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BMJ. Jul 4, 1998; 317(7150): 61–65.
PMCID: PMC1113460
Looking forward

Clinical governance and the drive for quality improvement in the new NHS in England

Gabriel Scally, regional director of public healtha and Liam J Donaldson, regional director, NHS Executive (Northern and Yorkshire)b

A commitment to deliver high quality care should be at the heart of everyday clinical practice. In the past many health professionals have watched as board agendas and management meetings have become dominated by financial issues and activity targets. The government’s white paper on the NHS in England outlines a new style of NHS that will redress this imbalance.1 For the first time, all health organisations will have a statutory duty to seek quality improvement through clinical governance. In the future, well managed organisations will be those in which financial control, service performance, and clinical quality are fully integrated at every level.

Summary points

  • Clinical governance is to be the main vehicle for continuously improving the quality of patient care and developing the capacity of the NHS in England to maintain high standards (including dealing with poor professional performance)
  • It requires an organisation-wide transformation; clinical leadership and positive organisational cultures are particularly important
  • Local professional self regulation will be the key to dealing with the complex problems of poor performance among clinicians
  • New approaches are needed to enable the recognition and replication of good clinical practice to ensure that lessons are reliably learned from failures in standards of care

The new concept has echoes of corporate governance, an initiative originally aimed at redressing failed standards in the business world through the Cadbury report2 and later extended to public services (including the NHS). The resonance of the two terms is important, for if clinical governance is to be successful it must be underpinned by the same strengths as corporate governance: it must be rigorous in its application, organisation-wide in its emphasis, accountable in its delivery, developmental in its thrust, and positive in its connotations. The introduction of clinical governance, aimed as it is at improving the quality of clinical care at all levels of healthcare provision, is by far the most ambitious quality initiative that will ever have been implemented in the NHS.

Origins of clinical governance

Although clinical governance can be viewed generally as positive and developmental, it will also be seen as a way of addressing concerns about the quality of health care. Some changes in healthcare organisations have been prompted by failings of such seriousness that they have resulted in major inquiries. Variations in standards of care between different services have been well documented. Under the previous government’s market driven system for the NHS, many felt that the quality of professional care had become subservient to price and quantity in a competitive ethos. Moreover, some serious clinical failures—for example, in breast and cervical cancer screening programmes3—have been widely publicised and helped to make clinical quality a public confidence issue.

What is clinical governance?

Clinical governance is 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

Clinical quality has always engendered a multiplicity of approaches. Universally accepted definitions have been difficult to achieve, and some have even considered the term too subjective to be useful.4 The World Health Organisation is helpful in exploring the idea of clinical governance.5 It divides quality into four aspects:

  • Professional performance (technical quality)
  • Resource use (efficiency)
  • Risk management (the risk of injury or illness associated with the service provided)
  • Patients’ satisfaction with the service provided.

These dimensions of quality are taken a stage further in the components identified in the new NHS white paper as being the attributes of an organisation providing high quality clinical care. The development of clinical governance is designed to consolidate, codify, and universalise often fragmented and far from clear policies and approaches, to create organisations in which the final accountability for clinical governance rests with the chief executive of the health organisation—with regular reports to board meetings (equally as important as monthly financial reports)—and daily responsibility rests with a senior clinician. Each organisation will have to work out these accountability arrangements in detail and ensure that they are communicated throughout the organisation.

Quality improvement philosophy

At any one time, the organisations making up a health service show variation in their performance against quality criteria (fig (fig1).1). Quality improvement must address the whole range of performances. Failures in standards of care—whether detected through complaints, audit, untoward incidents, or routine surveillance—represent one end of the range. Organisations that are exemplars represent the other end. At present once good practice is recognised, the scope for more general applicability and methods to transfer it both locally and nationally are not well developed.

Figure 1
Variation in the quality of health organisations

The process of learning lessons from both exemplar and problem services has never before been tackled systematically in the NHS. However, a major shift towards improved quality will occur only if health organisations in the middle range of performance are transformed—that is, if the mean of the quality curve is shifted. This will necessitate a more widespread adoption of the principles and methods of continuous quality improvement initially developed in the industrial sector and then later applied to health care.6 Generally these involve an organisation-wide approach to quality improvement with emphasis on preventing adverse outcomes through simplifying and improving the process of care. Leadership and commitment from the top of the organisation, team work, consumer focus, and good data are also important.

In the NHS a key part of establishing a new philosophy of quality improvement will be to decide how clinical audit fits in to an integrated approach. Although the concept of peer review is well established in the United Kingdom, the implementation of clinical audit in the NHS is not a complete success. Concerns have focused on the failure of audit processes to detect and moderate significant clinical failures; on incomplete participation (table (table1);1); on the lack of connection and flow of information to those responsible for managing services; on substantial declines in the amount of regional audit; and on the value for money for what amounts to a significant annual investment.8

Table 1
Percentage of questionnaires returned in the 1994-5 national confidential inquiry into perioperative deaths7

Two new external bodies will facilitate and reinforce the local duty for quality in the NHS. The style of working of the Commission for Health Improvement and the National Institute for Clinical Excellence will be important, as will the way in which they are viewed by local services. Any external body can add value in different ways: inspecting, investigating, advising, supplying expertise, facilitating, accrediting. The role of the two new bodies could contain elements of all these functions. However, it will be important that they establish an overall philosophy which will be based (at least in their initial approach to local organisations) on facilitating improvement and encouraging evaluation. Health organisations must not be defensive if the full benefits of these important additions to the national scene are to be realised.

Case study: Gridstone Royal Infirmary NHS Trust

Gridstone Royal Infirmary NHS Trust has advertised for a new medical director with specific lead responsibility for developing clinical governance in its hospital, which serves a small city and its surrounding county population. The hospital has had a troubled past four years: a recurrent financial deficit has increased each year; targets for inpatient waiting times agreed in annual performance plans have repeatedly not been met; and members of the senior medical staff have regularly used the local newspaper to criticise decisions by the trust’s management. The hospital has a higher number of medical posts filled by locums than any hospital in the region. A confidential survey of general practitioners’ opinions conducted for the community health council showed that many were referring to hospitals outside the county because of concerns about standards of care in some of the local hospital’s clinical departments. There have been two chief executives in the past four years. The current, newly appointed chief executive is the first woman senior manager ever appointed to the hospital’s staff. She states that the key to creating an organisation with a reputation for high quality is successful implementation of clinical governance.

The case study (box) describes an imaginary hospital (Gridstone) that is ailing as an organisation. Conventional indicators of performance—for example, response times and budgetary control—are showing up badly. Other indicators, such as general practitioners’ referral preferences and the inability to fill vacant posts, suggest that all is not well with the quality of care provided. It is obvious too that the relationship between doctors and management is dysfunctional. Clinical governance offers the opportunity for the hospital to look at itself afresh and start to rebuild its quality ethos—a fact that is recognised by the new chief executive.

Culture, leadership, and teams

The feature that distinguishes the best health organisations is their culture. The applicant for the medical directorship of Gridstone Royal Infirmary at her interview recognises that an organisation that creates a working environment which is open and participative, where ideas and good practice are shared, where education and research are valued, and where blame is used exceptionally is likely to be one where clinical governance thrives (box next page). The challenge for the NHS is the active creation of such cultures in most hospitals and primary care groups of the future. However, evidence on how to define a “good” culture and on the methods required to promote one is largely lacking in the healthcare field. The fact that those leading health services do not traditionally think along these lines perhaps explains the initial scepticism of some of the panel members at the medical director’s interview at Gridstone. But although the management literature deals with such subjects extensively, uncertainty exists about how best to appraise it critically.

A consultant rheumatologist is an external applicant for the post of medical director of Gridstone Royal Infirmary NHS Trust. If she is appointed she will be expected to take the lead on implementation of clinical governance. Here is an extract from her interview

Q: In your vision of clinical governance will our doctors be more accountable than they are now?

A: I think the scope of professional responsibility will be much broader than at present—covering commitment not just to delivery of a safe and effective service but to the quality goals of the organisation as a whole and to the clinical team.

Q: Isn’t clinical governance just a more formal way for us to weed out the poor performers?

A: No, I think the concept is much more fundamental than that. Certainly, it is vital that poor performance is recognised and dealt with better than it has been in the past. That’s what people mean when they talk of local self regulation. We need to identify problems of poor performance much earlier, through mechanisms like making sure everyone takes part in effective clinical audit, and having more open communication within teams. But we must also try to prevent many of these problems. This will mean learning where possible from failures in standards of care—for example, by looking at our record of complaints and untoward incidents. It will also mean having better data to review quality in each clinical service; ensuring that clinical teams work more effectively so that individuals are taking fewer decisions in isolation; being clearer about the skills and competencies needed in each area of service; and being willing to change things to make them better.

Q: Okay, you’ve convinced us that there’s more to addressing poor performance than sorting out the bad apples, but you say there is also more to the concept of clinical governance?

A: Yes, I see the first and most important task as an organisational one—to create the kind of service where high quality is assured and improvement takes place month on month, year on year.

Q: Sounds a little “mother pie,” doctor, doesn’t it? I mean, how could you possibly suggest anything else?

A: I think you mean “motherhood and apple pie,” don’t you? I know that you and the chairman run private companies. You are surely not going to tell me that establishing the right leadership and culture are not keys to successful organisations are you?

Q: Okay, could you be a bit more specific? How will we recognise a good culture in the hospital if we see it?

A: It is because the leadership and the culture have been wrong that you have had so many problems over the past four years. I see a positive culture as one in which doctors, managers, and other healthcare professionals work closely together with a minimum of hierarchies and boundaries. It would also be one with an environment in which learning and evaluation are encouraged and blame is rarely used. This will be brought about only through the leadership of the chief executive and the board (including me as medical director if I am appointed), by the clinical directors of each service, and by individual team leaders in every clinical area. A safe, high quality service for patients attending your accident and emergency department depends just as much on the leadership skills of the staff nurse in the department as it does on the clinical skills of the trauma surgeon or the management skills of the medical director at trust board level. That is why I emphasise leadership and culture and why I will eat “mother pie” if I am wrong.

Q: Are there any other points about clinical governance you would like to make? Time is short, and we do want to ask you about your attitude to consultants having reserved spaces in the car park.

A: There is a great deal more I could say, but just two points for now. Firstly, it is vital that the right infrastructure is in place for clinical governance: information technology, access to evidence, and education and training, as well as some protected time for individuals and teams to think about the quality of their services, review data, appraise evidence, and plan improvements. Secondly, we must find ways of involving patients much more than we have in the past—they are, after all, the people we are doing this for.

Most observers would identify leadership as an equally important ingredient in successful organisational change. However, leadership too is a rather vague concept. Among professionals it is often based on a model of wise authority rather than of authority conferred by virtue of position. The introduction of clinical and medical directors in NHS trusts has changed this approach dramatically. Posts may well be publicly advertised and are invested with significant responsibilities and authority. Although this change has taken place, little effort has been expended in developing leadership skills among members of the professions expected to take on these posts. Moreover, many who hold such posts (as in the Gridstone example) will find themselves leading clinical governance strategies within their organisations. Medical directors of NHS trusts may recognise that they have skill deficits, but although these may be addressed when someone is in post, a proactive approach would undoubtedly be preferable.9

New approaches to undergraduate medical education, such as the introduction of problem based learning and joint education with other professional disciplines, should in time improve teamworking skills; the importance of teamworking has been emphasised by the General Medical Council.10

One of the strongest statements in the recent NHS white paper for England was that a new era of collaboration would begin. Competition, a feature of the previous eight years, was to be ended. The strength of the working relationship between senior managers and health professionals will be at the heart of successful clinical governance. Other partnerships will be important too. Day to day and longer term developmental progress will depend on effective partnerships with universities, local authorities, patients’ representative groups, and voluntary organisations.

Evidence and good practice

The evidence based medicine movement11 has always had a major influence on many healthcare systems of the world. Accessing and appraising evidence is rapidly becoming a core clinical competency. Increasingly, neither clinical decisions nor health policy can any longer be comfortably based on opinion alone.

The NHS research and development programme has helped with the production and marshalling of the evidence needed to inform clinical decision making and service planning. Clinical governance will require a greater emphasis at local level, where currently the infrastructure to support evidence based practice is not always in place. The most obvious is information technology to enable access to specialist databases (such as the Cochrane collaboration). However, libraries, for example, are a basic requirement for access to professional knowledge, and a recent review in one English region has shown wide variation in funding for and access to library services.12

Although presenting evidence, or providing access to it, is a necessary condition for adopting new practices, it is not sufficient. The field of behaviour change among health professionals is itself developing an evidence base, through which it is becoming clear that single measures (such as general feedback) are not effective and multifaceted strategies are needed—using techniques such as input from a respected colleague, academic detailing, and individual audit and feedback.13

Much of the evidence based work to improve clinical decision making has centred on specific interventions and clinical policies. However, clinical governance is also expected to address how good practice can be recognised in one service and transferred to others. Where whole services—for example, a community diabetic service or a service for women with menstrual problems—are concerned, it is much more difficult to identify the benficial elements and replicate them elsewhere. A new major strand in the NHS research and development programme—addressing so called service delivery and organisation—is intended to tackle this problem.

Changes to the NHS complaints procedure in 1996 reduced the fragmentation and inconsistency of previous arrangements as well as introducing more openness and lay participation.14 The health service has yet to develop a simple way to allow the important, generalisable lessons to be extracted from the extensive analysis, information gathering, and independent judgment which now underpin the handling of complaints. Moreover, a wealth of other information on clinical incidents which are the subject of internal and external inquiries is generated, but there is no obvious route for this information to be channelled to prevent similar errors from recurring. Clinical governance has the opportunity to address this weakness—requiring organisational as well as individual learning.

Dealing with poor performance

Poorly performing doctors and other health staff are a risk not only to patients but also to the organisation they work for. Though relatively few in number, their existence, and the tenacity with which the problem is addressed, is very important to the standing of the NHS and the healthcare professions in the eyes of the public. The controversy generated by this subject can lead some to believe that the sole purpose of clinical governance is to sort out problem doctors (see interview (box)). A small proportion of hospital based medical staff are likely to have sufficient deficiencies in their performance to warrant consideration of disciplinary action.15 The introduction of new performance procedures by the General Medical Council has signalled a change in approach—away from a reluctance to do anything that might be seen as criticism of a fellow professional. It would be wrong, however, to rely on a body such as the General Medical Council to deal with most problems. Local professional regulation needs to be developed so that satisfactory and timely solutions can be found to what can be complex problems. The test will be whether such cases can be dealt with in a sympathetic manner which, while correctly putting the protection of patients first, will also deal fairly with experienced and highly trained professionals.

Professional development

The staff of a healthcare organisation will be the key to how it rises to the challenges of the new agenda. Firstly, good recruitment, retention, and development of staff will make a major contribution. Secondly, staff must be supported if they are to practise well: skills training, modern information technology, access to evidence are all important. Thirdly, staff must participate in developing quality strategies and be encouraged to look critically at existing processes of care and improve them. Finally, valuing staff and letting them know that they are valued—easily espoused but often overlooked—is a common feature of organisations that show sustained excellence in other sectors16,17

In the NHS the development of educational consortiums has for the first time given NHS trusts and health authorities direct control over the type of training received by large numbers of professional staff. The alignment of this new system to the goals of clinical governance will be essential. Systematic reviews are beginning to inform the design of training and continuing professional development programmes for doctors.18 Designing programmes that help to advance the quality goals of every organisation and which draw on an evidence base will also be part of the principles of good clinical governance.

Data quality

The importance of clinical record keeping is well established. The collection and analysis of routine patient data has been a central part of the health service’s planning and administration. At the outset, the internal market in the NHS (which operated between 1990 and 1997) was seen as highly dependent on the exchange of data about the quality of care provided. However, the emphasis in data collection was on the number of treatments, length of stay, and costs of care. There are substantial failings in the completeness of some of the vital clinical data (table (table2).2). A renewed commitment to the accuracy, appropriateness, completeness, and analysis of healthcare information will be required if judgments about clinical quality are to be made and the impact of clinical governance is to be assessed. These issues are so important and have been so unsatisfactorily dealt with in the past that they will need to be addressed nationally not only locally.

Table 2
Percentage of hospital episodes in which the primary diagnosis or primary operative procedure is unknown, England 1995-619

Conclusion

Clinical governance is a big idea that has shown that it can inspire and enthuse. The challenge for the NHS—health professionals and managers alike—is to turn this new concept into reality (fig (fig2).2). To do this requires the drawing together of many strands of professional endeavour and managerial commitment into a cohesive programme of action in each healthcare organisation in England. This will need leadership and creativity. If this challenge is met the beneficial consequences will flow to every hospital, practice, and patient in the country.

Figure 2
Integrating approaches of clinical governance

References

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