Over The Counter (OTC) Home Testing and CLIA Applicability

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

There’s new FAQ guidance posted as of Monday, November 22, 2021 on the CMS Current Emergencies website: Over The Counter (OTC) Home Testing and CLIA Applicability.

This 4-page FAQ addresses:

  • Does use of over the counter (OTC) tests authorized by the FDA intended for home use require CLIA certification?
  • Do facilities such as schools, shelters, jails, etc., need a CLIA certificate to perform OTC tests authorized by the FDA for home use?
  • What is the rationale for the distinction between an OTC home test being self-administered and being administered by someone in a facility outside of the home?
  • Can over the counter (OTC) home tests be used in facilities that perform waived, moderate and high complexity testing?
  • Can over the counter (OTC) home use testing be performed in a setting other than homes (e.g., workplace)?
  • Can a COVID-19 test be used for self-testing at my facility if that test has not been authorized by the FDA for OTC home use without a CLIA certificate?
  • Can a staff member or employee of a facility provide assistance to an individual performing self-testing?
  • If an OTC test is used in a CLIA certified facility, does that make the COVID-19 result reportable?

You’ll have access to additional, helpful links for more information at the bottom of page 3 and throughout page 4 of the FAQ.