Designing safer health care through responsive regulation

The health sector is characterised by complexity, a plurality of players (national and state governments, public and private providers, professions, and consumer groups), rapid change in its environment (eg, new technology and new global diseases), and a recent proliferation of regulatory agencies and regulatory strategies. We argue that “responsive” regulation — the use by regulators of mechanisms that are responsive to the context, conduct and culture of those being regulated — is a promising strategy for improving the quality and safety of patient care. These ideas were elaborated in our discussion paper The governance of health safety and quality, which presents contemporary research on regulatory thinking, including examples from other high-risk industries.1 While definitions of regulation abound, we use the term to mean governance in the broad sense of steering the flow of events, rather than the narrow sense of enforced compliance with rules.2

In the “new regulatory state”, with its increasing privatisation, regulation by government and its agents has become more rather than less common, but the crucial difference from the old “command and control” view is that governments increasingly “steer not row” and are seeking flexible, participatory and devolved forms of regulation. These changes are possible given the changed nature of organisations in the information age, where power flows through networks that are more fluid and complex than older structures of governance.3 This perspective is particularly appropriate in the health sector with its multiple players and where the state generally has left the regulation of health care performance to the medical profession. However, external pressures have been mounting over the past decade for governance systems to insist on more accountability and transparency from health care providers.4 Until recently, most mechanisms intended to improve performance have relied on internal rather than external monitoring; for example, hospitals were left to monitor their own surgical mortality rates. The normative assumption has been that techniques for improving performance rely on voluntary adoption by a professional or an organisation, whether incident reporting or clinical protocols. Walshe argues that the problem with this “soft” approach is that it treats a health provider as if it exists in isolation from its environment, oblivious to the institutional, social and economic pressures that drive organisational willingness to contemplate internal reforms.5 Moreover, the medical profession has traditionally resisted what it sees as encroachment on professional autonomy,6 although, in the United Kingdom at least, it has been claimed that the old system of self-regulation by doctors is dead.7

The public expects a high standard from 21st century health care given the dramatic advances in technology and in medical and surgical knowledge. However, greater scrutiny of performance, and more media interest in its failings, has shaken public confidence. Ongoing medical “scandals” in many countries, including Australia8 — most recently at Bundaberg Hospital9 — mean that the public is no longer confident about leaving safety and quality to doctors and health departments. Realisation has dawned that health care is a risky business, as shown by the Quality in Australian Health Care Study, where re-analysis of data revealed that over 10% of patients experience some type of adverse event in hospital.10 Estimates and consensus from other countries suggest that a large proportion of errors are preventable.11,12

The challenge for safety and quality is to design safer systems and inculcate a culture of safety, while the challenge for governance is to ensure that these systems and practices are actually applied. The argument of responsive regulation is that regulators are more likely to succeed if they use strategies that are responsive to the culture of those being regulated.13 For example, bringing about change in hospitals must take into account professional and organisational cultures,14 as shown in the research on “magnet” hospitals (so termed because of their success in attracting and retaining nursing staff).15 Similarly, designing safer systems must take into account human factors.16

Responsive regulation is an approach that values trust, transparency and professionalism. It aims to transcend the polarised choice between punishment and persuasion. The regulatory pyramid is an attempt to solve the puzzle of when to persuade and when to punish. Key elements of responsive regulation are:

• The regulator begins at the base of the pyramid with persuasion;

• A single regulatory mechanism is seldom sufficient as the weaknesses of one mechanism must be complemented by the strengths of another; and

• There must be the capacity for escalation if persuasion fails.

At the base of the pyramid, we must craft the most persuasive and dialogue-based approach for securing compliance with a just rule or standard, through invoking informal rewards such as praise, rather than sanctions. The presumption is to start at the base of the pyramid (“soft words before hard”), but, in ascending, to invoke more demanding strategies. The pyramidal presumption of persuasion gives the cheaper and more respectful option a chance to work first. Polite requests followed by threats are more likely to work when everyone knows that non-compliance will result in an inexorable progression up the enforcement pyramid, and that “owning up” results in learning, while cover-up risks escalation.

Box 1 depicts some examples of regulatory mechanisms from the health sector that range upwards in a pyramid from persuasion to punishment — although some mechanisms, such as accreditation, might be voluntary or mandatory depending on the context. Thus, a policy maker or hospital manager could use the pyramid to think responsively in choosing among a range of regulatory options.

The idea of responsive regulation is that informal interventions to address problems, as well as positive feedback on achievements and strengths, may be all that is required to persuade a health provider. Persistent infractions may eventually elicit repeat inspections and public disclosure of failure to meet standards. But, even at this level, referral to support services or mentoring should be offered. Every escalation up the pyramid should also indicate a path to de-escalation. Continued and serious breaches of the regulatory guidelines may incur financial penalties and result in activities being curtailed. For example, a hospital might be refused public funding for extra elective surgery until a problem is fixed, or a physician might be deregistered. Licence removal or closure are last resorts and signal the failure of both parties to ensure the public is well served.

The idea of responsive regulation arose out of the actual experiences of private firms. Some argue that business people understand only the “bottom line” profit and therefore must be consistently punished for lawbreaking, while others assert that business people are responsible citizens who can be persuaded. There is truth in both positions, depending on the context. But neither consistent punishment nor consistent persuasion has proven effective in the long term. Consistent punishment is too costly, and consistent cajoling of the incorrigibly unethical or incompetent is naïve. For example, a study of 410 chief executive officers of small health care organisations found that while expected severity of sanctions did not predict compliance, regulators who were consistently “tolerant and understanding” increased non-compliance.17 Although there is no body of evidence that responsive regulation will work in more complex organisations such as hospitals — that remains to be tested — there is a body of evidence that responsive regulation works in settings such as mines and nursing homes, and also in more complex domains, such as the nuclear industry.18

Despite the emergence of new regulatory bodies, commentators in several countries, including the United States19 and Australia,20 are frustrated by an apparent lack of progress. This is despite the large body of widely disseminated research and recommendations over the past 5 years by the Australian Council for Safety and Quality in Health Care, and the host of initiatives underway.21 For example, there are no national published measures of adverse events, despite the beginnings of state-based monitoring of sentinel events. Without some form of standardised reporting, there is no way to benchmark performance and to systematically trace progress.20

A second gap is in innovation through systematic learning, as undertaken in other risky enterprises. For example, this philosophy underwrote the dramatic improvements in the safety of air travel in the 20th century. The aviation industry has systematised error reporting and staff training to produce a safety culture that offers lessons for medicine.22 The challenge for health care is to shift from a blame culture to a learning culture, in order to learn from adverse events.

Two approaches — metaregulation and learning models — illustrate how we might rise to the challenge of shifting from blame to learning.

1 Regulatory pyramid and examples of safety and quality mechanisms (from Braithwaite et al, 20051)

2 Triple-loop learning (from Parker, 200226)