Montgomery County Government has announced that it is terminating its contract with AdvaGenix, a Rockville lab, to provide COVID-19 testing. When the county signed the contract in May, County Executive Marc Elrich called it “a game changer” and the company was expected to provide up to one million tests over the course of a year. Instead, the county has stated that about 19,000 tests were provided under the contract and has advised residents and county employees who received them to get retested.
The company is pushing back hard. Its founder, Dr. William Kearns, told WJLA-7, “We are being slandered… I think there’s a lot more going on here than meets the eye.” Kearns further said, “Our tests are very accurate… Saying anything otherwise is nonsense.”
AdvaGenix was a major player in the county government’s testing program, although the private sector has supplied many more tests than the county. It’s unclear what the county’s plan to resume ongoing testing will look like going forward. There are also MANY more questions to be asked about this and, so far, few answers.
The county’s press release appears below.
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Montgomery County Announces Termination of AdvaGenix Contract For Immediate Release: Tuesday, Aug. 18, 2020
Montgomery County announced today that it has terminated its contract with AdvaGenix, the Rockville-based company that had been providing and processing tests for the County Government’s free COVID-19 test clinics. This action was taken following the cease and desist directive and order issued by the Maryland Department of Health on Aug. 14, 2020, prohibiting AdvaGenix from processing COVID-19 tests.
In response to the State’s announcement last week, the County has been working to restore its testing capacity and reopen testing sites. The Maryland Department of Health has committed to replace the weekly supply of tests for the next four weeks. County officials are working to identify additional test sources to support the County Government’s effort to offer broadly available free tests.
On Thursday, Aug. 13, the County announced it was temporarily suspending tests at County-sponsored clinics. Testing at these clinics was designed primarily to serve asymptomatic individuals. The County continues to provide testing to symptomatic individuals using existing partnerships with other labs. Since the beginning of the COVID-19 pandemic, more than 265,000 COVID-19 tests have been administered to County residents. Tests provided by AdvaGenix were approximately 8 percent of these tests.
Montgomery County Government has sent the email below to county employees regarding the suspension of COVID testing by county vendor AdvaGenix. County employees, particularly first responders and essential workers, were among the first people to receive the tests. The email tells employees, “Although the data we have reviewed does not suggest that the test results were affected by the apparent flaws in AdvaGenix’s lab process, we encourage you to take advantage of one of the other COVID-19 testing resources to be re-tested.”
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From: “MCG.Postmaster” MCG.Postmaster@montgomerycountymd.gov Date: August 14, 2020 To: #MCG_All <#MCG_All@montgomerycountymd.gov> Subject: COVID-19 Testing Update
On May 21, 2020, the County announced the signing of an agreement with County-based testing firm, AdvaGenix, to provide COVID-19 testing to County employees and the general public. Since that date, the County has been working to expand free testing for asymptomatic residents and employees using the AdvaGenix tests, with more than 19,000 tests administered in the last 2 months. Unfortunately, yesterday that momentum came to a halt. As you may have seen, the County has suspended the AdvaGenix testing program after learning that the Maryland Department of Health had issued an order formally halting testing at their lab.
Your health and safety are our top priority. Therefore, we want to provide you with some guidance as to what this situation means to you. In the interim, County officials are working rigorously to determine an alternative source of test analysis so the testing program can resume.
First, all Department testing schedules are suspended until further notice. We are identifying new testing options so that we can have an employee testing program back up and running as soon as possible. There are a multitude of free testing options that remain available to anyone who needs or wants to be tested, including local urgent care centers, CVS locations, hospitals, etc. For additional testing sites, visit the State of Maryland’s Testing Locator page, which can be found at https://coronavirus.maryland.gov/pages/symptoms-testing#siteapp, or call the County’s Testing Helpline at 240-777-1755.
Second, for those of you who were tested by AdvaGenix, you should receive an e-mail from AdvaGenix informing you of what has happened. Although the data we have reviewed does not suggest that the test results were affected by the apparent flaws in AdvaGenix’s lab process, we encourage you to take advantage of one of the other COVID-19 testing resources to be re-tested.
Third, the County’s asymptomatic individual testing program using the oral swab or saliva method has been temporarily paused. However, the County will continue to offer free public testing using a variety of nasal tests. In fact, the state has already committed to provide us with 20,000 nasal kits while we transition to a new self-administered test.
Finally, the County’s testing program through AdvaGenix was only a very small piece of the overall available market for tests in Montgomery County. To date, more than 261,000 COVID-19 tests have been administered to County residents. The AdvaGenix test only accounted for 8 percent of the total. Once again, there are a multitude of free testing options that remain available to anyone who needs or wants to be tested, including local urgent care centers, CVS locations, hospitals, etc. For additional testing sites, visit the state’s Testing Locator page, which can be found at https://coronavirus.maryland.gov/pages/symptoms-testing#siteapp, or call the County’s Testing Helpline at (240) 777-1755.
If you have any additional questions, please contact Don Scheuerman at Don.Scheuerman@montgomerycountymd.gov.
Everyone involved in our testing effort is deeply disappointed with this development. It is so very frustrating that communities across our country are having to invent and reinvent testing programs since the federal government refuses to take responsibility for a national strategy.
Yet, in these difficult times, we have no choice but to pull together as a community to survive the pandemic. Together, we will overcome this newest obstacle. Together we will beat this frustrating virus.
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.
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.
In May, Elrich said, “This is a game-changer for us. This greatly increases our ability to get more testing… Testing is an essential part of the road to reopening. It is great that we are doing this and that we are able to partner with a local company on this important step.”
The county has now suspended its testing through AdvaGenix but did not state exactly why in its press release, which is reprinted below.
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Montgomery County Announces Suspension of COVID-19 Testing Amid Concerns with AdvaGenix’s Testing Process For Immediate Release: Thursday, Aug. 13, 2020
Montgomery County Executive Marc Elrich and County Health Officer Dr. Travis Gayles announced today that the portion of the Montgomery County-administered COVID-19 testing program processed through Rockville-based AdvaGenix is suspended immediately pending a thorough review of the AdvaGenix testing and lab process. The clinic scheduled for tomorrow at the Wheaton Library and Community Recreation Center will continue, using tests provided through the State.
Dr. Gayles recommends that residents who have been tested in the past two weeks at County Government-sponsored clinics using the AdvaGenix test kits should be retested at one of the 30-plus other locations across the County.
More than 19,000 AdvaGenix tests have been used over the past two months. This represents roughly 8 percent of the more than 251,000 COVID-19 tests that have been administered to County residents. Residents with confirmed appointments at upcoming testing clinics are being notified of the cancellations.
County officials are working to determine an alternative source of test analysis so the testing program can resume as quickly as possible and to develop a revised plan for County-sponsored testing.
The County’s contract with AdvaGenix provided self-administered tests for primarily asymptomatic individuals. County residents will be informed when additional County-sponsored COVID-19 test options are made available. For additional testing sites, visit the State of Maryland’s Testing Locator page.
If you are symptomatic and need help in finding testing, please call the Testing Helpline at 240-777-1755.
Montgomery County health officer Travis Gayles just issued a new order rescinding his recent order shutting down MoCo private schools for in-person instruction. Gayles’s new order states, “I, Travis A. Gayles, M.D., Ph.D., Health Officer for Montgomery County, Maryland, despite believing that it is necessary to close nonpublic schools for in person instruction to protect the public, do hereby, pursuant to the August 6, 2020 Memorandum issued by the Secretary of the Maryland Department of Health, rescind the August 5, 2020 Health Officer Directive Regarding Nonpublic Schools.”
That doesn’t mean private schools can do whatever they want. The state’s memorandum says that private school reopenings should be done in “close consultation” with local health departments using guidance from the state health department. That means there is still a role for regulation. But MoCo has conceded that there won’t be a blanket shutdown.
The county’s press release appears below.
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Health Order Prohibiting Nonpublic Schools Rescinded by Montgomery County Health Officer For Immediate Release: Friday, August 7, 2020
Reemphasizing the need to protect the health and safety of Montgomery County residents as well as parents, students, teachers and staff from the spread of COVID-19, County Health Officer Dr. Travis Gayles today announced that he has rescinded his health order that prohibited nonpublic schools from opening for in-person instruction until after Oct. 1, 2020. The decision was made due to the new policy announced yesterday by the State Department of Health prohibiting the blanket closure of nonpublic schools.
Today’s new Health Officer Directive and Order regarding public, private and independent schools, dated Aug. 7, 2020, is effective immediately and rescinds the order dated Aug 5, 2020.
The Health Officer continues to strongly advise schools against in-person learning due to the risks posed by COVID-19 and has asked that the Department of Health provide articulable criteria to be used in determining acceptable and safe levels of activity in schools.
Last November, I wrote about the growing feud between Montgomery County Executive Marc Elrich and Governor Larry Hogan. Back then, the issues were the governor’s proposed Beltway widening project, the dispute about how to fix MoCo’s crumbling public safety communications system, the thin blue line flag that was delivered to a MoCo police station and transportation funding. Some of those issues have faded over time but the general radioactivity between the two men can still melt hazmat suits. And now the feud is threatening to blow up MoCo’s private schools.
According to the U.S. Census Bureau, there were roughly 190,000 people age 5 through 18 living in MoCo in 2018. MCPS K-12 enrollment was 158,101 in the 2018-19 school year, suggesting that about 30,000 students, or almost one-sixth of all MoCo kids, were in private school or home school. The Census Bureau’s County Business Patterns series identified 108 private school establishments in the county with 6,610 employees in 2017. Their combined annual payroll was $322 million.
Private schools are a big deal in MoCo.
Right now, private school employees, parents and students are caught in a tit-for-tat power struggle between Elrich and Hogan. This isn’t the typical sparring that the two do over social media. With the county saying one thing and the state saying the opposite, what are these families and employees supposed to do? If you’re a school and you open, the county could fine you. If you don’t, your own parents could sue you and/or pull their kids from your school.
It’s the worst of all worlds!
The situation calls for the low-key tactics of former County Executive Ike Leggett. Hogan, a good old boy developer and son of a Republican politician, and Leggett, a soft-spoken law professor who had risen from a childhood of poverty, couldn’t be more different. But despite their different backgrounds and beliefs, Leggett understood the powers of the governor and learned how to work him. Leggett succeeded in getting Hogan to back off a campaign promise to cancel the Purple Line and the two worked hand-in-hand to lure Amazon to MoCo. If Leggett had any criticism of Hogan, he kept it private. Leggett took a loooooong time to endorse Hogan’s general election rival, Democrat Ben Jealous, and never campaigned against Hogan. The two became peas in a pod – and an odd-looking pod at that!
The lesson of Leggett is not one of capitulation but of continuing to talk despite areas of disagreement. Leggett never made things personal even when other people wanted to. I wrote many tough pieces on his administration and Leggett would respond by seeing me at an event, shaking my hand and saying, “How are you? Is everything OK? Let me know if you need something.” Then I would feel bad about being so hard on him and I would go beat up someone else for a while!
Leggett, who originally hired current health officer Travis Gayles, would have found a way to work this current dispute out. Working the phones with Hogan and state health secretary Bobby Neall, Leggett and his people would have devised a stringent network to regulate private school reopenings without provoking a legal war with the state. And he would have kept it out of the press. The only sign of discussion would have been mutual praise between Leggett and Hogan of what a great job each was doing on handling COVID. As for the private schools, many would probably have opted for distance learning rather than deal with cumbersome county bureaucracy and plan approvals, thereby producing a similar result to the one desired by Elrich. It just would have happened without yelling and screaming.
Leggett is happily retired from elected service now and is probably laughing as he reads this column. He is still around. Maybe Elrich and Hogan should bring him back, always the calmest guy in the room, to settle their increasingly bitter feud.
Maryland Secretary of Health Robert Neall has responded to Montgomery County’s new order shutting down private schools for in-person instruction. In a memo to the state’s health officers (including MoCo health officer Travis Gayles), Neall wrote, “The State of Maryland’s position is that all schools, including public school systems and non-public schools, be provided with the individualized opportunity to determine how they are able to comply with the federal and state COVID-19 guidance to reopen safely and protect students and staff. Those determinations should be made in close consultation with the affected schools and local health departments with Maryland Department of Health guidance.”
In other words, the state is saying once again that there should not be blanket closures of private schools.
So let’s stop back and take a broader view. The county’s original order shutting down private schools was based on authority contained in Governor Larry Hogan’s original emergency order. So Hogan amended his emergency order to exempt private schools from private shutdowns. The county said fine, we will issue a new shutdown order based on a different section of state law. Now Hogan’s health secretary is reiterating state authority over health policy and saying, “No you’re not.”
Looming over all of this is the tangled structure of appointment and reporting relationships between health officers and the state. Calvert County has a good description of that.
Neall’s memo to county health officers appears below.
The post about a restaurant not requiring face masks was one of the top five most-read stories in the history of this blog. (That puts some perspective on the relative importance of politics!) Marilyn Balcombe and Sunil Dasgupta deserve congratulations for their excellent and widely read guest posts. Aside from those, the top posts generally reflect the top two stories of the month: MCPS’s reopening decision and the county’s ethics-challenged Chief Administrative Officer Andrew Kleine.
Defying an amended state executive order by Governor Larry Hogan, Montgomery County Health Officer Travis Gayles has issued a new order shutting down private schools for in-person instruction through October 1. The new order follows a call with reporters today in which Gayles said county officials were “continuing to evaluate the impact of the governor’s order on the directive that we put out.”
Bring on the lawyers, folks.
The county’s press release appears below.
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Montgomery County Health Officer Issues Amended Directive to Protect Public Health; Prohibiting In-Person Instruction at Nonpublic Schools Until at Least Oct. 1 For Immediate Release: Wednesday, Aug. 5, 2020
Reemphasizing the need to protect the health and safety of Montgomery County residents as well as parents, students, teachers and staff from the spread of COVID-19, County Health Officer Dr. Travis Gayles today issued a new Health Officer Directive and Order that continued to direct nonpublic schools in Montgomery County to remain closed for in-person instruction until at least Oct. 1, 2020. Today’s order, citing the Maryland Code Annotated Health General § 18-208 and COMAR 10.06.01.06, rescinds and replaces the Health Officer Directive and Order Regarding Private and Independent Schools dated July 31, 2020. The new order, which is effective immediately, remains valid until Oct. 1, 2020, or until rescinded, superseded, amended, or revised by additional orders.
County officials continue to base their public health decisions on data and the data and science and at this point, the data does not suggest that in-person instruction is safe for students, teachers and others who work in a school building. There have been increases in transmission rates of COVID-19 in the State of Maryland, the District of Columbia and the Commonwealth of Virginia, particularly in younger age groups, and this step is necessary to protect the health and safety of Montgomery County residents.
Nonpublic schools are defined as any school located in Montgomery County, Maryland that are not public schools. This includes, but is not limited to all private pay schools, schools affiliated with religious institutions, or schools that are otherwise considered to be independent schools. The Order does not apply to programs licensed or regulated by the Maryland Office of Childcare. Those programs were reopened effective July 19, 2020 pursuant to County Executive Order 082-20.
Based on CDC best practices for the reopening of schools, County health officials will continue to monitor the epidemiological surveillance data and that will guide the decision as to when it is safe to reopen nonpublic and public schools.
Minutes ago, Governor Larry Hogan issued an amended executive order preventing political subdivisions from closing or modifying the operations of schools. The governor issued this statement:
The recovery plan for Maryland public schools stresses local flexibility within the parameters set by state officials. Over the last several weeks, school boards and superintendents made their own decisions about how and when to reopen public schools, after consultation with state and local health officials.
Private and parochial schools deserve the same opportunity and flexibility to make reopening decisions based on public health guidelines. The blanket closure mandate imposed by Montgomery County was overly broad and inconsistent with the powers intended to be delegated to the county health officer.
To be clear, Maryland’s recovery continues to be based on a flexible, community-based approach that follows science, not politics. As long as schools develop safe and detailed plans that follow CDC and state guidelines, they should be empowered to do what’s best for their community.
I want to thank all the parents, students, and school administrators who have spoken out in recent days about this important issue.
If a political subdivision determines that doing so is necessary and reasonable to save lives or prevent exposure to COVID-19, the political subdivision is hereby authorized to issue Orders that are more restrictive than this Order (“Local Orders”):
i. requiring any businesses, organizations, establishments, or facilities (except schools) to close or modify their operations; and/or
ii. requiring individuals to remain indoors or to refrain from congregating.
