After Montgomery County’s main supplier of coronavirus testing was ordered to halt COVID-19 testing last month, about 3,500 test samples in the Maryland county are essentially gathering dust — they were never analyzed, the results are unknown.
And some county residents told WTOP they were never told they wouldn’t be getting their results.
It’s all part of the continued fallout from a complicated dispute between state officials and Rockville, Maryland-based AdvaGenix over the Aug. 14 state order barring the lab from processing coronavirus tests.
In May, Montgomery County made a deal with the lab, which it said would boost COVID-19 testing in the county. County Executive Marc Elrich called it “a game-changer.”
But Maryland health officials said an inspection by federal investigators last month turned up deficient practices that mean all of the lab’s test results are “erroneous or questionable.” The exact findings have not been made publicly available.
AdvaGenix argues its test results are safe and accurate and that it has already resolved the issues flagged by the inspectors, which it characterized as being caused by government red tape and other regulatory issues.
Caught in the middle are thousands of people who went to one of several walk-up testing clinics run by Montgomery County before the lab was barred from COVID-19 testing. They said they waited for test results that never came, and they’re frustrated with both the county and the lab for not notifying patients directly about any problems, or warning them they might not ever receive results.
Steven, a Montgomery County resident, said his young son was tested at a county-run clinic in White Oak on Aug. 11. He said he never received his child’s test results or any word from AdvaGenix or the county about any of the issues at the lab. He requested that WTOP not publish his last name.
“We’re very much in the dark,” he said.
‘It sort of boggles the mind’
The number of unprocessed tests caught up in the cease-and-desist order was confirmed by a source with knowledge of the lab’s operations who was not authorized to speak publicly.
Montgomery County officials weren’t aware of the exact number of people who were awaiting test results from AdvaGenix around the time the lab was ordered to cease its COVID-19 operations, according to Mary Anderson, a spokeswoman for Montgomery County’s Health Department.
In part, that’s because data on tests that were run at county-run clinics was uploaded directly to a portal controlled by AdvaGenix. That’s also why the county didn’t directly notify patients who were awaiting test results, Anderson said. The county collected some contact information, but it does not have a definitive list, she said in an email to WTOP.
Instead, she pointed out that the county sent out a news release recommending that everyone who had been tested in the two weeks before AdvaGenix testing was suspended be re-tested. That release said patients should be re-tested to “to confirm their results,” but it did not say some patients would never receive results in the first place.
Steven said he is disappointed with how the situation was handled.
“My main beef is, people should be directly communicated with,” he said, adding that he only learned of the issues with the lab through news articles.
He said he was fortunate: His son is doing fine; his symptoms resolved; and no one else in the family got sick. But, “It boggles the mind that there hasn’t been more of a response” by the county, he said.
Montgomery County Health Officer Dr. Travis Gayles said on Wednesday that the county attempted to reach patients by notifying the public to alert them to the possible need to be retested.
“We apologize for any frustrations that folks experienced in terms of the delays associated with the lab … we take full responsibility,” Gayles said during an online news briefing with other county officials.
Lab ordered to ‘immediately’ notify patients
When the state ordered the lab to halt COVID-19 testing last month, the responsibility for notifying patients was placed on AdvaGenix. Maryland Health Secretary Robert Neall’s eight-point order directed the lab to “immediately” notify all patients, whose tests the labs had processed, that their results are “erroneous or questionable” and that they should consider getting retested.
So far, those notices haven’t gone out. In a brief statement provided to WTOP, a spokesman for the lab said, “Since it was issued, we have been in communication with the state about the items contained in the order.”
In a statement provided to WTOP Wednesday night, Maryland Department of Health spokesman Charlie Gischlar said the state Office of Health Care Quality is now holding off on requiring the lab to notify all the patients it tested because state officials and the federal Centers for Medicare and Medicaid Services are reviewing “additional information” the lab submitted to inspectors.
In a letter made public last week, AdvaGenix officials told CMS that they had addressed the issues identified in the inspection.
Late last week, the lab also posted a short message on its website, reading in part:
“COVID-19 testing by AdvaGenix is temporarily on hold. We understand your concern and frustration that AdvaGenix is currently not permitted to release COVID-19 test results. We are eager to return to supporting the needs of our community and doing our part to keep the public safe and healthy. The State of Maryland advises that you consider being retested, out of an abundance of caution, if you were tested at a Montgomery County facility between June 5 – August 14, 2020.”
‘It’s hard to go on day by day with that question lingering’
But in the meantime, people were left waiting for results that never arrived.
Benny Martinez, 34, a communications professional who lives in Montgomery County, was also tested Aug. 11 and never received his test results.
Martinez said he got tested after he started feeling “a little off.” Perhaps it was just a sinus infection, he thought, but he was “a little bit paranoid” about the coronavirus since his wife was eight months pregnant.
After he was tested at the Mid-County Recreation Center in Silver Spring, he was told he would get his results via a secure encrypted email.
“As the days went by, I kept looking for that email — maybe it got caught in my spam folder or something like that,” Martinez said. “And the more and more days that went by, the more I thought, ‘Well, something’s got to be off here.’ So that’s when I started my hunt to try and figure out where my test was, what the results of it were — to no avail.”
Martinez said he doesn’t receive county-issued news releases, so he had no idea the lab’s contract had been terminated, or that the state had issued a cease-and-desist order before that. All he knew was that the delay in getting his results was starting to worry him.
“There’s a period of not knowing whether or not you’re positive because, you know, so many people are asymptomatic,” he said. “It’s hard to go on day by day with that question lingering.”
After twice calling the county’s testing helpline for answers about where his test was, Martinez said he only got a definitive answer Aug. 24: His test was “just lost,” he recalled the response he received, “and that if I wanted to get my results, I’d have to go in to one of their walk-up clinics and get another test to figure out whether or not I tested positive for COVID.”
Martinez said he never went for a follow-up test; he said he feels better now, and his wife never developed any symptoms. But he thinks the county and the lab should have done more — sooner — to proactively reach out to people who were awaiting test results.
“It would have been extremely helpful in alleviating some of that concern that I had about whether or not I had the virus or whether or not I was asymptomatic. … It seems like there was a lot going on that just got lost in the shuffle,” he said.
‘They assured me that I would receive an email’
Jacob Perry, 28, said he waited even longer for test results that never came.
A freelance musician, Perry needed to get a test to travel for a gig. He scheduled an appointment at the Silver Spring Civic Center for July 30, and after getting his test there, he was told he would receive an email within two to three days with his results.
“I basically didn’t receive any communication from AdvaGenix after that,” Perry said. “There were no emails; there were no phone calls, no voicemails.”
A week after his test, with his trip fast approaching, he called a phone number for the lab that had been provided to him. It took several days of trying before he got through to somebody on the phone on Aug. 11, he said.
The person on the phone told him his results were on file, and he would receive an email that night with the results. “They were staying late that night and sending out everyone’s results,” he said.
But Perry never received it, and “I was not able to get anyone on the phone from that point on,” he added.
Three days after that phone call, the state ordered AdvaGenix to halt its coronavirus operations. And a few days later, Perry said his mom sent him a clip from a local news station about the county terminating its contract with the lab.
In the end, Perry had to scramble to get another test in order to make his trip.
“It was very stressful for sure,” he said. “To this day, I have not received any communication from AdvaGenix, whether it be a phone call to me from their office or an email — nothing whatsoever.”
In a statement, an AdvaGenix spokesman said, “Without knowing the specifics of the patient in question it’s hard to say what happened in any particular case. But specimens delivered to the lab with the necessary labeling information would have been processed by AdvaGenix within their typical 48-hour turnaround time.”
Anderson, the Montgomery County Health Department spokeswoman, said that the county has requested, but not yet received, data from AdvaGenix showing the length of time between when specimens were submitted to the lab and when the results were reported to patients. She added that her department has received calls from residents looking for their results, and found sometimes delays were caused because results would get stuck in email spam filters.
At issue: Disputed heat study
The issue of notifying patients is complicated by the fact that the exact problem uncovered by inspectors remains largely unknown, and the severity of the issue has been in dispute from the beginning.
Dr. William Kearns, CEO and chief scientist of AdvaGenix, publicly disagrees with the state’s contention that his lab’s results are inaccurate.
In letters to the Montgomery County Council and federal officials, Kearns has said the issue flagged by inspectors dealt with whether the lab had performed a study of saliva samples to examine whether they would be adversely impacted by hot weather.
Similar studies had already been performed by the manufacturers of the test kits AdvaGenix used, which were developed by Rutgers University and Utah-based company Spectrum Solutions.
But during an unscheduled inspection by the Center for Medicare and Medicaid Services at the AdvaGenix lab in early August, “The inspectors talked with us about additional specimen validation studies that they felt were necessary,” Kearns said in an Aug. 19 letter describing the inspection.
The lab agreed to carry out the study, Kearns wrote, but two days after the visit, AdvaGenix was hit with the state’s cease-and-desist order anyway. The order cited improper lab procedures that “endanger patient health, safety, and welfare” and called into question all of the lab’s test results for Montgomery County — nearly 19,000 tests since June. Days later, the county announced that it was terminating its contract with AdvaGenix.
The Centers for Medicare and Medicaid Services oversees the program that carried out the lab inspection. CMS has not responded to repeated requests for a copy of the report or a summary of its findings.
But Kearns said in an Aug. 22 letter to CMS’ Center for Clinical Standards and Quality that the lab performed the requested temperature study anyway, and completed it within a week.
In the letter, Kearns said the lab’s study echoed the results of the manufacturers’ study. Specifically, Kearns said the study, which simulated hot outdoor and hot shipping conditions, showed the saliva samples remained stable at 104 degrees Fahrenheit and that temperatures in Montgomery County during June, July and August never got that hot in any case.
“Our study confirms that specimens are stable and are not adversely affected by the high temperatures that are common in Montgomery County during the summer,” Kearns wrote.
The letter ended with: “We look forward to prompt review by CMS and the State so that we can resume the important work of testing during this public health crisis.”
What happens now?
The cancellation of the AdvaGenix contract took a chunk out of the county’s testing capacity. The county suspended all testing at its clinics for nearly a week and has only recently begun building back its testing capacity, using kits supplied by the state of Maryland and by a company called CIAN Diagnostic Laboratories in Frederick.
Meanwhile, County Executive Marc Elrich and Health Officer Dr. Travis Gayles have been noncommittal about whether they’ll go into business with AdvaGenix again — even if the lab is eventually given the green light by the state to resume coronavirus testing.
Speaking during the online news briefing Wednesday, Gayles said three weeks after the inspection at the lab, the county is still waiting to see a report from state and federal inspectors.
“We will continue to wait for those updates to determine any future steps,” Gayles said.
Anyone who needs a re-test because of the issues at the AdvaGenix lab is encouraged to call the county’s disease control line at 240-777-1755 to schedule a retest, Gayles said.
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