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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.
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.
Any establishment that intends to revoke their licence should retain traceability records in accordance with their documented record retention requirements in place during the period of licensing. Particular things to consider are:
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
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.
HTA-licensed NHS Trusts should adhere to the Records Management: NHS Code of Practice, available on the Department of Health and Social Care website,
Records that enable traceability must be maintained at least until the tissue has been disposed of. Staff at HTA-licensed establishments should refer to the Documentation and Record Keeping section of the HTA’s Code of Practice C on Anatomical Examination.
Records that enable traceability must be maintained until the tissue has been disposed or reaches an age when it falls outside the Human Tissue Act 2004 (i.e. more than 100 years old).
Records that enable traceability must be maintained at least until the tissue has been disposed of, used to extinction or otherwise brought outside of the regulatory framework, or will never be used again in research.
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.