- Clinical governance
‘The set of relationships and responsibilities established by a health service organisation between its executive, workforce and stakeholders (including consumers)’ to support safe, quality care (Australian Commission on Safety and Quality in Health Care, 2012a, p. 6)
- Corporate governance
‘The framework of rules, relationships, systems and processes within and by which authority is exercised and controlled in corporations’ (Australian Institute of Company Directors, 2011, p. 2)
- Clinical governance framework
The rules, roles, relationships, systems and processes that support safe, quality care within an organisation
Why do we need clinical governance? There is a long history of quality improvement programs in Australian and New Zealand healthcare organisations, stretching back before the Australian Council on Healthcare Standards made organisation-wide quality programs a formal requirement for accreditation in 1986. Health professionals have traditionally pursued high standards through data collection, professional associations and education programs. In the decades prior to the 1974 introduction of accreditation in Australia, many health services had developed some form of improvement, variously motivated by government initiatives, clinically driven audit programs and individual clinical improvement champions. And before the introduction of clinical governance in Australia in the early 2000s, many improvement approaches had been adopted to improve these systems’ weaknesses, with some systems implemented from other industries with varying success. Quality programs evolved slowly, limited by a lack of focus, data and resources and minimal attention paid to this aspect of the professional role in clinical education (Balding, 2008).
There remained large variations in care practices and processes, and when things went wrong, resulting in patient harm, there were few mechanisms for identifying, discussing and learning from suboptimal care, with blame and shame being the most likely outcomes. Fear of legal consequences and a hospital culture that blamed error on human failing ensured that healthcare was slow to acknowledge and learn from mistakes. This culture, the lack of reliable data and the heavy reliance on individuals to provide consistently good care masked many clinical and systems inadequacies (Spear & Schmidhofer, 2005).
Turning point
The first large-scale Australian study of hospital-acquired adverse events provided much-needed focus and clarity. The 1995 Quality in Australian Health Care Study revealed that 16.6 per cent of reviewed admissions were associated with an adverse event, with 51 per cent of these considered preventable (Wilson et al., 1995). The study results were presented in federal parliament, and for the first time the safety of the healthcare provided in hospitals joined healthcare access and efficiency as public and political issues. Australia responded in 2000 by setting up the Australian Council for Safety and Quality in Health Care, charged with developing Australia’s first national approach to system-wide quality issues (Wilson & Van Der Weyden, 2005). New Zealand instituted national certification of health and aged care services in 2001, and in 2010, to lead a national safety and quality approach, the New Zealand Health Quality & Safety Commission (2013) was established.
Just as health professionals were coming to terms with the problems identified by the Australian data, and with other studies from around the world showing similar results, the statistics were given a startlingly human face by a series of public inquiries into safety and quality of care in hospitals, firstly in the United Kingdom, with the Bristol Royal Infirmary case (United Kingdom Department of Health, 2001), and then in a number of Australian hospitals (Dunbar, Reddy, Beresford, Ramsey & Lord, 2007). The United Kingdom’s National Health Service introduced clinical governance after the Bristol inquiry in 1998 and subsequently built a whole reform program around it, defining it as ‘a system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’ (Scally & Donaldson, 1998, p. 62).
Australia has also had its share of public inquiries, with investigations into Camden and Campbelltown hospitals in New South Wales, Canberra hospital in the Australian Capital Territory, King Edward Memorial hospital in Western Australia and Bundaberg hospital in Queensland. Each review arose after internal mechanisms failed to resolve perceived issues and whistleblowers alerted politicians directly. ‘None of the substantiated problems had been uncovered or previously resolved by extensive accreditation or national safety and quality processes; in each instance, the problems were exacerbated by a poor institutional culture of self-regulation, error reporting or investigation’ (Faunce & Bolsin, 2004, p. 44).
Publicly reported reviews of care in the United Kingdom, Australia and other countries provided impetus for the development of clinical governance to underpin and strengthen traditional quality improvement programs. Each Australian jurisdiction and New Zealand district health board defined a purpose and approach, with most including common issues such as the management of complaints, clinical risk, medical credentialing and evidence-based care. These continue to be central components of all clinical governance frameworks. In addition, some early national approaches were achieved, such as an Australian medication collaborative that agreed on a national generic medication chart.
Despite the introduction of clinical governance in the United Kingdom in 1998, a decade on, through the Mid Staffordshire inquiry, the National Health Service found itself embroiled in another major public inquiry which embodied the issues of all previous inquiries at a level previously unseen. The chair of the inquiry, Robert Francis (2013, p. 1), summarised the issues raised as ‘a story of appalling and unnecessary suffering of hundreds of people [over three to four years] … failed by a system which ignored the warning signs and put corporate self interest and cost control ahead of patients and their safety’. Consistent organisational and management issues have been identified from analysis of the series of public inquiries held around the world; these are listed below:
- culture of blame and inattention
- focus on meeting external key performance indicators and targets at the expense of internal standards of care
- lack of leadership of, clear lines of accountability for, and reporting on the quality and safety of the services provided
- insufficient consideration of patients and their families
- tolerance of substandard care
- ineffective credentialing, training and support for staff
- preoccupation with corporate matters at the expense of focus on clinical care
- ineffective reporting and action relating to clinical care. (Mid Staffordshire NHS Foundation Trust Public Inquiry, 2013; Walshe & Shortell, 2004)
The Mid Staffordshire inquiry’s recommendations are consistent with those from all similar public inquiries. While each inquiry addresses its own context, the common actions required for change are clear: leadership of safety and quality from the top of the organisation, engagement of patients and families in care, rigorous implementation and monitoring of basic care standards, and support for staff to provide quality care and robust, transparent reporting and action (Travaglia, Hughes & Braithwaite, 2011). Clinicians, consumers and their families have played a key role in blowing the whistle on substandard care, and in some cases this has resulted in the executives involved losing or leaving their jobs.
Above all, the combination of studies into adverse events and public inquiries into poor care have reinforced the knowledge that reliance on well-trained and well-intentioned individuals trying hard is not enough to guarantee consistently good care in a complex environment such as healthcare.
The Mid Staffordshire hospitals underwent two public inquiries investigating poor care during the period from 2005 to 2009. The case represents perhaps the best example in healthcare of what can happen without a system of leadership, accountability and monitoring. It caught international attention in a way that many other public inquiries have not, possibly because it was about the denial of basic standards of care.
At these hospitals, elderly and vulnerable patients were left unwashed, unfed and without fluids. Some were left in excrement-stained sheets and beds. Patients who could not eat or drink without help did not receive it. Medicines were prescribed but not given.
How could this happen in a modern hospital in 21st-century England? The chair of the inquiry, Robert Francis, was clear: it happened because of a complete breakdown of clinical governance. According to Francis, the hospital trust board did not listen sufficiently to its patients and staff or ensure the correction of deficiencies that were brought to their attention. It failed to tackle a culture involving tolerance of poor standards and disengagement from managerial and leadership responsibilities. The board and executive were preoccupied with achieving access and budget targets rather than focusing on the standard of care they were providing. The hospitals met their external compliance requirements, but these were focused more on corporate than on clinical matters (Mid Staffordshire NHS Foundation Trust Public Inquiry, 2013).
Evolution
Clinical governance has changed in response to these lessons. What began as a focus on risk and credentialing by governments, boards and executives has evolved over the past two decades into a complete system that supports governing bodies to address clinical safety and quality with the same rigour as corporate governance.
The challenge for boards is the associated requirement that they have the same knowledge of clinical quality matters as they do of financial matters. Boards must be satisfied that there is sufficient focus on staff accountability and responsibility for quality and safety throughout the organisation. This requires chief executive officers and senior managers to implement and report on a planned and systematic organisational approach to monitoring, managing and improving safety and quality.
Implementation
Clinical governance is a system within the existing corporate governance system. Ultimately, the board of a healthcare facility or service is accountable for the clinical care provided by the organisation and requires organisation-wide clinical governance that provides feedback on the quality of care that is delivered, the prevention of unacceptable events and the management of clinical and non-clinical risks. Clinical governance is essential to ensure that accreditation will be maintained and that the organisation will survive and prosper over the long term. In addition, insurance may not cover negligence if adequate clinical governance is not in place (Australian Institute of Company Directors, 2011).
International research suggests that hospitals with boards that are actively engaged in quality issues are more likely to have effective clinical governance programs in place, which enable better performance on indicators such as risk-adjusted mortality rates (Jiang, Lockee, Bass & Fraser, 2009). Some boards lack understanding of patient safety problems and receive inadequate information for sound decision-making (Bismark, Walter & Studdert, 2013). The establishment of clinical governance is challenging for many Australasian boards for a range of reasons, including concern about the technical competence required by directors to understand clinical matters, the independent contractor model of doctors in Australian hospitals and health services that separates medical and management functions, and resistance from clinicians and a fear of interfering with clinicians’ business (Australian Institute of Company Directors, 2011).
Australian system
The introduction of clinical governance in Australia received a significant boost by the requirement from 2013 for health services to meet a national mandatory set of 10 safety and quality standards, the first two of which provide a governance platform for supporting safe, high-quality care in high-risk services.
The Australian Commission on Safety and Quality in Health Care (2014) developed these National Safety and Quality Health Service Standards in partnership with a wide range of stakeholders, and they have been endorsed by health ministers for use in health services across Australia. Accreditation to the standards came into effect on 1 January 2013 for hospitals (including inpatient mental health services), day procedure services and most public dental services.
Standard 1, which is concerned with ‘governance for safety and quality in health service organisations’, provides comprehensive information on the requirements of an effective health service governance system, incorporating ‘the set of processes, customs, policy directives, laws and conventions affecting the way an organisation is directed, administered or controlled’ (Australian Commission on Safety and Quality in Health Care, 2012a, p. 6).
The introduction to the standard says that ‘health service organisation leaders implement governance systems to set, monitor and improve the performance of the organisation and communicate the importance of the patient experience and quality management to all members of the workforce. Clinicians and other members of the workforce use the governance systems’ (Australian Commission on Safety and Quality in Health Care, 2012a, p. 7). They do this to create safe, quality consumer experiences. As an overview, Standard 1 requires the following conditions of health organisations:
- There is an integrated system of governance that actively manages patient safety and quality risks.
- The governance system sets out safety and quality policy, procedures and/or protocols, and assigns roles, responsibilities and accountabilities for patient safety and quality.
- The clinical workforce is guided by current best practice and uses clinical guidelines that are supported by the best available evidence.
- Managers and the clinical workforce have the right qualifications, skills and approach to provide safe, high-quality healthcare.
- Patient safety and quality incidents are recognised, reported and analysed, and this information is used to improve safety systems. (Australian Commission on Safety and Quality in Health Care, 2012a)
Standard 2, which is concerned with ‘partnering with consumers’ aims to ensure that health services are ‘responsive to patient, carer and consumer input and needs’ (Australian Commission on Safety and Quality in Health Care, 2012b, p. 6), based on the premise that the importance of health services partnering with patients, families, carers and consumers is recognised at a national and international level. According to the standard, significant benefits to clinical quality and outcomes, the experience of care and the business and operations of delivering care are created by such partnerships (Australian Commission on Safety and Quality in Health Care, 2012b).
Other sectors, such as primary, mental and community health and aged care, have developed their own approaches, usually emanating from accreditation requirements. These models may look different, but the components are essentially the same, and include the following requirements:
- The leadership plans, resource and implement a culture and systems for creating quality consumer experiences.
- There is a focus on learning from mistakes in a just way – that is, not blaming people for honest mistakes or systems failures, but holding people to account for errors arising from flouting rules and policies.
- Systems are in place to support consumer participation in their care and in improvement of the service more broadly.
- There is workforce development, support and guidance.
- There are compliance, risk and improvement systems to get the basics right and monitor and improve care.
Responsive regulation
The National Safety and Quality Health Service Standards form part of a broader national accreditation reform agenda, based on a responsive regulation approach to clinical governance. Responsive regulation is a hierarchical approach with mechanisms that range from persuasion to command and control, as shown in the following list:
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