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Update GEN.54400 - Personnel Qualification Records

To College of American Pathologists (CAP) Accredited Laboratories:

As a service to CAP-accredited laboratories, the CAP is providing the following update on the Laboratory General Checklist requirement GEN.54400 Personnel Qualifications Records.

Effective immediately, the CAP's Laboratory Accreditation Program will accept the use of primary source verification (PSV) reports as evidence of compliance for GEN.54400 to confirm testing personnel qualifications in lieu of obtaining paper copies of these records. PSV is typically performed by a third-party agent or company that directly contacts institutions and former employers to verify training and experience, such as diploma, board certification, licensure, and reported work history. This change is pursuant to the Centers for Medicare and Medicaid Services (CMS) Survey and Certification Memorandum S & C:16-18 CLIA issued on April 1, 2016. The use of PSV is optional and laboratories may choose to continue to maintain copies of other personnel qualification records (e.g. diploma, transcripts) instead.

The CAP advocated for use of PSV with the CMS and is pleased to offer this option to laboratories. The related checklist requirement GEN.54400 will be revised in the summer 2016 checklist edition to reflect this change. Laboratories being inspected with the 2015 CAP Checklist edition may implement this change now, if desired.

Please note that the PSV company is not responsible for determining whether a given individual meets the personnel qualifications for the duties performed; PSV companies merely confirm that the asserted training, diplomas, and certifications have been achieved or conferred. If there are required elements for the qualification that the PSV report does not adequately verify, there must be records showing that qualifications are met using other means.

The following changes to GEN.54400 (Personnel Records) will be published in the 2016 Checklist edition and are effective immediately:

  • A copy of the academic diploma, transcript, or PSV report may be used to confirm credentials.
  • If PSV reports are used, the laboratory must have a defined system for reviewing the reports, with written criteria for acceptance.
  • If there are required elements for the qualification that the PSV report does not adequately verify (eg, transcripts, educational equivalency for personnel trained outside of the US, or reports lacking the type of degree earned), there must be records showing that qualifications are met using other means.
  • The training and qualifications of all personnel trained outside of the US must be evaluated to determine equivalency of their education to an education obtained in the United States, with records of the evaluation available in the personnel file. The equivalency evaluations should be performed by a nationally recognized organization. For Department of Defense laboratories, the equivalency must be performed using a process approved by the Center for Laboratory Medicine Services.
  • Previous provisions in the checklist note for obtaining a paper copy of the diploma or transcript within seven days of request and for initial validation and ongoing verification of a credentials verification organization will be removed from the checklist.

The CAP offers compliance alerts to help your laboratory maintain continuous compliance. If this impacts your laboratory’s operations, a copy of this eAlert should be retained in your files to present to inspectors as needed.

Questions? Contact us at 800-323-4040 or accred@cap.org.