Background - CMS Approval of Accreditation Organizations

6150 - Background - CMS Approval of Accreditation Organizations (AO) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Section 353(e) of the PHSA permits the Secretary to approve private nonprofit accreditation organizations and thereby determine that laboratories accredited by the approved accreditation organization (AO) are deemed to meet CLIA requirements. An AO may be approved for a maximum of 6 years and must re-apply for each succeeding approval. When CMS approves an AO, a notice is published in the “Federal Register” stating the name of the organization, the specialties, and subspecialties for which it is approved, and the basis for the approval of that accreditation organization. If it is later determined that the accreditation organization no longer meets the applicable requirements set forth in 42 CFR 493, Subpart E of the regulations, CMS will publish a notice in the “Federal Register” containing a justification of the basis for removing deeming authority from an accreditation organization. The AOs are: • Association for the Advancement of Blood and Biotherapies (AABB); • American Association for Laboratory Accreditation (A2LA); • Accreditation Commission for Health Care, Inc (ACHC) • American Society for Histocompatibility and Immunogenetics (ASHI); • COLA; • College of American Pathologists (CAP); and • The Joint Commission (TJC).