TY - JOUR
T1 - Practical guide to personnel competency assessment in clinical histocompatibility laboratories
AU - Ho, Sam
AU - Hod-Dvorai, Reut
AU - Bravo-Egana, Valia
AU - Kheradmand, Taba
AU - Bishop, Christina
AU - Brown, Nicholas K.
AU - Eilrich, Heather
AU - O'Shields, Elaine Forrest
AU - Houp, Julie A.
AU - Sanfilippo, Alan M.
AU - Timofeeva, Olga
N1 - Publisher Copyright:
© 2025 American Society for Histocompatibility and Immunogenetics
PY - 2025
Y1 - 2025
N2 - 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.
AB - 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.
KW - ASHI
KW - CLIA
KW - High complexity testing
KW - Histocompatibility testing
KW - Personnel competency assessment
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U2 - 10.1016/j.humimm.2025.111321
DO - 10.1016/j.humimm.2025.111321
M3 - Review article
AN - SCOPUS:105003677082
SN - 0198-8859
JO - Human Immunology
JF - Human Immunology
M1 - 111321
ER -