Incident Reporting - Organ Donation and Transplantation


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.

http://www.hta.gov.uk/_db/_documents/EUODD_Directive_August_2011.pdf

The EUODD has been written into UK law through the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

http://www.legislation.gov.uk/uksi/2012/1501/pdfs/uksi_20121501_en.pdf

The framework for the quality and safety of human organs intended for transplantation


TThe 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.

http://www.hta.gov.uk/_db/_documents/Organs_Intended_for_Transplantation_-_documentary_framework_July_2012.pdf

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):

  • i. 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;
  • ii. 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:

  • i. Manage a system to report, investigate, register and transmit information about SAEARs associated with organ donation and transplantation; and
  • iii. 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.

http://www.hta.gov.uk/_db/_documents/Guidance_-_SAEARs.pdf

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.

Join the Organ Donor Register 0300 123 23 23

Click here to report an incident