Risk Assessment in Clinical Histocompatibility Testing: Challenges, Strategies, and Future Directions
Abstract
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 fo [...]