European Project adressing the safety
of blood transfusion


Project Summary

The EU-Blood-Inspection Project falls within area 2.2.4 of the Public Health Programme (2003-2008) Call 2006 - addressing the quality and safety of blood. The Project is targeted at those responsible for the operation of blood establishments and those responsible for inspecting them, in compliance with the requirements of Directive 2002/98/EC and its technical annexes.

Background: In recent years, significant progress has been made with the entry into force of EU legislation on blood, based on Directive 2002/98/EC and its technical annexes. The Directives' main objectives are to ensure the provision of consistently safe blood components across Europe.

EU expansion has increased the importance of these Directives to a level where it is vital to implement a common pan-European standard. Inspection of blood establishments is a key element in the implementation of good practice, according to the Directives. Currently these inspections are performed according to national criteria and standards which differ between Member States. This implies there is a risk that by itself the Directive will not guarantee consistently safe blood across Europe.

According to the Work Plan 2006 of the Public Health Programme (Area 2.2.4), there is now a need to give impetus to ensuring equivalent recognition of inspections of blood establishments among Member States through the development and implementation of commonly accepted criteria and standards. This is important because, without it, there will remain different levels of risk from having a blood transfusion in different Member States.

Projects objectives:
The overall objective of the Project is to develop and implement commonly accepted criteria and standards to ensure equivalent recognition of inspection of blood establishments among Member States.

It will deliver this through the development of a manual that will define:
  • common inspection criteria and standards for the inspection of blood establishments
  • requirements for the implementation or expansion of quality management systems to be inspected
  • the development of inspection checklists which closely follow Directive 2002/98/EC and its technical annexes
  • evaluation criteria for inspections and a benchmark system for deviations and improvements
The manual will be used as a basis of a training programme for the inspectors of blood establishments. This will ensure that the standards and criteria are commonly accepted.