[Labile blood product traceability: definition, regulation, evaluation, and perspectives].
The traceability of blood products is an essential part of hemovigilance and transfusion safety. Law no 94-68 of 24 January 1994 is the legal foundation of the system of traceability. In this article, the structures of the system and the main actors are discussed. An evaluation of the system of traceability showed that it is both feasible and adaptable. An evaluation process is needed to assess the proper functioning of the system and to detect and prevent possible deficiencies.
Unité bioclinique d'hémovigilance, hôpital Saint-Vincent-de-Paul, Paris, France.
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Pélissier
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Nguyen
D000906:Antibodies; D001688:Biological Products / Q000592:standards*; D001769:Blood; D001798:Blood Proteins / Q000592:standards; D001803:Blood Transfusion; D003140:Communicable Disease Control / Q000331:legislation & jurisprudence / Q000379:methods* / Q000458:organization & administration; D005568:Forms and Records Control; D005602:France; D006801:Humans; D011356:Product Labeling; D015397:Program Evaluation; D011786:Quality Control; D011996:Records / Q000592:standards
D000906:Antibodies; D001688:Biological Products; D001798:Blood Proteins