee complained to outside agencies.
In a letter to President Donald Trump, Special Counsel Henry J. Kerner said VA investigators were unable to substantiate the claims because they loosely interpreted the deadline for the Miami VAMC to comply with the new HIV testing policy.
Kerner added that Miami VAMC officials failed to respond to concerns raised by the employee, Roman Miguel, a lab director, until after Miguel complained to the OSC in May 2016 and hand-delivered a notice to Miami VAMC Director Paul Russo on June 30, 2016.
“I am incredulous that compliance with Directive 1113 (the policy) and implementation of fourth generation HIV testing occurred only after Mr. Miguel’s disclosures and OSC’s intercession,” Kerner wrote in the letter.
Kerner noted that the OSC also asked VA Secretary David Shulkin to report on whether all of the agency’s medical facilities around the country were using the latest HIV testing procedures as required by the 2015 policy.
Shane Suzuki, public affairs officer for the Miami VA Healthcare System, which oversees the medical center, said administrators “strongly disagree” with the OSC’s allegations.
“As VA mentioned in its formal response provided to the OSC in January 2017, we did not substantiate any of the allegations; rather, VA confirmed compliance with VA and CDC recommendations and did not validate a public health risk,” Suzuki said in a written statement. “A comprehensive review of patients revealed they were tested under the appropriate CDC-approved alternative HIV testing procedures pending the receipt and installation of new laboratory equipment.”
The new HIV testing policy, known as Directive 1113, was implemented in May 2015 and involves general processes and programs for HIV testing as part of the VA’s routine medical care. It includes guidance from the Centers for Disease Control and Prevention for recommended and alternate testing sequences that updated the standard used since 1987.
Each VA medical facility is required to establish a written testing policy, and to follow requirements and processes for obtaining oral consent for HIV testing. The policy also details procedures for performing HIV tests and establishes timely notification of results in order to link newly diagnosed patients with the appropriate medical care.
But the VA’s investigation identified eight veterans whose HIV test results from outside labs differed from the Miami VAMC’s test results, including one patient who was deemed “high risk” for HIV and tested positive for the virus after follow-up screening.
In a second case, the Miami VAMC tried at least five times between June and December 2016 to contact a veteran with differing HIV test results. Eventually, the veteran returned for repeat screening and tested positive for HIV. The remaining six veterans with differing results returned to the Miami VAMC for retesting and were negative.
It’s unclear how many HIV tests from the Miami VAMC were sent to an outside lab. But the VA’s investigative report notes that the eight cases identified were produced by the Miami VAMC in response to the agency’s request for all differing test results from Oct. 1, 2015 to Oct. 11, 2016.
Reached by phone on Wednesday, Miguel said he was unaware of the OSC’s letter to the president and unprepared to comment. But he added that Miami VAMC administrators had taken steps to ensure the integrity of the facility’s HIV testing process.
“I’m happy that this came out,” Miguel said, “because it’s for the best of the patient. That’s what we want to do here. We try to give the patient what they need.”