Conducting Investigations in a Laboratory with a Certificate of

5510.1 – Conducting Investigations in a Laboratory with a Certificate of Waiver (Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25) If the SA receives a complaint on a CoW laboratory, CMS authorizes an unannounced complaint survey of a laboratory only if it is based on an allegation of noncompliance. The fact that a deficiency is not at the condition-level does not preclude taking adverse action based on provisions contained in 42 CFR 493.1775. As with other laboratories, the SA investigates complaints made against laboratories with a CoW by means of an on-site survey, by telephone, letter, or by a review of documents. The SA performs the on-site investigation based on the allegation and determines whether a laboratory is performing only waived tests and if the laboratory is following the manufacturer’s instructions for performing the tests. See SOM Appendix C. If a survey determines that a laboratory is performing tests that are not waived, the laboratory should cease testing of the non-waived tests that do not qualify under 42 CFR 493.15(c) and 493.39(a). If the laboratory wants to continue performing non-waived tests, they must submit a CLIA application for the appropriate level of testing and designate a qualified laboratory director. The SA should notify CMS so a cease-and- desist letter and/or notice of other adverse actions for testing outside of the current CLIA certificate can be sent by CMS to the laboratory.