[Lessons learned from a distribution incident at the Alps-Mediterranean Division of the French Blood Establishment].

The Alps-Mediterranean division of the French blood establishment (EFS Alpes-Mediterranée) has implemented a risk management program. Within this framework, the labile blood product distribution process was assessed to identify critical steps. Subsequently, safety measures were instituted including computer-assisted decision support, detailed written instructions and control checks at each step. Failure of these measures to prevent an incident underlines the vulnerability of the process to the human factor. Indeed root cause analysis showed that the incident was due to underestimation of the danger by one individual. Elimination of this type of risk will require continuous training, testing and updating of personnel. Identification and reporting of nonconformities will allow personnel at all levels (local, regional, and national) to share lessons and implement appropriate risk mitigation strategies.