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For whom the bell tolls: the future of regulation and inspection in the NHS

Driven by changes in health policy and practice, regulation and inspection in the NHS is facing an existential crisis – causing them to question their purpose, organisation and methods. As William Edwards Deming wrote, “Inspection does not improve the quality, nor guarantee quality. Inspection is too late. The quality, good or bad, is already in the product. As Harold F Dodge said, ‘you cannot inspect quality into a product.’”

In the NHS, there are four main kinds of regulation and inspection.

  1. The regulation of professions, by bodies such as the General Medical Council.
  2. The regulation of drugs and devices, by bodies such as the National Institute for Health and Care Excellence.
  3. The inspection of services and statutory organisations, by bodies such as the Care Quality Commission.
  4. The regulation of the NHS internal market though activities like price setting, by organisations such as NHS Improvement and NHS England.

In this blog, I focus on the key challenges facing numbers three and four.

Demonstrating value

When finances are tight, those responsible for front line delivery will reasonably ask what value back office functions – like regulation and inspection – are adding to service quality and whether those resources could be better used in other ways. Regulation and inspection can help improve the quality, safety and efficiency of front line services; but the organisations concerned could do more to promote the good work they do, as well as demonstrating how they are reducing some of the burdens they impose. Providing the NHS with comparative benchmarking data that has been collected using time-efficient methods is a good example of something that adds value and would be difficult or costly for NHS organisations to do individually for themselves.

Remaining relevant

NHS policy and practice are reducing the sovereignty of individual statutory bodies, but regulation and inspection are lagging behind in these changes. Acute care collaboratives (hospital chains), accountable care organisations (wider partnerships of care providers), sustainability and transformation plan footprints (collaborative commissioning arrangements) and integrated care pathways that cut across organisational boundaries all imply a pooling of sovereignty, meaning traditional approaches to regulation and inspection are less relevant.

Avoiding regulatory capture

Regulators and inspectorates perform an important and independent function protecting patients. But regulators have sometimes failed to maintain their independence from government. Think about when the National Institute for Health and Care Excellence stopped work on setting safe staffing levels – something well-established in other safety-critical industries. They have also gradually become performance managers, too close to operational decision making. Take when NHS England and NHS Improvement felt compelled to fill the strategic planning void, left following the Health and Social Care Act 2012.

Preventing regulatory arbitrage

Regulation and inspection in the NHS has been reinvented almost as many times as commissioning, and it’s increasingly difficult to separate the functions of regulation and inspection from those of strategic commissioning. The current structure, which has three separate organisations responsible for regulating and inspecting commissioning, provider performance and service quality, isn’t helpful because it divides authority and responsibility. This has led to gaming by some NHS organisations that frustrates progress towards greater integration of planning and delivery.

The way forward

Unless the organisations responsible for regulating and inspecting the NHS address these challenges, they risk losing their relevance and independence, together with the confidence of the NHS and the patients they are there to protect. The key to overcoming this crisis is to move towards an approach to regulation and inspection that assures the quality of services across patient pathways in a defined place, rather than simply those services delivered by a single organisation. It would also be helpful if the assurance methods made better use of data and peer review; and concentrated on future risks to services, rather than retrospective performance.

Although it was later abolished by the coalition government, the Comprehensive Area Assessment involved all local public service regulators and inspectorates and is a useful case study into the challenges and opportunities of designing a more holistic approach to regulation and inspection. 

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