January 13, 2021
The Centers for Medicare and Medicaid Services (CMS) released an updated memo on Friday, Jan. 8, that provides information necessary for CLIA surveyors to consistently survey laboratories for implementation of the CLIA SARS-CoV-2 reporting requirements, which were implemented as a result of an interim final rule published in the Federal Register on Sept. 2, 2020. The updated memo expands on the guidance provided in a previous memo published on Aug. 26, 2020, and takes effect immediately.
The Department of Health and Human Services also released a related document on Friday that outlines the agency’s requirements for data submission. The document includes a list of options to satisfy the reporting requirements. The requirements apply to all laboratories—including laboratories, testing locations operating as temporary overflow or remote locations for a laboratory, and other facilities or locations performing testing at point of care or with at-home specimen collection related to SARS-CoV-2.
Following an October 2020 request for clarification from AABB, America’s Blood Centers and the American Red Cross, David R. Wright, director Quality Safety & Oversight Group, Center for Clinical Standards and Quality, CMS, confirmed that SARS-CoV-2 antibody tests performed by blood centers are subject to CLIA and the test results reporting requirements. He indicated that CLIA will only assess if laboratories have, or have not, reported SARS-CoV-2 test results to state and local health departments.
Organizations for which AABB is the CLIA provider may submit questions to email@example.com. Other organizations may submit questions to LabExcellence@cms.hhs.gov.