Hospital Blood Banks
A Hospital Blood Bank is a part of a health care unit that stores, distributes, can further process blood products and perform compatibility testing for blood transfusion activities under the leadership of a health care unit. Hospital Blood Banks must submit a free-form notification of their processes and any essential changes to them either by e-mail, by secure mail or by post to the Fimea’s registry (according to section 5 of the Blood Service Decree).
Hospital Blood Banks must use the Good Practice Guidelines in their quality system. The minimum requirements concerning Hospital Blood Banks are specified in the guidelines:
- 1.1.7: The requirements for implementing a quality system also apply to hospital blood banks.
- 1.2.6: Senior management should establish a quality policy that describes the overall intentions and direction of the blood establishment and/or hospital blood bank (hereinafter referred to as ‘organisation’) related to quality. They should also ensure quality system management and Good Practice governance through management review to ensure its continuing suitability and effectiveness.
- 1.2.8: All blood establishments and hospital blood banks must be supported by a quality assurance function, whether internal or related, in fulfilling quality assurance. That function must be involved in all quality-related matters, and must review and approve all appropriate quality-related documents (Directive 2005/62/EC, Annex 1.2.1).
- 1.3.1.2: Quality control is the part of Good Practice that is concerned with sampling, specifications and testing, as well as with the organisation, documentation and release procedures which ensure that materials are not released for use in preparation, and blood and blood components are not released for distribution, until their quality has been judged to be satisfactory and that the necessary and relevant tests have been carried out. The basic requirements are:
- 1.3.1.2.1: adequate facilities, trained personnel and approved procedures are available for sampling, inspecting/testing starting materials, packaging materials, intermediate components, and finished blood and blood components and, if appropriate, for monitoring environmental conditions;
- 1.3.1.2.2: samples of starting materials, packaging materials, and intermediate and finished blood components are taken by approved personnel and methods;
- 1.3.1.2.3: test methods are validated;
- 1.3.1.2.4: records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are recorded and investigated fully;
- 1.3.1.2.5: the finished blood and blood components comply with the specifications and are correctly labelled;
- 1.3.1.2.6: records are made of the results of inspection, and that testing of materials, intermediate and finished blood and blood components are formally assessed against specifications;
- 1.3.1.2.7: no blood or blood components are released for distribution that do not comply with the requirements of the relevant authorisations.
- 2.2: The organisation should have an adequate number of personnel with the necessary qualifications and experience. Management has the ultimate responsibility to determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the quality management system and continually improve its suitability and effectiveness through participation in management review. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
- 2.15: It is the organisation’s responsibility to provide instructions on hygiene and health conditions that can be of relevance to the quality of blood components (e.g. during collection) and to ensure that staff report relevant health problems. These procedures should be understood and followed in a strict way by all staff members whose duties take them into the processing and laboratory areas. Personnel should be instructed when and how to wash their hands.
- 4.3.1.2: The principles of qualification and validation are applicable to the preparation, distribution and issuance of blood components. It is a requirement of good practice that blood establishments and hospital blood banks control the critical aspects of their operations through the life cycle of the blood components and the associated processes. Any planned changes to the facilities, equipment, utilities and processes should be formally documented and the impact on the quality of blood components should be validated.
- 4.7.1.2.1: The contracting process should include checks prior to awarding the contract to help ensure suppliers meet the organisation’s needs.
- 5.1.1: Good documentation constitutes an essential part of the quality system and is key to operating in compliance with Good Practice requirements. Various types of documents and media used should be defined fully in the quality management system of the organisation.
- 7.8: Records should be kept of the distribution of blood components between blood establishments, blood establishments and hospital blood banks and between hospital blood banks. These records should show the date of supply, unique component identifier and name of the blood component, the quantity received or supplied, and the name and address of the supplier or consignee.
- 9.3.5: The persons authorised to initiate and co-ordinate the recall actions should normally be independent of the commercial management within the organisation. If they do not include the senior management and the Responsible Person (blood establishment), the latter should be made aware of any recall operation.