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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.
There is no requirement for licence holders to report directly to the HTA; however, if the licence holder or any party involved in a SAEAR has concerns relating to a potential conflict of interest involving NHSBT they can contact the HTA directly by emailing firstname.lastname@example.org.
A serious adverse event (SAE) can occur at any stage from donation to transplantation to post transplantation. A suspected SAE must be reported when one or more of the following applies:
Events which are commonly referred to as ‘near misses' should be reported as SAEs if any of the above criteria are met.
Any serious adverse reaction in a living donor which may influence the quality and / or safety of organs must be reported. A suspected SAR must also be reported when one or more of the following applies: