CLINICAL GOVERNANCE

Clinical governance is a systematic approach to maintaining and improving the quality of patient
care within a health system (NHS). Clinical governance became important in health care after the
Bristol heart scandal in 1995, during which an anaesthetist, Dr Stephen Bolsin, exposed the high
mortality rate for paediatric cardiac surgery at the Bristol Royal Infirmary. It was originally
elaborated within the United Kingdom National Health Service (NHS), and its most widely cited
formal definition describes it as:

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." (Scally and Donaldson 1998, p.61)

This definition is intended to embody three key attributes: recognisably high standards of care,
transparent responsibility and accountability for those standards, and a constant dynamic of
improvement.

The concept has some parallels with the more widely known corporate governance, in that it
addresses those structures, systems and processes that assure the quality, accountability and
proper management of an organisation's operation and delivery of service. However clinical
governance applies only to health and social care organisations, and only those aspects of such
organisations that relate to the delivery of care to patients and their carers; it is not concerned with
the other business processes of the organisation except insofar as they affect the delivery of care.
The concept of "integrated governance" has emerged to refer jointly to the corporate governance
and clinical governance duties of healthcare organisations.

Prior to 1999, the principal statutory responsibilities of UK NHS Trust Boards were to ensure proper
financial management of the organisation and an acceptable level of patient safety. Trust Boards
had no statutory duty to ensure a particular level of quality. Maintaining and improving the quality
of care was understood to be the responsibility of the relevant clinical professions. In 1999, Trust
Boards assumed a legal responsibility for quality of care that is equal in measure to their other
statutory duties. Clinical governance is the mechanism by which that responsibility is discharged.
"Clinical governance" does not mandate any particular structure, system or process for maintaining
and improving the quality of care, except that designated responsibility for clinical governance must
exist at Trust Board level, and that each Trust must prepare an Annual Review of Clinical Governance
to report on quality of care and its maintenance. Beyond that, the Trust and its various clinical
departments are obliged to interpret the principle of clinical governance into locally appropriate
structures, processes, roles and responsibilities.

1. Elements of clinical governance

Clinical governance is an aggregation of service improvement processes that are regulated by a
single ideology.
Clinical governance is composed of at least the following elements:
 Education and Training
 Clinical audit
 Clinical effectiveness
 Research and development
 Openness
 Risk management
 Information Management

2. Education and training

It is no longer considered acceptable for any clinician to abstain from continuing education after
qualification - too much of what is learned during training becomes quickly outdated. In NHS Trusts,
the continuing professional development (CPD) of clinicians has been the responsibility of the Trust
and it has also been the professional duty of clinicians to remain up-to-date.

3. Clinical audit
Clinical audit is the review of clinical performance, the refining of clinical practice as a result and the
measurement of performance against agreed standards - a cyclical process of improving the quality
of clinical care. In one form or another, audit has been part of good clinical practice for generations.
Whilst audit has been a requirement of NHS Trust employees, in primary care clinical audit has only
been encouraged, where audit time has had to compete with other priorities.
 4. Clinical effectiveness
Clinical effectiveness is a measure of the extent to which a particular intervention works. The
measure on its own is useful, but decisions are enhanced by considering additional factors, such as
whether the intervention is appropriate and whether it represents value for money. In the modern
health service, clinical practice needs to be refined in the light of emerging evidence of effectiveness
but also has to consider aspects of efficiency and safety from the perspective of the individual
patient and carers in the wider community.

5. Research and development

Good professional practice has always sought to change in the light of evidence from research. The
time lag for introducing such change can be very long and reducing time lag and associated
morbidity requires emphasis not only on carrying out research, but also on using and implementing
such research. Techniques such as critical appraisal of the literature, project management and the
development of guidelines, protocols and implementation strategies are all tools for promoting the
implementation of research practice.

6. Openness
Poor performance and poor practice can too often thrive behind closed doors. Processes which are
open to public scrutiny, while respecting individual patient and practitioner confidentiality, and
which can be justified openly, are an essential part of quality assurance. Open proceedings and
discussion about clinical governance issues should be a feature of the framework.
Any organisation providing high quality care has to show that it is meeting the needs of the
population it serves. Health needs assessment and understanding the problems and aspirations of
the community requires the cooperation between NHS organisations, public health departments,
local authorities and community health councils.
The system of clinical governance brings together all the elements which seek to promote quality of
care.

7. Risk management
Risk management involves consideration of the following components:
Risks to patients: compliance with statutory regulations can help to minimise risks to patients. In
addition, patient risks can be minimised by ensuring that systems are regularly reviewed and
questioned - for example, by critical event audit and learning from complaints. Medical ethical
standards are also a key factor in maintaining patient and public safety and well-being.

Risks to practitioners: ensuring that clinicians are immunised against infectious diseases, work in a
safe environment and are helped to keep up-to-date are important parts of quality assurance.

Risks to the organisation: poor quality is a threat to any organisation. In addition to reducing risks
to patients and practitioners, organisations need to reduce their own risks by ensuring high quality
employment practice (including locum procedures and reviews of individual and team
performance), a safe environment (including estates and privacy), and well designed policies on
public involvement.

Balancing these risk components may be an ideal that is difficult to achieve in practice. Recent
research by Fischer and colleagues at the University of Oxford finds that tensions between 'first
order' risks (based on clinical care) and 'second order' risks (based on organisational reputation) can
produce unintended contradictions, conflict, and may even precipitate organisational crisis.

8. Information management
Information management in health: Patient records (demographic, Socioeconomic, Clinical
information) proper collection, management and use of information within healthcare systems “will
determine the system’s effectiveness in detecting health problems, defining priorities, identifying
innovative solutions and allocating resources to improve health outcomes.

9. Applying clinical governance in the field

If clinical governance is to truly function effectively as a systematic approach to maintaining and
improving the quality of patient care within a health system, it requires advocates. It also requires
systems and people to be in place to promote and develop it.
The system has found supporters outside of the UK. The not-for-profit UK hospital accreditation
group the Trent Accreditation Scheme base their system upon NHS clinical governance, and apply it
to hospitals in Hong Kong and Malta.