Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting (REVISED)

• CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to be prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On September 2, 2020, an interim final rule with comment period (CMS-3401-IFC) was published in the Federal Register (85 FR 54820). • CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary. • CMS is providing surveyor guidance for State Agency and CMS Branch Location surveyors related to the CMS-3401-IFC CLIA SARS-CoV-2 test reporting requirements. • The Secretary published updated reporting guidance on March 8, 2022. As a result, CMS has updated the CLIA Surveyor Guidance and Frequently Asked Questions.