Conducting Investigations in a Laboratory with a Certificate

5510.2 - Conducting Investigations in a Laboratory with a Certificate for Provider-performed Microscopy Procedures (Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25) If the SA receives a complaint on a certificate for PPM laboratory, CMS authorizes an unannounced complaint survey of a laboratory only if based on an allegation of noncompliance. If a survey determines that a laboratory is performing tests that do not qualify under 42 CFR 493.19(c), the laboratory should cease testing. 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 in accordance with 42 CFR 493.47(d). The survey should not differ from a complaint survey done in any other laboratory performing non-waived testing, as all requirements for moderate complexity testing apply, except the routine survey. Note that there are separate D-tags for PPM personnel (D5980-5995). These specific citations should be used for personnel citations in PPM laboratories. The moderate complexity personnel requirements (D6000-D6075, D6190, D6191) should not be used for PPM laboratories. If a PPM laboratory's noncompliance with waived testing is found during the survey and the laboratory is not following the manufacturer’s instructions when performing the waived tests, cite D1001.