Monitoring Quality and Safety
Applying best practice - A Framework for Quality and Safety of Human Organs Intended for Transplantation
In December 2014, the Health Services Executive (HSE), via the office for Organ Donation and Transplantation Ireland (ODTI), in conjunction with the HPRA, published the Framework for the Quality and Safety of Human Organs Intended for Transplantation as required by Part 3, Regulation 12 of S.I. 325 of 2012.
The framework provides for, and includes details on, the roles and responsibilities regarding the adoption and implementation of operating procedures to cover all stages of the chain from organ donation to transplantation. It outlines the principles for quality management systems and lays down specific requirements for the quality and safety of organs for transplantation.
Procurement organisations and transplantation centres involved at any stage of the chain from organ donation to transplantation should comply with the requirements of the framework for quality and safety.
Learning from events
In accordance with organ legislation, a system to facilitate reporting, evaluation and the management measures applied to Serious Adverse Reactions and Events (SAR/Es) have been developed in collaboration with the HPRA and relevant parties. The Guide to Serious Adverse Reactions and Events Reporting for human organs for transplantation outlines reporting requirements and notification procedures, including advice on completion of SAR/E report forms, information on reportable reactions and events and examples of SAR/Es, for use by procurement organisations, transplant centres, testing laboratories and donor hospitals.
The reporting of SAR/Es is important to highlight any unexpected complication, particularly if recipients may be at risk. It provides a mechanism for monitoring the quality and safety of organs during the entire chain from donation to transplantation through report investigation and implementation of Corrective and Preventative Actions (CAPA). Completed forms should be forwarded by email or posted to ODTI and the HPRA, as outlined in the guidance document.
Serious Adverse Reaction / Event Report Form for Human Organs Intended for Transplantation
Guide to Serious Adverse Reactions and Events Reporting for Human Organs for Transplantation
A ‘serious adverse event’ is defined 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.
A ‘serious adverse reaction’ is defined as any 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, or which results in, or prolongs hospitalisation or morbidity.
Further information is available on the HPRA website.
National Organ Donation Transplantation Advisory Group
The ODTI is governed by the HSE and there is a clinical advisory group, namely the National Organ Donation and Transplant Advisory Group, which provides recommendations and sets direction for the office.