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Résumé: Les vigilances sanitaires sont apparues au fil du temps. Certaines possèdent un échelon régional, et toutes se trouvent regroupées à l'Agence nationale de sécurité du médicament et des produits de santé. Avec la certification des établissements de santé (ES), la coordination des vigilances a évolué : son existence semblait facultative dans la première version de la certification, puis s'est imposée aux ES dans les versions suivantes, en précisant les actions à entreprendre. En parallèle, la gestion des risques au sein d'un établissement de santé est en plein essor. La coordination des vigilances trouve avantage dans le partage d'un système déclaratif commun avec la gestion des risques associés aux soins. La collaboration de la coordination des vigilances et de la gestion des risques permet d'élaborer une cartographie a priori des risques, de mettre en place des analyses des évènements indésirables et d'utiliser la notion de criticité dans le cadre d'une culture sécuritaire globale pour l'établissement de santé. [ABSTRACT FROM AUTHOR]

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 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]