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.
If you would like further guidance on whether your establishment can report using the system, please contact a member of the serious adverse events and reactions (SAEARs) team on 020 7269 1900 or email firstname.lastname@example.org.
Reporting serious adverse events and reactions
Under the European Union Tissue and Cells Directive (EUTCD), the HTA is required to set up a system for tissue establishments to report serious adverse events and reactions. The definitions of serious adverse events and reactions as set out in the EUTCD are as follows:
Serious Adverse Event (SAE)
‘serious adverse event’ means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.
Serious Adverse Reaction (SAR)
‘serious adverse reaction’ means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
Logging in to the notification system
Serious adverse events can now be reported via the HTA portal. You will need to log in to the HTA Portal using the same user name and password as when you applied for a licence. Only Designated Individuals (DI) and Persons Designated (PD) at licensed establishments will currently have a user name and password. Therefore, anyone wishing to use this system who is not reporting from a licensed establishment, will be unable to at present.
If you are a third party provider or you purchase material from a licensed establishment and you wish to report a serious adverse event or reaction, please contact the DI at the relevant licensed establishment and advise them that they need to report to the HTA on your behalf. If you would like further guidance on whether your establishment can report using the system, please contact a member of the SAEARs team on 020 7269 1900 or email email@example.com.
A requirement of the EUTCD is that you submit notification of a serious adverse event/reaction which is then followed up by the submission of a report once local investigations have taken place. As a 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. In addition to local arrangements you are now required to report to the HTA what you as a professional consider to be a serious adverse event / reaction (not relating to whole organs), as guided by the definitions above. Some information reported to the HTA may be shared with the Medicines and Healthcare products Regulatory Agency, as per the informal understanding detailed here.
If you are unsure whether to report, please contact a member of the SAEARs team on 020 7269 1900 or email firstname.lastname@example.org.
Below are five slide presentations from the Vigilance and Surveillance of Tissue and Cells events conducted by the HTA.
- EU Rapid Alert for Tissues and Cells (RATC) platform
- Lessons learned from the SOHO V&S Project
- Reporting SAEARs
- Review of reported incidents - UK and EU