Published on 24 May 2021
Changes to the way we publish information on HTARIs and SAEARs
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 Donation and Transplantation sectors.
Previously, we have published descriptions of incidents following freedom of information requests and as part of standard reporting to our Authority (the HTA’s Board) on regulatory activity. Before publishing details of incidents, we contact all establishments with the information that we intend to publish.
From the 1 July 2020 the way in which we publish this information will change.
We will now be producing a quarterly report detailing the volume and nature of incidents, which will be published on our website. This report will include the following information for all incidents that have been investigated and closed in the quarter:
- Case number
- Type of incident
- Establishment name
- Licence number
- Brief description of the incident
We will no longer routinely be contacting establishments before publishing this information. Instead, a Regulation Manager will confirm the details we intend to publish for each incident at the point of case closure. Establishments will have five working days to provide any comments or concerns about the information we intend to publish.
This change in our approach is aimed at giving greater consistency to the information that we publish and should reduce the number of occasions on which we ask establishments to review incident summaries.
These changes will apply to any incidents closed on or after 1 July 2020.
If you have any questions, please get in touch with us.