11/29/2021: Lab Advisory: CMS Publishes New FAQ about CLIA and Over-the-Counter Home Testing
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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Online resources:
- Self-Testing
- Clinical Laboratory Improvement Amendments (CLIA)
- Testing for COVID-19
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
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)