2023/24 review: Maintaining trust in the safe use of human tissue
We work to ensure the safe and trusted use of human tissue in our regulated sectors by improving compliance, supporting innovation and developing a strong reputation as an expert regulator.
When carrying out our activities, we take a pragmatic and constructive approach to regulation.
As a result, our impact as a regulator is largely achieved through our core functions of licensing, inspection and providing guidance.
Assessing compliance
In 2023/24, we took the bold decision to broaden our regulatory oversight and carry out over 40% more inspections than we completed at the start of our strategy in 2021/22. We set a target of 222 inspections and exceeded it by taking a more risk-based and bespoke approach. Overall, we inspected 226 of all our licensed establishments – almost a quarter – using the same resource as the previous year.
Number of inspections (planned and unplanned)
2023/24 | 2022/23 | 2021/22 | |
Target number of inspections | 222 | 210 | 140 |
Actual number of inspections | 226 | 210 | 157 |
Number of inspections per sector
Sector | Number of licences (main) | Number of licences (satellite) | Number of inspections |
Post-mortem | 167 | 89 | 83 |
Human application | 159 | 78 | 65 |
Research | 207 | 166 | 51 |
Anatomy | 48 | 12 | 12 |
Organ donation and transplantation | 36 | 0 | 12 |
Public display | 13 | 4 | 3 |
Total | 630 | 349 | 226 |
… the style and process of this inspection has been much more helpful and felt less pressured that previous inspections, but with the same level of rigour, detail and honest and open reporting of findings, both adverse and positive.
To meet the target and gauge compliance, we used a range of inspection methods that were proportionate to the anticipated risk presented – both at a sector and establishment level. In the anatomy, human application, post-mortem, public display and research sectors, methods include typical site-based inspections, themed site-based inspections, and virtual regulatory assessments (VRAs). At any point – either while planning an assessment or as a result of what we uncover – we can adapt our approach and add a site-based component (resulting in a hybrid inspection).
In the organ donation and transplantation sector, we carry out site-based audits. These involve assessing establishments against specific criteria and gathering evidence through a combination of reviews and discussions with staff.
Although any inspection can be stressful and time consuming, my experience on the day was good and thought provoking. The inspector was clear in her expectations and explanations and the overall effect of the process is to strive to improve services. It was a positive experience.
As well as assessing compliance through inspections, we also routinely use desk-based assessments to ensure establishments are compliant with licensing requirements. In 2023/24, we captured 929 updates to existing licences and assessed 35 new licence applications. We also used 182 pieces of intel to ensure establishments continued to be correctly licensed.
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