Introduction

The terms ‘quality’ and ‘safety’ are frequently used in health and social care. But what does quality mean? In healthcare, quality is defined as “how well healthcare services for individuals and populations achieve desired health outcomes that are consistent with current professional knowledge and standards” (Kelly Vana, Vottero, and Altmiller, 2023, p. 5). Safety, then, is to provide care without harm. Like all things, health, quality and safety are dynamic and should never be considered separate from everyday business but should be ‘business as usual’. In a health and social care system that is ever-evolving, attention to quality and safety is of utmost importance.

Clinical standards and governance systems are central to safety and quality. They are the backbone of effective healthcare and must be in place to ensure quality care, without which expected patient outcomes are threatened. The six domains of a healthcare quality framework were developed by the Institute of Medicine (2001), and assert that care provision should be safe, timely, efficient, equitable, effective, and patient-centred. These were further expanded by the Agency for Healthcare Research and Quality, (2015), and adopted by agencies worldwide, to include “doing the right thing, at the right time, in the right way, to achieve the best possible results” (Kelly Vana, Vottero, and Altmiller, 2023, p. 5). These are reflected in the Australian context through the National Model Clinical Governance Framework (Australian Commission on Safety and Quality in Healthcare [ACSQHC], 2017), and in the United Kingdom (UK) through the National Institute for Health and Care Excellence (2023) standards and guidelines.

Throughout this chapter, we will discuss the following topics in the hope that it will provide you with a better understanding of these processes and the confidence to manage them in your workplace:

• The concepts of safety and quality in healthcare
• Challenges to quality and safety improvement in healthcare
• Human factors and systems thinking
• Clinical governance
• Standards and accreditation
• Practices within healthcare organisations that support quality and safety in healthcare

Background

The landmark report from the Institute of Medicine, now the National Academy of Medicine, in 2000, To err is human, highlighted the significance of medical errors and adverse events in the United States of America (USA) up until that time. In the 23 years since, healthcare providers globally have been striving to improve patient outcomes by introducing clinical governance and quality improvement strategies. The gaps in quality identified by the Institute of Medicine (2001) include the growing complexity of science and technology, the increase in chronic conditions, and constraints on exploiting the revolution in information technology. This issue does not solely affect the USA. There have been reports of patient safety failures globally. Of note is the Bristol Royal Infirmary Inquiry (Kennedy, 2001), the Queensland Public Hospitals Commission of Inquiry (Davies, 2005), the Special Commission of Inquiry into Acute Care Services in New South Wales Public Hospitals (Garling, 2008), the Mid-Staffordshire National Health Service (NHS) Foundation Trust Public Inquiry (Francis, 2013), the investigation into perinatal outcomes at Djerriwarrh Health Services (Wallace, 2016), and the Royal Commission into Aged Care Quality and Safety (Commonwealth of Australia, 2021). These are a few examples of investigations and reports into poor quality care across the UK and Australia. Whilst considerable improvements have been made worldwide, there is still significant room for improvement.

In response to these global reports of poor patient care and adverse events, the World Health Organization (WHO, 2018) initiated their series of global patient safety challenges. The first challenge of ‘Clean Care is Safer Care’ put handwashing in the spotlight, and is where the Australian National Hand Hygiene initiative (ACSQHC, 2023) began. The WHO’s (2018) second challenge, ‘Safe Surgery Saves Lives’, saw the surgical safety checklist introduced into operating rooms as the ‘time out’ procedure; and the third and current challenge is ‘Medication Without Harm’ aiming to decrease medication errors globally by 50% over five years. These challenges can be viewed as large-scale quality improvement activities aiming to decrease preventable adverse events globally (WHO, 2018).

In 2006, the Council of Australian Governments made a commitment to improve quality of health services, resulting in the establishment in 2011 of the Australian Commission on Quality and Safety in Healthcare (ACSQHC, 2023) (the Commission). The Commission is the primary organisation charged with national improvements for healthcare in Australia. Many changes have been instigated since the Commission was established, including the implementation of the National Safety and Quality Health Service Standards (NSQHSS) (ACSQHC, 2017), the National Inpatient Medication Chart (ACSQHC, 2023), and the Early Warning System observation charts (ACSQHC, 2012), to name a few (ACSQHC, 2023). These changes have proved effective through the demonstration of improved patient outcomes nationally. Evidence of this can be seen in the decrease in potentially preventable healthcare-acquired complications, or adverse events, following the guidance offered in NSQHSS’ Preventing and Controlling Infections standard.  We have seen a decrease in Australia, from 10% in 2014/15 to approximately 2% of all hospital separations in Australia in 2021 (Australian Institute of Health and Welfare, 2022). However, the health system is reliant on human beings and errors and adverse events are going to occur.  Clinical governance and quality improvement (QI) systems therefore must be robust enough to manage the challenge.

What is clinical governance?

According to the ACSQHC (2017, p. iii), clinical governance “…ensures that everyone – from frontline clinicians to managers and members of governing bodies, such as boards – is accountable to patients and the community for assuring the delivery of health services that are safe, effective, integrated, high quality and continuously improving”. Clinical governance has been introduced into healthcare worldwide to address the extensive variations in standards and quality of care. Many frameworks are available, and the Commission published the National Model Clinical Governance Framework (the Framework) in 2017, supporting the NSQHS Clinical Governance Standard (ACSQHC, 2017). While being an individual standard, clinical governance is also embedded throughout all eight NSQHS standards as action item one. This specifically addresses the minimum quality standards expected in all Australian healthcare organisations concerning governance, leadership and culture, patient safety and quality systems, clinical performance and effectiveness, and a safe environment for the delivery of care (ACSQHC, 2021, Standard 1). The figure below illustrates Australia’s clinical governance framework.

The many incidents of poor care around the world can be linked to a lack of clinical governance. All organisations require some form of corporate governance encompassing all aspects, specifically risk, finance, and other areas such as human resources (HR), and information technology (IT). Frameworks may vary; however, the consumer is central to most.

As with any framework, there are often supports and challenges. Examples of supporting principles underpinning effective clinical governance are:

• vision and values;
• clear organisation and committee structures;
• cultural and professional safety;
• recruitment and retention strategy;
• induction and orientation programs, performance reviews, goal setting, and performance management; and
• mandatory training and clinical competency framework.

Challenges of implementing a clinical governance system include the following:

• knowledge and understanding of the concept,
• unclear organisation expectations and outcomes,
• lack of infrastructure to support the organisation’s vision,
• not having the right people to deliver on the vision,
• budget,
• tools,
• time,
• accountability, and
• gradients of hierarchy that are often the cause of conflict.

Clinical governance is only as effective as the effort and commitment put in to achieve it. Spend the time to find the right interested people who have passion and are keen to learn, as these are your champions and will fight for your vision. Make the time to hold workshops, let everyone share their ideas, and decide how all the pieces fit together. Shared learning creates team-ship, builds trust, and develops a common goal, getting everyone on the same page.

Quality Improvement

Quality improvement (QI) is central to the success of any clinical governance program, and a well-executed program offers structure, accountability, and oversight of progress. In recent years, the emphasis on QI in healthcare has become a major focus, with the Commission publishing the National Clinical Governance Framework at the same time as detailing what an effective quality improvement system looks like under Action 1.8 of the NSQHSS Version 2 (ACSQHC, 2017, updated 2021).

However, QI is one of the most challenging principles to implement consistently, because it has its fingers in the pies of all the other pillars of safety and quality systems. Additionally, despite QI being recognised as the key to advancing quality processes, we quite often find that QI barely gets a mention in textbooks, with a measly offering of a couple of pages outlining only the high-level concept. Not at all helpful! So, what is the potential of QI?

Well, we already know the systems that can help us identify opportunities for making improvements, audit, staff suggestions, complaints, and incidents, but QI is so much bigger and can be so much better. Quality improvement practices give us an opening to collaborate with our people, we can use it to encourage professional development, promote trust through the sharing or delegation of responsibility, and when your people are recognised for their input, no matter how big or small, their commitment will grow. QI is the perfect opportunity for you to invest in your people, show your respect for them, celebrate the successes together, and watch your organisation embrace change.

A method used to monitor the quality of Australian health services is regular accreditation surveys. Accreditation to the NSQHSS is a national approach to set a minimum expected quality, safety, and care standard throughout all healthcare facilities (ACSQHC, 2017). Developing a strong safety culture and achieving successful accreditation outcomes requires commitment from all levels within the organisation, from the executive to the bedside. This principle underpins the success of any clinical governance framework, assuring best and consistent practice across the continuum, including risk management and quality improvement.

Although QI is essential to improving patient safety and outcomes, as with any change or QI activity, there will be barriers and facilitators. Some barriers highlighted in the literature include lack of protected time to undertake QI, healthcare workers (primarily nursing staff) prioritising other duties, lack of leadership support, lack of QI champions, and ineffective or poor communication (Zoutman and Ford, 2017).

To support ongoing quality care, the New South Wales Health Clinical Excellence Commission put together the following resource that explains the practical application of the six domains of healthcare quality for improving practice.

The Six Dimensions of Healthcare Quality was created by Clinical Excellence Commission and is available from https://www.youtube.com/watch?v=I8Y962VTiBY

Theories and Models

There is no one way to approach quality and safety. Here, we will briefly discuss some different theories and models that may underpin your organisations approach to safety, risk, and QI.

Safety-I to Safety-II

Smith and Plunkett (2019) proposed that the approach to safety, and subsequently, incident and accident investigation, has moved into a third ‘age’. The first two ages being the “age of technology” and the “age of human factors”, with the third being “age of safety management” (Smith and Plunkett, 2019, p. 508). In 2015, Hollnagel et al. (2015) published a white paper describing the perspectives of safety and the shift from ‘safety-I’ to ‘safety-II’. The safety-II approach to investigation is that the focus should be on “how things usually go right” (p. 4), rather than the safety-I philosophy of safety being “…a state whereas few things as possible go wrong” (Hollnagel et al., 2015, p. 3). While we are advancing from the ‘age of human factors’, consideration of human factors during development and optimisation of systems supports the safety-II approach. Humans are fallible but flexible and can adjust where necessary to avoid an incident, whereas fixed systems are often not flexible, and errors will inevitably occur.

Incident investigation – Root Cause Analysis

Many organisations undertake incident investigations by way of a root cause analysis (RCA), a somewhat linear approach seeking a cause amongst the many layers of an organisation. Despite its linearity, this model can be very effective if used appropriately. The following video developed by ThinkReliability© (Galley, 2018) provides a simple overview that demonstrates how the cause-and-effect tools, the 5 why’s, and Ishikawa (fishbone) diagram can be used at various depths to seek the underlying systems issues that lead to incident occurrences.

Systems Thinking

Industries outside of health, such as the safety-critical aviation industry, continually search for new ways of assessing incidents to ensure maximum levels of safety. However, healthcare often lags. Systems thinking and the systems approach to safety and investigations are more holistic approaches that acknowledge the complexities of a system such as health (McNab et al., 2020). However, the systems approach needs to be supported by the whole organisation to ensure a culture of safety and effective leadership is essential. Engagement of all healthcare team members is necessary for successful outcomes and, more importantly, overall safety culture. With the significant advancement and integration of technology into healthcare, quality and safety issues have also been associated with this (McNab et al., 2020). As such, a multidisciplinary approach, including Information Technology (IT), is required (Bates and Singh, 2018). As you saw in the RCA video, getting to the ‘root/s’ of the problem requires us to look at the systems as a whole and not stop at the individual/s who made the error.

Plan, Do, Study, Act (PDSA)

A QI activity needs a structured approach. The Plan, Do, Study Act (PDSA) cycle is the common model used in healthcare, initially developed by Shewhart around 1936, and further refined by Deming throughout the 1990’s, with the model we know today described in 1996. The figure below illustrates the cycle and provides a brief outline of what occurs in each stage. You may see some similar features from this model in the nursing process of assess, diagnose, plan, implement, evaluate (ADPIE) (Mason and Attree, 1997), or the Clinical Reasoning Cycle (consider the situation and collect cues, process the information, plan, implement, evaluate, and reflect) (Levett-Jones, 2017). It would be rare that you follow the cycle just once.  QI cycles, as with the nursing and clinical reasoning cycles and continue iteratively as situations evolve.

Human Factors

Human factors are about understanding human behaviour and performance to recognise the capabilities and limitations of working with people. This is important in healthcare, as when we understand these behaviours, capabilities, and limitations, we can better design systems to consider these, and thus reduce the likelihood of errors (Lock, 2018). In 1993, Gordon Dupont, an aircraft maintenance engineer and accident investigator, sought to better understand the commonalities among the accidents he was investigating (Dupont-Adam, 2021). A retrospective review of thousands of maintenance error records found 12 ‘preconditions’ associated with these reports. These became known as the ‘dirty dozen’, and have been adopted worldwide to help develop systems to mitigate these issues. The dirty dozen are:

• lack of communication,
• complacency,
• distraction,
• stress,
• lack of teamwork,
• lack of resources,
• pressure,
• lack of assertiveness,
• lack of knowledge,
• norms,
• fatigue,
• lack of awareness.

These 12 factors have been shared by the Clinical Excellence Commission (2021) in an effort to provide strategies to address some of the issues that have arisen in health systems during the COVID-19 pandemic.

When investigating incidents, it is important to take into consideration any influencing human factors such as those in the list. It is extremely rare that anyone purposely acts to cause harm. However, there are often a series of issues in the lead up to a particular event where human factors plays a role. Poor communication, or the lack of, is often a significant factor that can result patient death. Many coroner’s reports outline communication failures at critical points throughout a patient’s journey that significantly contributed to a patient’s death. While lack of communication is just one of the ‘dirty dozen’, many of the other 11 can each effect how someone communicates. Many can also influence the safety culture of the environment, particularly where complacency is accepted. These factors also need to be considered in the overall risk management of an organisation.

Action Plan Example