State Operations Manual (Pub. 100-07), Ch. 6 § 6140.3
Conducting Surveys of Laboratories Performing Waived Tests
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).