Clinical Laboratory Improvement Amendments of 1988 (CLIA) CMS Locations and State Agency Remote Survey Guidance - Optional Process

• CMS is committed to taking critical steps to allow CMS Locations and State Agency surveyors flexibility to perform CLIA recertification surveys to ensure America’s clinical laboratories are in compliance with the CLIA regulations amid the public health emergency (PHE) caused by the SARS-CoV-2 virus that causes Coronavirus Disease 2019 (COVID-19). • CMS is issuing this memorandum to CMS Locations and CLIA State Agencies to provide important guidance to surveyors for optional implementation of this remote survey process during the PHE. • All guidance in this memo is applicable only during the PHE. • Laboratories must follow applicable Federal, State, and local laboratory requirements. • This optional remote CLIA recertification survey process will only apply to laboratories with good compliance history. This does not apply to initial surveys.