12/19/2020: Lab Update: CMS Updates FAQs for CLIA Guidance during the COVID-19 Public Health Emergency

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Update

On December 17, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) updated the “Frequently Asked Questions (FAQS), CLIA Guidance During the COVID-19 Public Health Emergencypdf iconexternal icon” document to provide additional clarification on the following topics:

  • How CMS defines a “CLIA-waived” facility
  • Developing an Individualized Quality Control Plan (IQCP) for COVID-19 test systems
  • FDA authorization of the Lucira™ COVID-19 All-In-One Test Kit for home use and at the point of care

For additional information, refer to the LOCS message sent on November 12, 2020.

Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Laboratory Outreach Communication System | 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: December 19, 2020