Managing Authority
- Inspections
As an Authority Member, I and my colleagues are effectively Non-Executive Directors of the Human Tissue Authority (HTA). This gives us a fascinating oversight for the wide range of work across the HTA’s operational sectors.
Authority Members have a diverse set of backgrounds. Some of us have sector-specific experience and others are ‘lay’ members although, by law, the Chair of the HTA is required to be a lay member.
The diversity of our background and experience, together with the diversity of HTA’s sectors provides a counterpoint for our roles. As curious individuals, we are somewhat analytical, although we can never know as much about each sector as our HTA colleagues. This can lead to a temptation (at least in my case) to dive into detail to better understand the work of the HTA, as we review its effectiveness and efficiency, as well as its strategic direction.
This is a familiar balancing act. We avoid getting too deeply into the day to day workings, providing the correct level of oversight and challenge. The range of experiences and personal styles of Authority Members provides a complementary set of skills, whereby those with specific sector expertise will keep us ‘enthusiastic amateurs’ in check.
Similarly, ‘lay’ members bring their essential perspectives that, while not necessarily sector related, provide vital insights to the environment in which we work and how the HTA may be perceived by those less close to our daily activities and most importantly, the public in general. It is for them that we exist and for whom we must continue to ensure confidence in our work.
In this context, our Authority, other Committee and Working Group meetings provide a range of topics that stretch from policy, through strategy, governance and operational matters, to data analysis and its interpretation. Our discussions are always animated as we bring these diverse strands together, being well informed by our comprehensive briefing materials.
One of the most important topics recently has been the change to the law surrounding deemed consent in England. As an Authority we have been clear to ensure that we do not have an opinion on the merits of the legislation but have provided directional input on its implementation to ensure consistency with our principles and to maintain public confidence. Ensuring a clear understanding of these principles in the context of expression of wishes is one of our central tenets. This has allowed us to benefit from the expertise of the HTA staff and its executive, to analyse the existing data, learn from colleagues in Wales and understand the experience in other countries already operating deemed consent. In this way, plans have been developed for its implementation to cover likely scenarios and their contingencies.
Perhaps less high profile, but no less important, is the Post Mortem sector where we regularly review and assess data on HTA Reportable Incidents (HTARIs). This is another balancing act where we have the benefit of data but have to be cautious to not over analyse it. We recognise the work required by the HTA teams to generate these data as we continue to refine our reports, to enable us to look for systemic trends or trends by sites so that we can provide advice and guidance to establishments and to inform our inspection activities.
A similar theme has emerged in the Human Application sector where we have discussed how best to quality assure the work of establishments who utilise external providers of technical or laboratory services that may not be directly regulated by HTA. As these specialist providers may work with more than one HTA licensed establishment, a quality-related issue at one provider could have a wider impact. As such we monitor data for any emerging trends, whilst establishing a full picture of which establishments utilise which specialist providers and are developing plans on how we might further assure their work. This mix of tactical analysis and strategic planning is a great example of how the expertise of HTA teams, with the input of Authority Members, has helped develop a proactive approach to improve patient safety.
Our roles give us the opportunity to work on policy, strategy and its implementation, as well as governance and compliance activities including finance, audit and areas such as GDPR. Our weekly review of living organ donation cases as part of HTA’s Panel Approvals is a similarly important governance role as we assure there is no evidence of reward, coercion or duress for the donor. It is a privilege to have these insights into patients’ lives and the personal impact of our area of work. Authority Members regularly review interesting or unusual cases to discuss learning points and any policy elements that come from them.
I feel privileged to be an Authority Member and am acutely aware that our role in ‘right touch regulation’ should always have a close eye on public confidence. As we all know, confidence and trust develop over time but can be severely damaged in an instant, perhaps taking years to rebuild. We work in a time of rapid scientific advances and changing environmental and social expectations. These constantly remind us of how important it is that we continue to be attuned to these changes to retain public confidence through our work and that of our establishments.
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