Last year we carried out an unannounced inspection of an establishment which resulted in a number of shortfalls against the HTA’s licensing standards, some of which were classified as being ‘Critical’. A critical shortfall is a shortfall which poses a significant risk to human safety and/or dignity and is the most severe level of shortfall requiring immediate action.
On this page you can find the most recent inspection reports.
HTA inspections can include a desk-based assessment, on-site assessment, and analysis of information to assess whether the conditions of a licence and HTA licensing standards are met. The inspection guidance section of our website has more information about our inspection processes.
We’ve published new inspection reports from establishments in research, human application, anatomy, and post-mortem sectors.
Today, the Human Tissue Authority (HTA) has published an updated version of Code of Practice F, part two. The HTA undertook a review of the Code to reflect the introduction of deemed consent for deceased organ and tissue donation for the purpose of transplantation in Northern Ireland (NI).
The amendments made to the Code in relation to Northern Ireland will not apply until the Northern Ireland Deemed Consent Act comes into force.
Today we’ve issued a regulatory alert regarding contamination issues with Carnamedica Belzer UW Cold Storage and Machine Perfusion solutions imported by Bridge to Life. Discolouration of solution/microbial contamination and leaking bags have been found in the 1L size of the Cold Storage Solution, while particulate matter has been found in the 2L size of the same solution.
Today we’ve published an updated version of our Anatomy sector Licensing Standards and Guidance
The updated version was informed by an internal review and engagement with external stakeholders.
In making these updates, we have also taken into account the revisions that we made to the guidance that supports our Post Mortem sector licensing standards in 2022.
In quarter 3 2022/23 we closed 107 incidents as reported to the HTA. Licensed establishments need to report that an incident has taken place and provide a follow-up investigation report within two months for review.
When an incident occurs, we aim to support establishments in their review of the incident and the actions taken to help mitigate the risk of a similar incident occurring in future.
Damage to a body that has the potential to cause distress to the family or may lead to damage in public confidence must be reported to the HTA. Incidents in this category include damage to a body during post-mortem examination, for example during evisceration or reconstruction of a body. Near-miss incidents should be reported to the HTA.
We’ve published new inspection reports from establishments in research, human application, organ donation and transplantation, and post-mortem sectors.
