State Operations Manual (Pub. 100-07), Ch. 6 § 6140.3

Conducting Surveys of Laboratories Performing Waived Tests

Last amended: 2020Year: 2020Length: 58 wordsOfficial source
6140.3 - Conducting Surveys of Laboratories Performing Waived Tests (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) In any laboratory holding a CLIA certificate, waived tests are generally not subject to routine survey. If the SA is surveying a CoC or CoA and finds cause that points towards problems in waived testing, the SA should investigate the problem(s).
State Operations Manual (Pub. 100-07), Ch. 6 § 6140.3: Conducting Surveys of Laboratories Performing Waived Tests | Justis AI