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The HTA was asked to provide information relating to serious adverse events and adverse reactions (SAEARs) in the organ donation and transplantation sector in the year 2015.
Please note that if you are not undertaking activities relating to material for human application, for example you carry out organ donation and transplantation, post mortems or anatomical examinations, this system is not applicable to you.
HTA-licensed establishments in the Post Mortem sector are required to report incidents (HTARIs), and those in the Human Application and Organ Donation and Transplantation sectors are required to report serious adverse events or reactions (SAEARs), as part of their licensing with us.
In line with the HTA’s commitment to increase transparency, we publish details about the volume and nature of incidents that are reported to us. This includes HTA Reportable Incidents (HTARIs) in the Post Mortem sector and Serious Adverse Events and Reactions in the Human Application and Organ...
Licence holders are required to notify NHSBT of serious adverse events (SAEs) or serious adverse reactions (SARs) within 24 hours of discovery. Establishments should take note that a full investigation of an event or reaction is not required for the purposes of initial reporting.
A serious adverse event (SAE) is defined in the Regulations 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...
A serious adverse reaction (SAR) is defined in the Regulations 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,...
The system of reporting and investigating SAEARs is managed by NHSBT on behalf of the HTA as an assisted function. All suspected SAEARs must be reported to NHSBT using the online incident reporting system.
In cases where an urgent notification is required the establishment must telephone ODT Hub Operations on 0117 9757580 immediately upon discovery. The telephone call must be followed up by an online submission of a report form detailing any immediate actions taken.