Verification of Laboratory Director Qualifications

6006.7 – Verification of Laboratory Director Qualifications (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Laboratories applying for a Certificate for PPM procedures, Certificate of Compliance or Certificate of Accreditation must meet the qualifications of Laboratory Director as found in Sections 493.1357, 493.1405, 493.1406 and 493.1443. The SA is responsible for verifying that the Director meets the appropriate personnel qualifications. The SA may request the Director to provide the following documentation: evidence of meeting state licensure requirements (if applicable), copy of diploma, transcripts from an accredited institution, evidence of Continuing Education (CE) credits in laboratory practice, appropriate laboratory experience, etc. Laboratories may choose to use primary source verification (PSV) to confirm personnel credentials and provide PSV documentation as evidence of compliance with the personnel requirements stated in 42 CFR Part 493, Subpart M. The use of a PSV report as evidence of meeting CLIA personnel qualifications is optional for the laboratory. The laboratory may provide both direct observation of documents, PSV documents, or a combination of both to achieve compliance. PSV is the process of confirming an applicant's credentials by verifying that a degree, certificate, or diploma was received; that licenses were granted; and, by confirming reported work history, such as company names and locations, dates, and positions held. Verifications are obtained either directly from an institution, former employers, or their authorized agents.