In August 2023, the shocking case of nurse Lucy Letby's murders raised many difficult questions for trusts, including on governance, management and culture. It rightly triggered deep reflection among provider leaders.
One of the potential solutions widely discussed in the immediate aftermath was whether a formal regulatory system for NHS managers could prevent a repeat of this appalling case.
Soon after the verdict, the then health and social care secretary, Steve Barclay, asked NHS England to revisit proposals for manager regulation. The Labour Party also made a commitment to introduce manager regulation, should they win the next general election. In that context the Shadow Health and Social Care Secretary Wes Streeting wrote to NHS Providers and NHS Confederation to ask what a regulatory framework that strengthens the accountability of managers and enhances patient safety should look like.
Over the months since the Letby verdict, trust leaders have been reviewing and reinforcing their organisational mechanisms for staff to raise concerns, considering how they can get the truest possible picture of the services they provide, and reflecting on the attention they give to patient safety at board level. They acknowledge their accountabilities and responsibilities in ensuring patient safety and the ability of patients, families and staff members to speak up when they need to.
Trust leaders are clear that regulation on its own cannot guarantee patient safety or stop a determined criminal – and indeed there is no single system, process or action that can do this. But many believe that a supportive regulatory system, focused on managers' development, is a means to increase the overall trust, respect and confidence that colleagues, patients and the public have in NHS management and leadership.
Principles for a system of manager regulation
Designing a new regulatory system is a job for seasoned regulators. However, those experienced in leading and managing NHS trusts are clear about the principles that should underpin that system. Any new system must be focused on patient safety and quality of care, as well as a transparent and positive working culture, which enables staff to raise concerns. This must be fair, be seen to be fair, and must not reinforce the structural inequalities, discrimination and prejudice which persist in healthcare and in society more widely.
If we are to design a new system, it should provide a progressive and positive framework, both in the language it uses and in the support it provides to managers. We need to take proper account of what influences and motivates people and their behaviour. That is, a human factors-informed approach would add significant value here, recognising the positive correlation between staff who feel valued and engaged and the quality of care they provide. This means a framework designed around support and improvement, not punishment.
Critically, regulation must be proportionate: the burden and cost must match the benefits it brings in improving patient safety and raising the quality of management. Regulatory action or intervention must be a last resort, not the first course of action. The regulator must be independent of those regulated, and, importantly, of political influence.
Finally, those designing the system should bear in mind how accountability in the NHS currently operates, and build on this, rather than duplicate. Working with, rather than around, well-established board governance, existing regulatory regimes, and newer elements, such as the fit and proper persons framework, and NHS England's leadership competency framework will, in our view, deliver better results.
The scope of manager regulation
If manager regulation is taken forward, there is a set of important decisions to be made around who would be affected by the proposals. Should there be a cut-off point linked to the level of seniority? Should some roles be included, but not others? Should regulation extend to arms-length bodies? Should managers who are already regulated – such as clinicians and nurses – be covered by two separate regulatory regimes? Assuming the goal is to ensure that the NHS has the best possible management, regulation should apply to all NHS managers, with an explicit remit to complement, rather than duplicate, existing professional regulation.
The horrific case of Lucy Letby demands a rigorous and carefully considered response, and this is part of the purpose of the Thirlwall Inquiry.
Limits of regulation
While acknowledging the positive intent of proposals to introduce manager regulation, we must be clear-sighted about what regulation can and cannot do. It could not guarantee that a determined criminal such as Lucy Letby would be stopped. Neither could it, on its own, guarantee patient safety or enforce a better speaking up culture in organisations. It cannot be quickly designed and introduced and will be costly to maintain.
Provided that it is introduced and exercised in a supportive and positive way, and coupled with the right support and developmental opportunities, statutory regulation may well be an important part of the answer. It could help raise standards of management throughout the service and may, over time, increase public, patient and staff confidence in NHS leadership and management. But what it cannot do is replace the important work of creating a positive, just and open culture.
This opinion piece was first published by HSJ.
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