Human Tissue Authority

The regulator for human tissue and organs

Human application serious adverse event and reaction (SAEARs) reporting

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.

If you wish to report a serious adverse event or reaction relating to organ donation and transplantation, please use the NHSBT incident submission system.

FAQs on the reporting of SAEARs can be found here 

Reporting SAEARs

Serious adverse events and reactions are defined in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) as:

Serious Adverse Event (SAE)

Any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissue or cells intended for human application and which, in relation to a donor of tissue or cells intended for human application or a recipient of tissue or cells –

(a) might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions; or

(b) might result in, or prolong, hospitalisation or morbidity.

Serious Adverse Reaction (SAR)

An unintended response, including a communicable disease, in a donor of tissue or cells intended for human application or a recipient of tissue or cells, which may be associated with the procurement or human application of tissue or cells and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

Logging in to the notification system

SAEARs can now be reported via the HTA portal. You will need to log in to the HTA Portal using the same username and password as when you applied for a licence. Only Designated Individuals (DI) and Persons Designated (PD) at licensed establishments will currently have a username and password.

  1. Login to the HTA Portal
  2. SAEARs Portal Guidance (PDF)

If you are a third party provider or you purchase material from a licensed establishment and you wish to report a SAEAR, please contact the DI at the relevant licensed establishment and advise them that they need to report a SAEAR to the HTA on your behalf. If you would like further guidance on whether your establishment can report using the Portal, please contact a member of the SAEARs team on 020 7269 1900 or email enquiries@hta.gov.uk for further advice.

After you have submitted an initial notification of a SAEAR to the HTA, you will be required to submit a follow-up report once local investigations have taken place.  As a HTA Portal user, you will have a ‘workspace’ containing a searchable library of all your notifications and follow up reports which only you can access.

Please note that this system does not replace existing local reporting arrangements.

If you are unsure whether to report an incident, please contact a member of the SAEARs team on 020 7269 1900 or email enquiries@hta.gov.uk.

 

Audience: 
Last updated on: 10 Feb 2021