22.17.1: General requirements
- All patient records and results should be maintained to the requirements of the Caldicott Report (1997) and the Data Protection Act (1998).
- Records shall be accurate, legible and indelible.
- Records must be made concurrently with each step of the harvesting, processing, testing, cryopreservation, storage, issue and transplant or disposal of each component in such a way that all the steps may be accurately traced from donor to recipient.
- All records and communications between the collection, processing and transplant centres must be regarded as privileged and confidential. Safeguards to assure this confidentiality must be established and followed.
- Records required for full traceability must be kept for a minimum of 30 years after clinical use, in an appropriate and readable storage medium.
- Records including raw data, such as original temperature monitoring records, which are critical to the safety and quality of the tissues and cells, must be kept for at least 10 years after any expiry date, clinical use or disposal of the tissues and cells.
22.17.2: Records to be maintained
The requirements for these are described in the EU Directives on Tissues and Cells, FACT-JACIE Standards and NetCord-FACT Standards. Records of the following must be kept:
- donor and patient details
- collection and processing
- storage, issue and administration
- compatibility testing
- quality control
- personnel, training, continued education, competency testing
- incidents, errors and corrective action taken.
22.17.3: Records in cases of divided responsibility
If two or more facilities participate in the collection, processing or distribution of the product, the records of the processing facility shall show clearly the extent of its responsibility.