Today we are publishing data about incidents reported to Human Tissue Authority (HTA) during quarter three of 2024 to 2025. You can find it here:
HTA licensed establishments in the Post Mortem, Human Application and Organ Donation and Transplantation sector are required to report incidents to the HTA as part of their licensing requirements.
In the Human Application and Organ Donation and Transplantation sectors they are called Serious Adverse Events or Reactions (SAEARs). In the post-mortem sector we call these HTA Reportable Incidents (HTARIs).
Licensed establishments need to report that an incident has taken place and provide a follow-up investigation report within two months for review.
HTA typically inspects post mortem licence holders every two to three years. From September 2024 unannounced inspections have also been taking place for Post Mortem. This action is intended to drive up standards and encourage prompt reporting of incidents which could impact the care and dignity of the deceased.
Where there is non-compliance HTA will use its regulatory powers. This could include issuing directions, adding conditions, suspension or revocation of a licence. The Human Tissue Act 2004 explains that a person found guilty of a breach of licence offence could be liable to imprisonment for a term not exceeding three years, a fine, or both.