Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.
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.
Documented records are used by licensed and unlicensed establishments to evidence traceability and ensure a robust audit trail. The actual types of records that enable traceability may vary from establishment to establishment, depending on what kinds of records are created during the licensed activity.
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.
Additional guidance for each of the sectors is provided below
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.
Establishments licensed in the ODT sector should refer to the HTA's Guide to the Quality and Safety of Organs Intended for transplantation: A documentary framework for specific requirements for record retention.
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.
The HTA endorses the most up to date guidance from the Royal College of Pathologists: The retention and storage of pathological records and specimens.
Additionally, where HTA-licensed Post Mortem establishments are part of an NHS Trust, consideration should be given to the general advice for NHS Trusts.
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.
Licensed research establishments should refer to the Governance and Quality Systems section of the HTA’s Code of Practice E on Research. Staff at licensed establishments should also adhere to any relevant organisational/committee policies and procedures for records management, for example, NHS Trust requirements, Medical Research Council requirements.
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). For temporary exhibitions where relevant material will be exported rather than disposed of, it is acceptable that traceability records are exported with the exhibition once the HTA licences have been revoked.
Staff at HTA-licensed establishments in the public display sector should refer to the Governance and Quality Systems section of the HTA’s Code of Practice D on Public Display.
Additionally, museums and other public display establishments may wish to refer to the UK Museum Accreditation Scheme published on the Art’s Council website.
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 Management Code of Practice for Health and Social Care 2016. This sets out what people working with or in NHS organisations in England need to do to manage records correctly. The current position is that all NHS records created as a result of work taking place in accordance with the Human Tissue Act 2004 are to be retained for 30 years.
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. Retention schedules are to be made available to the HTA on inspection or as otherwise requested in writing or by Directions.
- The DI should consider undertaking a documented risk assessment of retaining/disposing of each type of record to enable a robust and appropriate records management policy to be established.
- The DI may wish to consider good practice examples from other similar organisations.
- The DI should ensure that the records retention policy considers the storage of documents beyond the minimum requirements e.g. if the establishment were to shut down.
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’.
The Data Protection Act 2018 does not apply to personal records relating to the deceased. These are covered by common law and confidentiality.
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:
- If any relevant material is being transferred to alternative licensed premises, the records to enable traceability should be transferred to those premises also.
- If the licence to be revoked is associated with other licensed premises e.g. where a satellite licence is being revoked but the hub is remaining licensed, the records should be transferred to the associated licensed premises (in this case, the hub).
- If there is no alternative site that the records could be transferred to (e.g. a private organisation which has gone out of business), it is good practice to retain those records and provide the HTA with contact details.
The disposal of traceability records should be carried out in such a way that the confidentiality of the data is maintained. For more information please refer to the Information Commissioner’s Office.