12.9: Laboratory test categories Laboratory tests include the following categories: Mandatory tests – required as part of the criteria for release of all blood donations …
12.8: Release of tested components Standard procedures must ensure that blood and blood components cannot be released for issue until all the required laboratory tests (mandatory and add…
12.7: Reporting of results The report must indicate the result of each and every test, by a system that provides positive sample identification. Reporting a series of tests by a…
12.6: Test procedure Test procedures must: be validated before being introduced into routine use be written in the form of standard operating procedures <…
12.5: Equipment Test equipment should be validated before being introduced into routine use and procedures must be in place to ensure that test systems and equipment are able to produce …
12.4: Reagents and test kits Acceptance testing should be performed on each batch/delivery of reagents and test kits. Reagents and test kits should be stored and used according …
12.3: Samples Samples may be ethylenediamine tetra-acetic acid (EDTA) or clotted. Where equipment/reagent manufacturers have defined protocols for storage and preparation, then …
12.1: Scope These specifications provide guidance on the tests required for blood donations in the UK.
12.2: General requirements Secure and effective procedures must be in place to ensure that: Specific procedures are written in the form of standard operating procedures.<…
6.13: References Council of Europe (2023). Guide for the Preparation, Use and Quality Assurance of Blood Components, 21st edition. Council of Europe Publishing. …
6.12: Component recall and traceability There must be a documented system available in each Blood Establishment whereby adverse effects caused by the administration of any component, or …
6.9: Component release All components must be appropriately labelled in accordance with these guideline specifications including those general guidelines outlined in section 6.5 and Chap…
6.8: Non-conforming components and biohazards 6.8.1: Discard of non-conforming components (including outdated components) Procedures for the discard of non-conforming componen…
6.6: Labelling 6.6.1: Component labelling Barcoded labels and on-demand printing must be used whenever possible. The design, content and use of labels for blood compo…
6.5: Component shelf life Component storage specifications are given in Chapter 7. Where components are pooled or undergo procedures that influence the shelf life, the maximum s…
6.1: Scope of the guidelines These guidelines provide a framework on which Blood Establishments should assemble standard operating procedures (SOPs) for the manufacture of blood componen…
Chapter 6: Evaluation and manufacture of blood components
JPAC Position Statement on SARS-CoV-2 - January 2023.pdf (118KB)
CN 06-2023 - Red Book Updates, Batch 1.pdf (1MB)
21.13: References Health Technical Memorandum (HTM) 01-01 Decontamination of surgical instruments. Available at www.tsoshop.co.uk…
21.12: Ocular tissue retrieval, processing and storage 21.12.1: Eye retrieval All required documentation must be fully completed by the eye retriever, including information re…
21.10: Cardiovascular tissue retrieval and processing 21.10.1: General This section predominantly relates to the banking of heart valves. 21.10.2: Sizing and evaluat…
21.9: Additional guidelines for skeletal tissue retrieval and processing 21.9.1: Procurement of surgically removed bone A system of documentation must be in place to ensu…
21.7: Tracking of tissues Each Tissue Establishment shall ensure that it has the ability to locate and identify all tissues/cells during any step from procurement through to distribution…