Dr. Ellen Shaver

Last Friday a federal appeals court lifted the stay order on President Joe Biden’s COVID vaccine mandate, leaving many organizations and businesses scrambling to comply. Pressure will continue to mount from a host of state governors and attorneys general against the mandate, likely sending the case to the U.S. Supreme Court. But in the meantime, businesses with 100-plus employees should be dotting the Is and crossing the Ts in preparation– especially in the midst of the Omicron variant.

The natural tendency is to pause when the tides of uncertainty pull in multiple directions and there is no doubt the private sector has seen its fair share of mandate confusion. However, considering the Occupational Safety and Health Administration’s ultimate job is to protect workers and workspaces, Biden’s mandate places OSHA and the Supreme Court in a precarious situation. Will the Court dare reverse course and cut the feet out from under OSHA and roll-back the mandate? With the lower courts having shown their hand, a roll-back decision by the Supreme Court would have a ripple-effect on OSHA’s ability to do its job and would create a precedent for challenges to other long standing OSHA guidance and responsibilities.

“Covered employers must develop, implement, and enforce a mandatory COVID–19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID–19 testing and wear a face covering at work in lieu of vaccination.”

With two options to comply, there is a distinct possibility that a modified form of the mandate will result and, if history provides any indication, government programs of this magnitude generally follow-through in some capacity once in motion.

Secure Your Supply Chain

The first wave of the pandemic caused major shortages; ventilators and COVID testing supplies were scarce and labs could not fulfill test capacity demand. As we approach the January 2022 deadline, the sudden influx of testing spurred by the mandate will likely create an exponentially greater supply chain burden.

Confirming a plan of action and securing a reliable testing method now is vitally important to businesses facing the mandate, especially those that can’t afford to lose more employees and plan to test their unvaccinated. If a company waits to secure a test provider for guaranteed test capacity/availability at a reasonably negotiated rate, the company will likely find themselves in situations of no, little and/or expensive testing. They may be forced to terminate employees or risk noncompliance and face exorbitant daily fines under the mandate. Additionally, requirements for keeping records from the beginning of the testing period may induce logistical nightmares for the unprepared company, especially if test proctoring is involved.

Proctoring Oversight?

“Under the Emergency Temporary Standard, a COVID-19 test must be a test for SARS-CoV-2 that is:

1. cleared, approved, or authorized, including in an Emergency Use Authorization (EUA), by the U.S. Food and Drug Administration (FDA) to detect current infection with the SARS-CoV-2 virus (e.g., a viral test);

2. administered in accordance with the authorized instructions; and

3. not both self-administered and self-read unless observed by the employer or an authorized telehealth proctor.

Examples of tests that satisfy this requirement include tests with specimens that are processed by a laboratory (including home or on-site collected specimens which are processed either individually or as pooled specimens), proctored over-the-counter tests, point of care tests, and tests where specimen collection and processing is either done or observed by an employer.” – https://www.osha.gov/coronavirus/ets2/faqs

The third stipulation for testing is crucial. Laboratory PCR tests do not require proctoring; however, rapid self-administered antigen tests do require a proctor. While several rapid test manufacturers have phone apps to produce a certified/compliant result without the need of a proctor, those types of tests are in high demand, expensive, and currently have significant supply chain issues. The majority of companies using rapid tests will be required to use a proctor for compliant results to be rendered.

In light of the recent lower court decision, every business with 100-plus employees should be securing appropriate vendors and finalizing mandate preparations with a documented plan per OSHA guidelines. Test capacity issues, supply chain problems and unmanageable cost factors are likely to be worse in January than they are now.

Final words of advice: Be very leery of companies offering free testing for your employees. The federal government, under the Cares Act, has allocated funds for testing the uninsured and insurance companies are not covering testing without medical necessity. Considering businesses having 100-plus full-time eligible employees are required to offer health insurance, “free testing” under the mandate is essentially non-existent.

Dr. Ellen Shaver serves as medical director of The COVID Consortium, a full-service COVID testing logistics company with its own high complexity CLIA certified molecular laboratory located in Peachtree Corners, Georgia.


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