Certificate of Accreditation

6006.5 – Certificate of Accreditation (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A Certificate of Accreditation is issued to a laboratory after the accrediting organization certifies the laboratory according to its certification requirements. The Certificate of Accreditation will reflect the effective date for each specialty/subspecialty approved by the accreditation organization. Upon a certificate’s expiration, and after payment of appropriate fees, the laboratory’s certificate will be renewed with a new 2-year effective date unless CMS is notified by the accreditation organization of a laboratory’s loss of accreditation status. In the event of a condition-level noncompliance determination as a result of a random sample validation or complaint survey, a laboratory with a Certificate of Accreditation is subject to a full review by CMS or its designee. A Certificate of Accreditation may be issued to an accredited laboratory that is out of compliance at the condition-level provided a credible Allegation of Compliance (AoC) is received by CMS or its designee, and the non-compliance does not constitute immediate jeopardy, even if a hearing is pending.