Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-028663 on 9 July 2019. Downloaded from Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare Eirini Oikonomou,1 Jane Carthey,2 Carl Macrae,3 Charles Vincent1 To cite: Oikonomou E, ABSTRACT Strengths and limitations of this study Carthey J, Macrae C, et al. Objectives The current research project sought to map Patient safety regulation out the regulatory landscape for patient safety in the ► This is the first study to attempt a complete mapping in the NHS: mapping the English National Health Service (NHS). regulatory landscape of of all organisations engaged in regulatory activities Method We used a systematic desk-based search healthcare. BMJ Open in the NHS. using a variety of sources to identify the total number of 2019;9:e028663. doi:10.1136/ ► We have included all statutory regulators but also organisations with regulatory influence in the NHS; we bmjopen-2018-028663 many others who may not see themselves as regula- researched publicly available documents listing external tors but nevertheless carry out regulatory activities. ► Prepublication history and inspection agencies, participated in advisory consultations ► Understanding the full regulatory landscape enables additional material for this paper with NHS regulatory compliance teams and reviewed the are available online. To view more precise assessment of the benefits and costs websites of all regulatory agencies. please visit the journal (http:// of regulation. Results Our mapping revealed over 126 organisations dx. doi. org/ 10. 1136/ bmjopen- ► Due to resource constraints, we were only able to who exert some regulatory influence on NHS provider 2018- 028663). identify regulatory activities from the websites of the organisations in addition to 211 Clinical Commissioning relevant organisations. Received 14 January 2019 Groups. The majority of these organisations set standards ► Although we have searched extensively, we cannot Revised 4 April 2019 and collect data from provider organisations and a be sure that this is a complete mapping. Accepted 13 June 2019 considerable number carry out investigations. We found a multitude of overlapping functions and activities. The variability in approach and overlapping functions suggest regulation may have valuable effects, it is that there is no overall integrated regulatory approach. 2 3 Conclusion Regulation potentially provides a variety of too often ineffective, inflexible and gener- benefits in terms of maintaining the safety and quality ates ticking box behaviour and bureaucratic http://bmjopen.bmj.com/ 4 of care by providing an external perspective on the care compliance. being delivered. However, the variability, extent and A number of organisations and commenta- fragmentation of the regulatory system of the NHS make it tors have called for reform, proposing that the hard for regulators to act effectively and places a massive regulatory system needs to be simpler, organ- burden on NHS provider organisations. Overlapping ised around a common approach to regula- regulatory requests may distract locally driven initiatives tion and less burdensome for providers.5 6 to improve safety and quality. Further research is needed However, before such broad proposals can be to understand the full extent of regulatory activity and the true benefits and costs incurred. given, proper consideration of a fundamental on October 25, 2020 by guest. Protected copyright. question must be addressed. What is the nature and extent of the current system? In this study, we aimed to map the current regu- INTRODUCTION latory system for patient safety in the NHS, Regulation is one important means of moni- © Author(s) (or their including both statutory regulators and other employer(s)) 2019. Re-use toring and improving the safety of healthcare organisations with regulatory influence. permitted under CC BY-NC. No with the aim of ensuring safe, reliable treat- Understanding this landscape of regulation commercial re-use. See rights ment for patients and a safe working environ- of safety is an essential preliminary to any and permissions. Published by ment for healthcare professionals. Regulation BMJ. rational reform of the regulatory system but in healthcare takes a variety of different 1Experimental Psychology, has, to our knowledge, never been previously University of Oxford, Oxford, UK forms and is conducted by many different attempted. 2Jane Carthey Consulting, actors, from formal regulatory inspections to London, UK voluntary efforts to promote good practice. Regulation, regulators and patient safety 3Business School, University of Regulatory processes and activities poten- The term ‘regulation’ can be viewed nega- Nottingham, Nottingham, UK tially provide valuable feedback to provider tively and narrowly by those who are subject 7 Correspondence to organisations, supporting improvement and to regulatory oversight. In healthcare Miss Eirini Oikonomou; ensuring that high standards of performance settings in particular, regulation can often be Eirini. oikonomou@ psy. ox. ac. uk are maintained.1 Critics argue that although seen as intrusive and inefficient interference Oikonomou E, et al. BMJ Open 2019;9:e028663. doi:10.1136/bmjopen-2018-028663 1 Open access by external authorities that distracts from the important which had failed to detect and respond to early signs BMJ Open: first published as 10.1136/bmjopen-2018-028663 on 9 July 2019. Downloaded from tasks of clinical care.8 However, activities of regulation of organisational failure.16 The governmental response are typically much broader and more constructive than generated more structural changes to the system, with an this.9 10 Regulation represents a wide range of different increased focus on devolution of central oversight. activities that seek to shape motives and attitudes within The evolution of regulation in the NHS needs to be organisations, as well as policies and protocols.11 In seen in the context of continual widespread reform and healthcare, regulatory activities can encompass every- restructuring of the wider NHS. In 2002, the National thing from formal regulatory inspections, attempts to Health Service Reform and Healthcare Professionals promote good practice, to efforts to support and initiate Act merged 95 health authorities into 28 strategic health culture improvement.12 13 Moreover, regulatory activities authorities (SHAs).17 In 2006, the number of SHAs are commonly engaged in by a diverse range of different reduced to 10 and later transformed into four clusters actors and institutions across healthcare, from statutory (North, South, Midlands and East of England) before regulators to national agencies to professional bodies finally been abolished in April 2013.18 During this time, and charitable organisations. health services commissioning was undertaken by 481 The regulatory landscape of healthcare is therefore Primary Care Groups, later reduced to 152 Primary complex and multifacetted. To begin mapping the Care Trusts (PCTs) in 2002, solely responsible for all current regulatory system around patient safety, it is NHS commissioning.17 Finally, under the Health and necessary to define the scope of our enquiries. In this Social Care Act in 2012, PCTs were replaced by statutory, study, we define patient safety regulation as the processes commissioning ‘consortia’, the Clinical Commissioning engaged in by institutional actors that seek to shape, monitor, Groups (CCGs).19 control or modify activities within healthcare organisations in The 5-year forward review20 brought the planning and order to reduce the risk of patients being harmed during their care. regulation of primary, secondary and social care together This definition aims to focus attention on the specific with local authority influence under seven models of care activities that are engaged in by ‘external’ actors to influ- each covering a core set of related services (for instance, ence ‘internal’ processes of patient safety in healthcare urgent and emergency care networks). Local leaders in organisations. It also aims to encompass the breadth of 44 geographical areas have been asked to design sustain- diverse institutional actors that engage in these processes ability and transformation plans (STPs) to demonstrate of regulation, even when some of those actors may not how they intend to transform services in their local define themselves as formal ‘regulators’. areas.21 Ten integrated care systems (ICSs) have evolved from STPs, responsible for planning and commissioning Evolution of regulation in the NHS care for their populations.22 Before continuing to the mapping process, it is important http://bmjopen.bmj.com/ to provide a brief historical perspective on regulation The need to map the regulatory landscape of the NHS across the NHS. The 1944 National Health Service White This short overview of regulation history in the UK Paper recognised that regular inspections of hospitals demonstrates a stream of structural reforms over the would be valuable but the first true external oversight last 25+ years, which have gradually increased the extent body was not established until 1969, following a series of and complexity of the regulatory structures.16 23 In 2002, healthcare scandals.14 Until the late 1970s, the Depart- Walshe argued that: ‘Current regulators vary widely in ment of Health fulfilled most of the regulatory functions, their statutory authority, powers, scope of action, and but between 1979 and 1997, the