03/26/2020: Lab Advisory: CMS Issues CLIA Guidance for Laboratories Performing COVID-19 Testing
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory
CMS Issues CLIA Guidance for Laboratories Performing COVID-19 Testing
Today, the Centers for Medicare & Medicaid Services (CMS) issued important guidanceexternal icon and frequently asked questionspdf iconexternal icon (FAQs) to help ensure that clinical laboratories in the United States are prepared to respond to the coronavirus disease (COVID-19) pandemic, while at the same time making sure they can fulfill CLIA requirements. This guidance provides information related to remote reviewing of pathology slides, proficiency testing, alternate collection devices, and requirements for obtaining a Clinical Laboratory Improvement Amendments (CLIA) certificate during a public health emergency. CMS is exercising some flexibilities during this time. However, the agency does not have the authority under the CLIA program to approve waivers (which allow for program modifications).
- CDC’s Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- CDC COVID-19 website
- Clinical Laboratory Improvement Amendments (CLIA)
If you have any questions, please contact us at LOCS@cdc.gov.