More Vax-or-Test ETS Guidance from OSHA on Over-the-Counter Tests

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Now that the stay on the vax-or-test ETS has been lifted, the Occupational Safety and Health Administration has plunged back into its implementation activities, including updating the FAQs. Of particular interest, OSHA has added a number of questions addressing the use of over-the-counter (OTC) tests.

The ETS allows for the use of COVID tests that have been cleared, approved or authorized by the Food and Drug Administration, which would include certain OTC tests. However, the ETS also provides that such tests may not be self-administered and self-read unless observed by the employer or an authorized telehealth proctor. The ETS further requires employers to maintain a record of each test result, but it was not clear how this could be accomplished for OTC tests.

The new FAQs provide the following clarifications:

  • Certain OTC tests may be digitally read and produce a date and time stamped result (e.g. results are available through an app, QR code, or RFID). Such tests are not considered to be “self-read” and thus may be used without requiring employer/proctor observation.
  • Although some test kits include two tests that are supposed to be used serially several days apart, per FDA authorization, OSHA will consider the result from a single test to meet the requirements of the ETS.
  • The employee cannot submit a photo of their self-administered and self-read OTC test result, as that is not a substitute for employer/proctor observation.
  • Employers may observe more than one OTC test at the same time – but no more than they can actually validate with confidence. Proctors may do so only if permitted by the FDA’s authorization.
  • Employer/proctor observation must be done in real time. Videos of the test reviewed after the fact are not acceptable.
  • Employer observation may be done through a live streaming video conference program, like Zoom, Microsoft Teams, or Skype.
  • Documentation of an observed OTC test may be done through a written statement (e.g., a notation indicating the date and time observed, the observer, and the results), a photograph of the test result, or a video of the test result, if documented and recorded by the employer-observer at the time the test is conducted or observed.