Accreditation Validation Surveys - Citations and General

6152 - Accreditation Validation Surveys - Citations and General Description (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The statutory basis for validation surveys of accredited laboratories is found in 353(e)(2)(D) of the PHSA. This section requires the Secretary to evaluate and report to Congress annually on the performance of each approved accreditation organization. Further, it requires the Secretary to evaluate the performance of each organization by: • Surveying a sufficient number of laboratories accredited by the organization to allow a reasonable estimate of performance by the organization, and • Using such other means as the Secretary determines appropriate. Regulations authorizing such surveys are found at 42 CFR Part 493, Subpart E, Accreditation by a Private, Nonprofit Accreditation Organization or Exemption under Approved State Laboratory Programs. Section 493.563 provides that validation surveys may be conducted on a representative sample basis, (sample validation survey) or in response to a substantial allegation of noncompliance (complaint). The SA performs all validation surveys of accredited laboratories except accredited federal laboratories, which are performed by CMS. The SA and CMS conduct the validation surveys according to established procedures for certification surveys of non-accredited laboratories (see Appendix C) in order to assure a fair basis for comparing the effectiveness of the AO programs. Validation surveys cover all CLIA conditions in the specialties and subspecialties listed on the CLIA certificate for which the AO is approved. Sample validation surveys are performed no later than 90 calendar days after AO’s inspection. As part of the validation review process, CMS may conduct onsite visits at the AO’s headquarters to verify administrative integrity.