Chapter 17: adverse incidents reporting
Updated 21 May 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-organs-tissues-and-cells-used-in-transplantation/chapter-17-adverse-incidents-reporting
It is a mandatory requirement to report serious adverse events (SAEs) and serious adverse reactions (SARs) to the relevant competent authority. For organs, the Human Tissue Authority (HTA) has delegated the responsibility for managing the adverse event reporting system to NHS Blood and Transplant (NHSBT). The ‘designated individual’ has responsibility to ensure that any and all SAEs and SARs are reported.
Organ donation and transplantation
For organ donation and transplantation, the European Union Organ Donation Directive (EUODD) defines an SAE as:
any undesired and unexpected occurrence associated with any stage of the chain, from donation to transplantation, that might lead to the transmission of a communicable disease; to death or life-threatening, disabling or incapacitating conditions for patients; or which results in, or prolongs, hospitalisation or morbidity.
SAEs that may influence the quality and safety of an organ, and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, must be reported and investigated.
For organ donation and transplantation, EUODD defines an SAR as:
an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain, from donation to transplantation, that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.
SARs observed during or after transplantation, which may be connected to the testing, characterisation, procurement, preservation and transport of organs, must be reported and investigated.
Tissues and cells
For tissues and cells, the European Union Tissues and Cells Directive (EUTCD) defines an SAE as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.
For tissues and cells, EUTCD defines an SAR as an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
Reporting SEAs and SARs
HTA has published guidance on human application serious adverse event and reaction (SAEARs) reporting regarding tissues and cells.
The Human Fertilisation and Embryology Authority (HFEA) has published guidance regarding reporting SAEARs regarding gametes and embryos for human applications in note 27 of the Code of Practice.
For organ donation and transplantation, see the NHSBT incident submission system and report to the responsible organisation (NHSBT) using the NHSBT incident submission form.
For tissues, cells and stem cells, report to the responsible organisation (HTA). See HTA’s human application SAEARs reporting guidance.
For gametes and embryos, complete the incident report form (available to download on the HFEA incident submission system) and email it to incident.reporting@hfea.gov.uk.
In the case of tissue donors, many donations increasingly cross-national boundaries. The EU mandated requirement to inform competent authorities of adverse reactions will allow other competent authorities (UK or otherwise) to be informed.