Authors : Vikash Chandra Mishra, Dinesh Chandra, Vimarsh Raina
DOI : 10.21926/obm.transplant.2504260
Volume : 9
Issue : 4
Year : 2025
Page No : 1-12
Though the role of clinical histocompatibility testing is fundamental to successful transplant, systematic risk assessment and mitigation strategies remain underutilised in this domain. This review addresses risk identification, analysis, and control measures across the pre-analytical, analytical, and post-analytical phases of clinical histocompatibility testing, in line with international standards such as ISO 15189:2022. A structured, risk-based quality management system (QMS) is imperative for ensuring accurate testing, timely reporting, and subsequently optimal transplant outcomes. Future directions include leveraging digital tools and fostering a culture of continuous improvement in histocompatibility laboratories.