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.
Establishments are encouraged to supply all relevant information at an appropriate level of detail so that the HTA can maintain regulatory oversight of our sectors. The provision of frank and suitably detailed reports makes a very important contribution to our ability to raise standards and make sure that action is taken to prevent similar incidents happening elsewhere. As the regulator we identify trends and share learning so that sector-wide risks can be identified and acted upon. For example, we regularly issue learning reports and guidance.
Following freedom of information requests, we have published brief descriptions of the HTARIs and SAEARs which have been reported to us. This includes the category and brief description of the HTARI or SAEAR and the name of establishment (where requested). We will start publishing this information on a quarterly basis later this year as part of our report on regulatory activity to our Authority . This is to increase transparency about the volume and nature of HTARIs and SAEARs. The report will include a brief description of the reported incident and the action taken.
Establishments should continue to supply us with full and frank information so that we can support them to resolve any issues which have arisen and share any learning with other establishments. If, when reporting an incident, you have concerns about the publication of details please discuss this with us so that we can take these into account. If you have any questions about this, please contact the HTA.