IDENTIFYING THE PROBLEM

For this chapter, a policy problem is taken to be one that receives government’s attention and leads to responses like advocacy, reform, funding, or regulation.² In the 1990s, medical error and patient safety became a policy problem for many reasons. It was generally recognised that medical error was a threat to health, especially with the repeated use of the estimate of 18,000 deaths a year caused by adverse events (see McL Wilson et al. 1995). There were efforts in healthcare to improve safety and quality, such as hospital units seeking to improve quality and safety across wards and clinics, and lead clinicians seeking to improve practices in some specialties, which has long been the case for anaesthetics (Runciman & Moller 2001 p 2). Consumerism in healthcare meant that patients were willing and able to demand high standards, and criticise authorities when these demands were not met. Government became more willing to make sure its funding delivered good results, which included dealing with problems such as medical error.

However, the government would have been reluctant to intervene if the problem was defined only in clinical terms. Before the 1990s, medical error had been largely dealt with in clinical, professional and legal ways. For example, professional boards could restrict, suspend or bar clinicians from practice if found to be guilty of, say, ‘infamous conduct in any professional respect’. A patient could sue a doctor if it were proved the patient was harmed by negligence. There may have been reason for government to respond, but the problem needed to be made relevant to government influence.

Another difficulty for dealing with medical error and patient safety in policy terms is its complexity. Medical error could be loosely described as producing harmful, unintended results from healthcare. However, as noted by one overview, ‘(a)lmost every study uses different methods, terms, and definitions’ (Thomas & Brennan 2001 p 32). Different terms include adverse events, medical mistakes, complications, medical negligence, and incidents, each with its own shade of meaning. By contrast, terms such as patient safety emphasise the results rather than the process of care. The complexity of the problem is demonstrated in Box 15.1 by way of example.

A system problem

In a similar way, since the early 1990s, error experts have argued medical error and patient safety should be defined in system rather than individual terms. Aviation and manufacturing are often used as examples to show that error rates can be reduced in the right conditions. Rather than only looking at the ‘hand that wields the scalpel’, planning decisions, system management, and error-provoking conditions such as time pressure, understaffing, workplace morale and conditions, inadequate equipment, fatigue, and inexperience may all contribute to error (Bognor 1994 pp vii–xv, 4, Leape 1994 pp 1852–5, Reason 1994 p 11, Vincent 2001 pp 9–30, Reason 2000 p 769).

This approach, at least in some of its forms, has its critics. For example, Leape suggests that the training of medical practitioners to be individualistic and perfectionist had resisted the systems approach (1994 p 1851). There is also a popular demand to find individuals responsible and accountable, as reflected in statements like ‘the buck stops here’. This demand partly explains the New South Wales Government’s criticism of its health complaints commission’s report on unsafe care at Campbelltown and Camden hospitals. The government was concerned that the commission did not find any one person accountable (see Iemma 2003).

However, the power of defining medical error in system terms has proved resilient, with efforts to convince a wider audience of the experts’ view. For example, in his essay ‘When Doctors Make Mistakes’, Gawande argued against a ‘tidy version of misdeeds and misdoers’ and instead that:

In complex systems, a single failure rarely leads to harm … But errors do not always become apparent, and backup systems themselves often fail as a result of latent errors. A pharmacist forgets to check one of a thousand prescriptions. A machine’s alarm bell malfunctions. The one attending trauma surgeon available gets stuck in the operating room. When things go wrong, it is usually because a series of failures conspires to produce disaster.

(Gawande 2002 pp 63–4)

Since the second world war, government has become largely responsible for running the healthcare system, especially after it started to fund population-wide access to medicine, pharmaceuticals, hospitals, and primary healthcare. It is government that undertakes system-wide planning, and makes decisions about system resources and infrastructure such as major buildings, logistics, purchasing, administration, and information technology. As system manager, government is expected to deal with system problems such as medical error.

A financial problem

Adverse events in hospitals have been variously estimated to cost $1.7 billion (Rigby et al. 1999 p 9) to $2 billion a year (Ehsani et al. 2006 pp 553–4). Both include non-preventable events, which if estimated at around 50% of all events, then perhaps $1 billion a year could be saved or redirected. The Productivity Commission reports an estimate of 1.8% fewer re-admissions if surveyed hospitals matched the performance of the top 20% of reporting hospitals (2007 9.33–9.34).

Placing a financial value on medical error and efforts to prevent it is difficult. Systemic change and reform to prevent error and improve safety do cost in effort and resources. For example, accreditation which might arguably make safety and quality gains, also costs in systems development, preparing documentation, and training and upgrading (Australian Commission on Safety and Quality in Health Care [ACSQHC] 2006 p 17).

However, estimates of health system cost have tended to focus on hospital cost, as this is where medical error has been most analysed, but there are costs to other parts of the system; for example, with the management of ongoing chronic conditions. There are costs due to time and productivity lost from work and disability benefits (Vincent 1999), and there are also costs of compensation in cases of proved negligence, which in turn contributes to pressure on insurance premiums and costs of running health services. Despite these difficulties, the discussion of medical error as a funding problem prevails. For example, a publication by the former Australian Council for Safety and Quality in Health Care notes ‘poor quality is extremely costly and drains the system of precious resources’ (Pearse 2004 p 10).

Government has been a majority funder of healthcare since at least the 1960s, if tax expenditure is included (Butler 1998). As financial pressure on the healthcare system grows, so too does pressure to deal with preventable expense, although the problem is not simply the amount of money lost. From the 1980s, government became increasingly interested in the results of funding, and not just funding amounts and method. For the Commonwealth, this was reflected in the public sector reforms of 1983 and the evaluation strategy which started in 1988 (Mackay 1993). This expanded the scope of government’s financial responsibilities for healthcare: it wanted to be not simply a majority and largely passive funder, but rather also to measure and improve how funding delivered results. This includes reducing the extent and consequences of medical error, and improving patient safety.

A human problem

Inglehart argues that in prosperity, people ask more questions, are sceptical towards authority, evaluate politics with more demanding standards, and deal with politics less by mass participation and more through particular issues (Inglehart 1997). Established institutions like healthcare and government are subject to more questioning, scepticism, and criticism, and they are more frequently called to account.

In its reportage of medical error, the media has drawn upon an increasing willingness to demand higher standards and to criticise if these standards are not met, and in doing so it emphasises the human angle. Personal experience is a powerful symbol and the coverage of innocent suffering and tragedy makes medical error seem a real and an immediate threat. Family members tell of their grief at the death of a relative, spouse, or child; and patients tell of their anger, pain, and suffering. The definition of medical error and patient safety as a human problem, which is then mediated through newspaper articles and television reports, exerts a powerful influence on those in authority to respond.

As well as running and funding healthcare, government is also responsible for taking reasonable measures to protect the population from harm. This is a long held idea about responsible government (see Osborne 1997 pp 176–7). Applications of this idea are seen in 19th century public health measures to enforce quarantine and public health, and are now reflected in bioterrorist measures and prevention of infectious disease. Media accounts of medical error often draw upon this idea and appeal to government to intervene to deal with the human problem of medical error, whether implicitly or explicitly.

POLICY RESPONSES

Definitions of medical error in system, financial and human terms helped take the attention of government. They also helped frame a policy response. On the one hand, government is largely responsible for running and funding the healthcare system, but it also must negotiate with other interests, sometimes cooperatively and other times in conflict (see Sax 1984). On the other hand, responsible government takes reasonable measures to protect the population from harm. This has led to a mix of advocacy, reform, funding, and regulation in response to medical error, which will be examined in this section.

Government advocates

Advocacy is one way that government tries to influence the system of healthcare, and it used this to deal with medical error and improve safety. The Commonwealth started a review of professional indemnity for healthcare professionals in 1991. The review took submissions, funded research, published papers, and in 1995 reported to the Commonwealth health minister. The objective of the review was to minimise the human and financial costs of adverse patient outcomes from healthcare (Review of Professional Indemnity Arrangements for Health Care Professionals [RPIAHCP] 1995). Its work anticipated policy concerns to follow in the next decade, including access to the tort system, with high costs and delays for plaintiffs.

One piece of research funded by the review, the Quality in Australian Health Care Study, estimated adverse events in Australian hospitals. The then Commonwealth health minister released early results from the study in the House of Representatives on 1 June 1995, concluding:

We can no longer be complacent about the issue of patient safety in healthcare. It is no longer satisfactory for us to simply assert that we have a high-quality health system. We need to measure outcomes and performance. We need to ensure that the system has a clear and strong patient focus. We need to actively address the problem areas. I congratulate those who carried out the study – the challenge of response lies before us.

(Lawrence 1995)

The minister indicated that she had written to state health ministers and would raise the problem at health ministers’ meetings, and consult with professionals. A taskforce on quality in Australian healthcare was established in 1995, and reported in 1996. This was followed by a national expert advisory group on safety and quality in Australian healthcare, which made its final report in 1999.

Since 1998, health ministers have issued five statements on safety and quality matters, announcing the creation of new safety and quality agencies, new funding, and agreements to lead on improving the quality and safety of healthcare. In addition, many other releases touch on safety or quality issues, such as better coordination of Indigenous service delivery, more accurate screening of blood donations, improved quality of services for people with chronic conditions, and improving responsiveness of mental health services (see Australian Health Ministers Advisory Council [AHMAC] 2007).

Government reforms

New organisations with new powers were also created. Health complaints bodies were established to give patients an independent means to complain about their care (Thomas 2002). The Australian Council for Safety and Quality in Health Care started in 2000, mediating between medicine and government to help drive systems and long-term reform. In 2006 the council was replaced by a new commission responsible for improving safety and quality across the whole healthcare system. The Commonwealth created a National Institute of Clinical Studies in 2000, the ‘national agency for closing the gaps between evidence and practice in healthcare’ (NICS 2007). The Centre for Research Excellence in Patient Safety was created to strengthen the evidence for system improvements and to reduce adverse events (CREPS 2007).

Together, these new institutions have created new materials such as information for patients about safety and quality, new processes such as pilots for open disclosure when talking with patients, new data such as reporting on sentinel events to indicate systemic problems, and new research and evidence to improve safety and quality. These agencies sought to make systemic change to the way that healthcare was practised, especially by professionals working with their peers to promote change.

Government funds

Safety and quality funding is also transferred between governments, as part of the larger financial transfer from the Commonwealth to the states and territories. In particular, the Commonwealth helps pay the costs of public hospitals through 5-year agreements. Although some states had created health complaints bodies beforehand, the 1993–98 agreements required all states and territories to do so, and make sure they operated independently of health departments and hospitals (Council on the Ageing [COTA] 1993). In the following 1998–2003 agreements, the Commonwealth made around $660 million out of $31 billion over 5 years available for quality activities (Maskell-Knight 1999).

It is said that ‘he who pays the piper calls the tune’, and with funding comes influence. However, balanced against this is the sheer complexity of the healthcare system, involving millions of clinical care events provided each year by a mix of public and private providers working across different settings. Accordingly, government to date has used funding to support good clinical practice, encourage good governance, and create the right environment for safety and quality.

Government regulates

The increasing complexity, diversity and power of therapeutic goods, and their supply, also means increasing risk. In response, government has strengthened its regulation of the safety and quality of these products, consistent with a growth of consumer protection measures taken in many Western countries, such as the United States (see Moss 2002).

Legislation, licensing, policy directives, approvals, inspections, and guidelines are all ways used to regulate safety and quality in healthcare. For example, a state might require all public hospitals to be accredited, have specialist committees to promote safe clinical practice, such as the use of blood and blood products, and to report any sentinel adverse events for patients.

Nationally, new healthcare regulatory agencies have been created. The Therapeutic Goods Administration (TGA) regulates the safety and quality of medicines and medical devices, such as pharmaceuticals, complementary medicines and blood products. Other regulatory agencies include Food Standards Australia New Zealand which sets and regulates food standards; the National Industrial Chemicals Notification and Assessment Scheme which regulates industrial chemicals; and the Office of the Gene Technology Regulator (see Department of Health and Aged Care [DHAC] 2001).

Regulation is a direct intervention by government, and enables greater control for government to protect the population from harm. However, it also brings with it risk, as insufficient knowledge, incapacity, or plain error may cause unintended effects of regulation, or too costly a result. Failure to protect consumers from defective products may also lead to accusations that government has not lived up to its responsibilities (see Drache & Sullivan 1999 p 8).

It is now useful to turn to a specific case of how the definition of medical error in system, financial and human terms helps frame the policy response. Box 15.2 sets out the case of safety in Queensland’s public hospital system.

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