Reporting of serious adverse events or adverse reactions under The Quality and Safety of Organs Intended for Transplantation Regulations 2012.
The European Union Organ Donation Directive (EUODD) sets minimum standards that must be met across all Member States in the EU, ensuring the quality and safety of human organs for transplantation. Achieving equivalent minimum standards will promote effective movement and end use of donated organs across all Member States. Members of the public in each Member State will have increased confidence in the quality and safety of donated organs.
The EUODD has been written into UK law through the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
The 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, which builds on many of the existing processes in the donation and transplantation sector, to specify how the requirements for the quality and safety of organs intended for transplantation shall be ensured to secure compliance with the Directive.
Reporting of serious adverse events and adverse reactions under the Regulations
It is a statutory condition of a licence for a procurement or a transplantation activity to rapidly report to NHSBT (acting on behalf of the HTA):
- 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 Quality and Safety of Organs Intended for Transplantation Regulations 2012.
In its role as the Competent Authority, the HTA will conclude an agreement with NHSBT to assist it with the following 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 will require 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.
SAE/SARs reporting requirement
The requirement to report SAEs and SARs applies to all UK establishments licensed under the Regulations, regardless of geographical location or whether they are a private or an NHS organisation.
To do this the establishment licensed under the Regulations must complete a new NHSBT incident report form which replaces the previous word document and which can be automatically submitted to ODT.
Please note if this incident is urgent - in that it may effect the quality and safety of an organ for transplantation or the treatment of recipients or potential recipients then please urgently call NHSBT Duty Office 01179757580 and inform them of the event prior to completing and submitting the incident report form.
Serious Untoward Incident and Never Event Management
NHSBT will ensure that all incidents whether they have caused actual harm or were a near miss, are reported by their staff in a timely manner. All incidents will be managed and investigated in a manner appropriate to their severity in order to learn, identify trends and make any changes necessary to improve safety. A non-punitive approach towards incident reporting will improve the safety culture of the organisation.
The purpose of SUI/Never Event investigation is to:
- Safeguard people, property, NHSBT's resources and reputation
- Understand why an event occurred
- Ensure that steps are taken to reduce the chance of a similar incident happening again
- Report to other bodies where necessary
- Share learning across the organisation and the wider NHS where applicable