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Background: Transfusion-related acute lung injury (TRALI) is a major cause of transfusion-related mortality and morbidity. Epidemiologic studies using data from national transfusion schemes can help achieve a better understanding of TRALI incidence., Study Design and Methods: A multidisciplinary working group analyzed TRALI cases extracted from the French Hemovigilance Network Database (2007-2008). All notified cases were reviewed for diagnosis. Those meeting the Canadian Consensus Conference criteria for TRALI were classified according to imputability to transfusion and clinical severity. Patient data (clinical characteristics, number and types of products transfused, and serology results) were obtained., Results: There were 62 TRALI cases and 23 possible TRALI cases during the 2-year period. An immune-mediated mechanism was identified in 30 of 50 TRALI cases with complete serology. TRALI was considered to be the cause of death in 7.1% of patients and might have contributed to death in an additional 9.4% of TRALI or possible TRALI patients. Occurrence ranked high in obstetrics (15%), after surgery (34%), and in hematologic malignancies (21%). Single-donor high-plasma-volume components were involved in half of the cases where the implicated blood product could be determined and carried the highest risk per component (1:31,000 for single-donor fresh-frozen plasma units and apheresis platelet [PLT] concentrates, and 1:173,000 for red blood cells). No incident could be definitively related to the transfusion of solvent/detergent-treated pooled plasma (>200,000 units transfused), nor to pooled PLT concentrates., Conclusion: The proportion of TRALI cases related to plasma-rich components was lower than previously described., (© 2011 American Association of Blood Banks.)

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 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

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.

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.