CMS CLIA - Surveillance Testing SARS-CoV-2 Frequently Asked Questions The CMS CLIA “SARS-CoV-2 Surveillance Testing” FAQ (revised 10/21/21) explains when facilities using pooled surveillance testing with non-patient-specific cohort reporting do not need a CLIA certificate during the COVID-19 public health emergency. It highlights key risks of pooled surveillance testing (including dilution-related false negatives/positives) and states that any positive/inconclusive pool results must be confirmed via individual testing at a CLIA-certified facility. It also notes that because these facilities are not CLIA-certified, CMS does not have oversight authority over their quality and safety of result reporting. primary file regulatory surveillance CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md regulatory/surveillance/CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md 2021_10_21 pdf public domain 287 393 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