Accredited Laboratories

6106.2 - Accredited Laboratories (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Laboratories accredited by a CMS approved organization are deemed to meet the requirements of 42 CFR Part 493. When CMS/SA receives notification from a laboratory, which was previously inspected by CMS/SA, that it has been accredited, the SA verifies the laboratory’s accreditation status by asking the laboratory for documentation of its application to the accreditation organization before removing the laboratory from the CMS/SAs biennial survey schedule. A laboratory requesting a change from a Certificate of Compliance (CoC) to a Certificate of Accreditation (CoA) remains under CMS’ jurisdiction until the condition-level deficiencies are corrected. If any standard-level deficiencies are pending, the SA discontinues any follow-up on the deficiencies and forwards the pending deficiencies to the laboratory’s accreditation organization. If the pending deficiencies are serious and represent a threat to the quality and reliability of the laboratory’s testing, i.e., condition-level non-compliance exists, the matter is referred to CMS. A laboratory’s accreditation cannot be recognized until it has corrected its condition-level deficiencies. Withdrawal or Denial of Laboratory Accreditation When an accreditation organization withdraws or denies a laboratory’s accreditation, CMS will authorize the SA to conduct a complaint investigation to determine compliance with all CLIA requirements. (See SOM Chapter 5, “Complaint Procedures”). CMS takes appropriate enforcement action if deficiencies are found. If the laboratory is found to be in compliance with all CLIA requirements, the SA obtains an updated Form CMS-116 and processes the change in certification type.