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Commentary |
Guy's Hospital, Guy's & St Thomas' Hospital Trust, St Thomas' Street, London SE1 9RT, UK
Clinical governance is no longer in its infancy. Although introduced 3 years ago into the National Health Service (NHS) through the Government's paper "The new NHS—modern . dependable" [1], it has not reached its final objective in becoming the essential habit of everyone who works in the health service and so it is not yet mature. It is in those terrible teenage years!
It is now accepted that clinical governance is the local part of the Government's national initiative on clinical quality in the NHS, aimed at setting and maintaining standards of clinical care. Since its inception, the principles of clinical governance have been further developed in subsequent papers from the NHS: "A first class service: quality in the NHS" [2] and "Clinical governance: in the new NHS" [3]. The quotation from these documents that I think is most relevant to the understanding of clinical governance is "the new NHS will have quality at its heart, without it there is unfairness. Every patient who is treated in the NHS wants to know that they can rely on receiving high quality care when they need it. Every part of the NHS and everyone who works in it should take responsibility for working to improve quality".
Since 1997 we have seen the development of the national framework for clinical quality in the form of the National Institute for Clinical Excellence (NICE), the National Service Frameworks and the Commission for Health Improvement (CHI). Some progress has also been made in identifying patients' views on the service. The now well recognized diagram (Figure 1)
shows clinical governance sitting between the NICE and the CHI, but alongside professional self-regulation and lifelong learning. The fundamental elements of clinical governance (Figure 2) were first enunciated in 1997 and were not unfamiliar to professional staff working within the NHS. However, this reminder of good clinical practice was accompanied by significant organizational change associated with "governance". The concept of governance is now widespread throughout society and originated in relation to the principles of corporate governance in the Cadbury Report of 1992 [4]. Under governance guidance, Trusts are required to ensure that there are mechanisms in place to facilitate high standards of practice. Until clinical governance arrived, governance in the NHS largely related to financial affairs. The responsibility of Trust Boards has been clarified and in particular the Chief Executive has been made fully responsible for ensuring that controlling mechanisms exist to interrogate the internal controls of standards. This is part of the general concept of controls assurance [5]. Through these mechanisms, the Board, the Trust and all staff are to be accountable to the public for providing the best possible care to the patients using the service. During the infant years of clinical governance the main response of Trusts was to set policies and structures at an executive level. Until recently it has been difficult to identify whether this has led to significant patient benefit. There have no doubt been multiple meetings, new appointments, new structures, lengthy discussions and regional and national stocktakes of activity following the initial documents. In our Trust, like many others, we introduced a Board policy on standards of patient care; defined the underlying principles of that policy; set up a Board Clinical Governance Subcommittee; created a Clinical Standards Committee to provide inter alia a mechanism for whistle blowing; and last year we set annual objectives for each clinical directorate for clinical governance. The time has now come to ensure that all these good words are turned into practice for the benefit of patients. The tools for clinical governance identified in Figure 2 are not new to us, but it is their further development and the requirement that they affect our everyday practice that is the challenge. For example, initiatives around clinical audit have been with us for a number of years and the main difficulty has been to set common standards against which to audit practice, to find the time to conduct audit surveys thoroughly and to identify the resources to effect the changes indicated by audit.
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An essential feature of clinical governance is the philosophy that we should be able to provide evidence of high standards of clinical care as a routine. This information needs to be incorporated in annual reports to the public that should be available on demand. For many professional people this is a significant change in philosophy in relation to one's personal practice. In the past, individuals have only been required to address their own performance when they have found themselves under the spotlight for one reason or another. It is now expected to be an element of all our lives and will be an essential part of revalidation. There is a widespread feeling that the time required to do this detracts from the time available to provide direct patient care. I have no doubt that re-adjustment of the balance of our day-to-day activities will occur.
Further development
This year, to encourage individual services and individual professional staff to address the principles of clinical governance in their everyday working lives in our Trust, we have required each clinical directorate to identify a clinical governance strategy. The areas that this must include will not be a surprise; they are clinical audit, risk management, learning from complaints and surveys, staff appraisal and development, maintenance of professional accountability and standards, clinical guidelines and protocols, and working with others. Each directorate is expected to identify for itself the standards to be aspired to and the mechanisms for monitoring so that there is relevance to everyday practice. There has been considerable discussion about what outcome measures one should be using. For surgeons it is relatively easy to identify mortality as a clinical indicator of performance because it is easily defined, but even with that there are difficulties in comparing individuals and departments because of the difficulties of case mix, for example. In other areas of clinical practice, clinical indicators are more difficult to define. For example, in clinical oncology, do we have to wait for 5-year survival rates to identify whether a service is meeting best practice? Clearly this time-scale would be too long—hence the Government's emphasis on clinical guidelines and protocols. The philosophy here is that if a guideline or protocol is set by peer agreement on the best evidence available at the time, this acts as a proxy measure for best clinical outcome. It is then a logical step to say that the measure of clinical quality is the adherence to guidelines and protocols. It is expected that the combination of recommendations from the NICE, the National Service Frameworks and the CHI will set national standards in difficult areas. However, this approach does pose problems for departments that wish to be at the leading edge in developing services. Inevitably they will be providing services that do not comply with the guidelines from the NICE and one hopes that the CHI will recognize that the evidence to move to new ways of delivering health care has to be obtained somewhere!
More recently, guidance has been provided from the Department of Health in two further inter-related areas. First, in relation to medical practice [6, 7], and second, learning from mistakes [8, 9].
Job planning
Individual professionalism has been a key feature of clinical governance from its inception. The much beleaguered medical profession is changing rapidly and radically. For the individual doctor there are two main elements here—job planning and revalidation. Both can be perceived as either unnecessary tiresome chores to be resisted, or opportunities for change and improvement.
British medicine in particular has always been a balance between individual independent practice representing the best interests of an individual patient and organizational efficiency. Medical training encourages us to think and work independently in an attempt to represent the best interests of our individual patient. The first duty of a doctor, as identified by the General Medical Council (GMC) [10], is to place the patient's interest as our first concern. In hospital practice, difficulties often arise where this ideal clashes with the requirement of the financially constrained NHS to provide a service to all patients. This conflict has been represented as the divide between clinicians and management and, of course, it is always the management's fault. But is it? There is a fundamental difficulty that many consultants either do not, or cannot, recognize. There is a potential conflict between the exercise of independent thought and behaviour at the bedside and the recognition that we are employees. Does it seem unreasonable for the employer to have some expectations of their own for their employee? Experience shows that difficulties have arisen around a consultant's practice because it has been unclear what the exact expectations are of that individual's contribution to the overall service that the Trust or hospital is expected to provide. Job planning is about providing clarity in this area. Performance management should not consist simply of number crunching for waiting lists and waiting times, but under clinical governance it should also aim to specify the clinical standard of care that is expected from individual services and individual clinicians or teams. Although at first sight this may appear threatening to clinicians, I believe it is a tool that we can use to identify more clearly how the service should be organized and resourced, in order to reach the standards that the public are expecting of us.
Revalidation
Revalidation is an issue that is being discussed widely at present and will take some time to settle down. Some of the issues are largely about responsibility for the process and the standards to be worked to, between the Government, the GMC, the Colleges and individuals. But in the context of clinical governance its relevance is related to concepts of annual appraisal and lifelong learning. Annual appraisal for consultants is now an established feature for the future [11] and, if we accept that revalidation and annual appraisal are there as tools to maintain quality of individual professional practice, we should encourage and embrace them. The principle of annual appraisal is that regular analysis of the standards of one's work will lead to early identification of adverse change before that change leads to unacceptable practice. Identification of such change should lead to corrective action either in the form of re-training and the development of new skills, or to an adjustment of the clinical activity of the individual by excluding them from practice in those areas where performance is substandard. Hopefully, the system will lead to such adjustments being made by mutual agreement before practice becomes substandard. To improve on old skills or develop new ones requires proper resourcing for professional development. That, as we all know, is significantly lacking at present in the NHS. Similarly, to be able to give up "at risk areas" of one's practice requires other colleagues to take up that work if the service to patients is not to be eroded. Making the system work is not only dependent upon the attitude of consultants towards it, but requires the NHS to be clear and specific about the requirements of each particular service, both in numbers and quality to be achieved. We all know we are a long way from that.
Adverse incidents
Finally, I would like to turn to the theme of incident reporting and its potential to improve clinical care. Recent literature has drawn our attention to the lack of systems in the NHS to identify and learn from adverse incidents, with particular comparison to the aviation industry [8–10, 12–14].
It is recognized in the airline industry that human beings are fundamentally fallible and that to run a service that is safe, back-up systems must be created that raise signals when errors are made in order to limit the immediate damage and reduce the risk of recurrence. The concept of incident reporting and risk management is being applied to our clinical care in the health service. A considerable amount of emphasis is being laid on the fact that, in the past, staff in the NHS have only paid attention to adverse events when actual harm was caused to patients. This often leads to an enquiry that many feel is set up to identify individual rather than system failure. There are, of course, examples of good practice where analysis of adverse events not causing harm to patients leads to change in practice, thus reducing that risk. However, throughout the health service there is no standardized system whereby one part of the service can easily learn from errors, or potential errors, made in another. The theory is that if adverse events can be identified as near misses, these will produce a positive impact on clinical quality. One of the major obstacles to developing this within the NHS is the abundant evidence that the service is currently run with a very strong blame culture. This is not only within the professions, but also largely generated by public and political attitudes. If clinical incident reporting is to become a useful tool, it will lead to a much higher level of recognition of adverse events that occur in everyday practice. In clinical radiology and clinical oncology, this system is very poorly developed in comparison with other areas such as obstetrics and anaesthesia. Consultants' responsibilities in leading this process need to be recognized. We have to create an atmosphere in which members of staff can discuss the "errors" that they have made to develop more sophisticated safety systems. This must be done without the members of staff feeling victimized and indeed it should be a positive event for them. There are, within clinical radiology, many aspects of the service that we provide that we already recognize represent a clinical risk, such as irradiation, drug errors and deficiencies in the reporting of radiographs, for example. If one asks clinical radiologists about clinical risk management, their first thoughts often turn towards an analysis of error rates of individual radiologists. Error rates in observation and interpretation are only one small component of the radiological services that affect patient care. Failure to communicate results in a timely manner to the clinician so that the appropriate clinical action can be taken, or failure to read the films in the first place, are much more widespread and serious errors that we need to address. But clinical radiology is also in a particularly strong position to add its weight to clinical incident reporting for a hospital or service as a whole. We often observe unnecessary delays in either the investigation of patients or the transmission of results to clinicians, which ought to form the basis of questions about the systems that support patient care. How many times have we performed a barium enema to find a carcinoma of the colon that we have reported promptly, only to see the patient's next attendance delayed by 6 months before admission owing to clerical disorganization? Development of a so called "no blame culture" is clearly an ideal, although it is difficult to achieve in a health service that is led by politicians whose whole lives appear to rotate around identifying and apportioning blame. Within our own professions we should be able to develop a low blame or "acceptable error" culture.
Much attention is given to identification of lessons to be learnt from claims and complaints. However, the same attention should be given to the plaudits or compliments that are received during our practice. These comments should tell us what we are doing well, so that we can ensure that we extend that aspect of our care to all patients' benefit.
This year!
The Government paper "Assuring the quality of medical practice" [7] supports the development of the National Clinical Assessment Authority to oversee implementation of the principles outlined in "Supporting doctors, protecting patients" [6], the Chief Medical Officer's consultation document published in the summer of 2000. More recently, plans to create a National Patient Safety Agency have been announced [9]. Exactly how these two bodies will fit into the other arrangements for clinical governance and what effect they will have on the maintenance of high quality care to patients is yet to be seen.
Despite the 3 years of clinical governance, there is still much to be done. Factual evidence to support the hypothesis that the Government's initiatives are leading to an improvement in the quality of clinical care to patients is, as yet, sparse.
As with most teenagers, the potential is awesome, guidance is not always easily received and the believers have to believe. We have to show confidence. It might just turn out fine.
Received for publication March 29, 2001. Revision received May 29, 2001. Accepted for publication June 18, 2001.
References
This article has been cited by other articles:
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  M. M. Maher, P. A. Hodnett, and M. K. Kalra Evidence-based Practice in Radiology: Steps 3 and 4--Appraise and Apply Interventional Radiology Literature Radiology, March 1, 2007; 242(3): 658 - 670. [Abstract] [Full Text] [PDF]
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