Work Process and Deliverables

EU-Q-Blood Survey

EU-Q-Blood Survey on Quality Management Systems implemented in the participating EU member, Applicant and EFTA countries Definition of areas of particular interest and risk in blood transfusion

The questionnaire has been structured into 4 Sections and was sent out to the participating blood establishments and governmental institutitons in November 2005

Questionnaire sections:
  • Basic Validation (Q1-Q9)
  • Principle Management Requirements (Q11)
  • Working Areas (Q12 and Q13)
  • Areas of Interest and Risk.
The questionnaire was used to assess the regulatory status regarding the Quality management systems (QMS)-Systems in the participating countries. It was also intended to get basic information about the size of the services, the kind of laboratory tests and the testing process (blood component related, patient diagnostic, subcontracted testing). In order to address logistic and managerial issues, a question was designed, on how the logistics in blood collection and donor recruitment is organized in the different blood establishments. Based on the individual response given by the participants in the questionnaire a final evaluation was performed to assign the participants to the Project's working group structure.

(Q5) Number of produced standard products within the 15 blood establishments

  < 50.000 50.000 - 100.000 > 100.000
Erythrocyte concentrates 7 0 8
Platelet concentrates 10 1 4
FFP 8 3 4

(Q7) Logistics in blood collection and donor recruitment

Question Met by
Blood collection within the institute / hospital (in-house-donors) 11 of 15
Blood collection within buildings dedicated to blood collection but physically separated from the institute / hospital 11 of 15
Blood collection from mobile collection teams using buildings which are not dedicated to blood collection 12 of 15
Blood collection from mobile units (e.g. blood collection bus) which are dedicated to blood collection 10 of 15

(Q9) Number of SOPs in the participating blood establishments

Participants with SOPs < 100 100 - 500 > 500
14 of 15 3 4 8

All 14 participating blood establishments have SOPs established in their institutions, the one with a negative reply represents a governmental institution. All participants who have SOPs indicated by "YES", that their SOP-System is based on international guidelines like AABB, GMP / GAMP and ISO.
7 of 15 participants (47%) considered, that the currently used SOP-System needs to be changed or adapted in the light of the European Blood Directive 2002/98. These were mainly participants from the new and applicant EU-countries. 2 blood establishments from applicant EU-countries and 2 from established EU-countries indicated, that their blood establishment is not inspected by governmental authorities.
  • Table 1 - Summary of the areas of interest and risk in Area I - IV

    • Working group 1 (WG 1):
    donor recruitement, collection, production, (QC-testing)
    Area I
    1. Donor identification / Donor re-identification prior to vena-puncture
    2. Donor acceptability / selection / interview
    3. Self-Sufficiency / Blood donor recruitement and communication
    4. Communication with specific risk groups for blood donation
    5. Blood collection / Maximum collection time
    6. Disinfection of donor skin
    7. GMP conform production of sterile blood components / Production of components with an 'open' system
    8. Labelling and Identification
    9. Logistics of donor recruitment, donor motivation and donor satisfaction
    10. Management of mobile collections
    11. Storage and transport of whole blood units from collection units before processing
    12. In-Process storage of blood components
    13. Bacterial inactivation of blood components
    14. Algorithm of testing blood components
    15. Training of personnel
  • Table 2 - Summary of the areas of interest and risk in Area I - IV

    • Working group 2 (WG 2):
    Testing (Immunohematology, Molecular Diagnostics)
    Area II
    1. Testing of blood groups and blood group variants (in particular ABO and Rhesus)
    2. Labelling and identification of samples
    3. Manual transfer of test results / records
    4. Immunohaematology testing in emergency
    5. Verification of patient sample identity
    6. Introduction of new methods: Change management, validation and training
    7. Testing requirements for re-entry of reactive, non confirmed donors / Exclusion of blood components with reactive results
    8. Sensitivity and specificity of serological methods in
    • blood group typing and antibody identification
    • infectious disease marker
    9. Best practice for viral screening methodologies in small populations with limited cost / benefit relation
    10. Donor registries (rare blood groups)
  • Table 3 - Summary of the areas of interest and risk in Area I - IV

    • Working group 3 (WG 3):
    Special blood component production
    Area III
    1. Processing of Platelet Apheresis Concentrates
    2. Processing of Pediatric units
    3. Processing of Granulocyte Concentrates
    4. Donor selection criteria / Stimulation protocol and quality requirements for granulocyte donors
    5. Recipient (patient) critieria
    6. In-line production sterility: Use of sterile connection devices / Detection of bacterial contamination of components
    7. Validation requirements for production procedures of special components
    8. Reproducibility of products
    9. Labelling and Identification
    10. Training of personnel and adherence to procedure
  • Table 4 - Summary of the areas of interest and risk in Area I - IV

    • Working group 4 (WG 4):
    Logistics, storage, distribution, management
    Area IV
    1. Transportation and storage temperature control of whole blood and blood components (including production line)
    • Type of equipment needed
    • Temperature recording (Use of electronically devices and/or manually controlled)
    • Maintenance of cold chain in distribution to peripheral site
    2. Validation of temperature systems used to control blood components.
    3. Blood component release and/or issuing
    4. Traceability of collected and transfused blood units
    5. Resource management: cost effectiveness including analysis of priorities
    6. Central blood stock management and distribution including
    • avoiding unnecessary outdated blood components
    • temporal changes in blood stocks and donor availability
    7. Distribution of blood components in case of emergencies
    8. Centralisation of processing of collected blood
    9. Validation of equipment and premises
    10. Reclamation management (including materiovigilance)
    11. Risk and error management
    12. Training of personnel