Referrals to the Office of Inspector General (OIG) for CLIA

6036 - Referrals to the Office of Inspector General (OIG) for CLIA Violations (e.g., Testing without a CLIA Certificate) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If a laboratory is operating without a CLIA certificate, the SA or CMS as applicable, notifies the laboratory that it is violating CLIA requirements and warns the laboratory of the consequences of such violations. The laboratory is afforded an opportunity to respond within 14 days. If it does not respond or does not cease testing without a certificate within 30 days of the date of the notification to the laboratory, CMS will notify the OIG of the violation. If applicable, the SA forwards documentation to CMS within 20 days of the date the violation notice was sent to the laboratory. In addition, CMS also refers to the OIG: • Cases of misrepresentation in obtaining a CLIA certificate; • Laboratories that perform or represent themselves as a laboratory entitled to perform tests not authorized by its CLIA certificate; and • Laboratories that violated or aided or abetted in the violation of any provision of CLIA and its implementing regulations.