Complaint Investigations in Non-Accredited, Non-Exempt

5500 - Complaint Investigations in Non-Accredited, Non-Exempt Laboratories (Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25) NOTE: This section applies to complaints against laboratories that hold a CLIA certificate of compliance (CoC), certificate of waiver (CoW), and certificate for Provider- performed Microscopy (PPM) procedures. See sections 5540-5590 for complaints regarding accredited laboratories, and sections 5510-5530 for State laboratory licensure program (SLLP). A complaint is an allegation that could result in citing noncompliance with CLIA requirements. A complaint may be substantiated or unsubstantiated as a result of an investigation or survey. • A substantiated complaint is one resulting in a finding of noncompliance at the time of the investigation, or a finding that noncompliance was proven to exist, but was corrected prior to the investigation. • An unsubstantiated complaint is an allegation where sufficient evidence could not be found to conclude that noncompliance with CLIA requirements existed during the investigation or at the time of the alleged violation. A complaint may be received by either the State Agency (SA) or CMS. The receiving organization should follow the procedures outlined below. The SA or CMS should attempt to obtain the following information for every complaint: • Complainant’s name, address, and telephone number, unless the complainant requests anonymity; • Laboratory’s name and address; • CLIA number; and • Description of problem, (e.g., personnel, places, and dates of occurrence). The SA or CMS should gather as much information as possible to help focus the complaint survey. If a laboratory representative refuses to permit a complaint survey, the SA should contact CMS. There are several entities that may address laboratory complaints including: CMS, SAs, SLLPs, and Accreditation Organizations (AO). Each of these entities share a strong interest ensuring the quality of patient care and the services provided by laboratories. When the complaint involves more than one of these entities, CMS should coordinate communication to ensure an effective and timely resolution of the issue. NOTE: If a SA surveyor identifies potential fraudulent billing activities on a complaint survey, the surveyor should refer the information to CMS so that the information can be referred to the State OIG with a copy to CMS. CMS can then refer the laboratory to the federal OIG.