Patient Safety First

Responsive regulation in health care

Paul Dugdale, Judith Healy

• Publisher: Routledge
• Year: 2020
• Print ISBN:
  9780367718909
• eBook ISBN:
  9781000246766
• Topic: Medicine
• Subtopic: Medical Law

Each year more people die in health care accidents than in road accidents. Increasingly complex medical treatments and overstretched health systems create more opportunities for things to go wrong, and they do.

Patient safety is now a major regulatory issue around the world, and Australia has been at its leading edge. Self-regulation by professional and industry groups is now widely regarded as insufficient, and government is stepping in.

In Patient Safety First eading experts survey the governance of clinical care. Framed within a theory of responsive regulation, core regulatory approaches to patient safety are analysed for their effectiveness, including information systems, corporate and public institution governance models, the design of safe systems,

the role of medical boards, open disclosure and public inquiries.

Patient Safety First includes chapters by Bruce Barraclough, John Braithwaite, Stephen Duckett and Ian Freckleton SC. It is essential reading for all medical and legal professionals working in patient safety as well as readers in public health, health policy and governance.

1
REGULATORY STRATEGIES FOR SAFER PATIENT HEALTH CARE

Judith Healy and Paul Dugdale

REGULATING PATIENT SAFETY

Health care can be risky for patients. Public inquiries continue to reveal unsafe practices in busy modern hospitals, surveys report that around one in ten patients experiences ‘things that go wrong’— that is, they suffer an adverse event during their hospital stay—and more people die each year in health care accidents than in road accidents. Realisation is dawning that medical errors are common events. Large numbers of adverse events do not necessarily mean that doctors and nurses are making more errors than in the past, but rather that there are now more opportunities for things to go wrong. Technological advances have substantially expanded the reach of health care, and more people undergo medical and surgical treatments; however, greater opportunities for intervention also increase the potential for harm. The Hippocratic injunction, ‘first, do no harm’, thus has new relevance for modern medicine, and patients now are less reassured by the mantra ‘Trust me, I’m a doctor’.

Health care governance has been undergoing substantial change since the beginning of the twenty-first century. Many countries, including Australia, have set up new regulatory bodies and are strengthening both internal regulation (by the professions and health industry) and external regulation (by the state and the public) in order to ensure better and safer health care (McLoughlin et al. 2001). This is a major regulatory shift. Historically, clinical performance in the health sector (to the limited extent that it was regulated) was handled by the medical profession and not subjected to external scrutiny (Chief Medical Officer 2006). While most other sectors of the economy were brought under the purview of ‘the new regulatory state’ in the 1980s (Osborne and Gaebler 1992), the state’s regulatory response to the health sector has been somewhat belated. First, the state traditionally has not sought to govern the medical profession but rather to ensure that medicine governed itself (Osborne 1993). Second, the medical profession has strongly opposed external regulation as antithetical to medical professionalism. Third, medical practitioners have a very narrow and negative view of regulation as being about inspections and rules.

We take a much broader view of regulation in this book. We take it to mean governing the flow of events (Ayres and Braithwaite 1992). The chapters are framed within the responsive regulation model and seek to both describe and prescribe health sector governance. Responsive regulation involves multiple regulatory actors and multiple mechanisms, beginning with persuasion, but with the capacity to range upwards to punishment for the most recalcitrant (Braithwaite 2002; Braithwaite et al. 2007). The contributors all argue that better regulation in the health sector is warranted in order to improve the safety of health care for patients— although their views about how best to do this differ somewhat. The nuanced and participative approach of responsive regulation is proposed here as an appropriate model, since it proceeds on the basis that health professionals, after all, seek to do good and not harm.

This review of patient safety regulatory strategies is timely. A flood of initiatives is currently being proposed. These promise solutions in reducing well-known risks to patient safety. For example, the Patient Safety Alliance has endorsed five priority practices, dubbed ‘the High 5s’. These are standardised protocols to prevent errors in the following areas: patient care handover, correct site/correct procedure/correct person surgery, medication continuity, high-concentration drugs, and effective hand hygiene (World Health Organization 2007). About a dozen other evidence-based patient safety practices have also been recommended, arising from systematic reviews of the research literature (Shojania et al. 2001; Leape and Davis 2005).

The first point is that many of the recommended patient safety practices are clinical interventions—such as prescribing anti-clotting drugs before surgery—rather than more upstream regulatory interventions. This book addresses the issue of which regulatory strategies are most effective in ensuring that patient safety practices, such as risk-reducing drug prescriptions, are actually carried out. The second point is that patient safety research must also look beyond the confines of evidence-based clinical medicine. Health systems research encompasses a variety of methods, since many issues are not amenable to classic scientific double-blind control trials and also involve political and cultural considerations (World Health Organization 2004). The chapters in this book thus consider complex regulatory issues from different points of view, including the legal tradition of reasoned argument. The third point is that since many studies come from the United States and United Kingdom, we must consider whether research findings can be generalised to the Australian policy context.

The following chapters by leading patient safety experts discuss key regulatory strategies underway in Australia that are intended to make health care better and safer for patients. They address the following questions:

• How is a particular regulatory strategy intended to impact upon patient safety?
• What reform proposals and debates are underway in Australia and internationally?
• Is there evidence the strategy will improve the safety and quality of patient care?

THINGS THAT GO WRONG

Malcolm Sparrow (2000) argues that the central purpose of regulation is the abatement or control of risks to society, while the essence of the regulatory craft is to ‘pick important problems and fix them’. Are risks to the safety of patients significant enough to warrant regulatory intervention? One way to gauge the significance of the patient safety problem is to measure the frequency of adverse events. Medical language uses somewhat euphemistic terms, such as iatrogenic (doctor-caused) injury and nosocomial (hospital-acquired) infections. Pending a taxonomy being agreed by the World Health Organization, the following is a useful definition of an adverse event: ‘An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.’ (Institute of Medicine 2004: 327)

The Quality in Australian Health Care Study (QAHCS) conducted in 1995 still provides the most comprehensive estimate of the scale of adverse events in Australian public hospitals (Runciman et al. 2000; Wilson and Van Der Weyden 2005). A re-analysis of the data for comparability with overseas studies found that adverse events occur in 10.6 per cent of annual hospital admissions, with 51 per cent of these events considered preventable; 1.7 per cent of admissions experienced serious disability resulting from an adverse event; and 0.3 per cent of patients died from an adverse event (Thomas et al. 2000). Studies in other countries, including the United States (Brennan et al. 1991; Thomas et al. 2000), Canada (Baker et al. 2004) and Britain (Vincent et al. 2001), report that between 4 and 12 per cent of hospital patients experience adverse events. While there is a compelling humanitarian reason for reducing adverse events, there is also an economic rationale, since several studies have estimated that adverse events account for over 15 per cent of hospital budgets, mainly because patients end up staying much longer in hospital (Runciman and Moller 2001; Ehsani et al. 2006). Patient safety, therefore, has been revealed to be a major and costly problem in modern hospitals around the world.

Extrapolating the QAHCS findings to 2003–04 Australian public hospital admissions (Australian Institute of Health and Welfare 2006) suggests an annual hospital toll of 6300 preventable deaths from adverse events. The ‘jumbo jet’ analogy (based on 416 passengers in a Boeing 747) is that 6300 hospital deaths is equivalent to the number of lives lost in fifteen plane crashes. The lack of public outcry about the magnitude of the hospital toll attests to the power of the medical mystique, and also shows that ignorance is bliss, since few state health departments report publicly on the number of adverse events occurring in their hospitals.

Adverse events can be classified in many ways, but the main point here is that an enormous variety of things can go wrong—which makes it difficult to address the multifarious causes. For example, the QAHCS review of adverse events in Australian hospitals identified 518 principal categories of harm to patients, of which the top ten accounted for only 25 per cent of all adverse events (Runciman and Moller 2001). The causes of adverse events are much debated, with a distinction frequently drawn between people error and system error. Of course, different causes suggest different solutions, depending on whether the proximate cause was illegible medication labelling or a lapse in concentration by an exhausted intern. For example, a national medication alert was issued after fatalities where vincristine was mistakenly injected into the spine instead of into a vein, with contributing factors being confusing storage and labelling, and inexperienced staff (Australian Council for Safety and Quality in Health Care 2005).

Regulatory rhetoric in the health sector generally avoids ‘naming, blaming and shaming’. The idea is to promote a ‘safety culture’, not ‘a blame culture’, in order to encourage learning from near-misses and adverse events, and so prevent future occurrences. James Reason’s work is influential and salutary in pointing out that errors usually have intertwined and multiple causes, so a high-risk organisation such as a hospital should engineer a series of safeguards to prevent the confluence of factors that allows an error to occur (Reason 2000). The case of wrong-site surgery (shown in Box 1.1) illustrates a series of errors that are understandable individually, but which together were disastrous for the patient and distressing for the doctor.

Box 1.1 In the matter of Dr A

Event description

In November 2002, Patient S was seen by Dr A and diagnosed with cancer of the left breast. In December 2002, Dr A assisted the surgical registrar in performing a right total mastectomy. Prior to the surgery, Dr A had failed to correctly complete the patient’s consent form and the hospital admission request form, and did not have the patient’s medical records in the operating theatre.

Contributing factors

Patient S was an elderly woman who suffered from dementia and spoke little English. The patient’s daughter attended the first consultation but the patient was admitted to hospital from the nursing home by her son-in-law. Dr A was very busy on the day of the surgery, completed the admission forms without consulting the patient’s medical record, and entered R as shorthand for ‘right mastectomy’ instead of entering ‘left mastectomy’. The patient was not brought to the hospital’s pre-admission clinic and thus did not go through the usual hospital checking procedure.

What action followed

After the error was discovered, Dr A spoke to the family and performed the left mastectomy that evening. The patient recovered with no evidence of further cancer (as at December 2003). Dr A instituted several safety changes to his surgical checking procedure. The hospital instituted a correct patient/site/procedure protocol. The Medical Tribunal of NSW, at its hearing in 2006, reprimanded Dr A and ordered him to pay 70 per cent of the costs of the complainant (Medical Tribunal of New South Wales 2006).

Widespread patient safety problems and associated regulatory failures are uncovered during public inquiries into ‘medical scandals’. For example, the cases of Dr Patel in Queensland and Dr Reeves in New South Wales, widely reported in the Australia media, have produced pressures for regulatory reform. A...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Contents
• Figures and Tables
• Acknowledgments
• List of Contributors
• 1. Regulatory strategies for safer patient health care
• 2. Leading from behind with plural regulation
• 3. International trends in patient safety governance
• 4. Voluntary initiatives by clinicians
• 5. Integrating corporate and clinical governance
• 6. Transforming clinical governance in Queensland Health
• 7. Regulating health professionals
• 8. Non-disciplinary pathways in practitioner regulation
• 9. Regulating clinical practice
• 10. Surgeon report cards
• 11. Disclosure of medical injury
• 12. Does litigation against doctors and hospitals improve quality?
• 13. Hospital licensure, certification and accreditation
• 14. Connecting health care through information technology
• 15. Do public inquiries improve health care?
• Index