The role of rules and regulation in patient safety

Like most parents, I want my children to become good, honest, responsible adults. But which parenting techniques will turn my hope into reality? How do I get my daughters (currently aged two and four) to refrain from snatching toys from others, to tell the truth, to consider others, to share, and to avoid lashing out aggressively when life just doesn’t go their way?

Should I lay down a set of clearly defined rules identifying a set of unacceptable behaviours? Will these rules ‘work’ through consistent and vigilant parental enforcement (including the punishment of non-compliance) to ensure they grow into honest, considerate and responsible individuals? Perhaps they will. Perhaps they won’t.

My worry is that this approach will produce individuals who are unreflective rule-followers lacking strength of character, genuine kindness and compassion for others, and cope poorly with life’s complexity.

Similar questions arise when thinking about the role of rules and regulation in promoting social policy goals more generally, including regulation aimed at fostering patient safety in healthcare. Different responses are evident in the Francis report, authored by a distinguished barrister, and the Berwick report, chaired by an experienced clinician and patient safety expert.

Both emphasise the need to foster a culture in which patient safety is prioritised above all else. Yet they adopt strikingly different understandings of the appropriate role of rules and regulation in fostering such a culture.

For Robert Francis QC, readily accessible rules (which he calls ‘fundamental standards’) below which standards must not fall are vital, and must be vigorously enforced through a zero tolerance approach to non-compliance.

Don Berwick is considerably more sceptical. For him, rules are a blunt instrument for generating the cultural change he sees as necessary to the infrastructure of patient safety. He agrees with Robert Francis that regulation has a role in setting out what is expected, monitoring the extent to which those expectations are met, and taking action when they are not.

But for Berwick the role of regulation is of secondary, rather than primary, importance. As his report puts it, 'in the end, culture will trump rules, standards and control strategies every single time, and achieving a vastly safer NHS will depend far more on major cultural change than on a new regulatory regime'.

Berwick’s desired culture of continuous learning and improvement, which patient safety requires, demands alertness to the operation of healthcare services at the system level. Dynamism, expert judgment and sensitivity to context are needed, rather than rigid adherence to rules. It’s almost impossible to find reasons not to support the ideal vision of an agile, responsive proportionate healthcare system that Berwick portrays.

Who could be against an NHS which wholeheartedly embraces a culture of learning and continuous improvement in relation to quality of care, of which patient safety is but one element? How this vision is to be achieved remains the stubborn challenge, however, and the role of rules and regulation deserves critical scrutiny.

As a lawyer and legal academic, I have much sympathy for Francis’s fondness for rules. Rules can guide behaviour. In regulatory contexts, they are expected to perform social management functions and help to facilitate the achievement of social goals. The use of clear, precise, stable rules is closely associated with a set of ‘rule of law’ values, such as openness, transparency, consistency, due process and participation.

All of these are important elements of the perceived legitimacy of any control regime. But I am also acutely aware of the limitations of rules. Regulatory literature includes numerous empirical studies demonstrating that rules are imperfect mechanisms for guiding behaviour due to their inescapable under-inclusiveness (failing to capture situations which ought to be included), over-inclusiveness (capturing situations which ought not be included), uncertainty and divergence in their interpretation.

Poorly designed rules may fail to promote compliance with their underlying goals, so that one might comply with the rules but nevertheless fail to promote their underlying goals.

I cannot expect my daughters to become paragons of virtue, but I hope that they will become decent, caring, compassionate and thoughtful individuals who endeavour, on a vast majority of occasions, to act with honesty and integrity. My instincts tell me that demanding their strict adherence to detailed behavioural rules is unlikely to be the best way to foster their growth and development.

But the concrete steps we should take in making progress towards Berwick’s noble vision are unlikely to involve dispensing with rules and regulation altogether; the question is how to design them so that they promote behaviour deemed desirable without thwarting the very conduct we seek to encourage.   

Karen is a Professor of Law and Director of the Centre for Technology, Ethics, Law and Society at King's College London.