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BREAKING NEWS: OSHA Has Updated Its Vax or Test ETS FAQs

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Hey Compliance Warriors!

 

So, last week the news broke about the January 7th date for SCOTUS to hear arguments (and probably rule) on the OSHA ETS and CMS vaccine mandate.  I don’t have an update on the CMS piece, but I am here to tell you that OSHA has updated its ETS FAQs since my last post. Basically, OSHA has said that if the employee uses a digitally-read test, which produces a date and time-stamped result (e.g., results available through an app, QR code, RFID), it is not considered to be “self-read” under the ETS and therefore would not require observation by an employer or an authorized telehealth proctor in order to satisfy the requirements of the ETS. Tests that are digitally read in this way reduce the potential for falsified results by ensuring a new test result is generated each week and each test is used only once.

 

Here are the updates:

 

Under the ETS, 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.

COVID-19 tests can broadly be divided into two categories, diagnostic tests and antibody tests. Diagnostic tests detect parts of the SARS-CoV-2 virus and can be used to diagnose current infection. On the other hand, antibody tests look for antibodies in the immune system produced in response to SARS-CoV-2, and are not used to diagnose an active COVID-19 infection. Antibody tests do not meet the definition of COVID-19 test for the purposes of this ETS.

Diagnostic tests for current infection fall into two categories: nucleic acid amplification tests (NAATs) and antigen tests. NAATs are a type of molecular test that detect genetic material (nucleic acids); NAATs for COVID-19 identify the ribonucleic acid (RNA) sequences that comprise the genetic material of the virus. Most NAATs need to be processed in a laboratory with variable time to receive results (approximately 1–2 days), but some NAATs are point-of-care tests, including a limited number of over-the-counter (OTC) tests, with results available in about 15–45 minutes.

Antigen tests may also meet the definition of COVID-19 test under this standard. Antigen tests indicate current infection by detecting the presence of a specific viral antigen. Most can be processed at the point of care and many are available over-the-counter, with results available in about 15­-30 minutes. Antigen tests generally have similar specificity to, but are less sensitive than, NAATs.

To be a valid COVID-19 test under this standard, a test may not be both self-administered and self-read unless observed by the employer or an authorized telehealth proctor. If an OTC test is being used, it must be used in accordance with the authorized instructions. The employer can validate the test through the use of a proctored test that is supervised by an authorized telehealth provider. Alternatively, the employer could proctor the OTC test itself. OTC tests that feature digital reporting of date and time-stamped results are not considered to be “self-read” and therefore do not require observation by the employer or an authorized telehealth proctor to satisfy the standard.

It should be noted that point-of-care (POC) testing must be performed in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The FDA has authorized POC tests that can be used at a place of employment when the facility is operating under a CLIA certificate of waiver. A CLIA certificate of waiver can be issued by the Centers for Medicare and Medicaid Services (CMS).

Yes; however, to satisfy the requirements of the standard an over-the-counter (OTC) test may not be both self-administered and self-read unless observed by the employer or an authorized telehealth proctor. Antigen tests indicate current infection by detecting the presence of a specific viral antigen. Most can be processed at the point of care with results available in about 15­-30 minutes. OSHA included the requirement for some type of independent confirmation of the test result in order to ensure the integrity of the result. This independent confirmation can be accomplished in multiple ways, including through the involvement of a licensed healthcare provider or a point-of-care test provider. If an OTC test is being used, the employer can validate the test through the use of a proctored test that is supervised by an authorized telehealth provider. Alternatively, the employer could proctor the OTC test itself. OTC Tests that feature digital reporting of date and time-stamped results are not considered to be “self-read” and therefore observation by the employer or an authorized telehealth proctor is not required.

No. To be a valid COVID-19 test under this standard, a test may not be both self-administered and self-read unless observed by the employer or an authorized telehealth proctor. OSHA included the requirement for some type of independent confirmation of the test result in order to ensure the integrity of the result. A digitally-read test, which produces a date and time-stamped result (e.g., results available through an app, QR code, RFID), is not considered to be “self-read” under the ETS and therefore would not require observation by an employer or an authorized telehealth proctor in order to satisfy the requirements of the ETS. Tests that are digitally read in this way reduce the potential for falsified results by ensuring a new test result is generated each week and each test is used only once.

The ETS permits compliance through use of a wide range of FDA-authorized tests that are readily available. To be a valid COVID-19 test under this standard, a test may not be both self-administered and self-read unless observed by the employer or an authorized telehealth proctor. OSHA included the requirement for some type of independent confirmation of the test result in order to ensure the integrity of the result. Examples of tests that satisfy the ETS requirements 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 (OTC) tests, point of care tests, and tests where specimen collection and processing is either done or observed by an employer.

Employers have the flexibility to select the testing scenario that is most appropriate for their workplace. Some employees and employers may rely on testing that is conducted by a healthcare provider (e.g., doctor or nurse) who arranges for the specimen to be analyzed at a laboratory or at a point-of-care testing location (e.g., a pharmacy). The involvement of licensed or accredited healthcare providers allows employers to have a high degree of confidence in the suitability of the test and the test results. Other employers may simply require that employees perform and read their own OTC test while an authorized telehealth proctor observes the administration and reading of the test to ensure that a new test kit was used and that the test was administered properly (e.g., nostrils were swabbed), and to witness the test result. Additionally, employers may allow the use of OTC tests that feature digital reporting of date and time-stamped results. These digitally-read tests are not considered to be “self-read” and therefore do not require observation by the employer or an authorized telehealth proctor to satisfy the standard.

 

 

So, for now, keep your eyes and ears open and stay tuned and seriously plan your next move for January 10th, 2022 based on the outcome of the January 7th, 2022 hearings.

 

Remember, if the ETS is upheld and moves forward, the Pfizer-BioNTech COVID-19 vaccine primary vaccination series takes 21 days to complete. Therefore, employees receiving the Pfizer-BioNTech series must get their first dose on or before January 19, 2022, and get their second dose 21 days later.

 

For the Moderna COVID-19 vaccine, the vaccination series takes 28 days to complete. Therefore, employees receiving the Moderna series must get their first dose on or before January 12, 2022, and get their second dose 28 days later.

 

Your Breaking News on the subject will be right here at HelpDeskforHR.com.

 

Be Audit-Secure™

 

 

Lisa Smith, SPHR, SHRM – SCP

Certified EEO Investigator (EEOC)

Lead Support and Content Chief – HelpDeskforHR.com

“You cannot be audit-proof, but you can Be Audit-Secure.”


 

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