12/15/2020: Lab Advisory: CMS Issues Guidance for SARS-CoV-2 Point-of-Care Tests and CLIA Certificates of Waiver

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

On December 14, 2020, the Centers for Medicare & Medicaid Services (CMS) posted a question and answerpdf iconexternal icon (Q&A) document that provides guidance on the temporary enforcement discretion for any facility that has applied for a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver (CoW) to perform SARS-CoV-2 point-of-care (POC) testing, but has not yet been assigned a CLIA number:

  • In order to perform SARS-CoV-2 POC testing, a facility must be a CLIA-certified laboratory that meets applicable regulatory requirements.
  • Facilities that have submitted a CLIA 116 application for a CoW must check with their State Agency (SA) before they begin testing. States may have more stringent licensure requirements that the facility is required to meet before POC testing can begin.
  • Facilities that have applied for a CLIA CoW to perform SARS-CoV-2 POC testing may begin testing and reporting patient results as soon as they have submitted their application to their State Agency (SA) and meet all applicable State licensure requirements.

Refer to the Q&A document for more information.

Online CDC resources:

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)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: December 15, 2020