Practical guide to personnel competency assessment in clinical histocompatibility laboratories

Deficiencies in personnel competency assessment are among the most frequent citations of the Clinical Laboratory Improvement Amendments (CLIA) and Accreditation Organizations with deeming authority, such as the American Society for Histocompatibility and Immunogenetics (ASHI). Despite having been introduced decades ago in the CLIA regulations of 1988, potential confusion and misinterpretation on who, what, when, and how to assess competency remain. Herein, the ASHI Professional Standards Division taskforce, consisting of leadership from the Accreditation Review Board, the American College of Histocompatibility and Immunogenetics, the Proficiency Testing Committee, and the Quality Assurance and Standards Committee, sought to provide clarifications, guidelines, recommendations, and best practice suggestions on how personnel competency should be assessed in clinical histocompatibility laboratories to achieve regulatory compliance.