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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...
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.
An organ was inadvertently damaged during retrieval.reportable as a suspected SAE as the damage associated with retrieval resulted in an otherwise transplantable organ being unsuitable for transplantation.
Extended cold ischaemic time (CIT).
An organ recipient was anesthetised in preparation for an organ transplant.
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.
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.
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.
Events which are commonly referred to as ‘near misses' should be reported as SAEs if any of the above criteria are met.
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.