12/19/2020: Lab Update: CMS Updates FAQs for CLIA Guidance during the COVID-19 Public Health Emergency
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 Emergency” 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:
- Individualized Quality Control Plan (IQCP)
- Clinical Laboratory Improvement Amendments (CLIA)
- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
- Information for Laboratories about COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up.
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)