By Adam Pagnucco.
Yesterday, the county announced that it has suspended COVID testing by AdvaGenix, a Rockville-based lab with whom the county contracted in May. At that time, County Executive Marc Elrich called the contract “a game changer,” saying, “This greatly increases our ability to get more testing.”
The county’s press release provided no reasons on why the testing was suspended. However, yesterday afternoon, Elrich sent a memo to the county council elaborating a little more on the issue. Elrich wrote:
On Wednesday, August 12, 2020 we were alerted that our supplier of tests and lab analysis, AdvaGenix would be receiving a Cease and Desist order from the State Office of Health Care Quality (OHCQ).
The order is allegedly being issued following a joint site visit by the Center for Medicaid Services (CMS) following a previous site visit earlier this week during which they identified several procedural problems related to the handling of test kits in the laboratory.
While the test kits and the analysis process used by AdvaGenix are not in question, we are awaiting formal notification from the Maryland Department of Health (MDH) on the exact nature of the problem and what corrective actions will be required by the company. We expect to receive notification from the State sometime Thursday, August 13, 2020.
As a precaution we have canceled testing in locations where we had planned to use AdvaGenix test kits. We are concurrently exploring other testing options in the event that we will no longer be able to use AdvaGenix as our supplier for testing.
Multiple sources agree on the following: the situation is developing, there are many more questions than answers at the moment and the issue is serious. One source said, “It’s a complete mess.” Because the state and the feds are involved, the county lacks both complete information and complete control over the matter.
All of this gives rise to many, many questions. Here are a few that need to be answered.
Is there an accuracy issue with the tests?
Specifically, have they generated false positives or false negatives, and if so, how many? Will we ever know?
Is there an impact on county health data?
County health data on cases and test positivity rates have been used to guide decisions on business reopenings. Given the issues with the tests, is this data accurate? If not, what happens then?
Are the issues with the tests correctible?
This question can’t be fully answered until the problems with the tests, and their effects, are fully understood.
How long will it take to rebuild county testing capacity?
If the issues with AdvaGenix can be fixed easily, it could happen quickly. Otherwise no one knows.
Is there a disproportionate impact on first responders and essential workers?
Back in May, when the contract with AdvaGenix was first signed, LocalDVM.com reported:
In the first phase of the contract, which is underway, the County will receive a minimum of 7,500 tests per week. Priority groups to be tested initially will be first responders; nursing home and long-term facility staff and residents; and employees of the County’s Department of Correction and Rehabilitation. The second phase of the testing plan will begin the week of May 31 and will test County employees who are essential workers, and hospital workers and health care providers. Phase three begins June 8; and at that point, the County will begin receiving 20,000 tests per week. By then, testing is scheduled to begin at sites such as grocery stores and other essential businesses for their employees; and testing will also be available for the general public.
This means a lot of county employees have been administered these tests. The county employee unions will be intensely interested in how this issue proceeds. Health and safety is a mandatory subject of bargaining and is subject to grievance procedures and arbitration. This comes in a context of strained labor relations between the unions and the executive branch.
What about the public?
AdvaGenix tests were available to the public at the Silver Spring Civic Building, the White Oak Community Recreation Center and other sites. The county has shut down nearly all its testing sites and county health officer Travis Gayles has recommended that residents using AdvaGenix tests in the last two weeks get retested. This raises the possibility that residents have used flawed tests provided by a county vendor. Does that create legal liability for the county? And what about the impact on public health?
What are the legal implications?
Speaking of legal issues, there could be a whole lot of them associated with the AdvaGenix contract. How much has the county paid AdvaGenix? When did the issues with the tests begin? What recourse is available for the taxpayers? Legal issues are generally not discussed in public but they can have millions of dollars of implications.
What role will the state play?
The fact that the state issued a cease and desist order on AdvaGenix is an interesting development. Elrich and Governor Larry Hogan have a terrible relationship that was exacerbated by their dispute over closing private schools. (Predictably, the state won that battle.) Elrich’s new Chief Administrative Officer, Rich Madaleno, ran for governor in 2018 and spent much of his time on the campaign trail (and even before) blasting Hogan at every opportunity. There is no love lost on Team Hogan for either Elrich or Madaleno. If this issue turns political, then it will get truly complicated.
The full dimensions of this problem are currently unknown. It may take a while for it to be worked out and the legal questions alone will probably prevent some information from being made public, at least for now.
Elrich’s memo to the council is reprinted below.