Montgomery County officials said Wednesday that they still don’t know the state’s specific concerns about the Rockville lab AdvaGenix, which forced almost all of the county’s COVID-19 testing sites to close, but the county is setting up alternate testing options.
AdvaGenix was testing and processing the majority of the tests administered through county-operated testing sites. However, the state last week issued a cease-and-desist order for the testing to stop, citing “improper laboratory and COVID-19 testing procedures that endanger patient health, safety and welfare.” AdvaGenix disputes that there were any safety risks.
Six days after the county closed its testing sites, it is reopening two sites for walk-up, no-appointment testing. Symptomatic residents are encouraged to make appointments to separate them for testing.
The county is administering tests on Thursday and Friday and will not require appointments. The testing sites are:
● Plum Gar Recreation Center in Germantown: Thursday from 1 to 4 p.m.
● White Oak Recreation Center in White Oak: Friday from 9 a.m. to 4 p.m.
The state promised to provide 5,000 COVID-19 tests to the county for the next four weeks. County officials are looking into expanding existing testing contracts or considering other options.
AdvaGenix signed a one-year contract with the county in May for testing. After two months of processing tests, county officials say they haven’t received any invoices from the company.
The county is declining to reveal how much AdvaGenix was charging the county for tests in the contract, calling it confidential information.
The county terminated its contract with AdvaGenix on Tuesday after a joint state and federal investigation found problems with the company’s testing and processing protocols and ordered the lab to stop COVID-19 testing.
But the details of the investigation have not been released or shared with the county yet, according to Dr. Travis Gayles, the county’s health officer.
In a statement sent to Bethesda Beat Monday evening, Dr. William Kearns, CEO and chief scientific officer of AdvaGenix, said the company’s coronavirus tests are “safe and effective.”
“The crux of this dispute lies in regulatory issues between FDA and other federal laboratory regulators for COVID-19 testing, not the health, safety or substance of our testing,” he said. “This has to do with regulatory approvals, not with test results.”
In a statement released Tuesday afternoon, Kearns said the company is still working to resolve the dispute and get back to testing.
“It’s unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question,” he said.
In a letter to the County Council on Wednesday, Kearns provided more details about the state’s investigation. The lab had an unscheduled Clinical Laboratory Improvement Amendments (CLIA) federal inspection on Aug 10, according to Kearns.
“After two days of working cooperatively with investigators, providing full access to our facilities and data, the inspectors talked with us about additional specimen validation studies that they felt were necessary,” Kearns wrote. “We have complied with their requests and will have these additional studies completed shortly.”
He stated that the lab is doing its own in-house temperature stability study that will be completed this week. The study “should solve stated concerns by the state,” he wrote.
“We should be fighting the virus, not red tape,” Kearns wrote.
Charlie Gischlar, a spokesman for the state’s health department, could not be immediately reached Thursday morning.
AdvaGenix released the letter at the same time as the county’s media briefing on Wednesday. When asked about the letter, Gayles said he had not seen it.
The county is still working on how to fill the gap of testing left by the contract termination. AdvaGenix processed 88% of the tests at county-operated testing sites. It accounted for 8% of the total tests provided by the county, state, medical providers and others.
The state has stepped in and offered 5,000 tests a week for four weeks.
The county encourages anyone who has testing questions to call its Testing Helpline at 240-777-1755.
Bethesda Beat obtained a copy of the county’s contracts with testing partners through a Maryland Public Information Act (MPIA) request.
The request was submitted on June 22. The county Department of Health and Human Services provided copies of the contracts on Friday — 53 days later. The PIA requires government bodies in Maryland to respond within 30 days, and sooner if the information is readily available.
For both contracts — with AdvaGenix and Bio-Reference Laboratories — the county redacted how much it will pay the companies.
Barry Hudson, a spokesman for the county, wrote in an email on Monday that based on the PIA, it isn’t the county’s practice to “disclose confidential commercial and financial information unless the vendor releases us to do so.”
“In this case, the contract provides that the pricing is the laboratory’s confidential commercial and financial information,” Hudson wrote.
He cited a section of the PIA that says the government body shall not release “a trade secret,” “confidential commercial information,” “confidential financial information” or “confidential geological or geophysical information.”
Asked on Wednesday about the county’s reasoning for not revealing the financial terms of its deal with AdvaGenix, Alia Smith, a media attorney with the Washington, D.C., firm Ballard Spahr, said courts have ruled in favor of businesses being allowed to keep proprietary information in a government contract confidential.
A government body usually specifies in advance if it’s an open bidding process, with financial details made public, or a confidential process, she said.
Smith said, however, that she doesn’t think withholding information about spending is “the proper way for the government body to behave.”
Ballard Spahr answers legal questions for the Maryland-Delaware-DC Press Association and its members. Bethesda Beat is a member.
No ‘definitive findings’
At a media briefing on Wednesday, Gayles reiterated that as a precaution, the county recommended that residents who used an AdvaGenix test within the last two weeks should consider being retested.
Gayles said he has not received a copy of the state’s findings and did not know whether any test results were wrong.
“The reason why we can’t comment on what issues may be brought up with the tests is we don’t have a copy of a report, we don’t have the definitive findings,” he said. “I can’t tell you definitely there was an issue with ‘A,’ ‘B’ and ‘C’ that caused the concern. We’re merely going off of what has been shared with us in terms of knowing that there was an investigation and the order that was put into place by the secretary of health.”
On Friday, the state ordered AdvaGenix to stop providing COVID-19 testing and processing.
When asked whether the county would consider reentering a contract with AdvaGenix if the state cleared up the problems, County Executive Marc Elrich said at a media briefing on Wednesday that he felt “uncomfortable talking about something that could wind up under litigation.”
The contracts received through Bethesda Beat’s MPIA request include agreements with AdvaGenix and Bio-Reference Laboratories, which owns the Gaithersburg lab GeneDX and uses the space to process tests.
Under an amendment made on June 28 to the contract, the county would be billed for COVID-19 testing of county employees and uninsured residents.
A “detailed written” invoice to the county would be sent weekly, specifying the amount due from the county for COVID-19 testing of county employees and uninsured residents, according to the contract. Payments of the invoices would be due within 30 days.
But on Wednesday morning, Hudson told Bethesda Beat in an email that the county “has not made any payments to AdvaGenix on this contract” and has not received any invoices from the company.
At the media briefing on Wednesday, Silvia Kinch, the division chief of the Office of the County Attorney, said that when officials receive an invoice from AdvaGenix, they will “review it and then decide how we’re proceeding from there.”
License for testing
The county can terminate the contract if the lab can’t fulfill its contractual obligations, as well as if the Maryland Department of Health suspends or revokes the lab’s license for laboratory testing.
On Wednesday afternoon, AdvaGenix spokeswoman Claire Bischoff wrote in an email to Bethesda Beat that the company was notified on Tuesday that the state’s order for the lab to stop COVID-19 testing “contained a mistake and was amended.”
“The order inaccurately stated AdvaGenix’s laboratory license was suspended,” she wrote. “That is not correct. Our license has not been suspended.”
The amended order states that the lab cannot collect or process coronavirus tests in Maryland unless the state allows it to resume testing. The order is effective until Sept. 13 or upon termination.
In his letter to the council on Wednesday, Kearns wrote that he was “relieved” the order was amended, but the “mistake did not come without consequences.”
“This error caused great disruption to the county’s testing program. As a result of the error, the county paused testing at its clinics where residents could receive free testing,” he wrote. “The error also caused confusion to the public, calling into question test results for more than 17,000 residents.”
Under the contract, AdvaGenix was required to process a minimum of 7,500 tests per week.
On June 8, the testing capacity had to increase to a minimum of 80,000 tests over four weeks. The capacity was not reached for several reasons, including technical problems with the lab’s testing platform and trouble finding adequate facilities and staffing for testing sites.
In the contract — which started May 21 and was supposed to end on May 21, 2021 —
AdvaGenix and Bio-Reference were test processing partners. Ready Responders, a separate entity, served as the county’s Rapid Response Team to conduct medical visits to homes of residents who have been affected by COVID-19.
Bethesda Beat also received a copy of the Ready Responders contract through a PIA request. Financial information on that contract was not redacted.
According to that July 13 contract, the county is paying Ready Responders based on hours worked. There is a minimum compensation for two teams working 8 hours per day, seven days a week.
Responders and human services workers under Ready Responders earn $50 per hour.
The roughly 90-day contract with Ready Responders requires that payment not exceed $288,000. If the contract is extended, the same hourly rates apply. Total compensation under the contract, including extension periods, is capped at $500,000.
Managing Editor Andrew Schotz contributed to this story.
Briana Adhikusuma can be reached at firstname.lastname@example.org.