Certificate of Compliance

6006.4 – Certificate of Compliance (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A Certificate of Compliance is issued to a laboratory after an inspection finds the laboratory to be in compliance with all applicable requirements. The certificate will reflect the effective date for each approved specialty/subspecialty. A Certificate of Compliance may also be reissued to a laboratory that has one or more condition-level deficiencies that do not pose immediate jeopardy (see section 6262). If a Certificate of Compliance is due to expire prior to a hearing date, it may be reissued if CMS finds that conditions in the laboratory do not pose immediate jeopardy. The certificate remains effective while awaiting the hearing decision. All sanctions imposed against the certificate carry forth when the certificate is reissued. A Certificate of Compliance is valid for a period of two years. Upon certificate expiration, and after recertification and payment of appropriate fees, the laboratory’s certificate will be renewed for another 2-year period.