Action
Enhancing the
capability of responding rapidly and
in a co-ordinated fashion to health
threats
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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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
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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.
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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.
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