European Project adressing the safety
of blood transfusion
Project Working Groups
The Project will be carried out by working groups (WG) covering the complete inspection process for blood establishments. The inspection process will be divided into four areas as follows:
System requirements (Directive 2002/98/EC and 2005/62/EC)
WG 1: Quality management system evaluation
Technical requirements (Directive 2002/98/EC and 2004/33/EC)
WG 2: Donor recruitment and blood collection
WG 3: Processing and testing
WG 4: Blood component issuing, storage and logistics
Based on framework documents delivered during the survey phase of the Project, the working groups will specify the common criteria for inspections in their working areas. This will include defining the inspection requirements for the structure of quality systems used by blood establishments to assure best practice. They will develop checklists based on the blood legislative to be fulfilled by blood establishments to assure good practice.
The working groups will identify criteria for the evaluation of the checklist (acceptance or rejection) and a benchmark system to allow for systematic evaluation of these results on a European level.