CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020) The CMS CLIA Surveillance Testing notice (Dec. 28, 2020) explains when a facility is considered a CLIA-regulated laboratory and states that COVID-19 testing generally requires CLIA certification if patient-specific results are reported. It describes CMS’s temporary enforcement discretion for SARS-CoV-2 surveillance testing in non-CLIA facilities, allowing non-FDA-authorized methods so long as no individual results (e.g., negative/positive/inconclusive) are provided and individuals are only referred to CLIA-certified labs for follow-up. primary file regulatory surveillance CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md regulatory/surveillance/CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md 2020_12_28 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 507 741 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