Area of activity
Safety of blood, tissues and organs 

Summary
The overall project falls within the area addressing the quality and safety of blood.
The project is targeted primarily at those responsible for implementing quality systems in blood establishments, in compliance with the requirements of Directive 2002/98/EC, as well as relevant staff. 

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Total cost
495.028,87 €
Subsidy from the Commission
 297.017,32 €

Results to be achieved
Work Package n°1 - Startup Phase
- project information to participants (communication C1)
- designation of contact persons
- set-up of a communication platform

Work Package n°2 - Preparatory Phase
- design questionnaire and send out (C2)
- fill-in questionnaires by participants and return
- compile responses into a working document

Work Package n°3 - 1st Meeting Phase
- send-out invitation to the meeting  (C3)
- compile agenda for the meeting
- Project 1st meeting
- identify areas that need to be developed (priority areas)
- define working groups
- distribute work activities among participants
- write meeting summary including consensus document on manual contents and EU-SOP-survey report

Work Package n°4 - Manual Drafting Phase
- draft quality relevant contents in working groups
- accompany working groups start-up
- exchange of interim results between working groups
- create a list of minimum requirements - SOP structure including a checklist on formal requirements of SOP structure
- create framework document on the manual

Work Package n°5 - Test Phase
- 1 SOP example / priority area (working groups)
- SOP draft (topic crossing between working groups)
- liaison of project team with working groups
- pre-evaluation of SOP examples by working groups
- final evaluation (project team)
- send-out of test results (evaluation report) to participants

Work Package n°6 - Manual Completion Phase
- collecting feedback (revision) by working groups on drafted manual
- unit all revised WG drafts into one document
- send-out invitation to the meeting (C3)
2nd project meeting
- discussion of the draft manual
- agreement on the draft manual document
- assignment of persons (contact or other) for translation of the manual

- complete annexes
- finalize 50 page consensus manual
- perform provisional translations (German, French, Czech, Polish)

Work Package n°7 - Conclusion Phase
- editing of manual
- advertise copies on web
- distribute replicates of manual
- write final report and publications

Interim report

Statement of project aim(s) and objectives
The overall objective of the project is to contribute to good quality management (QM) in blood services, based on the requirements set out in Directive 2002/98/EC and its technical annexes. It will deliver this through the development of a manual that will assist blood services to implement or expand their standard operating procedures (SOPs). It is recognized that SOPs are only one aspect of QM.
This SOP "tool" will address the responsibilities of blood establishments, including those that carry out routine activities and those that are highly specialised, as well as hospital blood banks.
Specifically the project will
1. assess the existence of SOP manuals and guidelines currently used in the 16 blood services involved in the project in order to identify (A) international and national SOP manuals already in place and (B) the current inspection practice;
2. develop a manual to assist blood establishments to develop and implement their own SOPs.
3. test this new SOP methodology among the partner institutions.
4. produce this manual in 5 languages and distribute it to the participating blood establishments.
 

Methods
1. Within each of the 16 participant blood services from 16 member states, a nominated person will be appointed who will be the formal point of contact. This person should be competent in transfusion medicine, experienced in quality management, bilingual (native and English or German) and will assist in setting-up the multilingual structure of the project and its accompanying documents.
2. An internet-based communication platform will be set up with the project participants, and the information linkages will be identified and integrated with each of the participants.
3. A questionnaire will be designed in order to find out the current status of SOPs, their structures and any potential manuals or regulations that are in place in the various participant institutions and countries, including the current inspection practice.
4. Based on this questionnaire an SOP-survey-report will be prepared. This will include differences and commonalities in the approach to basic structural questions in quality management and specific aspects considering SOPs. It will identify some of the perceived high risk areas in blood collection, preparation, laboratory testing, storage and distribution.
5. Based on the EU directive 2002/98/EC and its technical annexes, quality relevant contents of SOPs, documents related to SOPs and the described working practice will be agreed by the partners in the areas of donor recruitment and blood collection, standard blood component production and testing, molecular diagnostics (blood group and virus testing), special blood component and logistics and management in order to form a common EU-SOP methodology. This new EU-SOP methodology will comprise precise quality requirements, requisites and quality terms linked to the EU directive and based on GLP/GMP-standards that have to be specified (filled-out) in order to complete the documents. These quality requirements will be set-up in a modular fashion, in order to tailor the SOPs to meet local circumstances. Four working groups will be established and, in continuous work and in two consecutive working group meetings to be held within each of the groups, will cover the following four areas: (1) donor recruitment, collection, component production and testing; (2) immunohematology and molecular diagnostics; (3) special component production; (4) logistics, storage, distribution and management.
6. Within the participants of the project, the SOP manual will be tested. This will be ideally in areas where no similar SOPs have yet been established, and in institutions, or with persons, who have not been part of the project's working groups.
7. Based on the validation process all quality relevant contents will be summarised in an EU-SOP-Manual on the steps required to create and write SOPs for blood establishments. This manual will be supplemented by practical examples of SOPs used during the SOP testing phase.