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Staff at HTA-licensed establishments should refer to the Governance and Quality Systems section of the HTA’s Code of Practice B on Post-mortem Examination.
All information relating to donor and organ characterisation must be kept for a period of 30 years from the date of retrieval of the organ.
The HTA was asked to provide information on the traceability requirements of organs that are sent to, or received from, a country which is not in the European Union.
Today the Department of Health (DH) has published the Government’s response to the consultation on Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017.
Traceability is the ability to trace all processes for the use of relevant material, from consent, use of the tissue through to disposal for auditable purposes.
Records may be retained in various formats, such as paper or electronic forms. It is up to each establishment to determine the best format and storage method for their records.
With the exception of the Human Application and Organ Donation and Transplantation sectors, the HTA is not prescriptive about the length of time for which traceability records should be retained. Other regulatory bodies may have their own specific requirements for the retention of records.
Establishments licensed in the HA sector should refer to the HTA’s Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment