Accounting for failure: risk-based regulation and the problems of ensuring healthcare quality in the NHS

Abstract

In this paper, we examine why risk-based policy instruments have failed to improve the proportionality, effectiveness, and legitimacy of healthcare quality regulation in the National Health Service (NHS) in England. Rather than trying to prevent all possible harms, risk-based approaches promise to rationalise and manage the inevitable limits of what regulation can hope to achieve by focusing regulatory standard-setting and enforcement activity on the highest priority risks, as determined through formal assessments of their probability and consequences. As such, risk-based approaches have been enthusiastically adopted by healthcare quality regulators over the last decade. However, by drawing on historical policy analysis and in-depth interviews with 15 high-level UK informants in 2013–2015, we identify a series of practical problems in using risk-based policy instruments for defining, assessing, and ensuring compliance with healthcare quality standards. Based on our analysis, we go on to consider why, despite a succession of failures, healthcare regulators remain committed to developing and using risk-based approaches. We conclude by identifying several preconditions for successful risk-based regulation: goals must be clear and trade-offs between them amenable to agreement; regulators must be able to reliably assess the probability and consequences of adverse outcomes; regulators must have a range of enforcement tools that can be deployed in proportion to risk; and there must be political tolerance for adverse outcomes.

Keywords:

• risk
• regulation and governance
• healthcare quality
• National Health Service (NHS)
• Care Quality Commission

Acknowledgements

This research was funded by the Economic and Social Research Council (No. ES/K006169/1). We would also like to thank the practitioners interviewed for this research for their valuable help. We also acknowledge the editor and three anonymous peer reviewers for constructive criticisms of previous drafts, though the views expressed herein are of course the authors’ own.

Disclosure statement

Alex Griffiths reports part-time employment with the Care Quality Commission during some of the period in which the paper was authored (though the work was conceived, conducted and authored with complete independence). The opinions expressed in this article are the authors’ own and do not reflect the view of CQC.

Additional information

Funding

This work was supported by the Economic and Social Research Council: [grant number ES/K006169/1].