Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare

Abstract

ObjectivesThe current research project sought to map out the regulatory landscape for patient safety in the English National Health Service (NHS).MethodWe used a systematic desk-based search using a variety of sources to identify the total number of organisations with regulatory influence in the NHS; we researched publicly available documents listing external inspection agencies, participated in advisory consultations with NHS regulatory compliance teams and reviewed the websites of all regulatory agencies.ResultsOur mapping revealed over 126 organisations who exert some regulatory influence on NHS provider organisations in addition to 211 Clinical Commissioning Groups. The majority of these organisations set standards and collect data from provider organisations and a considerable number carry out investigations. We found a multitude of overlapping functions and activities. The variability in approach and overlapping functions suggest that there is no overall integrated regulatory approach.ConclusionRegulation potentially provides a variety of benefits in terms of maintaining the safety and quality of care by providing an external perspective on the care being delivered. However, the variability, extent and fragmentation of the regulatory system of the NHS make it hard for regulators to act effectively and places a massive burden on NHS provider organisations. Overlapping regulatory requests may distract locally driven initiatives to improve safety and quality. Further research is needed to understand the full extent of regulatory activity and the true benefits and costs incurred.

Redesigning safety regulation in the NHS

“…None of these reports, however, have described the totality of the regulatory system, making it difficult to make concrete plans for reform. We recently identified 126 organisations with regulatory influence that might interact with each English NHS trust (see supplementary figure) 5. Arrangements differ for Wales, Northern Ireland, and Scotland, but these systems face some similar problems.…”

“…We identified over 100 other organisations that might exert a regulatory influence on the NHS through their actions and activities 5. This group includes national agencies (such as the National Institute for Health and Care Excellence and the Healthcare Safety Investigation Branch), professional bodies (such as the Royal College of Physicians), and organisations that seek patient views, which are used to improve services (such as Healthwatch England).…”

Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study

“…Investigations into major healthcare failures, such as the Mid Staffordshire and Morecambe Bay inquiries in the UK, found issues with poor management and organizational oversight of safety [4,5]. One important issue is therefore how regulators should try and address issues of organizational leadership, engagement and management of patient safety [6,7].…”

“…Previous research from the British National Health Service reveals a vast number of guidelines and standards that clinicians are expected to comply with, which can create practical challenges and difficulties in identifying the most relevant or essential rules [8]. Equally, there are concerns that the complexity and demands of external regulation might distract organizations rather than support them in efforts to improve quality and safety [7]. Therefore, it is important to explore how regulators seek to shape and co-opt organizational activities to effectively manage and improve quality and safety.…”

System governance towards improved patient safety

“…New policies included opportunities for public input on environmental review of oil and gas programs as well as renewable energy proposals (Bureau of Ocean Energy Management, 2019 [123]). The extent to which the targets of regulation know and understand the rules is another key aspect of regulatory compliance (OECD, 2000 [124]).…”