Common Citations: Personnel Qualifications and Personnel Files

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Common Citations: Personnel Qualifications and Personnel Files

The following is a list of common inspection citations due to inappropriate personnel qualifications and personnel files:
  1. Laboratory Director
    • Cited for not being qualified under CLIA regulations
    • Cited for the lack of complete or correct qualifying documents in the laboratory director's personnel file
    • Cited when serving as technical consultant without appropriate experience
  2. Technical Consultant
    • Cited for not being qualified under CLIA regulations
    • Cited for the lack of complete or correct qualifying documents in the technical consultant's personnel file
  3. Testing Personnel
    • Moderate complexity: cited when personnel file is missing required documentation inclusive of either a H.S. diploma or a GED
    • High complexity: cited when the personnel file is not inclusive of documentation of certification and highest level of education, as required by CLIA and accreditation agencies
  4. Licensing
    • Cited for state licenses not on file for appropriate personnel, where required
  5. Personnel Qualifying Documentation Incorrect
    • Cited for documentation that does not fulfill the requirements for the designated position, e.g., non-laboratory professional licenses, RN, LPN, etc., vocational training certificates such as phlebotomy training programs, and Professional Organization Certificates (e.g., ASCP)