[Reporting and notification of transfusion serious adverse events in France].
Surveillance of serious adverse events in transfusion has recently been enforced in all European Union member states, and in France in 2007. This is an important expansion of the field of haemovigilance towards risk management in transfusion from donor selection to recipients follow up. Participation in this notification system is mandatory for all health professionals. They have to report immediately all serious adverse events to the haemovigilance officer of their hospital or transfusion centre. In accordance with a national procedure, the latter has to notify all serious adverse events to regional and national competent authorities using a web-based application. They also have to perform a root case analysis and propose corrective measures. However, as the definition of the seriousness of adverse events is still imprecise, there is a dramatic heterogeneity in the notification level among regions. Therefore, basic criteria of evaluation of surveillance systems, such as sensitivity or representativeness, are not fulfilled. Next step will be the introduction of a more precise definition of seriousness, through a list of events to be notified, in order to achieve a quality level similar to that of transfusion adverse reactions surveillance.
Agence Régionale de Santé du Languedoc-Roussillon, 28 Parc-Club-du-Millénaire, 1025 rue Henri-Becquerel, CS 30001, 34067 Montpellier cedex 2, France. gerald.daurat@ars.sante.fr
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D058731:Blood Safety; D001803:Blood Transfusion / Q000331:legislation & jurisprudence; D005062:European Union; D005568:Forms and Records Control; D005602:France; D006801:Humans; D019221:Mandatory Reporting; D011159:Population Surveillance; D012308:Risk Management; D065227:Transfusion Reaction