Human Tissue Authority

The regulator for human tissue and organs

Post mortem HTA reportable incidents

Since 2010, HTA-licensed establishments in the post mortem sector have been required to notify the HTA of any reportable incidents, including near misses, within five working days of the incident being discovered. Establishments must not wait until any internal review or investigation is complete before reporting the incident. Please provide as much detail as possible when writing a description of the incident, but do not include any person identifiable information, such as names of patients or staff or photographs of people. We will contact you should any additional information be required.

The licensed establishment’s Designated Individual (DI) must ensure HTARIs are reported to the HTA via the web Portal(link is external). This is a change from the previous email notification system, which was in place until 31 March 2013. Only DIs and Persons Designated (PDs) are able to submit notifications using the secure web Portal. Once a report has been submitted, the DI or PD will be able to download a PDF copy of the information to view, save and print it as desired. The DI can view all HTARIs submitted since 1 April 2013 on their web Portal account.

The DI must ensure a follow-up report is submitted to the HTA via the web Portal within two months of making the initial notification. This should ideally be a copy of the establishment’s internal investigation report. Please refer to the guidance document on the left for assistance in submitting and managing notifications on the Portal.

If you would like to discuss an incident before notifying us formally using the web Portal, please telephone 020 7269 1900 and ask to speak to one of the HTARI team.  Alternatively, you can contact us.

  1. General guidance for reporting HTARIs (updated Feb 2016)
  2. Guide to submitting HTARI notifications using the HTA portal
  3. 2012/2013 analysis of HTARI reporting
  4. How the HTA plans to disclose information about HTARIs and SAEARs

 

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PDF icon Guidance_for_reporting_HTARIs.pdf268.99 KB
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