[Inspection of transfusion sites by the French Blood Establishment].
Blood transfusion was concerned by two important reforms. The first one followed the French law dated January 4th, 1993, which created the French Blood Agency, Agence française du Sang (AFS). The second reform followed the law dated July 1st, 1998, which founded the French national blood service and set up the Etablissement Français du Sang (EFS) as a unique operator, as well as the Agence Française de Sécurité Sanitaire des produits de Santé (AFS-SAPS) as the control instrument of blood cell products. There are several kinds of inspections concerning the production of products, the manufacturing of reagents, tissue banks, cellular therapy and product irradiation. The inspections are always followed by a report that points out malfunctions. The inspections may also lead to the issue of warning letters or official notifications. In those cases, it is the EFS chairman who directly answers to the general director of the AFSSaPS. Those inspections are supported by a close follow-up done by the EFS.
Chevrolle
F
F
françoise.chevrolle@efs.sante.fr
Hadzlik
E
E
Suchel
P L
PL
D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D001803:Blood Transfusion / Q000592:standards*; D005568:Forms and Records Control; D005602:France; D006077:Government Agencies; D006801:Humans; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control; D012449:Safety