12/08/2020: Lab Advisory: CMS Revises Enforcement Discretion for SARS-CoV-2 Point-of-Care Tests
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory
On Monday, December 7, 2020, the Centers for Medicare & Medicaid Services (CMS) updated the frequently asked questions (FAQs) to include revised Clinical Laboratory Improvement Amendments (CLIA) enforcement discretion guidance during the COVID-19 public health emergency, for the use of SARS-CoV-2 molecular and antigen tests authorized by the U.S. Food and Drug Administration (FDA) in the following situations:
- When the POC tests are performed on asymptomatic individuals outside of the test’s Emergency Use Authorization (EUA) based on the recommendations and information provided by FDA
- When nonwaived facilities modify the point-of-care tests and perform them for asymptomatic individuals without establishing performance specifications
Refer to the updated FAQs for more information.
Online CDC resources:
- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
- Frequently Asked Questions about Coronavirus for Laboratories
- Clinical Laboratory COVID-19 Response Calls
- CDC Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- CDC COVID-19 website
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For questions, please contact us at LOCS@cdc.gov.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)