Quality and Safety of Organs Intended for Transplantation Regulations
The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended) set the standards for the quality and safety of organs intended for transplantation.
Licensing under the Regulations
For the purposes of licensing by the Human Tissue Authority (HTA), there are two separate groups of activity detailed in the Regulations - procurement and transplantation.
Procurement activities may include one or more of the following:
- Donor characterisation
- Organ characterisation
- Preservation of an organ
- Arrangements to transport an organ
- Retrieval of an organ
Transplantation activities may include one or more of the following:
- Organ characterisation
- Preservation of an organ
- Making arrangements to transport an organ
- Implantation of an organ
Hospital’s undertaking organ transplants must be licensed by the HTA and must state on the licence application form which activity or activities they wish to undertake.
Multiple activities, both procurement and transplantation, can be carried out under a single licence.
HTA framework for the quality and safety of human organs
The HTA framework document is designed to support corporate bodies or individual people who are licensed, or intending to be licensed, under the Regulations.
It forms part of the regulatory framework and specifies how the requirements of the Regulations can be met.
It is a statutory condition of a licence for procurement or a transplantation activity to rapidly report to NHSBT:
- Relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation, which may be connected to those activities
- The management measures taken with regard to such a serious adverse event or reaction.
NHSBT assisted functions under the Regulations
In its role as regulator the HTA has put in place an agreement with NHSBT to assist with some functions, as permitted by regulation 21 of the Regulations. One of the assisted functions is the management of a reporting system for serious adverse events and serious adverse reactions (SAEARs).
This requires NHSBT to:
- Manage a system to report, investigate, register and transmit information about SAEARs associated with organ donation and transplantation; and
- notify the HTA of any SAEAR associated with organ donation and transplantation, the steps being taken to manage the SAEAR and confirmation that all actions associated with the SAEAR have been concluded.
NHSBT therefore has a system in place where incidents are reported, investigated and managed. NHSBT are required to report these serious adverse events or adverse incidents to the HTA. Further information, including the responsibilities of transplant centres, is provided in the HTA guidance on SAEAR reporting (PDF 553KB).