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Culture and regulation: the necessary partnership for quality and safety


The government recently published terms of reference for the Thirlwall Inquiry following the crimes committed by former neonatal nurse Lucy Letby while working for the Countess of Chester Hospital NHS Foundation Trust. As well as examining the detail of the offences, the inquiry will also probe whether the trust’s culture, management, governance structures and processes contributed to the failure to protect babies. In the wake of this tragedy, it became apparent that staff had sounded the alarm about Lucy Letby, but that their concerns were not acted on. The case has propelled the issue of NHS management structures and the regulation of managers back into the headlines and made it the subject of political debate.

This year marked the 10-year anniversary of the Mid Staffordshire Inquiry. As others have pointed out, including Judith Smith, Professor of Health Policy and Management at the University of Birmingham, there have been dozens of inquiries into the NHS, including the Francis Report into the Mid Staffordshire NHS Foundation Trust, which have found an over-reliance on regulation and inspection to be a ‘cure’ for patient safety failings. In 2013, Professor Don Berwick led a review on patient safety commissioned by Jeremy Hunt, then Secretary of State for Health, in which he stressed that ‘vigilance cannot come from regulation. It requires culture change and therefore countless, consistent and repeated messages and deeds over a period of years.’ Berwick wrote to senior officials and executives stating that, ‘acting on rare and outlying behaviours and on exceptional cases of poor performance – though necessary, will not create an overall far safer and better NHS; it cannot’.

'In the most recent NHS Staff Survey, only half of those surveyed were confident that their organisation would address their concerns if they raised an issue'

In addition, in recent years, there have been a large number of other reviews and significant developments affecting NHS leadership, all of which have served to demonstrate variation in the standards of leadership and management. It’s also clear that large numbers of staff do not feel they are listened to by their managers. In the most recent NHS Staff Survey, only half of those surveyed were confident that their organisation would address their concerns if they raised an issue. Similarly, many patients and families also report not being listened to, sometimes with tragic consequences as with the death of Martha Mills.

NHS England recently published the Fit and Proper Person Test (FPPT) Framework for board members, aimed at preventing directors who have been involved in or enabled serious misconduct or mismanagement from joining a new NHS organisation. This framework was developed in response to the recommendations made by Tom Kark KC in his 2019 review of the FPPT, in which he stopped short of recommending a ‘fully blown regulatory system’ as he believed his other recommendations would lead to improvements in director and board development.

At The King’s Fund we have the privilege of working with senior leaders and managers across the UK who are seeking ways to improve the quality of care and deliver value, despite immense and often competing pressures. In recent conversations, I have not come across any senior leader who has argued against the principle of introducing professional regulation of managers.

It seems inevitable that some form of new professional regulation will be introduced within the next political term. But there are many outstanding questions, including how new regulation would operate in practice, at what stage of a management career regulation would be applied, and whether a new independent regulatory body is required. It is important to hold in mind that all clinical managers in the health service are already regulated, for example, by the General Medical Council, the Nursing and Midwifery Council, and the Health and Care Professions Council. It is also evident that the existing professional regulation did not prevent Lucy Letby from committing murder while working for the NHS.

'Will the professional regulation of managers take us any further in measurably improving patient safety and outcomes?'

It is essential that any new regulatory framework is designed with a critical lens on what does and doesn’t work in the existing landscape. To have meaningful impact, any new regulation must go beyond dealing with individuals of poor quality and high-risk outliers; it must also include measures and investment to drive up management standards, including the quality of education and training, as well as continuous professional development for managers and leaders. In their government-commissioned review of leadership in health and social care in 2022, Sir Gordon Messenger and Dame Linda Pollard made two key observations: first, the material difference that great leadership can make in health and social care and, second, that the development of quality leadership and management is not sufficiently institutionalised in the NHS in England.

The current debate on rooting out rogue managers is also missing something more fundamental about how quality and safety is led within the health care system. W Edwards Deming, a leading management thinker, argued that quality is everyone’s responsibility and ‘every system is perfectly designed to get the results it gets’. So if the current NHS system is failing the public and NHS staff on quality and safety, what more fundamental changes are required? Will the professional regulation of managers take us any further in measurably improving patient safety and outcomes?

As we head into an election year, the bigger question is whether a future government and its national bodies are willing to take much bolder, and arguably tougher, steps alongside new professional regulation to ensure enabling, supportive and aligned regulation and oversight. Will NHS leaders be actively supported to create the right local cultures to enable the capability and capacity for learning and change at scale by ensuring that staff and patients are consistently listened to? And will they be able to learn routinely from failure.