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F Chevrolle

Publications and source records attributed to F Chevrolle.

5 recordsLinked to original sources

[Quality assurance in blood transfusion].

Quality assurance is a legal obligation in the blood transfusion sector, dictating good practice procedures for blood banks. Application of good practices leads to the construction of a quality assurance system guaranteeing transfusion safety from donor to patient and from donation to dispensing of blood products that must meet recognized standards and predetermined targets. Good practice procedures are thus designed to meet legal requirements but an appropriate quality assurance system should not be limited to this regulatory approach. Considering public health and medical safety goals, quality assurance management must be conducted within the framework of a solid organization of team responsibilities and complementary interactions. Changing legal regulations concerning the blood transfusion sector offers a real opportunity for the organization of a homogeneous approach implying self-sufficient supply, product quality, and transfusion safety.

Blood Transfusion↗

[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.

Blood Banks↗

[Blood transfusion audit methodology: the auditors, reference systems and audit guidelines].

The audit has become an essential aspect of the blood transfusion sector, and is a management tool that should be used judiciously. The main types of audit that can be envisaged in blood transfusion are the following: operational audit concerning a predetermined activity; systems quality audit; competence audit, combining the operational audit on a specific activity with quality management, e.g., laboratory accreditation; audit of the environmental management system; and social audit involving the organization of an activity and the management of human resources. However, the main type of audit considered in this article is the conformity audit, which in this context does not refer to internal control but to conformity with an internal guideline issued by the French National Blood Service. All audits are carried out on the basis of a predescribed method (contained in ISO 10 011). The audit is a system of investigation, evaluation and measurement, and also a means of continuous assessment and therefore improvement. The audit is based on set guidelines, but in fact consists of determining the difference between the directions given and what has actually been done. Auditing requires operational rigor and integrity, and has now become a profession in its own right.

Blood Banks↗

[Inspection of blood transfusion establishments].

Required by the law, the medico-technical inspection of blood banks is a centralized, specialized and pluridisciplinary inspection in order to check that blood transfusion centers abide by the official regulations implemented to assure the quality of products and transfusion safety.

Blood Transfusion↗