One of the key requirements of the Human Tissue Authority is that institutions should ensure a full and robust traceability trail is maintained and documented for the storage and movement of all licensable material from the time of its receipt to end use, disposal or distribution.
The person responsible for the project and/or person responsible for storing tissue should ensure that their holdings are fully documented. As a minimum, the following information should be kept in a safe, accessible place for each sample:
- Sample ID reference. This should be unique and anonymous. It should not include patient details.
- Tissue type (if more than one stored/used).
- Date of receipt and details of where it came from.
- Consent details. Where the consent form is held.
- Storage location (building, room, fridge/freezer/cupboard number, shelf).
- Details and dates of processing.
- Details and dates of any transfers (if relevant).
- Date, method and reason for disposal.
The system for recording this information should be proportionate to the activity being carried out. Ideally, the information should be in electronic format (spreadsheet or database) but, if the collection is small, a paper-based system would be acceptable.
Records of consent, tissue transfer and tissue disposal must be kept for 7 years after the transfer or destruction of the human tissue as an audit trail to demonstrate that the transfer or destruction complied with HT Act and with the conditions of consent given by the donor.
A template Access database and Excel spreadsheet have been developed for keeping records of human tissue, these can be downloaded from the Resource section at the top right of this page, along with guidance notes. The Access database allows records of tissue transfers to be easily maintained and has a number of built-in queries to obtain summary information on the tissue records.
Each unit/project should not delay in implementing a traceability trail for its holdings of licensable material.
Electronic Record Security
It is important that any electronic record is securely stored and that regular back up of the electronic record is undertaken. The best place to store the record would be on a computer linked to the University system, on the S: or H: drive. These drives are secure and regularly backed up by INSRV. Any file stored on the S: drive should be password-protected to avoid access by unauthorised staff.
It would not acceptable to store the record on a computer internal hard drive, or on a memory stick or other removable storage device.
Any supporting documentation (such as MTAs, receipts, log books of processing, disposal registers or receipts, consent documentation) should be kept separately.
Material Transfer Agreements
A Material Transfer Agreement (MTA) must be in place for all incoming and outgoing tissue transfers. An MTA should define how the human tissue will be preserved, any potential contamination risks associated with it and who will be responsible for disposal if applicable. For incoming tissue, the supplier will usually provide the MTA. For outgoing transfers, the University or UHB will provide the MTA. MTAs must not be signed by individual researchers and must go through either Cardiff University Research and Commercial Division or the UHB R&D Office.