Putting the jigsaw together…
Clinical Governance Work Book
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A Guide to Clinical Governance.
Introduction.
A guide to Clinical Governance has been produced by the Clinical Governance Support Team
(CGST) and key members of the Community Health Partnership. Do not be misled by the words
‘Clinical’. All those who work for the Board, directly or indirectly contribute to the care of
patients. The important thing to bear in mind as you read this guide is to think about the
principles discussed. ‘Quality’ and accountability apply to us all.
This guide is designed to give you an introduction into the ‘basics’ of clinical governance. It
complements the workshop ‘Putting the Jigsaw together’ which is delivered by the CGST,
although it can be used in smaller groups or just picked up and read in a spare moment. It has
been written for all staff, at all grades, in all departments in primary and secondary care.
When you read through the guide look out for the pause for thought questions
Here you
are asked to consider a number of questions and jot down your answers. Answer the questions
honestly and if you are unsure of the answers then no problem. After each pause for thought
section there is a comment
which discusses possible answers. Clinical Governance can be very
subjective and you may have your own firm views and disagree with the comments. You can also
discuss your thoughts with your colleagues or contact the Clinical Governance Support Team or
any member of the Clinical Governance Coordinating Group (CGCG) who will be more than happy to
discuss (debate) answers and comments.
This guide and the workshop both have a central objective, which is to as far as possible
‘demystify’ and make clearer the concept of clinical governance as it applies to us all. It is
appreciated that the knowledge of clinical governance will vary greatly throughout the
organisation and it is hoped this guide will work on two levels;
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If you are new to clinical governance or it is a concept you know little about we hope to
provide enough information to give you a clearer understanding of the concept and what it
means to you.
If you have a good working knowledge of governance then this guide may act as a refresher
for you as well as giving you the opportunity to review your opinions of the concept and
working of governance.
The guide is set out under the following broad headings:
 What is clinical governance?
 What are the parts that make up the whole?
 What are the Internal and External Responsibities for ensuring Clinical Governance?

Where do I go from here? What part do I play in the process?
Why are you reading / working through this guide?
This may seem an odd question, after all, there is no right answer and there are many
valid responses. Please hold in the back of your mind why you are here as it is
something we will return to at the end of this guide.
The Origins of Clinical Governance
In the United Kingdom as a whole the concept of clinical governance was first publicised in the
document ‘The New NHS: Modern, Dependable’ (Department of Health, 1997) This document
set out the new Labour governments 10 year plan for the Health service. This was against a
background of the effects (positive or negative depending on your political colour) of 18 years of
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Conservative rule, which saw the introduction of Hospital Trusts and internal markets within the
Health Service.
In Scotland the Scottish Office Department of Health indicated its intention to pursue the
Clinical Governance agenda in 1998 with the publication of MEL (1998) 75, this document
complemented the white paper ‘Designed to Care’ and highlighted the legal requirement for all
Trusts and Boards in Scotland to have in place systems of Clinical Governance as well as guidance
in how to set in place such a framework. This framework was required to be in place by April of
1999 which is effectively the ‘birthday’ of clinical governance. The Scottish Executive Health
Department followed this with the publication of MEL (2000) 29 and HDL (2001) 74 which
provided further guidance on implementing the clinical governance framework and reinforced the
Executives commitment to the principles of this framework. ‘Partnership to Care’ (SEHD
2003) is the latest white paper to map the direction of the NHS in Scotland and draws many of
the elements of clinical governance together.
What is Clinical Governance?
How would you define clinical governance?
There are a number of textbook definitions:
‘…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…’
(A First Class Service – Quality in the new NHS, 1998)
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"…Clinical governance is the vital ingredient which will enable us to achieve a Health Service
in which the quality of health care is paramount. The best definition that I have seen of
clinical
governance
is
simply
that
it
means
"corporate
accountability
for
clinical
performance". Clinical governance will not replace professional self-regulation and individual
clinical judgement, concepts that lie at the heart of health care in this country, but it will
add an extra dimension that will provide the public with guarantees about standards of
clinical care… “ (Sam Gilbraith 1998.)
These quotes and the many others that attempt to define clinical governance are often
‘wordy’ and come across to staff as political sound bites. As a result, the real definition
of clinical governance can be lost in rhetoric. Clinical Governance can also be seen solely
in the terms of a legal requirement or political dictate. Perhaps a simple but not
glamorous definition of clinical governance is:
The adoption of principles that lead to high quality care for patients by a workforce
who are motivated to do this. Some of the principles that define clinical governance may
be summarised as:
 Ensuring that quality is placed at the heart of the health care we provide.
 Ensure that we achieve the highest standards of care possible.
 Ensure we prevent mistakes and not be afraid to learn from those we do make.
 Help secure public confidence in our services.
 Meet our responsibilities as laid down by the Scottish Executive and UK
Government.
It is also useful to mention that Clinical governance sits alongside Corporate Governance and
Staff Governance in an approach to healthcare delivery that is summed up as total quality
management. We do not discuss these two strands in this guide but any member of the CGST
would be happy to further advise you.
What are the component parts of Clinical Governance?
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Figure 1:The Building Blocks of Clinical Governance.
(Adapted from Clinical Governance Model, National Clinical Governance Support Team)
Research & Development
Continuing Professional Development
Professional Self-Regulation
Interface between primary /secondary
care
Patient focus
Risk Management
Clinical Effectiveness
HIGH QUALITY CARE
Safety / No Blame / Open and Fair Culture
Communication
Leadership
Patient Involvement
High Quality Data
Ownership
This diagram provides a model for what are generally accepted to be the ‘components’ or
‘elements’ of clinical governance. The model is based around the premise that it is the
responsibility of all those employed in healthcare to provide high quality care and to achieve this
goal certain things must be done and principles adhered to. There are of course variations of this
model but the principles contained within are central to them all.
The next few pages provide some explanations on the terms used in figure 1.
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The foundations of Clinical Governance
 Communication: For a number of reasons very important. Good communication throughout
any organisation is vital and it starts in wards and departments amongst staff, between
staff and Ward Sisters / Departmental Heads. Then it permeates through the
organisational structure via middle management through to senior management ultimately
to the Chief Executive and Board. Communication not only covers the obvious factors such
as talking to one another but also producing systems by which information can flow
throughout the organisation effectively which may include electronic or paper processes.
 Leadership: Organisations require dynamic leaders to move forward. Whilst leadership is
required at the highest level it also essential in wards and departments. Sisters and
departmental heads must not be afraid to push forward changes and when appropriate
challenge practices and procedures that could be improved. Clinical leadership has been
heavily invested in over the past few years.
 Patient and Public Involvement: It may seem self evident to say, but it is the patient who
lives with their disease or disability. Only they know how they feel and how ‘well’ the
treatment or therapy they receive makes them feel. It makes sense therefore to involve
patients in the treatment and planning of their care at all stages from admission through
to discharge. The experience that patients and their relatives and carers have can also be
utilised by the Board and external organisations in the planning of services and setting of
standards. Public involvement is about involving people in service planning on the wider
scale.
 High Quality Data: In order to assess progress against local and national standards and to
participate in national surveys the Board requires accurate data to measure its progress.
This data will also be required by external agencies to gauge the boards progress in
meeting national standards and targets. Without high quality, data on the outcomes of
procedures and effectiveness of treatments progress cannot be measured nor easily made.
Data can also be used to provide an empirical measure of progress in clinical governance.
Simply put if the boards clinical outcomes/ performance indicators are good then progress
and adherence to the principles of clinical governance can said to be good.
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 Ownership: If clinical governance is to be more than a paper exercise, then all staff, at all
levels throughout the organisation need to take ownership of the concept and commit to
make it work.
 Safety Culture: Also Known As a ‘blame free culture’ or ‘learning environment’ or ‘fair
and open culture’. Traditionally the NHS has been quick to place blame for incidents.
Sometimes, especially where individuals have been professionally or criminally negligent
they must be held to account. Often however it may be the case that incidents or near
misses occur whereby it is difficult or wrong to attribute blame. The incident may have
been the result of the combination of factors such as information systems being at fault,
communications between staff being poor or the wrong guidance being in place to start
with. The individual who is directly involved in the incident therefore may be at the end of
a long chain of contributory factors. To prevent the same problems occurring again it is
important to talk about the incident, considering all the issues involved and to learn from
them. To do this staff must not be afraid to come forward for fear of being punished.
Staff must be encouraged to learn from mistakes that have been made and to move
forward. This is what we might consider a safety culture.
What elements do you consider the most important in the foundations of clinical
governance?
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Such a question may have many answers and all may have equal validity. This is a very
subjective area. Perhaps the development of a safety culture is very important. If
staff do not feel that they can discuss issues or learn from mistakes without exacting
some form of punishment from the “management” then progress is difficult. Ownership
is also an important concept. Often it is easy when you are busy with your ‘day job’ to
think clinical governance is the responsibility of someone else. Effectively this is not the
case, it is the responsibility of us all, after all we are all ultimately accountable for the
quality of care we give.
Perhaps the most difficult of the pillars to make-work in practice is patient and public
involvement. There is no doubting that patients should be involved in their care and on a
wider scale the planning of services. However, in practice this can be difficult. Not all
patients and their carers want to be involved in what goes on. The opinion of some
health care practitioners places them, as ‘experts’ at the centre of the care giving
process and it can be difficult for them to move past this view. Old habits and cultures
can take time to change. It would seem the trick with patient involvement is to strike a
balance between too much and too little.
Ultimately it could be argued that all areas have equal importance as weakness in one
may prevent effective delivery of the clinical governance agenda.
The ‘Pillars’ of Clinical Governance.
 Clinical Effectiveness is about making sure the right people get the right care at the right
place in an effective way. Effectiveness is about a number of component items. Do we have
the guidelines and standards in place to ensure that care is current and effective? Are
these guidelines valid? (Are they based on the latest practice and research and do they
work in the Shetland Context?) Do we audit our practice to ensure that it is delivered in
line with the standards and guidelines we use.? What are the outcomes of our treatments?
Do they make the patient well? If not why not? What actions do we then take to remedy
shortfalls?
 Risk Management. Normally considered in terms of clinical and non-clinical risk. This pillar
of clinical governance involves giving consideration on a clinical level to the benefits a
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potential treatment / procedure/ intervention might have for a patient measured against
its actual and or potential harmful effects. This is of benefit to the patient and the
practitioner. Non-clinical risk can cover many areas relating to hazards in the environment
we work in and potential harm that might come to staff or patients. It is important the
Board is aware of risks, develops a register of these risks and the actions and
interventions that are employed to remove or reduce as much as practical the adverse
effects the risk might present. Risk Management is a complex and evolving discipline.
 Patient Focus. One of the elements to the foundation of clinical governance is patient
focus. Patient focus can involve many sub elements such as providing easily accessible
patient information through to ensuring high quality nutrition. Patient focus is rapidly
moving to the centre of clinical governance.
 Interface between primary and secondary care. Traditionally care is delivered by acute
hospitals (Secondary care) and by health care practitioners in the community (Primary
care) Even if both areas are well developed in applying the principles of clinical governance
if the practitioners based within them do not work effectively together the quality of care
can be affected. Whilst these areas should remain distinct there needs to be good systems
of communication and team working between staff and practitioners in both areas to
prevent the quality of care being affected.
 Professional Self-Regulation. Clinical governance is not about taking away choice or
judgement from practitioners. Professionals such as Doctors, Nurses, Physiotherapists,
Occupational Therapists etc regularly have to make judgments in relation to the care they
give. Professionals are regulated by codes of conduct which provide a framework for
practice and accountability which governs practice. The concept and principles of clinical
governance support and reinforce the principle of self-regulation.
 Continuing Professional Development (CPD). Practitioners must be able to deliver
effective care. To do this they must ensure that they have the practical skills and
knowledge to do this. CPD or lifelong learning as it sometimes known is about ensuring that
skills are attained and knowledge acquired. CPD may require attendance at certain
mandatory courses which the Board is legally required to provide balanced against
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development that is required by the individual for career development. This may take the
form of short courses or degree / diplomas.

Research and Development. (R&D) Treatments and care provided by the Board must be
current and effective. R&D is about ensuring that the boundaries of care are continually
pushed forward searching for more effective and safer ways to do things.
Which of the pillars of clinical governance do you consider most important and
why?
Comment: It is difficult to single out any one pillar as more important than others.
Some such as Clinical Effectiveness and professional self-regulation are terms familiar
with most health care practitioners and have existed in one form or another for many
years.
Risk management is playing a more prominent role in both its clinical and non-clinical
guises and the development of the Clinical Negligence and Other Risks Indemnity
Scheme highlights this. QIS are currently investing a good deal of time in Risk.
Patient information is an area of clinical governance that is also expanding rapidly.
Often patients have not had the information available to them to make informed choices
and consent therefore may not have been totally informed for procedure, operations
etc. Production of information can be costly and time consuming but none the less
essential.
The interface between secondary and primary care is an essential area to get right. In
Shetland this should be more achievable given the numbers of staff involved but as in
any organisation culture and tradition, as well as professional boundaries, can play a
part in preventing this being a smooth process.
So far, clinical governance has been defined and its component elements noted. How
then is clinical governance organised within the Shetland NHS Board?
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Internal and External Responsibities for Governance.
So far, the guide has briefly explored the orgins of clinical governance and presented a
framework and explanation of some component elements that go to make up clinical
governance in practice.
External Agencies Involved in Clinical Governance
There are a number of agencies involved in the clinical governance agenda. These are
summarised below. Please note these only include organisations in the NHS in
Scotland, not their English and Welsh equivalents. Details of these may be found in
the Audit Basics fact sheet, which can be found on the Clinical Governance
Department’s intranet site.
NHS Quality Improvement Scotland. Was formed by the merger of agencies in
January 2003. These are noted below:

Clinical Resource Audit Group (CRAG)

Clinical Standards Board for Scotland (CSBS),

Nursing and Midwifery Practice Development Unit (NMPDU),

Health Technology Board for Scotland (HTBS)

Scottish Health Advisory Service (SHAS)
This new agency has a number of responsibities and these centre around setting national
standards in a number of clinical and non-clinical areas and then providing assessment and
ongoing review to ensure these standards are met by trusts and boards. This new agency
also issues notices and guidance that recommend best treatments/therapy for certain
clinical conditions. The new agency also has a support role and provides help and advice in
a number of areas chiefly those relating to clinical effectiveness and patient involvement
in services.
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Scottish Intercollegiate Guidelines Network. This organisation has the responsibility
for researching and producing guidelines indicating best practice in treatment of clinical
conditions, which are then disseminated for health care practitioners to consider
Willis. Willis are the organisation that administer the Clinical Negligence and other Risks
Indemnity Scheme, also known as CNORIS. This scheme assesses trusts and boards risk
management organisation and processes. There are three levels of accreditation that can
be gained and gaining accreditation benefits the organisation in a number of ways
including:

Showing other organisations and the public that the organisation has developed
sound risk management processes.

Improving clinical and staff governance within the organisation

Reducing payments for the organisations negligence / indemnity insurance.
Willis work closely with NHS Quality Improvement Scotland. It should be noted that in
2004 CNORIS standards merged with Generic Standards for Clinical Governance to form
Health Care Governance Standards.
Scottish Executive Health Department. This department, which is part of the Scottish
Executive, is responsible for setting national policies and the strategic direction of
Health Care in Scotland. The department has a number of arms such as the Information
Statistics Division which collects data from Trust and Boards in a diverse number of
areas. This information can be then used to inform both practice and policy making.
Based on what you know of these external agencies in your opinion is their
involvement in Clinical Governance and Health Care in general a good or bad thing?
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Comment:
There are of course a range of professional and personal views that you may hold
regarding this pause for thought. Professionally it is important to have externally
set standards on the services and care delivered. This allows consistent care to be
delivered to the patient. Such agencies can also provide help and guidance on a
number of issues surrounding the standards they set. Of course balanced against
this is the issue of the burden the assessment process can place on organisations
with increasing resources required to administer the review visits which it could be
argued take resources away from patient care. The arguments are complex and will
be coloured by your personal opinions of how things should be done. It is good to
have healthy debate and to question the role of external agencies but it must be
remembered that Shetland NHS Board still needs to cooperate and work with them,
an arrangement which is unlikely to change.
Internal Responsibilities for Clinical Governance.
Internal responsibities for ensuring clinical governance within Shetland NHS Board are
noted in figures 2 & 3.
Jot down the internal arrangements for clinical governance within the Shetland NHS
Board.
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Figure 2.
Responsibilities for Clinical
Governance in Shetland
NHS Board.
Individuals are responsible for:





Ensuring the provision of high
quality care
Professional accountability and
self-regulation
Commitment to CPD and
creating a learning environment
Input to appraisal process,
clinical audit and risk
management
Sharing good practice
Managers are responsible for:



Supporting individuals (e.g.
using appraisal, service
development,
supervision/direction,
leadership)
Ensuring accountability
arrangements and systems
are in place within their
services
Promoting a culture that
supports learning and
encourages reporting
The Patient
Experience
The Clinical Governance Support Team is
responsible for:






Providing support with Audit
Providing support with patient
involvement
Managing the process of producing
patient information
Organising the visits of external
agencies and coordinating work
toward meeting standards set by such
agencies
Coordination of the risk management
process
Liasing with other departments to
pull together other aspects of clinical
governance such as CPD and training
/ education issues and staff issues.
The Shetland NHS Board are
responsible for:

Facilitating an environment
in which clinical governance
can flourish.

Promoting and ensuring a
safety culture.

Ensuring adequate resources
are provided to deliver the
clinical governance agenda.

Maintaining over all
accountability for clinical
governance.
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Figure 3
Clinical Governance Structure in
Shetland NHS Board.
Shetland
NHS Board
Board
Clinical
Governance
Committee
Chief Executive
Medical Director
Senior Management Team
Clinical Governance
Co-ordinating Group
Everyone engaged in the provision of healthcare for and on behalf of Shetland NHS Board
Supported by CGST, CHP Lead Nurse, ADPS - Nursing, Nursing Development Officer, Area Clinical Forum, Area Nursing and
Midwifery Advisory Committee, Infection Control Committee, Resuscitation committee, Fire Committee, Health and Safety Committee,
Staff Partnership forum, CHP and Chief Administrative Dental Officer.
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Comment: The last two figures show firstly the responsibilities for
clinical governance within the Board and secondly the formal structure for its
delivery. Figure 2 will be similar to frameworks in other trusts and boards
throughout the country. The patient is always at the centre of what we do
and all clinical governance activity is ultimately about ensuring the patient
receives the highest possible standards of care. However, it should also be
remembered that in order for staff to be able to do this they must feel and
be supported in what they do. Staff Governance is distinct from clinical
governance but has an important effect on the ability of the organisation to
deliver clinical governance.
The formal arrangements shown in Figure 3 may well be different than might
be found in other trusts throughout the country. Staff in Shetland need to
undertake a number of tasks and roles in their everyday work that they
might not otherwise have to. Managers will have to attend a larger number of
committees where as in other organisations they may attend half the number.
Organisational tools such as directorates are more difficult to implement due
to the relatively few wards, departments and staff. Such a system offers
both benefits and drawbacks.
Consider the advantages and disadvantages of the clinical governance
structure that Shetland has.
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Comment. Shetland has a very flat management structure, which should mean
that certain aspects of the clinical governance agenda could be easily
implemented. Those that spring to mind are communication – information has
to pass through fewer people in the chain and the process should be quicker.
Team working – should be easier to achieve as fewer people work in the
Board. Patient involvement should be more easily attained due to the fewer
numbers treated. Patients should get more personalised services. Senior
mangers will be more aware of issues such as risk that can affect the
organisation.
Balanced against this of course is the fact that there are fewer people to do
things. This can add to work pressure and stress levels. Pressure can be
placed on the organisation by the demands it places on itself as well as those
placed on it by external agencies such as NHS Quality Improvement
Scotland, an organisation responsible for setting and assessing standards and
issuing guidelines for clinical care. The Board has to meet these obligations
but with fewer resources than larger trusts, which again can place pressure
on staff. Unfortunately, whatever personal views are held about the way
healthcare is administered in Scotland we are still obligated to follow the
political agenda.
What Part Do I play in Clinical Governance?
Thus far we have looking at the origins of clinical governance, defined what clinical governance
is, what elements make it up and briefly looked at how it is organised within the Shetland NHS
Board. The final and most important question relates to the role you as an individual has in
clinical governance and ultimately ensuring high quality care.
What role do you think you have in clinical governance?
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Comment: The following points might apply:
 You must remember that care should be always centred on the patient experience.
 Remember that regardless of your job, grade or seniority you must recognise your
role and responsibility in providing high quality care and sharing good practice.
 If you are a health care practitioner, you must remain responsible for the quality
of your own clinical practice. Professional self-regulation remains an essential
element in the delivery of quality patient services.
 You can improve care using quality improvement methods (e.g. Clinical Audit
patient surveys etc), identifying aspects of care that need improvement, making
plans for improvement and monitoring the outcome.
 You should not be afraid to learn from your practice. If you’ve done it well can you
do it better? If you haven’t done it quite so well what went wrong and what can
you do next time to do it better.
 You should become involved in the daily business of clinical governance. Remember
this doesn’t just mean involvement with the direct elements of what you do it
includes taking an interest and becoming involved in Risk Management and incident
reporting as well as helping use the skills you have to help develop other people in
other areas.
What role do you think the Shetland NHS Board has in providing clinical
governance?
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Comment: The following points may apply:
 Encouraging a culture of excellence, partnership and accountability
 Ensuring there are clear management arrangements for health care provided
 Promoting a culture of learning - having systems in place to deal with and
learn from incidents and complaints, and to identify and manage risks
 Ensuring that all staff are appropriately qualified and receive training and
development in line with their personal development plans
 Celebrating success as well as looking to improve
 Linking with National standards, internal and external systems of accountability
Conclusions
This guide has briefly defined clinical governance, explored its component parts, looked at how
the Shetland NHS Board is organised to deliver clinical governance and finally has looked at
what individuals and the board can practically do to achieve the principles of governance.
Comment:
It is recognised that are many factors that can prevent effective clinical governance
and that perhaps the principles that have been highlighted can seem a little idealistic
in the everyday world. At the start of the guide the question ‘why are you
here/reading this guide’ was asked. Of course there are many reasons why you might
be at a clinical governance workshop or simply reading this guide, but a good one
would be because you want to be, to learn more about clinical governance. Just as
you should want to be here to learn, you should want to adopt the principles of
clinical governance in your everyday practice. Not because you’ve been told to, not
because the Scottish Executive, Shetland NHS Board or Ward Sister says so.
Because in a caring profession delivery of high quality safe care is the right thing to
do and clinical governance is the right way to achieve this .
This version August 2005.
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Clinical Governance Work Book Feedback Sheet
1. Did you find the Work Book easy to use?
Yes
No
If “No” please describe the problems you encountered?
2. Did it meet your learning needs around clinical governance?
Yes
No
3. How would you like to see it improved?
Please add any further comments you wish to make on the reverse of this form and return
to Diane Coleman the CGST office at Montfield Hospital.
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