Chapter 28 Clinical governance
Clinical governance sits at the heart of the government’s quality agenda for the National Health Service (NHS) and, indeed, the wider healthcare arena. The statutory duty now placed on everyone working in healthcare is that of overall quality improvement, year upon year, backed up by the evidence to prove it.
This is not a threat to podiatrists, any more than it is to any other healthcare professional, the majority of whom have consistently worked for the good of their patients, and in the main have provided excellent care on a very tight budget. Neither is clinical governance particularly onerous – it merely formalises that which most clinicians certainly should have been doing and usually have.
The well-publicised spate of extremely damaging and tragic cases in the late 1990s, such as Shipman, Bristol and Alderhey, brought into sharp relief the damage caused by the gross shortcomings and casual behaviour of the few, against the philosophy of the many. The government’s answer to the general outcry and loss of public confidence was, in effect, clinical governance, tied in with a raft of other regulations, rules and requirements.
For the vast majority of clinicians in the healthcare arena, public or private, clinical governance actually offers a sensible way of determining priorities, developing staff and underpinning learning with experience. It offers clinicians the time to ‘do things properly’ in the way there has never been time before, and therefore offers an opportunity to examine activity and reflect on how that activity could be carried out differently and in a better way.
This chapter examines the evolution of clinical governance systems out of the myriad of good intentions, hard work and innovation that have always characterised the NHS. As clinical governance is now a contractual duty of all NHS employees, and its tenets underpin healthcare regulation, its presence cannot be ignored or sidestepped.
It is not just about public protection – it can be about promoting the good practice provided by clinicians throughout modern history. It places the patient at the centre of the healthcare provision and gives us the chance to prove just how we make the rhetoric live on a daily basis.
Clinical governance covers every aspect of healthcare. The quote given in Box 28.1 is taken from ‘Clinical Governance in the New NHS’ (Department of Health 1999) and is a full detailing of the areas affected by clinical governance requirements.
Box 28.1 NHS trusts (source: Department of Health 1999) Main components of clinical governance
Clear lines of responsibility and accountability for the overall quality of clinical care through:
A comprehensive programme of quality improvement activities, which includes:
Clear policies aimed at managing risks:
Procedures for all professional groups to identify and remedy poor performance, for example:
In December 1997 the newly elected government published a White Paper for consultation entitled ‘The New NHS – Modern and Dependable’ (Secretary of State for Health 1997). In introducing the White Paper, the then Secretary of State for Health, the Right Honourable Frank Dobson, said ‘This White Paper means a ten year programme of modernisation which will make the National Health Service (NHS) better every year. It will be an NHS for the next century, based on its founding principles of high quality care for all, delivered on the basis of need, and need alone.’
The Prime Minister, in his foreword to the document, was rather more explicit: ‘For the first time the need to ensure that high quality care is spread throughout the service will be taken seriously. National standards of care will be guaranteed.’ Chapter 3 of the document stated ‘that the new NHS will have quality at its heart’.
The new measures that were proposed in order to fulfil the government’s objectives were divided into three areas:
The stated aim of the White Paper was to replace the previous government’s internal market with integrated care, and to reduce health inequalities. The key proposals included:
The White Paper was closely followed by another White Paper entitled ‘Designed to Care’ in Scotland, ‘Putting Patients First’ in Wales and ‘Fit for the Purpose’ in Northern Ireland. Although there are several differences in approach between the documents, they are all heralding a period of great change in the NHS.
Thus the ‘new NHS’ introduced for the first time the concept of clinical governance, and advanced the notion that Trusts should be held strictly accountable for the quality of care they advanced. The objectives of health improvement and quality applied equally across the UK, and bodies such as NICE and the Healthcare Commission and others have national remits.
The standards, once set, would allow the public to judge the performance of the NHS, both nationally and locally, and all monies saved were to be redirected into front-line patient care.
In July 1998, the government took its plans one stage further with the publication of another White Paper entitled ‘A First Class Service – Quality in the new NHS’ (Department of Health 1998), which detailed the elements of clinical governance, bringing the concept to life, and outlining the first of several timetables for its full implementation.
The new White Paper defined clinical governance as ‘a framework through which the NHS organisations are accountable for continuously updating the quality of their services and safeguarding high standards of care by creating an environment in which evidence in clinical care will flourish’. The text continues ‘Clinical Governance has an important role to play in restoring public confidence in the NHS … NHS Trust Clinical Governance reports will set out progress made and demonstrate to local people that their confidence in the NHS is well placed’ and then ‘the requirements of Clinical Governance will be backed up by the new statutory duty for quality, which will be placed on Trusts and PCTs’.
NHS organisations now faced the enormous task of welding together systems such as clinical audit, risk management and continuous professional development (CPD) for all staff in order to produce a comprehensive measurable and implementable quality programme. The agenda was daunting, and in 1999 another White Paper ‘Clinical Governance – Quality in the New NHS’ moved it on again by defining the government’s requirements further.
Quality is not a new concept. The relationship between quality improvement and organisational culture has been understood in business and industry for many years. In an organisation such as the NHS, and within the wider healthcare area, the need to ‘change the way of things’ was accepted long before the government’s introduction of clinical governance as a named contractual requirement. But, for this to happen, time was required to think, discuss and redesign services and processes and implement the changes, then to await the effect of those changes, and in the day-to-day delivery of health and social care time is a precious commodity.
All health professionals have incessantly striven to achieve quality in their daily clinical practice, but have too often found themselves hampered by a lack of resources and time. There was, therefore, evidence of an increasing awareness of quality issues and of governance in the widest sense throughout healthcare. But for all the elements to come together, it required the impetus and imperative provided in 1997 by the government to drive clinical governance firmly into the centre of decision-making and action. In 1997, therefore, the government set out its vision for quality healthcare: ‘achieving meaningful and sustainable quality improvements in the NHS requires a fundamental shift in culture, to focus effort where it is needed and to enable and empower those who work in the NHS to improve quality locally’.
Clinical governance is not in itself, wholly innovative – its components have existed for some time in most of the NHS. What is new is that the government’s initiative provided the driver for the coordination of information and activity, which in turn should lead to performance improvement. Many have welcomed clinical governance as a positive and long-overdue official process. It is now a contractual requirement of all those working within the NHS, and much progress has been made towards implementation of systems to support clinical governance initiatives. However, a shortage of funding, a lack of guidance, a concern over the speed of implementation, the volume of it and the impact of mergers (of Trusts) have hampered progress. Most Trusts now have a department dedicated to coordinating clinical governance activity.
There remains a constant danger that clinical governance could be reduced to a system that looks at a series of processes and, at its best, is just a paper exercise. However, that would defeat the object of the exercise and effectively waste the opportunity we have been given to take time to stand and reflect. Clinical governance will not happen without ownership by staff – partnership between professionals and patients must develop.
The NHS comprises a multitude of highly skilled, highly motivated hard-working and creative individuals. In the past, the inevitable unpredictability that such a rich mix of talent creates sometimes encouraged organisations to design complex rules and systems, to build in check upon check – to control and command in order to safeguard. However, it is now recognised that ‘the key resource for the NHS is the staff’ and clinical governance offers an opportunity to bring together and value the talents and experience of those at the ‘sharp end’ of healthcare delivery.
It invites clinicians to ask ‘Where do we want to go?’ and ‘How are we going to get there?’ A multidisciplinary approach needs to be encouraged from the outset to ensure that every profession contributes to the implementation of clinical governance in the same way that Trust multidisciplinary teams have been established to elaborate, collate and develop initiatives. The successful implementation of clinical governance relies on team work, whether within professions, cross-boundary and/or cross-organisational.
Clinical governance was founded on the NHS Act 1999 that established, among other things, a new duty of quality, a new duty of partnership and a new framework for professional recognition. The duty of quality states: ‘it is the only duty of each PCT and NHS Trust to put and keep in place arrangements for the purposes of monitoring and improving the quality of healthcare which it provides to individuals’. The duty of partnership is placed on Health Authorities, Strategic Health Authorities, Primary Care Trusts and NHS Trusts to cooperate with one another as necessary for the full implementation of clinical governance.
The third strand of professional regulation is beyond the remit of this chapter, but it could be said that one of the elements of clinical governance is that clinicians employed in whatever sphere to provide health and social care must be expected to have attained a basic level of competencies in order to be able to take forward the wider issues of sound evidence-based practice.
Clinical governance comprises:
In short, clinical governance is about making sure that all patients/clients receive high-quality healthcare. It does this by monitoring clinical quality, encouraging evidence-based practice, safeguarding high standards, encouraging clinical excellence and sharing good practice. The government’s aim in 1997 and now is to tackle national differences in quality of care and help to reassure people after the adverse publicity surrounding poor clinical performance.
The elements, in short, relate to all aspects of care:
It was apparent from the inception of clinical governance as an entity that, henceforth, all health professionals were going to have to demonstrate transparently their clinical effectiveness.
Clinical governance also covers contractual arrangements made by the NHS with independent contractors, such as dental practitioners, opticians and pharmacists. In order for all parts of the NHS to act in a cohesive fashion, strategies have to be developed to link all organisational elements and establish a ‘no-blame’ culture that fosters ongoing learning.
It is true to say that there are variations in different parts of the country as to the quality of care available. In podiatry we would go further and say that there are unacceptable variations in the availability of care across the country.
All local services plan the care they intend to provide, in liaison with the Strategic Health Authority and upwards. There are imperatives to meet, such as national targets. However, the concept of quality planning is that attention must be paid to the quality of the services at the same time as the level and type. That is, whenever it is determined during planning that a particular service will be offered, that service needs to be analysed in order to identify the deficiencies and detail the remedial action to be taken to rectify them. The skills, knowledge and experience of staff are to be used in order to assess the service’s strengths and weaknesses and to plan accordingly.
Invariably, resource implications for any improvement measures must be identified, and it may not always be possible to carry out all the remedial actions in one move. The concept of looking at the planning process as a whole and as a rolling programme of improvements will allow informed and rational decisions to be made – and then publicised – about what is and what is not possible in any given time-frame.
The initial example of ‘jump starting’ the process of quality planning was the Health Improvement Programmes (HIMPs), which now form an integral part of each Local Delivery Plan (LDP), and these draw together all aspects of health and social care planning for the purposes of decision-making.
This covers all aspects of staffing for a modern day NHS. It therefore comprises the elements shown in Table 28.1.
Table 28.1 Staffing in the modern NHS
| Needs analysis | Lifelong learning |
| Commissioning and funding | CPD of professional education |
| Recruitment | Skills mix |
| Retention | Extended-scope practitioners Human resources + pay + conditions |
For some time Strategic Health Authorities devolved the responsibility for all those areas to the Workforce Development Confederations, who were set the task of drawing information together for the purposes of fulfilling the requirements of the NHS Plan. Now there are workforce leads within each Strategic Health Authority, pulling the planning of the future workforce back towards the hub of commissioning decision-making.
The theme of clinical governance, which lays great importance on the reflective practitioner, continued learning, retention of and development of skills, remains the underpinning ethos. The importance is stated again in the human resources strategy ‘Working Together: Securing a Quality Workforce for the NHS’ (Department of Health 1998).
However, there now also looms the stated aim of ensuring that, by 2012, the majority of the workforce is at Band 4 (the level below registration in the UK) or below, and utilising the Knowledge and Skills Framework to achieve this. There are still ongoing opportunities for further training and support mechanisms to underpin these elements, such as library facilities, internet access and dedicated time for CPD, but there is also an increasing emphasis on ‘step-on/step-off’ mechanisms for developing lesser trained staff to undertake specified tightly defined roles.
The new professional regulatory systems also place great store by the need for clinicians to act within their assessed or learned competencies. This places the onus on each registrant to ensure that they are themselves comfortable with their ability to perform the interventions they undertake and only refer to those health professionals who are appropriately qualified. The outcome of the debates about revalidation and CPD evidencing will inform the future.
Such emphasis on continued learning and reflection is an opportunity that healthcare professionals have rarely been offered. At its best, it can mean dedicated time set aside during a working day for continued education. For private practitioners this is not necessarily as easy, but the underlying ethos of clinical governance and of regulation is quite clear. Clinicians are expected to maintain their clinical and theoretical knowledge, learn from failures, implement improvements and evaluate their interventions. However, further work is required across the country for this to become reality and to deliver the intended benefits to patients.
It goes without saying that any organisation requires robust, accurate and useful information to underpin its planning activity. Such information also draws comparisons to be made about the standards of services locally and nationally, and such comparisons form the basis of ‘league tables’. Organisations now expect to be judged against published benchmarks, and public accountability is achieved by the publication of such information and the conclusions drawn. The results and trends can then be fed back into the planning process.
All NHS organisations are required to have in place local strategies for Information, Management and Technology, and the NHS Performance Assessment framework, with its associated set of high-level performance indicators, will be used to make comparisons within organisations. The increasing emphasis on an ‘outcomes-led’ commissioning strategy will be hampered by any delay in the introduction of the national IT systems.
In order for clinicians to have access to sound evidence upon which all interventions should depend, there is a need for robust, ongoing research. The government’s initiatives now encourage all healthcare professionals to become actively engaged in research and audit and to develop the skills necessary for those activities. Such research is to be shared with front-line clinicians in order to support and improve high-quality clinical decision-making.
The guidelines state that: ‘there needs to be a systematic approach to the collection and dissemination of evidence, within an organisation, to ensure clinicians are able to access the most up-to-date information derived from research’. To this end Trusts are encouraged to disseminate articles via bulletins and newsletters as part of their clinical governance infrastructure and to provide simple access to such national resources as the Cochrane Library, the National Research Register (which gives information about research underway in the NHS) and the NHS Centre for Review and Dissemination (CRD), which commissions and supports clinicians to undertake reviews on areas of importance to the NHS.
At the same time, of course, NICE produces and disseminates high-quality evidence-based guidance ‘to support front-line staff, indicating guidelines for the management of diseases and the information on new and existing interventions’. The timescales for the production of such advice have been criticised, and NICE is now promising to reduce the time taken for decisions to be reached and disseminated.
The National Electronic Library for health has also developed swiftly in order to produce systematic reviews of primary and secondary research evidence. All NHS organisations are expected to monitor staff, usually through the appraisal system, to ensure that they are gaining access to the knowledge and evidence they need to improve the quality of their work, thus looking to an improvement in the quality of patient care. Research and audit will necessarily produce short-term restraints on already overstretched services, in pursuit of this long-term objective and the production of each new target and system reduces the time available even further.
The government has acknowledged repeatedly that the percentage of poor performance in the NHS as a whole is very small. However, the adverse publicity and harm that even one isolated instance of it can cause in terms of human suffering and resources are such that specific mention is made of poor performance as an area to be monitored, reported and managed.
The systems of professional self-regulation were altered in the 1999 guidelines as ‘being hitherto unsuccessful in preventing, recognising and dealing effectively with the problem of poor clinical performance’.
Reference is made to the proposed changes to be made to the regulatory systems for the professions, and nowadays it is easy to see how those now established systems dovetail with and overlap the requirements, ethos and wording of clinical governance. Of paramount importance throughout is public protection, leading to an upturn in public confidence. Regulatory processes are changing again in response to challenge about the rectitude and probity of one organisation protecting the public by carrying out the role of investigator and prosecutor of the same case, whilst also selecting, training and employing the individuals who make such decisions. An independent adjudicating body has now been established to delineate more clearly between the functions.
This is the concept of drawing together all the information pertaining to complaints, adverse incidents and service failures and examining trends, in order to identify remedial measures, thereby minimising the risk of recurrence. There is an expectation that not only will organisations learn from information about such incidents and act before similar things happen in their locality, but that they will also share good practice and adapt appropriate elements for themselves, thereby obviating the need for costly, time-consuming exercises. Out of this concept has developed the practice of peer review and validation or accreditation of whole services or parts of them, either by external agencies such as user groups or by professional bodies.
In 1999 an NHS website was set up, with a ‘learning zone’ to allow clinicians to share areas of good practice with others. This zone contains an NHS Trust benchmarking database to allow comparison of cost and outcomes by NHS Trusts.
Beacon services were selected, in recognition of good and innovative practice in six areas, such as waiting lists and times and services were encouraged to bid for the increased funding, offered by the Department of Health to help them disseminate their good practices to other NHS organisations.
The subsequent development of Performance Accelerator systems and Root Cause Analysis models has built on this highly important and sensitive work.
This is divided up into clinical and organisational. Clinical risks are defined as those risks that have a cause or effect that is primarily clinical or medical.
At the same time, controls assurance, or organisational risk management (i.e. sound financial systems and the management of non-financial and non-clinical risks) was drawn together with the clinical risk management systems to provide a cohesive approach to quality management. The division of the two is not easy because issues from either side impinge on each other.
Throughout the world there are many variations on the theme of consent, and the wise practitioner will seek clarification of the meaning attributed to the words in the legal framework that operates where they practise. The broad general principle that applies universally is that valid consent must be obtained before starting treatment or physical examination of a patient, based on the right of the patient to determine what happens to their own body.
Consent should be viewed as a process and not a ‘once and for all’ happening. It is good practice to start the process well in advance of the procedure so that there is time to respond to the patient’s concerns as well as allowing the patient to give due consideration to the information about what is proposed to be done.
To give informed consent the patient must be supplied with adequate information about the nature of the procedure and the likely good and bad outcomes. So far as the latter is concerned these need to be identified clearly and the amount of risk stated unequivocally. Consent should be given freely by the patient (i.e. without any pressure to have the procedure) and on the basis of full information. The format for recording consent is also unclear, and it is generally accepted that written consent provides the best basis for the record. However, consent is only valid if the person giving the consent is in possession of all the facts and is competent to sign.
In addition, if there is to be a photographic record made of the procedure, for whatever purpose, then this must also form part of the consent process and the patient must be informed of the purpose of the photographs. This may be needed as part of a research programme and the patient should be clearly advised of the scope of the programme. These photographs should not be used for any other purpose without the express permission of the patient. The patient should also be made aware that if they refuse to be photographed this will not compromise their care.
The legal position of those aged under 18 years is complicated. The law states that those aged 16–17 years are entitled to consent to their medical treatment. This, too, should be given on the basis of full information and without pressure to accept. The major difference from adults is that a person aged 16 or 17 years who refuses to give consent could be overridden by a person with parental responsibility or by a court. The Gillick (1986) judgement made the position of children under the age of 16 years less clear, but the wise practitioner will always seek to have informed consent from the child and the parent or legal guardian before proceeding.
The law on consent is complex, and practitioners should ensure that they clearly understand the law as it applies to them. In England the Department of Health provides useful documentation.
Department of Health. www.doh.gov.uk/consent.
Department of Health. A first class service – quality in the new NHS. London: Department of Health; 1998.
Department of Health. Guidance. Working together: securing a quality workforce for the NHS. London: Her Majesty’s Stationary Office (HMSO); 1998.
Department of Health. Clinical governance in the new NHS. Health Services Circular 1999/065. Available at http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004883, 1999. (19 September 2009)
Gillick v West Norfolk and Wisbech AHA 1986 AC 112.
Secretary of State for Health. The New NHS – Modern and Dependable. London: HMSO; 1997.
NHS Wales. Putting patients first. Available at http://www.wales.nhs.uk/publications/whitepaper98_e.pdf, 1998. (19 September 2009)