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Today the Department of Health (DH) has published the Government’s response to the consultation on Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017.
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.
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.
This document describes the HTA’s policy on the management and traceability of tissue samples retained by independent pathologists when undertaking post mortem examinations (PME) at HTA-licensed premises where they are not employed.
The aims of this policy are:
The HTA was asked to provide information on the traceability requirements of organs that are sent to, or received from, a country which is not in the European Union.
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:
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
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.