The development of healthcare quality is associated with the profession of medicine as a craft, with quality based almost solely on the skill of the ‘craftspeople’. As outlined by Leggat in Chapter 2, this craft-based approach to professional practice vested the control of quality with individual clinicians more at an implicit level, within the overall scope of their professional practice. Consequently, the competence of individual practitioners is a major contributor to the delivery of high-quality care, something that has traditionally been regulated through controlling entry into the profession and upholding standards of professional education.

The influence of the craft-based model is apparent in some of the early approaches to quality evaluation in medical practice. For example, in outcome-related morbidity and mortality studies, clinical case conferences and the early introduction of medical audit, the emphasis was on closed discussions about quality and standards, typically through applying peer review methods (Harvey 1996). As quality became a more prominent feature in healthcare policy, so too more formal requirements for doctors to engage in quality and audit emerged, for example through the mandatory introduction of medical audit in the UK in the late 1980s (Department of Health 1989). For some doctors, these changes were seen as a threat to the traditional craft-based organisation of medical work, resulting in resistance to medical audit and distinctions being drawn between audit as an internal, peer review activity and audit as an external, regulatory mechanism (Shaw 1980).

Throughout these developments, a number of prominent clinicians have challenged traditional ways of thinking and pioneered developments in medical quality evaluation and improvement. As early as 1916, Ernest Codman, a US surgeon, used and published the ‘ends results’ system of auditing surgical care (Codman 1916). In the 1960s and 1970s, Avedis Donabedian went further, presenting quality as a multidimensional concept, influenced not just by the technical quality of care, but also by features of the interpersonal relationship between doctor and patient and by the physical amenities of care (Donabedian 1966). He is perhaps best known for his structure–process–outcome model of quality.

More recently, influential figures such as Don Berwick have led the way in calling for a move beyond medical audit towards more improvement-based approaches to quality (Berwick 1992) largely because of perceived failures to act on the results of audit to achieve meaningful change. In refocusing efforts towards the action phase of audit, the medical profession needs to look beyond its immediate sphere of knowledge and experience defining and measuring standards and criteria, towards more general theories of organisational change and industrially based approaches to quality improvement. As such, the narrow evaluation of practitioner performance needs to be widened to a more patient/client-focused view of quality, with clinicians taking on a so called new set of ‘clinical skills’, including skills in teamworking, process analysis, guideline development and collaborative working with patients, managers and other professional colleagues (Berwick et al 1992).

Other professional groups in healthcare have been less influenced by the craft-based model of practice, largely as a result of their position in the professional hierarchy relative to medicine. The nursing profession, for example, had their own pioneer of quality and standards in the early work of Florence Nightingale. However, early developments in nursing quality evaluation were largely focused on methods of external monitoring, through the development and application of quality indicators and measurement instruments (Harvey 1996). Such developments were superseded by more practitioner-based methods that typically involved local teams of practitioners working together to identify and work on topics for improvement. These approaches had more in common with industrially based approaches such as quality circles, although sometimes failed to become integrated within overall organisational systems for quality management (Morrell et al 1997). More recent clinically focused initiatives such as practice development in nursing that aim to transform the context and culture of care (McCormack et al 2004) may have the same effect.

More recently, developments emanating from the evidence-based medicine movement and from public inquiries into major healthcare failures have introduced a number of new concepts to the field of clinical quality, which may have the potential to create better integration with organisational quality. The evidence-based practice agenda, with its focus on synthesising existing research through systematic review methods, has contributed to the development of clinical guidelines, described as ‘systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances’ (Institute of Medicine 1992, cited in Duff et al 1996:888). A key defining attribute of clinical guidelines is that they should be based on available research evidence (Duff et al 1996) and the focus on distilling evidence of clinical and cost effectiveness into recommendations for clinical practice is an attempt to standardise care, within the operations management methods outlined by Leggat in Chapter 2. However, despite the extent of investment in guideline development, evidence to date suggests that their impact on actual practice and patient outcomes is variable (Grimshaw et al 2004), highlighting the challenges and complexities involved in translating evidence into practice.

Care pathways are another tool that has been applied in healthcare in an attempt to standardise processes of care delivery (see Claridge & Cook, Chapter 4). Pathways have been used in different ways, for example as a way of translating national guidelines into local practice or as a way of mapping ideal processes for specific care groups. Typically they are presented as structured, multidisciplinary plans of care designed to support the implementation of clinical guidelines and protocols, providing guidance about each stage of the management of a patient with a particular condition, including details of both process and outcome. They aim to improve continuity and coordination of care and enable more effective resource planning, as well as providing comparative data on many aspects of quality of care. Claims made are that they reduce variation and improve outcomes (Middleton et al 2001).

Clinical governance, defined as the ‘action, the system or the manner of governing clinical affairs’ (Lugon & Secker-Walker 1999:1), developed as an overall strategy within a policy on quality in the UK’s National Health Service (NHS) (Department of Health 1989). After a high-profile failure of care in a hospital providing paediatric cardiac surgery services that highlighted organisational shortcomings (Kennedy 2001), statutory changes were introduced to impose a legal duty of quality on the chief executives and boards of NHS organisations, for the first time creating a corporate responsibility for the quality of clinical care. The significance of this is apparent in cases where poor clinical quality is observed and the boards of healthcare organisations are held to account for this, as opposed to individual clinicians or clinical teams, as illustrated by the case study in Box 10.1 later in the chapter.

In summary, developments in clinical quality have been professionally led and reflect the different traditions and ways of working within the profession. As a consequence, a range of healthcare definitions and ‘dimensions of quality’ have developed (see Table 10.1). Over time, there has been a move away from uniprofessional, clinical quality initiatives towards more multiprofessional, patient-centred models that are integrated within wider organisational structures and processes. This, in turn, has led to increasing awareness and application of some of the industrially based approaches and techniques that are described in the next section.

The concept of ‘quality’ in industry can again be argued to have developed from early models of production management (see Leggat, Chapter 2) but was formalised through Shewhart’s work on statistical process control (SPC) in the 1920s (Shewhart 1931) with the result that ‘the management of quality acquired a scientific and statistical foundation’ (Kolesar 1993:319). Many of the concepts of SPC are now being applied in healthcare with evidence that ‘SPC is a versatile tool which can help diverse stakeholders to manage changes in healthcare and improve patients’ health’ (Thor et al 2007:387).

The concepts of quality then were developed by a number of key figures (‘gurus’). Four in particular stand out:

Until the 1980s most of the emphasis on quality improvement, and most of the empirical utilisation of the associated techniques, was within the manufacturing industry. However, the field of ‘service quality’ developed initially from a marketing focus (Groonroos 1984) but relatively little attention is paid explicitly to the ‘service’ aspects of healthcare quality. This is despite the fact that many of the philosophies that underpin industrial quality improvement and the techniques that are associated with it are increasingly being applied in the healthcare sector in both the US and Europe.

During the same period there was also an increasing emphasis on overall organisational approaches to quality improvement, such as total quality management (TQM): a ‘set of powerful interventions wrapped in a highly attractive package’ (Hackman & Wageman 1995:339). Its attractiveness may have been its apparent simplicity; it offers ‘a unified set of principles which can guide managers through the numerous choices [open to them] or might even make choosing unnecessary’ (Huczynski 1993:289). Similar claims have been made for other packages of improvement such as business process re-engineering (BPR) (McNulty & Ferlie 2002).

Other techniques that are also described as approaches to quality improvement include six sigma, an improvement approach initially developed by Motorola in 1987. A sigma score represents the amount of variation in a process, and the term ‘six sigma’ refers to a process that has at least six standard deviations (6σ) between the process mean and the nearest specification limit, that is, a defect rate of 3.4 parts per million. Many argue that six sigma is both a set of improvement tools and an overall philosophy, with the tools ‘strikingly similar to prior quality management approaches’, although the way in which six sigma is implemented is claimed to ‘represent a new organisation structural approach to improvement’ (Schroeder et al 2007). The evidence for applying six sigma in healthcare is limited (Sehwail & DeYong 2003) and often methodologically weak with studies based on the assumption that six sigma can be applied in healthcare, rather than whether it is appropriate.

The concepts from lean thinking based on the Toyota Production System (Womack & Jones 1996) have become popular recently in healthcare. Although there are now reviews of its implementation in the public sector (Radnor et al 2006), including health (Kollberg et al 2007), there is as yet little systematic evaluation of its impact.

The issue of errors and patient safety is also important (see Sorensen & Iedema, Chapter 1; Warburton, Chapter 9; and Merry, Chapter 11). The link between quality and safety is not always clear although more recent definitions of quality (refer back to Table 10.1) include ‘safety’ as one of its key dimensions. Many assert that it is a prerequisite for quality: ‘achieving a high level of safety is an essential first step in improving the quality of care overall’ (Institute of Medicine & Committee on Quality Healthcare in America 2001:46). A review of patient safety research (Cooper et al 2001:2) concluded that there is ‘substantial ambiguity in the definition of patient safety … the boundary between safety and quality of care is indistinct’. While most interviewees in this study viewed safety as a part of quality, they recognised that there was a tendency to utilise the most fashionable term: ‘patient safety has become the issue “du jour” and so almost everything gets redefined in that’ (Cooper et al 2001:8). There is a strong argument for regarding patient safety as one aspect of quality improvement and ensuring that learning from other types of quality improvement are also applied when safety is the focus, rather than reinventing the wheel (Walshe & Boaden 2006).

This is often where the conflict between clinical and managerial priorities is most apparent, especially when performance metrics are associated with tangible aspects of process quality, such as waiting times, rather than patient experience or clinical outcomes. Most commentators agree that quality is a multidimensional concept, encompassing factors such as the effectiveness of care, accessibility, equity and appropriateness of services offered, efficiency of delivery and so on (again, see Table 10.1). At a strategic level, many organisations use a so-called ‘balanced scorecard’ approach to performance measurement to ensure that overall performance is judged against a set of key indicators (financial, internal process, customer and learning and growth measures), thus enabling a more complete picture of quality to be obtained (Boaden 2006). However, in practice there is a danger that some sets of performance metrics get prioritised above others, particularly where external inspection and ranking of organisational performance takes place, as is the case, for example, with many national, government-led performance management systems. In these situations what gets measured by external inspection can become the main definer of quality within the organisation, as the example in Box 10.1 illustrates. In this example, the organisation became focused on one set of performance measures at the expense of other important dimensions of quality.

Taking a process view, it is argued, is one of the key characteristics of organisations that are successful in improvement, along with adopting evidence-based practice, learning collaboratively and being ready and able to change (Plsek 1999). It is not sufficient, however, to focus on anything less than the total process (system) of patient care, when doing so could lead to too much focus on one element at the expense of others. This ‘systems thinking’ can be described as exploration of ‘the properties which exist once the parts [of the system] have been combined into a whole’ (Iles & Sutherland 2001:17) and is in some ways simply a combination of processes. Systems thinking has been proposed as a means of understanding medical systems (Nolan 1998) based on the following principles that:

This process view is therefore not only about changing organisations but also examining and improving the interaction between elements of the organisation, including the individuals who work within them. It can also be seen in the clinical emphasis on systematisation and standardisation, such as pathways and the use of clinical guidelines. Box 10.2 gives an example.

All ‘industrial’ approaches to quality improvement involve identifying the customer, who may be internal or external to the organisation, and, subsequently, their needs. The purpose of the process has to be clear before improvement can take place. It is in this area that the issue of professionalism and the increasing role of the patient have an impact; while much rhetoric about healthcare systems states that they are patient driven, this does not appear to be the case in practice. Whether the ‘customer’ can be defined as the patient is open to question but it is clear that to date patient involvement in quality improvement has been limited, and has been noted in regard to the lack of attention to the presence of the patient in processes (Shortell et al 1995a).

Most perspectives on improvement focus on the motivation and beliefs of individuals in the organisation, which contribute to defining the culture as well as the behaviour that results from them. In one study a participative, flexible, risk-taking culture was strongly associated with the implementation of quality improvement (Shortell et al 1995b). However approaches to culture in the literature are ambiguous. On the one hand, some authors describe a ‘quality culture’ as one ‘whereby everyone in the organisation shares a commitment to continuous improvement aimed at customer satisfaction’ (Wilkinson & Brown 2003:184). Others believe that culture cannot be ‘managed’ (Schein 1985) despite many policy innovations intended to achieve exactly this.

However, the ‘people’ implications are broader than organisational culture, relating to individual employment arrangements, and need to take into account both individuals and systems and the way they interact (see Stanton, Chapter 3). In particular, professional motivation is important in improving quality, and organisations would do well to review the lessons already learnt ‘the hard way’ by many others in different sectors who have attempted to improve process and outcome quality.

This involves identifying the key characteristics of the process in terms of variation and flow raised in Chapter 4 by Claridge and Cook:

The involvement of top management, use of teamwork and the ability to foster innovation were shown to be important in quality improvement (Parker et al 1999). In fact, quality improvement can be seen to be dependent on leaders, both in relation to clarifying the overall mission and strategy and creating a commitment to change (Berwick et al 1990/2002). Leaders have a key role to play in planning for quality, creating the right cultural conditions and setting organisational structures that empower staff to become actively involved in improvement (Juran 1989). These views are supported by research undertaken by Stanton et al reported in Chapter 3.