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Abstract: Incidents and accidents analysis is one part of risk management in healthcare organisations. It is based on methods such as healthcare process analysis and the Association of Litigation and Risk Management (ALARM) method, to understand not only immediate causes but also root causes. The goal is to implement relevant remedial and preventive actions to secure healthcare processes. The hospital''s risk management unit has to be involved in the methodological analysis of every grade zero transfusion incident. The system is based on a retrospective analysis process in compliance with the French National Authority for Health''s ongoing requirements for risk reactive approach, allowing to identify failures and start relevant actions. Healthcare teams should overcome difficulties in order to be totally involved in the process. Human factors recognition, establishment of clear and effective communication between individuals and critical points of control should provide optimum quality care services that are safe and free of unnecessary risks. [Copyright &y& Elsevier]

Abstract: The hospital risk management department is firstly involved in the methodological analysis of grade zero transfusion incidents. The system is based on a subsequent analysis process in compliance with the ongoing requirements of the Haute Autorité de santé (HAS) for a reactive approach to risk, allowing to identify failures and start the appropriate preventive and corrective measures. The use of the association of litigation and risk management method makes easier the grade zero analysis and brings to light the team or institutional, organizational, temporal, individual factors representative of undesirable effects. Two main factors come out again from this analysis, the absence of the identification bracelet coupled with a disrespect of transfusion procedures in force. The whole institution must be concerned by these improvement actions. Health teams should overcome difficulties to be totally involved in such a process. Human factors’ recognition, establishment of clear and effective communication between individuals and information sharing should provide optimum quality care services which are safe and free of unnecessary risks. [Copyright &y& Elsevier]

Abstract: 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. [Copyright &y& Elsevier]

Abstract: The sanitary vigilances represent a permanent sanitary surveillance. They signal, enregister, treat and investigate the adverse events occurring through the use of health products. They assure the traceability of these health products and the management of the sanitary alerts. The sanitary vigilances are part of the sanitary security. They are optimized when coordinated and integrated to the global risk management process of the health care establishments. [Copyright &y& Elsevier]