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…
21.5: General guidelines for tissue processing Processing must not change the physical properties of the tissue so as to make it unacceptable for clinical use. Processing steps must be v…
21.2: Retrieval 21.2.1: Retrieval times and preliminary storage Tissue retrieval should be completed as soon after death as possible. For eye donation retrieval must be comple…
21.1: General considerations Tissue Establishments should have dedicated processing and storage facilities designed and be operated to prevent contamination, cross-contamination, mislabe…
20.12: References SaBTO (2017) Blood, tissue and cell donor selection criteria report: 2017 (updated 2019)
20.11: Release criteria For allogeneic donors the concluded result of all microbiological assays, with the exception of syphilis and anti-HBc, must be negative for a tissue to be release…
20.10: Archiving of donor samples An archive blood sample should be kept for look-back investigations in the event of an adverse reaction. It is recommended that this should be for a min…
20.9: Autologous tissue donation The designated clinician should decide the policy in relation to the provision of an autologous service. Autologous donors should be tested for the same …
20.8: Follow-up There is a duty of care to the donor and/or donor’s family. For donors who on confirmatory testing have positive or indeterminate results, there should be protocols in pl…
20.7: Deceased donor samples Appropriate mechanisms must be in place to ensure: The secure identification of samples obtained from hospital laboratories. Where there is d…
20.6: Living tissue donor samples All blood samples from living tissue donors must be acquired using positive donor identification by an individual trained to ensure the security of the …
20.5: Donor testing The general principles of microbiological testing and the specific testing requirements for tissue donors are covered in Annex B of the HTA’s Guide to Quality and Saf…
20.4: Tissue-specific donor considerations Reference must be made to the JPAC Donor Selection Guidelines3 document for ages and other specific donor requ…
20.2: Consent Consent must be obtained and documented by appropriately trained professionals competent in the issues and processes of tissue donation. No coercion or inducement to donate…
20.1: General considerations The overall responsibility for applying the policies for the selection and care of tissue donors lies with the Tissue Establishment authorised clinician, who…