Total Quality Management in Primary Health Care

Total quality management and continuous quality improvement

Introduction
The technological breakthroughs of modern medicine have also created a growing unease about quality, especially in primary care. It is hard to understand why a profession that can transplant hearts cannot provide higher rates of preventive services or control more hypertension. Consequently, interest in applying the concepts and tools of Total Quality Management (TQM) and Continuous Quality Improvement (CQI), adapted from industry, has grown rapidly in health care.
The terms TQM and CQI are used here interchangeably and refer to a comprehensive, organization-wide, systematic effort to coordinate, monitor and improve quality, with a focus that includes patient satisfaction, cost reduction, process efficiency, clinical outcomes, and (in some public health settings) societal impact.(1,2 and 3) While individual improvement projects begin and end, TQM/CQI is an ongoing effort to improve the whole organization. It is related to the discipline of systems thinking(4) in that it is holistic in its approach, recognizing that for an organization to be truly effective, each part of it must work properly together. The World Association of Family Doctors (WONCA) recently concluded ‘Quality work in health care is increasingly heading towards quality systemsâ€.(5)
Despite the seeming logic of this approach and many anecdotal reports of success, TQM/CQI has not yet demonstrated effectiveness in randomized trials in health care.(6,7) We will describe the somewhat disappointing current evidence for TQM/CQI and suggest that this experience is due primarily to the challenge associated with the effort required to actually implement a total quality system. Next, we will provide a description of basic principles and models, followed by a brief description of what is needed to adapt these principles to primary care. Since TQM requires that primary care practices understand the organizational aspects of quality that have traditionally not been a part of clinical training, we will then describe this critical new way of thinking. Finally, we will describe some encouraging trends and conclude that TQM/CQI does hold promise for dramatic improvements in primary care, provided that leaders rise to the challenge its implementation presents. (Note: we will simply use the term TQM to refer to TQM/CQI.)
Disappointing evidence for TQM in primary care
Total quality management efforts in primary care began in the mid-1990s with a number of observational and before/after studies suggesting that this methodology was likely to be effective.(8,9,10,11,12,13 and 14) However, each of these studies only partially addressed the issue of the general effectiveness of TQM.
For example, Carlin et al.( provided a case report of 19 clinics in the United States using QI teams to improve 2-year-old immunization rates from 53.5 to 86.5 per cent. Many similar reports describe improvement in a single topic area. While these are certainly a benefit to the patients and clinics involved, it is not the comprehensive, organization-wide effort envisioned by true TQM, and the changes may not persist without such an effort. Goebers et al.(12) describe a study involving 20 small practices in the Netherlands who were provided with trained TQM facilitators, and then compared to 19 control practices after 18 months. While all practices accepted the TQM model, and 33 projects on a variety of topics were completed during the study period, this did not result in sustainable changes in practice and physician performance. Hearnshaw et al.(14) describe an observational study of primary care teams in England participating in education on organization-wide TQM in which follow-up evaluations indicated that changes were still in place 3 years after the education. Unfortunately, this was true for only three of the six teams who participated in the education, and these six were self-selected from among 147 teams that were invited.
The first scientific trials of TQM in health care took place in primary care. Goldberg et al. describe an effort to implement guidelines for depression and hypertension that involved 15 teams in four clinics, with five teams randomized to add TQM to academic detailing.(15) The net impact on care of this addition was no greater than in control teams.
A second, larger trial involving 44 private primary care clinics was designed to test whether systems changes could improve the delivery of a broad range of important preventive services in the half of the clinics randomly assigned to a TQM-based training and facilitation intervention.(16) Each intervention clinic identified an internal team, whose leader and facilitator were then trained in both systems content and change management through a collaborative multisession process that was contiguous with their teams' actions. Most of the teams were enthusiastic, worked hard, and most (but not all) eventually implemented a common system to more consistently provide for mammography, Pap smears, immunizations, and screening for smoking, hypertension, and hypercholesterolaemia in adults. Optimism was fuelled by anecdotes of clinic change efforts and by early studies showing a doubling of system elements in the intervention clinics only.(17) Unfortunately, when the results of patient surveys and chart audits were finally analysed, only one preventive service had a small statistically significantly greater change in the intervention clinics over the course of 2 years.(18) The investigators suggested that there were multiple causes for this failure, including ‘inadequate tension for change, limited organizational change experience, mixed leadership support, a sub-optimal CQI improvement model, inadequate content, enormous environmental turmoil, inexperienced team leadership, and insufficient time pressures and calendar timeâ€.(19)
Since these problems seemed potentially solvable, the principal investigator went on to test a revised approach for depression management.(20) This time, three primary care clinics whose leaders had chosen to work on this problem used more modern ‘rapid cycle†methods in a combined CQI team with an experienced leader and facilitator facing a 7-month deadline. An explicit goal was set by clinic leaders to improve follow-up care of depressed patients by creating a nurse care-manager role with systems support to provide periodic phone calls. Unfortunately, despite similar team enthusiasm and hard work, no overall changes could be demonstrated in either the process or outcome of care as compared to six matched control clinics in the same medical group. The principal cause for this failure appeared to be inadequate perceived necessity for change and a related lack of leadership pressure to truly implement the change in care processes.
Secondary care has a similar disappointing story to tell with regard to randomized trials of TQM in that many early efforts tended to view quality improvement in terms of specific projects rather than in its organizational context. However, since secondary care typically occurs in large institutions with clearer administrative leadership and systems, these shortcomings were recognized more quickly.
These remain the only scientific trials of TQM methods in primary care and they force the thoughtful practitioner embarking on such efforts to pay more attention to the organizational aspects of change. We remain convinced that some version of this approach to quality improvement is essential and will work; the anecdotal, observational, and before/after evidence is highly suggestive. What the above examples illustrate is that TQM is more than tools and individual projects; it requires truly committed effective leadership and the right mix of contextual and organizational factors.

TQM principles and models

While tools and projects are the place to start in any effort to improve quality in a primary care setting, successful implementation of TQM in primary care must be built upon a realization of what is meant by a comprehensive, organization-wide effort to improve quality. Various authors, both in general industry and health care, and various national and international bodies, have described the basic principles of TQM.(1,2,21,22,23 and 24) Typically cited principles include the following.
Understanding of processes and systems: All work involves the execution of processes. An organization effectively practicing TQM explicitly defines its processes in order to continuously redesign them to improve output and service, while reducing waste and unnecessary complexity.(25) For example, a practice might follow the flow of a laboratory order and then eliminate several transcription and handling steps by redesigning the order form and having it printed on paper that automatically produces multiple copies as the order is written. Organizations practicing TQM also understand that processes are further embedded within one another and linked in complex ways.
Patient- (or customer-) centred focus: Processes and systems exist to produce outputs and services that provide a benefit to, or meet the needs of, patients, families, and society.(26) These customers can be external to the organization (e.g. the patient is the customer of the drug prescribing system) or internal (e.g. the lab technician is a customer of the physician who writes the order for a test). It follows, therefore, that if an organization is going to carry out a process, it should seek to provide the greatest benefit to the customers of that process. TQM encourages such ‘customer thinking†throughout the organization.
Understanding of variation: The outcomes of processes and systems are naturally variable.(27) For example, patients will not always take their medications as prescribed, and physicians will not always provide all of the preventive services that are needed by individual patients. This variation in outcome is due to both the intended and unintended variation in the people, machines, materials, methods, and measurements that make up the process.(2) Some of this variation is desirable, and some is undesirable or harmful. TQM tries to remove the undesirable variation while preserving what is needed to best meet the needs of individuals and situations.
Pursuit of continuous improvement: Organizations that implement TQM seek to push the performance of systems beyond existing standards and norms. The goal is to achieve and maintain a never-before-achieved level of performance. An effective total quality system should facilitate continuous improvements and redesigns by encouraging alternating cycles of change, followed by relative stability, followed by more change.(28)
Management by facts and continuous learning: Fundamental to TQM is the commitment to use data and a logical process to build knowledge, make decisions, and promote ongoing learning.(29) Systematic building of knowledge through disciplined data collection, evidence-based practice, and deliberate experimentation lies at the foundation of all effective TQM efforts.
Positive view of people: While some see people as the ultimate cause of all problems and inefficiencies, TQM views the people who work in the process as the ultimate source of knowledge about how to improve it.(30,31) TQM seeks to engage the people who actually do the work in efforts designed to improve that work. In keeping with an understanding of processes and systems, this also typically requires an unprecedented level of multidisciplinary teamwork.
Key role of leadership: The need for effective and visionary leadership is a central theme in TQM.(2,12,31) Without strong leadership and an organizational infrastructure to support quality efforts, improvement may not happen; or, if it does happen, may quickly dissipate because of neglect and lack of integration with other activities in the organization.
To facilitate attention to these principles, several ‘frameworks†for TQM have emerged. These frameworks are all simply formalizations of the principles described above; often captured in the form of questions that can be used to plan for and assess the quality system in an organization.
For example, The Baldrige Award in the United States provides a seven-element framework of what constitutes a total quality management system (see Box 1).(23) Note that while individual quality improvement efforts in primary care answer somewhat narrower questions—Did the care match the relevant guidelines? or How can we lower HbA1c values in persons with diabetes?—the Baldrige framework for TQM pertains to much larger, more all-encompassing questions about how the organization runs in general. McFarland et al. report on their use of the Baldrige framework in a community mental health facility in the United States with 120 staff and 1300 outpatients.(32) However, their report describes plans and early efforts only; no specific results.

Box 1 USA Malcolm Baldrige Award framework

Leadership:
How do senior leaders address values, performance expectations, a focus on patients and other key customers and stakeholders, empowerment, innovation, learning, organizational direction, and responsibility to the public?

Strategic planning:
What is the organization's strategic development process? By what means does it set, deploy, and track strategic objectives, action plans, and related financial and staffing plans?

Focus on patients, other customers, and communities: How does the organization determine the requirements and expectations of patients, other customers and the community in which it is embedded? How does it build ongoing relationships and determine satisfaction?

Information and analysis: What is the organization's performance measures system and how does it analyse and act upon information?

Staff focus: What does the organization do to enable all staff to develop and utilize their full potential, in a way that is aligned with the organization's objectives? How does it build and constantly improve the work environment and staff support climate to make it conducive to performance excellence, full participation, and personal and organizational growth?

Process management: How does the organization design and deliver processes that are aligned with customer expectations and waste-free? How does it work to involve suppliers and staff in all departments to produce smooth-flowing systems of work?

Organizational performance results management: How does the organization measure and feed back into the system its results on clinical outcomes; satisfaction of patients, staff, and public financial performance; and operational performance? How does the organization compare itself to other organizations?


The European Framework for Quality Management (EFQM) is another high-level model for a total quality system based on the principles described above. It has been used to assess a primary health care centre in Spain.(33) Further initiatives to make the EFQM model applicable in primary care are underway in the Netherlands. Similarly, the International Standards Organization ISO-9000 framework forms the basis for the total quality management systems in Finnish primary care and social services centres in Espoonlahti, Finland (population of 41 000). Results cited in the Finnish case include winning local awards for quality, easing a merger, building cooperation, improving service orientation, and enhancing patient focus; but no quantitative outcomes have been reported.(34)

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Adapting TQM to primary care
Understanding the general principles and frameworks for TQM gives insight into why there is simultaneously good evidence of success in individual improvement projects in organizations that are internally compelled to improve, and little evidence of success when one attempts to implement comprehensive TQM in a randomly selected primary care organization. The work required to implement TQM is broad, deep, and time-consuming; not every organization will be up to it. In addition, the nature of general or family practice lends additional challenges. Many practices have structures in which the doctor is simultaneously an owner, manager, and worker. Many also have small staff that may lack the time, knowledge, and skills needed for formal quality improvement activities.(13) Nevertheless, case reports suggest that the basic concepts can be, and have been, adapted to primary care.
For example, Goebers et al.(22) describe a quality system model for primary care based on four core principles: leading role of management, actions based on factual data, a systematic approach, and close collaboration in quality improvement among all those who are involved in the care processes. Their quality system model includes: (i) involving all staff; (ii) setting targets for improvement; (iii) establishing priorities for subjects that especially need improvement; (iv) doing small and easy to handle improvement projects; and (v) using the quality cycle and easy to use tools and techniques. They describe favourable changes in participating practices, such as: having regular practice meetings on quality improvement with all staff, enhancing leadership by designating a quality coordinator role, making annual plans on improvement, and making annual reports on quality improvement activities and results.
This work illustrates that the principles and systems of TQM can be adapted conceptually to small, primary care practices. It should also be clear, however, that making the adaptation requires a considerable amount of effort on the part of the practice and represents nothing short of a transformation in thinking and action.

Organizational aspects of TQM
In order to be successful in adopting TQM, the practitioner needs to take advantage of the thinking and experiences of other industries, and the related fields of change management and organizational development, who have dealt with improvement and change far longer than has medical care.(35)
Unfortunately, the scientific studies on quality improvement through guideline implementation are virtually bereft of any recognition of the role of systems or organizational factors and have drawn little from current thinking in management theory and from the experiences of other industries.(36,37) The fields of change management and organizational development are summarized in an excellent overview by Weber and Joshi, the key points of which are outlined in Box 2.(38) The literature in these fields should be read early and re-read periodically by those wishing to implement TQM in a primary care setting.

Box 2 Key strategies for change (as summarized by Weber and Joshi(38))

The literature and experience on change in health care organizations points to eight crucial strategies:

1. Develop a long-term vision for change, but start with things that can be accomplished in a relatively short period of time in order to build momentum.
   
   
2. Focus on the change process itself; the ‘how†of change is just as important as the ‘what†of change.
   
   
3. Think carefully about which individuals and opinion leaders in the organization must respond to the change and what barrier may exist for these individuals.
   
   
4. Build constructive partnerships between physicians and administration.
   
   
5. Create a culture of continuous commitment to change where learning is always taking place.
   
   
6. Ensure that change begins with leadership; leaders should not expect others to change if they themselves are not role models for change.
   
   
7. Ensure that change is well communicated, through multiple channels, and in ways that create a positive ‘buzz†throughout the organization.
   
   
8. Build in expectations, accountabilities, and rewards for change.
   

The lessons learned in other fields and industries are that the context and culture of the organization matters a great deal when implementing TQM. Randomly selected organizations may not be prepared to implement TQM in its fullest sense.(39) Studies of the use of guidelines and evidence-based practice note that improvement efforts are sensitive to local differences in organizations, personnel, and disease condition that are poorly understood.(15,40) Øvretveit summarizes it best in his review of quality improvement work in Europe when he states:
Transferring a method or approach that works in one organization to another organization, or changing the organization in a particular way, may not produce the same effect. The result in one setting is an effect of the method or approach working within that system, not just an effect of the method or approach alone.(41)
The experience in primary care teaches some simple but critical lessons for effective quality improvement that the thoughtful practitioner wishing to implement TQM would be wise to heed:
Unless the leaders of the organization are strongly committed to change, improvement teams are likely to have only limited success with the improvement concepts and tools described in other chapters in this section.
Leaders must be capable of leading the change. This is as true of a two-doctor practice as it is of one with 500 physicians; whether the ‘leaders†are physicians or managers.
It is unlikely that the organizational leaders will be sufficiently committed to the change unless they perceive that the external environment requires it and will reward those who achieve it.


The practical advice then is to start with leadership and build a case for why a concerted and long-term effort to systematically improve quality is needed. Questions such as: Why is TQM important for our patients? What will TQM mean to us? and How do we intend to incorporate the principles of TQM in our practice? must be answered uniquely by every organization that pursues TQM. Unless these questions are clearly addressed by leaders, it will be difficult for the organization to move much beyond simply doing a few improvement projects.
In order to better understand what organizational factors are important for successful improvement (in this case for implementation of clinical guidelines), Solberg et al. collected the thinking of people responsible for managing change in medical practices of all sizes.(42) Participants were not top organizational leaders, but rather physicians, nurses, and administrators who had extensive experience (at least 5 years) with leading quality improvement efforts within their medical groups. Participants were asked to suggest important factors, and then to vote on which factors were the most important. The top five factors identified by this group (out of 87 possibilities) were:

• the pre-existing presence of organized systems in the clinic;
  
• commitment to the change by clinic leadership;
  
• leadership of the change process by enthusiastic volunteers;
  
• internal clinician champions for the clinical content of the change;
  
• clinic priority for quality over finance.
  

The need for the active engagement of both clinical and administrative leaders clearly runs through these five factors. This theme is further evidenced in an evaluation of the Primary Care Clinical Effectiveness Project (PRICCE) in the United Kingdom.(43) The evaluators there found that leadership and teamwork were fundamental to success. Importantly, they also found that these improved with participation; indicating that there is some value in ‘getting on with it†and not waiting until leadership and teamwork are perfected. In the end, we suggest a balanced approach that involves clear attention to leadership and organizational culture, with initial action informed by critical thinking rather than naivety.
Systems and systems thinking (the first factor in the list above) are probably the most important prerequisite for successful change management and improvement in care.(4,44) Recently, this field has further expanded beyond classic systems thinking based on mechanical metaphors to embrace new findings from the field of complex adaptive systems science based on biological metaphors.(45,46,47 and 48) Leaders who use mechanical systems thinking for guiding changes (e.g. developing detailed specifications for new behaviour) are likely to come away thinking that the clinic personnel are simply resistant to change. Complex adaptive systems thinking leads to an approach to change in which the leader is more like a farmer than an engineer (i.e. working to create the best conditions for participation and creative thinking by all, rather than trying to construct the desired result with detailed plans and specifications). Plsek and Kilo(49) report how quickly primary care practice personnel become flexible facilitators of change when leaders adopt these complexity-inspired approaches. Miller et al.(45) similarly report how these approaches help explain changes that succeeded and failed at two primary care practices.

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Encouraging trends for TQM in primary care
The lessons of the organizational development literature are receiving more notice in recent large-scale efforts to establish TQM in primary care organizations. While we must await formal evaluations, the depth of the approach in these newer efforts clearly exceeds that of the past, and initial case reports are encouraging.

Clinical Governance Programme
Halligan and Donaldson describe clinical governance in the United Kingdom as ‘… the systematic joining
up of initiatives to improve quality’.(50) The concept is applied to both primary and scondary care and includes elements addressing: (a) effective leadership; (b) planning of quality; (c) being truly patient-centred; (d) information, analysis, and insight; (e) staff development; (f) redesign of services and processes; and (g) demonstrated success. These seven elements closely mirror the Baldrige TQM framework described previously in Box 1.
The work is supported by a Clinical Governance Support Team that provides expertise and advice, and runs training and development programmes. The process begins at the Board level to stress the importance of the most senior leadership taking it upon themselves to develop an organizational culture that supports improvement, whole systems thinking, multidisciplinary teamwork, and ongoing development for all staff. The start-up process includes a large-scale review of current services and processes, along with comparisons to best practice. Multidisciplinary leadership teams from participating organizations attend a series of five workshops, punctuated by 8-week action periods spread over 9 months. As of mid-2001, 250 organizations (including primary care, specialty care, acute care, and other services) had committed to the effort.
The fact that leadership and organizational development are explicitly addressed in such a health system-wide, centrally funded and supported effort is encouraging relative to the observed shortcomings of past efforts. Primary care organizations working to establish TQM would seem to have a much higher likelihood of success in the presence of these enabling factors.
Case reports from the efforts in primary care settings describe radical redesign to provide family-centred care for children with complex needs, better detection and improved care for women with postnatal depression, and improved care and referrals processes for adolescents needing mental health services. Further examples of results are available through a regularly updated Internet website (www.cgsupport.org).
National Primary Care Collaborative (UK)
As of mid-2001, some 20 per cent of English primary care practices, covering a total patient population of 3 million people, are engaged in comprehensive quality improvement efforts through the work of the National Primary Care Development Team, under the auspices of the Modernization Agency. Multidisciplinary teams from enrolled practices meet periodically for learning workshops and have active project management help to implement changes in such areas as coronary heart disease (CHD), appointment access, and demand management. The teams learn TQM tools such as process mapping, understanding the patients' perspective, and rapid-cycle improvement, and are provided with ideas for change from recognized experts. The goal is to eventually ensure the systematic transfer of the learning from the project to all practices in England.(51)
Measurement is formalized in the project and results have been encouraging.(52) Practices in the effort report having the percentage of patients with diabetes who have had their eyes examined rise from 65 to 85 per cent, and those having their HbA1c levels measured rise from 47 to 80 per cent. The percentage of practices prescribing aspirin for over 80 per cent of their patients with CHD increased from 23 to 50 per cent in 10 months and continued to show a positive trajectory upward. A group of seven practices reduced the average number of days patients had to wait for a new appointment from 8 to 2 days in just 5 months. Formal evaluation of the overall effort is pending.
The Idealized Design of Clinical Office Practice Project
The most extensive efforts at a deep and comprehensive approach to quality in primary care are those being taken by participating organizations working in the Idealized Design of Clinical Office Practice Project (IDCOP), led by the Institute for Healthcare Improvement (IHI, Boston, USA).
The IDCOP project was born from observations about transformational change with regard to quality in the automotive industry.(53) The project began with an expert design team comprised of researchers and practitioners from around the United States and Europe who were asked to develop new design concepts that would result in office practices with fundamentally different performance characteristics from prevailing ones. These design concepts were then tested by over 30 prototype sites, ranging in size from a single-handed practice to groups of 200 or more doctors in a site.
Incorporating ideas from complex adaptive systems thinking,(46) the project is organized around statements of purpose in the form of simple rules. The goal is to have patients and staff say of a practice: ‘They give me exactly the help I want and need, exactly when I want and need it, while maintaining and improving a joyful work environment and a financially viable organization’.
The redesign work is further organized around fundamental changes in four theme areas:

Access: The goal is to offer patients appointments, with the provider they wish to see, on the day they call. A further goal is to provide access to health information around the clock through, for example, the Internet.

Interaction: The goal is to individualize care to match the patient's preferences regarding such things as the communication of information, control over decisions, self-care options, involvement of family and friends, and cultural values.

Reliability: The goal is to match actions to the best available knowledge and evidence, and to strive for a defect-free system of care.

Vitality: The goal is to sustain the new design through structures and leadership actions that assure on-going financial viability and the constant adaptability inherent in a learning organization.(4)


This is clearly a comprehensive and deep change effort that touches every aspect of how the organization functions. Smith(52) cites leadership as the core ingredient behind the project; noting that it is ‘hard work’ and that some sites have ‘fallen by the wayside’.
Case reports of initial results are impressive. ThedaCare, a 21-site primary care system in the United States covering 160 000 people, reports substantial improvement in diabetic care and estimates that annual hospital costs are reduced by $250 000 as a result of such efforts. La Clinica Campesina, a safety-net community health provider in the US reports that the percentage of patients with diabetes who were engaged in self-care methods rose from fewer than 5 to 60 per cent, and the percentage of patients with good control of blood sugar levels increased from fewer than 15 to 70 per cent. Sixteen primary care sites in a health system in the United States reduced the average number of days for a new appointment from 4.3 to 1.8. Participants in the project in the United States, United Kingdom, and Sweden also report other wide-ranging improvements involving the use of e-mail and Internet sites for interaction with patients, the establishment of locally derived care guidelines, better flow of patients and information, better interaction with specialists and acute care organizations, and higher levels of staff satisfaction. Formal evaluations of IDCOP are underway and should produce peer-reviewed publications in the early years of this decade.

Conclusions
The understanding of TQM in other industries is that it is an all-encompassing, leadership- and systems-intensive effort to improve everything that an organization does. It is much more than the establishment of a few improvement teams and projects.
The breadth and depth of organizational effort required to implement TQM was not fully appreciated in early efforts in primary care. Leadership and organizational culture are fundamentally important determinants of success in such efforts, but these attributes vary widely. Because primary care organizations are not homogeneous on these critical attributes, the use of simple randomized controlled trial designs to evaluate the effectiveness of TQM is questionable.(39) We do not believe that randomly selected health care organizations will respond in similar ways to an ‘intervention’ of TQM. More sophisticated designs and hypotheses are needed. Case reports and before–after comparisons in more recent efforts to utilize TQM in primary care are encouraging and do demonstrate that these methods from general industry can be usefully adapted to health care.
Leaders in primary care interested in adopting TQM should reflect carefully before embarking on the effort. Experience suggests that unless a significant proportion of key clinical and managerial leaders and staff feel an intense need for fundamental change, and are willing to support the change effort through the commitment of time and resources, comprehensive TQM efforts will likely stall.
This does not mean that leaders who are committed to individual quality improvement projects are forced to do nothing. It is possible to complete many such projects using the tools and concepts covered in other chapters in this section. Each project will have to stand on its own in terms of generating tension for change and securing resources for that change; but each project completed will provide some benefit to patients and staff. Leaders may also need to take special steps to maintain the gains over time from each improvement project, as the culture of the organization may not provide natural support systems.
Having stated these cautions, we encourage thoughtful practitioners to begin now the efforts to build TQM into primary care organizations. The first steps should involve assembling leaders for a reflective and honest dialogue about the extent to which the principles of TQM are currently practised or lacking in the organization, along with an honest assessment of the patients' experiences of care. The leadership team should engage in studying the lessons learned in health care and other industries about organizational culture, organizational development, systems thinking and change management. The leadership team should also build the case for TQM in a way that reflects the unique needs of the organization's patients, staff, and situation. Building on this foundation, the next steps would involve an assessment of its systems for demonstrating leadership, setting goals, building teamwork, redesigning processes, and measuring progress in order to begin the long-term effort to continuously improve these systems.

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