Report an SAE, SAR or HTARI

This page outlines the reporting requirements for notifying the HTA of serious incidents that have occurred in the human application, organ donation and transplantation and post mortem sectors.

Human application adverse event and reaction reporting

The HTA has an online system for the reporting of any serious adverse events and / or reactions that are linked to the procurement, testing, processing, storage and distribution of human tissues and cells for human application.  Further information and the online system can be accessed here:

Human application adverse event and reaction reporting

Post mortem sector HTA Reportable Incident notification

HTA-licensed establishments have been required to notify the HTA about reportable incidents since 1 May 2010.  Until 31 March 2013, these incidents were known as ‘serious untoward incidents’.  They are now known as HTA Reportable Incidents (HTARIs). Further information about HTARIs and how to report them to the HTA is available here:

Post mortem sector HTA reportable incident notification

Organ donation and transplantation adverse event and reaction reporting

As of the 27 August 2012 HTA-licensed establishments in the organ donation and transplantation sector are required to report any serious adverse events and reactions to NHSBT, who will be managing the system on behalf of the HTA.  Further information and the online system can be accessed here:

Organ donation and transplantation adverse event and reaction reporting

Updated March 2013