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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
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, used to extinction or otherwise brought outside of the regulatory framework, or will never be used again in research.
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).
If there is no overarching records retention policy in place at the establishment, the Designated Individual should ensure that relevant policies and procedures are put in place. These should be in line with the establishment’s own internal requirements.
Staff at Establishments that store records containing personal data for tissue which has been taken from the living need to consider that ‘Personal data processed for any purpose or purposes shall not be kept for longer than is necessary for that purpose or those purposes’.