Effect analysis of failure mode and effects analysis-based quality improvement activities in the organ donation after...

Organ donation after brain death is a time-critical, structurally complex process involving multiple multidisciplinary teams, but systemic risk management approaches remain limited. This study applied stage-specific failure mode and effects analysis (FMEA) to identify procedural risk factors and evaluate quality improvement (QI) activities. This study was designed as a single-center pilot to evaluate the feasibility of stage-specific FMEA as a structured risk management approach in this setting.

In this retrospective observational study, the organ donation after brain death process was defined as seven stages with 45 failure modes. A multidisciplinary FMEA team evaluated stage-specific risk priority numbers (RPNs) before and after implementing five targeted QI activities. Following implementation across four consecutive donor cases, pre- and postintervention RPNs were compared using the Wilcoxon signed-rank test.

Preintervention, the highest-priority stages were stage 1 (family interview; mean RPN, 2304.5), stage 3 (donor organ suitability evaluation; 1171.3), and stage 2 (first brain death examination; 532.3). Postintervention, RPNs decreased across all seven stages. The greatest reductions occurred in stage 3 (1171.3-583.6), stage 1 (2304.5-1546.2), and stage 2 (532.3-455.6). The mean±standard deviation of stage-level mean RPNs decreased from 777.1±737.8 to 525.2±466.5 (P=0.016).

Stage-specific FMEA identified structural risk factors throughout the donation process. QI activities, notably the Donation Q-pass system, significantly reduced procedural risk, providing a practical operational model for systemic risk management in organ donation after brain death.