Certificate of Registration

6006.1 – Certificate of Registration (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A Certificate of Registration is issued initially to any laboratory that applies for a Certificate of Compliance or Certificate of Accreditation and pays appropriate registration fee(s). A Registration Certificate is valid for no more than a period of two years. When a laboratory applies for a Certificate of Compliance, the Certificate of Registration only indicates that the laboratory is registered with CMS and does not indicate approval or compliance with CLIA requirements. It permits the laboratory to operate until CMS or its designee determines through an inspection that all applicable requirements are met. A Certificate of Registration can be reissued if a laboratory requests an appeal of a sanction imposed as a result of noncompliance with one or more CLIA conditions, which does not pose immediate jeopardy. In such a case, a Certificate of Registration is reissued and remains effective until an Administrative Law Judge (ALJ) of the Department of Appeals Board (DAB) makes a decision. All sanctions imposed against the registration certificate carry forth when reissued. For laboratories applying for a Certificate of Accreditation, the Certificate of Registration indicates only that the laboratory is registered with CMS. It permits the laboratory to operate until CMS receives verification of accreditation approval. Laboratories must provide CMS with proof of accreditation by an approved accreditation program within 11 months of issuance of the Certificate of Registration. When a laboratory has been granted accreditation, a confirmation checkmark is entered into the CLIA Data System by the approving accreditation organization (AO) along with the AO inspection date and inspection specialties information.