[Patient safety and root cause analysis]. / Sécurité des patients et analyse des causes racines.

Safety in the field of transfusion medicine has greatly improved in France. The risk of viral transmission has decreased by a factor greater than 1500 within the last 20 years. In comparison, the risk related to ABO error has decreased only by half. The reporting of critical incidents, which occur at any step of the transfusion procedure is now mandatory in France and is subject to an in-depth analysis, using methods close to that used in aviation safety. The goal of these analyses is to better understand human factors in order to implement more adequate prevention measures.

[Post-transfusion pulmonary oedema: the French hemovigilance network classification method]. / Œdèmes pulmonaires transfusionnels: classification des cas notifiés en hémovigilance.

Pulmonary oedema after transfusion of blood products may be hydrostatic (transfusion-associated circulatory overload [taco]) or exsudative (transfusion-related acute lung injury [trali]). Both conditions have been recognized as major hazards to transfusion recipients. Risk characterization is necessary to improve safety and to monitor trends in the national blood transfusion system. A collaborative multidisciplinary working group of the French National Hemovigilance Committee has proposed an analysis framework for case definitions and classification. The method relies on internationally used definitions and is adapted to the codification procedures used in the french transfusion incident reports electronic data management.

[Coordination of health vigilances: for a global management of hospital risks]. / La coordination des vigilances sanitaires : pour une gestion plus globale des risques hospitaliers.

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.

[Transfusion safety and haemovigilance committees]. / Le comité de sécurité transfusionnelle et d'hémovigilance.

Transfusion safety and haemovigilance committees (TSHC) were initially created in the public health care sector. Nowadays, they are also a mandatory committee of private health care institutions. The members of the TSHC, as well as the way the committee is driven and organized, are defined by law. The aim of the committee is focused on the management of transfusion safety and haemovigilance. The TSHC takes part in the improvement of the safety of transfused patients, and monitors the applying of haemovigilance rules. It also handles the training of all staff members involved in the blood transfusion process.

[Materials surveillance, a surveillance performed on the use of medical devices]. / La matériovigilance, une vigilance exercée sur l'utilisation des dispositifs médicaux.

One of the missions of the Agence Française due Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whole blood chain from blood collection to receivers' follow-up. This system is now operational and contributes with efficacy to the safety of blood transfusions (see: A quoi sert l'hémovigilance? Transfus Clin Biol 1998; 5: 415-21.). The French law No. 98-535 dated July 1st 1998, whose enforcement orders were published in March 1999, is the legal foundation of the system. In this article the national and regional structures of the national system of sanitary safety are described, and the main guidelines of material vigilance, the last element of this system, is presented.

[Risk management program in a health facility using a project approach: transfusion risk management]. / Un programme de gestion des risques dans l'établissement de santé à travers une démarche par projet: la gestion du risque transfusionnel.

Risk management in the hospital, which is one of the referentiels of the ANAES accreditation manual, may be considered on two levels. Firstly, risk management may be approached globally, in the same way as it is tackled in the accreditation process. Secondly, risk management may be more definite. A specific risk chosen in accordance with the priorities of a particular plan may be dealt with individually. In this respect, the tranfusion process allows the risk management method to be tested and developed. f1

[What is the use of hemovigilance?]. / A quoi sert l'hémovigilance?

The French Blood Agency has developed a national system of surveillance and alert, from blood collection to the follow-up of the recipients, called haemovigilance. The French haemovigilance network is now operational, and aims at detecting, gathering and analysing unexpected or undesirable effects associated with transfusion in order to remedy their causes and prevent their recurrence. Thanks to 1) traceability of blood products from donors to recipients, 2) spontaneous reports of transfusion adverse events, and 3) rigorous management of information related to the transfusion process, haemovigilance effectively contributes to blood transfusion safety.

[Implementation of a continuous quality improvement program in transfusion medicine]. / Mise en place d'un programme d'amélioration continue de la qualité en médecine transfusionnelle. "Programme Assurance Qualite" (PAQ) et la commission de sécurité transfusionnelle et d'hémovigilance (CSTH) du CHU de nice.

The transfusion safety is one of the themes of National Quality Assurance Programme 1995/1996 (National Agency for the Promotion of Medical Evaluation-ANDEM/Direction des Hôpitaux (National Hospital Authority)). The Quality Assurance Programme (QAP) in transfusion medicine of our University Hospital has been selected. The QAP is a prospective and normative programme, in which all the actors of the transfusion process are involved. The goals are: i) to assure the quality and the safety of the blood products delivered all along the chain leading to blood or blood components transfusion; ii) the guarantee of the exhaustiveness and the quality of information about the transfusion process that are used to mark out blood products; iii) the standardization of the different steps and the creation of "tools" in order to control the application of written procedures.