AdvaGenix, the Rockville lab that was supplying and processing COVID-19 tests for the county’s free sites, says the Maryland Department of Health (MDH) incorrectly said their laboratory permit was suspended.
On Friday the MDH ordered AdvaGenix to stop processing COVID-19 tests. The MDH said that federal and state investigators found “certain improper laboratory and COVID-19 testing procedures that endanger patient health, safety, and welfare” within the lab.
The order also said that AdvaGenix is prohibited from conducting testing “until OHCQ lifts the suspension of AdvaGenix’s laboratory permit.” The Office of Health Care Quality (OHCQ) is an agency within the MDH.
In an email to MyMCMedia, AdvaGenix Spokesperson Claire Bischoff said the order was incorrect and the lab’s permit was not suspended. On Tuesday, the MDH put out an amended order with new language. Instead of saying AdvaGenix cannot do testing unless their license is reinstated, the new order says the lab must wait “until OHCQ authorizes AdvaGenix to resume COVID-19 testing.”
On Wednesday AdvaGenix CEO and Chief Scientific Officer Dr. William Kearns sent a letter to the Montgomery County Council to address the inspection as well as the erroneous order. He said the error carried consequences for the company.
“As a result of the error, the County paused testing at its clinics where residents could receive free testing. The error also caused confusion to the public, calling into question test results for more than 17,000 residents,” Kearns said.
Montgomery County announced on Tuesday that it terminated its contract with AdvaGenix after the state health department’s investigation. It had already suspended testing at county sites on Thursday while the investigation was underway.
🆕 Montgomery County has terminated its contract with AdvaGenix, the Rockville-based company that had been providing and processing COVID-19 tests for the County. Read the news release: https://t.co/ZpvXeVNCIm. pic.twitter.com/w2SWD7fT7t
— Montgomery County MD (@MontgomeryCoMD) August 18, 2020
Also in the letter, Kearns said AdvaGenix had an unscheduled inspection on Aug. 10. He said inspectors felt they needed “additional specimen validation studies.” AdvaGenix has been complying and will have the studies done soon, Kearns said.
“We have cooperated and done all that has been asked of us at every step, and are continuing to cooperate fully with federal, state, and local authorities to resolve this situation as quickly as possible.” He said AdvaGenix is also doing an in-house study to help resolve MDH concerns.
Kearns released a statement Tuesday when the county announced the contract termination.
“It’s unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question. AdvaGenix’s COVID-19 tests are safe and accurate. We have fully cooperated with federal, state, and local officials at every step in this process. AdvaGenix wants to resolve this dispute as quickly as possible and get back to the important work of helping our community,” he said.
