Navigating the Human Tissue Authority Inspection: Insights from a Designated Individual in the South Wales Valleys

  • Post mortem

I am the Designated Individual for Cwm Taf Morgannwg University Health Board within the heart of the South Wales Valleys. During my appointment in 2020 I anticipated our next Human Tissue Authority (HTA) inspection would be during 2022/2023 and up to the point of inspection I spent much of my time working with clinical teams across our Mortuary services, and other relevant areas such as Midwifery, ensuring all standards were being met. The team and I conducted a gap analysis of every single standard within Code A and B published by the HTA through a series of deep dive events supported by our Quality Department. This was very helpful in not only addressing the gaps but also identifying the resources and timescale to achieve better compliance. Importantly the gap analysis provided the confidence we required looking forward to the inspection. Of course, it all comes down to what the inspectors assess as compliance so there was always that feeling of anticipation of how the inspection would go. I also put in place a clear governance structure with formal quarterly meetings of stakeholders, invaluable in assuring compliance, supported by 6 weekly meetings with Persons Designated and HTA Champions.


Those feelings of anticipation faded away when we actually met the inspection team who very clearly guided us through the process. Rather than the inspection being a 3 -4 day on-site event as in previous years, we experienced the new approach of pre-inspection self-assessment, Virtual Regulatory assessment through Teams meetings and on-site inspection. In a pre-meeting with our inspectors, Michelle and Victoria, there was a clear explanation of the process and importantly time to answer all the questions we had. During November 2022 we completed a self-assessment questionnaire and submitted this with all the relevant Policies, Standard Operating Procedures, Risk Assessments and other evidence to a secure portal. Because we had spent time conducting the gap analysis and worked to address those gaps, this pre-assessment went ahead relatively smoothly and was around 3 days work for me personally in terms of data collection and uploading to the secure portal.

The inspection date was set for February 2023 and the communication from Michelle as lead inspector was very clear in terms of what was required for the Virtual meetings to examine Consent, Governance and Tissue Traceability and the on-site inspection week itself. In addition there were individual assessment meetings with myself as the Designated Individual and others which all went to plan. Of course, these meetings do take some degree of organising and I took a personal lead in all the preparations to ensure the assessment went as smooth as possible. It was certainly time worth spent. Whilst these pre-inspection meetings were formal, there is no doubt that the methodical manner in which both Michelle and Victoria asked questions definitely got the best out of myself and the team.

The on-site inspection was over 2 full days and it was pleasing for myself and the team to eventually meet Michelle and Victoria in person. We commenced with brief introductions (including our Licence Holder) and an overview of our governance arrangements followed by the inspection of our three Mortuary Departments over three hospital sites, including an inspection visit to Midwifery Services. I must say that it was more or less as we expected because of the preparatory work and pre-inspection assessments.

The Mortuary Manager and I were at hand to ensure all questions could be answered promptly and where there were requests for additional evidence I was able to immediately upload these to the HTA secure portal. There was also an opportunity to share examples of good practice including our HTA Sharepoint portal for our Persons Designated & HTA Champions. This is an intranet site which was commissioned by our Director for ICT and aims to be a central resource for learning and communication. Because our HTA Licence covers three Mortuaries and related services across three District General Hospitals over a wide geographical region, the need for instant access to such a resource is helpful to Persons Designated and HTA Champions. The intranet site has many functions including filing reports, audits, policies, forms, booklets, training modules and importantly sharing good practice. During the inspection the intranet site also enabled the inspectors to instantly review evidence such as Ventilation Service Reports and a range of local audit inspections.

What was really helpful during the on-site inspection was that both Michelle and Victoria were able to give an overview of their findings through a Teams meeting to myself, the Licence Holder, Mortuary Team and Senior Midwives. This was really beneficial to our clinical teams in anticipation of the written report a few weeks later. It meant that any identified shortfalls could be immediately actioned and advisory items also considered.

Overall, not only was my first inspection a positive experience it added greatly to my personal learning regarding the Human Tissue Act. After spending over 41 years in the NHS there is always more to learn and develop as an individual. As a team, we continue to work to maintain the high standards we have set and provide a high quality service. The inspection was an essential point in time for us post-Covid pandemic and it validated the preparatory work. Indeed, the way both Michelle and Victoria guided us through the requirements led to a very smooth and effective inspection. As always, I continue to liaise with the Human Tissue Authority on a regular basis regarding a range of matters such as incidents, policy queries and related service developments. I find that this is one of the most supportive aspects to my role and ensures we anticipate any issues beforehand with the expert advice from our designated HTA advisor. Whilst being a Designated Individual brings with it a high degree of accountability to the Human Tissue Authority, the Health Board and of course the public we serve, for myself it is one of the most rewarding roles I have undertaken in my career and one I would recommend to those who may be thinking about accepting this important responsibility.

Dr Paul D Davies
Assistant Director (Operational Support) & Designated Individual (HTA)
Cwm Taf Morgannwg University Health Board

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