Objective of Validation Surveys of Accredited Laboratories

6154 - Objective of Validation Surveys of Accredited Laboratories (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The validation program is designed to evaluate the premise that a laboratory that receives accreditation is in fact meeting CLIA requirements. By comparing the CLIA findings of each validation survey to the AO’s inspection results, calculating the disparity rate as prescribed by the regulations, and reporting the results to Congress annually, CMS fulfills the statutory responsibility. The results of the validation surveys provide: • On a laboratory-specific basis, insight into the effectiveness of the accreditation organization’s program, and • In the aggregate, an indication of the organization’s capability to assure laboratory performance equal to or more stringent than that required by CLIA.