HTA licensed establishments in the Post-mortem, Human Application and Organ Donation and Transplantation sector are required to report incidents to the HTA.
How to report them are different for each sector.
Licensed establishments in the Post Mortem sector must tell the HTA of serious incidents and near-miss incidents that may affect the dignity of the deceased and damage public confidence.
Establishments must notify the HTA of incidents or near-miss incidents within five working days of the incident occurring or being discovered.
Establishments are required to notify the HTA of serious adverse events (SAEs) or serious adverse reactions (SARs) within 24 hours of discovery. Establishments should take note that a full investigation of an event or reaction is not required for the purposes of initial reporting. The results of a root cause analysis and corrective preventative actions can be submitted as a follow-up report at a later date.
HTA-licensed establishments in the organ donation and transplantation sector are required to report any serious adverse events and reactions to NHSBT, who will be managing the system on behalf of the HTA.