Primary Source Verification to Be Used for Verifying Personnel Qualifications Under CLIA

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), surveyors may now accept Primary Source Verification (PSV) as evidence of compliance with mandated personnel qualifications. A policy memorandum posted on March 26 supersedes a previously expired (as of Dec. 6, 2024) CLIA provision regarding personnel policies for individuals directing or performing nonwaived tests under CLIA regulations. If PSV is unable to verify certain required elements in the personnel regulations, it is the responsibility of the laboratory director to verify they are met by other means. PSV may be submitted for laboratory director qualifications.

No changes have been made to CLIA personnel regulations or the policy on mandatory citations.

Source: https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-16-18