CMS CLIA - University Lab Testing FAQ (2020-08-28) The CMS Q&A explains when SARS-CoV-2 surveillance testing requires CLIA certification, emphasizing that pooled, non-patient-specific cohort reporting is not considered diagnostic and does not require a CLIA certificate. It clarifies that reporting patient-specific results generally triggers CLIA requirements, but CMS exercised temporary enforcement discretion during the public health emergency if non-CLIA labs only issue presumptive positive/inconclusive referrals to a CLIA-certified lab rather than reporting definitive results. It also outlines pathways for universities to operate under an affiliated lab’s CLIA certificate (including temporary sites) or to apply for an expedited CLIA certificate with a qualified lab director. primary file regulatory surveillance CMS - CLIA University Lab Testing FAQ (2020-08-28).md regulatory/surveillance/CMS - CLIA University Lab Testing FAQ (2020-08-28).md 2020_08_28 pdf Public Domain 566 727 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