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 [3] for specific requirements for record retention.

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 [6].  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 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disposed of, it is acceptable that traceability records are exported with the exhibition once the HTA licences have been revoked.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 [8].

Additionally, museums and other public display establishments may wish to refer to the UK Museum Accreditation Scheme [9] published on the Art’s Council website.

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.

1. 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.
    
2. The DI may wish to consider good practice examples from other similar organisations.
    
3. 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.

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:

1. If any relevant material is being transferred to alternative licensed premises, the records to enable traceability should be transferred to those premises also.

2. 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).

3. 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.