Commission Directive 2005/62/ECShow full title

6. BLOOD COLLECTION, TESTING AND PROCESSING U.K.

6.1. Donor eligibility U.K.

1. Procedures for safe donor identification, suitability interview and eligibility assessment shall be implemented and maintained. They shall take place before each donation and comply with the requirements set out in Annex II and Annex III to Directive 2004/33/EC. U.K.

2. The donor interview shall be conducted in such a way as to ensure confidentiality. U.K.

3. The donor suitability records and final assessment shall be signed by a qualified health professional. U.K.

6.2. Collection of blood and blood components U.K.

1. The blood collection procedure shall be designed to ensure that the identity of the donor is verified and securely recorded and that the link between the donor and the blood, blood components and blood samples is clearly established. U.K.

2. The sterile blood bag systems used for the collection of blood and blood components and their processing shall be CE-marked or comply with equivalent standards if the blood and blood components are collected in third countries. The batch number of the blood bag shall be traceable for each blood component. U.K.

3. Blood collection procedures shall minimise the risk of microbial contamination. U.K.

4. Laboratory samples shall be taken at the time of donation and appropriately stored prior to testing. U.K.

5. The procedure used for the labelling of records, blood bags and laboratory samples with donation numbers shall be designed to avoid any risk of identification error and mix-up. U.K.

6. After blood collection, the blood bags shall be handled in a way that maintains the quality of the blood and at a storage and transport temperature appropriate to further processing requirements. U.K.

7. There shall be a system in place to ensure that each donation can be linked to the collection and processing system into which it was collected and/or processed. U.K.

6.3. Laboratory testing U.K.

1. All laboratory testing procedures shall be validated before use. U.K.

2. Each donation shall be tested in conformity with the requirements laid down in Annex IV to Directive 2002/98/EC. U.K.

3. There shall be clearly defined procedures to resolve discrepant results and ensure that blood and blood components that have a repeatedly reactive result in a serological screening test for infection with the viruses mentioned in Annex IV to Directive 2002/98/EC shall be excluded from therapeutic use and be stored separately in a dedicated environment. Appropriate confirmatory testing shall take place. In case of confirmed positive results, appropriate donor management shall take place including the provision of information to the donor and follow-up procedures. U.K.

4. There shall be data confirming the suitability of any laboratory reagents used in the testing of donor samples and blood component samples. U.K.

5. The quality of the laboratory testing shall be regularly assessed by the participation in a formal system of proficiency testing, such as an external quality assurance programme. U.K.

6. Blood group serology testing shall include procedures for testing specific groups of donors (e.g. first time donors, donors with a history of transfusion). U.K.

6.4. Processing and validation U.K.

1. All equipment and technical devices shall be used in accordance with validated procedures. U.K.

2. The processing of blood components shall be carried out using appropriate and validated procedures including measures to avoid the risk of contamination and microbial growth in the prepared blood components. U.K.

6.5. Labelling U.K.

1. At all stages, all containers shall be labelled with relevant information of their identity. In the absence of a validated computerised system for status control, the labelling shall clearly distinguish released from non-released units of blood and blood components. U.K.

2. The labelling system for the collected blood, intermediate and finished blood components and samples must unmistakably identify the type of content, and comply with the labelling and traceability requirements referred to in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC(1). The label for a final blood component shall comply with the requirements of Annex III to Directive 2002/98/EC. U.K.

3. For autologous blood and blood components, the label also shall comply with Article 7 of Directive 2004/33/EC and the additional requirements for autologous donations specified in Annex IV to that Directive. U.K.

6.6. Release of blood and blood components U.K.

1. There shall be a safe and secure system to prevent each single blood and blood component from being released until all mandatory requirements set out in this Directive have been fulfilled. Each blood establishment shall be able to demonstrate that each blood or blood component has been formally released by an authorised person. Records shall demonstrate that before a blood component is released, all current declaration forms, relevant medical records and test results meet all acceptance criteria. U.K.

2. Before release, blood and blood components shall be kept administratively and physically segregated from released blood and blood components. In the absence of a validated computerised system for status control the label of a unit of blood or blood component shall identify the release status in accordance with 6.5.1. U.K.

3. In the event that the final component fails release due to a confirmed positive infection test result, in conformity with the requirements set out in Section 6.3.2 and 6.3.3, a check shall be made to ensure that other components from the same donation and components prepared from previous donations given by the donor are identified. There shall be an immediate update of the donor record. U.K.

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See page 32 of this Official Journal.