Établissement Français du Sang Auvergne-Loire, Saint-Étienne ; Université Jean-Monnet, Faculté de médecine, EA 3064-GIMAP, Saint-Étienne
Soon after the black 80’-90’ period for blood transfusion, a need for a dedicated information to patients has emerged; it became mandatory in France in 1996, first through the decision to prescribe pre- and post-transfusion lab testing, and then through a regulatory decision indicted in 1998 and still in place. The 2002 Law named after Kouchner did not significantly modify this regulatory decision but precised it. First, information to the patient is the law; and second, the physician has to obtain the informed consent of his/her patient who thus, participates to the decision. The information must be given orally but can be achieved by means of a written document. To date, however, no signature is requested, though the traceability must absolutely be completed. A patient’s file relative to transfusion must be opened and completion of this file best guarantees not only the transfusion but also the related information traceability, along with subsidiary means such as letters to family practice physician, presence of witnesses etc. It may happen that information is rendered difficult either in case of emergency or when communication is difficult or impossible. Further, information relative to transfusion may be delivered along with several others, some of them being harsh (severe disease diagnosis, heavy treatment, etc.); in such cases, it may be necessary to deliver the transfusion information sequentially and to check its completion. Last, information must concern actual data, including rare but severe complications, as far as they are described; it can omit exceptional hazards. It must focus on recorded data, and be precise on the most feared hazards such as viral contamination which are presently very low. To comply with his/her obligations, the physician must be informed himself/herself and trained. This process can certainly be improved in a quality process.