11/29/2021: Lab Advisory: CMS Publishes New FAQ about CLIA and Over-the-Counter Home Testing

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Advisory

On November 22, 2021, the Centers for Medicare & Medicaid Services (CMS) published a new frequently asked questions (FAQ) document which outlines how the Clinical Laboratory Improvement Amendments of 1988 (CLIA) apply to over-the-counter (OTC) home testing (also called self-testing) when used in different settings, particularly when the test is performed by someone other than the individual who needs testing. Refer to this new FAQ document to learn more about when CLIA requirements apply to the use of OTC home tests.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: November 29, 2021