CMS CLIA - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question The CMS CLIA “SARS-CoV-2 Variant Testing” FAQ (3/19/2021) outlines when sequencing-based surveillance for genetic variants can be done without a CLIA certificate, so long as results are not reported to individuals or their health care providers and are not used for individual decision-making. It describes CMS’s temporary enforcement discretion allowing non-CLIA facilities (and certain CLIA labs) to report patient-specific variant results to state/local public health departments for public health uses like outbreak detection and contact tracing. It also clarifies that if variant results are intended for diagnosis, prevention, treatment, or health assessment, testing must be performed in a CLIA-certified lab in compliance with CLIA requirements (including performance specifications expectations). primary file regulatory surveillance CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md regulatory/surveillance/CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md 2021_03_19 pdf public domain 749 1012 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url