Clinical Governance in Britain Defined

In addition, the NHS Report in 2000 entitled "An Organisation with a Memory" ⁶ retrospectively identified the following:

• Research suggests that an estimated 850,000 (range 300,000 to 1.4 million) adverse incidents occur each year in the NHS hospital sector, resulting in a £2 billion direct cost in additional hospital days alone. Some adverse events are inevitable complications of treatment but around half are avoidable.
• The NHS paid out around £400 million in clinical litigation settlements in the financial year 1998/99 and has a potential liability of around £2.4 billion from existing and expected claims. When analysed many cases of litigation show potentially avoidable causes.
• During 1998/99 there were over 38,000 complaints about all aspects of Family Health Services and nearly 28,000 written complaints about aspects of clinical treatment in hospitals alone.
• At least 13 patients have died or been paralysed since 1985 because a drug has been wrongly administered by spinal injection.
• Over 66,000 adverse incidents involving medical devices were reported to the Medical Devices Agency in 1999, including 87 deaths and 345 serious injuries.
• Experiences from within the serious incident reporting system run by one of the NHS Executive’s Regional Offices suggest that, nationally in the UK, at least 2,500 adverse events occur each year that should be serious enough to register on such systems.
• The costs to the NHS of hospital-acquired infections have been estimated at nearly £1 billion a year and around 15% of these cases are regarded to be preventable.

The Bristol Inquiry, which investigated in 1999 the circumstances surrounding the unacceptable mortality rates of 23 paediatric cardiac surgical patients between 1992 and 1995 at the Bristol Royal Infirmary, reported how, following the 1983 Griffiths Report, a "Total Quality Management" (TQM) approach was adopted within the NHS which led to health sector management implementing TQM in the pursuit of better quality health care ⁹.

The implementation of TQM involved high levels of activity. By 1989 there were 1,478 initiatives in 116 districts. However, this strategy, which has arisen in an industrial context, failed to involve all parts of the NHS organisations and evolved along "tribal" lines, excluding medical practitioners.

The Bristol Inquiry Secretariat report ⁹ highlights a 1989 NHS report about 23 TQM schemes that "made it quite clear that these projects were not intended to address quality within professional boundaries nor to impinge on the exercise of judgement".

This left a disenfranchised medical workforce, alienated from the quality discipline, which had previously had rights of collective autonomy and self-regulation within the NHS since the 1940s ⁹.

The General Medical Council’s review ¹⁰ describes how, since the 1990s, public attitudes and expectations regarding doctors and levels of health care were changing. The report concluded that "too many doctors were seen by the public as limited in their willingness and ability to act promptly to protect patients from poor practice, to be open to risk and unjustified variations in performance and admit errors".

There was a clash of cultures and this erupted during the 1998 General Medical Council’s hearing into the deaths of young cardiac patients at the Bristol Royal Infirmary. This incident blew up on top of a number of trends concerning the medical profession, which had been building since the 1980s. These are highlighted in the 1999 Bristol Inquiry Report on Medical and Clinical Audit in the NHS and were cited as:

• growing evidence of unexplained variations in clinical practice
• variation in outcomes of health care between medical practitioners, different hospitals and regions
• a number of well publicised findings about clinical competence, eg, fallibility of medical diagnosis in child abuse
• increasingly better informed public
• changing attitudes about medicine within the profession itself, eg implementation of formal quality assurance, however involvement by doctors and other health professionals lacked coherence.

While the clinical activities of doctors and their accountability had been left out of the NHS initiatives the Bristol Inquiry is reported by the General Medical Council as having provided "the emotional fuel for change" ¹⁰.

As a result, the new Labour Government introduced policy to drive the NHS to provide a "first class service and provide patients with high quality care" ^5,11.

The government policy spelt out by the NHS Executive in "A First Class Service" placed quality and accessibility of health care at the centre of health services together with a "modern and dependable National Health Service" ^5,11. Unacceptable variations in performance and practice were described as "wasteful and unfair" and a 10-year modernisation strategy designed to overcome these was outlined.

The modernisation strategy had five clear central elements as follows.

First was the setting, delivering and monitoring of quality standards, providing a national framework for assessing performance and setting out a timeframed action plan to achieve quality and change. Secondly, the setting of clear national standards for the expected quality of health care was to be supported by evidence-based medicine and consistently implemented throughout the NHS. Third, a National Institute of Clinical Excellence (NICE) was to be established as well as a National Service Framework (NSF) to produce "care blueprints". Fourth, these blueprints were to be made available to current and prospective patients so that they were informed of the health services available to them. Fifth, the delivery of consistent quality standards nationally was to be ensured through the new system of clinical governance and life-long learning to ensure that NHS staff were competent and equipped to deliver skilled care and were professionally accountable.

Quality standards could be monitored nationally through three new mechanisms:

1. The Commission for Health Improvement (CHI), which was to be a new statutory body providing independent assessment of local service delivery quality, to review implementation of the new regime and the strength of local clinical governance programmes and to act as a "trouble shooter" in dealing with serious adverse incidents or situations.
2. A national framework for assessing NHS service-wide performance focused on six key areas: health improvement, access, effective delivery of health care, efficiency, patient and carer experience and health outcomes. These performance measures were to be benchmarked across England ensuring that like was compared to like.
3. A national survey of patient and health care user experience to provide indicators and contributors to the service quality was proposed. Such surveys were to be performed annually and reported to the NHS Executive to ensure consumer satisfaction was attained and maintained.

Clinical governance was dealt with more specifically in a separate NHS Executive circular dated 16 March 1999. The circular was sent to all Health Authorities, NHS Trusts and Services. In it, clinical governance and its implementation were spelt out within a framework which local health organisations could work toward to improve and assure quality of clinical care.

Clinical governance within the NHS was intended to create a systematic set of mechanisms to support all staff and to develop all NHS Trusts and organisations to adopt a new approach to delivery of high quality care using national principles and national standard setting, delivery and monitoring mechanisms.

Clinical governance was defined as "A framework 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". This definition and concept applied to all NHS Health Authorities, Primary Care Groups, Primary Care Trusts and NHS Trusts including Special Health Authorities. It also applied to clinical practitioners working outside these organisations. Clinical governance was underpinned by a new statutory duty of NHS Trusts and Primary Care Trusts, which required them to put in place and be accountable for arrangements and structures to monitor and improve the quality of health care and to manage the risk of adverse events.

The successful implementation plan for clinical governance was broadly spelt out, ie:

• The development of a new culture throughout the NHS, based not on blame but embracing constructive criticism and new ideas.
• A commitment to high quality care, shared by staff and managers, supported by local human and financial resources and skill development, e.g. "the right number of people, with the right skills to deliver the quality agenda".
• An ethos of multi-disciplinary teams working at all levels in the organisation on a foundation of evidence-based clinical decision-making.
• The availability of good information to identify scope for improvement (baseline assessment), to plan and monitor progress, to make comparisons between services (benchmarking), to provide information to the public (openness and accountability) and to monitor adverse outcomes (early warning systems).
• The provision of three major new initiatives in NICE, CHI and the National Electronic Library for Health to promote clinical cost effectiveness, source and access scientific knowledge and to monitor quality.

Poor performance, described in the circular as "weaknesses in quality of care" and resulting in serious repercussions, was also dealt with. The Bristol Inquiry had highlighted within the NHS the lack of professional self-regulation and doctors’ performance proposals were outlined in conjunction with similar proposals from the General Medical Council (GMC). These were that the GMC should strengthen procedures for monitoring the clinical performance of individual practitioners through revalidation. Revalidation was to occur every five years and required each individual medical practitioner to maintain certain required standards in order to stay on the medical register.

The NHS circular further highlighted learning from experience as a crucial element of a clinical governance structure and processes, based on continuous quality improvement together with the adoption of "good practice" through networking opportunities. The establishment of "beacons", where service provision has been selected as a "particularly good example" of excellence, was to occur in future. Beacons should be given additional financial support to enable them to disseminate learning about their high quality service and practice.

The roles of and relationships between Health Authorities, Primary Care Groups, Primary Care Trusts, NHS Trusts Regional Offices of the NHS Executive and the Commission for Health Improvement were outlined. Primary Care Groups/Trusts and NHS Trusts all had similar roles and responsibilities. That is to undertake the four key implementation steps: establishing leadership and accountability arrangements; making a baseline assessment; developing action plans; and reporting arrangements across all services. The reporting arrangements were to ensure joint accountability for clinical governance based on a multi-sector, multi-agency approach within a climate of open learning relationships. In addition, NHS hospitals were to ensure that all hospital doctors took part in national clinical audit.

The monitoring of clinical governance implementation and performance was to take several forms, through Regional NHS Executive Offices, the Commission for Health Improvement (CHI) and statutory regulatory bodies for health professionals.

These four steps once completed would begin the process of putting into place the framework for clinical governance. Such a framework is described by Scally in the reporting requirements of NHS Trusts and Primary Care organisations in the South West of England ¹².

That framework incorporates the following:

1. A baseline assessment of clinical quality and management of risk and development plan.
2. Development of the clinical governance arrangements across community health.
3. Information and reporting systems developed for ensuring clinical governance is in place and monitored effectively.
4. Roles and resources (time) allocated to designated lead and senior management support.
5. Risk management infrastructure, complaint and adverse event procedures including health and safety procedures. Mechanisms are established to ensure that lessons are learnt from complaints, adverse events and incidents together with reporting mechanisms to board level.
6. Human resource strategies that underpin clinical governance and workforce planning throughout the organisation.
7. Continuing professional development including information on how development programmes meet the individual health professional’s and the services’ needs.
8. Consumer involvement and strategies that incorporate their experience.
9. Clinical indicators, which are developed and monitor the performance of clinical service provision, ensuring that appropriate action is taken if necessary.
10. Information management and technology with all staff having access to information and evidence-based practice.
11. Research on effectiveness of clinical governance and its impact on the culture and creation of best practice.
12. Accreditation progress and status.
13. Links with clinical governance and the health improvement programme as well as implementation of national guidelines from NSF and NICE.