Clinical Governance A Study of Implementation A Study of Change

CLINICAL GOVERNANCE
A STUDY OF IMPLEMENTATION; A STUDY OF CHANGE
by
LINDA ANN LATHAM
A thesis submitted to
The Faculty of Commerce and Social Science
The University of Birmingham
for the degree of
DOCTOR OF PHILOSOPHY
Health Services Management Centre

University of Birmingham
Birmingham
B152TT
February 2003
University of Birmingham Research Archive
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ABSTRACT
The concept of clinical governance was first introduced to the National Health
Service in the White Paper published in 1997 (Department of Health); it has been
described as the 'linchpin' of the quality reforms and, as of April 1999, is one of the
statutory duties placed on NHS Trust Boards. Clinical governance is defined as:
'A framework through which NHS organisations are accountable for

continuously improving the quality if their services and safeguarding high
standards of care by creating an environment in which excellence in clinical
care will flourish.' (Department of Health, 1998; p33).
The research project upon which this thesis is based took place over an 18 month
period and has followed one NHS Trust as it implemented this new policy.
Implementation may be conceptualised as both a change process and an end state; to
capture this duality, two broad research questions are posed namely: what
constitutes the local clinical governance agenda (content) and how has clinical
governance been implemented (process). Given that the main purpose of these
research questions is to explore and describe, an overarching qualitative framework
has been adopted and, within this, an action research approach utilised.
To Dilys Davies......
my grandmother and a fellow traveller

ACKNOWLEDGEMENTS
I would like to thank all of the friends and colleagues who have
provided support and encouragement throughout the life-time of this
research project. I would also like to express my thanks and
appreciation to the following:
To all at the NHS Trust who took part in the research; in particular the
Clinical Governance Lead whose support of this work made the project
feasible.
To Professor Peter Spurgeon for his experienced supervision, support

and expert advice.
To my husband Tim Cairns who now knows far more about clinical
governance than he ever wanted or, as a non-clinician, will ever need -
thank you for everything.
CONTENTS
LIST OF TABLES
LIST OF APPENDICES
CHAPTER 1 1
INTRODUCTION AND OVERVIEW OF THESIS
1.1 The emergence of clinical governance 1

1.2 Case study site profile 8
1.3 Thesis overview 9
CHAPTER! 11
LITERATURE REVIEW - CLINICAL GOVERNANCE
2.1 Introduction 11
2.2 Clinical governance - an emerging concept 11
2.3 Clinical governance and related concepts 13
2.3.1 Total quality management and continuous quality
improvement 13
2.3.2 Corporate governance 15
2.3.3 Hospital governance 15
2.4 Making sense of clinical governance 17

2.5 Clinical governance - early implementation 22
2.6 Implementation insights from the policy literature 26
2.7 Chapter summary 30
CHAPTER 3 32
LITERATURE REVIEW - TOTAL QUALITY MANAGEMENT
AND CONTINUOUS QUALITY IMPROVEMENT
3.1 Introduction 32
3.2 Quality in health care 33
3.2.1 Quality in health care - a mixed picture 33
3.2.2 Quality - a complex concept 34
3.2.3 Quality and the challenge of CQI 37
3.3 Total Quality Management - the concept 38

3.3.1 TQM - a hazy and ambiguous concept 38
3.3.2 The search for core principles 40
3.3.3 In search of theoretical underpinnings 45
3.4 Implementing Total Quality Management 50

3.4.1 TQM implementation frameworks 50
3.4.2 TQM implementation - critical success factors 53
3.4.3 Barriers, pitfalls and obstacles to the implementation of
TQM 57
3.4.4 Implementation case studies 62
3.5 TQM and CQI in health care - a general overview 66

3.5.1 TQM - an ambiguous and hazy concept within health care 66
3.5.2 The challenge of TQM implementation in health care 68
3.6 Experimenting with TQM in the UK National Health Service

and the Norwegian Health Service 72
CHAPTER 4 76
LITERATURE REVIEW - CHANGE AND CHANGE MANAGEMENT
4.1 Introduction 76
4.2 Theories of change 77
4.3 Change conceptualised 79
4.3.1 Incremental and discontinuous change 79
4.3.2 Planned and emergent change 83
4.3.3 Ideal types and composites of change 83
4.4 Change management 85

4.4.1 Models and frameworks for change management 87
4.4.2 Change in eight steps 89
4.4.3 Ten keys to effective change management 89
4.4.4 A framework for transformational change 90
4.4.5 Common themes 92
4.4.6 Culture change 97
CHAPTER 5 100
RESEARCH METHODOLOGY
5.1 Introduction 100

5.2 Research design 101
5.2.1 A qualitative framework to provide a flexible approach 101
5.2.2 Qualitative designs 102
5.2.3 A conceptual framework 104
5.3 Research strategy 106

5.3.1 Case studies, surveys and experiments 106
5.3.2 The single site case study 107
5.3.3 Generalising from case studies 109
5.4 Action research 109

5.4.1 Origins and applications 109
5.4.2 Definitions and principles 111
5.4.3 The researcher role in action research 112
5.4.4 A model for action research 113
5.4.5 Collaboration and participation as key components 114
5.5 Data collection and data management 115

5.5.1 Data collection methods 115
5.5.2 Data management 118
5.6 Research in action 118

5.6.1 Phase one - gaining entry 118
5.6.2 Phase two - rapid appraisal 120
5.6.3 Feeding back to the Trust - Report One 121
5.6.4 Phase three - widening the corporate-level interview set 122
5.6.5 Phase four - Primary Care Division 123
5.6.6 Phase five - The Final Report 126
5.6.7 The action research cycle 126
5.7 Research quality 127

5.7.1 Quality criteria for qualitative inquiry 127
5.7.2 Research strategy: design and operationalisation 128
5.7.3 Sampling strategy 129
5.7.4 Generalising from case studies 129
5.7.5 Rigour in the field 130
5.7.6 Analysis and reporting 130
5.7.7 Participant feedback 131
CHAPTER 6 132
RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION
CORPORATE ACTIVITY: CONTENT
6.2 A vision and a strategy for clinical governance 132

6.2.1 The Clinical Governance Report 132
6.2.2 The Clinical Governance Development Plan 134
6.3 Structures to support a developing agenda 136

6.3.1 Clinical Governance Lead 136
6.3.2 Clinical Governance Sub-committee 138
6.3.3 Divisional structures 143
6.3.4 Clinical Governance Development Team 144
6.3.5 Risk Management Team 147
6.3.6 Training and Development Group 150
6.3.7 Libraries 152
6.3.8 Related structures 153
6.4 Systems and Processes 154

6.4.1 Dissemination and Implementation of Good Practice Guidelines
6.4.2 Clinical audit 156
6.4.3 Raising issues of concern 158
6.4.4 Incident reporting, trigger events, significant case reviews 159
6.4.5 Significant clinical incident review 160
6.4.6 User involvement 163
6.4.7 Appraisal and professional development 165
6.4.8 Communicating the clinical governance agenda 166
6.4.9 Monitoring and reporting progress 171
6.5 People 173

6.5.1 The human resource 173
6.5.2 Linking HR and clinical governance 174
6.6 Organisational culture 176

6.6.1 The need for culture change 176
6.6.2 Culture conceptualised 177
6.6.3 A culture of trust 178
CHAPTER 7 182
RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION -
CORPORATE ACTIVITY: PROCESS

7.2 Leadership and management 182
7.3 Confronting reality 184
7.4 Creating a vision of clinical governance 184
7.5 Planning for implementation 185
7.6 Creating and reallocating resources 186
7.7 From vision to operations 187
7.8 Energy for change 189
7.8.1 Education and involvement 190
7.8.2 Co-ordination 197
7.8.3 Feedback 199
7.8.4 Communication 203
7.8.5 Support 205
CHAPTER 8 210
RESULTS: CLINICAL GOVERNANCE - A DIVISIONAL VIEW

8.2 Primary Care Division - an overview 210
8.3 Clinical governance implementation in the Division: content 212
8.4 Clinical governance implementation in the Locality: content 215
8.4.1 Structures for quality improvement 216
8.4.2 Clinical supervision 217
8.4.3 Appraisal and personal development 218
8.4.4 Clinical audit 218
8.4.5 User involvement 219
8.4.6 Clinical governance - knowledge and skills 219
8.5 Clinical governance: the implementation process in the

Division and Locality 222
8.5.1 Clinical governance implementation - a late start 222

8.5.2 An action plan for the Division 222
8.5.3 Organisation development - a missing component 224
CHAPTER 9
DISCUSSION OF RESULTS 228

9.2 Factors which predict significant movement towards total 230
quality
9.2.1 Demonstrated senior management commitment and understanding 231
9.2.2 A well-developed and well-documented implementation strategy 238
9.2.3 Comprehensive baseline assessment of service quality 246
9.2.4 A structure to oversee implementation 250
9.2.5 Strong/persevering co-ordinator - board-level appointment 256
9.2.5 Early involvement of clinicians 261
9.2.6 Comprehensive training 263
9.2.7 Explicit strategy/resources for recognising and rewarding progress 268
9.2.8 Organisational changes after evaluation 269
9.3 Key messages from the experience of the Emerald NHS Trust 271
9.3.1 Learning from the past 272
9.3.2 A study of implementation-a study of change 274
9.3.3 Clarifying the'what'of implementation 275
9.3.4 Implementation frameworks to deliver the 'what' and the 'how' 276
of the change process
9.3.5 Culture matters 280
9.4 Limitations 281
9.5 Further research 284
CHAPTER 10 CONCLUSION 287
APPENDICES 291
REFERENCES 314
LIST OF TABLES
CHAPTER 1 INTRODUCTION AND OVERVIEW OF THESIS

Table 1.1 Mechanisms for delivering the national quality agenda 2
Table 1.2 A framework for quality 3
Table 1.3 Key components of clinical governance 4
Table 1.4 For key steps in clinical governance implementation 6
Table 1.5 Clinical governance conceptualised 7
CHAPTER 2 LITERATURE REVIEW - CLINICAL GOVERNANCE

Table 2.1 Five critical areas for effective governance 17
Table 2.2 Clinical governance - emerging themes 21
Table 2.3 Perceived barriers to clinical governance implementation 24
Table 2.4 Factors influencing the success of policy implementation 28
Table 2.5 Perfect implementation 29
CHAPTER 3 LITERATURE REVIEW - TOTAL QUALITY

MANAGEMENT AND CONTINUOUS QUALITY
IMPROVEMENT
Table 3.1 Dimensions of quality 35
Table 3.2 TQM conceptualised 41
Table 3.3 The TQM 'Gurus' 42
Table 3.4 TQM and core principles 43
Table 3.5 Degrees of TQM conceptualisation 49
Table 3.6 Characteristics of a TQM implementation framework 52
Table 3.7 TQM implementation - process CSFs 55
Table 3.8 TQM implementation - end state CSFs 55
Table 3.9 Organisational factors in TQM implementation 56
Table 3.10 Barriers to TQM implementation 59
Table 3.11 A whole system view of the barriers to TQM 61
Table 3.12 TQM design requirements 63
Table 3.13 Common themes from TQM case studies 65
Table 3.14 The professional paradigm and the TQM paradigm 71
Table 3.15 Factors predictive of TQM movement 73
CHAPTER 4 LITERATURE REVIEW - CHANGE AND CHANGE

MANAGEMENT
Table 4.1 A matrix of continuity and time 82
CHAPTER 6 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION

- CORPORATE ACTIVITY; CONTENT
Table 6.1 The main components of clinical governance - Trust model 133
CHAPTER 7 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION

- CORPORATE ACTIVITY; PROCESS
Table 7.1 Process architecture 190
CHAPTER 9 DISCUSSION OF RESULTS

Table 9.1 Predicting movement towards total quality 231
LIST OF APPENDICES
Appendix! Typologies of TQM implementation 291
Appendix 2 Framework for transformational change 294
Appendix 3 Eight stage process for change 295
Appendix 4 Ten keys to effective change management 296
Appendix 5 Action research - a model for practice 297
Appendix 6 Recommendations - action set 1 298
Appendix 7 Recommendations - action set 2 299
Appendix 8 A selection of interview schedules/guides 301

CHAPTER 1
INTRODUCTION AND OVERVIEW OF THESIS
'The new NHS will have quality at its heart1

(Department of Health, 1997; p!7)
1.1 THE EMERGENCE OF CLINICAL GOVERNANCE
Historically, the quality of care provided by the National Health Service (NHS) had
been regarded as an inherent component of the system and, as such, thought to be
assured by the 'ethos and skills' of the health professionals who worked within it
(Donaldson and Muir Gray, 1998). However, there has been growing disquiet over the
medical profession's claim to self-regulation and concern that this mechanism is no
longer sufficient to assure the quality of health care (Sutherland and Dawson, 1998).
This has been fuelled by changes in health policy (0vretveit, 1998) and by a steady
increase in public access to the 'coded knowledge base' of professionals (Sutherland
and Dawson, 1998). There have also been a number of high profile failures in health
service quality which have received a considerable amount of publicity. Amongst those
which have achieved a particular notoriety is paediatric cardiac surgery at Bristol Royal
Infirmary and also the cervical screening service at the Kent and Canterbury NHS
Trust. More recently, the disturbing activities of Harold Shipman have come to light; a
GP convicted of murdering hundreds of patients over years spent in general practice.
The negative impact on public confidence in the NHS of cases such as those described
has not gone unnoticed by policy makers (Donaldson, 1998). Such incidents also
highlight another cause for concern - the variations in health service quality that appear
to exist not only between health care organisations but also within the same health care
1
provider. Shortly after gaining office, the UK Labour Government identified quality
assurance, quality improvement and unexplained variations in health services as areas
which must be addressed (Department of Health, 1997; 1998). Thus, when the
ambitious programme of reform of the NHS was launched through the White Paper
The new NHS: Modern, Dependable1 (Department of Health, 1997), the Government
signalled that quality of health care would be high on the policy agenda. This was
backed by the pledge that 'the new NHS will have quality at its heart'; quality 'in its
broadest sense: doing the right things, at the right time, for the right people, and doing
them right -first time' (Department of Health, 1997; p 17).
The White Paper (ibid; p 17, 18) announced that 'new and systematic action is needed
to raise standards and ensure consistency* and that the aim of this action would be to
'drive quality into all parts of the NHS'. This document briefly introduced the
mechanisms that would deliver the quality agenda (Table 1.1).
Table 1.1: Mechanisms for delivering the national quality agenda
• National Institute of Clinical Excellence • National Patient and User Survey;

(NICE); • National Service Frameworks (NSF);
• The Commission for Health Improvement; . National Performance Framework;
• Clinical Governance;
Department of Health (1997)__________________________________
The quality framework was outlined in greater detail the following year in the
consultation document 'A First Class Service' (Department of Health, 1998) (Table
1.2). At the time, several commentators on health policy pointed to a promising degree
of consistency and coherence in approach across the key components of the quality
framework (Walshe, 1997; Thomson, 1998); in particular the introduction of

mechanisms to set standards nationally, deliver locally and monitor centrally.
Table 1.2: A framework for quality
National Institute for Clinical Excellence Clear standards

National Service Frameworks of service
Professional self-regulation Dependable

Patient/ Clinical governance local delivery
Public Involvement Lifelong learning
Commission for Health Improvement Monitored

National Performance Framework standards
National Patient and User Survey
Department of Health (1998)
Whilst strengthening the existing notions of patient/public involvement, professional
self-regulation and lifelong learning, the quality framework also introduces a mix of
new structures and initiatives. The centrepiece or rather the 'linchpin' of the quality
strategy (Department of Health, 1999) is the new system of clinical governance;
defined below 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'. (Department of Health, 1998; p 33)
Clinical governance applies to all areas of the NHS and, as part of an overall
governance framework, it is explicitly linked to the concept of corporate governance
(Department of Health, 1998). Whilst the latter approach reaffirms the importance of
maintaining financial probity within the Health Service, the former recognises the need
to increase the status of quality at the corporate level. Consequently, as of 1 April
1999, health organisations now have a statutory duty to maintain and improve standards
of heath care (Donaldson, 1999); a development that the public might have assumed
was already present in the current system even pre-reform.
Although quality is to become 'everybody's business' in the 'new' NHS (Department of
Health, 1997; 1998), clinical governance brings a greater emphasis on the corporate
responsibility for quality. Within the clinical governance framework (ibid), the chief
executive is explicitly identified as the officer accountable for quality on behalf of the
board of all NHS Trusts. In future, quality, which includes clinical quality, should be
awarded a status on the corporate agenda that is equal to finance. In the past, it has not
always been clear exactly who was responsible for this aspect of the service (Walshe,
1998a) and problems with clinical quality issues have often been regarded as the
province of the individual clinician (Walshe, 1998b).
Whilst the clinical governance concept is closely linked to that of corporate
governance, it also incorporates a number of quality-specific components (Department
of Health, 1998) (Table 1.3).
Table 1.3: Key components of clinical governance
• Clear lines of responsibility and accountability for the overall quality of clinical care;
• A comprehensive programme of quality improvement activity;
• Clear policies aimed at managing risks;
• Procedures for all professional groups to identify and remedy poor performance.
Department of Health (1998; p36)
Although the White Paper (Department of Health, 1997) provided a taster of what was
to come, it was the later consultation document (Department of Health, 1998) which
provided further detail on the nature of clinical governance; a concept which had not
previously been presented in this form as a search of Medline pre-1997 demonstrated.

NHS Trusts were now provided with a clearer idea of the sort of systems needed to
support the quality improvement activities they would be required to undertake. Many
of these activities such as risk management and clinical audit are not new to the NHS
although their effectiveness, and in particular that of clinical audit, in delivering
improvement appears in some doubt (Walshe, 1999). However, what is new is the
notion of deliberate action to integrate what are often completely unconnected vehicles
for improvement into a unified, whole-organisation approach to quality. Whilst 'A First
Class Service' (Department of Health, 1998) gave an insight into the key components of
clinical governance, there was little in this document to guide Trusts in terms of
implementation; this guidance did not appear until the following year. This gradual
unveiling suggests that policy makers were developing the detail over time - thus
clinical governance was not a fully formed concept when introduced to the NHS back
in 1997.
'Clinical governance: Quality in the new NHS' (Department of Health, 1999) provided
the first detailed guidance on the implementation of this policy. According to the
document, its intention was to be developmental and this notion seemed to translate as -
although a 'clear framework for action' would be outlined, there would be no
prescription as to the methods to be used by the organisations. In reality, the document
does present a clear action set which, in some areas, is distinctly prescriptive with
objectives explicitly stated. In other areas there is more scope for local interpretation
and objectives are rather more abstract - however, the guidance does make it clear that
all Trusts must show progress against these objectives. The actions outlined in Table
1.4 below are an attempt by the Department of Health to ensure that a number of key
elements of the clinical governance agenda (leadership, strategy, structures,
infrastructure) are addressed at an early stage in the implementation process. However,
the guidance essentially stops short of providing a blueprint that would address all of
the design elements required for effective implementation.
Table 1.4: Four key steps in clinical governance implementation
• Establish leadership, accountability and working arrangements;

• Carry out a baseline assessment of capacity and capability;
• Formulate and agree a development plan in the light of this assessment;
• Clarify reporting arrangements for clinical governance within Board and
Annual reports.
Department of Health (1999)
Taken together, the aforementioned White Paper, Consultation Document and guidance
constitute the key, centrally-generated documents that refer to clinical governance in
terms of policy/implementation in any detail. Despite the fact that The NHS Plan'
(Department of Health, 2000) outlines a 10 year strategy for investment and reform of
the NHS, constitutes a major improvement programme to address a multitude of quality
issues and outlines specific improvement methodologies such as the collaboratives, it is
rather curious that the most substantial reference to clinical governance seems to
consist of a single paragraph and this is in connection with the regulation and
development of medics. This does little to reinforce the connection between clinical
governance as a concept and the practice of Continuous Quality Improvement (CQI).
Publication of the NHS Plan (ibid) has been followed up with clear statements of
detailed targets and milestones for the achievement of specific elements, an
implementation plan, and the year 2002 saw the publication of a progress report -
essentially a centralised approach to implementation which is in sharp contrast to the
one adopted in relation to clinical governance.
6
The National Clinical Governance Support Unit was created to provide support to NHS
Trusts around the clinical governance agenda. The Support Unit has developed a
model of clinical governance consisting of 13 key components (Nicholls, Cullen,
O'Neill et al, 2000) (Table 1.5) and this has largely been disseminated through
presentations, training courses and journal publications. The Commission for Health
Improvement (CHI) which undertakes clinical governance reviews of all NHS Trusts,
publishes, on its web site, details of the pre-information currently sought from Trusts
which should give organisations an idea of how this national body conceptualises
clinical governance. In addition, CHI is also developing a model for clinical
governance; however, from the details on the web site (CHI: www.chi.nhs.uk), it seems
that this is still being refined (Table 1.5).
Table 1.5: Clinical governance conceptualised
Clinical Governance Support Unit Commission for Health Improvement

1. Patient-professional partnership 1. Strategic Capacity
2. Clinical effectiveness • Patient focus
3. Risk management effectiveness • Leadership
4. Patient experience • Direction and Planning
5. Communication effectiveness
6. Resource effectiveness 2. Resources and processes
7. Strategic effectiveness • Processes for quality improvement
8. Learning effectiveness • Staff focus
9. Systems awareness
10. Teamwork 3. Results
11. Communication • Patient experience
12. Ownership • Outcomes
13. Leadership
4. Use of information
CHI web site (www.chlnhs.uk) accessed
Nicholls, Cullen, O'Neill et al (2000) 30 Oct 02
Whilst there is clearly some overlap between the two models from the information
presented here (Table 1.5), there is insufficient detail on the CHI web site of the sub-
components of the four main areas to make any meaningful comparisons between them.
In reality, there is no single, agreed model of clinical governance to guide Trusts in

their efforts to implement this complex, far-reaching policy. Commenting on this two
years after the concept of clinical governance was introduced to the NHS, Lugon and
Seeker-Walker (1999, pi6) note that:
'Clinical governance is such a new concept that there is no 'right' way to

manage it and each Trust will adapt to fit its own circumstances and a
national consensus will be arrived at by trial and error over a period of
time'.
The observation above might well turn out to be an accurate description of the
development of clinical governance over time; however, those Trusts preparing for a
visit from CHI might appreciate more explicit guidance from the centre given that the
extent of each Trust's 'trial and error' will be published on the Department of Health
web site for all with an interest in these matters to see. It seems that, in the early days,
there was a lack of clarity in the field about just what clinical governance meant as a
concept never mind what it would look like in practice (Walshe, 1998b; Grainger,
Hopkinson, Barrett et al, 2002). This obviously adds to the challenge faced by NHS
Trusts; that of turning policy into practice.
1.2 CASE STUDY SITE PROFILE
This thesis presents a detailed description of one NHS Trust as it implements clinical
governance. The Trust will be referred to throughout as the Emerald NHS Trust or the
Emerald Trust although this is not its real name. Since achieving Trust status in the
early 1990s, the Emerald NHS Trust has grown and expanded due to a combination of
service reconfigurations and mergers. As a result, the Trust provides a complex array
of community, mental health and learning disability services from a large number of
dispersed sites over a wide geographical area. The Trust employs around 3,000 staff
8
and the turnover for year 2000/01 was £64 million.
The Chief Executive, the Trust Chair, the Executive Team and two of the Non-
executive Directors have been in post since the Trust was formed; the membership of
the other Non-executives has changed intermittently. The forum for senior
management is the Management Team (MT); membership of which includes the Chief
Executive, the Clinical Governance Lead, the Finance Director, six Divisional
Managers (two of whom are also Executive Directors), the Head of Human Resources,
the Information and Technology Manager, and the Estates Manager. A number of
Management Team members have been in post since the Trust formed originally and
although others have joined more recently, tenure has, for the most part, been stable and
consistent for several years; thus, senior people at the corporate level are well used to
working with each other.
During the research period, consultation took place on the development of a county-
wide Primary Care Trust (PCT). The outcome of this consultation was that the Emerald
Trust was later dissolved and its services transferred to the PCT as of April 2002. Thus
it is against a backdrop of significant structural change that the Trust was and is taking
forward the clinical governance agenda albeit that the organisation, as described in this
case study, no longer exists.
1.3 THESIS OVERVIEW
This research represents perhaps the most in-depth, action research study of the clinical
governance implementation process to have taken place over an extended period of

time (18 months) and, as such, it is hoped that it will provide interesting insights for the
reader. Implementation may be conceptualised as both a change process and an end
state; to capture this duality, two broad research questions have been posed namely:
what constitutes the local clinical governance agenda (content) and how has clinical
governance been implemented (process). However, before this account of the Trust's
journey proceeds any further, an overview of the structure of the thesis will now be
presented.
The purpose of this introductory chapter has been to provide an overview of the
emergence of clinical governance as a national policy and this will now be followed by
a review of the relevant literature. The literature on clinical governance will be
presented, and, as this body of literature is still emerging, it will be complemented by
two further chapters which consider the related literatures of Total Quality Management
(TQM)/Continuous Quality Improvement (CQI) and change/change management. A
comprehensive description and discussion of the research methodology will then be
presented. Three chapters will be devoted to presentation of the results; two dealing
with implementation at the corporate level and a third with divisional findings. The
following chapter will focus on a discussion of the results and the final chapter will
present the concluding comments and draw the thesis to a close.
10
CHAPTER 2
LITERATURE REVIEW - CLINICAL GOVERNANCE
'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'
(Department of Health, 1998; p33)
2.1 INTRODUCTION
The previous chapter has outlined the emergence of clinical governance as national
policy (Department of Health, 1997; 1998; 1999). The purpose of this chapter is to
give an overview of the body of literature which has been steadily growing since the
publication of The new NHS; Modern, Dependable' (Department of Health, 1997) in
which the term clinical governance appears to have been first utilised in relation to UK
health care. As the main focus of this study is on the implementation of a national
policy - clinical governance, a number of important insights on aspects of
implementation from the wider policy literature will also be presented.
2.2 CLINICAL GOVERNANCE - AN EMERGING CONCEPT
As a further testimony to the newness of the clinical governance concept and its
literature-base, it is worth noting that a search for 'clinical governance' using the
Medline database produces no hits pre-1997 but yields 357 between the years 1997 to
2002. Early contributors to the emerging literature include academics, clinicians,
clinician/managers and managers. With little to draw on in terms of the specifics of
clinical governance other than the policy documents themselves, they sought to put
some 'flesh on the bones' of this new concept. The first papers were often dedicated to
11
the clarification of what clinical governance might actually mean. Most authors seem
to start with and indeed stay with the Department of Health definition cited at the start
of this chapter. This definition highlights the need for an integrated approach, stresses
corporate accountability, implies not only quality assurance but also a more dynamic
aspect of quality - continuous improvement. Although the goal is the achievement of
high standards of care, the definition implies that a whole organisation approach will be
needed to create the alignment necessary to deliver this objective.
Some writers have sought to offer an alternative definition to the one cited above:
'A proper level of clinical governance in an organisation requires that

substantially the whole of clinical activity meets commonly accepted
standards, where these exist, and can be shown as meeting them'
(Scotland, 1998).
'It (clinical governance) means corporate accountability for clinical

performance' (Walshe, 1998b).
'It (clinical governance) can be defined as the action, the system or the
manner of governing clinical affairs. This requires two components; an
explicit means of setting policy and an equally explicit means of
monitoring compliance with such policy (Lugon and Seeker-Walker,
1999, pi).
'A systematic approach to assure the delivery of high quality health

services with the active participation of clinicians and patients
supported by managers' (Winter, 1999).
Unsurprisingly, given the concept is clinical governance, there is a distinctly 'clinical'
flavour to the above. There is a risk that the focus is explicitly on clinical activity
which could ignore the fact that health care provision does not rely on clinical input
alone. As an example, the neurosurgeon waiting in theatre relies on the porter to
deliver the right patient to the right place at the right time; the right investment in the
service to provide appropriate staffing levels, skill mix and so on all contribute to the
12
surgeon's ability to undertake almost any form of clinical intervention. Also, the
definitions cited above appear to offer more of an assurance flavour as opposed to that
of continuous quality improvement.
Walshe's definition (1998b) emphasises the corporate accountability for clinical
performance which seems to assume an active role for managers as well as clinicians in
the delivery of the clinical governance agenda. In contrast, Winter (1999) seems to
relegate managers merely to a supporting role which, perhaps, gives added weight to
the concern expressed by Bloor and Maynard (1998) that managers may be held legally
accountable for the standard of clinical care and yet have little influence over practice
due to professional self-regulation. Nevertheless, this chief executive clearly regards
clinical governance as a key element of the business planning process and thus an
integral part of the management function (Lloyd, 2001; p47):
'If the outcome of clinical governance processes - which include service

development based on evidence and examples of good practice - is
placed at the heart of the business planning process in the NHS, real,
quantifiable improvements in patient care might be made that can be
underpinned by an effective monitoring system.'
2.3 CLINICAL GOVERNANCE AND RELATED CONCEPTS
2.3.1 Total Quality Management and Continuous Quality Improvement
In 1998(b), Walshe commented that 'no-one seems entirely sure what it (clinical
governance) means'. Perhaps the secret to understanding this concept lies in the
original definition, and perhaps clinical governance is intended as Total Quality
Management/Continuous Quality Improvement (TQM/CQI) by another name - in
effect, a new prescription for an old remedy. Whilst some authors draw attention to
13
past experiments with whole system approaches to quality in the NHS, namely TQM
and Re-engineering (Walshe, 2000a), there are few who seem to have noticed how
closely the language and philosophy of clinical governance resonates with TQM and
CQI. In contrast, Huws (2000) sees a clear link with la TQM-style frame-work' and
regards this approach as a realistic mechanism for taking clinical governance and the
wider quality agenda forward. In addition, one of the early and perhaps seminal papers
on the emerging concept points clearly in the direction of TQM and CQI. Scally and
Donaldson (1998) advocate quality improvement through:
'......A more widespread adoption of the principles and methods of

continuous quality improvement initially developed in the industrial
sector and then later applied to health care. Generally these involve an
organisation-wide approach to quality improvement...... '
The authors (ibid) also talk of the well managed organisation which integrates
'financial control, service performance, and clinical quality at every level'. This
suggests a holistic conceptualisation of clinical governance as a way of running the
business and not merely a narrow definition of quality in terms of clinical or technical
quality alone. This notion does not appear to be an explicit theme in the early literature
but there is a flavour of it in the Commission for Health Improvement (CHI) Clinical
Governance Review Process (CHI, 2002) and the approach of the Clinical Governance
Support Unit (Hallett and Thompson, 2001). The models of both organisations include
a focus on strategic effectiveness which might reasonably be regarded as a precursor to
the creation of the environment of excellence referred to in the original definition of
clinical governance (Department of Health, 1998).
14
2.3.2 Corporate Governance
The notion of 'governance1 is addressed by a number of authors. There are those who
highlight the parallels with corporate governance (Scally and Donaldson, 1998) and the
requirement for openness, probity and accountability in corporate affairs. Others, such
as Bloor and Maynard (1998), also draw parallels with the concept of corporate
governance and emphasise clearly the regulation and accountability aspects of the
clinical governance agenda. Davies and Mannion (1999) consider clinical governance
in terms of principal-agent theory and explore the notions of trust and checking. The
authors (ibid) conclude that there must be a balance between the two elements and that
trust should not be synonymous with the abandonment of management controls.
2.3.3 Hospital Governance
Whilst clinical governance was a new concept to the UK NHS, the notion of "hospital
governance' has received considerable attention for some time in the US. This notion
of governance seems to have preceded the clinical governance agenda in the UK by at
least a decade and offers some valuable insights for those trying to make sense of the
more recent UK initiative as the following discussion will seek to demonstrate.
Arlington and colleagues (Arrington, Gautum and McCabe, 1995) suggest both a broad
and a narrow definition of governance:
'In the largest sense, governance is the process of leading and directing
the work and effective performance of an organisation, a group of
organisations or of a community that involves shared effort or
partnership among directors, executives and other relevant leaders.
Governance, in its narrowest sense, is commonly considered a synonym
for the work done by boards of directors'.
15
Thus from the above, it would appear that, in the US context, governance is concerned
with the way the business/organisation is run; so much so that the effectiveness of
governance arrangements are considered to mean the difference between organisational
success or bankruptcy (Alexander, Weiner and Bogue, 2001). Many writers refer to the
strategic management element of the hospital governance agenda and, way before the
emergence of clinical governance in the UK, there were calls to combine the
governance of clinical and administrative aspects of governance in an effort to increase
effectiveness (Kovner, 1990). In addition, although quality improvement had
traditionally been in the domain of the clinicians, the growth of competition in the US
health care industry was causing a shift in the responsibility for the development and
oversight of quality improvement efforts so that this rested 'first and foremost with the
hospital governing board', the body ultimately accountable in law for the quality of
care (Weiner and Alexander, 1993). Thus, it appears the notion of clinical governance,
whilst new to the UK, was already being promulgated in the US.
The established and growing body of literature on US hospital governance is testimony
to the length of time the notion of governance has been around the wider health care
industry. Although there does not appear to be a universally accepted definition of
governance, one can detect a shift in the content of US literature from sense-making to
other more practical issues. Authors highlight problems in board performance such as
lack of vision, reactiveness, passivity and rubber stamping, and inexperience (Carver,
1990). Others suggest approaches to ensure the effectiveness of hospital governance
(Umbdenstock, Hageman and Amundson, 1990) which may serve as useful learning
points for the NHS Trust Boards (Table 2.1).
16
Table 2.1: Five critical areas for effective governance
• A common working definition of governance;

• A clearly defined mission with specific goals and objectives;
• A well-planned decision-making process;
• A board structure tailored to the priorities at hand;
• An information, reporting and communication system that focuses priorities.
Umbdenstock, Hageman and Amundson (1990)_________________
Whilst it is sensible to try and learn from the experience of others, it is also important to
remember that any comparison between governing boards in the US and Trust Boards
in the UK is not generally on the basis of like for like. Alexander and colleagues,
(Alexander, Weiner, and Bogue, 2001) highlight the fact that governance arrangements
differ within the US depending on the nature of the institution; specifically whether it is
not-for-profit, public, or investor-owned. Vertical integration of health care
organisations in the US create multiple levels of governance even at the corporate level
and accountability to a higher authority might vary between a combination of state and
local government, religious organisations or universities depending on ownership
arrangements. Unlike the Trust Boards in the UK which are composed of executive
and non-executive directors, the governing boards in the US do not necessarily
incorporate the senior management team. In the case of some US boards, the chief
executive is the only representative of the management function and s/he may not have
full voting rights.
2.4 MAKING SENSE OF CLINICAL GOVERNANCE
Thus, the above discussion provides a flavour of how a number of writers have
attempted to get to the core of clinical governance, either by trying to dissect the term
itself or drawing on other literature; not the easiest task when the policy does not
17
necessarily arrive fully formed and ready for implementation. This is, apparently, not a
rare occurrence in the policy process and, according to Gunn (1978), complete
understanding of the objectives is more an ideal than the reality. This will no doubt
strike a chord with Scotland (1998) who comments on the lack of consensus around the
concept of clinical governance. Whilst the resemblance to TQM and CQI has been
suggested earlier in this chapter, the lack of an explicit policy statement in this respect
or the apparent absence of any other empirically tested theoretical basis for clinical
governance leaves the policy open to charges such as Goodman's (1998) who argues
that the Department's definition represents little more than ' empty phrases'.
Whilst there is an obvious need to make sense of clinical governance at a conceptual
level, it is also necessary to try and translate this into tangible objectives for
implementation at both the corporate and operational levels of real organisations.
Although the consultation documentation (Department of Health, 1998) highlighted the
key components of clinical governance, advocated structural arrangements at the
corporate level and spoke in broad terms of a comprehensive framework for quality
improvement, it was the perception of some in the field that there was little else to go
on (Huws, 2000). This absence of a blueprint has not prevented authors bringing a
prescriptive flavour to much of the early literature which has aroused criticism for an
overuse of words such as 'should' and 'need to ensure' (Wall, 1999).
Early papers often revisit the policy documentation and/or reflect the writer's personal
view/interpretation and, in this, there are offerings from managers, academics,
clinicians and clinician/managers. Some writers have addressed a particular aspect of
18
clinical governance in practice: Walshe (1999) and Garland (1998) highlight the
importance of an initial baseline assessment of existing systems for quality
improvement given that their effectiveness is often highly variable - particularly with
regard to clinical audit. Others address the implications of clinical governance with
respect to clinical competence and clinical behaviour (Scotland, 1998), or issues such
as the information requirements to support the clinical governance agenda (Hopkinson,
1999). The Clinical Governance Support Unit published a series of articles which
appeared monthly in the journal 'Professional Nurse1 from July 2000 to June 2001.
Each deals with an aspect of the clinical governance model outlined in the previous
chapter (Table 1.5) and, taken together, provides a coherent overview of the 'what' of
clinical governance as conceptualised by the Support Unit; however, there is little on
the 'how1 of implementation per se.
The need for effective leadership and culture change is often cited in the literature but
generally not dealt with in any depth. Walshe (2000b) includes a very brief comment
on leadership and clinical governance in an early, superficial review of the literature.
The author (ibid) presents the notions of transformational and transactional leadership
and suggests that the former is likely to be more appropriate in order to meet the
demands of clinical governance.
Hackett and Spurgeon (1999) provide a more in depth discussion on culture change and
clinical governance. They draw attention to the fact that there are multiple cultures
within NHS organisations and argue that culture change is a secondary outcome to the
implementation of clinical governance rather than an end in itself. The authors (ibid)
19
point to the different levels of organisational culture and suggest that making structural
changes to support clinical governance may address the more visible and perhaps more
easily manipulated manifestation of culture - the artefacts. Other interventions will be
required to change the deeper, less apparent aspects of culture such as values and
beliefs.
Davies and colleagues (Davies, Nutley and Mannion, 2000) warn that culture change
should be approached with caution for a number of reasons; not least because the
'cultural destination' in terms of clinical governance has not been clearly and
unambiguously specified. It is also argued (ibid) that wholesale, simultaneous change
in all aspects of organisational culture is unfeasible and probably undesirable.
Although certain aspects may need changing, there are others which serve as a sound
basis upon which clinical governance may be built.
Other writers have attempted to provide a more holistic sense of clinical governance
and take a wider organisational perspective. In one of the early edited texts on the
subject, Lugon and Seeker-Walker (1999) present clinical governance from a variety of
perspectives. Thus an organisational framework for clinical governance is offered
which outlines the structures and systems that should be introduced - not only at the
corporate level but also at the clinical team level where it is envisioned that the
operationalisation of clinical governance would take place through improvement
groups. The roles and responsibilities from the chief executive and the board to clinical
teams and individuals are outlined and chapters deal with some of the building blocks
of clinical governance such as clinical audit, risk management, complaints and so on.
20
Importantly, the text makes explicit the need for effective change management
processes and also the need for a clear clinical governance implementation plan which
is linked to the organisation development plan for the organisation as a whole.
Still others (BAMM, 1998; Holt, 1999; Wright, Smith and Jackson, 1999) have sought
to offer a broader sense of clinical governance within the organisation. Whilst there is,
in some cases, a sense of internal consistency in what is being proposed, the lack of a
common model for clinical governance means that it is not always possible to discern
why elements have been included for discussion and others omitted. Each of the
writers provide a perspective which offers interesting insights in itself; it is also
possible to identify some early themes amongst the 'should do's' reproduced in Table
2.2. These may be regarded as sensible suggestions but, in the absence of a coherent
whole, are offered for consideration only.
Table 2.2: Clinical governance - emerging themes
• Clinical governance needs to be part of the main business of the organisation - it is not an add-on or
optional extra;
• There needs to be a structure at both corporate and directorate levels to both support clinical governance
and clarify lines of accountability;
• There needs to be systems in place to ensure the alignment of corporate and directorate quality goals;
achievement of these goals is through performance management;
• Communication needs to be up, down and across the organisation;
• People need to be trained in quality improvement methods - not only clinical audit etc but also CQI
methods;
• Leadership and management development to ensure people have the skills to take forward the agenda;
change management skills important;
• Clinical governance activity needs to be supported by trained facilitators;
• Clinical governance needs to be appropriately resourced in terms of funding, time, training and
information technology;
• Culture change required but from-to highly variable.
21
2.5 CLINICAL GOVERNANCE - EARLY IMPLEMENTATION
The early literature outlined in the preceding discussion is extremely valuable in that it
provides a flavour of the emergent thinking both in terms of how clinical governance
has been perceived - as a 'big idea that has shown that it can inspire and enthuse ',
(Scally and Donaldson, 1998), inevitable so make the best of it (Wright, Smith and
Jackson, 1999), 'emptyphrases' (Goodman, 1998) - and also how the concept is being
interpreted for implementation. Gradually, this literature pool has been augmented by
the emergence of accounts providing details of actual implementation efforts. Holland
and Fennell (2000) describe an approach to the mandatory initial baseline assessment
using the European Foundation for Quality Excellence Model (EFQM). Although this
initiative apparently raised issues around the maturity of some of the clinical teams and
the time needed to undertake the assessment, the reported view was that the use of the
model brought positive outcomes - a common approach to assessment was achieved
and the self-assessment aspect contributed to the ownership of the resulting action
plans. Hewer and Lugon (2001) focus on the development of Clinical Improvement
Groups which serve as the main vehicle for the operationalisation of clinical
governance down the organisational hierarchy and into the directorates.
Greater detail is provided by Hittinger (2001) on the implementation of clinical
governance in a teaching Trust. The framework used incorporates the elements of
strategy, structure, technical support and culture. The more recent paper by Lewis and
colleagues (Lewis, Saunders and Fenton, 2002) demonstrates the importance of
evaluation and a recognition that the initial approach had 'not facilitated effective
progress'. The authors (ibid) subsequently describe the changes made to address the
22
gaps identified.
These accounts are important as they provide information on actual attempts to
implement clinical governance. Although the level of detail varies, each offers
different insights which range from the benefits of using a uniform approach to
assessment (Holland and Fennell, 2000), the need for a clear, widely communicated
strategy to guide clinical governance (Hittinger, 2001), to the need for structures at both
the corporate and directorate levels to support clinical governance (Hewer and Lugon,
2001; Lewis, Saunders and Fenton, 2002). Although the focus of these papers varies, a
consistent theme is evident - the need to prepare staff for their role in relation to the
clinical governance agenda, whether it is to support the baseline assessment or to
function effectively as a member of a quality improvement group. This finding
inevitably highlights the need for appropriate investment in education and training.
In addition to the within-organisation accounts described above, in a relatively short
space of time, a number of research reports have also been published which focus on a
variety of aspects of implementation, some of which will now be considered.
Latham and colleagues (Latham, Freeman, Walshe et al, 2000) undertook a postal
survey of NHS Trusts located within two English Regions to explore, amongst other
things, the early activity associated with implementation. The majority of the Trusts
reported that they had undertaken the baseline assessment and existing systems for
quality improvement were found to be highly variable in terms of effectiveness and
coverage both within and between these organisations. Most had developed or were in
23
the process of developing a strategy for clinical governance; all had established a
clinical governance committee although the size and membership varied. All Trusts
had put in place leadership arrangements for clinical governance at the corporate level
although most leads had little or no time formally allocated for this new responsibility.
The study also reported a number of anticipated barriers to implementation; an
overview is presented in Table 2.3 below; some of which, particularly the time element,
were also highlighted by Dewar (1999) during interviews with chief executives.
Table 2.3: Perceived barriers to clinical governance implementation
Lack of time and money;

Lack of access to library facilities;
Lack of IT systems to underpin clinical governance;
Fear of change;
Too much change;
Lack of understanding;
Cultural change needed;
Competing priorities;
Professional boundaries.
Latham, Freeman, Walshe et al (2000)
As part of the same project as that described above, Walshe and colleagues (Walshe,
Freeman, Latham et al, 2000) visited all of the Trusts in one Region and undertook a
series of structured interviews with the senior people charged with taking clinical
governance forward in the organisation. Usually the interview set comprised the chief
executive, the non-executive director lead, and the executive lead(s) - often a joint
appointment of the medical and nurse directors. This confirmed that early attention had
been devoted to putting structures and systems in place. Although the need for
leadership and culture change was often mentioned by interviewees, there was little
evidence to suggest that deliberate interventions were being introduced to address the
second of these two issues.
24
Conduit and colleagues (Conduit, Morgan and Willetts, 1999) devised a 20-point self-
assessment tool which was sent out to all Trusts in the Trent region. Apparently scores
ranged from 8-63 out of a possible 80 and the 'weakest1 category tended to be quality
improvement. Although the paper highlights the contribution this tool made to the
completion of baseline assessments and the development of subsequent action plans,
there is little else in the way of detail to this publication and it would have been
interesting to know if/how the gaps identified were addressed by the Regional Office
driving the assessment.
Firth-Cozens (1999) reports on a study of the development needs of a cross section of
employees in relation to clinical governance. The findings demonstrate that needs
differ depending on the background of the interviewee; the author states:
'There were very large differences between the development of chief

executives and those of clinical staff: the former had had considerable
personal and management development covering areas like team
leadership, change management, decision-making and negotiation; the
latter, including consultants, had had very little development with most
of their education being clinically focused'.
Firth-Cozens (ibid) also highlighted common areas for development; these include: risk
management, change management, team dynamics, basic clinical audit training, IT
training. Interestingly, the research highlighted the fragmented way in which the
elements of clinical governance were being considered in contrast to the integrated
whole aspired to in the policy (Department of Health, 1999). Thus, it is proposed that
development programmes do not address individual elements as such but instead are
problem based so that staff learn to integrate the tools of quality management through
practical application. Barriers to development included: time pressures, a lack of
25
information technology, inadequate funding, and the lack of a coherent strategy for
post-qualification training in general outwith the demands of clinical governance.
Professional isolation and the geographical demands of life working in the community
were also cited as barriers for those not in a secondary care setting.
In addition to the academic research reports, there has also been a steady stream of
reports from CHI which are published on the internet and are the outcome of the routine
review process. This is an extremely valuable source of information on the progress of
implementation as the reports highlight both the positive and negative aspects of this
process and each is supplemented with an action plan for further work. Searching the
CHI web site, there does not appear to be any summary of key themes from the
reviews; hopefully this is already under consideration by the policy makers.
The literature described above makes a valuable contribution to what appears to be a
rather emergent understanding of clinical governance. This review of the literature
highlights the virtual absence of data from longitudinal, in-depth case studies of clinical
governance implementation - hence the decision to undertake the study which will form
the focus of this thesis. However, before moving from clinical governance to related
literatures, it is worth noting some of the issues surrounding the notion of
'implementation' to be found in the wider policy literature.
2.6 IMPLEMENTATION INSIGHTS FROM THE POLICY LITERATURE
Firstly, although not always acknowledged by writers on the subject, it is important to
make explicit that implementation has a double meaning (Lane, 1987) - 'either the act
26
of implementing or the state of having been implemented' thus, from this description,
implementation constitutes a process (how) and an end state (what). Of these two
notions of implementation, it seems that the former had received the least attention
(Elmore, 1978; Hogwood and Gunn, 1984; Parsons, 1995). An area initially considered
as 'a series of mundane decisions and interaction unworthy of the attention of scholars'
(Van Meter and Van Horn, 1975; p450) the implementation process has apparently
attracted greater interest as policy has, in some areas, failed to deliver the anticipated
outcomes (Hogwood and Gunn, 1984). Consequently, policy analysts have sought to
understand the 'implementation gap' (Dunsire, 1978) not only in terms of end state
success or failure but also with regard to process effectiveness. Given the newness of
clinical governance, it will be important to capture both facets of implementation in
order to start building up a sense of how policy is turned into practice and what that
looks like on the ground.
Secondly, it is worth noting that Hogwood and Gunn (1984), in considering
implementation failure, distinguish between non-implementation and unsuccessful
implementation. The authors (ibid) view the former as a policy which has not been put
into effect as intended; in the case of the latter, the policy has been carried out in full
but fails to produce the outcomes intended. Apparently, either of these circumstances
may arise from what has been described as bad implementation, bad luck and bad
policy - apparently the latter is usually the least likely to be offered as a cause of
failure.
Wolman (1981) makes a similar point and suggests that failure is not necessarily due to
27
poor implementation but may in fact be the result of problems or inadequacies in one or
more components of the policy process either in the policy formulation stage or what he
calls the 'carrying out stage' or both (Table 2.4).
Table 2.4: Factors influencing the success of policy implementation
Components of the formulation process Components of the carrying out process

1. Problem conceptualisation Resource adequacy
2. Theory evaluation and selection • Program funding
3. Specification and objectives • Staff resources
4. Program design Management and control structure
Causal efficacy • Authority leakage due to lack of
Political feasibility knowledge/will
Technical feasibility Bureaucratic rules and regulations
Secondary consequences Political effectiveness
Regulation vs. incentives implementation Feedback and evaluation
considerations • Substantive
5. Program structure • Agency response
• Co-ordination
• Intergovernmental administration
• The carrying out process
Wolman (1981)__________________
If, as Wolman (ibid) suggests, policy failures are more often due to failures of
formulation than implementation, then this poses an additional challenge for the
implementers. Successful implementation will not only depend on their skills in
relation to the implementation process but will also depend on their ability to critically
evaluate the policy process upstream and also the level of discretion they have been
afforded to overcome any problems inherited from the earlier part of the process.
Given the problems that may originate upstream, it would seem prudent not to make the
assumption that policy, in the form it reaches those charged with its implementation, is
necessarily amenable to implementation with any degree of success.
Finally, Gunn (1978) has taken the ideal type approach in presenting a model of 'perfect
implementation' (Table 2.5). Although the author (ibid) regards this as an 'unreal
28
concept', its purpose is to aid systematic thinking, not only about the reasons for
implementation failure but also about possible ways in which these elements may be
addressed in order to improve the chances of success.
Table 2.5: Perfect implementation
1. That circumstances external to the implementing agency do not impose crippling constraints;
2. That adequate time and sufficient resources are made available to the programme;
3. Not only are there no constraints in terms of overall resources but also that, at each stage in
the implementation process, the required combination of resources is actually available;
4. That policy to be implemented is based upon a valid theory of cause and effect;
5. That the relationship between cause and effect is direct and that there are few, if any,
intervening links;
6. That there is a single implementing agency which need not depend on other agencies for
success or, if other agencies must be involved, that the dependency relationships are minimal
in number and importance;
7. That there is complete understanding of, and agreement upon, the objectives to be achieved,
and that these conditions persist throughout the implementation process;
8. That in moving towards agreed objectives, it is possible to specify, in complete detail and in
perfect sequence, the tasks to be performed by each participant;
9. That there is perfect communication among and co-ordination of, the various elements or
agencies involved in the programme;
10. That those in authority can demand and obtain perfect obedience.
Gunn (1978) __________________________
To those involved with policy implementation generally, and clinical governance in
particular, there is probably no need to labour the notion of ideal type when considering
the 10 aspects of 'perfect' implementation outlined above. Although Harrison (2000)
commenting on this makes the point that Gunn's ideas do not represent a model of
organisational change, he still seems to regard them as constituting a 'classic
management text' equally relevant after the passage of over 20 years as both a
mechanism for illuminating implementation situations and as a tool for getting policy
into practice.
29
2.7 CHAPTER SUMMARY
This chapter has provided an overview of the emerging literature around clinical
governance. From this, it has been possible to follow the shift from contributors
offering personal perspectives and views on what clinical governance 'should' look like
in practice and how it 'should' be implemented to details of actual implementation
efforts from insider and outsider researchers. There is, apparently, no consensus on the
meaning of clinical governance and interpretations seem to range from business
excellence through to clinical standards.
The newness of the clinical governance concept and the absence of a definitive model
of clinical governance or a blueprint for the implementation process is likely to pose
something of a challenge to health care managers and practitioners. However, insights
from the wider policy literature on implementation suggest this level of under-
development is not uncommon. This literature also alerts the reader to the dual
meaning of implementation and to the fact that problems with implementation are not
necessarily due to the implementation process but may originate from a number of
sources 'upstream' in the policy formulation process. Finally, the notion of perfect
implementation is a sobering one and clearly highlights some of the pitfalls that may lie
ahead.
The lack of any 'received wisdom' concerning exactly what clinical governance should
look like or how it should be introduced into the Trusts also poses a challenge in terms
of research design. Given the lack of literature around clinical governance per se, the
30
most logical step is to seek out related literatures; and, since clinical governance seems
to resonate with the language of TQM and CQI, a review of this body of literature
seemed perfectly appropriate under the circumstances.
31
CHAPTER 3
LITERATURE REVIEW - TOTAL QUALITY MANAGEMENT &

CONTINUOUS QUALITY IMPROVEMENT
Total Quality Management... 'a sort of Rorschach test'

(Dean and Bowen, 1994)
3.1 INTRODUCTION
With the publication of documents such as 'The new NHS: Modern, Dependable'
(Department of Health, 1997) and 'A First Class Service' (Department of Health,
1998), the UK government has undoubtedly raised the profile of Health Service quality;
however, it would be wrong to think that a regard for quality in medicine is a new
phenomenon. On the contrary, Ellis and Whittington (1993) argue that this interest in
quality dates back to ancient times and cite early guidelines for education and practice
as examples. Whilst this may indeed be so, Morgan and Murgatroyd (1994) point out
that concern for quality is quite different from systematic management which needs an
'intentional framework'. This rather suggests that the emphasis on quality management
is a more modern concept and the emergence of Total Quality Management (TQM) as a
whole system approach would appear to support this.
As highlighted in earlier chapters, the influence of TQM on the language of clinical
governance is evident. What is less clearly expressed is the contribution the field of
TQM may make to the implementation of clinical governance; a notion that will be
explored in this chapter. Firstly, the complexity of health care quality will be
discussed; the review will then move on to the wider TQM literature focusing on the
philosophy and principles of this concept and certain aspects of implementation; in
32
particular, frameworks, critical success factors and barriers. Finally, the review will
consider the challenge of implementing TQM in health care with specific reference to
earlier experiments in the UK (Joss, Kogan and Henkel, 1994; Joss and Kogan, 1995)
and Norway (0vretveit, 1999; 0vretveit and Aslaksen, 1999).
3.2 QUALITY IN HEALTH CARE
3.2.1 Quality in Health Care - A Mixed Picture
Over the years, there has been a wide variety of quality initiatives. Taylor (1996) lists a
total of 25 examples ranging from accreditation systems to TQM whilst Pollitt (1993)
paints an evocative picture of the NHS 'bubbling with a mixed stew of quality
initiatives'. Whilst there has undoubtedly been an admirable amount of activity taking
place in this area, much of this has been less than a resounding success (Pollitt, 1996).
More recently, in a review of Continuous Quality Improvement (CQI) in American
health care organisations, Blumenthal and Kilo (1998) conclude:
'...... there simply are no organisation-wide success stories out there -

no shining castles on the hill to serve as inspirations for a struggling
industry'.
One of the reasons for the rather mixed picture of health care quality presented above is
an apparent failure of the NHS to learn from past experience. According to Klein
(1998), the NHS consistently seems to fall pray to a 'collective amnesia' and in doing
so not only loses its "collective memory' but also its 'understanding of NHS history'
(0vretveit, 1998). Governments have been struggling for decades with the notion of
quality in health care (Klein, 1998) and the boards of NHS Trusts will do well to
remember this as they strive to discharge their new statutory duty for quality through
the clinical governance framework. Given this tendency to forget, it is less than
33
surprising to find the importance of learning from the past stressed both in policy
documents (Department of Health, 1998; 1999) and also in the recent literature
(Donaldson and Muir Gray, 1998; Klein, 1998; Walshe, 1998b). It therefore seems
appropriate to explore further the concept of quality and consider some of the reasons
why it seems to represent such a challenge for its many stakeholders.
3.2.2 Quality - A Complex Concept
Quality is notoriously difficult to define irrespective of whether the concept is applied
to health care or the commercial context (Ellis and Whittington, 1993; Dale, 1994).
Quality is often used as an umbrella term which covers everything but touches nothing
in particular; however, in order to manage quality, it is necessary to be explicit about
what is meant when the term is used (Moss, 1995). This is no easy task particularly in
the absence of any universally agreed definition of health care quality (Walshe, 1998c).
In fact, there seems to be almost as many definitions as there are authors on the subject
and a number of factors which contribute to this lack of consensus will now be
considered.
Quality - 'in the eye of the beholder'
Few would deny the complexity of the arena within which health care is delivered.
There are multiple stakeholders, both internal and external to the organisation. These
include a variety of professional groups who deliver a myriad of services ranging from
physical to psychosocial interventions. In addition, there are the consumers of health
care who invariably have needs which are highly heterogeneous. Added to this,
individual perceptions of service quality may be influenced by personal values, beliefs,
34
past experience and even one's own vested interests. This richness is often captured by
writers in their descriptions of health care quality; a concept some see as complex and
often contested (Sutherland and Dawson, 1998) or even 'slippery' (Kerrison, Packwood
and Buxton, 1994). For others, 'quality is like beauty' and whilst it has positive
connotations, its meaning usually lies '/« the eye of the beholder' (Kritchevsky and
Simmons,1991).
Table 3.1: Dimensions of quality
Maxwell (1984) Klein (1998) Ovretveit (1992)
Relevance to need • Respect • Client quality

Effectiveness • Choice • Professional quality
Access to services • Information • Organisational quality
Equity • Technical competence
Social acceptability
Efficiency and economy
Quality: more to it than meets the eye
Just as the context of quality is multidimensional, so it seems is the concept; elements
of which are illustrated in Table 3.1. Maxwell (1984), for example, describes six
dimensions to which Klein (1998) has added a further four (perhaps somewhat tongue
in cheek) to make the '10 Commandments' for the NHS and still another perspective is
offered by Ovretveit (1992).
Quality: a political concept

Given the complexities described above, the difficulties in reaching a universal
definition of health care quality may be appreciated; however, there are those who
argue that the lack of an explicit definition is not accidental and suggest this is due to
the political nature of the quality concept (0vretveit, 1998). Within this paradigm,
35
issues of power and professionalism are interlinked both at the macro and micro levels.
At the macro level, control of quality is considered to lie at the heart of professionalism.
Through control of both initial entry to the profession and also of subsequent practice,
professional bodies such as the General Medical Council and Medical Royal Colleges
claim to provide their own quality assurance (Pollitt, 1990). At the micro or individual
level, the unique body of knowledge which distinguishes the professions from other
groups in the NHS also confers a significant level of autonomy (Weiner, Shoetree and
Alexander, 1997) which, it is argued, is translated to mean that the professionals know
best and if left alone will assure quality in health care (Pollitt, 1996). This medical
model of quality is criticised as paternalistic as the needs of patients are invariably
defined by the professionals (Pollitt, 1996; Packwood, Pollitt and Roberts, 1998) and,
within this model, the voice of the patient tends to be the one least heard (Hart, 1996).
The introduction of clinical governance has made explicit the fact that the quality of
health services is a corporate concern. The whole system approach which is embedded
in the concept brings clinical as well as non-clinical quality within the remit of
managers as well as individual clinicians who are professionally responsible and
accountable for their actions. Certain objectives contained within the modernisation
agenda and outlined in the NHS Plan (Department of Health, 2000) will be delivered
using quality improvement methodologies which have been imported from industry and
which are based on the philosophy of TQM and CQI. In this way, clinical governance
poses an interesting challenge to the notions of professional control over the quality
agenda; how this will be played out in practice remains to be seen but some of the
36
reasons for this challenge will now be discussed.
3.2.3 Quality and the Challenge of CQI
The concept of CQI, defined as 'an ongoing effort to provide care that meets or
exceeds customer expectations' (Weiner, Shoetree and Alexander 1997; p493), is at the
heart of a total quality or a whole systems framework and the ideas contained within the
above definition may be regarded as a considerable challenge to the medical model of
quality in two ways.
Firstly, whilst all change may not bring improvement, CQI always implies change
(Berwick, 1996; Garside, 1998) so it follows that individual clinical practice will have
to change to reflect this if improvement is to occur. Such change is not always
welcome. Preferred ways of working may have been followed for many years and not
only serve as a frame of reference for the working life of the clinician concerned but
can also form the basis of empires carefully nurtured over a long career (Marris, 1993).
Secondly, CQI focuses on the customer definition of quality whereas, in health care, the
concept of the patient as a customer is relatively new and "the very idea of asking
customers what they value is seen by some as revolutionary' (Morgan and Murgatroyd,
1994; p74). In addition, the notion of the customer relates to internal customers in
addition to the patient or carer as end user. The idea of internal customer-supplier
relationships brings a focus onto the processes of care and clinical teams, which, for
those who operate in a more individualistic mode, seems to suggest something of a
change in practice which is not always appreciated.
37
Thus, from the preceding discussion, it can be seen that the concept of quality is, in
itself, a complex phenomenon which invariably serves as a challenge to all associated
with it. As the next section will demonstrate, the complexity of quality is matched by
the complexity of TQM, not only as a concept but also in practice.
3.3 TOTAL QUALITY MANAGEMENT - THE CONCEPT
3.3.1 TQM - A Hazy and Ambiguous Concept
Given the growing body of literature addressing some or other aspect of TQM, Dean
and Bowen's (1994) assertion that it is a 'ubiquitous organisational phenomenon' has
some resonance. The anacronyms TQM/CQI not only feature widely in the peer
reviewed literature but also in general discussion within organisations around the topic
of quality -a discourse not uncommonly peppered with associated slogans such as 'right
first time', 'quality is everyone's business', 'a journey not a destination'. Whilst such
slogans may be regarded as buzzwords, they may also contribute to a sense that this
'phenomenon' is based on a codified theoretical base, reinforced by some who refer to
the notions of 'conventional wisdom' (Boerstler, Foster, O'Connor et al, 1996), or
'received wisdom' (Dale, Boaden and Lascelles, 1994).
This author's initial exploration of the literature was accompanied by a growing sense
of bewilderment. It was, therefore, somewhat comforting to find that this sense of
confusion is not uncommon (Teixeira, 1999) and that, far from being a 'cut and dried
reality' (Spencer, 1994), TQM is variously described as 'a hazy ambiguous concept'
and 'a sort of Rorschach test' (Dean and Bowen, 1994), an 'amorphous philosophy*
38
(Spencer, 1994), which means 'different things to different people' (Yong and
Wilkinson, 2001). It is therefore unsurprising to find a profusion of definitions in the
literature which gives credence to those who highlight the fact that there is no universal
definition of TQM (Wilkinson and Witcher, 1993; Grant, Shani and Krishnan, 1994;
Teixeira, 1999).
Dean and Bowen (1994) suggest that the meaning attributed to TQM is a function of
belief and experience, aspects of which are also likely to colour one's perception of
TQM and vice versa. TQM has been described as, for example, 'a major change
movement' (Scon and Cole, 2000), 'a tool for change' (Yong and Wilkinson, 2001), 'a
new and emerging paradigm of management' (Wilkinson and Witcher, 1993; Teixeira,
1999), 'a company-wide philosophy of quality improvement' (Grant, Shani and
Krishnan, 1994) and 'a systematic approach to management' (Spencer, 1994). Whilst
understanding is likely to influence definition, Boaden (1997) also suggests that authors
tend to adopt that which is most suited to their own particular purposes whilst some
avoid any explicit definition altogether. This is apparently not confined to the literature
but is also a feature of practice; diversity of academic background and opinion
contributed to the decision of one project team not to adopt a single definition of TQM
(Boaden, 1997) - unfortunately the author does not comment on whether this proved
problematical for either the team or the research process as a whole.
In the absence of a universal definition, Teixeira, (1999) advises the practitioner to
return to core principles as a means of navigating what he has termed 'an oversupply of
ideas'. However, this approach does not offer the safe passage suggested as, in reality,
39
much of the generic TQM literature appears to present a very varied picture of the
conventional/received wisdom. Hill and Wilkinson (1995) rather optimistically suggest
that there is now reasonable agreement around the basic principles of TQM; however,
this was apparently not borne out by The Conference Board (1993). In citing this
study, Boaden (1997) highlights the fact that out of the 20 studies examined by the
Board, only six out of 23 elements were cited three or more times and these in only
seven studies.
3.3.2 The Search For Core Principles
To demonstrate this lack of consistency, Table 3.2 highlights some of the ways in
which TQM has been conceptualised. Some authors offer three similar albeit not
entirely the same principles (Dean and Bowen, 1994; Sitkin, Sutcliffe and Schroeder;
Hill and Wilkinson, 1995), others opt for eight elements (Dale, Boaden and Lascelles,
1994), ten points (Oakland, 1995) or twelve factors (Powell, 1995). In some instances,
the origins or the process by which the author has arrived at these conceptualisations
have not been stated. In several cases they have been distilled from the writings of the
'gurus'; in others they represent a synthesis of the syntheses of others. Dean and Bowen
(1994) on the other hand present their notion of TQM in terms of principles, practices
and techniques; however, Boaden (1997) does not appear convinced this categorisation
is as neatly nested as it first appears. The author (ibid) challenges the value of such
'lists' except as a basis for discussion and debate.
40
Table 3.2: TQM conceptualised
Dean and Bowen (1994) Sitkin, Sutcliffe and Schroeder Hill and WUkinson (1995)
(1994)
Customer focus Customer satisfaction • Customer orientation
Continuous Continuous improvement • Continuous improvement
improvement Organisation as a total system • Process orientation
Teamwork
Dale, Boaden and Oakland (1995) Powell(1995)

Lascelles (1994)
Commitment and 1. Organisation needs long term 1. Committed leadership

leadership of CEO commitment to constant 2. Adoption and
Planning and improvement communication of
organisation 2. Adopt the philosophy of zero TQM
Using tools and defects and change culture to 3. Closer customer
techniques right first time relationships
4. Education and training 3. Train the people to understand 4. Closer supplier
5. Involvement the customer-supplier relationships
6. Teamwork relationship 5. Benchmarking
7. Measurement and 4. Do not buy products or services 6. Increased training
feedback on price alone - look at total cost 7. Open organisation
8. Culture change 5. Recognise that improvements of 8. Employee
systems need to be managed empowerment
6. Adopt modern methods of 9. Zero-defects mentality
supervision and training- 10. Flexible manufacturing
eliminate fear 11. Process improvement
7. Eliminate barriers between 12. Measurement
departments by managing the
process - improve
communications and teamwork
8. Eliminate - arbitrary goals
without methods; all standards
based on numbers alone; barriers
to pride of workmanship; fiction
- get facts by using the correct
tools
9. Constantly educate and retrain -
develop the 'experts' in the
business
10. Develop a systematic approach
to manage the implementation of
TQM _______________
The diversity of offerings in Table 3.2 does not indicate a consensus in the core
principles of TQM. One might look to the work of the 'quality gurus' to illuminate this
quest - but apparently this does not provide a neat solution either. Although there is a
recognition that TQM has evolved from the work of a number of early 'founding
41
fathers', views about who enjoys membership of this club appears to vary. In the
literature supporting this part of the review, where the authors have referred to the
'gurus', each has included Deming and Juran; however, as Table 3.3 demonstrates, the
configurations vary, usually without any explanation as to why a trio has been selected
rather than a quintet.
Table 3.3: The TQM 'Gurus'
Dean & Bowen (1994) Hackman &Wageman Boaden (1996)

(1995)
• Deming • Deming
• Juran • Deming • Juran
• Crosby • Juran • Feigenbaum
• Ishikawa
Dale, Boaden &Lascelles Wilkinson (1995) Hill & Wilkinson (1995)

(1994)
• Deming • Deming Deming
• Juran • Juran Juran
• Crosby • Feigenbaum Crosby
• Feigenbaum • Ishikawa Feigenbaum
Ishikawa
These multiple configurations may demonstrate the richness of the landscape but any
syntheses based on such different configurations as illustrated above perhaps need to be
explicit about the rationale upon which they are derived otherwise the value of any such
exercise may be limited and even contribute to further obfuscation.
In searching for the core principles of TQM, it is perhaps worth noting Boaden's (1997)
claim that the early authors did not use the term TQM'; certainly their key texts do not
contain either the anacronym or the term Total Quality Management in the indices
(Crosby, 1979; Deming, 1986; Juran, 1988) although Feigenbaum is an exception
(1991).
42
In an interview (Romano, 1994), Deming's comments on the subject, cited below, seem
to add weight to Boaden's assertion regarding terminology (1997):
'The trouble with Total Quality Management -failure ofTQM, you call
it - is that there is no such thing. It is a buzzword I have never used the
term, as it carries no meaning '.
Hackman and Wageman (1995), perhaps rather optimistically in light of this discussion,
assert that there is substantial agreement amongst the work of those they describe as
'the movement's founders' however, others are not convinced (Dean and Bowen, 1994).
Table 3.4 summarises the core principles of Deming (1986), Crosby (1979) and Juran
(1988); Feigenbaum, however, did not develop such a convenient, pocket-sized
encapsulation of his teaching.
Table 3.4: TQM core principles
Deming -14 Points Crosby -14 steps Juran - 'Trilogy'
1. Create constancy of purpose 1. Management commitment 1. Quality planning

2. Adopt the new philosophy 2. Establish quality 2. Quality control
3. Cease dependence on mass improvement teams 3. Quality improvement
inspection 3. Introduce quality
4. End practice of awarding measurement
business on price alone 4. Evaluate cost of quality
5. Improve constantly and 5. Develop quality awareness
forever the system of 6. Take corrective action
production and service 7 Establish committee for zero
6. Institute training defects program
7. Adopt and institute 8. Supervisor training
leadership 9. Zero Defects Day
8. Drive out fear 10. Goal setting
9. Break down barriers between 11. Error cause removal
staff areas 12. Recognition
10. Eliminate slogans, 13. Quality councils
exhortations and targets for 14. Do it over again
the workforce
11. Eliminate work
standards/quotas
12. Remove barriers to pride of
workmanship
13. Institute education and self-
improvement
14. Take action to accomplish
the transformation
43
Dale and colleagues (Dale, Boaden and Lascelles, 1994) take the view that the writings
of the 'founding fathers' represent variations on a theme and point out that they were all
consultants who sought to differentiate their work from that of others in order to
position themselves in the market and attract clients. In the eyes of these authors (ibid;
p20) this appears to have been a successful tactic and they suggest that the teachings of
four men at least can be characterised by a particular approach: Crosby - company-wide
motivation; Deming - statistical process control; Feigenbaum - systems management
and Juran - project management.
A number of authors have commented on the similarities and differences within the
early work on TQM (Dean and Bowen, 1994; Dale, Boaden and Lascelles, 1994;
Beckford, 1998). Others would point to a failure to establish links with the existing
management literature (Spencer, 1994; Teixeira, 1999; Scott and Cole, 2000).
Consequently, elements in the early work may appear at odds with management theory;
a particular example of this is in relation to the notions of reward and appraisal
(Hackman and Wageman, 1995). In addition, there are those that point to omissions;
for example, there is a sense of rational linearity surrounding TQM which ignores the
political nature of organisations (Wilkinson and Witcher, 1993), the notion of
universality in TQM application does not recognise contingency theory (Sitkin,
Sutcliffe and Schroeder, 1994) and, although there are potentially profound
implications for the human resource, little attention is given to how this might be
managed (Wilkinson, 1995).
44
3.3.3 In Search of Theoretical Underpinnings
Whilst there might seem to be little in the way of consensus around what constitutes the
core principles of TQM, there is some agreement over the perception that a theoretical
basis underpinning the work of the early practitioners was not articulated (Grant, Shani
and Krishnan, 1994; Anderson, Rungtusanatham and Schroeder, 1994; Sitkin, Sutcliffe
and Schroeder, 1994). Anderson and colleagues (Anderson, Rungtusanatham and
Schroeder, 1994) take the view that Demings' '14 Points' evolved over a number of
decades and represent generalisations based on his experience as a consultant and, as
such, his energies were directed at implementation rather than theory development and
empirical testing. In terms of empirical evidence, Anderson and colleagues (Anderson,
Rungtusanatham and Schroeder, 1994) argue that there is little available to support the
effectiveness of Deming's approach in particular. Others (Dean and Bowen, 1994) look
at the broader and varied picture of TQM implementation in general and assert that
there is little in the way of theory to explain why TQM is considered a success in some
organisations and a failure in others. This apparent lack of a solid theoretical
foundation underpinning TQM is attributed to a number of factors which will now be
explored.
TQM - A practitioner-led movement
An area of agreement amongst certain academics is an acknowledgement that academia
has not been in the vanguard of the TQM movement (Wilkinson and Witcher, 1993;
Dean and Bowen, 1994; Anderson, Rungtusanatham and Schroeder, 1994; Boaden,
1996; Scott and Cole, 2000), instead, this has largely been practitioner-led. There have
been a number of criticisms of the 'practitioner literature' that has emerged; the
45
approach has been largely personal anecdotes (Hackman and Wageman, 1995) aimed at
managers who, in their desire to believe their efforts are successful, will settle for
anecdote (Scott and Cole, 2000). Again, with the managerial audience in mind, some
suggest that the publications have been 'long on prescription and shorter on analysis'
(Hill and Wilkinson, 1995) thus promoting a 'quick-fix' for those searching for off-the-
shelf solutions or as Deming (1986) has described such products - 'instant puddings'.
Lack of academic interest
The lack of theory however, is not just attributed to the practitioner focus; the lack of
academic interest in this phenomenon has also been acknowledged. According to
Powell (1995), 'no other management concept/practice has received so much
practitioner attention with so little academic study'. As a result of this, Yong and
Wilkinson (2001) argue that the practitioners and consultants have had a free hand in
shaping the formative stages of the movement's development and contributed to the
diversity within the field. Boaden (1997) suggests that TQM has been dismissed by
some as one in a long line of managerial fads which is likely to have a fairly predictable
life-cycle.
Dean and Bo wen (1994) suggest that, given the lack of theoretical frameworks,
researchers have been reluctant to conduct research based on the consultant-oriented
frameworks that were available. The authors (ibid) also suggest that TQM transcends
the boundaries of existing theories and, although the field of management theory is
populated by multiple disciplines, individual theories are often discipline-bound. As a
result, it is argued that existing theories are unlikely to be broad enough to support
46
research into this phenomenon. This may be true of some theories but perhaps does not
take account of systems theory or certain change theories which focus on large-scale
organisational change. Also, research should not necessarily preclude the use of single
theories if the intention is to bring new insights from existing disciplines. However, the
boundary-spanning nature of TQM might pose more of a challenge in practice - as
highlighted earlier when even the task of definition appeared troublesome within a
particular project team (Boaden 1997). The issue might be more around trying to
capture the holistic nature of the phenomenon; an example of which is Deming's (1986)
emphasis on the importance of implementing all of the '14 Points'.
Whatever the reason for the apparent lack of earlier academic interest, one outcome of
this seems to have been that practice has been 'propelled ahead of theory' (Anderson,
Rungtusanatham and Schroeder, 1994) so much so that, in an issue of the Harvard
Business Review, voices from industry called for a greater engagement of the academic
community which, it appears, did not fall on deaf ears (Robinson, Akers, Artzt et al,
1991).
In addition to papers appearing across a wide range of peer reviewed academic
journals, special issues of journals such as the Academy of Management Review have
sought to develop a forum for theory development and, in that issue alone, a number of
valuable, albeit different, contributions were in fact made. For example, Dean and
Bowen (1994) present their interpretation of the principles and practices of TQM and
compare these to the domains included in the Malcolm Baldrige National Quality
Award. Spencer (1994) takes three organisational models - mechanistic, organismic,
47
cultural, as a basis for examining TQM and highlights similarities and differences
between each of the models and aspects of TQM. Anderson and colleagues (Anderson,
Rungtusanatham and Schroeder, 1994) use a number of methods to identify a theory
underlying the Deming approach. Sitkin and colleagues (Sitkin, Sutcliffe and
Schroeder, 1994) apply a contingency theory perspective to the implementation of
TQM.
Edited texts such as that by Cole and Scott (2000) have sought to make explicit the
contribution of existing organisational theory to the work of researchers in the field of
quality. Contributors have highlighted a number of related dimensions such as the
concept of culture (Cameron and Barnett, 2000; Hamada, 2000), corporate
performance (Easton and Jarrell, 2000), and different aspects of Human Resource
Management (HRM) (Ichniowski and Shaw, 2000; Kochan and Rubinstein, 2000).
These publications demonstrate the increasing contribution academics are making to
the quality movement and to the ever-growing body of literature surrounding it.
However, there is the view that the audience of management theorists is essentially
academia with the expectation that, in time, there will be a diffusion of the content to
the practitioner community through either teaching or consultancy (Dean and Bowen,
1994). Whilst this work may indeed serve to formalise the theoretical context over time
as advocated by Anderson and colleagues (Anderson, Rungtusanatham and Schroeder,
1994), one wonders where this leaves action researchers and practitioners in the
meantime.
48
Teixeira, (1999) advises the practitioner to start by seeking out the core principles of
TQM but, given the previous discussion, one may question whether there is such a
thing. Witcher (1995) takes the view that there is no core, arguing instead that the
debate is about its very absence. On the other hand Dean and Bowen (1994) present a
very clear core and claim that, far from being 'a hodgepodge of slogans and tools, it is
a set of mutually reinforcing principles each of which is supported by a set ofpractices
and techniques'. Teixeira (1999) suggests that the practitioner's mindset should be a
dynamic balance of all contributions, but how realistic is this? Although the notion of
'conventional/received wisdom' has a certain intuitive appeal to the hard-pressed
practitioner, it is important to heed the warnings that TQM is not based upon a sound
theoretical foundation and any such 'dynamic balance of all contributions' may lead to
confusion with concepts being misunderstood and misapplied or even to what Dale and
colleagues have termed TQM paralysis (Dale, Boaden and Lascelles, 1994). Whilst
Teixeira (1999) may argue that lack of any universal definition gives a freedom to act,
Wilkinson (1995) suggests that a 'fuzzy' understanding of the concept will result in the
adoption of a 'fuzzy' model. Table 3.5 outlines a number of ways in which TQM may
be conceptualised. These range from a way of managing the business to a tool;
operationalisation of either would require very different approaches.
Table 3.5; Degrees of TQM conceptualisation________

1. TQM as a program;
2. TQM as human resource management;
3. TQM as quality management;
4. TQM as business process management;
5. TQM as a concept and a tool;
6. TQM as marketing;
7. TQM as a paradigm;
8. TQM as a manifestation of post-modern organisation.
Witcher (1995)______________________
49
This brings the review round to Hackman and Wageman's question - is there such a
thing as TQM or is it merely a 'potpourri' of initiatives under a common banner (1995)?
In practice, many of the key elements of the early founders are perceived to have been
ignored altogether or sanded down which has left the authors (ibid) to conclude that
'rhetoric is winning over substance' and that the 'science is fading and the slogans
staying'. In the absence of any definitive 'received wisdom', it seems important that
those seeking to implement total quality are explicit about the way in which it is being
conceptualised and that the model chosen to translate the concept into practice is
consistent with this. The following section will now consider some of the frameworks
and critical success factors for and barriers to implementation.
3.4 IMPLEMENTING TOTAL QUALITY MANAGEMENT
As with many other aspects of TQM, the literature on implementation is wide and, for
the purpose of this section, the discussion will focus on three main areas: models and
frameworks, critical success factors (CSFs), barriers to and problems associated with
the implementation of TQM. The aim is to provide a flavour of the literature around
these aspects rather than an in-depth analysis and discussion.
3.4.1 TQM Implementation Frameworks
The earlier discussion around policy implementation in Chapter 2 highlighted the
difference between two aspects of implementation - that is the end state and the change
process. Some have observed that not all authors differentiate accordingly (Yusof and
Aspinwall, 2000a) and, in the field, this may lead to confusion and possible
inconsistency with regard to the 'what' and the 'how1 of TQM implementation; factors
50
which are considered to contribute to implementation failures (Glover, 1993).
The implementation of TQM is considered by some (Kanji and Barker, 1990; Glover,
1993) as the most complex activity an organisation can undertake and the need for
culture change is cited as the main reason for this complexity. Culture change
notwithstanding, if TQM is conceptualised as a way of managing the business rather
than some sort of localised initiative, then the scale of the change required to deliver the
whole system intervention which is intended, over time, to move the organisation from
one state to another, will undoubtedly contribute to the complexity of the task. Despite
(or perhaps because of) this inherent complexity, TQM implementation, as with
implementation per se, has received relatively less attention than other aspects of total
quality until recently. Sproull and Hofmeister (1986) suggest that the lack of interest is,
in part, because implementation is not generally glamorous or exciting but is, instead,
about the 'nuts and bolts, details, and mundane problems.' Also, because
implementation is often not clearly bounded, it does not merely follow on from a
decision and it may take place through a large number of actors.
One mechanism for providing a boundary for and increasing the explicitness of the
implementation process is to adopt a framework. In fact, the importance of this is
highlighted below:
'......one of the most influential factors in ensuring total quality

management adoption success is the formulation of a sound
implementation frame-work prior to embarking on such a change
process' (Yusof and Aspinwall, 2000a).
Yusof and Aspinwall (2000b) propose that an implementation framework should
51
consist of a number of characteristics (Table 3.6).
Table 3.6: Characteristics of a TQM implementation framework
Systematic;
Simple in structure; easily understood;
Clear links between elements outlined,
General enough to suit different contexts;
Represent a road map and a planning tool for implementation;
Answers 'how to1 and not 'what is';
Implementable.
Yusof and Aspinwall, (2000b) _________
The authors (Yusof and Aspinwall, 2000a) also suggest that the utilisation of a
framework will bring a number of benefits: it may serve as a vehicle for raising
awareness of the concept and facilitate a common understanding of what is to be
achieved and how; it could also enable the organisation to introduce the elements in a
'more comprehensive, controlled and timely manner'.
At Appendix 1, seven implementation typologies are outlined; the authors have
presented these variously as TQM implementation frameworks (Dale and Boaden,
1994; Ghobadian and Gallear, 1997), stages (Kanji and Barker, 1990), steps (Glover,
1993; Stamatis, 1994; Oakland, 1995), or process (Rand, 1994). Across this collection,
there is a variation in the level of abstraction, range and focus. As an example of the
latter, Stamatis (1994) emphasises the importance of project management whilst
Ghobadian and Gallear (1997) aim their framework at small and medium sized
enterprises. Some frameworks are written by consultants and others by academics;
some are based on experience whilst others have been derived from case studies. Some
include what could be considered end state elements but most deal with the process of
implementation and also emphasise the central aspect of change within this. Whilst
52
Dale and Boaden (1994) explicitly state that their framework is not designed as a 'how
to', the accompanying text does include 'process' aspects in its discussion of the four
main elements.
Rather than presenting a comparison of these typologies which would be of limited
value given the diversity referred to above, the intention is merely to demonstrate the
variation that exists within. This adds weight to the notion that there are no simple
recipes or prescriptions for successful TQM implementation; largely because, as
demonstrated previously, there is little consensus over the 'what' and, given the
complexity and uniqueness of individual organisations, the 'how' must therefore be
adapted to the specific context. Owing to the variation between authors, frameworks
must be adopted with caution and adapted with regard to the local context rather than
treated as the received wisdom which, in view of the earlier discussion on the 'what' of
TQM, seems a matter of interpretation. However, the following discussion of critical
success factors and pitfalls should provide valuable insights which may aid this
interpretation process.
3.4.2 TQM Implementation - Critical Success Factors
A concept which is related to the notion of the frameworks discussed in the previous
section is that of critical success factors (CSFs). Oakland (1995, p25) defines CSFs as
'what must be accomplished for the mission to be achieved.' In this sense, CSFs serve
as an important vehicle for the translation of the goal into practice through the
subsequent identification of critical processes, activities and tasks and then the
development of key indicators to measure performance. Oakland (1995) stresses that
53
the CSFs should inform the design stage of the implementation process thus enabling
the match of the 'what' to the 'how' and thereby reducing the likelihood of what he
terms the 'danger gap', a situation in which there are goals but no mechanisms for their
achievement.
A number of authors have proposed a set of factors which they consider to be critical to
successful implementation. Whilst the title of their papers may refer to successful
implementation, it seems one must bear in mind the distinction between
implementation as a process and as an end state because both or either may be
discussed under this banner. Although some elements such as leadership or senior
management commitment may relate to both content and process, their
operationalisation will vary depending on how they are categorised (the 'what' and/or
the 'how'). By way of illustration, Table (3.7) outlines two examples of mainly
'process' CSFs and Table 3.8 a further two examples of mainly 'end state' CSFs.
54
Table 3.7: TQM implementation - process CSFs
Porter and Parker (1993) Yusof and AspinwaU (1999)

1. Management behaviours Leadership and support from top
• clear leadership management
• vision Providing effective and appropriate training
• commitment to TQM for employees
• involved in TQM process Measuring results and performance
• strategic issue Conducting continuous improvement
2. Strategy for TQM Adopting a QA system
• specific objectives Sufficient financial resources
• incorporate into business plans Providing relevant training for senior
• establish means for CQI management/staff level
Favourable work environment
3. Organisation for TQM
Selective application of tools and techniques
• organisational structure 10. Involving suppliers in improvement
• team structure 11. Desirable HR practices
• hierarchy for authority
4. Communication for TQM
• Quality awareness
• Publish achievements
5. Training for TQM
• All employees
• Ongoing process
• Scope and depth to meet individual need
6. Employee involvement
7. Process management and systems
• Documented quality system
8. Quality technologies
• SPC etc
Table 3.8: TQM implementation - end state CSFs
Ahire, Golhar and Waller (1996) Saraph, Benson and Schroeder (1989)
1. Top Management Commitment 1. Divisional top management leadership for
2. Customer focus quality
3. Supplier Quality Management 2. The role of the quality department
4. Design Quality Management 3. Training
5. Benchmarking 4. Product/service design
6. SPC Usage 5. Supplier quality management
7. Internal Quality Information Usage 6. Process management (design and control)
8. Employee Empowerment 7. Quality data and reporting
9. Employee Involvement 8. Employee relations
10. Employee Training
11. Product Quality
12. Supplier Performance
Other authors have adopted a particular perspective in their quest to increase the
effectiveness of implementation (Table 3.9) and have considered organisational factors
which affect implementation success (Mann and Kehoe, 1995), organisational factors
55
which are 'most likely to result in TQM-consistent behaviors' thereby impacting on
implementation success (Shea and Howell, 1998) and factors relating to the 'mind-set'
of senior managers which are also thought to contribute to successful TQM
implementation (Taylor, 1996).
Table 3.9: Organisational factors in TQM implementation
Mann and Kehoe (1995) Shea and Howell (1998) Taylor (1996)
1. Process 1. Persuasion 1. Understanding of TQM

2. Type of employees • Leadership 2. Motivation for
3. Shared values 2. Enactive attainment implementation
4. Management style • Organisation structure 3. Perception of customer
5. Organisational structures • Job design satisfaction
6. Number of employees 3. Vicarious experience 4. Perception of financial
7. Industrial relations • Modelled behavior impact of TQM
• Training 5. Perception of extent of
4. Cognitive mediators employee involvement
• Self-efficacy
• Outcome expectancy
Although there are some similarities across the authors cited above either in relation to
specific elements such as senior manager commitment/leadership and the more
generally expressed management style, the key purpose of presentation has been to
display the diversity of approaches and to highlight once again how the duality of
implementation may/may not be explicitly expressed and therefore may pose a danger
to the unwary.
The CSFs in Tables 3.7 and 3.8 could be perceived as the positive side of the coin - the
enablers; the next section will look at the opposite side of the same coin - the potential
barriers to implementation.
56
3.4.3 Barriers, Pitfalls, and Obstacles to the Implementation of TQM
Given the variation in the sets of CSFs presented earlier, it is worth adopting a different
perspective and reviewing the other side of the CSF 'coin'; of particular significance
given the fact that two in three TQM efforts are not considered successful (Brown,
1993). A number of consultants and academics, either from their own general
experience in the field (Brown, 1993; Katz, 1993; Dale and Cooper, 1994; Whalen and
Rahim, 1994; Yong and Wilkinson, 1999), based on a review and synthesis of the
literature (Davis, 1997) or from case study research (Newall and Dale, 1991; Krishnan,
Shani, Grant et al, 1993; Koeslar, 1995; Kanji, 1996) have presented a range of issues
likely to impact on the success or otherwise of the implementation effort (Table 3.10).
These have variously been described in terms of pitfalls (Katz, 1993; Kanji, 1996), the
common mistakes of managers (Dale and Cooper, 1994), barriers (Whalen and Rahim,
1994), obstacles (Yong and Wilkinson, 1999), breakdowns (Davis, 1997), problems
(Krishnan, Shani, Grant et al, 1993; Newall and Dale, 1991) and 'reasons why TQfails'
(Brown, 1993).
The level of detail varies amongst the papers cited above but it is generally a broad
treatment of a range of issues; albeit some with a particular perspective such as
management mistakes (Dale and Cooper, 1994) or, less commonly, the failings of a
particular managing director (Krishnan, Shani, Grant et al, 1993). Others have focused
their attention more closely on areas such as organisational politics (Wilkinson and
Witcher, 1993), culture and structure (Tata and Prasad, 1998) or the human resource
issues associated with TQM implementation (Snape and Redman, 1995).
57
Amongst the observations cited above which are experiential in origin, there is a sense
that implementation failure is generally due to the implementation process rather than
the concept itself. The authors tend to recognise that TQM involves 'change'; this may
be reflected as the cultural change required to move from a fire-fighting approach to
running the business to one which is based upon 'planning, prevention and
improvement' (Dale and Cooper, 1994). Alternatively, the nature of the change may
reflect a whole system perception of TQM where implementation will require changes
to the way the business itself is run thereby addressing change on multiple fronts
(Davis, 1997). However, although the authors refer to TQM, not all are explicit about
what 'it' is, or the organisational context in which 'it' has been implemented. Whilst this
does not preclude the identification of general themes, it suggests that any comparison
of the issues raised by the authors in Table 3.10 on a like for like basis may be of
limited value.
58
Table 3.10: Barriers to TQM implementation
8 TQM pitfalls (Katz, 1993) Common mistakes made by 10 reasons why total
senior managers (Dale and quality fails (Brown, 1993)
Cooper, 1994)________
1. CEO delegates 1. Lack of commitment, 1. Disguising cost control as
responsibility for TQM awareness and vision TQ
2. Failing to recognise that 2. Failure to commit sufficient 2. Measuring too many of the
every company and time to learn about TQM wrong things
environment is different 3. Failure to become 3. Lack of support from the
3. Applying tools of TQM personally involved in top
before needs determined planning for its introduction 4. Too much too soon
and direction established and development 5. Too little too late
4. Conducting training before 4. Underestimating the 6. Dual structures
support for TQM resources needed to start 7 Focus on activities vs.
5. Training employees before and develop a process of QI results
managers 5. Not establishing an 8. Can't get out of phase 1
6. Overemphasis on technical effective infrastructure 9. No one gets rewarded for
tools over personal skills, 6. Not committing sufficient quality and customer
leadership and management resources to TQM satisfaction
7. Failure to incorporate education and training 10. Total quality as a fad
suppliers 7. Treating output and cost
8. Not celebrating success targets as the main business
priorities
Breakdowns in TQM Obstacles to full TQM Common barriers to

(Davis, 1997) (Yong and Wilkinson, implementation (Whalen
1999) and Rahim, 1994)
1. Failure to execute 6 Lack of senior level 1. Poor planning

fundamentals leadership 2. Lack of management
2. Lack of focus and Lack of long-term strategy commitment
dissipation of resources or vision 3. Resistance of the workforce
3. Creation of a separate TQM Lack of time 4. Lack of proper training
organisation Lack of resources and 5. Teamwork complacency
4. Poorly integrated infrastructure 6. Use of an off-the-shelf
complimentary Lack of action and programme
management programs consistency 7. Failure to change
5. Inadequate linkages with Lack of middle organisational philosophy
financial results management commitment 8. Lack of resources provided
Fear among front line 9. Lack of effective
employees measurement of QI
Values and attitudes of
organisational actors
Barriers between
departments/functions
High labour turnover
Cultural issues
Certification and
measurement issues
59
Table 3.10 contd: Barriers to TQM implementation
Pitfalls to implementation Problems (Krishnan, Shani, Problems (Newall and Dale

(Kanji, 1996) Grant, Baer, 1993) 1991)
MD undermined creation of Confusion from pursuit of Management commitment

constancy of purpose multiple quality initiatives Hostility
2. MD failed to adopt new Inability to translate broad Reluctance to change
philosophy quality goals into Outdated working practices
MD failed to become a quantitative targets Lack of drive and
leader of change Appropriate organisational determination by senior
4. MD would not resource structure for managers
training implementation Poor managerial skills
5. MD management style Communication difficulties Union relationships
relied on fear and Managing transition from Individual performance
intimidation individual to organisational appraisal
6. MD created barriers learning
between departments Emphasis on short term
7. MD inhibited growth of profits
learning culture Lack of understanding
8. MD allowed certain people
to become overworked Kolesar, 1995
9. MD failed to make
decisions based on evidence Failure to manage by fact
10. MD blocked company-wide Initiatives running out of
CQI gas
11. MD made teamworking and Lack of infrastructure to
quality improvement support problem solving
second Lack of understanding
12. MD created policies in Delegation of
secret implementation
Indicate posturing-
implementation gap
Rather than trying to fit the elements in Table 3.10 into a single taxonomy, perhaps the
value lies in their diversity. These authors identify a wide range of issues which,
collectively, appear to encompass many aspects of the total system. To illustrate this,
elements have been selected and aggregated in a whole system framework (Miles,
1997) which illustrates the pervasive nature of the potential barriers to successful TQM
implementation.
60
Table 3.11: A whole system view of the barriers to TQM implementation
1. Vision 4. Infrastructure 6. Competencies

• lack of vision • poor communications • teamwork issues
• total quality as a fad • poor planning • managerial skills
• lack of focus • lack of measurement
2. Strategy 5. People 7. Culture

• lack of strategy • lack of training/education • values/attitudes
• uncoordinated activity • workforce resistance • organisational philosophy
• lack of time • front line fear
• lack of resources
3. Structure
• lack of leadership
• lack of management
commitment/responsibility
• lack of implementation
structure
According to the experience of one author (Kolesar, 1995), the issues he has
highlighted (Table 3.10) are 'not isolated horror stories unfairly selected from
otherwise healthy TQM implementations'. Thus, as seemingly common occurrences,
these issues represent important challenges to the implementation of TQM not only in
relation to the process itself but ultimately to the quality of the outcome achieved.
Whether an awareness of such challenges originates from the experiences of others or
from an internal analysis of TQM initiatives which have failed to deliver the results
anticipated, Katz (1993) warns that organisations that fail to identify and address such
pitfalls do so at their own peril. These organisations tend to seek 'afresh TQ Something
Else' (Kolesar, 1995) which Brown (1993) regards as a 'waste of time when we haven Y
properly applied what we have'.
Given that CSFs and other aspects of implementation are highly context-specific, Black
and Porter (1996) suggest that the nature of TQM has now passed beyond trying to
capture it in convenient taxonomies and instead the research effort needs to focus on
61
the practical experiences of organisations. In light of these comments, the next section
will focus on case studies of TQM implementation.
3.4.4 Implementation Case Studies
In the preface to their collection of cases, Oakland and Porter (1994; p xxii) claim that
'the value of illustrative cases in an area such as TQM is that they inject a reality into
the conceptual frameworks developed by authors in the subject '. They go on to argue
that cases based on real situations provide a useful basis for analysis, evaluation and
comparison with one's own experience. Such cases may also serve as a learning
vehicle for groups to work through the issues raised in the safety of a theoretical
exercise without the responsibility of actual operationalisation.
Presentation of cases appears to take a variety of forms, not just in terms of single or
multiple cases but also a range of approaches within these two variables. Oakland and
Porter (1994) have arranged their cases in sequence to illustrate aspects of the 'Bradford
Model' of TQM which serves as the conceptual framework. Thus cases are included
which highlight specific issues around, for example, the 'foundations' of TQM, the role
of the quality systems, tools, techniques and measurement and so on. Olian and Rynes
(1991) adopt a similar approach; having identified a set of organisational processes to
support the implementation of TQM, the authors (ibid) then present well-known
companies such as Motorola and Honda as practical examples of the theory discussed
within the text.
In order to follow the implementation of TQM over a period of time, longitudinal case
62
studies have been undertaken which have enabled researchers to compare and contrast
approaches between study sites against selected criteria. A study carried out by Newall
and Dale (1991) looked at eight companies, in both manufacturing and service
industries, in respect of: quality department organisation, the introduction and
development of quality improvement, employee involvement, measurement of progress
and problems encountered with TQM introduction and subsequent development. The
paper highlights similarities and differences between the cases across these dimensions
and concludes that the majority of problems experienced throughout the
implementation process were the result of poor planning by the study sites.
Lillrank and colleagues (Lillrank, Shani and Kolodny et al, 1998) researched eight
companies in eight countries over a three year period to understand how they organised
for continuous improvement. Seven design requirements and seven corresponding
design elements are identified. A comparative analysis is presented across these cases
together with a discussion exploring the rationale underpinning the design choices
made. The authors conclude that there is no 'one best way' to design for continuous
improvement and suggest that whilst it might be wise not to transfer specific
programmes from one context to another, the design requirements might in themselves
be more transferable (Table 3.12).
Table 3.12; TQM design requirements_________________________

1. Is continuous improvement part of ordinary work (integrated) or not (parallel);
2. Is continuous improvement work performed at a permanent group or task group;
3. Are the group members from one or several functions;
4. Are the group members from the same or different levels;
5. Is goal setting made centrally or in groups;
6. Are decisions about implementation made by the management hierarchy or the group;
7. Are incentive and compensation systems to be used to reward effort and results.
Lillrank, Shani and Kolodny et al (1998)___________________________________
63
Single cases have included both private and public sector organisations. Some deal
specifically with TQM implementation in small and medium enterprises (SMEs) (Goh
and Ridgway, 1994; Yusof and Aspinwall, 2000c) and seek to demonstrate that they
incur particular problems during implementation due to their size and, consequently,
should not be treated as small versions of large organisations. Whilst this may certainly
be wise advice, one could argue that some of the specific issues highlighted, such as
lack of resources in terms of time, finance and human resources are not confined to
these smaller enterprises and this is supported by similar work with large organisations
(Dale and Cooper, 1994). Other authors have focused on large corporations and
illustrate the challenges of TQM implementation faced by both the private and public
sectors. Thus the experiences of a range of companies/organisations are captured and
presented as a case study format; these include commercial companies such as an
aluminium manufacturer (Kolesar, 1993), a manufacturing company in the oil
distribution industry (Snowberger, 1996), a telecommunications company (Krishnan,
Shani, Grant and Baer, 1993), oil pipeline and transport (Anderson and Adams, 1997)
through to the efforts of federal government (Dobbs, 1994).
Whether multiple or single site approaches are adopted, each provides valuable insights
from a variety of perspectives and those of Newall and Dale (1991) and Lillrank and
colleagues (Lillrank, Shani and Kolodny et al, 1998) have been cited above as
particular examples. From a careful study of cases, the reader is also likely to
determine similarities in terms of approaches, issues needing to be addressed, obstacles
experienced; however, the depth with which the cases may be explored often varies.
Common elements have been included as Table 3.13.
64
Table 3.13: Common themes from TQM case studies
• Senior management commitment/Leadership;

• Middle managers - their new role as coach/facilitator, threats to
their power base, potential or actual obstacles;
• Approaches to training and education;
• Teams - problem-solving; training and support needs;
• Stages/phases of implementation;
• Tools and techniques;
• Change - TQM fundamentally about change;
• Culture - culture to support CQI.
Diversity seems to be a common thread running through much of the TQM literature.
In the previous section, it was suggested that this needs to be acknowledged as a
pervasive feature. Perhaps it is a function of the lack of any precise definition of TQM
and the likelihood that there is 'no one best way' with regard to implementation
(Lillrank, Shani, Kolodny et al, 1998). In addition, issues receiving attention are likely
to be highly context specific; their inclusion reflecting the impact relative to other
aspects which, although relevant, may be obscured, perhaps not reported, but no less
present in the case (Oakland and Porter, 1994). The conceptual frameworks which may
have served as the lenses for the inquiry are not always as explicitly stated as in the
work of Oakland and Porter (1994) or Newall and Dale (1991) and, irrespective of
whether they are explicit or implicit, conceptually they may be quite different. As a
related but different point, given the argument that the implementation process is highly
context specific (Lillrank, Shani, Kolodny et al, 1998), it is perhaps relevant to note that
the level of contextual detail provided as background to the studies also varies. This
may have implications for the value of the case study as a learning vehicle where one is
hoping to make a comparative analysis between the case organisation and hypothetical
or real organisation experience.
65
The value of a case study could be encapsulated in a statement such as 'interesting as
far as it goes'. This should alert the reader to the fact that the case is not likely to be the
entire picture but rather a simplification which may bring an associated danger - 'the
danger of making implementation seem clear-cut and obvious' (Oakland and Porter,
1994; p xxi). Although the espoused premise guiding implementation may be that
TQM is a philosophy of management, a way of running the business, this does not
necessarily mean that the reader will get a sense of the whole system implications of
implementation from the cases. For example, Olian and Rynes (1991) address many
aspects of not only the 'what' of implementation but also the 'how'. The authors (ibid)
argue that the key to establishing TQM as a way of life is to bring all of the key
elements into alignment which they sum up broadly in terms of people, processes and
outcomes; unfortunately, there is no direct mention of the need to develop a structure
and infrastructure to support the processes described.
So far the discussion of TQM generally and cases in particular has largely been
confined to the literature from the industrial sectors. This has provided a useful
background for the main focus of this thesis and the remainder of this section will now
concentrate on TQM and CQI in health care.
3.5 TQM AND CQI IN HEALTH CARE - A GENERAL OVERVIEW
3.5.1 TQM - An Ambiguous and Hazy Concept within Health Care
Although contributors to the field of TQM and CQI in health care recommend that we
go outside of this context and investigate alternative models (McLaughlin and Kaluzny,
66
1990), the decision to start with the literature around TQM in industry largely followed
from an earlier sense of confusion generated from an initial scanning of the literature on
TQM and CQI in health care. This initial foray was accompanied by growing
confusion; terminology such as TQM and CQI is used interchangeably by some authors
(Shortell, O'Brien, Carmen et al, 1995; Motwani, Sower and Brashier, 1996; Zabada,
Rivers and Munchus, 1998), or defined as separate entities by the some of the same
authors (Shortell, Levin, O'Brien et al, 1995). There are also multiple definitions of the
concepts and characteristics; typologies of the key elements of TQM and CQI appear to
vary depending on the writer.
The rationale for looking at the industrial literature went along the lines of - TQM
started in industry over a decade before its spread to health care; therefore, there may
be greater clarity and consensus in that arena. As the discussion in the previous
sections would suggest, this search for clarity in another arena was built on an optimism
that turned out to be unfounded. The reality was indeed that a lack of clarity and
consensus was not confined to health care giving credibility to the description of TQM
as something of a "quagmire' (Nwabueze and Kanji, 1997). So as not to add to this
lack of clarity, for the remainder of this thesis, the abbreviation TQM' will be used to
denote the organisational framework that enables the process of 'CQI' to take place; the
terms will not be used interchangeably unless during the citation of other authors.
Recognition of the ambiguity described above was an important step forward but it also
suggested that many of the issues relating to the implementation of TQM and CQI in
health may be similar to those in industry. Although there are those who might
67
question the validity of this (Arndt and Bigelow, 1995), a degree of similarity is indeed
reflected in both literatures. In fact, a number of papers focusing on aspects of
implementation in health care seem to present models or sets of CSFs which appear to
have a generic flavour. For example, Nwabueze and Kanji (1997) claim that the failure
of implementation in the public sector is due to the absence of context-specific models;
the authors then present a model to overcome this which could easily be applicable to
the industrial setting. Jackson (2001) outlines a set of key actions for achieving
successful TQM implementation in health care - here again one could argue that, within
this approach, there is little unique to the health service context. These contributions
are interesting because they may serve as a challenge to the 'not invented here'
mentality described by Pollit (1996) and may even assist in the transfer of learning
from one industry to another; particularly with regard to the issues associated with
implementation.
3.5.2 The Challenge of TQM Implementation in Health Care
The challenges facing implementation in industry have been highlighted earlier in this
chapter; authors considering this notion from the health care perspective raise issues
related to a number of features which they regard as specific to this context. Short and
Rahim (1995) point to structural elements and comment on complex, bureaucratic
organisations which potentially limit cross-boundary working and communication.
Others note the presence of a culture of blame which may inhibit openness and cause
fear (Arndt and Bigelow, 1995) or the various subcultures (Zabada, Rivers and
Munchus, 1998) - related to which there is sometimes tribalism and even turf battles
(Wakefield and Wakefield, 1993). Wakefield and Wakefield (ibid) also draw attention
68
to the complexities of service delivery as opposed to manufacturing and batch
production which are considered to be easier to specify, control and measure. Still
others note that the complexity is compounded by the fact that the customer is a co-
producer of health care (Zabada, Rivers and Munchus, 1998).
Alternatively, one might take the view that the particular structural and cultural
challenges outlined above are unlikely to be confined to health care. Customer co-
production and the complexity of the service delivery process are a key characteristic of
services in general (Lovelock, 1992); however, the complexity is likely to vary
depending upon the nature of the service. Contrast, for instance, operative procedures
requiring the skill of the clinician with those of the highly regulated and scripted
delivery which occurs at some fast food outlets.
Whilst Blumenthal and Kilo (1998) share the view that many of the challenges to
implementation are not unique to health care, they also argue that there are exceptions
to this and offer two examples to illustrate this belief. The first concerns the wider
context in which health care organisations operate. The lack of competition means that,
unlike commercial organisations within a market where TQM may be considered a
matter of survival, those health care organisations that are meeting their financial
targets have little incentive to drive through the profound changes that TQM may
require. Attention may instead be focused elsewhere such as on expansion strategies
rather than the core business.
Secondly, the authors (ibid) see securing the involvement of medics as a key challenge.
69
This group is regarded as having considerable autonomy to practice which, before the
advent of clinical audit, was considered outside the remit of management. TQM may
be perceived as a challenge to both medical autonomy and independence and
consequently resisted. The authors also suggest (ibid) that medical training does not
prepare the profession for either TQM or CQI; instead, individualism is instilled
together with an allegiance to the profession. As a result, many medics find it difficult
to adopt the behaviours required to make TQM and CQI a reality - particularly with
regard to multi-disciplinary teamwork and notions of internal customer-supplier chains.
The challenge of securing medical involvement in TQM and CQI is a common theme
in the literature. Berwick and colleagues (Berwick, Godfrey and Roessner, 1990) point
to the fact that in terms of accountability, medics in the past have only, if at all, justified
their clinical decisions to each other and then only informally. Many fail to engage
with total quality for a variety of reasons; for example: they do not see its relevance to
their work believing they are already delivering quality care, thus the time involved in
improvement activity is regarded as an opportunity cost (Zabada, Rivers and Munchus,
1998). Some authors see implementation of TQM as requiring a paradigm shift.
McLaughlin and Kaluzny (1990, p9) present their perception of the professional and
TQM paradigms in Table 3.14 and this provides some indication of the likely 'shift'
that may be involved.
70
Table 3.14: The professional paradigm and the TQM paradigm
Professional TQM
Individual responsibilities Collective responsibilities
Professional leadership Managerial leadership
Autonomy Accountability
Administrative authority Participation
Professional authority Performance and process expectations
Goal expectations Flexible planning
Rigid planning Benchmarking
Response to complainants Concurrent performance appraisal
Retrospective performance appraisal Continuous improvement
Quality assurance
McLaughlin and Kaluzny (1990, p9)
In addition to the professional challenges, others relating to the health care context have
been identified. For instance, the patient as a consumer may now be gaining in terms of
Voice1 but is still unable to exert the pressure of the market mechanism and professional
knowledge and experience may still disproportionately reflect the shape of service
delivery (Wakefield and Wakefield, 1993). In the wider context, several authors have
brought to the fore a significant challenge to creating constancy of purpose - the
constant threat to goal deployment as a result of policy initiatives which seem to shift
the strategic goal posts (Kim and Johnson, 1994; Nwabueze and Kanji, 1997).
There is undoubtedly a vast US literature and an ever growing UK literature relating to
the implementation of TQM and CQI in health care to which academics, consultants
and practitioners have all made a significant contribution. There is much to be learned
from this wealth of writing and especially from the results of large-scale evaluations of
TQM implementation. Two such studies are of particular importance; one of which
took place in the UK NHS and the other in the Norwegian health care system. Both
studies provide a rich picture of the challenges posed by the attempt to implement TQM
71
and serve as important lessons for those involved in the more recent whole system
approach to quality management in the NHS - clinical governance. A brief overview of
each research project will now be presented.
3.6 EXPERIMENTING WITH TQM IN THE UK NATIONAL HEALTH

SERVICE AND THE NORWEGIAN HEALTH SERVICE
In 1989, a Department of Health initiative to pilot the implementation of TQM was
launched. Researchers subsequently evaluated the approach to quality improvement
adopted by sites in 12 health authorities over a three year period; eight of these were
taking part in the pilot and a further four non-TQM sites were studied as comparators
(Joss, Kogan and Henkel, 1994; Joss and Kogan, 1995). In 1993, three Norwegian
hospitals were selected by the Norwegian Medical Association to act as test sites for the
implementation of TQM and funding was provided. The three pilot sites and three
other hospitals (which did not receive additional funding) formed a network and met at
regular intervals to share their experiences and learn from each other. The quality
journeys of these six were evaluated over a four year period (0vretveit, 1999;
0vretveit and Aslaksen, 1999).
72
Table 3.15: Factors predictive of TQM movement
1. Demonstrated senior management commitment to and understanding of TQM;

2. A well-developed and well-documented implementation strategy put in place with clear
objectives, time-scales, action plans, and review mechanisms;
3. Strong/persevering TQM co-ordinator - board level appointment or at least direct access to
chief executive;
4. Structure overseeing implementation of TQM; strategy for integrating this with normal line-
management meetings as soon as managers are trained and continuous improvements have
moved out to front line staff;
5. Comprehensive baseline assessment of service quality;
6. Early effort to gain the support of the medical consultants;
7. Sufficient funding for TQM facilitators;
8. Standard setting only as part of strongly monitored CQI;
9. Comprehensive training using mixed classroom/workplace model; tools and techniques not
just awareness;
10. Explicit strategy/resources for recognising and rewarding progress;
11. Organisational changes only after evaluation.
Joss and Kogan (1995; p!51)
The authors of the final project report on the UK experiment (Joss, Kogan and Henkel,
1994) offered a number of factors which they regarded as predictive of significant
TQM movement (Table 3.15). Although the researchers acknowledged that there was
an extensive range of quality improvement initiatives taking place in the pilot sites and
that there had been a shift towards aspects of TQM practices, this was considered to be
variable not only between but also within sites. Overall, apart from two sites,
implementation was considered to have been unsuccessful and the final report
documents deficiencies across all 11 of the factors cited above. Those researching the
Norwegian TQM pilots (0vretveit, 1999; 0vretveit and Aslaksen; 1999) do not appear
to express any overarching view of the success or otherwise of the initiative. However,
the impression gained from their reports (ibid) is that although there were examples of
73
positive initiatives taking place, this did not constitute an integrated approach to quality
management. It would also seem that many of the implementation gaps highlighted in
the Norwegian hospitals relate to similar factors as those identified in Table 3.15 which
are derived from the UK experience.
Both of these evaluations provide extremely valuable insights into earlier efforts to
establish a whole system approach to quality within the UK NHS and within a
mainland European health system. Both experiments appear to have suffered, at least
in part, from a combination of partial implementation, implementation failure and non-
implementation. Progress was not uniform, in fact, it varied between and within sites.
The experiences of TQM implementation noted above suggest that many of the
challenges facing the pilot sites echo those identified in the earlier part of this review
dealing with barriers, pitfalls and so on. It would seem therefore that these are
problems not reserved for TQM in commercial settings but are also apparent in the
public sector. The identification of the 11 factors described in Table 3.15 should serve
as an important signpost for those presently implementing clinical governance in the
NHS as should the lessons from the wider TQM literature presented in this chapter.
The challenges to the successful implementation of TQM appear pervasive and pose a
significant threat to the unwary who do not learn lessons from those who have gone
before.
3.7 CHAPTER SUMMARY
This second part of the literature review has focused on quality in general and TQM in
particular. The literature has given a flavour of the complex and contested nature of
74
health care quality and provided an overview of the complexity surrounding TQM both
in industry and in the health sector. Far from being able to glean any form of
universally supported 'received wisdom1, the concept appears hazy and contested and
there is certainly no blueprint for the implementation process. Instead what seems very
apparent is that TQM is not for the faint-hearted as it poses a significant challenge to
the organisation which stems from multiple sources. The risk is that implementation is
only partial, perhaps only a watered down version of what the whole approach should
be. This lack of attention to the notion of wholeness may result in an initiative that
never achieves its full potential; perhaps because of the way it has been conceptualised
and/or gaps in the implementation process. The barriers to the successful
implementation of TQM are many, varied and well-documented. As such, they should
serve as valuable signposts for those wishing to avoid the pitfalls that await the unwary;
especially when the change that accompanies total quality is of such transformational
proportions.
One aspect of TQM for which there is some degree of consensus, in the literature at
least, is that an inherent feature of TQM is the notion of change. This is succinctly
expressed by Berwick (1996) who notes that while all change does not involve
improvement - all improvement involves change. Given the central role of change in
improvement, the next chapter will consider the notions of both change and change
management.
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CHAPTER 4
LITERATURE REVIEW - CHANGE AND CHANGE

MANAGEMENT
'In a changing world the only constant is change'

(Carnall, 1999; p!43)
4.1 INTRODUCTION
The phenomenon of change whether at the level of an industry or an individual
organisation has attracted considerable interest for decades. Whilst agreeing that
concepts of change originating in the private sector should not be 'mechanistically
trundled across the sectoral divide', Pettigrew and colleagues (Pettigrew, Ferlie and
McKee, 1992; p5) suggest a preoccupation with difference and sectoral transfer has
limited the extent to which understanding of the change processes observed within the
NHS has been informed by the wider literature. The authors (ibid) acknowledge that
there are sectoral differences - particularly in terms of politicisation and also the power
and social position of the professionals, but they argue that there are enough similarities
between the private sector and the NHS for experience gained in the former to
illuminate thinking in the latter.
An issue both sectors appear to share is the challenge of effective change management.
Tushman and O'Reilly (1996) ask why, when 'organisations are filled with sensible
people and usually led by smart managers' is change so difficult. In the context of
health care, the 'implementation deficit' is a problem commonly identified by
researchers (Ferlie, 1997). Ferlie (ibid) argues that the increasing awareness of the sort
of difficulties experienced by organisations seeking to deliver the change agenda has, in
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part, fuelled the emergence of the change management literature. This has increased
recognition that the change process can be facilitated (lies and Sutherland, 2001) and
should be managed (Nadler and Tushman 1995; Anderson and Ackerman-Anderson
2001; Cummings and Worley 2001).
Total Quality Management is considered by some as an important vehicle for delivering
large-scale change (Ferlie, 1997). TQM implementation frameworks were presented in
the previous chapter; this part of the literature review will continue with an exploration
of more generic change models. However, before reviewing the change management
literature and, in deference to Anderson and Ackerman-Anderson's warning (2001) that
change needs to be understood before it can be managed, theories of change will be
presented together with an overview of the more common conceptualisations of change
as a phenomenon.
4.2 THEORIES OF CHANGE
It appears that the literature on organisational change is not only diverse but at an early
stage of theoretical development (Dunphy, 1996). The author (ibid) observes that there
is 'no one, all-embracing, widely accepted theory of organisational change and no
agreed guidelines for action by change agents'. This diversity not only reflects the
complexity of the phenomenon but also the range of concepts imported from other
disciplines in an effort to increase understanding - punctuated equilibrium (Gersick,
1991), sense making and sense giving (Gioia and Chittipeddi, 1991), even tectonic
plates (Reger, Gustafson, Demarie et al, 1994). Given the complexity of the field,
Dunphy (1996) asks whether a search for some unitary theory would even be a
77
legitimate endeavour. On a similar theme, Hawkins (1997) advocates the use of
different lenses for organisational analysis arguing that this 'polyocularity' provides a
variety of perspectives which will ultimately lead to a more holistic view of the field.
Van de Ven and Poole (1995) make a similar point to those above and warn that
applying a single perspective will reveal only a partial account of a complex
phenomenon and advocate instead alternative pictures of the same organisational
processes. They offer four theories which they suggest might serve as the building
blocks for explaining the processes of organisational change; namely: life-cycle,
teleology, dialectics and evolution. They suggest the value of this approach is that
other theories tend to relate to outcomes rather than the process itself which is of
particular interest here, given the intended focus on both aspects of implementation,
and therefore worth presenting in a little more detail.
According to life-cycle theory, change is imminent and pre-programmed although
influenced by the environment. Change progresses as a unitary sequence of
phases/stages which must take place in a prescribed order because each is a precursor to
the next. Teleological theory assumes that the entity is purposeful and adaptive;
capable of constructing an end state, taking action to reach it and monitoring progress
along the way; development is seen as progression towards the goal although the
trajectory is not necessarily sequential as in the life-cycle theory. Dialectical theory
acknowledges the pluralistic nature of organisations and the presence of competition,
conflict and political activity. Change occurs when the status quo is overthrown but the
political process may equally sustain the status quo. Finally, evolutionary theory sees
78
the change process as a continuous cycle of 'variation, selection and retention' and, in
this way, is influenced by the natural sciences. Thus evolutionary change is ongoing,
incremental and cumulative. The authors (ibid) suggest that the four theories within
this typology offer fundamentally different explanations of the change process but
caution that they should be regarded as 'ideal types' and that change within
organisations is more complex than any one theory taken alone.
The following section will explore a number of ways in which change may be
conceptualised; the reader may recognise shades of the theories presented above in the
concepts that will now be considered.
4.3 CHANGE CONCEPTUALISED
4.3.1 Incremental and Discontinuous Change
Whilst acknowledging the theoretical pluralism surrounding the notion of change,
Wilson (1992) highlights a certain homogeneity in the language used to describe this
pervasive phenomenon. According to Nadler and Tushman (1995), at the broadest
level, there are two types of organisational change - incremental and discontinuous.
Writers on change seem to adopt a variety of synonyms in differentiating between the
two and, in addition to incremental/discontinuous change, references to first
order/second order, evolutionary/revolutionary, developmental/transformational,
continuous/episodic change may be found in the literature (Pettigrew, Ferlie and
McKee, 1992; Van de Yen and Poole, 1995; Weick and Quinn, 1999; Anderson and
Ackerman-Anderson, 2001; Cummings and Worley, 2001).
79
In describing incremental change, Nadler and Tushman (1995) present the phenomenon
in the context of organisational effectiveness where modification and improvement is
ongoing with the aim of continuously refining the fit between the strategy of the
organisation and components of the internal system. Such changes tend to be focused,
occur over a finite period of time - usually weeks/months; they are not necessarily
small, on the contrary some change may be significant in terms of the resources needed
and their subsequent impact. However, incremental changes are usually bounded by
the existing values and mission of the organisation and, in this sense, are within the
current organisational frame and so essentially concerned with continuity.
hi contrast, the focus of discontinuous change is on the creation of new configurations
rather than improvements to status quo; thus, a new strategic direction may be the
outcome accompanied by a radical reconstruction of the entire delivery system in
support of this. According to Nadler and Tushman (1995), discontinuous change
requires a complete break from the past; instead of working within the existing frame,
the goal is to change the organisational frame completely. This degree of change is
often associated with a degree of shock and is even painful and traumatic.
Discontinuous change is usually related to major change in the industry in which the
organisation operates.
Adding to the perspective outlined above, Weick and Quinn (1999) argue that
incremental change is characterised by learning and driven by an organisational
alertness and an inability to remain inert which reinforces the previous notion of
organisational effectiveness. This type of change tends to take place at the micro-level;
80
is therefore faster and consists of 'mini episodes' which could subsequently serve as the
building blocks for transformational change. In contrast, discontinuous change is
characterised by replacement and often triggered by the organisation's failure to adapt
incrementally. This type of change is strategic thus wider in scope and slower to
achieve.
As highlighted earlier, there is a certain amount of consistency in the literature
concerning the basic typology of change and its characteristics at a general level.
However, there are those who challenge the notion that discontinuous change requires
'a complete break from the past' (Nadler, and Tushman, 1995). In contrast, Goodstein
and Burke (1991) argue that frame-bending change does not imply wholesale, complete
change 'in any and all respects', some things inevitably stay the same which is
important for those experiencing the change:
'......the principle here is that for people to be able to deal with

enormous complex change - seeming chaos - they need to have
something to hold on to that is stable'. (Ibid).
According to Hamel (2001), it is more the balance between keeping hold of what is still
relevant and not being afraid to let go of what may have served the organisation well
but is no longer appropriate given the nature of the change.
Anderson and Ackerman-Anderson (2001) present a variation on the two dimensional
typology presented above and offer three types of change which are described in terms
of developmental, transitional and transformational. Developmental and
transformational change appear similar to the notions of incremental and discontinuous
change outlined earlier. Transitional change appears more as an interim point in the
81
incremental - discontinuous continuum and is offered as a response to more complex
environmental drivers which require replacement rather than improvement but not in all
components of the business. Inclusion of the notion of transitional change is a useful
reminder of hybrid forms however, it should not be confused with the notion of
transition. In the generic change implementation model developed by Beckhard and
Harris (1987), transition denotes movement from the current to future state irrespective
of the nature of the change.
In addition to this initial deconstruction of change presented by Nadler and Tushman
(1995), the authors have added another dimension, i.e. time, to that of continuity
(incremental/discontinuous). They reason that by differentiating between reactive and
anticipatory change and combining these with the continuity dimensions, a further four
types of change may be identified; each of which they regard as characteristically
different (Table 4.1).
Table 4.1: A matrix of continuity and time (Nadler and Tushman, 1995)
Incremental Discontinuous
Anticipatory TUNING REORIENTATION
Reactive ADAPTATION RE-CREATION
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4.3.2 Planned and Emergent Change
Another perspective on change relates to the extent to which it occurs as a result of a
deliberate effort or whether it emerges over time; these aspects are generally referred to
as planned and emergent change respectively. A recent review of the change literature
(lies and Sutherland, 2001) touches on both of these notions and defines planned
change as 'deliberate, a product of conscious reasoning and actions' (ibid, pi4).
Others, such as Cummings and Worley (2001) present a more detailed treatment of
planned change. In particular, they draw attention to the role of Organisation
Development (OD) in planned change efforts which, they argue, has moved from an
earlier concentration on incremental changes to one which increasingly incorporates
large-scale, discontinuous change. The authors (ibid, p39) are at pains to debunk the
criticism of planned change as a 'rationally controlled, orderly process' and highlight
instead:
'...... (its) chaotic quality, often involving shifting goals, discontinuous

activities, surprising events and unexpected combinations of changes.'
This chaos is often compounded in their opinion by managers who initiate change
without having any clear idea of either their goals or strategies for achievement. In
contrast, emergent change is described as a phenomenon which 'unfolds in an
apparently spontaneous and unplanned way' (lies and Sutherland, 2001; p!4). The
process is characterised by drift rather than design and presumably without the
deliberate intent which characterises planned change.
4.4.3 Ideal Types and Composites of Change
The body of literature surrounding change is massive and yet the phenomenon itself is
83
one which is often poorly understood and managed (Goodstein and Burke, 1991). The
preceding discussion has attempted to present just some of the conceptualisations of
this subject and, because of the vastness of the literature, this constitutes a small
proportion of the thinking in the field around how change might be viewed. Different
approaches offer different perspectives and insights and most of that which is presented
here takes the form of what Van de Ven and Poole (1995) refer to as 'ideal types'.
These serve not only as a valuable simplification tool but also as a mechanism for
organising thinking around change (Ferlie, 1997). Ideal types contrast with the reality
of the change process which is infinitely more complex whether at the level of an
industry or an individual organisation.
The reality of complex change is not bounded by either/or decisions but represents
composites of some/all of the elements outlined within the depictions of ideal type. For
instance, with regard to the notions of planned and emergent change, Pettigrew and
colleagues (Pettigrew, Ferlie and McKee, 1992), lies and Sutherland (2001) and
Cummings and Worley (2001) are keen to dispel the 'myth' of the linear change process
which seems to form the basis of criticisms of planned change. Even planned change is
likely to demonstrate emergent properties; Klein (1995), concerning the 1991 NHS
reforms, comments that 'the dynamics of change once unleashed, created their own side
effects and surprises.' This is perhaps to be expected given the author's earlier
observation that: 'the plans as initially announced were little more than outline
sketches. The details were filled in during the course of implementation' (Ibid). Given
the emergent nature of clinical governance as a policy, it seems that Klein's comments
are as relevant today as almost a decade ago.
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Continuing with the theme of composites, Wilson (1992) suggests that change is a
relative concept and therefore, it is more appropriate when considering organisational
change to think in terms of the degree of change taking place rather than
conceptualising it as the antithesis of stability. Nadler and Tushman (1995) make a
similar point - even when organisations appear to be going through a period of inertia,
they are not standing still. In this, Tushman and O'Reilly (1996) see the seeds of a
dilemma for managers. In the short term they are constantly struggling to increase the
degree of internal and external alignment but this evolutionary change is not enough for
sustained success. In the long run they may be required to destroy the processes which
have delivered the very alignment that has made the organisation successful.
Organisations need to become 'ambidextrous' and operate in a world that is
characterised by periods of stability and incremental change whilst at the same time
remain alert to the triggers for revolutionary change. As Pettigrew and colleagues
(Pettigrew, Ferlie and McKee, 1992; p299) observe, there is 'no respite from the ever
present duality of holding together an organisation -whilst simultaneously reshaping it'.
Given this enduring challenge, it is perhaps timely to explore the principles of change
management and identify models which might assist managers in the delivery of the
change agenda.
4.4 CHANGE MANAGEMENT
Whilst cliches such as the one cited at the beginning of this chapter are seemingly
abundant (Goodstein and Burke, 1991), they are still likely to strike a chord with those
currently working in the NHS - despite the New Labour promise of evolution not
revolution in the health care arena (Department of Health, 1997). Whilst the NHS
85
reforms of 1991 brought change within the existing structure, the more recent reforms
have heralded a new configuration of the health economy. The scale of this change
serves as a challenge to Klein's comment (1995) on the Thatcher Government reforms
about which he observed that 'the exhausting convulsions precipitated by Working for
Patients have dampened the appetite for further change'. It seems that Klein (ibid) was
a little premature in making this observation.
To facilitate the management of this most recent programme of NHS reform, a review
of the literature on change management was commissioned (lies and Sutherland, 2001).
This document aims to provide an introduction to a range of approaches, models and
tools and presents each using a uniform format - description, use, evidence and
commentary. Certain elements such as culture, organisational politics and leadership
were apparently outside the scope of the review which seems a lost opportunity as these
often present the biggest challenge to the management of change. As an introduction to
change, the review makes a valuable contribution to the literature in that it highlights a
number of concepts and tools; particularly those that will assist organisational
diagnostics and planning. However, practitioners will need to look elsewhere for a
guide to actually leading and managing the transition from the present to the future
state because, apart from Soft Systems Methodology (Checkland and Scholes, 1990),
the review does not appear to include much in the way of models that deal with the
actual process of change.
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4.4.1 Models and Frameworks for Change Management
Although the literature does not tend to distinguish between frameworks and models
and these terms are often used interchangeably, Anderson and Ackerman-Anderson
(2001) see these as two separate phenomena. They argue that a change framework
essentially highlights the areas which will require attention during the change and cite
the Peters and Waterman (1982) 7-S Framework' as an example of this. In contrast,
they see change process models as offering guidance on the 'what', 'how' and in 'what
order' change needs to happen citing the Kotter model (1996) as an illustration. Whilst
the frameworks are regarded as static representations, the process models are
considered to be dynamic; serving as roadmaps and a 'thinking discipline' rather than a
'prescription for action' or a check list (Anderson and Ackerman-Anderson, 2001).
The distinction between models and frameworks will not be emphasised in this thesis in
deference to other authors cited such as Miles (1997) whose framework will be utilised
for the case study (Appendix 2). Although Miles refers (ibid) to his construct as a
framework, it is dynamic and captures the what and the how and therefore would
constitute a model under Anderson and Ackerman-Anderson's (2001) criteria.
Anderson and Ackerman-Anderson (ibid) argue that frameworks have a place as
educational tools but have little value in the field other than as an 'organising
construct'. From experience in the field I would argue that, in itself, is of value given
the complexity of the change process and the omissions that may occur in the absence
of either an explicit framework or a model of the change process. Perhaps it is more
about how frameworks are utilised; as the review by lies and Sutherland (2001)
87
demonstrates, frameworks in themselves may have limited value outside of a change
process model.
Given the breadth of the field of change management and the different disciplines that
contribute to the ever expanding literature, it is not surprising to discover that change
process models abound (Kotter, 1996; Miles, 1997; Pendlebury, Grouard and Meston,
1998; Anderson and Ackerman-Anderson, 2001; Cummings and Worley, 2001).
Perhaps the most famous change model is the notion of unfreeze-move-refreeze
presented by Lewin (1951); upon which most of the subsequent models seem to be
based. The sheer choice within the field makes the selection of a model a somewhat
daunting activity, particularly when used in an action research setting where the
research process includes on-going feedback to the organisation as well as data
collection. Given the variation in conceptual content found by the review cited earlier
(lies and Sutherland, 2001), it seems unlikely that a single model could capture the full
complexity of the change process.
In light of the above comments, three change process models have been selected for
inclusion in this review (Kotter, 1996; Miles, 1997; Pendlebury, Grouard and Meston,
1998). Although the models vary in terms of emphasis, detail, and level of abstraction,
taken together they appear to cover much of the complex ground relating to the
practical aspects of making change happen in real organisations. Kotter (1996) seeks to
provide an 'action plan1 for the change effort (Appendix 3) and is the more abstract of
the three models whilst Pendlebury and colleagues (Pendlebury, Grouard and Meston,
1998) seem to have developed more of a blueprint and reach a level of detail which
includes individual tasks (Appendix 4). Miles (1997) seems to be in the middle of this
continuum and offers a 'framework for transformation' which gets across the messiness
of real world organisational change (Appendix 2). The remainder of this chapter will
consider each of these models in greater detail.
4.4.2 Change in Eight Steps
Kotter (1996) presents an eight step change process which has been derived from the
common errors he has observed over time spent working with organisations to bring
about major change. He argues that each of the eight steps must be followed: steps 1-4
are concerned with 'defrosting' the status quo, 5-7 putting new practices in place and
stage 8 is about making the change 'stick. Each stage needs to be completed so that a
solid foundation is gradually established and later built upon which gives the
impression of sequential movement. However, Kotter (ibid) acknowledges that the
presentation of this step model of the change process is a simplification of reality; given
the complexity and messiness of real world change, the steps are more likely to be
operationalised as multiple phases. One of the key concerns appears to be that, under
pressure to deliver results, there is always the temptation to address stages superficially
or even miss them out altogether. In this event, it is unlikely that a solid framework
will become established; consequently early progress may soon lose momentum or any
change achieved ultimately may not become institutionalised.
4.4.3 Ten Keys to Effective Change Management
Pendlebury and colleagues (Pendlebury, Grouard and Meston, 1998) have identified
what they have termed The Ten Keys to Successful Change Management'. They
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propose that this approach constitutes a coherent whole; each of the keys fulfils a
different function and should not be regarded as a one-off activity. In fact, to maximise
the likelihood of success, they advocate that the keys are 'applied not only
simultaneously but continuously throughout the change process' (Pendlebury, Grouard,
and Meston, 1998; p41). Although it is acknowledged that each key may be more
active during different phases of the change process, this sense of simultaneousness and
the continuity of these components is rather contradicted by the detail around
implementation which appears later in their text. Here there is a recognition that,
certain, if not most of the keys need to be in play prior to delivery. There is a logic to
the fact that some keys will need to be applied in sequence and will ultimately overlap
perhaps intermittently, perhaps continuously; this lends itself to the notion of a critical
path which highlights/predicts how and when these overlaps may occur. The core
message is that all of the keys are considered to be essential to the success of the
change effort; omitting one will cause problems, the authors (ibid) argue that omitting
more than one will cause failure.
4.4.4 A Framework for Transformational Change
Miles (1997) moves away from the 8/10 taxonomies presented above. He offers a
framework which outlines the fundamental attributes of transformation which deal with
energy, vision, alignment and what is termed 'process architecture' and presents within
these main headings, clusters of activity which must be performed in order to achieve
the transformation required.
Miles (ibid) stresses that the effectiveness of the framework relies on two important
90
factors; the initial change condition and leadership. He argues for an assessment of the
initial change condition along the axes of readiness for change and resources available.
Anything other than a state of high readiness and high resources (which he
acknowledges to be 'a largely vacant space where only a few notable companies
manage to reside for long' [Miles, 1997; pll]) needs to be addressed before the
framework may be implemented. The other factor concerns the issue of leadership
which Miles (ibid) argues needs to be of a transformational nature in order to
successfully catalyse and steer the organisation through the complexity of the change
process.
Although a total system perspective is regarded as a vital ingredient of the process
generally, perhaps it should be considered as a third factor of the initial change
condition. This demands the transition to the future state takes place, not in a
piecemeal way, but through the simultaneous articulation of all elements which are then
orchestrated to deliver the vision. As with the two earlier models cited here, success
relies on the implementation of the whole approach; if the initiative lacks more than
one of the significant elements, once again failure is predicted.
Although each of the models discussed above may present the management of change
in different ways, there is a certain internal consistency amongst several areas of
content; these will now be considered under the heading of common themes.
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4.4.5 Common Themes
Vision-led change
In the event of large-scale, complex change which is characterised by long time-scales
and unanticipated events, it is unlikely that the whole change process will be knowable
let alone controllable. In such circumstances, by defining and making explicit the
fundamental goal of the organisation, the vision can serve as a compass by which the
organisation may steer a course through the turbulent time to come and, ideally, provide
a common sense of purpose behind which the organisation may unite. The key
challenge is the translation of this broad goal into tangible objectives capable of being
operationalised over a defined timescale.
With the exception of Pendlebury and colleagues (Pendlebury, Grouard and Meston,
1998) who refer to the re-engineering work at Leicester Royal Infirmary, many of the
examples cited in the models discussed in this section are taken from industry. As with
any generic approach, they need to be adapted and implemented sensitively according
to the individual context; this applies equally when the transfer is from one industry to
another or from organisation to organisation. As an example of the different industries;
the visioning process in a commercial organisation is closely aligned to the strategic
management process which seeks to address fundamental questions such as 'what
business would we like to be in given the current competitive climate'. In contrast, the
visioning process of an NHS organisation is likely to be determined largely by central
policy. As another example, lowering complacency and raising the sense of urgency
may be in response to the threat to the survival of a commercial organisation. In
contrast, the sense of urgency in the NHS is often generated by the time-scales that may
92
accompany the introduction of a new policy and failure to meet these is not so much a
threat to the survival of the organisation but often career-limiting for the Chief
Executive. Nevertheless, whilst the triggers for visioning sometimes differ between the
private and public sector, the process of developing the vision and defining how it is to
be operationalised is often similar.
Leadership and management
Leadership is a recurring theme both within the models discussed here and also in the
wider literature. However, successful change is not just a matter of effective
leadership; it also requires effective management - change does not 'just happen' and as
Kotter (1996; pi 29) notes - 'a balance of the two is required'. Deliberate management
intervention across the whole system is required if 'implementation drift' is to be
avoided. This refers to both the long term objectives and the short terms gains for
which management should actively plan; to passively hope for the achievement of
either is an unreliable tactic (Kotter, 1996). Whilst visioning is regarded as a leadership
function, Pendlebury and colleagues (Pendlebury, Grouard and Meston, 1998) suggest
that the responsibility for change management lies squarely with the managers. This
not only entails the translation of the vision into reality through the definition of
tangible objectives which are prioritised according to the resources available, but also
the operationalisation of these objectives through the management process; the essence
of which Kotter (1996; pi 28) describes as:
'......systematically targeting objectives and budgeting for them,

creating plans to achieve those objectives, organising for
implementation, and then controlling the process to keep it on track'.
93
Energy and capacity for change
Each of the three models refer to the energy required not only to shift the organisation
away from the status quo (synonymous with Lewin's notion of unfreezing [Lewin,
1951]) but also to sustain the momentum for what is likely to be a long haul. This
emphasises the need for the creation of a sense of urgency and an associated lowering
of complacency - a state secured by what Miles (1997) terms the process of
'confronting reality'. This involves an assessment of the current state which accurately
identifies the gap between that and the vision state; mechanisms to achieve this include
benchmarking, industry analysis and a review of internal strengths and weaknesses.
Although it is Miles (1997) who explicitly addresses the notion of the initial change
condition, the other models also highlight the need to create the capacity for change
through the allocation or re-allocation of resources which sends powerful signals down
into the organisation about what is considered to be important. There are also issues
around meeting the needs of the organisation in relation to knowledge and skills, not
only in terms of the new roles that might be needed but also with regard to the change
process itself in order to secure participation and involvement.
Organisational politics and political behaviour
Each of the models described in this section address the issues of politics and political
behaviour albeit under different headings; for instance, as the need to handle the power
dimension (Pendlebury, Grouard, and Meston, 1998), as the creation of powerful
coalitions (Kotter, 1996) or as the need to deal with the personal dynamics of change as
part of early energy generation (Miles, 1997).
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Holism and alignment
A common theme running through the change models is the notion of wholeness; that
success relies on the application of the whole approach leaving no scope for a 'pick and
mix' attitude. Another important and related theme is the notion of internal alignment;
that is, ensuring that all elements of the system are aligned and mutually reinforcing of
the vision. According to Miles (1997), the total organisational system consists of the
vision, strategy, structures, infrastructure, people, culture and competencies; given the
scale of the change required to move all of these aspects from the current to the future
state, it would be unreasonable to expect the new internal context to emerge in what
Miles (ibid, p48) refers to as 'a moment of cosmic creation'. Therefore all of these
elements need to be carefully orchestrated (a term used by both Pendlebury and
colleagues [Pendlebury, Grouard and Meston, 1998] and Miles [1997]) to create and
maintain dynamic alignment in a way that builds up the organisational capacity to take
forward the change effort given the resources available.
Each of the models deal with the core components of the alignment mechanism slightly
differently. Pendlebury and colleagues (Pendlebury, Grouard and Meston, 1998) and
Kotter (1996) seem to present them either as separate keys or separate steps. In
contrast, Miles (1997) presents these activities together as a cluster which he terms
'process architecture'. These components are regarded as key requirements if
alignment is to be dynamic and responsive to the changes that will be needed if the
organisation is to navigate through the fluidity of the transition state. It is
recommended that all these elements are put in place at the earliest opportunity and
remain so as appropriate throughout the life of the change initiative. This suggests that
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alignment is not regarded as a one-off activity but as an on-going process which adapts
in response to the feedback from the whole system as the change process itself
proceeds. As with all aspects of the implementation process, it seems the clusters of
activity which make up the process architecture need to be deliberately designed and
executed in a manner which, once again, is consistent with and mutually reinforcing of
all other aspects of the total system. A certain added value may be perceived in the
way that the Miles model (1997) highlights these components as an important cluster.
Practical experience suggests that these activities often get overlooked in the flurry to
change the 'hard' elements of organisational design.
Continuing with the themes of alignment and deliberate intervention, the 'hard' or more
formal elements such as strategy and structure are those which tend to be addressed
first. These are perhaps more tangible and generally respond quicker than the 'softer',
less tangible elements such as culture and people issues. Miles (1997) suggests that
there has been a mind set that if the 'hard' elements are changed, then the 'softer' design
elements such as organisational culture will automatically come into alignment;
however, the author (ibid) warns that this is not necessarily so and this will shortly be
expanded upon further in section 4.4.6.
Resistance is to be expected
Not only should there be deliberate action to align the system but each of the models
cited here concur that there needs to be deliberate action to confront and, where
necessary, remove any obstacles to this alignment. Resistance to change is regarded as
a normal response, and, as such, should be anticipated and addressed. More usually,
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this is through enabling people to contribute effectively to the change process but,
where efforts fail to get people on board, it may then be more appropriate to move
people on or out rather than allow them to serve as obstacles/barriers during the
transition. Power issues are also considered as an inherent part of any change process.
Power seeks to be increased rather than decreased (Pendlebury, Grouard, and Meston,
1998) and organisational change threatens to disturb the existing balance of power
whether this arises from formal or informal power bases.
4.4.6 Culture Change
Another of the 'softer' elements of the whole system is that of corporate culture; a term
which can sometimes obscure the fact that most organisations consist of a variety of
subcultures (Kotter, 1996). Pendlebury and colleagues (Pendlebury, Grouard and
Meston, 1998; p30) describe the culture of an organisation as 'the set of lasting values
shared by its entire staff'. Values and beliefs are, in themselves, invisible, but their
expression in the form of behaviour is often all too apparent.
There is a consensus amongst the models that culture change, for a variety of reasons, is
extremely complex but essential nevertheless as corporate culture is regarded as the
'anchor' which serves to institutionalise the change once implemented (Kotter, 1996).
Cultural change may take years to achieve in contrast to structural change which
sometimes take weeks or months; despite this, the cultural components of the change
need to be considered at the outset if alignment is to be achieved. Whilst culture may,
because of its very nature, be difficult to address directly and values are difficult to
change, an important mechanism to achieve alignment is the translation of the vision,
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not only into specific business objectives, but also into behavioural outcomes; the
modelling of which is monitored and for which people are held to account (Miles,
1997). Whatever deliberate intervention is advocated, it seems that culture change is
about the long haul rather than a quick trip and occurs last not first. Kotter (1996;
pi 56) offers the following as 'good rule of thumb ':
'... Whenever you hear of a major restructuring, reeingineering, or

strategic direction in which step I is "changing the culture", you should
be concerned that it might be going down the wrong path'.
4.5 CHAPTER SUMMARY
The aim of this chapter has been to provide an overview of change and change
management. This third and final part of the literature review has sought to highlight
the complexity of large-scale organisational change. Attention has been drawn to the
theoretical pluralism which surrounds the notion of change and is reflected in concepts
of incrementalism, transformation, emergence and intention (this latter referring to
planned change). It would appear that, in practice, organisational change is often
poorly understood and poorly managed. That it could and should be managed is
attracting increasing attention in the literature which is often practitioner/academic-
practitioner generated; the need for leadership and management is presented in terms of
'both/and' rather than 'either/or' components of the design process.
A number of change management frameworks have been included for discussion which
have varied in terms of detail and also in the level of abstraction. Common themes
within these have been identified; namely that large-scale change involves the whole
system, it is not entirely controllable, the destination is not always identifiable but may
98
unfold as part of the journey, transformational change of this kind is a complex and
often a messy undertaking. It is worth remembering that models/frameworks are a
simplification of reality but, as such, may serve as a useful tool in guiding the change
programme.
This chapter concludes the literature review per se; the following chapter will describe
in detail the process of translating the research questions into research findings.
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CHAPTER 5
RESEARCH METHODOLOGY
'The biggest enemy of your learning is the gnawing worry that

you're not doing it right...but any given analytical problem can be
approached in many useful ways'
(Miles and Huberman, 1994; p!4)
5.1 INTRODUCTION
Earlier chapters have attempted to provide a flavour of the 'newness1 of clinical
governance as a concept and highlight the fact that, although many of its key
components have been in existence for some time, the introduction of an integrated
framework for quality improvement constituted an innovation for the NHS when first
presented in the White Paper of 1997 (Department of Health). Although a number of
initial 'must do's' were made explicit in subsequent guidance (Department of Health,
1999), the absence of any definitive 'blueprint' meant that the interpretation of both
content and implementation at the local level was left largely to individual NHS Trusts.
A number of surveys have been published which provide a snapshot of clinical
governance across various regions (Conduit, Morgan and Willetts, 1999; Firth-Cozens,
1999; Latham, Freeman, Walshe et al, 2000; Walshe, Freeman, Latham et al, 2000). In
contrast, the aim of this research study was to uncover, in rich detail, what clinical
governance looked like in one NHS Trust in terms of content and to describe how this
policy was being turned into practice over a period of time.
This thesis provides an insight into the journey of one large organisation as it faces the
complex tasks of both translating clinical governance from words on paper into
something tangible and also implementing this in the real world setting. The purpose of
100
this chapter is to describe the rationale for the research design selected, to provide a
detailed description of how the research strategy has been operationalised, and to give
some insights into the methods used to ensure the quality of both the research process
and the results obtained.
In writing this chapter, I have been influenced by the comments cited below and have
tended to use the first person in order to give a sense of the choices I have made from
research design through to the delivery of this work:
'Many is the time I have ploughed through a desperately boring

methodology chapter, usually written in the passive voice... ...usually
your readers will be more interested in a methodological discussion in
which you explain the actual course ofyour decision-making rather than
a series of blunt assertions in the passive voice' (Silverman, 2000;
p235).
5.2 RESEARCH DESIGN
5.2.1 A Qualitative Framework to Provide a Flexible Approach
The newness of clinical governance and the requirement for local interpretation
suggested that an exploratory study would best reflect the fact that this particular field
of enquiry is still relatively unknown (Hedrick, Bickman and Rog 1993), constituting
what Marshall and Rossman (1998) regard as new territory. Under such circumstances,
where the phenomenon itself or variables of interest cannot be defined precisely in
advance, it is considered entirely reasonable for the research questions to be expressed
in broad terms (Maxwell, 1998; Marshall and Rossman, 1998). In Maxwell's (1998)
experience, it may even be the case that a significant part of the research needs to take
place before one can get any real sense of what the specific questions should be. This
study began with two primary research questions and these have guided subsequent
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design decisions; namely: what constitutes the local clinical governance agenda
(content)? and how has clinical governance been implemented (process)?
The questions outlined above are both exploratory and descriptive. Their main purpose
is to discover and describe, as far as possible, 'what is1 as opposed to 'how many'; the
ultimate aim being to present what Hedrick and colleagues (Hedrick, Bickman and
Rog, 1993) describe as a 'rich picture' of both content and process in relation to clinical
governance. The overall approach needs to serve a number of purposes: to capture the
'real world research' which Marshall and Rossman (1998, p21) describe as 'often
confusing, messy, intensely frustrating and fundamentally non-linear'', focus on events
taking place in their natural settings (Miles and Huberman, 1994); go beyond the
snapshot and capture complexity (ibid); remain flexible enough to allow the precise
focus of the study to evolve (Marshall and Rossman, 1998); and thereby capture
emergent insights (Maxwell, 1998). Consequently, in light of these requirements, I
decided that an overarching qualitative framework would be most appropriate for this
study. Whilst a qualitative framework has the capacity to address the kind of
challenges of an exploratory real world inquiry described above, the manner in which
research questions are translated into results is a function partly of design. Owing to
the newness of the phenomenon to be researched - clinical governance - this raises an
issue concerning the degree to which this design should be pre-structured.
5.2.2 Qualitative Designs
There is support in the literature for the proposition that qualitative designs do exist
and, in fact, it is argued by some that all research studies are based on a design albeit
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some are more deliberate and explicit than others (Miles & Huberman, 1994). This is
proposed on the premise that, as soon as decisions and choices are made within the
research process, whether in relation to sampling or data collection, the focus of the
study is becoming defined and must therefore be based on some form of design. The
degree to which this may be implicit or explicit appears variable (Miles & Huberman,
1994; Maxwell, 1998).
An ongoing debate seems to be taking place amongst writers on the extent to which the
research design should be structured prior to field work (Miles & Huberman, 1994;
Maxwell, 1998). Patton (2002) points to the emergent nature of design which partly
unfolds during fieldwork and this is echoed by Maxwell (1998). Miles and Huberman
(1994) suggest that a case can be made for loosely structured, highly inductive,
emergent designs on the one hand and highly structured designs based on a clear
conceptual framework with well-developed research questions on the other. However,
the authors argue (ibid) that looser designs can mean that everything looks interesting
and, as a result, may lead to massive amounts of data collection which might yield little
in the way of real insight. Tight, pre-structured designs may not be sufficiently
sensitive to the reality of the situation and the research questions could turn out to be
the wrong ones. Their own preference seems to rest near the centre of the qualitative
design continuum; a preference shared by others such as Robson (1993, p20) who
points out that 'free range exploring is seldom on the cards' and the skill, therefore, is
to have a general view of what is being sought whilst being open to the unexpected. A
similar approach is advocated by Bickman and Rog (1998) who recommend the
development of a 'tentative' plan with the proviso that this will be revised should
103
emergent insights indicate this is necessary.
The views referred to above tend to add weight to the proposition that qualitative
design should be regarded as an iterative process in which modifications are made
throughout the study to incorporate new developments (Hedrick, Bickman and Rog,
1993). This unfolding and emergent approach to inquiry requires that the researcher
remains open to a degree of ambiguity and uncertainty (Patton, 2002); however, this
may prove extremely daunting for the novice and, for this reason, others advocate
(Miles and Huberman, 1994) that the "beginning1 researcher adopts a tighter design to
provide greater clarity and focus.
5.2.3 A Conceptual Framework
With this debate in mind, I decided to take a more structured approach to the design
which would require the development of a conceptual framework. This sets out to
describe the main variables that will be the focus of the study (Miles and Huberman,
1994). The framework may be derived in a variety of ways: from the knowledge and
experience of the researcher, from existing theory and research, from the findings of
pilot and exploratory studies and from speculative approaches that consider 'what if
(Maxwell, 1998).
Just as with the earlier discussion around explicit/implicit qualitative designs, there is a
view that all studies are based on some form of conceptual framework, acknowledged
or otherwise (Hedrick, Bickman and Rog, 1993; Miles and Huberman, 1994; Maxwell,
1998). What seems to be important in terms of exploratory, qualitative research is that
104
although the framework forces the researcher to be explicit about the variables for
attention, it does not have to be definitive (Robson, 1993). Conceptual frameworks can
change particularly if regarded merely as a map of the current terrain (Miles &
Huberman, 1994) upon which one's position presumably changes over time.
Marshall and Rossman (1998) warn that, in exploratory studies, the existing literature
may not entirely address the initial research questions and, to overcome this gap, the
researcher needs to look at new ways of connecting existing knowledge with the new
concept or phenomenon which is the focus of the current study. As the earlier literature
review of clinical governance demonstrates, the empirical work in this area is very
much of an emergent nature and thus there was little to shape this research in the early
stages of the study. However, there is a massive literature surrounding quality and
change which has influenced both the development of the conceptual framework for
this study and the design in general. Although the TQM literature provides valuable
insights into implementation and clinical governance may, in fact, be TQM by another
name, I thought I would be on 'safer1 ground to choose a generic change management
model to serve as the conceptual framework and, in time, selected one developed by
Miles (1997). The general themes of this model have already been discussed in
Chapter 4 and a diagram of the adapted version is at Appendix 2.
The value of the Miles model (ibid) as a conceptual framework to guide this study is
that is appears comprehensive and accommodates both the 'what1 (content in the form
of transformation initiatives) and the 'how' (process). The model also supports a whole
system perspective and a dynamic, non-linear approach which seems consistent with
105
the 'messiness' of real world research referred to earlier. It can be seen from the
framework (Appendix 2) that the whole system view of content is nested within the
change management model itself; compartmentalising the framework in this way serves
as a reminder that variables may be duplicated under the content and process categories
- for instance, communication which could be part of the implementation process or as
an element of the end state.
The intention from the outset was to remain flexible and open to the need to adjust the
conceptual framework. In practice, the choice of framework proved to be entirely
appropriate; it was specific enough to provide a focus and yet broad enough to
accommodate inductively generated insights. In this way, the Miles framework (1997)
provided a consistent structure not only for data collection but also for analysis and
subsequent reporting. Articulating a framework is one thing, what is also needed is a
mechanism for getting from the research questions to the findings and this requires a
research strategy.
5.3 RESEARCH STRATEGY
5.3.1 Case Studies, Surveys and Experiments
Once the general purpose, broad research questions and a tentative conceptual
framework had been developed, the next step was to formulate the research strategy.
Robson (1993) outlines three main strategies: the experiment to measure the effects of
manipulating one variable on another variable; the survey which permits the collection
of standardised information from groups or individuals; and the case study which is
106
defined as:
'......a strategy for doing research which involves an empirical

investigation of a contemporary phenomenon within its real life context
using multiple sources of evidence' (Robson, 1993; p52).
The choice of a strategy should reflect the research questions to be answered. Robson
(ibid) suggests that experiments will answer how and why questions but the researcher
needs to be able to exert control over the variables in the study; surveys will answer
questions concerning who, what, where, how many/much whilst the case study is best
suited to how, what and why questions. These strategies are not regarded as mutually
exclusive; however, Yin (1994; p8) argues that the case study is preferred in 'examining
contemporary events... when the relevant behaviours cannot be manipulated'. Patton
(2002) adds that case studies are particularly valuable where the phenomenon is
individualised; clinical governance is a good example of this as implementation is
reliant on the local interpretation of policy and the translation of this into practice.
Thus, the views of Robson (1993), Yin (1994) and Patton (2002) would seem to point
to the adoption of the case study as the primary strategy although with the caveat that
there would need to be enough flexibility to allow the incorporation of a survey if
subsequently indicated. An experiment was not considered to be appropriate given the
aims and context of the research.
5.3.2 The Single Site Case Study
For the purpose of this thesis, the research focus is on the single case which, as is
generally the norm, was selected purposively (Robson, 1993; Miles and Huberman,
1994; Bickman and Rog, 1998); the main criteria being that it is likely to be what
Patton (2002) describes as 'information-rich1. Patton (1999) suggests that final selection
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is best preceded by pre-study fieldwork of some sort before committing to an intensive
period of study. In this respect, I was fortunate to have been involved in an earlier
study of NHS Trusts (Latham, Freeman, Walshe et al, 2000) and consequently had
some prior knowledge of the target site. In reality, any of the Trusts would probably
have been data-rich; whether the case study suggested non-, sub- or exemplary
implementation, this would constitute an important finding given the newness of the
clinical governance agenda per se. However, I considered the Trust selected to be of
particular interest because it conceptualised clinical governance as a vehicle for
learning, espoused a reluctance to follow a 'tick box' approach to implementation (thus
aimed at gaining hearts and minds commitment and culture change) and, finally,
articulated a strong focus on service users.
It was envisaged that the case study would be 'nested' (Yin, 1994) which would allow
me to follow clinical governance at both the corporate and divisional level; this latter
would provide a cross-sectional view down to the front line of service delivery.
There is a certain danger in selecting a single site. Hart and Bond (1995) point out that
internal circumstances may change in some way which make continued study
unfeasible with the result that permission to access the case site is revoked. In light of
this potential precariousness, data collection would be designed and conducted to
provide both an ongoing picture of the implementation process but would also be
phased in targeted cycles that would secure particular outputs; thereby giving some
insurance against any premature termination of the study.
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5.3.3 Generalising from Case Studies
A particular concern surrounding the case study approach generally and the single case
in particular appears to relate to the notion of generalisation which is described by
Robson (1993) as the extent to which findings from one inquiry may be applied more
generally. There is a consensus amongst a number of authors that, in the qualitative
paradigm, any generalisation may only be theoretical as opposed to statistical (Hart and
Bond, 1995; Bickman and Rog, 1998; Marshall and Rossman, 1999; Yin, 1999). The
nature of qualitative findings are highly context and case specific (Patton, 1999); the
changing context of real world research means that exact replication is unachievable
(Marshall and Rossman, 1998) and the onus for determining generalisability seems to
rely on those seeking to make the generalisation rather than on the primary researcher
(Robson, 1993; Marshall and Rossman, 1998). The responsibility of the primary
researcher appears to revolve around ensuring that there is enough rich description from
design to reporting to allow the reader to assess whether there are sufficient parallels to
his/her own context/agenda (Robson, 1993).
5.4 ACTION RESEARCH
5.4.1 Origins and Applications
Early in the development process, I found it very reassuring to read the words of Miles
and Huberman (1994) quoted at the start of this chapter. It was also helpful to see this
sentiment echoed by others such as Marshall and Rossman (1998) who observe that
there is no one perfect research design. In fact, in order to capture the complexities of
real world research, it is often necessary to develop what Hedrick and colleagues
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(Hedrick, Bickman and Rog, 1993) call a hybrid strategy. With this in mind, it
appeared entirely reasonable to incorporate an action research (AR) approach into the
case study design.
The reason for my considering the action research approach was twofold: firstly there
was a concern for reciprocity (Patton, 2002); NHS Trusts face multiple challenges of
which clinical governance is, by necessity, one of several. Thus, participation was
likely to be more attractive if the target site perceived that it would derive some sort of
benefit from engaging in the project. Secondly, as the overall approach was conceived
as formative rather than summative, there would need to be an agreed mechanism for
feeding back the data to avoid the risk of the sort of dilemma faced by others. Studies
by Joss and Kogan (1995) and Bate and Robert (2002) describe instances where the
research process had yielded information that might contribute positively to the change
process; however, neither study had been designed to incorporate real-time feedback.
Although this was subsequently negotiated in both cases, Bate and Robert's (ibid)
perception was that their intervention was construed as 'meddling' rather than 'helping'
whereas a formal action research approach would have allowed for feedback to take
place as a legitimate part of the research process.
Action research has been a distinctive form of inquiry since the 1940s (Elden and
Chisholm, 1993; Hart and Bond, 1995). It is practised in a variety of settings such as
education (McTaggart, 1994), health care (Hart and Bond, 1995; Bate, 2000), industry
(Pasmore and Friedlander, 1981; Ledford and Mohrman, 1993), local communities
(Greenwood, Whyte, Harkavy, 1993), international communities (Brown, 1993) and at
110
a variety of levels: individual, group, small and large-scale organisations. A review of
the literature suggests that AR is a somewhat amorphous approach. Greenwood and
Levin (1998) point to a mounting confusion in the field as AR increasingly comes to
mean different things to different people. The apparent lack of clarity over what is
meant by AR has led to a wide variety of activity being labelled as such (Dash, 1999) to
the point where any cyclical process of research could be included (Hart and Bond,
1995) or even sloppy research justified (Eden and Huxham, 1996).
5.4.2 Definitions and Principles
Given the observations above, it does not come as a surprise to find that there is no
consensus over a definition to describe AR; however, a number appear to capture the
essence as these two examples seek to demonstrate. According to Eden and Huxham
(1996):
'AR involves the researcher in working with members of an organisation

over a matter -which is of genuine concern to them and in which there is
an intent by the organisation members to take action based on the
intervention'.
Elliot (1991) provides a somewhat shorter definition:
'(Action research is) the study of a social situation with a view to

improving the quality of action within it'.
An area where there is some agreement relates to certain common principles. Firstly
there is an emphasis on AR as an approach which aims at research with rather than
something done to the participants and, as a result, collaboration/participation is a key
component of the research process (Eden and Chisolm, 1993; Hart and Bond, 1995;
Bate, 2000; Meyer, 2001). Hart and Bond (1995) argue that participation cannot be
mandatory - for example, in the event that the context does not support participation
111
due to the prevailing culture and/or resource issues. In any case, there is the sense that
some authors regard genuine collaboration as an objective which proves rather difficult
to achieve (Foster, 1972). Thus, although one may start with the intent and deliberately
try to build in activity that will enable participation/collaboration to take shape, the
operationalisation of this is more likely to be emergent rather than pre-determined.
Secondly, AR may be seen as an approach which is capable of generating knowledge
whilst at the same time attempting to change or improve the phenomenon which is the
focus of the research (Hart and Bond, 1995; Bate, 2000; Meyer, 2001). This focus is
often described in terms of a problem and yet Cunningham (1993) cautions that this
implies that 'something1 is wrong which might not necessarily be the case. The author
(ibid) suggests that a problem in AR terms might mean that there is a recognition of the
need for change in some form which may be corrective in nature but may equally be
value adding.
5.4.3 The Researcher Role in Action Research
One area where there is rather less consensus relates to the role of the action researcher.
Hart and Bond (1995) have developed a typology of action research which spans from
the experimental at one end of a continuum to empowerment at the other. The further
toward the experimental end, the more likely that the role of the researcher is of a
research-consultant/expert; the further toward empowerment, the greater the
collaboration and the role will more likely represent that of a co-researcher/co-change
agent. Ledford and Mohrman (1993) suggest that the more typical approach is that of
'co-experimenter' which may lead to democratic power sharing over the research design
112
and process itself. This could entail the researcher providing the means for the system
itself to act (Bate, Khan and Pyle, 2000) or, in the case of Greenwood and colleagues
(Greenwood, Whyte and Harkavy, 1993), this involved teaching research skills to those
who would participate as inside-researchers. The researcher-consultant who generally
retains control over the research process and decision-making within seems a less
common occurrence. However, Hart and Bond (1995) offer a number of examples of
this role and Ledford and Mohrman (1993) provide an account of their experiences as
content and process experts in a large-scale organisational change process.
5.4.4 A Model for Action Research
In terms of the practice of AR, several writers refer to the cyclical nature of the
approach in action (Elliott, 1991); however, Bate (2000) usefully depicts this as a
model (Appendix 5) which emphasises an iterative rather than a linear sequence of
activities - diagnosis, analysis, feedback, action, evaluation. Bate (ibid) regards action
research as having a number of different levels of application: the research process
itself, the intervention and the change process. At the level of intervention and change
process, the actions in the Bate model (ibid) have a resonance with the 'Plan, Do,
Check, Act' (PDCA) cycle of continuous quality improvement outlined by Deming
(1986) which provides a sense of consistency particularly when the purpose of the AR
approach is improvement.
In selecting a model to serve as a guide to the action research element, I decided to use
Bate's (2000) for a number of reasons. Firstly, the elements of the model described
above were consistent with the change/improvement focus of the study. Secondly, the
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apparent simplicity of the model would facilitate discussions of the proposed approach
with the case study site and add a certain sense of tangibility to what can seem a rather
amorphous approach. Thirdly, the flexibility of the model meant that it was consistent
with other design choices such as the case study and qualitative framework and would
also accommodate the apparent unpredictability of AR. Finally, because the model
may be applied at multiple levels, it would support a variation in cycle times.
According to Elliot (1991), the higher the level of organisational focus, the longer and
more open-ended the AR cycle; the lower the level (for example: specific department,
group and so on), the cycle tends to be shorter and more focused.
5.4.5 Collaboration and Participation as Key Components
Decisions regarding the role and level of collaboration/participation of the case study
site were more problematic. I subscribe to the view that involvement is likely to bring a
greater commitment to the study findings (Hart and Bond, 1995) and have, what has
been described as, an 'ideological leaning' (Meyer, 2001) towards a democratic
approach. However, in practice the degree to which these considerations were
incorporated into the research design largely came down to pragmatism in view of the
resources available; an important consideration in any research design. Firstly, as the
only researcher, there was a real issue about what could be achieved in the time
available and it did not appear feasible, at the outset at least, for the study to support the
researcher input required to make this a genuinely collaborative study. Secondly, at the
start, the AR approach felt quite ambitious and I did not feel able to commit to a role as
expert or teacher in terms of the research process itself although I did feel comfortable
as a resource in relation to the quality and change processes. Consequently, I thought it
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might be prudent to start as what Hart and Bond (1995) describe as a researcher-
consultant but remain open to the possibility that both the role and the level of site
involvement might change over the course of the project. Although this starting point
was negotiated with the Trust, I did not raise the issue of a possible shift in the role of
either myself as researcher or the organisation as the feasibility of this would probably
only become clear as the research progressed.
5.5 DATA COLLECTION AND DATA MANAGEMENT
5.5.1 Data Collection Methods - Interview, Observation, Document Analysis
According to Robson (1993), once some of the initial decisions about what, why, where
and who have been made, the major question of how the data is to be obtained needs to
be addressed. Patton (2002) suggests that there are three main kinds of qualitative
methods of data collection; namely: interviews, observation and document analysis.
The benefit of using multiple methods is emphasised in the literature (Robson, 1993;
Yin, 1999; Patton, 2002); a multi-method approach is recommended partly to provide a
comprehensive perspective from a number of sources and partly to compensate for the
potential limitations of individual methods. The use of multiple methods will also
enable triangulation; this may be interpreted as a means of checking the consistency of
findings (Yin, 1999) or another perspective relating to the opposite side of the same
coin which looks for divergence - often the source of valuable insights (Patton, 2002).
Each of the above methods may be pre-structured to varying degrees depending on the
nature of the inquiry. Robson (1993, p!57) offers two extremes of advice. If it is an
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exploratory case study with little upon which to base a conceptual framework and only
very general research questions then it is inappropriate to have much in the way of pre-
structuring. However, 'ifyou know what you are after' then plan ahead. The intention
in this case is to use all three methods and keep the design flexible enough to
accommodate a survey should the emerging findings suggest this would be appropriate.
Also, although the research questions are broad, the initial conceptual framework has
identified a number of clear variables thus the level of pre-structuring of instruments
will vary depending on whether the exploratory shifts towards confirmatory.
Interviews
Given the type of information required, interviews based on open-ended questions will
be used throughout the case study to allow the respondent to use his/her own words
based on his/her perspective rather than being required to use a category constructed by
the interviewer. Patton (2002) outlines three approaches to interviewing: the informal
conversational interview which is largely unstructured, the general interview guide
approach which is semi-structured and the standardised open-ended interview where
the questions are specified in detail. At the outset, it is more likely that the interviews
will be less structured but may become more so with a desire to confirm emergent
findings.
Observation
Whilst interviews allow the researcher to hear what people say, observation provides
direct evidence not only of what they say but also what they do which is not always one
and the same. Observational methods provide the researcher with an opportunity to
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experience the context and see the key stakeholders in action. In addition to observing
action, behaviour, activity and so on, it also gives the researcher an opportunity to
obtain a sense of what is not happening which can be of particular value when the
objective is to provide feedback for improvement. The role of the observer may vary
considerably from participant observation at one end of the continuum to complete
spectator at the other (Patton, 2002). This may vary from event to event or over the
course of the research project and it is difficult to predict how this will unfold at the
outset; yet another emergent aspect of the design.
Document analysis
Documentary analysis is a less direct and relatively unobtrusive form of inquiry in
which the data may be extracted away from the field. Organisations are often a rich
source of documentation which includes the minutes of meetings, policy/strategy
documents, memos. Access to a range of documents is likely to provide insights into
who has been involved with the decision-making process that has surrounded the
phenomenon. It also allows the researcher to track back through the history of the
phenomenon where this pre-dates the study and follow its development to the start of
the research process. It is always of interest to look at the official statements and
compare this with what is subsequently seen and heard during fieldwork (Patton, 2002).
However, it is important to remember when undertaking content analysis that the
documents were likely to have been written for purposes other than the research process
which may have implications for the inferences that can be drawn from such sources.
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5.5.2 Data Management
It seems to be the norm that a consistent aspect of most qualitative inquiries is the large
amount of raw data accumulated from the fieldwork (Miles and Huberman, 1994;
Patton, 2002). At the outset it is difficult to predict how much data will ultimately be
collected; however, it is possible to plan the recording format and also the storage
arrangements. In this study, all fieldwork notes would be recorded sequentially in A4
booklets and stored according to units of analysis and cycle of inquiry. Detailed notes
of tapes would be made and illustrative quotes extracted. In view of the number of
participants, tapes from focus groups would be transcribed in full to assist subsequent
analysis. A decision regarding the use of qualitative software would be deferred and
reviewed as the data collection process progressed. In practice, time pressures
precluded the early investment in training needed to use this software and so its
incorporation into the research process was not an option.
5.6 RESEARCH IN ACTION
5.6.1 Phase One - Gaining Entry
As indicated earlier, I decided that the Bate model (2000) would be used to guide my
approach to the action research cycle. This is a dynamic and iterative model of
diagnosis, analysis, feedback, action and evaluation which will be illustrated through
the following account of the research process. Before the cycle could be initiated,
however, it was first necessary to negotiate entry into the organisation. The initial
agreement to participate in the study was obtained through a third party who had also
been involved in the earlier research and who was known to the Trust Chief Executive.
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Once the Chief Executive had agreed to take part, I arranged to meet with him and the
Clinical Governance Lead. The purpose of this meeting was to provide greater detail
on the purpose of the research and the AR approach proposed. The Trust
representatives regarded participation as an opportunity to receive external feedback on
their efforts. This was considered of particular value as, at some stage, the Trust would
undergo a routine review by the Commission for Health Improvement.
This initial meeting was followed up by a series of exploratory interviews with the
Clinical Governance Lead so that I could obtain a more detailed overview of the Trust
(key stakeholders, structures, services, geography) and a sense of the history of clinical
governance implementation in the organisation to date. It was also an opportunity to
develop a rapport which I considered to be extremely important as the Lead played a
pivotal role in the Trust not only in terms of clinical governance but also in her capacity
as an Executive Director. In addition, the Lead would effectively be my sponsor and, if
necessary, might need to sanction and facilitate access to people and services within the
organisation.
These exploratory interviews were semi-structured and the questions were open-ended;
this was to ensure that I could cover the areas I thought were important initially but
would also allow the interviewee to bring other insights and perspectives that could be
followed up subsequently. These initial interviews were not taped as I thought a more
informal approach was indicated at this stage. However, once data collection began in
earnest, all subsequent in-person interviews were taped, all telephone interviews were
taped once the appropriate equipment was obtained; taping followed explicit consent
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from interviewees.
The early interviews outlined above helped develop a map of the organisation and from
this I was able to identify the key meetings I would need to attend either as a one-off or
on a regular basis; the documents such a relevant strategies/policies that needed to be
obtained; the minutes of past meetings that would need to be retrieved plus
arrangements needed for my inclusion on the circulation lists for future minutes.
This initial entry period began in May 2000 and, in the months that followed, the
interviews with the Clinical Governance Lead continued. I was also able to meet and
present the proposed research to the Management Team and thereby made early contact
with Executive Directors, Divisional and other functional managers. In addition, I
observed a Trust Board meeting, started to attend the monthly meetings of the Clinical
Governance Sub-committee and the quarterly meetings of the Risk Management Team.
In that time I also undertook a preliminary analysis of the Trust documents relating to
clinical governance which included strategies and the minutes of earlier meetings.
5.6.2 Phase Two - Rapid Appraisal
The data from this entry phase formed part of the initial diagnosis and, in time, the
interview set was broadened to include the Chief Executive, the Non-executive Chair of
the Clinical Governance Sub-committee, the Executive Team and the Divisional
Managers. In this way, I was ensuring access to those who were likely to have been
involved in the development of the Trust approach to clinical governance and also those
who were responsible for its implementation. The purpose of phase two was to
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undertake a rapid appraisal of clinical governance at the corporate level.
All of these interviews (except one which was conducted via telephone due to the fuel
crisis) were conducted in person. This was a deliberate decision to facilitate the
development of a rapport with respondents as we would be coming into contact with
each other for some time to come either in meetings and/or through the reports I would
be producing. Once again, these interviews were semi-structured and consisted of
open-ended questions which provided the flexibility to probe and follow up issues
raised by the interviewees.
By November 2000, this first round of interviews was completed; whilst I continued to
attend and observe routine meetings, I now withdrew from the field. As far as possible,
I had followed recommended practice with regard to early analysis of raw data (Miles
and Huberman, 1994) but, given the large amount of data already gathered, I needed
protected time to undertake a more formal analysis and write the first feedback report.
5.6.3 Feeding Back to the Trust - Report One
This initial round of data collection and analysis (which included the rapid appraisal
September -November 2000) lasted eight months. In AR, there are inevitably a
number of audiences for the feedback of results (Robson, 2000) and the timing of such
feedback inevitably contributes to its perceived relevance. So, in order to ensure that
analysis and feedback would follow as soon as rigour permitted, this interim report was
kept succinct and framed as an internal briefing paper for the Trust rather than for any
external audience. The paper focused on a number of key aspects of clinical
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governance implementation and concluded with a series of recommendations offered to
the organisation for consideration (Appendix 6).
The briefing paper was initially sent to the Chief Executive and Clinical Governance
Lead with the understanding that it would be circulated to the Management Team and
the Clinical Governance Sub-committee. I subsequently presented the findings and
recommendations to both of these corporate-level groups. Although there was some
discussion of the report and content in both arenas, the Trust did not provide a formal
response, neither was any explicit action plan formulated in light of the findings, nor
evidence of further discussion in any detail. According to Hart and Bond (1995), this is
not an uncommon occurrence following feedback but I was aware that this could be a
precursor to further access being denied if it was an indication that my analysis and
recommendations had not been well received.
5.6.4 Phase Three - Widening the Corporate-Level Interview Set
Thus, with no action plan to monitor, I decided to maintain a lower profile for a period
of time and continue with a general focus on corporate level activity but, at the same
time, concentrate more on establishing a rapport with key stakeholders. Consequently,
I continued to observe the relevant meetings and also maintained an ongoing contact
with the Clinical Governance Lead. Often this was in the form of what Patton (2002)
describes as a conversational interview; highly unstructured but this approach allowed
me to keep in touch with new developments. I also broadened the interview set to
include the Chair of the Trust and two further members of the Clinical Governance
Sub-committee, a Non-executive Director and a Medical Officer (the other members
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had been interviewed earlier in their capacity as Executive Directors/Divisional
Managers). In addition, I invited all Non-executive Directors (excluding the Trust
Chair) to participate in a focus group; three out of a possible five attended. Of the two
who were not available, I had already interviewed one Non-executive Director in her
capacity as member of the Clinical Governance Sub-committee.
As time went on and a level of trust developed between the Clinical Governance Lead
and myself, I was able to provide feedback on a more opportunistic and informal basis.
This had a number of benefits: firstly, the Lead was now getting ongoing feedback
which would ensure that nothing in the final report would come as a surprise.
Secondly, it allowed me to check out findings and the interpretations I was making as a
result of ongoing analysis. Thirdly, it allowed space for a dialogue and, in this way, the
Clinical Governance Lead was able to participate in some of the more emergent design
decisions. Finally, in time, my role as an observer at meetings shifted from pure
spectator to participant observer where I offered feedback on what I was observing
within the Trust or responded to requests for an opinion on the issues under discussion.
5.6.5 Phase Four - Primary Care Division
In April 2001, whilst maintaining the focus at corporate level, I began preparations to
incorporate the Division and Locality as units of inquiry and analysis. The Mental
Health Division was the preferred option as it would provide the widest access to a
range of professional groups and also to both secondary and community based services.
However, at that time, the Acting Divisional Manager had just stepped down and the
Clinical Governance Lead and I decided not to focus the research spotlight on a service
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which was just about to get new leadership. Each of the learning disability services
were specialised in some way, consequently we were concerned that other audiences
within the Trust might not relate to issues raised in these areas. This meant that the
research focus would incorporate the Primary Care Division. Although we were aware
that there had been little deliberate clinical governance activity in this area, it was
hoped that feedback gained through the research process would facilitate future
progress. Ironically, just prior to the start of data collection in this Division, its senior
manager was moved to Mental Health which meant that Primary Care now had a new
Divisional Manager in an 'acting' capacity; however, the research went ahead as the
initial approaches and preparation had already been made. Within the Primary Care
Division, the Northern Locality was selected for closer study as funding had been
identified by both the Trust and the Primary Care Group (PCG) for the appointment of
a Clinical Governance Facilitator to work across the Locality and the PCG.
The AR approach in Primary Care followed a similar pattern to that undertaken at the
corporate level. Although access had been approved by the Clinical Governance Lead,
I met initially with the Acting Divisional Manager (ADM) and two of the three line
managers (the third was unable to attend) to provide details on the purpose of the
research and to discuss the AR approach proposed. Following this initial meeting I
conducted preliminary interviews with the ADM to gain an overview of both the
context and clinical governance activity to date. I was able to identify the key
stakeholders, documents needed, meetings of interest. I attended several of the
meetings of the Clinical Governance Forum and my role was generally that of an
observer although, occasionally, I provided feedback from the field. Participation was
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much less than at the corporate level as the timescale was considerably shorter and
consequently the opportunities to develop a rapport were less. However, I did attend a
meeting of the Clinical Leaders so that I could get a sense of the agenda as it proved
difficult to get a comprehensive set of previous minutes because of the chairing
arrangements. Also, because of the timescale issue, I thought it would provide the
managers with an additional opportunity to meet with me and, in this way, become
familiar with both the researcher and the research process.
Interviews took place with the ADM, senior and junior managers (district nursing and
health visiting; Division and Locality) and managers from the Professions Allied to
Medicine. The geographically dispersed nature of the Division and the timescale
available meant that, after the first meeting, the most efficient method of interviewing
tended to be via the telephone which was not entirely satisfactory for either the
interviewees or the researcher but it represented a seemingly inevitable trade-off. All
interviews were taped with permission. In addition, a separate focus group was held for
district nurses and another for health visitors; five and nine members of staff
participated respectively. Both sessions were taped with permission and subsequently
transcribed in full. The decision to undertake focus groups with front line staff was
made so that data collection could take place in a more relaxed manner. In this way, it
was hoped that the interaction of group members might surface new issues/insights and
would also encourage discussion around the clinical governance agenda generally and
Trust activity in particular thus facilitating a certain amount of awareness raising.
The fieldwork at the corporate and divisional levels was completed in October 2001.
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This end-date had been made explicit and thus my withdrawal from the Trust was
expected. Once again, analysis of the raw data had been ongoing throughout the study
but the end of data collection signalled an intensive phase of analysis necessitated by
the sheer volume of data and the timescale for reporting; it was agreed that the final
report would be distributed by the end of December 2001.
The final phase of analysis drew heavily on the conceptual framework outlined earlier.
This had been developed as an initial guide to the variables for attention and had proved
broad enough to serve as a guide for data collection, analysis and informal feedback
throughout the period of fieldwork. Thus, using the same framework to guide analysis
overall seemed entirely appropriate.
5.6.6 Phase Five - The Final Report
The final report was considerably more substantial than the earlier briefing paper. On
going, informal feedback to participants ensured that there would be no surprises for
the key stakeholders of the Trust. In the end, the report summarised what most of the
key participants had heard already and dealt with findings at both the corporate level
and the level of the Primary Care Division and Locality. In addition, the report made a
number of recommendations concerning the content of the clinical governance agenda
as conceptualised by the Trust and its future implementation (Appendix 7). The report
was released firstly to the Clinical Governance Lead and the Chief Executive and then
disseminated to key managers in the Division. In January 2002,1 met with the Clinical
Governance Lead, Chief Executive, ADM, line managers and the Clinical Governance
Facilitator for the Division to gain feedback on the report and the research experience.
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The Trust was complementary on both counts.
5.6.7 The Action Research Cycle
In terms of the AR cycle, the most overt stages at both levels of the study appear to be
diagnostics, analysis and feedback; the way in which this has contributed to action and
hence the opportunity for formal evaluation has been less apparent. It is important to
note, however, that action has taken place albeit not always as a discrete stage flowing
from an explicit declaration of intent. Owing to the ongoing informal feedback
provided at both the corporate and divisional levels, there was evidence of Trust
responsiveness in the form of real-time action. In addition, the Trust incorporated
many of the recommendations in its clinical governance plan for the new PCT. How
far this plan has been translated from policy to practice in the PCT was unfortunately
beyond the scope of this study.
5.7 RESEARCH QUALITY
5.7.1 Quality Criteria for Qualitative Inquiry
The issue of quality in qualitative research is part of a long and contested debate (Mays
and Pope, 2000). Robson (1993, p66) suggests that establishing the trustworthiness of
research lies within the realms of common-sense - whether the researcher has done a
thorough and honest job and has tried to 'explore, describe or explain in an open and
honest way'. However, the author (ibid) is also of the opinion that good intentions are
not enough to ensure the quality of research irrespective of whether this is of a
qualitative or quantitative nature and, in this sentiment, Robson echoes the view of
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another seasoned qualitative researcher (Silverman, 2000).
Whilst checklists for quantitative studies are apparently common, there is no definitive
set of guidelines for delivering quality in a qualitative approach; and, according to
Mays and Pope (2000), any attempt at prescription is to be avoided. Lincoln and Cuba
(1985) argue against the qualitative application of quality criteria derived from the
quantitative paradigm (internal and external validity, reliability and generalisability)
and suggest as alternatives the notions of credibility, transferability, dependability and
confirmability. These alternative criteria are commonly cited in research texts and
there is no shortage of additional criteria offered for consideration (Mays and Pope,
1995; Marshall and Rossman, 1998; Mays and Pope, 2000). Although it is clear that
there are no easy solutions to the limitation of error in qualitative inquiry, I have tried to
address this throughout the research process from design to reporting and an overview
of the steps taken will now be provided.
5.7.2 Research Strategy: Design and Operationalisation
The case for a qualitative study has been clearly stated at the outset of this chapter thus
the reader is immediately aware of the paradigm within which the work is situated. The
rationale for the overall design has been presented together with the strategic choices
relating to this. Although the research questions have been expressed in broad terms,
the conceptual framework has been described in detail which allows a judgement on
whether the strategy and methods are, in themselves, appropriate for the purpose of the
study. Multiple methods have been selected to allow for triangulation and, in
attempting this, the search was for both convergence and divergence of evidence. Also,
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by using more than one method, it was possible to compensate for any potential
weaknesses that might have served as a threat to validity if a single method had been
applied (Robson, 1993; Yin, 1999). The methods themselves were entirely consistent
with a qualitative approach and the literature attests to the fact that a combination of
interview, observation and document analysis had been adopted in similar studies (Yin,
1994; Hart and Bond, 1995; Bate, Khan and Pyle, 2000).
5.7.3 Sampling Strategy
Purposive sampling has ensured that data has been obtained from a variety of sources.
Although the sampling strategy had not been formulated prior to entry into the field, I
had identified the Clinical Governance Lead as a key informant. This led to the
evolution of, what has been described as, a 'snowball' approach (Robson, 1993) as I met
with other managers and staff. The relatively flat organisational structure and the fact
that the senior groupings were small provided the opportunity to purposefully select
whole populations such as the Executive Team, the Management Team, the locality
management structure which contributed to the comprehensiveness of the study. In
addition, I was allowed unrestricted access to key meetings over a long period of time
and to all relevant documentation and therefore did not rely on snapshots.
5.7.4 Generalising from Case Studies
The issue of generalisability has been outlined earlier in this chapter where it was
argued that the responsibility of the primary researcher was to provide enough rich
description to enable the reader to identify any potential parallels with his/her own
research context/agenda. With regard to generalisation, I will simply state that I have
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attempted to provide a rich picture throughout and invite the reader to make a
judgement on whether this has been sufficient for his/her purposes.
5.7.5 Rigour in the Field
The application of methods in the field was a rigorous as possible. For the most part,
interviews were semi-structured and a selection of interview schedules are included as
Appendix 8 which will allow the reader to assess the validity of the instrument. In
addition to contemporaneous notes, the majority of interviews were taped; detailed
notes made from these and illustrative quotations extracted. Owing to the presence of
multiple participants in the focus groups, the tape recording of each session was
transcribed in full. Observation was conducted without any form of pre-structuring and
extensive contemporaneous notes were made in the setting. In these records,
annotations provide a clear distinction between evidence, interpretation and
intervention (Yin, 1999). As most of the observation took place around specific events
such as meetings, there are also minutes of the meeting taken either by a participant or
secretary to the group which adds another perspective to the proceedings.
Documentary analysis was largely guided by the original conceptual framework. All
raw data has been stored in a manner that will ease retrieval if challenged. Field notes
and tapes are in date, level of analysis and collection cycle order.
5.7.6 Analysis and Reporting
Analysis and reporting has been guided by the conceptual framework. This has served
to focus the research throughout but has been broad enough to accommodate emergent
insights. The aim of the research was to provide rich description and the sustained
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association with the organisation has provided the opportunity to confirm my own
interpretations.
5.7.7 Participant Feedback
An extremely important test of validity was embedded in the AR approach itself and
the commitment to provide ongoing informal and periodic formal feedback to
individual participants and the organisation itself. The Trust response has been very
positive and confirmed the reports presented as fair representations of clinical
governance in the organisation.
5.8 CHAPTER SUMMARY
The purpose of this chapter has been to provide a comprehensive account of the
research process from the initial design to the presentation of the results. The rationale
for the various choices made in the design of this project is discussed; these choices
have led to the selection of a qualitative framework which has been flexible enough to
sustain a case study strategy and an action research approach. Details of data collection
methods and data management have been provided together with information
highlighting the action research process 'in action1. Finally, the notion of research
quality has been discussed together with the various steps taken by the researcher to
assure the quality of the entire research process. The design and implementation of the
overall research strategy have served as the focus of this current chapter; the results of
this effort will now be presented in the following three chapters.
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CHAPTER 6
RESULTS - CLINICAL GOVERNANCE IMPLEMENTATION

CORPORATE ACTIVITY: CONTENT
6.1 INTRODUCTION
Qualitative methods frequently give rise to massive amounts of data (Patton, 2002) and
this case study certainly adds weight to Patton's observation (ibid). Organising and
analysing this data so that the results could be presented in a coherent format was
always likely to be a challenge. However, this task was facilitated considerably by
utilising the same conceptual framework for the presentation of the results as that which
guided data collection and subsequent analysis. This framework is outlined in detail in
Appendix 2 and encompasses notions of both content and process or the 'what' and
'how' of implementation. There has been frequent reference to the duality of meaning
within the term implementation; the following results chapters will clearly demonstrate
this difference. The aim of this chapter is to present the clinical governance initiatives
of the Emerald Trust which correspond to corporate level content activity. Each of
these elements will now be presented using the Miles framework (1997) as sub
headings.
6.2 A VISION AND A STRATEGY FOR CLINICAL GOVERNANCE
6.2.1 The Clinical Governance Report
One of the first key clinical governance documents prepared by the Trust was the
briefing paper dated June 1999, the 'Clinical Governance Report' (Internal Trust
Document, 1999; unless otherwise stated, all future references to the 'Clinical
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Governance Report' or the 'Report' will relate to this document). This document
introduces the Trust's conceptualisation of the clinical governance agenda and distils
this into the six key components; the rationale for these elements is also presented and
each is deconstructed further into a number of sub-elements (Table 6.1).
Table 6.1: The main components of clinical governance (Internal Trust document,
1999)
CULTURE HUMAN RESOURCE KNOWLEDGE

MANAGEMENT
• Trust-wide commitment • Training Evidence based health
• Board level focus • Continuous professional care/clinical
development (CPD) effectiveness/audit
• Clinically focused management • Appraisal R&D
strategies • Performance Management Libraries/research
resource centres
CORPORATE LEARNING USER INVOLVEMENT INFORMATION
• Complaints • Advocacy • Clinical information

• Risk Management • Consultation systems
• Adverse incidents • Individual ownership of • Knowledge management
health • Patient information
A key message contained within this Report is that clinical governance is not entirely
new to the NHS and earlier initiatives such as clinical audit, care pathways, risk
management and so on have been incorporated. However, the Report does highlight
the fact that there are a number of new aspects to this policy which are identified as: an
organisational focus for quality improvement; corporate accountability for and the
involvement of management in clinical quality; and the need to integrate new and
existing systems for quality improvement. The Report identifies a key role for the
Trust Board in refocusing the culture from financial to clinical issues and also explores
what clinical governance might look like at different levels, for instance: the
organisation, division, team and the individual practitioner.
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Although a vision of what the organisation might want to see in place once clinical
governance is established is described, the Report does not include a comprehensive
overview of the present organisational situation in relation to this future state. Instead,
there is a brief reference to the challenges currently being experienced in relation to
several of the existing components such as clinical audit and risk management. Thus, it
is difficult to get a sense of the scale of change required in order to make this transition
merely from the information contained within the Report. Nevertheless, the Report
serves as a useful introduction as to how clinical governance has been conceptualised at
the corporate level. The stated intention was that the framework outlined in the
document would form the basis of future discussions with the divisions as part of the
process of formulating a development plan.
6.2.2 The Clinical Governance Development Plan
The 'Clinical Governance Development Plan' (Internal Trust Document, 2000a; unless
otherwise stated, all future references to the 'Clinical Governance Development Plan'
or the 'Development Plan' will relate to this document), was subsequently approved by
the Trust Board in January 2000 and has formed the basis of the corporate approach,
without revision, since that time. The Development Plan reiterates the framework for
clinical governance outlined in the earlier Report and specifies a series of short-term
objectives under each of these headings, identifies the managers with a key
responsibility for the achievement of these objectives together with the timescale for
completion.
In total, the Development Plan identifies a set of 39 objectives; of these, 36 are
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described either as ongoing or to be achieved in year one. Many of the objectives refer
to an end state such as the aim 'to achieve CNST level 2 ', the establishment of a
corporate focus for clinical audit, the development of a policy for the reporting of poor
clinical practice. Other objectives address certain process issues such as
communicating the agenda and providing training. In addition, a subset of the
objectives are targeted specifically at the divisions with Divisional Managers clearly
identified as having the lead responsibility for their achievement. In spite of this, a
series of interviews which took place with senior managers during September -
November 2000 (9-11 months after the Development Plan had been approved by the
Trust board) revealed that, whilst all interviewees knew that the Development Plan
existed, there was little evidence to suggest that it had become a living document within
divisions or that it was explicitly guiding local approaches to clinical governance
implementation. In fact, four out of the six divisions did not have an action plan to take
forward the clinical governance agenda.
In light of the apparent lack of goal deployment described above, a review of progress
against the Development Plan was a key recommendation of the research feedback
provided to the Trust in December 2000. At that time, a period of 12 months had
elapsed following the approval of the Development Plan by the Trust Board which
suggested that it would be timely for the organisation to evaluate its achievements to
date and assess the amount of work outstanding. However, the Trust view was that the
movement towards PCT status would have implications for the shape and
operationalisation of clinical governance in the new organisation; therefore, it preferred
to focus on consolidating rather than revisiting the existing objectives.
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The 'Clinical Governance Development Plan' represented an action set for
development rather than a comprehensive strategy for clinical governance
implementation. Taken together with the 'Clinical Governance Report', these two
documents formed the basis for the Trust approach to clinical governance
implementation; however, during the research period, these documents were not
augmented by a comprehensive implementation strategy.
6.3 STRUCTURES TO SUPPORT A DEVELOPING AGENDA
Early development activity within the Trust has included the establishment of structures
to support clinical governance. Committees and groups at both corporate and divisional
levels have been formed and an important first step has been the appointment of the
Clinical Governance Lead.
6.3.1 Clinical Governance Lead
In line with the guidance issued in 1999 (Department of Health), a senior clinician was
nominated to act as the Trust lead for clinical governance. In addition to leading the
clinical governance agenda, the Lead is also an Executive Director of the Trust with the
Research & Development (R&D) brief. Within this combined role, the implementation
of clinical governance forms a significant part of the Director's portfolio and this has
allowed the Clinical Governance Lead to protect time in order to focus on the
development of this agenda. Making this appointment at a senior level is regarded by
this Non-executive Director as an indication of the Trust's commitment to clinical
136
governance:
'Having a director almost working full time (on clinical governance) has
given clinical governance more kudos'.
Over time, the Lead's brief has expanded in line with the growing agenda at a rate not
anticipated at the outset. No formal Terms of Reference have been developed to focus
the role; although the Clinical Governance Lead has line management responsibility for
the library services, there is no functioning operational structure to support her in the
discharge of the wider clinical governance remit. As Clinical Governance Lead, she
either chairs or is a member of a number of the key groups/committees which are either
directly/indirectly associated with the clinical governance agenda. Partly because the
lack of a supporting operational structure, and partly because of the apparent difficulty
in engaging some 01
of the
me Key
key piayers
players with
wnn me
the impiemenianon
implementation process, me
the Lead
i>eaa has
n
become increasingly embroiled in operational clinical governance and this activity is in
danger of displacing the strategic aspects as the following comments illustrate:
'There is a problem with being the clinical governance lead because the
issue is, ifyou don't lead things... ... The job is about trying to get things
actioned and a lot of this takes my personal time because maybe some
people aren 't as engaged as they might be, that's maybe one of the
reasons why everything continuously comes back to me. If I haven't
done it, has it actually happened? I don't want clinical governance to
be something that I do but at this stage in the development, I often have
to be the person who kicks it off and how much time is there as the
clinical governance lead to do that. The problem is that if you have a
lead everyone thinks you are leading so it's a double whammy in a way'.
'That's one of the things I have been going on at the Chief Exec recently
to; I said I can't do this job unless I have time to think and for several
months this has just not been possible; I appreciate I generate this stuff
myself, but I can't even fit it in within very long working days, five days
a week; therefore the temptation is whenever you 're in the office I have
got loads of things I 've got to get out, got to get done, therefore there is
no time for reflection which I actually think is a weakness in my current
role at the moment... I don't have enough time to reflect. You're in
danger then of ending up being busy and I do get a lot of things just like
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producing stufffor meetings ... because I haven't got anyone who can
produce that sort of thing for me'.
'Also, just about trying to think; You 've come to me and asked me what
is my agenda for next year, and I must admit because you had e mailed
me... it did make me think but I have got to sit down and put some time
into that question. It's about finding the time to do that'.
6.3.2 Clinical Governance Sub-committee
In addition to appointing the Clinical Governance Lead, a new sub-committee of the
Trust Board was established in February 1999 - the Clinical Governance Sub
committee. The intention was that the Sub-committee would meet monthly and, apart
from one or two exceptions to this, has met on that basis. The Sub-committee is
chaired by a Non-executive Director of the Trust and the meetings have been
consistently attended by most of its members.
The Sub-committee's Terms of Reference suggest that it is responsible for ensuring that
arrangements are in place to deliver the overarching objectives of clinical governance
and for co-ordinating the activity required to support this which implies a responsibility
for both an assurance and a steering function. The Development Plan provides the
main vehicle for delivering both functions; and, in the absence of an implementation
plan, the objectives contained in this document provide some indication of the direction
of travel which will go some way to enabling the Sub-committee to discharge its
steering role. The Sub-committee did not go on to develop a work plan to focus its
attention in the first or subsequent year.
Whilst the Terms of Reference made clear that the minutes of the Clinical Governance
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Sub-committee meetings would be circulated to members of the Trust Board and the
Sub-committee, there was no formal arrangement to disseminate these to a wider
audience for quite some time. Although several members of the Management Team are
also members of the Sub-committee, not all are represented and the minutes of the
Clinical Governance Sub-committee meetings are not a standing item on the agenda of
that key operational group or, for that matter, on the agendas of the Clinical
Governance Development Team or the Risk Management Team. Thus, in the absence
of an operational structure, the Clinical Governance Lead is the only mechanism for
taking the recommendations of the Sub-committee out into the wider organisation.
Initially, membership consisted of two Non-executive Directors (one of whom chairs
the Sub-committee), the Trust Chief Executive, the Clinical Governance Lead, the
Nurse Director, and the Medical Director. Later a consultant psychiatrist joined the
Sub-committee to represent the Division of Psychiatry. In September 2001, after it had
been in existence for over two years, the membership of the Sub-committee was revised
and extended dramatically to include a representative from each of the divisional
clinical governance fora and representatives from each of the three Primary Care Group
(PCG) clinical governance committees. The rationale for this was to increase the
effectiveness of communication between the Clinical Governance Sub-committee and
the other clinical governance groups both within and outside of the organisation.
The absence of any representation from the Human Resource (HR) function,
Information Management and Technology (IM&T), User Involvement, Finance and the
Divisional Managers is perhaps curious given the centrality of these functions in the
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conceptualisation of the Trust's clinical governance agenda and the stated aim of
delivering greater integration: - 'to integrate and identify clear links between the
developed policies related to Human Resources Management, Information and
Knowledge Management' (Internal Trust Document, 2000a, p5). Although the Sub
committee had, for some time, been considering how best to incorporate the perspective
of service users and carers into the clinical governance agenda, there was also a
determination to avoid tokenism and to ensure that the users were enabled to contribute
effectively whilst maintaining their unique perspective. Although the Sub-committee
appears committed to the concept, this is an issue which is yet to be resolved, as one
Sub-committee member put it:
Within the Trust we do quite a lot of specific user involvement,

particularly with mental health. It's how to bring that all together and
see how it informs clinical governance? It's Just too easy to say we 'II
have two users on the committee and that's cracked it because it
obviously doesn't...... ...I've been on other committees where you have
the representatives of the users and before you know where you are
they 've become quasi professional and they are not doing what they are
supposed to be doing. We need to find proper methods of working with
the public outside the clinical governance arena and bring in the results
of that back into the clinical governance structure'.
From the minutes of the Clinical Governance Sub-committee, the breadth and content
of the agenda has developed over time; however, the agenda itself is generally
compiled by the Clinical Governance Lead - apparently it is rare for other members to
put forward items for inclusion. In the early days, the focus of attention was on
defining its Terms of Reference, considering the linkages with other groups, discussing
the format for reporting to the Trust Board. Over time, the Sub-committee has received
a greater amount of information upon which to base discussion; included as regular
items are the quarterly risk management reports and the Significant Clinical Incident
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Review reports.
The establishment of the reporting system has contributed to a feeling amongst some of
the original Sub-committee members that they are getting to grips with the agenda; this
may also be a function of sitting on a variety of committees:
'(Agenda) seemed huge at first and every meeting we went to it got

bigger and more worrying because you couldn 't really see how it would
begin to work because it was all terribly complicated but over the last
quarterly report that went to the Board, there you can see the various
strands come together and things beginning to interrelate - I'm on the
Complaints Committee and the Audit Committee and the Mental Health
Committee and all those things feed in to it'.
Another member noted that the presentation of information in the current format
enabled those reading the report to identify trends:
'We obviously look at quarterly returns; those things you see we didn '/
look at before; now we 've got all these quarterly returns, bringing all
this different information together so we can spot trends, we didn't do
that before... ... ...we are bringing from all these different areas of the
Trust all this information together in a very simple tabulated form, all
the different groups that meet - prescribing, complaints etc; all coming
together and we can simply look at it every quarter and spot
trends...... ...we've always had these floating around but they are
coming together in a more user-friendly, manageable form so we can
quickly look at them'.
The researcher has been a regular attendee at the Clinical Governance Sub-committee
meetings and has observed the lively discussion that is often a feature of the
proceedings. However, much of the information provided in the consolidated report is
operational data and primarily produced for other audiences. It is generally existing
data rather than information based on an assessment of what the Sub-committee
actually needs to be able to meet its Terms of Reference with particular regard to its
assurance and steering functions. Whilst the report does give an update against aspects
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of the Development Plan, the existing reporting framework is yet to capture the full
range of clinical governance activity in detail; for example, the coverage of appraisal
and Personal Development Plans (PDPs); the progress of clinical effectiveness or
clinical audit; the progress of the IM&T strategy. The information is essentially
passively received rather than actively sought. Members of the Clinical Governance
Sub-committee seem to appreciate what they receive but do not generally appear to
recognise gaps.
Whilst some of the more established Sub-committee members seem to think things are
coming together nicely, some of the newer members quoted below are not even clear
why they are on the Sub-committee or the implications of being a member of a formal
Sub-committee of the Trust Board:
7 'm not sure (why I 'm here), I 'vejust been told to come'.
7 just got a letter from (my manager) saying that she put my name
forward... ... ...Ididn 't get a chance to read them (the minutes before the
first meeting)... ...... well I sat there and was thinking - obviously he is
accountable as the chief exec but he was trying to say that the group as
a whole was responsible - and I sat there and thought so how
responsible does that make me and I don't know, I don't know... ... ...I
did actually think if anyone actually questioned it how far would they
take it. If there was an issue would it come down to me, little me, would
it really and I couldn 't really believe it'.
The issue of establishing tangible linkages with other structures has also proved a
challenge for the Clinical Governance Sub-committee. From the outset, an explicit
objective was to establish formal links with a number of existing sub-committees and
groups which included: Complaints Sub-Committee, Training and Development Group,
Risk Management Team, Professional Advisory Groups, Clinical Directors, Heads of
Therapy Services, and the Information Strategy Group. Although, as indicated earlier
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in this section, individual members of the Clinical Governance Sub-committee may
attend one or more of these groups, the link appears more in the form of the individual
as opposed to a formalised system of information exchange. Although recognised by
some in the Trust, this matter was not resolved during the 18 months of fieldwork.
6.3.3 Divisional Structures
In addition to developing a structure to support clinical governance at the corporate
level, an important objective in the 'Clinical Governance Development Plan1 was the
establishment of a clinical governance forum in each of the clinical divisions. It was
envisioned that each forum would provide direction, co-ordination and support to the
division as it took forward the clinical governance agenda. The forum would also
perform a monitoring and reporting function.
The divisions have been encouraged to develop a forum model that would reflect local
circumstances. All but one is chaired by a clinician or a manager with a clinical
background and the professional background of the chair understandably differs from
division to division. The rate at which these fora have been established has varied with
one local forum meeting for the first time as recently as February 2001 - 12 months
after the Development Plan identified this as an objective for all Divisional Managers.
The findings of the rapid appraisal, which took place towards the end of year 2000,
indicated that the divisions had not undertaken a baseline audit of the coverage or
effectiveness of existing quality improvement systems such as clinical effectiveness or
risk management processes; four out of six divisions were still to develop a local action
plan for clinical governance. In fact, there was little evidence that the Trust
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Development Plan had diffused into the organisation and become a living document.
By early 2001, each division had established a forum although they appeared to be at
different stages of development and performance. This appears to be a function of a
number of factors which include the length of time the forum had been operating, local
priorities and even the corporate style which has a tendency towards 'shaping' initially
rather than prescription but seems to become more directive and prescriptive in the
absence of progress.
Whilst there has been a growing emphasis on sending information upwards, there has
been less attention to the mechanisms for disseminating information downwards;
reliance has been on the Divisional Managers although the Management Team does not
routinely receive the minutes of the Clinical Governance Sub-committee meetings. It
was only when the membership of the Clinical Governance Sub-committee was
expanded to include representatives from each division that all local fora had access to
the minutes.
6.3.4 Clinical Governance Development Team
From the outset, the Trust anticipated the need to provide support and facilitation to the
divisions to enable them to take the clinical governance agenda forward. It was
proposed that this role would principally be fulfilled by a new team, the Clinical
Governance Development Team (CGDT).
Initially the role of CGDT was to focus largely, although not exclusively, around the
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'Knowledge1 component of clinical governance; however, over time, a greater emphasis
on the wider clinical governance agenda appears to have emerged. This is reflected in
the notes to the meetings which have taken place on a fairly regular basis for more than
18 months. Since the inception of CGDT, membership has gradually expanded to
ensure that all clinical divisions have access to a named CGDT member. Mid 2001, a
joint appointment was agreed for a facilitator to work across one of the PCGs and the
corresponding Locality of the Primary Care Division. Recruitment to a part-time post
of Care Pathway Facilitator is also planned but has not yet taken place.
Part of the role of the Clinical Governance Lead is to co-ordinate the work of the Team;
the characteristics of which indicate a project rather than functional group given that
several members have substantive, operational posts within the divisions for which they
also act as facilitator. Other Team members have broader, Trust-wide remits; for
example: one manager has specific objectives relating to areas such as clinical audit and
management responsibility for the Library services; another manager has a specific
remit in relation to R&D activity. Still others have functional roles within either the
Library Services or Formulary Pharmacy Audit and, as such, act in a more central-
resource capacity.
So far, the Team's input to the divisions appears to have been variable in terms of both
content and quantity. Activity has included the provision of general support to the local
divisional clinical governance fora and facilitation of the local reporting process in
relation to the Trust annual clinical governance report. The variability observed is due
to a number of issues which will now be considered. There has been a long delay in
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getting all of the members into post so the CGDT, as an entity, has been slow to
develop:
'Think that we have been forming and re-forming and forming and re-
forming so \ve have never really got to storming, haven't got near
norming'.
Related to the delay in establishing the Team, most members expressed a lack of clarity
around this role. Although objectives for the CGDT itself had been developed and
there had been some move to translate these to the level of individual team members, a
work plan setting out priorities in-year had not been developed. For some Team
members, the broad objectives need refocusing:
'My personal opinion is that we could do with vision and focus again.
We had a meeting last week at which that person, that person and that
person were there for the first time in their current roles. So over the
last 12 months the group hasn't stayed the same... ...could do with
looking at the team and roles and whether they are clear enough'.
'My personal feeling is that there is a sense of confusion about specific

detail of roles within the team so I think we still have some work to do
clarifying exactly what our responsibilities are and how they interface
because there is going to be a lot of overlap...... other people have role
extensions... ...we need to revisit our role as a team and
individuals...... need to revisit our objectives and what we have achieved
and where the gaps are'.
"Don't really know what my role is on that (CGDT). I am pretty clear

what my role is in relation to clinical governance, I think; I don't know
- I suppose I am probably a bit thick, but I don't know where the
Clinical Governance Development Team stops and clinical governance
begins or the other way around. I 've looked often at the aims of the
Clinical Governance Development Team and they don't give me any
direction really '.
There is also a capacity issue for some individuals whose Team role is performed in
addition to the operational requirements of the division. Although this dual role has
been negotiated with the respective Divisional Manager, the additional Team
responsibilities are not always reflected in the core role objectives and, in some cases,
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the part-time Team role has become an 'add-on' to full-time divisional duties:
' (Recent IPR) ...All my ongoing stuff was left out and I said, I'm sorry
but that is a big job, that is going to have to go in as well. The ongoing
stuff we leave out( of the IPR) because there is other stuff that needs to
be tackled... ... You obviously have a good idea of what the Clinical
Governance Development Team is set up to do; I don Y have any idea at
all because I just spend my life running between divisional objectives
and the stuff coming out of the clinical governance forum. 1 inherited
that role at the same time as I linked into the Clinical Governance
Development Team. So if the Clinical Governance Development Team
is very different to what I am doing, I don't know how I would fit it in
anyway'.
6.3.5 Risk Management Team
The Risk Management Team has been meeting regularly within the Trust for around
three years. More recently it has been chaired by the Clinical Governance Lead and
membership includes senior managers of both clinical and support divisions,
representatives from professional groups, staff-side representation and managers from
specialist areas, for example Health & Safety, Complaints. The Risk Management
Team reports to the Clinical Governance Sub-committee, the Trust Board and, in terms
of Controls Assurance, to the Audit Sub-committee.
In January 2000, the Terms of Reference of the Team were reviewed and amended to
reflect the need to incorporate clinical risk management into what had previously been
a non-clinical risk focus; thereby developing a more integrated approach to risk
management within the Trust. It was also intended that the Risk Management Team
would adopt a more proactive approach to the risk management process. The Team's
original dataset was therefore augmented to support a greater degree of both analysis
and also corrective/preventative action based on this analysis. One example of this is in
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the area collectively known as 'slips, trips and falls'. Previously, incidents would have
been discussed locally but the practise of reviewing an integrated dataset has meant that
the Risk Management Team was able to identify a shared and recurring problem. A
working group has subsequently been formed to explore the issue in greater depth,
identify root causes and propose action to manage the risk to both service users and, in
some cases, staff.
An intended function of the Risk Management Team is the co-ordination of elements
deemed to sit beneath the risk management umbrella. Therefore, this has become the
forum for taking forward the Clinical Negligence Scheme for Trusts (CNST)
accreditation at level one and, more recently, Controls Assurance.
The Trust has recently reviewed and revised its "Risk Management Strategy1 which was
approved by the Trust Board in September 2001. In addition to providing strategic
direction, the document also sets out a detailed plan designed to take the risk
management agenda forward over the next two years. The strategy not only makes
explicit the corporate and divisional/directorate responsibilities for delivering this
agenda but also defines the specific responsibilities of the Trust Board, divisional
managers, departmental/service managers and also those of staff within the Trust.
Discussions are currently taking place with regard to the mechanism for launching the
strategy and cascading the corporate objectives to and within the divisions/directorates.
This appears to be a very different approach to the implementation of clinical
governance per se in that it appears highly structured and deliberate.
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Risk management within the Trust is evolving with the intention that it will become
increasingly systematic and integrated. However, although there are managers leading
on a limited number of individual risk management components, there is a sense that
the only strategic and operational overview rests with the Clinical Governance Lead.
The Lead not only has the overview but also provides strategic leadership for risk
management and is engaged in delivering operational aspects of this agenda. This latter
has included: leading workshops, leading Significant Clinical Incident Reviews,
Significant Event Audits, providing facilitation and support to divisions/directorates.
Within the Trust structure, there is no provision for a risk manager post; the Health &
Safety officer collates and compiles reports on risk data quarterly for the Risk
Management Team but reports in a line management capacity to the Finance Director.
Thus, although the Clinical Governance Lead is heavily involved in the risk
management agenda, she does not exercise a line management role in this area.
It has been interesting to observe the development of this group over a period of time;
specifically the evolving agenda and the growing use of regular information as a basis
for further enquiry and action upon which a number of its members have commented
favourably:
'There has been a change in focus since (the Clinical Governance Lead)
has been chairing the meetings. Previously we just reported the
numbers but didn 't go beyond this'.
'We have become much more focused around the issue of risk
management. We've become more aware of the fact that we've got to
learn and take action from the risks that have been identified. In its
early days, it was very much a reporting mechanism with very little
direct action resulting from the risk management committee, that's the
area where we have started to build on. Once we started to identify
common risks we 've then tried to commission action to try and address
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those risks'.
'We 've become a lot more proactive and we 're working more as a team
now whereas before we had pockets of different people doing different
things - not saying people doing all bad but we didn 't have a forum
where we could discuss best practice... ...people can see not just a paper
chase (now)'.
The developments described above are part of an on-going process but significant gaps
in the present dataset such as clinical audit, complaints, and the Significant Clinical
Incident reports inevitably limits the ability of the Team to integrate the risk
management agenda and discharge its monitoring function. Also, there does not appear
to have been a systematic baseline assessment of the risk management process per se or
an assessment of manager/staff training needs around this agenda.
6.3.6 Training and Development Group
The Trust's 'Clinical Governance Report' highlighted education and development as a
central element in the establishment of clinical governance in the organisation:
'Effective clinical governance needs to be underpinned and supported by

the education and training of clinical staff that is relevant, up to date,
flexible in its delivery and meets the needs of individual practitioners as
well as the needs of the Trust'. (Internal Trust Document, 1999; p9)
The Development Plan identifies a number of specific objectives around the education
and training agenda; these include action around appraisal and Personal Development
Plans (PDPs), best practice in user involvement, training staff to access best evidence.
There is also a reference to the 'newly established Training Strategy Group' whose
brief includes the review of education and training needs across the organisation.
Membership of the Training and Development Group reflects the membership of the
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Management Team; essentially, the group is Management Team meeting to focus on
specific issues relating to the training and development agenda. Although the budget is
administered by an Executive Director of the Trust, training and development appears
to have been devolved to divisions; it is not part of the remit of the HR function.
Eighteen months after the Development Plan was produced, a strategy for education
and training had not been formulated. In the absence of a strategy and given that
employee appraisal is still not universal, it is not clear how priorities for education and
training are determined. Although there is training in appraisal and incident reporting,
there is no evidence to suggest that an integrated corporate approach has been adopted
to equip staff with the range of knowledge and skills to engage effectively in clinical
effectiveness, risk management, quality improvement and other specific elements of the
clinical governance agenda.
There is a sense amongst some interviewees that, apart from budgetary control, current
arrangements concerning accountability and responsibility for the delivery of training
and development within the organisation are less than clear. Some members of the
Training and Development Group did not necessarily feel they had an overview of the
whole agenda and were not entirely sure who amongst them would have:
We used to have a training manager who reported to (the ED) ... ...we
have come right away from that now and apart from the assessment
centre there is no centralised training function at all. I don't care who
leads the training function but my concern is that there is no overview
...... I don't think there is a feeling that it is being pulled together at all
...... this is not a criticism of (ED) because I don't think this is what her
role is envisaged as being. Think it is an area where you do need an
overview'.
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6.3.7 Libraries
Another key component of the Trust's clinical governance framework concerns
'knowledge management' which has, in theory, if not yet established in practice, a
strong connection with the education and training agenda. The geographical dispersion
of Trust services presents a particular challenge when considering how to facilitate staff
access to the knowledge for practice. The Trust provides library services from three
sites. Initiatives to improve these services have focused on a number of areas: an
increase in staffing to raise the level of professional input, the development of library
systems and processes to enhance the service and meet the needs of a multidisciplinary
workforce. As a consequence, there has apparently been an increased investment in
staff, IT equipment, electronic resources, books and a rationalisation of journals.
Access issues due to the geographical dispersal of services have been recognised by the
Trust which has acknowledged the need to provide 'virtual1 library services. However,
discussions with a number of front line staff suggest that, whilst physical access can
still pose a problem for some, there may also be a cultural barrier - this clinician
described how she felt guilty about accessing the library 'in work time':
7 'm just saying it is a luxury, and I often feel very guilty if I go to the
library in work time because they are all so far away ... ...you can 'tjust
pop in and pick a book up or drop a book off. It's couple of hours to go
there to look for something and then to follow it up; you tend to do all of
that in your own time. Feel there is a stress factor there - if you 're
doing that there's something you 're not doing; back to down to the
bones again in terms of time'.
The service has been working towards accreditation under the 'Line Health Panel
Accreditation Scheme' and recently achieved level three; in her report, the assessor paid
tribute to the hard work of the team involved. Although more work is needed, the
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content and tone of the accreditation report suggests that, in achieving level three
accreditation, the Trust has established a sound basis for future development.
6.3.8 Related Structures
Given the complex and far-reaching nature of the clinical governance concept, there
are, of course, a large number of groups within the Trust which contribute to the
delivery of the clinical governance agenda. Just some examples would be the Audit
and Complaints Sub-committees, committees and groups taking forward the work in
the areas of Health & Safety, Nursing Practices, Drugs and Therapeutics, Information
Management and Technology (IM&T). Many of these groups have been functioning
for some time and the need to establish formal links between new and existing
structures to achieve a greater degree of integration between systems was identified
early in the clinical governance implementation process. Although the Trust recognises
that progress has been made in some areas, there is an acknowledgement that more
work is needed and discussions have been ongoing in relation to mechanisms for
increasing the level of integration required but, as indicated earlier in this section, this
is an issue which is yet to be resolved.
As highlighted earlier in this report, individual managers sit on a number of groups or
committees but sharing information from one structure to another often relies on the
individual rather than an explicit system. As an example, although IM&T systems
underpin much of the work of the Trust, whether as clinical information systems or in
providing internet access to related information, it is difficult to see from the minutes of
the Clinical Governance Sub-committee how the strategy for IM&T explicitly
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influences/informs the agenda of this group. The minutes record little in the way of
discussion around this aspect of the Development Plan.
6.4 SYSTEMS AND PROCESSES
As new structures were being introduced and, in some cases, the work of existing
structures re-focused, development of the supporting infrastructure was also taking
place with the introduction of new and the re-focusing of existing systems and
processes. Many of these initiatives are intended to 'capture the learning' either from
within the organisation itself, the users of its services, and/or from external sources.
6.4.1 Dissemination and Implementation of Good Practice Guidelines
In order to strengthen existing mechanisms for capturing the increasing amount of
evidence-based information received by the Trust such as National Institute for Clinical
Excellence (NICE) Guidelines, Technology Appraisals and Effective Health Care
Bulletins, the Trust has developed a system for the Dissemination and Implementation
of Good Practice Guidelines'. This new approach was introduced mid 2001 to ensure
that all relevant documents entering the Trust are either received directly by or sent on
to the Clinical Governance Lead. These documents will then be logged, reviewed by
the Clinical Governance Development Team and allocated a priority rating which
ranges from 'immediate consideration', to 'planned review' and Tor note only'.
Once the initial review has taken place, a course of action for each priority is specified
which may include dissemination to the local clinical governance fora and/or other
Trust groups for consideration. In each case, responsibility for the process within the
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target group is accorded to a named individual. High priority will require a local/Trust
review of existing practice against that which is specified in the guidelines,
recommendations to address gaps identified, report on findings/action proposed to the
Clinical Governance Sub-committee - all within pre-determined time-scales.
The Trust recognises that, in addition to NICE guidance etc, it will also need to
consider how the reports arising from other external sources will be incorporated into
the system for explicit processing. Potentially, this will include the reports from
national inquiries (e.g. the Kennedy Report on paediatric cardiac surgery at Bristol
Royal Infirmary), Commission for Health Improvement reviews, external clinical
incidents (e.g. problems associated with the administration of Vincristine ) other
guidance/information such as that issued by the Royal Colleges and Department of
Health.
The system provides a clear framework for capturing, disseminating, discussing and
acting upon key information coming into the Trust. A mechanism is in place to track
these processes and a key challenge will be to incorporate this system within the
broader clinical governance agenda by, for example, informing the Trust clinical
effectiveness and audit programme, risk management etc. By the end of the fieldwork
period, the system had been in operation for approximately five months and a review
was planned of the process itself, the nature of outcomes arising from the process, and
the progress of any subsequent action (divisional or Trust-wide).
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6.4.2 Clinical Audit
Clinical audit is a component of the clinical governance agenda which has been
undertaken within the Trust for a number of years. Despite this, the Trust
acknowledges that a number of factors have presented a challenge to its efforts to
'maximise the benefits of the programme' (Internal Trust Document, 1999; pi 1). These
factors have apparently included: a less than multi-disciplinary approach,
fragmentation, issues around the implementation of change where indicated and also
perceptions and attitudes around the importance of clinical audit. A small number of
Trust-wide projects have been undertaken which focused on consent and record
keeping however, clinical audit activity has been devolved to the clinical divisions.
The local clinical governance fora are responsible for developing a programme for
audit as part of the local clinical governance plan but there is no corporate plan for
clinical audit which would guide the fora on the key issues facing the Trust from both a
national and more local perspective. However, as part of the system for the
'Dissemination and Implementation of Good Practice Guidelines', it is intended that
audit against the national guidance will contribute to the Trust programme of clinical
audit where there are Trust-wide implications. Alternatively, where guidance is more
locally relevant, it should inform the divisional programme.
Prior to the establishment of the Clinical Governance Development Team, clinical audit
was co-ordinated and facilitated centrally. Whilst members of the Team have provided
support around aspects of audit to divisions and latterly the local clinical governance
fora, the extent of this support has varied depending on the other operational aspects of
the Team member's remit and also the number of divisions for whom the individual has
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been acting as facilitator. It is anticipated that the recruitment of new members to the
Team will mean that support and advice around clinical audit becomes available to all
areas.
The level of clinical audit activity taking place is perceived as low overall although
some areas are doing more than others. Organisational changes are thought to have
created capacity issues but changes in arrangements for support and a lack of data are
also regarded as contributory factors as this manager commented:
'There probably isn 't (a lot happening). This is what disappoints me -

there has been a lot of audit going on and in the last 18 months it has
really rather withered and they really need to regenerate their focus.
The people who have been there are wanting to do it, it's just that they
have been applying for posts, re-organising, setting up new teams. They
are now at the point where they can start to think about quality... ... the
problem with audit work is that it is very time-consuming, just so labour-
intensive because we don't have the data. So one of the reasons why I
think we don't do a lot of re-audits is that people are so exhausted'
'I could weep; if I look at some of the stuff I am doing, it is small beer,
it's not changing practice because it is too small, it is not consistent
enough, we haven't got the data, we can't show things consistently
enough so we might do a bit of tinkering round the edges; but the time
for tinkering round the edges is gone'.
In December 2000, the Trust introduced a new summary report form to capture key
details of the audit work being undertaken in order to build up a profile of clinical audit
activity in the Trust. This not only gives an indication of coverage and methodology
but also seeks to establish the changes which have been made to practice and any
subsequent benefits to patients resulting from this audit activity - i.e. that the audit
cycle has been completed. Information on clinical audit is collated by the Clinical
Governance Support Manager. In addition to the summary sheets which are returned
centrally, the divisions have recently been required to include an overview of their
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clinical audit activity in their annual clinical governance reports; the data from which
has been incorporated into the annual clinical governance report of the Trust. These
centrally collated summary sheets provide valuable information on clinical audit
activity; however, it is not clear from the datasets currently available how this informs
the routine clinical governance monitoring and reporting system. The lack of a
deliberate integration mechanism means that clinical audit results are not considered
with other elements of the clinical governance agenda such as risk management,
complaints, Significant Clinical Incident Reviews etc thus there is less opportunity for
each to inform the other.
Whilst training in literature searching has recently been available, training around the
wider clinical effectiveness and the clinical audit agendas has not been provided in-
house for some time due to changes in the arrangements for facilitation. Whilst it is
important for staff and managers to have the relevant knowledge and skills if they are to
undertake this activity and many staff have apparently acquired this through post
graduate study, this is not the case for all.
6.4.3 Raising Issues of Concern
Continuous improvement in the quality of services for patients and clients is a central
aim of clinical governance and opportunities for improvement may be identified in a
number of ways. In addition to the group and committee structures described earlier,
the Trust has developed a policy and procedure to assist individual staff should they
identify gaps in service quality or wish to share concerns regarding service delivery.
Through its policy 'Raising Issues of Concern', the Trust has made explicit the
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responsibility of all staff to bring any such concerns to the attention of their managers.
A procedure for raising issues has been outlined which provides details of the multiple
avenues open to staff together with information on the action to be adopted by the Trust
in response. Both the policy and procedure have been incorporated into the Trust
Policy and Procedures Handbook.
Since the introduction of the policy in October 2000, the procedure has been invoked
on one occasion. Investigation revealed that the matter was already being addressed
locally although the individual who had made the report was apparently not yet aware
of this. It is anticipated that the investigation process will be similar to that established
for incidents in general or, if it meets the criteria for Significant Clinical Incident
Review, the latter approach could be considered more appropriate.
The Trust recognises that staff may find it difficult to report concerns, particularly
where the issue involves the actions of colleagues, some of whom may be in a more
senior position. The usage of this mechanism will continue to be monitored, and, if the
low level of reporting persists, an assessment of the underlying reasons for this will be
made.
6.4.4 Incident Reporting, Trigger Events and Significant Case Reviews
A mechanism for reporting incidents associated with the Health & Safety agenda has
been operating within the Trust for a number of years. The need to increase the
reporting around clinical incidents has been recognised and efforts are ongoing to raise
awareness of this; however, training courses have apparently been suspended due to
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low numbers. A workshop for senior managers took place in July 2001 and was well
attended, apparently well received and should, therefore, provide a positive starting
point for further efforts to raise the profile of clinical incident reporting and, indeed,
risk management in general.
As part of the development of clinical incident reporting, a pilot project is taking place
to develop the use of'trigger events' which, should they occur, will indicate to staff that
an incident report is required. A process of 'significant case reviews' is also being
piloted. This process is intended to focus on complex clinical cases or cases where the
boundaries of practice are being extended to address the specific needs of the clients
concerned. Each of these pilots is at a relatively early stage of implementation and the
intention is that an evaluation will take place in due course.
6.4.5 Significant Clinical Incident Review
When a clinical incident occurs, there may be important lessons to be learned which, if
acted upon, may minimise or, in some cases, even eliminate the risk of such events
happening again. The seriousness of such incidents often varies as does the outcome
for the patient/client, carer and the Trust. To address this issue, a system for the
investigation of significant clinical incidents - 'Significant Clinical Incident Review' -
was introduced early in year 2000. The aim of the review is to take a whole-system
approach to investigating the incident, determine the root cause and effect appropriate
remedial action. The procedure is clearly defined and extends from the notification of
the incident, rapid appraisal to determine whether it should be dealt with under the
Significant Clinical Incident Review procedure, through to the conduct of the
investigation, remedial action and the reporting mechanisms intended to support the
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monitoring of progress against the corrective action plan arising from the incident.
In an effort to signal a commitment to openness, to make explicit the lessons learned
and the subsequent action to be taken, the Trust has introduced a mechanism for
disseminating the Review report both internally and externally to the wider health
community. Depending on the audience for the report, the detail and format will vary;
full reports of the incident are sent to and discussed at the Clinical Governance Sub
committee and Management Team meetings. The Clinical Governance Lead will visit
the patient and/or family to discuss the findings of the report before sending a copy to
them. Anonymised summaries are also distributed to divisional clinical governance
fora, to the Trust Board, and to external organisations such as the PCGs and the County
Quality Board. A follow up audit is undertaken after an agreed period of time to
confirm that the required remedial action has taken place.
By the end of the fieldwork period, 18 Significant Clinical Incident Reviews had taken
place over a period of approximately 18 months. Although Divisional Managers felt
that such incidents had been taken seriously in the past, there was the sense that this
recent approach had provided those whose division was directly involved in the
incident with an explicit framework for investigation and action.
The Significant Clinical Incident Review is an important initiative and has started to
signal a change in the 'way we do things here1. However, observations in the field
suggest that there are still a number of issues to be addressed; in particular, those
relating to assumptions about the level of openness at the front line of service delivery,
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the perceived transferability of lessons learned and the report dissemination process.
As outlined earlier, reports are disseminated widely and the level of detail varies
depending on the intended audience. The effectiveness of dissemination relies on a
number of factors, one of which is the degree of openness within the different levels of
the organisational hierarchy. The openness at the corporate level may not be matched
by local approaches to complaints, significant incidents and so on. A number of front
line staff commented on the tendency to keep complaints and incidents as a local issue
involving only those staff directly affected; they see this as a cultural phenomenon.
Within the context of formal staff meetings, it does not appear that complaints or
incidents are discussed even in broad terms such as the numbers received on a quarterly
basis. Local staff are filling in incident forms but are not apparently receiving feedback
on their efforts which may lead to cynicism:
'/ think it 's about culture. We are looking at culture changes, ... ...from
a culture that hid away and didn 't discuss it at all (to) a culture that
allows you to discuss critical incidents, near misses, significant events in
an environment where you expect positives as well as negatives; it is this
sharing of information across divisions which could put you in a
negative light... ... and that is very embryonic but it's starting'.
'Feedback is really important but when you don't get any it's
demoralising; we 've done this, we 've sent in this form and you get
nothing back from it that's perhaps going to improve something - (that)
this, this and this has been done - you get a bit cynical - you think what's
changed?'
Feedback from several of the divisions suggests that, in some cases, where an incident
has occurred in a specialised part of the service, there is a risk that the relevance of the
lessons learned may not be appreciated in other areas. This has led to a situation where
local circumstances are less likely to be reviewed to determine whether similar
corrective or preventive action is indicated. In addition, whilst some managers are
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acting on the reports, not all managers know what to do with them once received:
' Significant Clinical Incident - this information cascading down to us;

how many of us in that room this afternoon know what to do with that?
Where do we take it, what do we do with it. Do we think about it or are
we just going through the motions. I knew about the (particular)
incident, I didn 't cascade it anywhere - should I have? It's around -
should we? There's one or two who probably think, I know what to do
with this, I know how to learn from it and get my staff to learn from it to
show my staff that clinical governance is working; but not all of us
would'.
Whilst the Significant Clinical Incident Review reports are widely disseminated, they
do not appear on the agenda of certain key committees such as the Risk Management
Team meetings. Members of the Risk Management Team who are also part of the
Management Team will receive the report through the latter group but other members
currently find themselves out of the loop. How far down into the divisions the Review
reports are communicated is variable; some of the junior managers and practitioners
only became aware of the existence of this system at the Risk Management Workshop
held over 12 months after the first of these incidents had been investigated.
6.4.6 User Involvement
User involvement is another core element of the Trust's clinical governance framework.
The Development Plan contains a number of objectives under this banner and makes
specific reference to the work of the Trust Board and to the divisions. The
Development Plan preceded a review and report on user involvement in the Trust. This
report concluded that although there was enthusiasm for developing this important
component of the clinical governance agenda, there was no mechanism for sharing
good practice across divisions. Initiatives often relied on the enthusiasm of individuals
rather than being an integral part of service delivery. Based on this assessment, in
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October 2000, the Trust developed an action plan to take user involvement forward.
The focus of this work is on three levels: care planning, service provision and
development and organisational development. Each of the clinical divisions was
required to identify an opportunity for piloting initiatives to address one or more of
these three levels; coverage has apparently been patchy and progress, overall, described
as variable. Although a number of initiatives are regarded as progressing well, one
division is yet to get any under way.
Operational monitoring of these initiatives has been undertaken by the lead manager;
however, there are no mechanisms for regular, formal reporting of the progress of these
pilots to the Management Team. Despite the fact that user involvement has been
devolved to the divisions and Divisional Managers are responsible for driving the
agenda forward, this key component of the clinical governance framework does not
appear as a regular agenda item on the Management Team meetings. Instead, updates
appear to take place on a more informal, one-to-one basis between individual managers.
Thus no mechanism has been established in the forum with explicit responsibility for
taking this agenda forward to enable collective monitoring of progress, discussion of
barriers to effectiveness and the institution of remedial action to address the current
lack of progress in these initiatives. Essentially, there is no corporate structure to drive
user involvement in the Trust other than the efforts of the User Involvement Lead. The
Lead has been trying to work with the staff on the front line but is moving more
towards trying to engage the Divisional Managers in an effort to develop a more top
down and bottom up approach.
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Although the User Involvement Lead has presented the topic to the Clinical
Governance Sub-committee and the issue of user input to this particular Sub-committee
has been under consideration for some time, little progress has been achieved in
establishing user representation onto the Sub-committee either in the form of service
users or the lead manager.
6.4.7 Appraisal and Professional Development
Monitoring the performance of staff and promoting life-long learning are key themes
within the national clinical governance agenda. The appraisal process is one of several
mechanisms proposed for highlighting and addressing performance and development
issues (Department of Health, 1999) and the Trust objective in this regard is as follows
(Internal Trust Document, 2000a; p6):
'By April 2000: To ensure all staff have regular appraisal and have
identified personal development plans which are linked to the business
plan'.
In December 2000, the Trust undertook a staff attitude survey; 2927 questionnaires
were sent out with payslips and 1170 were returned - a response rate of 40%. Of those
who responded to the statement 'my manager gives me regular feedback on how I am
doing in my job' - 47% agreed. Of those who responded to the statement 7 have a
Personal Development Plan (or Training and Development Plan) which has been
agreed with my manager" - 35% agreed. Clearly the Trust has some way to go in order
to meet its original objective. To facilitate this process, training sessions have been
provided for managers prior to appraisal of staff. There has apparently been an
increased corporate emphasis on the need to move forward with the appraisal system.
A number of managers interviewed now have this as a personal objective and
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consequently are requesting training in this area.
Apparently there have been a number of discussions in a variety of arenas around the
challenges of delivering the targets set for appraisal and Personal Development Plans
(PDPs). Contributory factors are thought to include, in some cases, negative
perceptions around the purpose of appraisal:
'(I) think that managers tend to use it as a whipping tool rather than an
opportunity to sit down and discuss things... ... sounds as if we may have
some staff who think it is a telling off session rather than what it should
be which is completely the opposite'. (Senior manager)
For some managers appraisal is perceived as a time-consuming extra rather than an
integral component of the management function. Current training courses not only
provide information on the appraisal process itself but also recognise the need to
overcome some of the negative perceptions surrounding appraisal and CPD that
currently exist.
Prior to the staff survey, there have been a number of ad hoc initiatives to monitor the
percentage of staff receiving appraisal however it is unclear how the progress of this
agenda is monitored on an ongoing basis, how a Trust overview is maintained or how
the development agenda informs business planning.
6.4.8 Communicating the Clinical Governance Agenda
During February 1999, the Trust undertook a series of road shows with the aim of
raising awareness around the emerging clinical governance agenda. These were held in
four locations and comprised; leaflets, posters, short presentations on clinical
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governance and clinical effectiveness. Staff also had an opportunity to try electronic
search facilities. Two hundred and seventy one (271) staff attended which represented
around 9% of the workforce. Feedback on this initiative was, apparently,
complementary in the main although some staff would have appreciated more time and
for the content to be have been more specific. Some interviewees suspected that the
majority of those attending the road shows were managers rather than staff:
'The road shows were put on for the directorate - not well attended. It
was well publicised but I think people thought it wasn 't important - the
managers came but they were told to come'.
'My hunch is the types of staff who attended were the more senior staff
who thought this is going to be something that my manager's going to
ask me about in my IPR rather than the untrained and the more clinical
staff who cannot as yet see how this is going to affect them when they go
and see Mrs X\
A small number of articles have since been published in the in-house newsletter and the
Trust Annual Reports have included information on progress against components of the
Development Plan.
Since the early Trust-wide initiative, awareness raising has continued on a more
opportunistic basis with presentations by the Clinical Governance Lead to divisional
meetings and meetings of the local fora. In addition, where members of the Clinical
Governance Development Team have been active within a division, they have engaged
groups and individuals often on a similarly opportunistic basis. In reality, the
implementation of clinical governance has not been supported by a communication plan
and, in this managers' opinion, communication of the clinical governance agenda is
essentially left to the Clinical Governance Lead:
'Everyone will leave it to (the Clinical Governance Lead) as the lead to
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think how do I make sure this (clinical governance) issue gets
communicated thoroughly across the Trust; that's how it will be left.
(Clinical Governance Lead) might say I think it will be a good idea if we
have a road show and that will happen. If she said today, I think it will
be a good idea to send out an update to staff in pay packets, that would
happen; but I don't think as a separate entity there is anybody sitting
down and saying this is a very important issue, what should our
communication strategy be on it?'
Although the responsibility for external communication has been assigned to a named
manager, the responsibility for internal communications is unclear; whilst there is a
framework for external communications, a corresponding framework for internal
communications has not been developed.
The Clinical Governance Development Team is currently reviewing the issue of
awareness raising in the Trust and is considering options for taking this forward. One
approach is the development of a standard presentation to provide managers and staff
with consistent, core messages around the clinical governance agenda that can
subsequently be adapted to reflect the needs of local audiences. Also under
consideration is the possibility of developing a resource/training package that will have
a Trust-wide relevance. In the meantime, a workshop is scheduled to take place to look
at the roles and responsibilities of the groups/committees and individuals; the target
audience is members of the Clinical Governance Sub-committee, the local clinical
governance fora and Divisional Managers. Whilst this is a positive initiative, it will
only connect with a small proportion of the organisation and there is currently nothing
planned for the wider audience.
The apparent gap in disseminating clinical governance is also highlighted by the
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arrangements for the distribution of the minutes of the Clinical Governance Sub
committee which, as mentioned earlier, tends to be to the Trust Board. The formal
Management Team membership does not routinely receive minutes and neither does the
Risk Management Team; latterly, however, the chairs of the divisional fora have been
included in the circulation. Some members of these groups will receive this
information by virtue of the fact that they are also on the Trust Board but there is a lack
of consistency in the dissemination process. Under the circumstances it was not
surprising to discover that levels of awareness and understanding around the clinical
governance agenda were variable. These trained staff when asked to say what clinical
governance meant to them had some difficulty in explaining the concept:
7 don Y really know anything about clinical governance although I feel 1

ought to'.
'Clinical governance - what is it? Is it about enlarging on topics and

finding out weaknesses? I don't really know'.
Some staff saw clinical governance as lists of elements such as evidence based practice,
clinical supervision etc; others articulated the agenda as a more integrated approach to
quality improvement:
'Government initiative to maintain, improve and monitor standards of

practice and care in the NHS - response to things that went wrong'.
'Responsibility to clients/patients to provide best practice possible and

research based... ...allowing staff to develop and discuss best practice
via clinical supervision and personal development...... initiation of NICE
and clinical excellence'.
'Providing a better service, value for money, more accessible, meets

health needs'.
'Clinical governance is everybody's concern. It is an umbrella term for

areas of practice which can be continuously reflected upon. For
example, team working, communication, to see if improvement is
required. Can also provide frameworks and strategies for quality
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improvement'.
'A framework aiming to deliver a quality, standardised service to

patients; using evidence-based practice is a vital part of that'.
Many of the professionally qualified staff interviewed perceived their knowledge to
have been gained through professional publications, associations or professional
training rather than from Trust-based initiatives. The quotations above suggest quite a
range in trained staff awareness; in contrast, managers specifically commenting on staff
awareness generally perceived this to be on the lower end of the knowledge spectrum:
Will be some (staff) who have a fair understanding and others who are
completely in the dark'.
'Clinical governance were two words that were talked about a lot but
their understanding of clinical governance was "it isn't going to affect
me; it's not going to have an impact on me, why should it impact on my
practice; I think that I do deliver the best service I can "... ...you have an
individual responsibility but I don't think that has been taken on board
either; so ifyou like they are actually saying - well clinical governance,
that's (the manager's) problem because she is the manager... or clinical
governance, well that's the PCG clinical governance forums
problem...that's not my problem, not my area because I have no
responsibility'.
'There is no point doing (a questionnaire on understanding),...... they do

not understand clinical governance, it does not, as yet inform their
practice'.
We all know about clinical governance (managers) but whether the staff
at groundfloor level actually know... ... ifyou walked up to a member of
staff and say how is clinical governance affecting your work - I don't
know whether they would know exactly what you are talking about'.
Despite the above perceptions of their staff, it seems that few managers initiated any
deliberate awareness raising initiatives within their own sphere of influence. Whilst
staff would likely benefit from more input, it would apparently be welcome to some
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managers too:
'There has been no awareness raising around the agenda or training for
clinical governance or CQI. Would welcome some myself - feel as if I
am fumbling in the dark'.
'It (clinical governance) is still woolly. One of the problems about the
adoption of it is there is a lot of work already been taking place but its
not tangible. Can't see it and feel it on a daily basis. Having looked at
the Trust action plan on clinical governance my first response was - how
on earth do you apply this to practice? Now I am sure I am not alone
there...... is it tangible, is it real; it will only make an impact if it's real
and tangible...... '.
6.4.9 Monitoring and Reporting Progress
The establishment of monitoring and reporting systems designed to capture clinical
governance activity within the Trust has been an evolving process. A template for
quarterly reporting has been introduced which collates data from a number of existing
quality systems into a single report format. Thus, data and information from Risk
Management, Control of Infection, Significant Clinical Incident Reviews and progress
against the Development Plan objectives has been presented for some time. More
recently, information on Complaints and Staff Sickness Absence has also be included in
an ongoing effort to present the wider and expanding picture.
The availability of data in this format is relatively recent but has already highlighted
trends within and across services. This has brought managers and staff together to look
at specific issues and, where appropriate, formulate corrective action which may be
appropriate for wider application across the Trust. This has been less evident in the
past when there was a feeling that the geographical dispersal and the diversity of
services often precluded such a joint approach; however, collective analysis of the
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collated data has, in some cases, identified common themes indicating that
collaboration might be appropriate.
A schedule has been developed which indicates the timing and sequence of reporting.
Reports by division are to be considered at Management Team and the Risk
Management Team. This data is then consolidated into a Trust report for consideration
at the Clinical Governance Sub-committee prior to being presented to the Trust Board
where it is received in the public part of the meeting.
Another mechanism for determining progress has been the development of an explicit
reporting framework to inform the Trust clinical governance annual report for 2000-
2001. This provides a clear indication of the areas which should be receiving divisional
attention and action as clinical governance is implemented. The framework has been
developed to ensure consistency in the annual returns in order to facilitate collation.
However, it could also provide a valuable mechanism for reporting progress against
objectives in-year rather than year end which would considerably augment the
information currently available to local groups, to the Clinical Governance Sub
committee and ultimately to the Trust Board.
Although the above constitutes important progress, it has already been highlighted that
there are still gaps in the clinical governance dataset which means that those receiving
the reports are unlikely to have a full picture of clinical governance within the Trust.
Whilst the reporting process is evolving this must be appreciated so that the Sub
committee understands the extent to which it may discharge its assurance function
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given the information at its disposal.
The IM&T implications of supporting the delivery of clinical governance are far
reaching; some of this diversity has been highlighted in the Clinical Governance
Development Plan. The Trust has developed an Information and Communication
Technology (ICT) Strategy to take forward the national and local agendas for IM&T.
The strategy is supported by the ICT Implementation Plan and progress is monitored
through the IM&T Development Board. Updates on progress against the objectives
outlined under the 'Information' component of the 'Clinical Governance Development
Plan' are incorporated into the quarterly clinical governance reports; however, the
objectives themselves are broad and give little specific information around the progress
of the IM&T agenda. Apart from this quarterly report, it is not clear how the IM&T
agenda explicitly informs the work of the Clinical Governance Sub-committee and vice
versa given the nature of the existing reporting framework and the absence of a
specialist as part of the Sub-committee membership. At times, verbal updates are
provided by the Clinical Governance Lead who is a member of the IM&T Board
however, it seems that this input is not systematic but tends to represent an individual
transfer of information rather than a formal monitoring and reporting mechanism.
6.5 PEOPLE
6.5.1 The Human Resource
At an aspirational level, the 'people' element within the clinical governance agenda,
both nationally and locally, is an important key to the achievement of quality in health
care. As indicated in Chapter 3, the nature of services, whether in health care or
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commercial settings, is such that the quality of the service offering is highly influenced
by the individuals engaged in the delivery process. The guidance document issued in
1999 (Department of Health, p6), explicitly reinforces the connection between quality
and the workforce:
'Closing the gap bet-ween the present service and the desired new level
of quality will often not be possible without addressing workforce
issues'.
6.5.2 Linking HR and Clinical Governance
The document (ibid) continues by stressing the importance of a local human resource
(HR) strategy to ensure that the connections between the numerous strands are made to
facilitate an integrated approach to HR's contribution to quality improvement in general
and the delivery of the clinical governance agenda in particular. Despite the explicit
reference to HR in the Trust clinical governance framework and the identification of
key objectives in relation to this, the realisation that HR underpins much of this agenda
has been rather slow to dawn on some managers and this important element has not
received as much attention as it might have:
'Essentially what you 're talking about is quality where, clearly because
you need to do that through the staff, then there will be some HR
implications but not all the HR initiatives that have come from the
Centre (are about clinical governance)... ...I suppose you could say that
staff involvement is about clinical governance because there is a
requirement to try and involve staff in the delivery of health
care...... now you've said that there might be more overlap than I had
even thought about before... ...I suppose at the end of the day, ifyou are
trying to do something through your staff then everything you do (in HR)
is going to have an impact on the quality of health care that they
actually deliver - but whether or not you could lump it all under the
umbrella of clinical governance or that would make it too big, I don't
know. You might even talk of harassment I suppose, policies on that; if
someone is feeling harassed they are not delivering a good service are
they, they are not improving their work - but would you put that under
the clinical governance umbrella?... . I suppose clinical governance is
something that affects everybody, it's the whole organisation so in some
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ways possibly it would'.
'There hasn 't been as much connection with HR as one would want -
became we haven't particularly focused on that'.
At the close of the fieldwork period, the HR strategy was still in draft; the explicit and
perhaps only reference to clinical governance is made in the section 'Quality
Workforce1 (Internal Trust Document, 2000b). In this section there is a brief paragraph
documenting that a clinical governance lead has been appointed, a Clinical Governance
Sub-committee established and that performance review has been introduced.
However, there is little to link clinical governance with the rest of the HR strategy and
it is not clear from the document how other elements, such as clinical supervision, are
specifically related to the clinical governance agenda. The implementation of the HR
strategy will be devolved to the divisions; however, it is unclear how this process will
be monitored.
The issues discussed above reflect the devolved nature of the HR function; the role of
which appears primarily to be one of providing operational advice and support to the
divisions. Accountability for delivering the overall HR agenda is unclear. Of particular
significance in terms of clinical governance is the lack of HR input into the Clinical
Governance Sub-committee - there is no mechanism for regular updates to the Sub
committee although some aspects of the HR agenda are included in the quarterly
reports. Sub-committee membership has not included a representative from the HR
function either at the outset or later on when the membership was expanded which
seems rather a surprising omission given the centrality of the human resource in the
delivery of the clinical governance agenda.
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6.6 ORGANISATIONAL CULTURE
6.6.1 The Need for Culture Change
A fundamental objective of the national clinical governance agenda is the introduction
of a new culture into the NHS; one that is open and participative, demonstrates a
commitment to quality, works with users and carers, supports multi-disciplinary team
working and so on (Department of Health, 1999). To reflect its key role in the national
picture, the Trust has incorporated 'culture' into its clinical governance framework. In
fact, culture takes prime position as the first element in both the 'Clinical Governance
Report' and the 'Clinical Governance Development Plan', two key Trust documents
referred to throughout this chapter.
In relation to culture, the 'Clinical Governance Report' highlights some of the barriers
to change within professional organisations and alerts the reader to the need for culture
change but stops short of stating explicitly what this change might entail relative to the
current culture of the organisation. From the excerpt below, culture appears to have
been conceptualised as a variable which must be addressed so that the rest of the
proposed change may follow on:
'Change implementation in the NHS is often seen as threatening to

health professionals. The concept of clinical autonomy and clinical
freedom, fear of failure and blame and often a lack of comparative
information and the non-identification of effective levers for change all
mitigate against the establishment of a culture of change within health
service organisations. Changing that culture is difficult but it is a pre-
requisite to the delivery of clinical governance. Once the culture is
changed, then challenging, reviewing and altering practice becomes
second nature'. (Internal Trust Document, 1999; p8)
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6.6.2 Culture conceptualised
The concept of culture has been interpreted within the Trust clinical governance
framework in terms of: a Trust-wide Commitment, Board-level Focus and Clinically
Focused Management Strategies. These have been translated into more tangible
objectives such as the development of an implementation plan for clinical governance;
the establishment of structures; and the development of a number of the systems
described earlier in this chapter. A great deal of the work undertaken by the Trust and
described throughout this section could be related to the cultural variable in some way.
For example, in setting up a system of reporting for clinical governance activity, the
Trust is indicating how one aspect of a 'reporting culture' will look in very practical
terms. Similarly, with the introduction of Significant Clinical Incident Reviews, a
powerful signal is being sent to the organisation around 'the way we do things here' -
indicating the sort of cultural shift that may need to take place in some areas in order to
integrate this new approach.
Despite the central role given to the cultural element, the data does not suggest that the
initial baselining work undertaken at the outset included any systematic assessment of
the existing culture per se or that of its various subcultures; for example: professional
cultures, non-professional cultures, an improvement culture, an incident reporting
culture, a blame culture, a fair culture, an open culture, a culture of trust and so on. As
a result, in documentation and conversation, culture is generally referred to in abstract
rather than specific terms but there are exceptions to this as indicated by the initiatives
described above and the change in focus expected of the Trust Board; this latter will
now be considered.
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6.6.3 A Culture of Trust
One of the policy objectives surrounding the introduction of clinical governance is to
ensure greater clarity around corporate accountability for quality. The intention is that
accountability will ultimately rest with the Trust board; the chief executive identified as
accountable officer on its behalf. Although the local documentation does not state the
accountability issues as explicitly as this, the Report suggests that, in order to deliver
the agenda, the Board will have to change the way it works and:
'... ...move away from (a culture) that is financially driven and focuses
predominantly on administration and contractual requirements to one
that has a clinical focus'. (Internal Trust Document, 1999; p8)
The Development Plan outlines specific objectives which identify the Trust Board as
having a key role in their achievement; these address such fundamentals as the
development of a clinical governance strategy and implementation plan. In addition,
one of the centrally mandated objectives for year one of implementation was the
clarification of reporting arrangements to the Trust Board. This led to the development
of the consolidated reports referred to in an earlier section which are submitted to the
Board on a quarterly basis after consideration by the Clinical Governance Sub
committee. As a result of these reports, some Non-executive Directors believe that
Trust Board meetings now devote more time to the quality agenda than previously:
'There has been a shift in our whole approach - when I first came, half
the Board meeting was taken up with finance but I think now it (clinical
governance element) is still not big enough but clinical governance is
becoming much more important for us (the Board) '.
These perceptions are particularly interesting as the minutes of the Trust Board
demonstrate that finance and activity is reported monthly whilst clinical governance
reports are quarterly; also the minutes do not reflect a high level of discussion/debate
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around the clinical governance submissions. Apart from initial briefings, there has
been no real development work with the Trust Board so that, as a body, it may clarify
its role and identify the information which will enable it to fulfil its new
responsibilities. Instead, as with the Clinical Governance Sub-committee, information
seems to be passively received and the gaps in the dataset appear to go unchallenged.
Nevertheless, there is a belief that systems are in place albeit a recognition by some of
the Non-executive Directors that determining the effectiveness of these is another
matter:
'Optimistic that the systems are rigorous but to be frank I wouldn 't
know'.
'Believe that it happens because there is good management'.
The lack of detail in relation to system effectiveness seems to be compensated for by
the sense of trust surrounding the Executive Team as individuals and also as a
collective as the following quotes demonstrate:
'(Lack of detail) I suppose I have implicit trust in the directors here;

that is a value judgement of mine. I suppose if I was (a non-exec) in a
Trust where I didn't trust the equivalent of the Clinical Governance
Lead and Chief Executive then that would be a problem wouldn't
it?...... (the agenda is) devolved down and fed back up and the board
sees the headlines, believes it happens because of good
management... ...question (how robust are the systems in place) shows
how much I rely on my faith in top management; in a way I suppose that
shows up a weakness in a sense because one of my jobs should be
making sure that the top management work through the system, because
I have such a good feeling about this Trust I would feel that those
systems are in place - my feeling would be that they are, I trust that they
are because we have been looking at incidents and picking things up'.
(The executive team) it's an established team, people had been working
together for a long time, trusted one another... ...working with this
mature team, there are other things you don't have to worry about so
much about because systems are up and running and they run well... ...if
I have any concerns or worries I would ring up (Clinical Governance
Lead) and ask,...... a lot of respect for her abilities'.
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The high level of trust suggested by the sentiments above is not confined to the
Executive Team but also extends to other Non-executive colleagues who play a more
direct role in the clinical governance agenda:
'I've got to be honest, I am not on the sub-committee and I've got

enough on so I haven't pushed myself...... why stick your nose in where
you are not required yet'.
7 would get much more involved if I wasn 't confident of those two
people (Trust Chair and Chief Executive)... ...we get regular feedback
anyway and we get feedback on clinical incidents for example - so I am
comfortable'.
'I know that (x) has got really involved in it and have the highest regard
for (x) abilities and consequently there doesn 't seem to be a great deal
ofpoint us poking our nose in - you are right to point out that we have
collective responsibility for it and the reports we get from (x) and
(Clinical Governance Lead)to the committee keep us sufficiently
informed so we don't have to get too involved'.
We all trust each other too much'.
Thus the culture of trust appears strong at the corporate level at least; but trust can also
be a heavy burden particularly for those further down the hierarchy who are committed
but do not necessarily have the capacity to deliver; as one junior manager explained:
'He (line manager) knows it doesn't matter if it's in my job description,

if he suddenly had something to be done by the end of the week,
something that he could pass it on to me, then I would pick it up and run
with it. That's how we work. If we didn't we'd never get the
improvements to practice that we want to see. He has said - "I could
employ several people full-time for 12 months and give them one ofyour
objectives each and it would be a full-time job but there are things we
need to do and we haven't got the bodies to do them"... ...you see we do
it because we are committed to the service as well. That's how they
have got people isn 't it'.
6.7 CHAPTER SUMMARY
The aim of this chapter has been to present the clinical governance initiatives
undertaken by the Emerald Trust that correspond to the 'what' or the content element of
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implementation. The whole system framework adapted from that of Miles (1997) has
proved to be a useful mechanism for organising the results coherently. The use of the
framework also highlights the fact that each aspect of the whole system has been
addressed in some way by the Trust. Whilst the initiatives described here are an
important step forward for the organisation, a number of gaps have been identified in its
conceptualisation of clinical governance. Although there has been an element of
interpretation within this chapter, the main discussion of the significance of the Trust's
approach will be deferred until Chapter 9.
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CHAPTER?
RESULTS - CLINICAL GOVERNANCE IMPLEMENTATION -

CORPORATE ACTIVITY: PROCESS
7.1 INTRODUCTION
Given that the previous chapter has addressed issues of design and content, the aim of
this current chapter is to describe the process elements of clinical governance
implementation within the Emerald NHS Trust. This is not intended as a chronological
account of process initiatives; instead clusters of activity are presented which have
either been inductively generated from the data or are reflective of elements contained
within the Miles change management framework (1997) (Appendix 2)
7.2 LEADERSHIP AND MANAGEMENT
As stated earlier in the introduction to this thesis, one of the key steps to be undertaken
by all NHS Trusts by April 2000 was the establishment of leadership arrangements for
clinical governance. The advent of clinical governance means that the Trust Board now
has an explicit responsibility for the quality of clinical services and the national policy
requires the chief executive to assume the role of accountable officer (Department of
Health, 1998). The Emerald Trust was ahead of the national deadline in appointing its
Clinical Governance Lead which provided her with an opportunity to shape and lead
this agenda from the outset. Whilst the Chief Executive is a member of the Clinical
Governance Sub-committee, much of the development work around this initiative has
been taken forward by the Clinical Governance Lead.
The Trust philosophy surrounding implementation suggests that some elements of the
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clinical governance agenda will need to be driven from the top whilst others will be
devolved for local development; therefore, it will be important for people with the
responsibility for taking forward clinical governance to know and understand what they
are accountable for. This transactional approach is set within what appears to be a
predominantly transformational style of leadership; a feature of which is the constant
articulation of Trust values such as a commitment to service. This style seems quite
pervasive and is generally espoused throughout the management hierarchy.
Traditionally, within the Trust, there has been less of an emphasis on systems and
processes and more on organisational culture; summarised by one Non-executive
Director as 'strong on culture, weak on systems or perhaps weaker on systems'. One
outcome of this is, being trusted to deliver, Divisional Managers do not appear to be
directly performance managed, and, until recently, have not been appraised on a regular
basis.
The Clinical Governance Lead also articulates these transformational aspirations and
demonstrates transformational attributes; however, there is also a strong sense of the
transactional in her style which seems more apparent when it is perhaps culturally
acceptable to act in this way. The transactional element is very apparent in some of the
new systems described in the previous chapter. Although this is often couched in terms
of 'capturing the learning', the reality is that formal feedback and control mechanisms
are being incorporated to determine whether the required change is, in fact, being
implemented. In the areas over which she has direct control, the Clinical Governance
Lead appears to drive the clinical governance agenda forward; in other areas she must
rely on influence and persuasion but seems willing to move to a more prescriptive and
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directive style if required in order to achieve the objective.
7.3 CONFRONTING REALITY
Part of the early work in the Trust consisted of mapping the existing system. This does
not appear to have been documented explicitly in a public format, at least a copy was
not seen by the researcher; and the process and scope of this remain rather unclear.
There does not appear to be any explicit evidence of benchmarking against other Trusts
although a routine external review of the Trust clinical governance arrangements was
undertaken. The findings from this review and from the internal mapping have
apparently informed the development of the 'Clinical Governance Report' outlined in
the previous chapter. Although the Report alludes to a number of issues relating to
existing systems within the Trust, the document does not provide a thorough overview
of the current state of clinical governance or its component parts. Given the experience
and the extensive local knowledge of the Clinical Governance Lead, it is likely that,
with or without a written document, she has an overview of the performance of the key
building blocks such as clinical audit, risk management and so on. Nevertheless, it is
not evident from the minutes of either the Trust Board or Clinical Governance Sub
committee how this has been shared in any detail with a wider audience, or, in fact,
how this assessment has explicitly informed the development of the objectives outlined
in the Development Plan.
7.4 CREATING A VISION OF CLINICAL GOVERNANCE
Another early activity was a visioning exercise undertaken with the fledgling Clinical
Governance Sub-committee at its second meeting in April 1999. Members of the group
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were asked to consider what clinical governance might look like in the organisation two
years hence. It is not clear from available documentation how this visioning initiative
was replicated in other arenas but the process preceded the publication of the 'Clinical
Governance Report' and, as highlighted previously, the draft publication of this
document was apparently followed up by discussions with a variety of divisional
groups to obtain their input.
7.5 PLANNING FOR IMPLEMENTATION
Although the process and scope of the baseline assessment does not appear to have
been documented in detail, the culmination of this early activity was the 'Clinical
Governance Development Plan'. The objectives outlined in the Development Plan
were a mixture of end state and change process; for example: the achievement of CNST
level 2, the development of a system for managing significant clinical incidents, the
creation of the Clinical Governance Development Team, and the introduction of
structures and systems to support the implementation of clinical governance. Thus, the
Development Plan appears as a mixture of the 'what' and the 'how'. It is interesting to
note that the first objective assigned to the Trust Board, Clinical Governance Lead and
Divisional Managers was the development of an implementation strategy by February
2000 - one month after the publication of the Development Plan itself. This had not
been achieved either before or during the fieldwork period; thus, the change process
which needed to take place to deliver the clinical governance agenda was not made
explicit neither were the key objectives embedded in a comprehensive, documented
implementation plan. Despite the fact that the implementation plan was an explicit
objective, this particular approach was apparently not the norm within the Trust as this
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senior manager indicates:
'We don't go big on implementation plans and documentation. That's

not the way we do things here and you (the researcher) won't change
us'.
Certainly the approach to the draft HR strategy and clinical audit seem to bear this out:
'(Implementation plan to accompany HR strategy) - not something I

would dignify with the word implementation plan; more a sort of lets get
on and do this bit although the business plan will pick up aspects of it
and will have time-scales and responsibilities...... (picked up by
divisions) - I suppose in a very opportunistic, incremental way rather
than any sort of plan saying we must incorporate that bit into what we
are doing... ...I don't think there is a very clearly defined way of getting
them (Divisional Managers) to implement it, it is rather opportunistic'.
We said that all departments must do clinical audit but still left the
topics to them. Then moved on to say after some time, you can do
anything as long as it fits in with the Trust's objectives.. ... there is more
emphasis now on the corporate plan'.
Other than a date for the completion of individual objectives, the Development Plan
does not give a sense of the priorities for action apart from the fact that some objectives
are scheduled for completion in 2000 and others in 2001. Within these parameters
there is no indication of the sequence in which the objectives need to be delivered or
the mechanism for monitoring progress.
7.6 CREATING AND REALLOCATING RESOURCES
A reallocation of resources has taken place to support the appointment of an Executive
Director into the Clinical Governance Lead post. The fact that the Lead has an
executive role and clinical governance forms the main, although not only, part of her
remit was seen by some Non-executive Directors as a significant investment in the
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clinical governance agenda:
'A lot of the resource has gone into (the Clinical Governance Lead)'.
'Having a director almost working full time (on clinical governance) has
given clinical governance more kudos'.
Additional investment has also been made available for other new appointments, for
instance, an R&D manager, and library staff. Resources have also been allocated for
equipment; training has been provided in evidence-based literature searching.
Developments are also taking place, in parallel, around DV1&T although it is not clear
how specific objectives in this area have been integrated with the clinical governance
agenda.
Whilst the Development Plan outlined the objectives to be delivered, these have not
been explicitly costed. This not only has implications for the operationalisation of the
clinical governance agenda generally but also for decision-making with regard to the
resourcing of this activity. Without a costed plan, it is difficult to see how priorities for
action are decided or how they will be funded given that some elements will not be cost
neutral; for example the provision of education and training and the setting up of the
Clinical Governance Development Team.
7.7 FROM VISION TO OPERATIONS
The majority of the objectives outlined in the Development Plan identified the
Divisional Managers as or amongst the key stakeholders and, in the absence of a
clinical governance group at the operational level, the Management Team was expected
to pick up the Plan and take it forward. In addition to the general objectives for the
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Trust, there are a number of specific ones aimed at the divisions, all of which have year
2000 time-scales or are classified as on-going. However, despite the fact that the rapid
appraisal took place 9-10 months after the Development Plan had been approved by the
Trust Board, the progress in the divisions was found to be highly variable. Although
the Clinical Governance Lead spent time discussing the implications of the
Development Plan with individuals, no development work was undertaken with the
Management Team as a collective. The rationale for this is described below:
'There has been no work done with them (Divisional Managers), we

suppose they know what to do.. ... send them the document and let them
get on with it...... there was an expectation that they would go out and
find out more what clinical governance is about'.
Given that the Divisional Managers had the Development Plan outlining their clinical
governance objectives, the Clinical Governance Lead focused on a number of
organisational design components - the 'what' elements outlined in the previous chapter.
Early efforts were made to bring existing systems such as risk management into greater
alignment and also to introduce new systems such as Significant Clinical Incident
Review; this latter serving, perhaps, as the most significant lever in the attempt to re
shape the corporate culture. The rationale for much of this alignment has been couched
in terms of 'capturing/sharing the learning' - in particular trying to identify the root
causes of problems before finding solutions and making changes to the system as
appropriate.
Generally, progress in relation to alignment appears to have been incremental.
Between-system linkages are often dependent on the multi-meeting attendance of the
individual rather than routine information flows. Whilst the Trust is endeavouring to
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bring a greater emphasis to the identification and correction of the root causes of
problems, a whole system approach is yet to develop. An example of this relates to the
Risk Management Team. There has been a considerable amount of work undertaken to
bring together the risk agenda; and yet, no thorough assessment of the risk management
process per se has taken place. Also, there has been little attention given to the
development of an appropriate risk management structure in support of the growing
risk management agenda.
7.8 ENERGY FOR CHANGE
Areas which have achieved the direct attention of the Clinical Governance Lead such as
Risk Management Team and Significant Clinical Incident Review have been perceived
within the Trust as having made progress. Other areas such as Human Resources,
Training and Development have received less direct attention from the Clinical
Governance Lead and there appears to be less in the way of explicit integration with the
clinical governance agenda; the Lead's attention and energy having been focused on
different areas. There is a sense that, in some cases, the progress of clinical governance
is relative to the capacity of the Clinical Governance Lead to drive this agenda forward.
Although progress has undoubtedly been made with specific initiatives, there is little
evidence that this is the result of a total system approach. Miles (1997) argues that in
order to achieve the latter, a process architecture consisting of a set of mutually
reinforcing mechanisms must be deliberately created to support large-scale
organisational transformation (Table 7.1). The Trust activity which reflects each of
these elements will now be presented although ordered differently from the list below.
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Table 7.1: Process architecture
• Education;
• Involvement;
• Co-ordination;
• Feedback;
• Communication;
• Consulting support.
MHes (1997)_______
7.8.1 Education and Involvement
Education
Early in the development process, a workshop had been planned for the Trust Board
members; unfortunately, this was postponed and, although rescheduled, the new date
was effectively two years after the publication of the Trust Development Plan. The
Trust Chair and two of the Non-executive members of the Clinical Governance Sub
committee have attended the occasional regional workshop/seminar on clinical
governance. There have been no specific initiatives for the senior teams to ensure that
members have a similar knowledge base in areas such as: the concept of clinical
governance, the implementation process within the Trust, the roles and responsibilities
of managers and their staff, monitoring and reporting arrangements.
A number of more widely targeted initiatives did take place and these included the
early road shows, training sessions focusing on searching the clinical evidence base, a
workshop on clinical risk management and appraisal. Since appraisal has been
included in middle/junior managers' objectives, demand for training in this area appears
to be outstripping supply. In sharp contrast are the training sessions around incident
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reporting; some of which have had to be cancelled because of the lack of uptake.
Although staff are starting to be appraised and complete PDPs, there has been no large-
scale assessment of training needs in relation to the clinical governance/change agendas
per se.
Knowledge for implementation is not just about dealing with the specifics of clinical
governance. An important component of the National Clinical Governance Support
Unit programme deals with the management of change; in contrast, this area does not
appear to have been addressed by the Trust. The level of manager knowledge and
know-how in terms of change management was not assessed as part of this research;
however, it is interesting to note that there has been no demand from the field for
education and training in this discipline. On a related issue, neither does it appear that
the formulation of the Development Plan was informed by an explicit change
management framework.
During the research process, it was apparent that a wide variation in the awareness and
understanding of clinical governance existed and this could be observed at all levels of
the organisation. Trust Board Non-executive Directors who were not members of the
Clinical Governance Sub-committee cited briefings from the Clinical Governance Lead
and also the NHS Confederation as the main sources of their clinical governance
knowledge. Many of the professionally qualified staff interviewed perceived their
knowledge to have been gained through professional publications, associations or
professional training rather than from Trust-based initiatives.
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Involvement
The process leading up to the development of the Trust Clinical Governance Plan
provided senior people with a number of opportunities to shape this emerging agenda.
The Clinical Governance Sub-committee members were engaged in an early visioning
exercise. Discussions were held with the Trust Board and Management Team; in
addition, a variety of unspecified groups within the Trust also took part in the shaping
process.
The phrase 'clinical governance is everybody's business' is an oft expressed cliche
however, perhaps less heard is the fact that the extent of one's knowledge base is an
important determinant (albeit one of a number) of a person's capacity to become
involved whether this is on an individual basis or as part of a group. In relation to the
clinical governance agenda, there have been a number of opportunities for manager
involvement: shaping the Trust approach, delivering the agenda and modelling
behaviour. Involvement may take place on a number of levels. Whilst the Clinical
Governance Sub-committee had the opportunity to shape the content at the outset, for
others within the Trust involvement has been a matter of commenting on what has
already been drafted. This latter situation constitutes a very different level of
involvement; the extent of which depends on how far into the process these discussions
have taken place.
A lack of understanding of what is expected might result in non-engagement; an
example of this arises in relation to the Significant Clinical Incident Review process. A
manager at a separate site from that at which the incident occurred took no action on
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receipt of a copy of the report as she was unsure about what to do with it. Thus, the
findings were not shared with the manager's own staff and no assessment was made of
the local situation in light of the report's findings. Whether this was an isolated
occurrence was not assessed but the individual referred to here manages a significant
number of front line staff; they might have heard of the incident through the 'grapevine'
but not, apparently, through any formal process.
One observable aspect of involvement is the modelling of desired behaviour, an
important role for managers in particular. Whilst two of the Divisional Managers
demonstrated a comprehensive grasp of the agenda and appeared to be taking it forward
proactively, another colleague had apparently initiated little in the way of deliberate
activity with regard to clinical governance implementation. In addition, although some
of the key components of clinical governance appeared on the agenda of Management
Team meetings, the progress of the implementation process itself was not a
standing/regular item for update/discussion. It was not surprising therefore to find this
non-action replicated at the front line and the quotes from clinical staff cited in the
previous chapter seem to confirm this.
Whilst understanding might be adequate at an abstract level, it appears that translating
this into individual behaviour is more problematic. If the desired behaviour is not
modelled at the senior level, the chance of others moving forward regardless does not
appear universally likely. One manager, when asked why she had not taken the agenda
forward herself given the lack of action from her own manager, responded "it hadn't
been high on my agenda' and that clinical governance didn't feature in her objectives.
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Interestingly, the Trust has apparently experienced a huge demand for training in
appraisal since it has been incorporated into individual IPRs. This suggests that one
mechanism for securing involvement is to translate corporate objectives into personal
objectives and assess performance against these as part of the subsequent appraisal
process; in a sense it seems that 'what gets measured gets done'. In reality, neither the
Divisional Managers or the middle/junior managers have been performance managed
on delivery of the clinical governance agenda per se. In fact, systematic appraisal
seems to have been as much a new experience for the Divisional Managers as it has
been for their staff. Other than the requirement to appraise their staff, a number of
middle and junior managers reported that they had no clinical governance objectives in
their personal objectives.
The Clinical Governance Lead appeared to be well aware of the spectrum of Divisional
Manager involvement in the clinical governance agenda and tended to spend time on a
one to one basis with those who were making less progress. In this way, she tried to
clarify what was required and even facilitate the process; however, her approach
appeared to become increasingly more directive if action was not taken. This pattern is
apparently not unique to the implementation of clinical governance but, as indicated
earlier, there are similarities between this and the approach adopted in the
implementation of clinical audit - devolved responsibility and the expectation of local
interpretation in the first instance but becoming increasingly prescriptive and directive
in the event of sub/non-delivery.
Generally, involvement does not just happen but requires some sort of vehicle for its
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achievement. One of the key mechanisms is structural and the efforts of the Clinical
Governance Lead have ensured that there are a number of new groups; some existing
groups have an expanded membership and taken on a new role whilst others, such as
the Trust Board, have new responsibilities. There is something new in each of these
groupings whether it is membership or remit. However, prior to or during the
fieldwork period, there did not appear to be any explicit investment in developing and
increasing the effectiveness of these groups through attention to team building, training
around the role and responsibility of the chair and of group members, exploring ways in
which the group will function or how individual members will make a contribution. In
fact, apart from the early 'brainstorming' in Clinical Governance Sub-committee, there
does not appear to have been much in the way of 'time out1 for these very significant
groups (including the Trust Board) despite their varied and sometimes large
membership. These are mostly high level groups, but if clinical governance is to be
everyone's business, it is equally important for the development of structures lower
down the hierarchy to enable front line staff to become involved other than through
their individual clinical practice. Despite this, as we have already seen in one particular
division, the main group forum for staff is the staff meeting and clinical governance has
not featured consistently on these agendas.
The degree of involvement for some managers also appears to be a function of time and
feelings of job security; both of which seem to be somewhat stretched:
'These people (managers) have also been very busy and are now not
confident about what their jobs are going to be in a year's time.'
In reality, areas where clinical audit, risk management activity, appraisal and so on are
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not already taking place, undertaking them anew will naturally represent an addition to
the existing workload. The issue of 'time1 was recognised in the development of the
Trust approach and one of the objectives in the Development Plan concerned an
assessment of organisational capacity. Whilst initial scoping work was apparently
undertaken, there does not appear to be evidence of a formal, systematic assessment of
capacity having taken place across the Trust and, in the absence of an implementation
plan, it is perhaps a question of 'time for what?' For instance, although there is a sense
that people believe more time is needed to deliver clinical governance, this does not
seem to take into consideration the time spent on activity which may be inappropriate
as this manager observed:
'There (may) be practices going on which are ineffective and if staff

spent some time looking at their practice then they wouldn 't be spending
their time doing ineffective things'.
The lack of an explicit assessment of capacity has implications for the allocation of
both human and financial resources for the delivery of the change agenda; however,
there does not appear to have been any deliberate phasing of objectives in line with
existing resources. Any phasing seems more in accordance with the energy of
individual managers which is naturally susceptible to highs and lows.
Scheduling time for clinical governance-related activity appears problematic for some
managers at all levels. Day to day activity with shorter deadlines appears to be
displacing the development of clinical governance; with the pressure to deliver the
routine work, clinical governance seems to be slowly sinking lower down the 'to-do'
pile. When asked directly about this, one manager answered:
'Oh gosh, yes. Clinical governance was not performance managed... '.
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Low involvement does not appear to be a 'hearts and minds thing'; it is difficult to argue
against spending time on quality per se but it seems a function, to some degree, of
blockages around knowledge, uncertainty around future employment and the time
factor.
7.8.2 Co-ordination
The discussion previously has touched on the facilitation role played by the Clinical
Governance Lead but she has also served as the main mechanism of co-ordination of
clinical governance activity across the Trust. As such, it is likely that she has the most
comprehensive overview of the progress of clinical governance implementation within
the organisation. The Terms of Reference of the Clinical Governance Sub-committee
suggest, in part, a steering role for this group. However, without a comprehensive
implementation plan against which progress of the process can be measured, and, given
the lack of collective development in preparation for this remit, this steering function
appears to serve as something of a challenge, as one Non-executive Director
commented:
We went to our first meeting (of the Clinical Governance Sub-

committee) and none of us really knew what it was (clinical
governance). I mean, in a sense, we are only just coming to the point
where we can come and say something meaningful to you (Trust Board)
- we are only just sorting it out ourselves'.
Although some divisions received input from a member of the Clinical Governance
Development Team early on, this has only recently been extended to all. In reality,
much of the co-ordinating function seems to have relied on the energy of the Clinical
Governance Lead. Although an Executive Director of the Trust, the Lead only has line
management responsibility for some members of the Clinical Governance Development
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Team and the library staff. Consequently, to move the initiative forward, she has relied
on influencing skills rather than the line management process and, at times, this
approach seems to have been rather circuitous.
The Clinical Governance Lead recognises the need to integrate the relevant systems
both new and existing and is trying to move away from a reliance on making the
connections through individual attendance at numerous meetings and move to a more
systematic process of information exchange. A particular area in which progress has
been made is risk management. The membership of the Risk Management Team now
consists of the right people operating at the right managerial level to ensure that the
information received is acted upon. A number of interviewees remarked that receiving
risk management data which is both consolidated and disaggregated by unit has
enabled members to recognise the trends and appreciate that other areas are
experiencing similar difficulties. Consequently, there is a greater willingness to work
together to find joint solutions and, indeed, an expectation that this should happen:
We 've noticed a few things at Risk Management - (x division) has the

same sort of things (problems/incidents) as (y division) so again, it has
been suggested that the two Divisional Managers get together to have a
look at the incidents to compare and learn from each other'.
However, this is not the case with all components of clinical governance and it is
recognised that more needs to be done in order to integrate the work of areas such as
the Complaints Committee into the mainstream clinical governance activity. There is
also a need to address the way in which the reporting of clinical audit activity informs
the clinical governance agenda as this does not appear to feed into the quarterly
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reporting framework:
'Nobody takes a blind bit of notice (of the audit reports) - that's what
(the Clinical Governance Lead) is trying to do - integrate it with all the
other stuff that is going on and say we are not going to do a separate
audit report - we are going to have a report on clinical governance
which will include clinical audit activity from each of the divisions'.
Although many individuals are contributing to clinical governance activity, the key co
ordination mechanism is in the person of the Clinical Governance Lead; unless and
until the Clinical Governance Development Team becomes fully operational, this is
likely to continue but, in the meantime, increasing operational involvement risks
displacement of work on the 'bigger picture'.
7.8.3 Feedback
When the Clinical Governance Sub-committee did the early Visioning' work which led
to the 'Clinical Governance Report' and subsequently the 'Clinical Governance
Development Plan', some of the Sub-committee members were by no means certain
that what they had come up with was 'it'. This sort of uncertainty is not uncommon
where policy is new and potentially so far-reaching but dealing with it is a key
challenge for the management of change. One way of decreasing uncertainty is the
establishment of multiple feedback mechanisms to gain as much information as
possible from within the system.
One route to such feedback is through the formal reporting structure. A key,
nationally-set objective was the establishment of a mechanism for regular clinical
governance reporting to the Trust Board. The initial dataset constructed by the Trust
consisted largely of data readily available from existing groups. The dataset has
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gradually been expanded and is now considered by a number of internal audiences
(Clinical Governance Sub-committee, clinical governance divisional fora) in addition to
being received quarterly in the public part of the Trust Board meeting. The report
consists of operational performance data, data from clinical governance-related groups
and provides an update on progress against the Development Plan objectives; the report
does not, however, reflect the implementation process per se. Thus it is perhaps not too
surprising to find this Trust Board member apparently unaware of the fact that the
Clinical Governance Development Team was not fully operational:
7 understand that the Trust has a clinical governance team who are
responsible for proselytising to the rest of their team and they each have
reps which then link in to your committee (Clinical Governance Sub-
committee) ... ...but their job is also to take the message out to the
troops'.
The dataset described above remained the basis of routine clinical governance reporting
during the research period. Although an additional framework was subsequently
developed to specifically address the components of clinical governance, this was for
the purpose of the Trust annual clinical governance report. In addition to acting as a
vehicle for the reporting of information upwards, this framework also gave a clear steer
to Divisional Managers regarding the corporate conceptualisation of the components
for clinical governance and the areas on which they should be focusing local attention.
Whilst this did provide a useful end of year summary, it could also have served as an
explicit tool for monitoring clinical governance activity on a regular basis in-year.
As in the case of the work around user involvement, some initiatives have not always
included explicit arrangements for the provision of feedback on progress; yet, there is
now a growing tendency within the Trust to incorporate this into the system and a good
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example is the Significant Clinical Incident Review process. All divisions are expected
to receive the final report, assess their area of responsibility against the learning points
and confirm to the Clinical Governance Lead whether local action will be required or is
not considered appropriate. A similar feedback mechanism has also been built into the
new system for the dissemination of guidelines. Nevertheless, as earlier comments
around incident reporting suggest, there is still a need to ensure feedback to staff on
specifics such as incidents and so on but also more generally on the progress of clinical
governance in the Trust.
Setting up feedback mechanisms is important but the ultimate test is how the
information is used once received. Early feedback to the Trust after a routine review by
the Regional Office was used to inform the Development Plan. Written and verbal
feedback was provided by the researcher to the Chief Executive and Management Team
after the rapid appraisal undertaken in the autumn of 2000. The recommendations of
this first report centred largely on the need to develop an implementation plan and the
need to clarify whether the Trust concept of clinical governance was based on an
assurance or improvement model or both. This recommendation was based on an
observation that systems were being implemented to address the assurance aspects of
clinical governance but the notion of continuous improvement did not feature
explicitly. An example of the latter was the lack of a mechanism at the local level to
facilitate the involvement of front line staff in CQI. Neither of these issues were
addressed directly by the Trust during the fieldwork period. The notion of models did
not appear to sit comfortably with the culture of the organisation. Whilst
acknowledging that the research report was much as the Trust expected, the minutes of
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the Clinical Governance Sub-committee dated 19 January 2001 record the following
comments:
'(The Clinical Governance Lead and the Chief Executive) would argue
with respect to the 'quality models' and pointed out that they would be
difficult to convince about adopting quality models'.
This apparent conflict with the prevailing organisational culture is similar to the Trust
response to the recommendation that it develop a comprehensive implementation plan.
The stated reason for not developing this latter was that, with the Trust moving towards
the creation of a PCT, the focus would be on consolidating what had already been
achieved. However, the dissolution of the Trust was to take a further 15 months during
which time the organisation was without a comprehensive implementation plan to guide
the change process. The final research feedback was submitted in December 2001 and
the Clinical Governance Lead confirmed that a number of the recommendations from
the second research report would directly inform the plan for clinical governance within
the new PCT.
In addition to the two formal written feedback points, verbal feedback was an ongoing
feature of the action research process and was offered at corporate and divisional
meetings. At times, the researcher was able to provide observations from the front line
that challenged the corporate assumptions about the extent to which the clinical
governance agenda had cascaded down into the organisation. Verbal feedback was also
offered to interviewees during the fieldwork and will be discussed later in the section
on 'support1.
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7.8.4 Communication
The association between change and uncertainty has already been commented upon.
The Emerald Trust is not only coping with the changes required by clinical governance
and the wider modernisation agenda but is also facing the prospect of large-scale
organisational change in the move towards PCT status. The role of feedback and
education in reducing the level of uncertainty has been discussed earlier in this section;
however, for greater impact, these elements should be incorporated into the wider
system of communication operating within the Trust generally. The need for extensive
communication in a period of change is appreciated by this interviewee:
'...... it's a pretty important issue because it's lack of communication or

poor communication that makes people make up their own minds on
what's happening. And all sorts of rumours start to fling around
then... ...with the changes taking place within the service, if you had
someone with a communications lead ...you would say - right come up
with views on how we are going to make staff appraised about what is
going on and get day to day questions answered - then someone would
(need to) come forward with a communication plan... ... no-one has been
identified with the role (internal communications), ...so it is not seen as
someone's responsibility'.
Whilst the Trust has undertaken clinical governance road shows, several articles have
appeared in the newsletter, and the Annual Clinical Governance Report has been
produced, these constitute discrete initiatives. In contrast, there is no evidence of an
on-going, multi-method communication campaign taking place to raise and maintain
the profile of the clinical governance agenda within the Trust. In fact, there is no
communication strategy to accompany the implementation process per se; indeed,
neither is there a strategy for internal communications and there is a lack of clarity
around where the responsibility for this particular activity lies. Thus, there was no
formal launch of the Development Plan prior to the road shows which reached less than
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10% of the workforce; of these, as indicated earlier, the majority of attendees were
thought to be managers. Communication of the Development Plan appears to have
relied on the cascade of information from corporate through divisional levels and on to
those in the front line of service delivery. However, it is clear from research in the
Primary Care Division that this approach has not been particularly effective in practice.
Although elements of the clinical governance agenda appear in the minutes of
Management Team meetings, there does not appear to have been a regular discussion
around clinical governance per se or its implementation in this arena. In some
divisions, this situation has been replicated further down the hierarchy; for instance,
some of the junior managers in the Primary Care Division had not seen the Significant
Clinical Incident Reports or, in fact, the Development Plan until a meeting with the
Clinical Governance Lead early in 2001. In addition, the feedback from the rapid
appraisal in 2000 confirmed that the Development Plan was not a living document
within the divisions generally although the Divisional Managers all knew of its
existence. This senior manager expressed strong opinions on the communication issues
with the Trust:
'People don't cascade information. The Management Team probably do

but what happens after that...... Could be a power theory; could be that
people do not have structures in place like team briefing to allow
cascade. Another of this - oh it's something to do with staff therefore I
haven't got time to do it - more important (things) to do like delivering
services to clients - (they are) not making the connection between those
two things. No, we don't have any structured way of cascading
information'.
And this was another senior manager's experience:
'My clinical governance forum - nothing cascades down. I 'm giving

them all this stuff but when I go out to the staff - they haven't heard
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about the information... ...I don't know where the blockages are or why
it's not being disseminated'.
The value of effective communication systems in establishing a common language and
a common understanding around clinical governance did not appear to have been
appreciated or these outcomes actively sought. The manager cited below was echoing
the views of a number of senior colleagues with regard to the junior staff:
'(I) don't expect people to tell me what clinical governance is but I

expect them to tell me how they use the evidence, how we can plan care,
how we monitor (it)'.
Given the sentiment above, it was therefore something of a surprise to read that the
issue of a manager briefing pack had been raised at Management Team two months
after the approval of the Development Plan; however, this was not produced within the
fieldwork period.
7.8.5 Support
The need to provide support for the divisions was recognised early on in the Trust's
developing approach to clinical governance implementation. The Clinical Governance
Development Team was established in principle in May 2000 but did not achieve its
full complement of members for almost 18 months. In the meantime, one or two team
members were able to form links with specific divisions; other than this, the main
source of internal support was the Clinical Governance Lead who provided advice to
the Divisional Managers on a one to one basis. Whilst some of the Trust Board
members thought the Team was up and running, it seems that not all managers were
clear of its remit some 18 months after the publication of the Development Plan:
'// 's like the Clinical Governance Development Team - I 've heard of it
but what are they actually doing, who are they and it's only when you
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start to sit down and think I don V know who these are, what are they
actually doing that you actually get an answer; it is automatically
assumed that everybody would actually know about it'.
External support was obtained through several routes. A small number of natural work
teams (two for certain) have taken part in the national programme offered by the
Clinical Governance Support Unit. The catalyst to the decision to put forward these
teams was not clear - i.e. the team's own request/nominated by the Trust; however, this
initiative does not appear to have been part of a deliberate corporate approach and there
has been no move to send a large number of teams for this training.
One opportunity for obtaining peer support was through the formation of a county-wide
network of clinical governance leads which was co-ordinated by the health authority.
The Trust Clinical Governance Lead also became a member of the Clinical Governance
Sub-committees of the local Primary Care Groups (PCGs) and, latterly, a representative
from each of these groups has been invited to join the Trust Clinical Governance Sub
committee. In contrast, the Lead does not appear to have established direct links with
other NHS Trusts providing the same/similar services as Emerald.
The action research process was also a source of external support for managers in
particular. In addition to providing real-time feedback, the contact offered an
opportunity for interviewees to explore some of the general issues around the
implementation of this agenda and obtain an outsider perspective on action they might
be considering.
Interviews generally followed a semi-structured format following a clear inquiry
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framework. Interviewees commented that the questions would often serve as prompts
to action; firstly causing them to think - 'why has she asked me this' and secondly to
consider whether they might need to take action on the issues being discussed. Many
of these questions related to process; issues such as awareness raising with staff,
whether clinical governance was a regular/standing agenda item at team meetings, how
are incidents and complaints considered collectively, how does clinical audit happen
locally (Appendix 8). Some found the interview process offered protected time and
within this an opportunity to talk through the agenda. This helped some managers gain
a greater clarity about the concept of clinical governance and the role of the interviewee
with regard to this policy and its implementation.
As a result of the ongoing data collection, the researcher was also able to challenge
some of the assumptions being made; examples of this include corporate-level
perceptions around the level of actual knowledge amongst some of the managers and a
belief that having a local PCG with an active Clinical Governance Sub-committee
could act as a substitute to the establishment of a forum for clinical governance in the
Division.
Although the Clinical Governance Lead has advised divisions on practical aspects of
clinical governance, there appears to have been little provision of formalised support
from an organisation development perspective. This was touched upon in the
'education and involvement1 section with reference to building teams and investing in
time-out for development. This type of deliberate intervention in team/group
development does not seem to be a Trust norm. In practice, there appears to have been
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a distinct lack of attention to the development needs of new and existing groups in
relation to implementation of the Trust's clinical governance agenda. This does not
appear to be confined to the clinical governance agenda as suggested by the following
comments from these Non-executive Directors:
'I'm unhappy at the training that I had as a non-exec - or lack of

training'.
When I first started here I was unhappy with the way I was inducted and
felt that I didn 't really have much info to work on and it took me a long
time to work out for myself what my role was... ...even now I probably
haven't got it right but that's how I felt at the time'.
'That is very typical of this Trust that it is presumed that we are going to
pick it (clinical governance) up; fortunately we are pretty able I think'.
In terms of the Non-executive Directors as a group, they do not meet separately from
the whole Trust Board although some felt that would be beneficial:
'One of the things we never do as non-execs is come together to discuss

something alone without the other directors there... ...but even if it was
once a year Ifeel the needfor us to meet'.
We (the non-execs) don't have the equivalent of a group meeting'.
'Never even discussed having a (separate) meeting'.
Earlier in this chapter, there was a comment on the lack of questions at Trust Board on
the quarterly clinical governance report; however, discussion with several Non
executive Directors revealed that papers for Trust Board did not generally arrive to give
them the five days notice that was intended. At times, papers even arrived on the
morning of the Trust Board meeting thus the Non-executives had little time to read,
digest or make some investigation around the information with which they had been
presented.
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The lack of group development at the corporate level is reflected in the Primary Care
Division and Locality under study and this will be discussed in the next chapter;
however, the expectation that the collective will pick up what it needs to know along
the way also seems to relate to the individual. The Trust does not appear to have made
any explicit arrangements to address the variation that exists in the experience,
knowledge and know-how of individual managers and staff, not only in terms of
clinical governance but also in relation to the process of change management.
Individuals within the Trust appear to be at different starting points regarding the above
and there has been little to address this although a workshop is planned for January
2002 - two years after the release of the Development Plan. This lack of deliberate
organisation development (OD) intervention is surprising given the centrality of
learning in the Trust's conceptualisation of clinical governance.
7.9 CHAPTER SUMMARY
As in the previous chapter, it is clear that the Trust has made a positive start in terms of
the implementation process. Each of the activity clusters have been addressed in some
way although gaps are apparent which may, ultimately, have a negative impact on the
likelihood of overall success of the clinical governance initiative. As with the Trust
approach in terms of content, the significance of these process initiatives will be
discussed in Chapter 9.
This chapter concludes the description of corporately-led clinical governance
initiatives, the following chapter will now present an overview of clinical governance in
one of the Emerald Trust divisions and a Locality within this.
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CHAPTER 8
RESULTS - CLINICAL GOVERNANCE IMPLEMENTATION- A

DIVISIONAL VIEW
8.1 INTRODUCTION
The previous chapter has described the work that has been taking place at the corporate
level to take forward clinical governance within the Trust. One of the key aims of the
Clinical Governance Lead was to ensure that the strategic objectives were translated
into the operational reality of the clinical divisions. Thus, one of the research
objectives has been to follow the translation process from the corporate level down
towards the front line of service delivery.
The Primary Care Division and the Northern Locality have been selected as targets for
further research and the rationale for this choice has been outlined in the earlier
methodology chapter. The aim of this chapter is to present firstly an overview of the
Division and Locality and then to describe the clinical governance initiatives that have
taken place within these areas. As far as possible the Miles framework (1997) will be
utilised to shape the presentation of these results.
8.2 PRIMARY CARE DIVISION - AN OVERVIEW
The Primary Care Division consists of three localities. Over a six month period, the
researcher followed the progress of clinical governance arrangements at divisional and
locality level - the latter focusing on the Northern Locality.
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The Division provides Health Visiting, District Nursing and Child Health Services;
health care for the older adult is provided in a Community Hospital. The Divisional
management structure comprises the Divisional Manager; three Community Health
Care Managers - each responsible for a Locality, and a Child Health Nursing Manager.
Within each of the localities there is a Clinical Leader for Health Visiting and one for
District Nursing; in Child Health, there is a Clinical Leader for School Health, the
Paediatric Nursing Team, Hospital at Home and Child Development Centres.
Since early 2001, the Divisional Manager post has been an acting position and, in
addition to the responsibilities as Acting Divisional Manager (ADM), the post holder
has retained her role as Board member on the Northern PCG. The Community Health
Care Manager post for the Northern Locality is also an acting post (the previous
manager is acting up as Divisional Manager) which comprises 50% of the post holder's
time. In the other 50%, the manager retains her responsibilities as Clinical Leader for
Health Visiting in one of the other localities which is geographically distant from the
Northern. The Clinical Leader posts were introduced in year 2000 to strengthen line
management arrangements; apparently 80% of those in post are new to a formal
operational management role.
Prior to the establishment of the Divisional Clinical Governance Forum, the key
meeting for managers within the Division was 'Clinical Leaders'; this takes place on a
monthly basis and is attended by all Clinical Leaders and Community Health Care
Managers. It is chaired by a different Community Health Care Manager each month;
access to minutes was highly problematic as there is no central generation of or
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repository for the record of these meetings; a situation attributed to the monthly change
of chair. This is meant to be an opportunity for top down - bottom up communication
but in practice there is apparently little contribution to the agenda by the junior
managers.
8.3 CLINICAL GOVERNANCE IMPLEMENTATION IN THE DIVISION -
CONTENT
During the rapid appraisal of clinical governance within the Trust undertaken in year
2000, it was apparent that clinical governance, as an integrated system for continuous
quality improvement (CQI), was yet to become established within the Division. This is
a rather euphemistic way of highlighting the difficulty in identifying deliberate
initiatives aimed at the implementation of the Trust 'Clinical Governance Development
Plan'; although, it should be noted that individual initiatives to develop and improve
Divisional services were taking place. The researcher's next contact with the Division
was in April 2001, seven months after the rapid appraisal. In the intervening time, little
progress had been made with this agenda other than the establishment of a Clinical
Governance Forum - 13 months after the publication of the Trust Development Plan.
When questioned on progress, the response from one of the managers summed it up as
follows:
'This will be short and sweet because the brutal truth is - very little (has
happened)'.
The first meeting of the Forum took place in February 2001. At this initial meeting it
was decided that the chair of the group should be nominated on a rotational basis to
provide a development opportunity for Clinical Leaders; selection would take place by
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drawing names out of a hat. This process duly took place and the first chair appointed
for three months accordingly; however, this person was not present during the selection
process and, therefore, did not have the opportunity to highlight the fact that she only
worked part-time in the Clinical Leader role.
Membership of the Forum included the ADM, Community Health Care Managers and
Clinical Leaders; latterly the newly appointed Clinical Governance Facilitator also
joined. The overall aim of the group was the development of Divisional strategies for
clinical governance; its Terms of Reference were to reflect the requirements of the
Trust 'Clinical Governance Development Plan'. The Terms of Reference suggest a
variety of roles for the group: assurance, steering and 'doing'; however, the integration
of all three is likely to present a challenge to this newly formed group.
Meetings of the Forum were scheduled at monthly intervals and have taken place
regularly. In general, agendas seem to have consisted of items cascaded by the ADM
or those which the Chair considered to be of interest. Once the Chair of the Forum
became the Divisional representative on the Trust Clinical Governance Sub-committee,
there appeared to be a clearer frame of reference for the local clinical governance
agenda.
The minutes of the meetings demonstrate that issues around specific components of
clinical governance such as clinical audit, clinical supervision, incident reporting are
discussed. The group has also been reviewing the progress of an initiative to re-
introduce Clinical Rounds and Individual Performance Review (IPR). The need for
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more work to raise staff awareness of clinical governance was recently recognised and
discussion has taken place around mechanisms for achieving this. However, although a
number of key actions were identified at the outset, these have not subsequently been
translated into an action plan and there was no sense of a systematic approach to the
implementation of clinical governance being considered. According to this member of
the Forum, there was a lack of direction in these early days:
7 've not got any direction. I haven't been given any direction. I don't
know what's expected. How can you drive anything forward if you
haven't got the time and you don't know what it is you are supposed to
be doing anyway'.
From direct observation of two meetings, 'discussion' was the predominant albeit not
exclusive activity with certain issues referred to the Clinical Leaders Group (despite the
similarity in membership) for further discussion. Although issues were being
highlighted, it was not always clear how and who would take these forward and there
appeared to be a lack of clarity around the authority vested in the roles of the Chair and
in the group as a whole. The arrival of the Clinical Governance Facilitator appears to
have coincided with a change in the group approach - action points and the responsible
individual(s) being clearly identified in the minutes and separate groups being set up
with a remit to look specifically at the issue in question.
Latterly, the group has started to receive a copy of the same consolidated dataset as that
submitted to the Trust Clinical Governance Sub-committee and also copies of the
Significant Clinical Incident Review report summaries; both of which could provide an
important focus for future discussion and action.
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8.4 CLINICAL GOVERNANCE IMPLEMENTATION IN THE LOCALITY -
CONTENT
The Northern Locality is a rural area with a population of approximately 60,000. There
are seven GP practices which are based in the main towns and the larger villages.
Health Visitors and District Nurse teams are attached to each of the seven practices;
services are provided within the Locality and, where necessary, across county
boundaries. The staffing profile as of September 2000 reported around 75 whole time
equivalent District Nursing and Health Visiting staff employed within the Locality on
Nursing Scales ranging from A to I grades. A Community Health Care Manager is
responsible for each Locality and District Nursing and Health Visiting staff are line
managed by a Clinical Leader.
Some evidence of clinical governance activity such as incident reporting, appraisal and
so on can be identified in the Locality, however, as highlighted earlier in this chapter,
clinical governance as an integrated system for quality improvement is yet to be
established within the Division and this situation is also reflected in the Locality. At
this point, it is important to recognise that, despite the fact that clinical governance is
apparently in the very early stages of development, improvement work does take place
locally. These initiatives may be enhancements to an existing service, may represent a
new service for clients or may improve clinical practice in some way; examples include
the Integrated Nursing Team pilot, the development of a wound care formulary, joint
working around smoking cessation and the introduction of client-specific support
groups such as 'Cradle Clubs' for first time mothers and Breast Feeding Support
Groups.
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8.4.1 Structures for Quality Improvement
Up until mid 1999, active standard setting groups existed for both Health Visiting and
District Nursing but these seem to have disbanded over time apparently as group
members moved on. This gradual decline also seems to have coincided with the change
in corporate arrangements for the facilitation of clinical effectiveness and audit; that is
the movement away from a central clinical audit function:
'Basically the standards group just fell apart; the person who was
leading it left and it's never really got back together again because of
pressure of time'.
In the absence of the Standard Setting Groups, the main forum for discussing
improvement opportunities appears to be the staff meetings. These take place on a
regular basis, usually monthly, and tend to be uni-disciplinary although speakers from
different specialties/professional groups/services are invited to attend and present on
issues of interest. Minutes of these meetings suggest a very varied agenda which is
largely around information exchange; this may relate to operational issues, details of
training, national policy - the NSF for Older People, 'Improving Working Lives' and
the NHS Plan all appear to have been discussed. In some areas, feedback is provided
from staff development such as courses, conferences etc, and there is evidence of
practical outcomes arising from efforts to bring the learning back into the organisation
such as the development of a leaflet on eczema. Feedback is also provided from joint
working groups on topics such as wound care.
Whilst 'clinical governance' does not appear as a regular, explicit item on the agenda of
these meetings, components of this agenda appear to have been discussed such as
clinical supervision, clinical audits for which the Locality has provided data,
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information around the introduction of staff appraisal and the re-introduction of Clinical
Rounds. However, there is a view that a more explicit focus on clinical governance per
se is required:
'When we meet for unit meetings, I think as many people as possible

should be informed about what clinical governance should mean in
practice because I don't think people realise it enough. We have never
had a unit meeting of all this area and said clinical governance is here
and this is what it means'.
Although one area has recently started to disseminate the summary reports of
Significant Clinical Incident Reviews, there does not appear to be a mechanism, either
as part of the staff meeting or through an alternative structure, to support regular,
collective review and discussion of clinical/non-clinical incidents or complaints. This
is despite the fact that routinely-collected data on these issues is available, albeit
centrally collated:
'Feedback is really important but when you don't get any it's
demoralising; we 've done this, we 've sent in this form and you get
nothing back from it that's perhaps going to improve something - (that)
this, this and this has been done - you get a bit cynical - you think what's
changed?'
'Things are pushedfrom one side - you 've got to improve quality, you 've
got to do this, you 've got to do that; when you do all that, nothing much
comes back from it'.
8.4.2 Clinical Supervision
There are groups within Health Visiting and District Nursing which meet regularly for
clinical supervision. The groups were established at different intervals and therefore
are at different stages of development. Some groups are perceived as working well
whilst others are apparently experiencing some difficulties. Some of this difficulty
appears to relate to the opportunity to meet as a group given operational demands
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which can be unpredictable particularly during periods of staff sickness:
'It all comes down to time; the idea is very good but it's time. Ifyou are
busy and you 've allocated an hour to do it, -what goes is that because
your visits or (something else will get in the way)'.
'It's time...... when you have got a day when you put it down and think
right we 'II do that, you get staff taken offyou to go to help somewhere
else'.
'The minute you get reasonably well staffed and you think - we can do
this- they take them (staff) to another group'.
The Clinical Leader for Health Visiting has recently proposed a review of the current
arrangements for clinical supervision.
8.4.3 Appraisal and Personal Development
Appraisal and the formulation of Personal Development Plans is starting to take place
and in 2001 there has apparently been a particular corporate emphasis on getting this
process established. Clinical Leaders are appraising their senior staff and, as they in
turn receive training, the senior staff will appraise their teams or in the case of Health
Visiting, the Health Visiting Co-ordinator and the Clinical Leader will share this
responsibility. Apparently there has been an increase in demand for training and the
delay in getting places on courses is thought to be holding up the cascade of appraisal.
8.4.4 Clinical Audit
The Standard Setting Groups were perceived as the main locus for clinical audit work
and, although staff may be involved in data collection for audit projects led by other
disciplines, in the absence of the previous structures, little in the way of clinical audit
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has been initiated recently by the Locality itself:
'It (clinical audit) doesn 't happen very often. Since I have been in post I
haven't done any audits. There is a real issue about getting meaningful
data... ...we do need to look at audit but sadly we lack the training and
skills'.
8.4.5 User Involvement
There was a perception amongst staff that user involvement tended to take the form of
client/patient satisfaction surveys; these would more likely be undertaken with clearly
defined groups which meet over a period of time. Involving individual clients/carers is
more likely to be seen as part of the care planning process.
8.4.6 Clinical Governance - Knowledge and Skills
As highlighted earlier in this report, the Trust led a number of road shows in 1999 to
raise awareness of clinical governance within the organisation. Most staff who took
part in this research project, either in interviews or focus groups, were aware of the
early initiatives but few had actually attended. Levels of awareness around the clinical
governance agenda vary as the earlier quotes have demonstrated. Staff interviewed
generally reported that their knowledge had been gained via external sources; for
example: post graduate study, attendance at conferences or through professional
publications or bodies. The level of knowledge around specific elements of clinical
governance such as clinical audit and risk management was also variable and whilst
front line staff might have taken part in audit or completed incident forms, there was
less understanding of how these practices formed part of clinical effectiveness/risk
management as quality improvement systems. Although a number of staff had attended
the risk management workshop held in July 2001, few reported they had received any
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specific training around clinical audit or risk management.
In terms of acquiring the detail around clinical governance, there is a sense that
delivering the service to clients is taking up all the energy of some and clinical
governance as a high level policy has not been effectively translated for those who are
at the front line. The following comments from clinicians illustrate a number of these
points:
'It's -workload. ... ...Most of us are working to capacity in an

environment that is constantly changing. Clinical governance is one of
many names that is just hanging there and there is this mad panic - good
God where's this one come from. It hasn 't translated into action and
it's one of many. We are fully occupied, we haven V got free time to
make connections... ... too busy doing the job'.
'It would be very nice if they (management) sent out or gave us the
information as to what parts of the (clinical governance) umbrella have
been addressed or completed'.
'Staff are bogged down with delivering the service... just no time to think
or to read... just hope that someone higher up will send directives'.
7 feel lost in the vision of the NHS, never mind clinical governance;
somebody must have sat around the table in Whitehall and said right
this is the vision for the new NHS and this is how it is going to be. As
the visionary has stayed at the top and they haven't found other
visionaries to carry the baton on down here, I don 't know my place in
the vision; I don't even see a vision; I have nobody re-affirming that
vision to me as a practitioner any of the time ...... whereas when I was a
newly trained nurse... you knew what she wanted (the matron) because
she came down to the wards and told you... ... but it has become unseen,
unseen down here - they have not got visionaries on the ground. There's
nobody sitting around the table (at Trust HQ) who has caught the vision
andean inspire people to carry it'.
'It just seems to be if you appear to be getting on with the job then no-
body has any involvement with us; as long as the boat is not
rocked... you just get on with it to what you consider to be the best of
your ability; giving the best service time allows to your clients; if
nothing happens to tip the scales, that's just how it rolls on. No-one
comes and tells you what's happening, what's changing, what's going to
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be expected of you in the future - just rolls on. If the wheel doesn 't
come off- then fine'.
The clinical governance agenda is also at risk of being displaced by the forthcoming
organisational changes:
'So much change isn 't there. We know come October they are going to
PCT status, so everything else almost goes on the back burner'.
Or as one manager commented:
'There is a huge change and transitional agenda around at the moment

in the NHS and staff at the moment may or may not have clinical
governance and some of the components within it high on their personal
agendas or on their professional agendas. But it is trying to ensure that
they do understand that some of the most important things they do are
part of the clinical governance agenda. But at the moment there will be
a very strong focus on the dissolution of the Trust which affects
everyone's terms and conditions of employment; -transition to PCT
status, am I going to have a job at the end of this, what will it mean for
me. I am aware that staff at the moment have a degree of vulnerability
and uncertainty that may or may not affect the way they are prioritising
other elements of the role they have to do'.
Others identify a clear priority for staff when there are competing demands on time:
'Clinical governance, clinical supervision, sharing good practice,

research, audit, they will all have to take a side step if a patient has to
be seen and that is difficult to marry up... ...the bottom line is, the
patients will always come first'.
The manager's assessment of clinical governance activity to date that was cited earlier
in this chapter (Very little') was supported by research in the field. There appears to
have been little in the way of deliberate attention to the implementation of this agenda
until the senior management arrangements changed. The following section will
highlight the process elements of implementation within both the Division and the
Locality.
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8.5 CLINICAL GOVERNANCE: THE IMPLEMENTATION PROCESS IN
THE DIVISION AND LOCALITY
8.5.1 Clinical Governance Implementation - A Late Start
Although there is evidence to suggest that service improvement does take place within
the Division, little in the way of deliberate activity to implement clinical governance
was apparent at the start of the current research. This situation had been allowed to
continue for 12 months after the publication of the Development Plan but, by the time
the ADM came into post, it was clear that this agenda needed urgent attention:
'...... this has been outstanding for some time, will someone please get a
handle on it for primary care.'
This urgency would have been difficult to ignore especially as it was emphasised in a
meeting of senior managers, facilitated by the Clinical Governance Lead, to agree a
local way forward. Shortly after this meeting, the Clinical Governance Forum was
convened, the Terms of Reference of the group were made explicit and a number of
action points identified.
8.5.2 An Action Plan for the Division
Around the same time as this initial work was taking place in the Forum, the ADM was
required, for the purpose of the Trust Annual Clinical Governance Report, to provide an
update on local progress around the clinical governance agenda using the framework
promulgated by the Clinical Governance Lead. The resulting document gave examples
of certain clinical governance related activity within the Division and highlighted a
number of gaps. At an 'Away Day' in September 2001, the ADM, Community Health
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care Managers, Clinical Leaders took 'time out1 to map the key areas for action across
the range of drivers which impact on the Division. The aim of this activity was to
develop an action plan to address the issues identified above over the period 2001-
2002.
Within the resulting action plan, a number of areas for attention have been identified
under the banner of clinical governance such a appraisal, personal development plans,
risk management, complaints. However, certain key elements such as clinical audit and
National Service Frameworks (NSF), although highlighted for action, appear to be
separate from clinical governance activity. Thus, amongst the Divisional objectives,
clinical governance appears as a discrete element and, in this way, clinical governance
seems to have been conceptualised as a separate entity to that of the modernisation
agenda. Consequently, clinical governance is something which requires prioritisation
along with everything else as this quote from a senior manager suggests:
'In order to do it (clinical governance) properly, you would need to have

one clear day a week dedicated purely and simply to driving forward the
clinical governance agenda - and that is not realistic in today's heath
agenda because it's just not clinical governance -you have drivers from
the modernisation agenda, from the national plan, from recruitment and
development, from improving working lives etc etc etc. - not to mention
the new National Service Frameworks; all of which are coming out with
clearly defined governmental time targets on them and so however high
a priority clinical governance may be both as an organisation and as a
personal view, the reality is that it will have to be prioritised along with
all the other drivers and if I was a full-time clinical governance project
manager then and only then would you see massive changes within each
area, each Division, each discipline'.
This fragmentation is surprising given the divisional framework for the Trust Annual
Report is inclusive and integrates a range of components, including the elements
identified above, under the clinical governance umbrella.
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Despite the Divisional activity described above which has seemingly culminated in
three 'action' documents, there was no evidence during the six months of fieldwork that
these had been brought together either to form an integrated clinical governance
strategy or an implementation plan that would facilitate operationalisation within the
Division. Also, although these different action sets seem to have been generated
through discussion with managers, there has been no comprehensive assessment of the
current coverage or effectiveness of existing systems for quality improvement such as
clinical audit and risk management or, in fact, an evaluation of the clinical governance
implementation process to date. Therefore, although the Division has action points to
guide it towards a destination, these do not appear to have been formulated with a clear
sense of the starting point. This approach may do little to either challenge the status
quo or provide a solid foundation upon which to build new systems.
8.5.3 Organisation Development - A Missing Component
The lack of a deliberate OD programme at the corporate level is also reflected within
the Division. At the collective level, the impression of the early Forum is of a group
struggling to deliver an agenda but without any initial investment in its own
development needs. Consequently, a number of gaps are apparent which are likely to
have a fundamental impact on the group's ultimate effectiveness. There is a lack of
clarity around the authority, role and responsibility of the group as both a collective and
as individual members. There was also a lack of clarity around what is meant to be in
place in clinical governance terms and how this should/could be achieved.
The minutes of these early meetings reflect the newness of the group. Although issues
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were being discussed, closure which led to action points was less evident. Items were
sometimes being passed to the Clinical Leaders' meeting for further discussion; same
people but in a different forum. In this way, issues are essentially being passed 'over
the wall' to another group rather than being taken forward in the present arena. From
August 2001, there is a clear change in the style and tone of the minutes which
coincides with the arrival of the Clinical Governance Facilitator; action points are
clearly identified and responsibility assigned to a named individual; separate working
groups are formed to address specific issues which need further action instead of these
being passed on for further discussion elsewhere.
Although the Forum holds the specific clinical governance remit for the Division, there
does not appear to have been a systematic process of translating the corporate clinical
governance objectives into a comprehensive, local strategy. Although there is now a
Divisional Development Plan which includes clinical governance objectives, the group
does not have an integrated work plan that will enable it to fulfil its Terms of Reference
in either the short or long term. As a group it had not defined its information needs or
made explicit how it would relate to the Division as a whole or to the wider
Trust/corporate clinical governance function. Neither has time been devoted to
developing a clear sense of how the group will function in terms of internal dynamics
or to making a considered assessment of the development/training needs either of the
collective or of individual members.
Organisation development is not just about ensuring collective effectiveness but also
that of individuals; this is important for all employees but particularly so where junior
225
staff are required to assume new responsibilities. The first Chair of the Forum was an
H grade, part-time Clinical Leader who was not even present at the meeting when her
name was drawn out of the hat. In adopting this approach, selection for this important
role was based on a random act rather than careful consideration of the knowledge,
skills and experience that would be required to discharge the responsibilities of the role,
the time that would be needed and the administrative support required.
The initial plan to rotate the role of Chair at three monthly intervals was soon revised; it
was decided that the present incumbent would remain but with the active support of the
Division's newly appointed Clinical Governance Facilitator. Prior to this, there had
been no provision for in-division support; the Chair did not meet on a one to one basis
with the ADM and the routine meetings with her own line manager appeared to deal
with the general business of the Locality rather than clinical governance per se.
Although the development needs of the Forum and its individual members is an
important matter that needs to be addressed, this gap is consistent with the approach to
a wider but connected issue of management development in general. Many of the
Clinical Leaders were new to line management and yet there was no systematic
assessment of their development needs which meant that, in some cases, junior staff
were going on leadership courses before their managers. This was, for some,
compounded by a sense of urgency to deliver which seemed to be reflected down the
line. One manager reported that, on appointment, she was told she would need to 'hit
the ground running'. Another manager felt that her own inexperience was holding
back progress in terms of delivering the service.
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Within the Locality, the lack of deliberate action to implement clinical governance from
the top of the Division is reflected closer to the front line services. Although the
researcher did not come across anyone who had not heard the words 'clinical
governance1, it was difficult to determine how the corporate agenda was being
operationalised at the professional-client interfaces. Given that there are no vehicles to
deal explicitly with the translation of the clinical governance at the front line, there is a
risk that any impact clinical governance may be having at the professional-client level
is likely to be the result of individual rather than corporate or divisional initiatives.
8.6 CHAPTER SUMMARY
The purpose of this chapter has been to present a picture of clinical governance at the
Divisional and local levels. It would appear that deliberate activity in relation to the
implementation of this initiative has been a relatively recent occurrence despite the fact
that corporately defined objectives for the Division have been in existence for some
time. There appears to be considerable scope for further work around this agenda in the
areas highlighted here and this has been recognised by key managers at the corporate
level and also in the Division and Locality. It has proved rather difficult to use the
Miles framework (1997) due to the lack of related activity in terms of both the 'what'
and the 'how1. Instead, this chapter has tried to focus on the work around clinical
governance that has actually taken place whilst, at the same time, identify some of the
gaps. A full discussion of the results presented in all three chapters will now take
place.
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CHAPTER 9
DISCUSSION OF RESULTS
'The past is never dead. It's not even past'

(Faulkner, 1951)
9.1 INTRODUCTION
The aim of this case study was to describe in detail the experience of one NHS Trust
as it implemented clinical governance. At the outset of fieldwork, clinical
governance was still a relatively new concept; its emergence as a policy has been
tracked in some detail in Chapter 1 of this thesis. Given this newness, the research
design sought to capture what the Trust was doing to implement the concept rather
than test this against some sort of blueprint. As a qualitative study, rich description is
an essential component in the presentation of the findings and Chapters 6-8 have
incorporated, as far as possible, direct quotations which bring the voice of the
interviewee to the reader. Also, rather than merely relaying a sequence of actions,
some degree of interpretation has been incorporated within the results to improve
readability, an approach recommended by some authors on this subject (Patton,
2002).
In the absence of a blueprint for clinical governance, Trusts have been allowed to
interpret this locally which is in sharp contrast to the NHS Plan (Department of
Health, 2000) with its centrally-specified action sets and corresponding milestones.
The Department of Health's approach to clinical governance seems more like the one
adopted in an earlier experiment with Total Quality Management which took place at
228
the end of the 1980s - early 1990s. Although on that occasion a technical note was
issued, during the course of the fieldwork it was apparent that the organisations had
either not accessed this or chosen to disregard it because there was little evidence that
it was being operationalised (Joss and Kogan, 1995).
Given the lack of clarity around the clinical governance concept, the Emerald Trust
should be applauded for its courage in agreeing to take part in this research. The
author was allowed unrestricted access and the Trust has not sought to edit or censor
the write up. Consequently, the trial and error of clinical governance predicted by
Lugon and Seeker-Walker (1999) has been played out under the stark spotlight of an
intensive and long-standing research process.
In the case of the previous NHS TQM experiment referred to above, just as with
clinical governance, the Department of Health encouraged an eclectic approach to
development in the hope that it would provide a rich source of initiatives for
evaluation. This posed a particular challenge for those evaluating TQM as there was
no definitive model depicting what needed to be implemented or how this should be
achieved. Then, the researchers based their evaluation on a traditional model of TQM
and also on the Trusts' own objectives. Faced with a similar situation, a similar
approach has been adopted by this researcher. Although clinical governance is not
explicitly depicted as Total Quality Management, the language and practice, where
specified in the policy documentation, is redolent with that of TQM and implies total
quality management or a whole system approach to quality if not explicitly named as
such.
229
Owing to the lack of theoretical underpinning to the emerging clinical governance
agenda, and despite the lack of a universally accepted theory of TQM, the TQM
literature has proved a useful guide to what clinical governance might look like in
terms of content or the 'what'. In light of the centrality of change to the notion of
improvement, a variety of change management models have also been utilised to
inform the 'how1; in particular Miles (1997), but also Kotter (1996), and Pendlebury
and colleagues (Pendlebury, Grouard and Meston, 1998).
Given the rich description and the initial interpretation which have been included in
the earlier results chapters, it has proved somewhat of a challenge to address this
chapter and draw out significant issues without repeating large sections of that which
has gone before. In addition, it has been important to remember that, due to the
emergent understanding of the clinical governance concept, this study set out to be of
a formative rather than summative nature and, in line with this, the researcher has
played a helping role rather than that of arbiter of success or failure. Besides, the
payback to the Trust for taking part was researcher input to the implementation
process; the deal did not include judgement per se.
9.2 FACTORS WHICH PREDICT SIGNIFICANT MOVEMENT
TOWARDS TOTAL QUALITY
In shaping this chapter, the author was strongly influenced by a sense of deja vu given
that clinical governance was not the first attempt to introduce a whole system
approach to quality improvement into the NHS. Thus, in an effort to avoid
succumbing to the 'collective amnesia' described by Klein (1998), it seemed highly
230
appropriate to draw on the lessons learned from this past experience. As a result of
this earlier experiment, Joss and Kogan (1995) offered 11 factors which they
considered to be predictive of significant TQM movement (Table 9.1). These factors
have been adapted and will be used as an umbrella framework to guide a discussion
of some of the significant findings of this most recent case study concerning the
implementation of clinical governance.
Table 9.1: Factors which predict significant movement towards total quality
1. Demonstrated senior management commitment and understanding ;

2. A well-developed and well-documented implementation strategy ;
3. Strong/persevering co-ordinator - board level appointment;
4. Structure overseeing implementation;
5. Comprehensive baseline assessment of service quality;
6. Early effort involvement of clinicians;
7. Sufficient funding for facilitators;
8. Standard setting only as part of strongly monitored CQI;
9. Comprehensive training;
10. Explicit strategy/resources for recognising and rewarding progress;
11. Organisational changes after evaluation.
Adapted from Joss and Kogan (1995; plSl)______________
9.2.1 Demonstrated Senior Management Commitment and Understanding
Joss and Kogan (1995, p!52) were of the view that demonstrated senior management
commitment was 'of central importance' to the successful implementation of TQM.
This is echoed by others writing in relation to TQM implementation specifically
(Saraph, Benson and Schroeder, 1989; Porter and Parker, 1993; Ahire, Golbar and
Waller, 1996) and change in general (Kotter, 1996; Miles, 1997; Pendlebury, Grouard
and Meston, 1998). Brown (1993) highlights the other side of this coin and
comments that hardly any TQM failure is reported without the executive being
231
blamed in some way. He goes on to comment that although most are committed in
their hearts, in practice, their employees will judge them by their behaviour and
actions.
It is for the reasons stated above that Joss and Kogan (1995) emphasise 'demonstrated'
commitment particularly as they found that management commitment to TQM at the
pilot sites was rather less than impressive. The authors (ibid) speculated that the
Department of Health's lack of any mandate to specify the leadership arrangements
required for this experiment contributed to the situation regarding management
commitment. In this matter, the Department's approach with the TQM pilot sites was
in stark contrast to its current approach to clinical governance. Clinical governance is
a statutory duty and the Department of Health has been explicit in the leadership and
accountability arrangements surrounding this at the corporate level (1998). The
consultation document (ibid) states that the Trust Board is accountable for the quality
of services and that the chief executive is the accountable officer; the lead for clinical
governance is to be a senior clinician. In this way there is no doubt where the
ultimate accountability for clinical governance lies and, in addition, by stressing that
clinical governance is the responsibility of all, the explicitness of ultimate
accountability does not displace individual accountability within the clinical
governance agenda.
The Emerald Trust clearly complied with the Department of Health requirements in
terms of making the accountability arrangements explicit at the corporate level;
however, it still faced the same challenge as all organisations currently
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operationalising this agenda; namely how to demonstrate its commitment to clinical
governance. Irrespective of individual commitment, it has been stated in a previous
chapter that the minutes of the Trust Board meetings do not give a sense of any
detailed debate around clinical governance generally or interrogation of the clinical
governance reports in particular. Also, members not on the Clinical Governance Sub
committee seemed to take a pragmatic view that clinical governance was in the safe
hands of their colleagues who served on this particular committee. Whilst this may
indeed be so, it is surely the duty of the Trust Board to model the spirit of the
consultation document in what has almost become a mantra - 'quality is everybody's
business' - and consider explicit and tangible mechanisms by which the Trust Board
as both a collective and as individual members may demonstrate its commitment.
Otherwise, it risks sending a signal to the rest of the organisation that quality is only
the business of some and can therefore be delegated.
The way in which clinical governance is operationalised locally will provide staff at
the front line of service delivery with a view of how seriously the organisation is
taking clinical governance generally and implementation in particular. At the time of
the initial rapid appraisal in November 2000, five out of six divisions had established
a local clinical governance forum; however, only two out of six had developed an
action plan to take forward the Trust 'Clinical Governance Development Plan'.
These early interviews with managers also suggested that little in the way of
awareness raising (other than the Trust initiative) or specific clinical governance
training had taken place in the divisions.
233
In effect, the Development Plan was not a living document within the organisation at
that time. In the division which had not established a forum, it was acknowledged by
senior managers that there had been little if any formal clinical governance activity in
between the development of the Trust Plan and the formation of the local forum, a
period of around 15 months. This supports the earlier findings of Joss and Kogan
(1995) in that, where there was no local structure in support of TQM, little local
progress with implementation was observed. In such circumstances, any perceived
rhetoric-reality gap could erode confidence in the commitment of senior managers
and lead swiftly to cynicism amongst front line staff; this and a sense of "business as
usual' was certainly evident from the focus groups undertaken as part of this latest
research.
Joss and Kogan (1995) also argue that, before commitment can be demonstrated,
there needs to be awareness and understanding. In many of the accounts of TQM
implementation, this notion is clearly appreciated (Glover, 1993; Rand, 1994;
Ghobadian and Gallear, 1994) and the most common approach to address this tends to
be through workshops. The preferred sequence for education and training (Porter and
Parker, 1993; Dale and Cooper, 1994) is to start with the senior executives of the
organisation and then cascade this down towards the front line or what Mintzberg
(1979) terms the operating core. The purpose of these workshops is generally to
ensure that everyone has the same basic understanding of the initiative and also to
provide an initial outline of the implications of clinical governance for participants.
There is some support in the literature for training to be carried out by managers from
234
one reporting level to the next and so on throughout the hierarchy in order to
demonstrate commitment and translate understanding into action (Kanji and Barker,
1990). This is particularly important for those at the corporate level because
executive behaviour sets the tone for the rest of the organisation and is even more
desirable where there is a lack of clarity around the initiative which has been the case
in both TQM and more recently clinical governance.
A workshop was scheduled for the Trust Board in the early days of implementation
but this was subsequently cancelled. Unfortunately, it was to be a full two years after
the publication of the Development Plan before this would be re-scheduled.
Such workshops as described above would have provided the Trust with a valuable
opportunity to test the existing understanding of the Trust Board and provide the
basic overview needed to bring all members to a similar level in terms of knowledge
and understanding. This shared knowledge base should ideally have given the Board
a clearer idea of what the new statutory duty of quality meant for them both as a
collective and as individuals and, in doing so, provided an insight into the very
significant and transformational nature of the change process that lay ahead. This in
turn could have laid the foundations for the work to come namely the development of
the strategic direction. It might have also allowed the Trust Board members to play a
more active role in the shaping of the agenda, the commitment of resources in support
of implementation, the identification of the information required to enable the
effective execution of the statutory duty for clinical governance and ultimately
ensured that the corporate body was in a position to challenge, if necessary, the nature
235
and rate of progress of this important initiative.
In reality, the role the Trust Board plays in relation to clinical governance is likely to
reflect its role in terms of the Trust business generally and, in the case of the latter,
some Trust Boards appear to operate as little more than 'rubber stamps' for the
executive team (Carver, 1990). If Boards are to operate effectively, they need the
knowledge and skills to do this and this requires deliberate attention to their
development needs - induction in the first instance and ongoing development
subsequently. The Non-executive Directors interviewed in this Trust were not
satisfied by the arrangements for their induction although they had subsequently been
on a number of training courses relating to their specific responsibilities. Also, as
demonstrated above, as a corporate entity there had been no collective attention to the
Trust Board's development needs in relation to clinical governance; this may have
contributed to the fact that, as a collective, it did not challenge the implementation
drift that was apparent during the research project.
An early assessment of the clinical governance knowledge base of the Management
Team would have been eminently appropriate given the relative newness of this
particular agenda and the complexity of implementing total quality per se (Kanji and
Barker, 1990). It would appear that to assume a level of knowledge around quality
management is risky; according to some (Dale and Cooper, 1994; Taylor, 1996; Yong
and Wilkinson, 1999), many senior managers have merely a superficial understanding
of TQM and that is often confined to the 'buzzwords'. According to Yong and
Wilkinson (ibid), making such assumptions without a proper assessment of
236
development needs is unwise as they regard many of the 'roadblocks' to the successful
implementation of total quality as having emanated from senior/middle managers -
often because they feel threatened in some way by the initiative (Walsh, 1995).
The lack of a shadow quality structure to bridge the gap between the corporate level
Clinical Governance Sub-committee and the divisional clinical governance fora
inevitably meant that the Management Team needed to play a central role in the
implementation of clinical governance for several reasons. Firstly, as Divisional
Managers, they were essentially responsible for turning the corporate objectives into
local objectives and subsequently ensuring the operationalisation of these within the
divisions. Secondly, most of the Divisional Managers had a relatively high level of
visibility within their area of responsibility and thus their response to the clinical
governance agenda would ultimately set the tone for the staff. Given the value of
behaviour over words in demonstrating commitment to the clinical governance
agenda, it was, therefore, important that they model the appropriate response through
local action (Brown, 1993; Katz, 1993; Shea and Howell, 1998). However, the
degree to which Divisional Managers took forward the clinical governance agenda
was extremely variable and, as indicated earlier, lack of deliberate action in one
particular division seems to have signalled a 'business as usual' approach which
cascaded down through the hierarchy to the front line. In reality, whilst some of the
senior managers did indeed have a good understanding of the agenda, others were less
fortunate but, despite this, the Management Team was expected to 'get on and do it'.
The experience of this Trust appears to add weight to Joss and Kogan's earlier
237
assertion (1995) that an important precursor to commitment is an understanding of the
principles of quality management and what is expected of the individuals involved.
In addition, in order to avoid the cynicism which may arise from any perceived
rhetoric-reality gap, the words need to be reflected in action. One vehicle for making
explicit both the words and the action required for implementation is the strategy and
this will now be considered.
9.2.2 A Well-Developed and Well-Documented Implementation Strategy
Corporate strategy is the main vehicle for making explicit the vision of the
organisation, the objectives that will deliver this vision, the people and other
resources required in its delivery and the time-scales by which the objectives are to be
achieved. The way in which clinical governance is conceptualised within this vision
will determine the scope and scale of the change involved in its implementation; for
many organisations, this will/should represent a transformational, frame-breaking
change rather than more of the same. Strategy in transformational change is vision-
led (Miles, 1997). This is largely because the future state is either not clear or,
perhaps because of the nature of the change, it is unknowable. In such circumstances,
it is easier to understand why the implementation of total quality is often referred to
as a journey rather than a destination (Dale, 1994). In this uncertain environment, the
vision acts as a compass outlining the general direction whilst the strategy becomes a
map of the route to be taken.
The Trust's vision does not suggest that clinical governance has been conceptualised
as TQM; albeit TQM by another name. In fact, although the term 'quality' is
238
mentioned frequently, there is no explicit statement within the two key Trust
documents of what constitutes 'quality'. As the literature review in Chapter 3 has
demonstrated, the notion of quality is often contested; thus an insight into the Trust's
conceptualisation of this core element of clinical governance might have served as a
useful starting point. The recurring theme within the Trust approach is 'learning' -
learning from problems that have arisen and learning from new knowledge that is
generated from within or outside of the organisation. This is subsequently reflected
in many of the 'what' elements of the Trust clinical governance implementation
outlined in Chapter 6; examples include the introduction of the Significant Clinical
Incident Review process and the development of the library and knowledge
resources. The aim of the Trust is to generate and capture the learning with the
intention that this will deliver improvement. However, the national experience of
existing quality improvement systems such as clinical audit and risk management is
that this knowledge does not always lead to a closure of the loop and the
implementation of the change and improvement required (Berger, 1998; Walshe and
Dineen, 1998). The Trust has recognised the potential for the lack of action
described above and built into many of the new systems a review process to
determine whether change is actually taking place.
The Significant Clinical Incident Review process is a particularly important example
of the above and it also highlights an attempt by the organisation to signal a change
in 'how we do things here'. The Review process aims to get to the root causes of
problems and take remedial action which addresses the whole system. The Trust
regards this as a very positive advance as this did not tend to happen before, at least
239
not in such a systematic way; however, the Significant Clinical Incident Review
process is yet to be incorporated within the wider risk management system.
Valuable as such initiatives are in themselves, they are yet to be encompassed in an
integrated framework for quality improvement; also a common problem for both the
NHS TQM pilot sites (Joss, Kogan and Henkel, 1994; Joss and Kogan,1995) and the
Norwegian sites (0vretveit, 1999; 0vretveit and Aslaksen, 1999).
Whilst 'learning' is important, when trying to implement improvement it is essential
that the learning process is regarded as a means to an end rather than the end in
itself. For this reason, perhaps it would be more appropriate to focus on the goal of
CQI and develop a vision which describes what this might look like in practical
terms. In this, the guidance from the Department of Health (1999, pll) is
informative, at least in relation to front line staff:
'It must be recognised, however, that the practice of clinical governance

at service level - clinical teams analysing and assessing the quality of
their services and seeking ways to improve them - will be a multi-
disciplinary and often also a multi-agency activity'.
The picture presented above captures a flavour of CQI at the operating core; groups
focused on processes in an effort to improve them. What is also needed is a vision of
CQI at the corporate and middle levels which brings the whole organisation at each
level of the hierarchy into alignment and thus creates an environment so that the front
line may, indeed, operate in the way described above. This notion of alignment is
emphasised throughout the TQM and the change management literature and plays an
important role in ensuring the consistency needed for a successful change process
(Miles, 1997; Pendlebury, Grouard and Meston, 1998). For instance, in one division
240
of the Trust, the vehicle for quality improvement had historically been the standard
setting process and there was a strong desire locally to re-establish the standard
setting groups. However, this may not be an appropriate way forward in the absence
of any other quality improvement structure at locality level. Joss and Kogan (1995)
recommended that standard setting should only be part of a broader CQI approach.
Their rationale is based on the observation that standards tend to be set but neither
audited in terms of compliance or revisited/revised in a timely manner - hardly
consistent with the dynamic nature of CQI.
The lack of a central blueprint for clinical governance has meant that Trusts have
been left to interpret the concept for local application and the action set outlined in
the Trust Development Plan reflects a vision of clinical governance derived in this
manner. In its present form, the Development Plan is not explicitly geared to deliver
a whole system approach to CQI and is therefore unlikely to achieve this with the
present focus. What is evident from the case study is that some of the quality
assurance elements are being put in place (reporting mechanisms etc); nevertheless,
whilst a CQI model may yet emerge, this was not apparent during the fieldwork
period.
Total Quality Management requires a strategic approach to quality management
(Walsh, 1995); for TQM to be considered a priority and receive appropriate funding,
CQI must be part of the corporate plan (Davis, 1997). Both of these statements might
be considered equally applicable to the implementation of clinical governance. In
addition, there needs to be a focus on the core processes which constitute the business
241
of health care and an ability to address both positive and negative quality. Positive
quality is regarded as proactive and is about adding value in the absence of any
identified problem. Negative quality is seen as reactive. It is usually a response to
complaints, incidents etc, and in this way focuses on dealing with the cost of poor
quality - that is putting right what should have been right first time (Zairi, 1994).
The strategic approach to total quality must recognise and deliberately address both of
these elements; unless there is a commitment to strive towards positive quality and
CQI, an organisation may find itself trapped in a reactive spiral of fire-fighting and
problem orientation.
Whilst the design and development of strategy is important, implementation is
everything. Without the implementation process, plans stay as words on paper and it
is often the process of getting them off the paper which is the most problematic
(Glover, 1993). As Sproull and Hofmeister (1986) commented, implementation is not
sexy, it is about the nuts and bolts of getting something in place. Although the Trust
Development Plan outlined an ambitious action set of 39 objectives (36 of which
were either ongoing or to be achieved in year one), it did not appear to be a living
document within the divisions even 12 months after its publication. Indeed, only two
out of six divisions had any form of local plan of action for clinical governance
despite there being some very explicit objectives specifically for these areas of the
Trust. Rather than a sense of dynamic goal deployment, there was evidence of a
general implementation drift having occurred despite a number of important
initiatives having been put in place (Chapters 6-8).
242
In reality, although milestones indicated a timescale for the achievement of the
objectives, there was little in the way of an explicit emphasis on the main priorities.
Although progress against the Development Plan was reported to the Clinical
Governance Sub-committee, the implementation drift continued throughout the first
12 months at least. Also, despite the fact that many of the objectives had resource
implications, the Plan was not explicitly costed.
In essence, despite the scale and scope of the implementation process, a project
management approach was not adopted; in fact there was even a sense that this would
be contrary to the prevailing culture. Although clinical governance is not a discrete
project, there are elements of the implementation process that clearly are. Several
TQM practitioners strongly advocate the adoption of a project management
methodology (Dale and Cooper, 1994; Stamatis, 1994). Given the stress placed upon
the active management of change and total quality (Oakland, 1995; Kotter, 1996), it
could be argued that project management could also provide a valuable underlying
structure for clinical governance implementation in that each aspect of the
management process is emphasised.
A project management approach may have helped this Trust in a number of ways. In
addition to identifying objectives, costing these would have likely forced explicit
prioritisation; although, ultimately quality might be free (Crosby, 1979), it is
recognised that the introduction of CQI involves set up costs (Porter and Parker,
1993; Joss and Kogan, 1995) which need to be resourced appropriately. The
allocation or re-allocation of resources is considered to be a powerful signal of what
243
the organisation considers important (Miles, 1997). Whilst the Trust did invest in
terms of the executive lead post, it failed to allocate specific resources at the outset
for the Clinical Governance Development Team. This delayed its formation for
almost two years despite the fact that it is generally advocated that the facilitation of
large-scale change generally needs to commence at the outset and remain ongoing
(Joss and Kogan, 1995; Miles, 1997; Pendlebury, Grouard and Meston, 1998).
The need to allocate resources could also have eased the process of identifying the
'critical few1 in terms of objectives and thus facilitated a move to phasing
implementation rather than having a large number of objectives to be
achieved/commenced in year one - as Miles (1997, p48) comments 'the new internal
context of the organisation does not emerge in a moment of cosmic creation'. The
Department of Health has also recognised that phased implementation would be
required in accordance with the resources available (Department of Health, 1999); an
approach which receives support from the wider TQM literature (Yusof and
Aspinwall, 2000a). In this way, the Trust could have produced some tangible, early
"wins' which included positive quality (Miles, 1997; Pendlebury, Grouard and Meston,
1998); thereby emphasising the proactive aspects and reinforcing the belief that
clinical governance is achievable rather than something so big as to almost induce the
sort of management paralysis that can be associated with TQM (Dale, 1994). Also,
the focusing of resources for delivery could also serve to emphasise the commitment
of senior management to the clinical governance objectives. Contrast this approach
with the reality of clinical supervision in the Primary Care Division where some staff
reported problems attending because of clinical duties. Where situations such as
244
these remain unresolved, there is a risk that the organisation inadvertently sends a
signal to staff that clinical supervision is not a high priority for the Trust despite its
continued encouragement of staff to take part.
According to Yusof and Aspinwall (2000a), one of the most influential factors in the
successful implementation of total quality is the development of a sound
implementation plan before embarking on the change process. The potential benefits
of utilising a model or framework to guide implementation have been discussed in the
earlier chapters of this thesis. Motwani and colleagues (Motwani, Sower and Bashier,
1996) highlight the fact that much of the implementation of total quality in health care
is not based on any specific implementation guidelines 'except for those in directives'.
The authors (ibid) consider the use of a model/framework to be a necessity if the
effectiveness of the implementation effort is to be improved. The use of an
overarching implementation framework such as the one developed by Miles (1997)
could serve to make explicit the elements of both 'what1 and 'how' and in this way
force managers to address issues that might be avoided either deliberately or through
oversight (Yusof and Aspinwall, 2000a). Certainly, utilisation of the Miles
framework (1997) would have highlighted to the Trust the gaps in what Miles has
termed the 'process architecture' (Appendix 2).
The elements which constitute the process architecture are apparently quite
commonly overlooked; both the TQM and the change management literatures abound
with examples of this. Unfortunately, these elements are considered to be the ones
that will 'orchestrate' the transition from the present to the future state. A consistent
245
message amongst practitioners of change management is the need to take a holistic
approach and omitting elements will have negative results (Kotter, 1996; Miles, 1997;
Pendlebury, Grouard and Meston, 1998). This tends to support the argument for a
well-formulated implementation framework albeit one that serves as a guide rather
than a prescription.
9.2.3 Comprehensive Baseline Assessment of Service Quality
Joss and Kogan (1995) found that few of the TQM pilot sites had undertaken what
they described as pre-implementation diagnostics; this led to a lack of clarity about
the exact starting position of the organisations in relation to TQM. The lack of any
clear view of the quality systems already in place obviously had implications for
planning and, in particular, decisions about what needed to be reinforced/changed in
order to implement the initiative. The subsequent measurement of progress was also
impeded by this general failure to obtain an accurate picture of the pre-change
position.
The omissions described above are apparently not uncommon and a number of
authors have commented on the propensity for managers to either by-pass or only
address superficially this important activity; alluding to a preference for action rather
than careful diagnostics and planning (Dale and Cooper, 1994; Anderson and
Ackerman-Anderson, 2001). Interestingly, the guidance on clinical governance
issued by the Department of Health (1999) included the need for a baseline
assessment in its 'must do1 list. The guidance also provided a clear indication of the
areas that Trusts need to address as part of this assessment: the effectiveness and
246
integration of existing systems for quality improvement (such as clinical audit), the
quality of existing data for monitoring quality activity, the identification of
problematic services, the degree to which existing strategies (HR, IM&T etc) support
the clinical governance agenda. In addition, it was also made clear (Department of
Health, 1999, pi7) that the findings of the assessment should be shared within the
organisation:
'The baseline assessment should let the whole organisation see what it is
good at, what it is less good at, and the areas needing to be developed'.
So, it seems from the above, not only is the baseline assessment required for planning
purposes but the findings should also be communicated to a wider audience than
those involved directly in the development process. Although it was reported that the
Trust had undertaken a baseline assessment, it proved difficult to determine what had
been included in this process, how it had been conducted and the findings in detail.
Although the 'Clinical Governance Report' made a broad reference to a number of
areas that needed attention, the findings were not presented in any detail in either of
the two key Trust documents neither, according to the minutes of the meetings
obtained by the researcher, does this appear to have been discussed in depth at the
Trust Board. Thus, although the Trust Development Plan presents the objectives to
be achieved, it is not possible to link these directly to the current state of the areas
prescribed within the guidance (Department of Health, 1999).
This lack of detail does not just have implications for the planning and monitoring
processes but is also likely to have implications for other aspects of implementation.
Kotter (1996) describes the need to create a sense of urgency whilst Miles (1997)
247
talks instead about confronting reality. Each approach is intended to increase the
ability of the organisation to create the energy needed to make the transition from the
present to the desired future state. However, the absence of a detailed baseline
assessment or any formal external benchmarking did not seem to affect the sense of
urgency of the Clinical Governance Sub-committee, at least at the outset. Although
the risk of paralysis when faced with the notion of implementing a whole system
approach to quality improvement is well documented (Dale, 1994), the Sub
committee was very keen to make a start. Whether the level of baseline information
available was sufficient for the Sub-committee to fully appreciate the reality of its
starting position is perhaps an issue for the Trust to consider. Given a clearer picture
of the effectiveness and coverage of existing systems such as clinical audit, risk
management, appraisal, and perhaps knowledge of the work taking place in other
Trusts, the strategy may have looked rather different. The Sub-committee may have
decided to focus initial efforts on addressing gaps in the existing systems in an effort
to provide a solid foundation for further development rather than setting up new
processes within these systems as was generally the case.
In the earlier review of the clinical governance literature (Chapter 2), details of one
Trust's devolved approach to baseline assessment was briefly outlined (Holland and
Fennell, 2000). In this case, directorates across the Trust undertook a self-assessment
against a selection of pre-determined criteria. This informed local clinical
governance action plans and also the corporate plan. Locally, it focused attention on
the issues to be addressed and, in the authors' view (ibid), this process fostered local
ownership of the objectives. It is unclear how the divisions within the Emerald Trust
248
were involved in the baseline assessment but, almost 12 months after the appearance
of the Development Plan, the rapid appraisal found that none had undertaken an
assessment of the effectiveness of their existing systems. Although, when eventually
produced, the Primary Care Division Plan included objectives relating to existing
systems, these were still not based upon a systematic review and this omission may
have contributed to the rather fragmented nature of the Divisional Plan.
Another important reason for undertaking the baselining work referred to here is the
need to make a careful assessment of the existing organisational capacity to pursue
the intended change. Miles (1997) argues that organisations that find themselves with
a high level of resource and a high capacity for change are in the minority and those
with low resources and low capacity should not embark on the change unless this
situation can be successfully remedied. Spurgeon (1999) makes a similar point and
observes that many health care organisations are not in a position to undertake
transformational change and asks whether commercial organisations facing similar
circumstances would embark on this; the author (ibid) concludes that they would not.
However, in the case of clinical governance, its status as statutory duty essentially
means that implementation is not optional and the establishment of the Commission
for Health Improvement to review progress reinforces this message. Where capacity
and resources are not high, Trusts will need to consider such issues carefully and take
a deliberate decision regarding prioritisation and phasing in order to increase the
likelihood of successful implementation. Related to this theme of 'first things first1,
one of the areas which normally receives early attention during organisational change
in genera] (Kotter, 1996; Miles, 1997) and clinical governance in particular is
249
structure (Latham, Freeman Walshe et al, 2000) and this will now be considered.
9.2.4 A Structure to Oversee Implementation
Structure is defined by Miles (1997, p36) as: 'the formal structural arrangements of
the organisation that delineate its basic units of authority and accountability'.
Expressed in another way, the structure provides a framework of order and command
through which the process of management in terms of planning, organising, directing
and controlling may be applied (Mullins, 1999). Thus, structure is regarded as an
important design feature in the implementation of transformational change generally
(Miles, 1997) and quality improvement specifically (Oakland, 1995). The TQM
experiment demonstrated that, in Trusts with no structure below corporate level,
implementation was observed to be poor (Joss and Kogan, 1995).
An important consideration in the implementation of total quality is whether the
structural design should reflect a 'shadow' or 'line' structure. Neither choice is
apparently without its problems. A shadow structure risks creating/reinforcing the
perception of quality as the responsibility of the quality function; however, where the
responsibility for implementation rests within the existing line management
arrangements, there is a risk that the quality agenda will be displaced by day to day
activities (Dale and Cooper, 1994). Joss and Kogan (1995) found that where
implementation was left to the line managers, there tended to be less progress
achieved. Consequently, the authors (ibid) recommend that a shadow structure
should be established initially but with a view to integration within the line as the
initiative becomes more established operationally. Irrespective of whether the
250
initiative starts with a shadow or line arrangement, there is support for the proposition
that responsibility for the management of quality should rest within the line
management remit (Brown, 1993;Davis, 1997).
Both of the issues raised above were apparent in the Emerald Trust. There was a
perception that the Clinical Governance Lead was responsible for driving the agenda.
The corollary of this seems to have been that several of the areas which did not
receive her personal attention did not necessarily move forward at the same pace as
others. Also, the lack of a forum in one division corresponded to a lack of specific
clinical governance activity in this area. Although managers locally were aware of the
clinical governance agenda, until the Forum was established, there did not appear to
be a vehicle to take it forward. In the absence of a specific structure for clinical
governance, there was no evidence that the existing line management arrangements
naturally incorporated the requirement to implement this initiative.
One important gap that needs to be addressed by the Trust is the lack of a quality
structure below the divisional fora. This may take the form of process improvement
teams, quality improvement teams or quality circles (Oakland, 1995) and, given their
absence at the case site, one must question how CQI is to be operationalised by
clinical teams. Although, as discussed earlier, this is not evident in the Trust vision
for clinical governance, it is an explicit feature of the Department of Health thinking
and highlighted in the guidance (Department of Health, 1999). Without a vehicle for
improvement, initiatives at the front line risk being piecemeal (Walsh, 1995) and/or
do not reflect corporate objectives which may ultimately limit the chances of
251
resources being released to ensure success.
In reality, clinical governance structure at the Emerald Trust appears to be a mixture
of shadow and line. There are explicit forums for clinical governance at the corporate
level (the Clinical Governance Sub-committee) and at division level (the divisional
fora); between these two levels, there is the line function in the form of the
Management Team. Although it was implied in the Development Plan that
Divisional Managers have a key role to play in the implementation of clinical
governance, it was not explicitly stated that Management Team would be the main
vehicle through which this agenda would be operationalised - it was merely assumed
that this would take place. In reality, the extent to which the Management Team as
individuals have taken the Development Plan forward has been variable. Although
clinical governance issues are taken to Management Team by the Clinical
Governance Lead, the minutes of these meetings do not reflect a collective
operational responsibility for managing the change process associated with clinical
governance. Thus, under the current arrangements, a lack of clarity around the lines
of accountability and authority at divisional management level and below appears to
have created something of an operational vacuum.
The structural gaps described above have implications for all aspects of the
management process. The minutes of the Clinical Governance Sub-committee are not
routinely circulated to the Management Team and, until the chairs of the divisional
fora became members of the Sub-committee, the minutes were not routinely received
by the divisional groups either. This gap has important implications for the
252
effectiveness of quality policy deployment and thus the likelihood of goal congruence
and alignment (Krishnan, Shani Grant et al, 1993; Zairi, 1994).
In addition to the above, there is also the question of accountability and control, both
of which are important core elements of clinical governance. Although the Clinical
Governance Lead has a clear overview of the progress of clinical governance
implementation throughout the Trust, this is not actively monitored by Management
Team and consequently this function rests with the Clinical Governance Sub
committee and ultimately the Trust Board. However, both the Sub-committee and the
Trust Board are presented with a mixture of detailed operational data and information
relating to performance against the Development Plan which tends to be stated in
broad terms reflecting the way in which the initial objectives were formulated.
To enable the Clinical Governance Sub-committee to perform this monitoring and
control function and for the Trust Board to be assured that this is being carried out, it
would seem that the form and content of the quarterly reports may benefit from
further consideration in terms of appropriateness and usefulness. Information is an
important determinant of the effectiveness of Trust Boards and finding the right
balance of providing enough detail to enable members to take a proactive approach
without 'drowning' them in data is recognised as an on-going challenge (Audit
Commission, 1995).
Data as opposed to information can obscure rather than enhance the picture presented.
The reporting mechanism currently in place does not seem to have led either the Trust
253
Board or the Clinical Governance Sub-committee to challenge the fact that one of the
divisions had not established a forum until 15 months after the publication of the
Development Plan or to question the presence of a general implementation drift. This
may be partly accounted for by the quality of the information but there is also an issue
of the nature of the control system in place to deal with any sub/non-implementation.
Where there was a lack of action, the Clinical Governance Lead approached this on a
one to one basis and, in this way, corrective action appeared to rely on her influencing
skills rather than any formal control mechanism. Given the centrality of
accountability to the notion of clinical governance, this is an area which the Trust
perhaps needs to address. Why this lack of a formal control function is allowed to
continue is unclear. This is not just a feature of the executive level but relates to
management at all levels within the hierarchy. As was the case in the earlier the
TQM experiment (Joss, Kogan and Henkel, 1994; Joss and Kogan, 1995), the
individual objectives for managers within the Emerald Trust did not contain specific
objectives relating to the clinical governance agenda other than perhaps the need to
undertake appraisal of subordinate staff.
Perhaps the above is a manifestation of the high trust culture operating within the
senior management tiers. Trust is an important element in all organisations but it is
especially so where there is a high level of professional judgement required which is
often the case in health care. Davies and Mannion (1999) argue that the
establishment of trust and control is not an either-or decision. Trust without a control
function may lead to the creation/maintenance of a dependent relationship between
254
the organisation and those who will deliver the services. Instead, the authors (ibid)
suggest that the challenge lies in 'finding the balance between checking and trusting'.
The advent of clinical governance and corporate accountability for quality means that
assuming certain action is taking place is no longer enough; systems need to be in
place that will not only demonstrate this is so but also that the appropriate remedial
action has been taken where necessary.
Given the scale and scope of change which has accompanied the 1997 White Paper
(Department of Health) and the NHS Plan (Department of Health, 2000), it is
reassuring to see the emphasis that is being placed on effective leadership and the
action being taken to make this available to the NHS. Whilst acknowledging the
importance of leadership, there are those who are also cautioning that management
must not be forgotten in the process (Spurgeon and Latham, 2003). Neither total
quality or change will 'just happen', both must be actively managed (Oakland, 1995;
Kotter, 1996). Kotter (ibid) suggests that the leadership/management notion is a
both/and situation rather than either/or, having argued in an earlier publication that
leadership and management are different conceptually and in practice (1990).
Structure plays an important role in the effectiveness or otherwise of both leadership
and management. Drucker (1989, p223) argues that a good structure does not
guarantee a positive performance but a poor structure 'makes good performance
impossible' irrespective of how good individual managers may be.
Having considered the issues surrounding structure and clinical governance in the
Emerald Trust, the next section will continue with a similar theme - namely the
255
establishment of a vehicle for co-ordination and facilitation.
9.2.5 Strong/Persevering Co-ordinator - Board-level Appointment
Joss and Kogan (1995) found that most of the Trusts in their study had appointed a
manager or co-ordinator to take the total quality initiative forward but generally these
posts were set too low within the hierarchy. In view of this, the authors (ibid)
recommended that this post should be a board-level appointment - a recommendation
which is clearly reflected in the Department of Health requirements for clinical
governance (1998).
Earlier research (Latham, Freeman, Walshe et al, 2000) found that the post of clinical
governance lead tended to be a jointly held appointment of the medical/nurse
directors and that the majority had little or no dedicated time to carry out this role. In
contrast to the above, the Emerald Trust created the executive post of Director of
Clinical Governance which has meant that most of the Lead's responsibilities are
concerned with the discharge of this wide-ranging remit. This particular director, in
addition to a clinical background, has also played a strong operational management
role within the Trust and seemed to be perceived as a credible lead throughout the
organisation.
The appointment of an executive clinical governance lead was regarded at the
corporate level as a powerful signal of its commitment to the clinical governance
agenda; however, as in the case of TQM, this has not eased the process of translating
corporate commitment into commitment and ownership locally. Although there was
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no evidence of managers breathing 'a sigh of relief because there was no longer a
need to worry about this quality stuff (Brown, 1993), there was certainly a variability
in the proactiveness of their approach - and some evidence that this was due to the
fact the Clinical Governance Lead seemed to be on top of the agenda. Whilst having
provided a strategic lead in terms of clinical governance, the Lead was nevertheless
becoming increasingly embroiled in operational detail. The lead took forward all of
the Significant Clinical Incident Reviews and, as Chair of the Risk Management
Team, was increasingly leading on risk management issues. A number of elements
relating to the implementation process could be contributing to this increasing
entanglement with the operational side of implementation and these will be now be
considered.
Firstly, against each of the objectives outlined in the Development Plan there is a
schedule of responsibility, however most of these are set against multiple 'key
players'. Identifying each person/group with a responsibility is important but seems
to have left the Clinical Governance Lead with the task of co-ordinating the activity
involved in reaching each of these goals across all of the six divisions. Alternatively,
in addition to each individual manager being assigned responsibility for the local
implementation of each objective, a Divisional Manager could have been identified as
co-ordinator for several objectives with the remit to take these forward across the
divisions. The Clinical Governance Lead would then have been free to retain an
overview and influence progress. At the same time, the Lead would be able to
devolve some responsibility, directly engage the Divisional Managers and streamline
the implementation and monitoring of the process.
257
Secondly, in the absence of an operational group to support the clinical governance
implementation process, there was little opportunity for the Clinical Governance Lead
to delegate. The issue of delegation related not only to the objectives discussed above
but also to those activities that would normally be the remit of more junior staff such
as the preparation of agendas, responsibility for minutes and the general servicing of
the various committees. In addition, the lack of a comprehensive risk management
function led to a situation where the Clinical Governance Lead increasingly assumed
responsibility for operational aspects of risk management almost by default.
Thirdly, a related but rather different issue is that of line management. In the absence
of a direct line of management to those tasked with the implementation of the
Development Plan, the role of the Clinical Governance Lead was inevitably one of
influencing rather than directly managing. This is consistent with the sort of 'shadow'
arrangements that are evident in certain models of total quality (Oakland, 1995) and
change management (Pendlebury, Grouard and Meston, 1998) initiatives; however, in
the absence of strong monitoring and control mechanisms, this could, as perhaps in
this case, contribute to a degree of implementation drift.
Finally, the provision of facilitation and support are important factors in the effective
implementation of total quality (Glover, 1993; Rand, 1994; Oakland, 1995) and large-
scale change generally (Miles, 1997; Pendlebury, Grouard and Meston, 1998). It is
important that this is available throughout the initiative and particularly in the early
stages when there is the risk of managerial paralysis (Whalen and Rhamin, 1994;
Dale, 1994). This may be due to a limited understanding of the requirements of
258
quality management (Dale and Cooper, 1994; Yong and Wilkinson, 1999), or simply
because of what some consider to be 'a fact of life' - that employees will give more
attention to the activities for which they are actively called to account (Dale and
Cooper, 1994). Whilst some managers were able to pick up the clinical governance
agenda and start taking it forward, others found this more problematic and did not
move forward until they had received assistance.
Pendlebury, and colleagues (Pendlebury, Grouard and Meston, 1998) suggest that
facilitators may play a valuable role as catalysts and in the Emerald Trust they could
probably have done much to clarify issues of local responsibility and accountability.
Through the provision of content and process expertise, the Clinical Governance
Development Team might also have helped in the translation and implementation of
the corporate objectives into the divisional setting. Accompanied by stronger
collective monitoring and control at the corporate level, the spotlight would thus have
focused very clearly on the responsibility of the divisions for delivering the clinical
governance agenda.
The Trust recognised, early on, that the divisions would need assistance - some more
than others. However, it was to be almost two years before the Clinical Governance
Development Team was fully established. During this time, some of the facilitators
made positive contributions to the divisions; other part-time members found their role
rather more difficult to discharge. In this, their experience was similar to that of
others elsewhere (Joss and Kogan, 1995); trying to work for the Team part-time,
members found that this activity was generally displaced by the demands of their
259
other role. This situation may have been avoided if, as suggested earlier, explicit
priorities had been set at the outset and funding allocated to ensure that the facilitation
had been available.
It is worth noting that the appointment of a facilitator to the Primary Care Division
brought immediate, observable added value to the implementation process. Amongst
other things, the Clinical Governance Facilitator ensured that the discussions within
the local Forum resulted in clearly minuted action points with deadlines for
completion and the identification of a member of the group as lead/manager
responsible. In addition, there was the creation of working groups to explore issues
outside of the meeting and a requirement to report back to the Forum at a later date.
This approach meant that issues that could not be addressed immediately would
remain within the remit of the Forum rather than 'going over the wall1 to another
group such as Clinical Leaders and risk falling into the 'white space' between the
various groups.
The Trust's appointment of a Clinical Governance Lead to such a senior post is to be
applauded; however, the Trust will need to address the current operational gap so that
the Executive Director may continue to take a strategic view and play a leadership
role. This will be essential in order to avoid the initiative degenerating into a 'list of
confusing projects' (Yong and Wilkinson, 1999) and/or the Executive Lead becoming
submerged by operational and administrative issues that essentially could and should
be delegated elsewhere.
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9.2.6 Early Involvement of Clinicians
Over a decade ago, Berwick (1989) warned:
'Quality improvement has little chance of success in health

organisations without the understanding, the participation, and in many
cases the leadership of individual doctors'.
Joss and Kogan (1995) remarked on what was considered to be a significant lack of
involvement of consultant medical staff in the pilots which they described as a
'serious blow to the credibility of TQM' (ibid, p!07). In the Emerald Trust, the
largest group of medics were employed in mental health and learning disabilities and
both specialties were represented by a consultant on the Clinical Governance Sub
committee.
Although, some might see the medical consultant as the key stakeholder in terms of
the clinical governance agenda in an acute unit (Hackett and Spurgeon, 1999), the
sheer diversity of the clinical workforce in a combined trust such as Emerald perhaps
challenges this notion in this context. It is interesting that, apart from the work on
consultant appraisal that was being taken forward by the Medical Director, the
initiatives highlighted in Chapters 6 and 7 do not reflect any significant corporate
engagement with the medics as a specific target group. Whether this has had any
impact on the progress of the mental health and learning disability divisions was not
explored explicitly as the focus shifted to the Primary Care Division which employs
few medics.
A review of the implementation activity outlined in earlier chapters suggests that
apart from the early awareness raising sessions and the risk management workshop
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much later in the process, there was little in the way of formal initiatives undertaken
to engage clinicians in the clinical governance agenda. Whilst new approaches such
as Significant Clinical Incident Review had been introduced, a number of managers
felt that staff did not see this as part of the Trust clinical governance approach per se.
In fact, some of the managers did not see that the recommendations arising from these
reviews could have any relevance in areas other than where the incident actually
occurred; this was not necessarily the case.
Interestingly, the conflict between business and clinical approaches to quality
described by Pollit (1996) was not apparent; perhaps this is not surprising because, as
suggested earlier, the Trust vision of clinical governance had not been conceptualised
as TQM and CQI. Instead, the main tools for its operationalisation related to clinical
audit, risk management and so on rather than cross-departmental/divisional quality
improvement teams using specific process improvement methodologies. Certainly, in
the Primary Care Division, there did not appear to be any vehicle to take forward CQI
in a systematic manner and, unfortunately, although improvements to services were
taking place, this did not appear to be the result of a systematic approach to quality
improvement but often the outcome of individual interest and effort - a situation also
found at many of the TQM pilot sites (Joss, Kogan and Henkel, 1994; Joss and
Kogan, 1995). In fact, there was a sense of'business as usual1 amongst interviewees
at the front line of service delivery.
Yong and Wilson (1999) found that confusion over what TQM meant in practical
terms was an important barrier to implementation. Any assumption that the Trust's
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clinical governance Development Plan was diffusing naturally towards the front line
staff seems to have been unfounded. In reality, although some of the clinical staff
interviewed had a good grasp of clinical governance in principle, others demonstrated
the sort of confusion found by the authors above (ibid). In the absence of an
organisation-wide training initiative, it is difficult to see how significant commitment
and involvement will be secured from front line staff.
9.2.7 Comprehensive Training
According to Oakland (1995, p26), the message for implementation is 'train, train,
train, train and train again' and the importance of education and training to the
effectiveness of implementation is echoed by others. Although there appears to be
some consensus that wholesale awareness raising is an important first step (Davis,
1997), more specific training in terms of both knowledge and skills needs to be
targeted at teams that will work together to solve real quality problems (Mann and
Kehoe 1995). In the absence of this 'just in time' approach, there is a risk that training
and education will take place in a vacuum; the knowledge gained quickly dissipating
unless employees are able to utilise this directly and become involved in quality
improvement activity (Dale and Cooper, 1994).
Joss and Kogan (1995) recommend a mixture of classroom education and workplace
application and this is now the approach adopted by the recently formed national
Clinical Governance Support Unit. The TQM experiment (ibid), highlighted a
significant difference between the amount of training provided at NHS and
commercial sites. The experience of the latter demonstrated that the provision of
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adequate training required a serious commitment in terms of funding so that
appropriate trainers could be engaged and also so that staff may be released from
daily responsibilities. In practice, few of the pilot Trusts progressed beyond
awareness raising; apart from the opportunistic, localised contacts of members of the
Clinical Governance Development Team and the work around appraisal, this was also
the case at the Emerald Trust.
The provision of the necessary knowledge and skills to deliver the clinical
governance agenda is essential. The complexity of the change means that a wide
range of issues need to be addressed from the principles of clinical governance
through to the tools to deliver this agenda. This latter includes both the theoretical
and technical aspects of existing systems such as clinical audit and risk management
through to change management, team dynamics and interpersonal skills. Any
programme should be based on a thorough assessment of the education and training
needs of staff. As Firth-Cozens (1999) discovered, these requirements will inevitably
vary; it is, therefore, not prudent to assume that even senior clinicians in management
will have the same skills as senior managers without a clinical background - they
have inevitably followed a different route to the top.
Neither should it be assumed that, because systems such as risk management and
clinical audit are not new to the NHS, clinicians have the skills to undertake this
activity. This current study has highlighted this as a gap in certain areas of the Trust;
however, it has been interesting to note how the increased attention being given to
clinical audit by the clinical governance agenda has led to calls for training from front
264
line clinicians in the Trust. Similarly the increased corporate focus on appraisal has
meant that managers must now appraise all staff and this requirement has been
incorporated into their individual objectives. However, the managers must
demonstrate that they have attended training before undertaking this activity which
has led to a considerable increase in demand for training in this area - so much so that
it is proving difficult for the Trust to meet the demand in a timely manner. In
contrast, courses in clinical incident reporting, not part of the IPR, are being cancelled
because of lack of uptake. This seems to add some weight to the adage 'what gets
measured gets attention1 and highlights the need for training and development to be
linked to a robust system of individual performance review; this is yet to become
established on a Trust-wide basis.
The earlier discussion around structural issues touched on the importance of
information flows to the effectiveness of teams/groups but, as alluded to above, issues
around knowledge and skills, team dynamics and so on also play an important role.
In reality, effective teams/groups do not 'just happen' and deliberate effort needs to be
directed at facilitating this process (Dale and Cooper, 1994). Members of committees
do not automatically have the experience and/or skills to add value in these arenas
(Katz, 1993). Despite this, there is a perception amongst some interviewees that they
have been left 'to get on with it' and this seems borne out by the fact that no formal
development work has taken place with new or existing groups either as collectives or
with individual members. This is something that the Trust needs to reconsider given
the number of new groups associated with clinical governance, the existing groups
such as the Trust Board and Management Team which have, in theory, taken on new
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responsibilities, and the fact that many of the junior managers in the Primary Care
Division are new to management per se.
From Trust Board through to divisional fora there appears to be a lack of clarity
around a variety of key issues such as roles, responsibilities, accountability and
authority in relation to the clinical governance agenda. This may have serious
implications for the effectiveness of these groups. For instance, it has been suggested
earlier in this thesis that the Trust Board minutes do not provide evidence of a robust
discussion of the reports. In addition, the reports received are largely based on
routinely available data rather than the Trust Board having taken time out to decide
what information is needed to discharge its statutory duty. Until the appointment of
the facilitator to the Primary Care Division, its Forum appeared to lack direction.
Although the group had developed Terms of Reference, these did not address the sort
of issues just described. Broad based objectives had been outlined and yet the group
did not go on to develop a work programme to ensure delivery. Neither did the
Forum identify the current information systems that should report into the group or
clarify arrangements for reporting to others (upwards, downwards or laterally within
the organisational hierarchy) on a regular basis.
Essentially, it did not appear that any of the groups discussed here took time out to
work through the elements that need to be addressed deliberately to ensure
effectiveness - whether this occurred in the other five divisional groups has not been
explored. This is an important activity for all levels of the clinical governance
hierarchy: the Trust Board is ultimately accountable for quality, the Clinical
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Governance Sub-committee is responsible for steering the initiative and also for
fulfilling an assurance function; the Management Team is meant to be translating the
corporate objectives into local objectives and the purpose of the divisional fora is to
operationalise the clinical governance agenda at the front line of service delivery.
When one considers the education and training needed to lay the foundations of
effectiveness for each of these groups, this provides some indication of the likely
commitment that is needed from the organisation and challenges the notion that
clinical governance is likely to be cost neutral. It also highlights the fact that any
education and training programme needs to be carefully developed and planned,
based on needs assessment, phased and adequately resourced both financially and in
terms of appropriately experienced personnel.
The need for training was recognised in the Development Plan as was the need for the
Training and Development Group to develop a corporate training strategy in support
of the clinical governance agenda. Unfortunately, neither objective was achieved
during the research period although the Trust's experience in this respect appears to
echo that of the TQM pilot sites (Joss, Kogan and Henkel, 1994; Joss and Kogan,
1995) and also the findings of others (Katz, 1993; Davis, 1997). Awareness and
understanding are important foundations for building commitment and involvement
within the organisation. Unless the Trust takes a proactive approach to the education
and training of employees, it may find itself having to go 'back to the drawing board'
(Kanji and Barker, 1990) at a future point in time just to ensure people have even the
basic knowledge and skills. If these elements are essential ingredients for successful
implementation, it would seem appropriate for the necessary investment in staff to be
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made sooner rather than later.
9.2.8 Explicit Strategy/Resources for Recognising and Rewarding Progress
The development of mechanisms to ensure the recognition and reward of initiatives
that demonstrate both the application of total quality principles and the improvements
achieved through this process are a central feature of the TQM literature; albeit one to
which Deming (1986) does not appear to subscribe. On one level, recognition and
reward may serve as an important mechanism for rewarding achievement; at another
level, rewarding certain behaviour over others is a powerful signal of what the
organisation regards as valuable (Miles, 1997).
In practice, this is a rather complex area if one differentiates between negative and
positive quality. The former is improvement through the correction of problems,
errors, service failures and the latter is improvement which constitutes added value
(Zairi, 1994). Initiatives such as the Significant Clinical Incident Reviews are aimed
at addressing negative quality which has very different connotations and how this is
recognised needs to be handled with care. As interviews with front line staff have
suggested, it should not be assumed that the openness at the corporate level which
surrounds Significant Clinical Incidents or complaints is as evident as one goes
further down the hierarchy and closer to those individuals and groups directly
associated with the incidents themselves. Some report that there is still a desire to
keep such occurrences in-house and even within the group as opposed to any wider
dissemination within the division. The Trust is approaching this issue by trying to
emphasise the learning that has arisen from investigation of the incident but it
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inevitably remains a process that puts poor quality and sometimes individuals under
the spotlight which challenges somewhat the notions of recognition and reward.
9.2.9 Organisational Changes after Evaluation
Although certain sites developed metrics in terms of TQM activity, Joss and Kogan
(1995) found that few of the TQM pilot sites had undertaken any formal evaluation of
the implementation process itself. The Emerald Trust received a written quarterly
report of progress against specific Development Plan objectives. This seemed to
provide a comforting sense of progress which one could argue was, in part, the result
of the lack of a clear appreciation of the starting point by some senior managers
which, in turn, seems to have almost obscured the true scale and scope of the task that
lay before them. Apart from the two formal feedback points which had been
deliberately incorporated into the research process, there were no other formal
collective evaluation points scheduled to enable a review of the implementation
process as a whole. Inclusion of an internal formal evaluation might have allowed
organisational members to identify for themselves gaps in vital areas such as
organisation and individual development, the lack of a project management approach
and so on. Alternatively, without the benefit of external facilitation, it is possible that
the prevailing culture might have supported the status quo rather than promote the
adoption of approaches which may have seemed different to the way implementation
is traditionally addressed by this particular organisation.
Written feedback from the research process was first provided in December 2000; the
second and final feedback was delivered in December 2001. The first report was
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short and succinct and a large proportion of the recommendations focused on the need
for an implementation plan to guide the process. The second report echoed this but
also highlighted specific issues relating to the whole system that might benefit from
further attention. The recommendations of each report are included in this thesis as
Appendix 6 and 7 respectively.
Although the first report was presented to the Clinical Governance Sub-committee
and the Management Team, there did not appear to be any subsequent in-depth
discussion of the findings and neither was an action plan developed to address its
recommendations. According to Hart and Bond (1995), this is not uncommon; but, at
least in this case, the research was allowed to continue. In contrast to the first report,
the second was almost a formality in that the issues raised had already been fed back
to key individuals and groups over the preceding period. In this way, there was little,
if anything, in the final document that had not previously been brought to the
attention of the Trust prior to publication. Most of the recommendations reflected the
gaps highlighted in this and the previous three results chapters; many were
subsequently addressed in the clinical governance plan which was a central feature of
the Trust application for PCT status.
It is difficult to say whether what appeared to be a greater acceptance of the feedback
second time round was because the message was presented in a manner more in
keeping with the Trust culture, whether the content was more acceptable or whether
the Trust had just got used to the messenger - perhaps it was a combination of all
three elements. However, irrespective of notions of the message and messenger etc,
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one message to the Trust was clear - change needs to be actively managed - even
more so in the face of the massive structural change that was about to take place as
the organisation moved towards PCT status.
9.3 KEY MESSAGES FROM THE EXPERIENCE OF EMERALD NHS
TRUST
Patton (2002) warns qualitative researchers against the temptation of making
excessive claims as to the generalisability of their results arguing that, in the past, this
has fuelled the arguments of those intent on criticising qualitative methodologies. I
have also taken note of Spurgeon (1999) who emphasised the fact that
transformational change is highly context-specific; Lane (1987) who warns that
recipes for successful implementation can seem deceptively simple and thus enticing
to the unwary and 0vretveit (1999) who suggests that it is the principles that are more
likely to be transferable rather than specific programmes of quality improvement.
Given the insights cited above, it is with extreme caution that I approach the task of
identifying 'lessons' from this case study. My aim has been to provide enough 'rich
description1 of one Trust's clinical governance journey to enable the reader to
compare Emerald with their own experience or the experience of other authors and/or
to make their own evaluation if minded to do so. Nevertheless, I would like to offer a
number of observations arising from this case study that will certainly inform my own
future work in the area of change management in general and clinical governance in
particular.
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9.3.1 Learning from the Past
The research completed almost a decade ago into the implementation of TQM in the
NHS (Joss and Kogan and Henkel, 1994; Joss and Kogan, 1995) and in Norway
(0vretveit, 1999; 0vretveit and Aslaksen, 1999) has provided valuable information
about the challenges faced by complex health care organisations as they attempt to
introduce a whole systems approach to quality management and improvement. It is
positive to see that certain key recommendations arising out of the earlier work in the
UK is reflected in the more recent thinking around clinical governance (Department
of Health, 1998; 1999). In addition, insights from of these earlier research projects
have also informed this most recent case study into the implementation of clinical
governance.
The factors outlined in Joss and Kogan's framework (1995) (Table 9.1) have served
as a useful heuristic for shaping the discussion contained within this chapter. This
framework has been used as an organising mechanism which has enabled me to
highlight and discuss not only the positive work undertaken by the Trust but also to
present what I consider to have been gaps in the implementation effort, both end state
and process. Deciding whether the Trust approach has been a success or failure is
beyond the scope of this research as the design was essentially formative rather than
summative. However, there is evidence of sub-implementation and even non-
implementation; the former in that the Trust did not deliver against some of its own
objectives for clinical governance implementation (training and development as an
example). An example of non-implementation was the prolonged lack of deliberate
activity around the implementation of clinical governance in one of the divisions.
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Perhaps a fair assessment of the Trust approach would be to say that it has made an
important start but still has a long way to go; in that respect, the organisation probably
has much in common with other NHS Trusts.
The action research process provided the Emerald Trust with a series of
recommendations for addressing the gaps highlighted in this and previous chapters
(Appendix 6 and Appendix 7). What should perhaps be of a more wider concern is
that many of the issues that seemed to get in the way of this Trust's progress have
much in common with the numerous pitfalls identified in the general literature review
on TQM (Chapter 3) and also in the UK and Norwegian experiments (Joss and
Kogan, 1995; 0vretviet, 1999). Thus, although clinical governance might be a newer
concept, many of the challenges to successful implementation are not. With regard to
TQM, these unresolved challenges have apparently led to partial implementation
(Kolesar, 1995; Yong and Wilkinson, 1999). Consequently, the concern is that that
the manner of introduction may ultimately detract from what could be achieved
through full implementation of the concept and philosophy (ibid, 1999). These
concerns are expressed in relation to TQM but it is easy to see how they may also be
applicable to the implementation of clinical governance.
Thus, it seems the NHS has much to learn from the past if it is not to succumb to the
'collective amnesia' described by Klein (1998) and risk repeating the same mistakes
as others; behaviour which some aspects of the Emerald Trust experience appear to
demonstrate only too well.
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9.3.2 A Study of Implementation - A Study Of Change
Jenkins (1978, p203) states unequivocally that 'a study of implementation is a study of
change' and it would seem important that this notion is kept to the fore of any
implementation effort. Whole system change is extremely complex and there is a risk
that the central theme of change may become lost in the subsequent activity. In the
case of clinical governance, the nature of the change required for implementation is
essentially transformational in nature as, for most organisations, it is a frame-breaking
concept; nevertheless, this does not exclude incremental improvement within this
transformational framework. This realisation is important so that the scale and scope
of the change effort likely to be involved may be appreciated and the energy,
resources and the timescale needed to move from the present to the future state
accurately assessed.
The effective leadership of transformational change is undoubtedly important but
arguably not enough in itself. The creation of the vision, the shaping of values and
beliefs are essential for mobilising and sustaining the workforce but change and
quality also need to be managed, neither will just happen (Oakland, 1995; Kotter,
1996). If the objectives within the clinical governance agenda are to be achieved, the
organisation must pay attention to each element of the management process and
managers at all levels need to have the knowledge and skills (as well as the other
resources) to deliver their objectives. The demands of delivering total quality and
transformational change quickly highlight the development needs of organisations,
teams and individuals. Given the scale of the intervention required to implement
clinical governance, it would also seem that the discipline of a project management
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methodology could serve as a considerable source of added value.
9.3.3 Clarifying the 'What' of Implementation
It would seem, from the early policy documentation (Department of Health, 1997,
1998, 1999), that clinical governance was not fully formed as a concept when it was
first presented to the NHS. As indicated previously, this is not uncommon and the
detail often emerges during the implementation process (Klein, 1998). However, as
Wolman (1981) has indicated, the likelihood of successful implementation is not
merely a function of the implementation process but is also influenced by factors that
originate further 'upstream1 during the policy formulation process itself. Whilst it is
important to recognise the role of local context (Spurgeon, 1999), it is perhaps
worthwhile questioning whether, in the case of clinical governance, conceptual
development upstream could have been taken further before its presentation to the
NHS.
Although clinical governance resonates with the language of TQM and the goal of the
initiative is CQI, the policy documentation somehow stops short of making the link
totally explicit. Although TQM might be implied, the lack of clarity around clinical
governance as a concept leaves space for local interpretation of the concept itself
rather than limiting the scope of this interpretation to decisions relating to the
customisation of the principles. As is evident from TQM, interpretations may range
from a philosophy for running the business to a particular quality programme
(Witcher, 1995); these constitute very different ends of a spectrum which would
require very different approaches to implementation.
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The Emerald Trust has conceptualised clinical governance as a vehicle for learning;
however, this is not automatically synonymous with either quality improvement per
se or the delivery of a comprehensive, integrated framework for CQI. The efforts of
the Trust during the period of the research seem to reinforce this; although the
initiatives introduced were positive steps, attempts to integrate the individual
approaches were far more problematic. This seems largely due to the Trust's
conceptualisation of clinical governance which led to a design which aimed to deliver
a vision of learning rather than CQI. In addition, designing a whole system approach
to CQI is challenging; as the earlier literature review in Chapter 3 has demonstrated,
TQM and CQI are not underpinned by a uniform set of principles nor are they
accompanied by tried and tested recipes for implementation. Thus it is unwise to
assume that managers have an in depth knowledge of TQM or CQI by virtue of their
position in management. I am able to confirm this through my own experience - it is
one thing talking about TQM and CQI at a conceptual level, it is quite another to get
past the "buzzwords' and translate the concept into something tangible that can be
operationalised in the real world.
9.3.4 Implementation Frameworks to Deliver the 'What' and the 'How' of the
Change Process
Motwani and colleagues (Motwani, Sower and Bashier, 1996) have drawn attention
to the general lack of adoption of formal frameworks to guide the implementation of
total quality in health care. Thus it appears that the Emerald Trust is not unusual as
there was no evidence that such an approach was adopted by this organisation either.
Each of the three results chapters and the previous sections of this current chapter
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have highlighted a number of significant gaps in both the 'what' or end state
objectives and also the 'how' or process objectives in the Trust approach to
implementation. Thus, in keeping with Yusof and Aspinwall's (2000a) argument that
implementation frameworks force managers to take a comprehensive rather than
selective approach to all elements, it is the contention of this writer that the
implementation efforts of the Trust could have been augmented significantly if
frameworks to guide both the 'what' and the 'how' of clinical governance had been
utilised. It is also acknowledged here that a single framework is unlikely to provide
all of the answers (Elmore, 1978; Lane, 1987) which points towards the use of more
than one as the following discussion will demonstrate.
Although it is appreciated that clinical governance has not been explicitly defined as
TQM in the Department of Health documentation (1997; 1998; 1999), the author
found sufficient similarity to use Oakland's work on total quality (1995) as a tentative
guide to possible design elements of a whole system approach to quality improvement
under a clinical governance umbrella. Even recognising that some of the tools and
techniques may vary if the Trust had utilised such a framework, the principles of
TQM and CQI might have been more apparent and the implementation design more
appropriate for the delivery of an integrated whole system approach to continuous
quality improvement. In order to realise this goal there needed to be a greater
emphasis on the improvement of key processes, clear initiatives to engage the users of
the service, structures and a supporting infrastructure from the corporate level through
to the operating core to provide the vehicles for quality and clinical governance to
take place in practice. Instead, there is the situation where, although important
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quality improvement initiatives have been introduced, there is a risk that they will
remain as individual initiatives rather than elements within the integrated whole.
A framework for the 'how' of implementation was based largely although not
exclusively on the Miles framework (1997). This framework served as a very useful
guide to the management of change; part of its attraction lay in its conceptual clarity
and also in the successful integration yet differentiation of the dual aspects of
implementation - end state and process. It has been seen from the discussions in
Chapters 2 and 3 that differentiation between the two is not always made explicit in
the literature and from the evidence of this case study, neither does this necessarily
happen in practice.
Just as the 'what' elements need to be made explicit, so do the 'how' elements. A lack
of clarity around the implementation process, particularly in terms of the scope and
scale of change required to establish clinical governance, may lead to insufficient
emphasis being given to significant elements or even to them being overlooked
completely as happened in some areas of the case study. An important theme within
each of the change management frameworks that have informed this inquiry has been
the notion of wholeness and its relationship with the success or otherwise of the
change initiative; omissions are likely lead to failure (Kotter, 1996; Miles, 1997;
Pendlebury, Grouard and Meston, 1998). Adoption of a framework such as the one
proposed by Miles (1997) could have alerted the Trust to a number of important gaps:
the lack of a communication strategy to support the implementation process, an over-
reliance on the Clinical Governance Lead to provide support, facilitation and co-
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ordination of the entire process across the whole organisation, the lack of an
organisation development programme and so on.
The notion of wholeness referred to above does not mean that everything should
happen at once but emphasises the need for deliberate phasing of activity. Phasing in
turn does not imply a piecemeal approach but instead a deliberate and dynamic
orchestration of all components to achieve internal alignment; the scope of this will
vary depending on the resources available (Miles, 1997). A lack of deliberate
intervention in the system such as that just described is one of the factors that leads to
the sort of piecemeal introduction of initiatives observed by Kolesar (1993) and Yong
and Wilkinson (1999) and there is also evidence of this in the approach of this case
study site.
Finally, frameworks should not be regarded as a recipe for success; as Lane (1987)
has warned, they can seem deceptively simple to the unwary. Successful application
requires knowledge and skills in relation to change and change management.
According to the literature and from the findings of this case study, it seems unwise to
assume that either will be found automatically in every level of the management
hierarchy. Frameworks should not be seen as a way of providing the answer to
implementation but instead as a mechanism for organising the questions. Careful
utilisation may ensure that any omissions are the result of a considered phasing
decision rather than a design element that has been overlooked.
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9.3.5 Culture Matters
The reader may, at this point, be wondering why, given this was an action research
project, these frameworks were not proposed by the researcher. Essentially, the key
recommendations of the first report drew attention to the need for a CQI model and
an implementation plan but the response from the Trust was clear:
'(The Clinical Governance Lead and the Chief Executive) would argue
with respect to the 'quality models' and pointed out that they would be
difficult to convince about adopting quality models'.
We don't go big on implementation plans and documentation. That's

not how we do things here and you (the researcher) won't change us'.
The above was interpreted as 'that's not the way we do things here1. Instead of trying
to impose a preferred approach, the researcher worked around this issue and used the
frameworks to guide her own work which then led to recommendations for future
action based on the areas illuminated by the frameworks selected. So, although the
frameworks were not used explicitly by the Trust, they have indirectly contributed to
its implementation approach.
This reluctance to use frameworks and models highlights an interesting aspect of
culture. The need for culture change in relation to clinical governance is expressed so
often it has almost become a mantra; however, this seems to be expressed most often
with reference to clinicians, for example, the need to adopt evidence-based practice.
Yet the notion of culture change also applies to managers who, it seems, need to be as
wary as their clinical colleagues of the neutralising force that the prevailing culture
may exert on new initiatives (Bate, 1994). This may be particularly evident in
successful organisations which continue to apply tried and tested formulae to
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innovations such as clinical governance which may actually require very different
ways of managing the business.
The clinical governance agenda brings a more explicit emphasis on openness, probity
and accountability not only to the clinical quality of services but, in a broader sense
which is partly the governance element, it also includes the quality of business
management. Thus, in this sense, frameworks that offer what Anderson and
Ackerman-Anderson (2001) describe as an organising vehicle for decision-making
rather than a prescription for action could allow an organisation to demonstrate not
only that a systematic approach to implementation is being adopted but also the
rationale for the design of both the 'what' and the 'how' of the initiative. With the
advent of corporate and clinical governance, managers may also need to look at their
practice and make changes accordingly in pursuit of increased effectiveness -
irrespective of whether this represents a departure from previous ways of managing.
9.4 LIMITATIONS
This was an ambitious study for a new researcher in a number of ways. It focuses
initially on the corporate and then divisional level and therefore includes breadth as
well as depth. An action research approach posed additional challenges given the
lack of clarity around the policy at the centre of the research process. Also, from past
experience (Latham, 1996), I was well aware that the use of qualitative methods may
precipitate the 'real research' debate. Despite these challenges, it is proposed that this
study makes a significant empirical contribution to the slowly emerging research into
clinical governance and its implementation. However, there are a number of
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limitations which will now be considered.
As highlighted in Chapter 5, action research may be regarded as something of a
continuum with a consultancy-type model at one end and a democratic, co-researcher-
type model at the other; this work sits nearer the consultancy end of the continuum.
Consequently, there is a flavour of the research having been 'done to' rather than
'done with' the organisation. This was a conscious design decision in light of an
important constraint - the time available to the researcher; hence, intervention in the
organisation was generally confined to the provision of feedback. Whilst the Trust
considered this to have been beneficial, a more facilitative approach might have made
a greater impact in terms of moving the implementation process forward. A co-
research approach in which the host played a more active part in the research process
might have secured greater ownership of the feedback which appeared to be
something of an issue at the outset.
The focus of the study initially rested on the corporate level and, whilst still keeping
the corporate level in view, attention was extended to one of the divisions. The
intention was to gain an overview of clinical governance as it was being
operationalised further down the hierarchy and nearer to the front line of service
delivery. Whilst this was achieved, it threw a spotlight on non-implementation which
was of value to the research process but, as the other divisions were not also studied
as closely, there is a risk that this is perceived as indicative of the state of clinical
governance implementation at divisional level across the Trust as a whole. The initial
rapid appraisal suggests that this was not the case although it was true that the other
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five divisions were at different stages of implementation. Unfortunately the research
design did not permit any subsequent work of any detail with divisions other than
Primary Care.
Joss and Kogan (1995) recommend that studies of this kind should be conducted over
as long a period as possible given the nature of a total quality initiative itself and the
scale of change required for implementation to take hold. Although this study took
place over a period of 18 months, the focus only specifically incorporated the
Division for the last six months. This was rather unfortunate as, during this period,
the local Forum was really still in the forming stage and rather lacking in direction
until the arrival of the facilitator whose early interventions appeared to promise
progress. Unfortunately, it had not been anticipated that there would be such a delay
in the setting up of this Forum so the research process ran out of time before it could
really capture movement at the local level.
Finally, a single case design may be regarded by some as a limitation in itself;
however, that surely must depend on how it is used subsequently. It has not been the
intention here to provide a universal prescription for others to follow given that the
implementation of clinical governance is likely to be of such a highly context-specific
nature. Instead a rich description is offered; this highlights the issues facing a real
organisation as it attempts to implement a concept whose inherent complexity is
increased by what might be perceived as a lack of conceptual development on the part
of the Department of Health. The rich picture in terms of the 'what' and the 'how1 will
allow practitioners to uncover similarities with their own efforts and the
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recommendations from the reports to the Trust indicate how gaps may be addressed
(Appendix 6, Appendix, 7). This study also provides a comprehensive account of
method and results which may help others intending to undertake similar research
within this arena.
9.5 FURTHER RESEARCH
The earlier view of the clinical governance literature presented in Chapter 2
highlights the fact that empirical work in this field is emerging slowly. Thus there
seems to be immense scope for further research into what is essentially 'new territory'.
In considering a possible focus for further work, it is worth noting the comments of
those who have been involved in researching TQM. Joss and Kogan (1995) and
Yong and Wilkinson (1999) make similar points in that, because of the different ways
in which TQM is interpreted, it is difficult to know what is actually being
implemented even though organisations may say (or think) they are implementing
TQM. In light of this, Black and Porter (1996) suggest that instead of trying to
capture convenient taxonomies what is required are more case studies which focus on
the practical experiences of organisations.
The observations above could also be applied to further research into clinical
governance. Clinical governance is a complex construct; there is no universal
blueprint either in terms of content or implementation and the Department of Health
approach has encouraged local interpretation. Dewar (1999) has described clinical
governance as being 'under construction', but it is perhaps more accurate to think of
this as being 'under local construction'. For this reason, there is a real need to
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understand how clinical governance is being conceptualised by NHS Trusts (the
'what') and also to identify the processes by which the policy is being implemented
(the 'how'). This would seem to suggest that additional descriptive case studies such
as that of the Emerald Trust would be desirable. Given the current absence of an
evidence base to support the notion that clinical governance will actually deliver
quality improvement (Goodman, 2002; Thomas, 2002), in depth case studies might
also be seen as an essential precursor to future attempts to establish the effectiveness
of clinical governance as policy.
The apparent emphasis on the whole system which the above discussion implies does
not preclude research into the various component parts which make up this complex
agenda. There is likely to be value in following research themes across organisations
such as the strategies, structures, systems and processes introduced; the roles of key
actors and in particular clinical governance leads, Trust boards and so on. However,
it should be remembered that at the core of clinical governance is the language and
rhetoric of a whole system approach to continuous quality improvement which is a
goal that requires the strategic alignment of all components and not merely the
summation of its parts. To capture this, one surely needs the kind of rich picture
provided by the case study.
9.6 CHAPTER SUMMARY
The focus of this chapter has centred on providing a review of the results arising from
the research process. Once again, faced with a rich picture from the field, a framework
has been utilised to shape the subsequent discussion. This time it is a framework
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derived from the evaluation of an experiment to implement TQM in the NHS over a
decade ago. Using this as a vehicle it has been possible to highlight areas of progress in
relation to clinical governance at the Emerald Trust and also gaps in both the content
and the process of implementation. Arising from this discussion, a number of key
messages are offered for the consideration of practitioners and researchers alike. The
limitations to the study are presented; and finally, suggestions for further research
proposed. Concluding comments are reserved for the final chapter which now follows.
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CHAPTER 10
CONCLUSION
'Those that cannot remember the past are condemned to repeat it'
(Santayana, 1905)
This thesis has been based on an action research project which has followed the
experience of one NHS Trust as it attempted to implement clinical governance.
Implementation may be conceptualised as both a change process and an end state; to
capture this duality, two broad research questions have been posed namely: what
constitutes the local clinical governance agenda (content) and how has clinical
governance been implemented (process). Given that the main purpose of these research
questions is to explore and describe, an overarching qualitative framework has been
adopted to guide this study. Data collected using a range of qualitative methods has
been presented in three earlier chapters: 6, 7 and 8. In these chapters, the readers may
find a rich picture of Trust progress in relation to the clinical governance agenda which
has been clearly differentiated in terms of both the what/content and the how/process of
implementation.
There are some who would say that the implementation of TQM is the most complex
activity an organisation can undertake (Kanji and Barker, 1990) and those tasked with
the implementation of clinical governance may say the same about this recent initiative.
The research evidence suggests that the Trust has succeeded in moving the clinical
governance agenda forward in terms of both content and process on a number of fronts;
sometimes these efforts have been constrained by the existing corporate culture and
287
other initiatives have been introduced which have signalled a definite change in 'the
way we do things here'. Significant gaps in the Trust approach have also been
identified during the course of the research process which have related to
implementation once again in terms of both content and process issues. However, the
organisation has addressed a number of these both in real-time during the life of the
project and has also incorporated many of the research recommendations into the
clinical governance plan for the new Primary Care Trust.
It has been argued earlier in this thesis that the effectiveness of policy implementation
is influenced by factors originating both upstream during formulation and downstream
during implementation; apparently deficiencies in the former are least likely to be
acknowledged (Hogwood and Gunn, 1984). Gaps in the implementation process have
been referred to above and elsewhere within this thesis. Whilst it is seemingly not
uncommon for the detail of a new policy to emerge during the implementation process,
this approach seems to have contributed to a lack of clarity in the field; the early
clinical governance literature attests to this with contributors trying to make sense of
the concept. It would appear that leaving the field to interpret the concept is very
different from leaving space for local interpretation of the design elements. The risk is,
as in the case of the Emerald Trust, that it will not be interpreted as CQI and alternative
conceptualisations will bring different goals and organisational designs. For instance,
the Trust focus on learning is different from a CQI focus; the former has brought,
amongst other things, an emphasis on negative quality and seen the creation of more
library facilities; the latter is intended to deliver an approach which results in the whole
organisation being aligned in support of natural work teams addressing both the
288
positive and negative aspects of quality.
Implementation is the most difficult aspect of change. Klein (1998) warns against
allowing the challenge of new policy to divert attention from the fact that there are
lessons to be learned from the decades worth of difficulties governments have
experienced with the quality agenda. To reinforce this view, it is worth noting that
most, if not all, of the gaps identified in the Emerald Trust's approach to
implementation have been seen before as the chapters reviewing the literature on total
quality management and change demonstrate quite clearly. On a more positive note,
the Emerald Trust has learned from its experience and sought to address the earlier gaps
in the implementation process. There is also evidence that the recommendations from
previous research (Joss, Kogan and Henkel, 1994) seem to have been heeded and are
reflected in the upstream formulation of clinical governance as policy.

*
Whilst clinical governance might be a new concept, the underlying principle of CQI
most definitely is not. In fact, one could be forgiven for thinking that clinical
governance was TQM by another name; an 'old wine in a new bottle' (Asubonteng,
McCleary and Munchus, 1996) or perhaps, more appropriately given the context, an old
medicine with a new prescription. It has been argued that business approaches to
quality are hard for the NHS to swallow (Pollitt, 1996) and so it will be fascinating to
watch whether the new prescription (clinical governance) proves easier to tolerate. The
Chief Medical Officer (Donaldson, 1998) is in no doubt that this remedy is needed as
289
the following reference to the 'Bristol Case' demonstrates:
"The spectre of bereaved parents picketing the General Medical Council

•with cardboard children's coffins was a harrowing sight. Through
clinical governance the NHS has the opportunity to make a major leap
forward in the prevention of such catastrophes so that history is never
seen to repeat itself and public confidence is sustained'.
Clinical governance is described as the 'linchpin' of the quality strategy for the NHS
(Department of Health, 1999; p4); whether it will successfully deliver the proposed
agenda, it is perhaps too early to say. What seems clear in the meantime is that unless
NHS Trusts recognise the magnitude of the change involved in implementing clinical
governance, unless these organisations understand exactly what it is they are meant to
be taking forward and unless the knowledge and skills around total quality and change
management are actually present in these organisations, the odds may be more in
favour of Goodman's assessment of clinical governance as 'empty phrases' (1998)
rather than that of Scally and Donaldson (1998) who paint a more positive picture 'of
the big idea that has shown that it can inspire and enthuse'.
oooooOOOOOooooo
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APPENDIX 1: IMPLEMENTATION TYPOLOGIES
Appendix la: Implementation typologies
Five steps to implementation (Glover, 1993)

1. Awareness 2. Education 3. Structural change 4. Necessary activities 5. Expected
improvements
Leadership Leaders TQM design Empowerment •
Employee ownership
Review of options Middle managers Steering committee Participation
•
Productivity and
Seminars, books Supervisors Quality teams Consensus
quality
Planning session Employees Revised information system Harmony
Selection of change agent Facilitators Facilitation process Measurement
• Consumer satisfaction
Readiness survey QT leaders Fact-based problem solving• Market share and
Involvement of union Continuous improvement demand
• Improved goals and
financial performance
Seven steps with project management Implementation framework for SME - 10 steps Stages of implementation (Kanji and Barker,
(Stamatis, 1994)_____________ (Ghobadian, Gallear, 1997)___________ 19900
1. Energise the organisation 1. Recognition of the need for the introduction of 1. Identification and preparation
2. Change the culture of the organisation TQM
3. Define the scope of your commitment 2. Developing understanding among management and 2. Management understanding and commitment
4 Identify key process and product variables supervisors
5. Implement SPC Establishing goals and objectives of the quality
6. Incorporate process improvement activities in the improvement process
organisation Plan the TQM implementation 3. Scheme for improvement
7. Assess the quality improvement in the organisation Educate and train all employees
Create a systematic procedure
Align organisation 4. Critical analysis
Implement the TQM concepts
Monitor the implementation of TQM concepts
10. Engage in continuous improvement by going back
to step 3
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Appendix 1 b: Implementation typologies
Process for designing and implementing a CQI strategy (Rand, 1994) TQM implementation (Oakland, 1995)
Three key phases: Initial steps following one day seminar for top management (links in with
commitment, communication, culture - see text):
1. Exploration and design
• Review mission, values and culture • Formation of quality council (top management team)
• Review theories, models and techniques • TQM attitude survey
• Select a framework profile of organization
• Gap analysis quality costs
• Develop model: principles, process, support strategies strengths/weaknesses
• Design organizational accountabilities • 2 day strategic planning workshop (quality council)
charter
2. Implementation mission statement
• Establish goals and plans quality policy
• Communicate - CSFs
• Educate Critical processes
• Implement model Implementation action plan
• Measure • Formation of process quality teams and/or site steering committees
• Reward and recognise • Teamwork seminar for quality council (may precede strategic planning
workshop)
3. Sustain • Identify team facilitators
• Measure and celebrate • Run specific training and team-forming workshops
• Revise model • Company-wide awareness training on customer/supplier interfaces
• Revise organizational accountabilities • Implementation/improvement projects for quality deployment
• Revise reward system quality costing
customer/supplier framework
- DPA
Systems
Techniques
• Feedback/follow-up workshops throughout implementation_______ _
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Appendix Ic: Implementation typologies
Dale and Boaden 1994
Organizing Tools and techniques Measurement & feedback Culture change
Long term strategy for quality Identification of applicable tools and Key internal and external performance Assess the current status of
improvement formulated and integrated techniques at each stage of QI measures identified, defined and organizational culture before developing
with other strategies; developed plans for change
Quality improvement plans developed
Definition of quality, TQM, and QI Training in the use of tools and On-going discussion with customers Recognise the ongoing nature of culture
developed and agreed techniques, for the right people at the about expected performance change and the need to outline specific
right time culture changes
Identification of sources of advice Use of a formal quality system Benchmarking once QI is under way Plan change consistently and
incrementally
Choice of approach to TQM Identification of other systems and Means for celebration and Recognize the role of people as an asset
standards that may be required by communication of success and teamwork
customers or legislation developed
Stages of improvement activity Identification of key business processes Consideration of the link between results Consider the inter-relationships of all
identified, taking the starting point into and improvement based on these from QI and rewards activities within the organization in order
account processes to minimize conflict
Vision and mission statements developed Means of assessing the progress towards Consider the national and local culture
and communicated to all members of the world-class performance; eg EQA,
org MBNQA
Formal programme of education and
training for al members of the
organization
Organizational infrastructure established
to facilitate local ownership of QI
Teamwork established as a way of
working and part of the infrastructure
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APPENDIX 2: FRAMEWORK FOR TRANSFORMATIONAL CHANGE
(Adapted from Miles [1997, p6])
Generating energy
• Confronting reality
• Creating and reallocating
resources
• Raising the bar
• Modelling desired behaviors
Process architecture \
Vision
• Education
• Involvement Transformational Visioning
• Co-ordination Leadership Business modelling
• Feedback Analyze total system
• Communication Focus on Transformation
• Support Initiatives (TI's)
Aligning the organization

The TIs (The 'what')
• Vision & Strategy
• Restructuring • Structure
• Implement infrastructure • Systems & processes
• Reshape culture • People
• Build core competencies • Culture
294
APPENDIX 3: EIGHT STAGE PROCESS FOR CHANGE
(Adapted from Kotter, 1996)
1. Establish a sense of urgency
2. Create the guiding coalition
3. Develop a vision and a strategy
4. Communicate the change vision
5. Empower employees for action
6. Generate short-term wins
7. Consolidate gains and produce more change
8. Anchor new approaches in the culture
295
APPENDIX 4: TEN KEYS TO EFFECTIVE CHANGE
MANAGEMENT (Pendlebury, Grouard, Meston, 1995)
1. Defining the vision
2. Mobilising
3. Catalysing
4. Steering
5. Delivering
6. Obtaining participation
7. Handling the emotional dimension
8. Handling the power issues
9. Training and coaching
10. Communicating actively
296
APPENDIX 5: ACTION RESEARCH - A MODEL FOR
PRACTICE (Adapted from Bate, 2000)
297
APPENDIX 6: RECOMMENDATIONS - ACTION SET 1
FIRST REPORT & FEEDBACK TO THE TRUST

December 2000
The trust is asked to consider the following action points:
1. Clarify and make explicit the model(s) of quality (QA/CQI) underpinning the
trust approach to clinical governance and ensure that the trust clinical
governance framework is congruent.
2. Distil the trust's vision for clinical governance into a short, concise paragraph
that is meaningful, likely to engage the organisation at all levels (clinical and
non-clinical staff) and convey clearly the trust aspirations. This should then be
communicated in a comprehensive and sustained manner internally and
externally and modelled at every opportunity.
3. The current clinical governance development plan offers a valuable outline of

the Trust's short term objectives for clinical governance. As it is now almost 12
months since the plan was published, a review is recommended in light of the
progress already made by the Trust and the comments contained in this paper.
The Trust's house style is recognised and it is acknowledged that the Trust will
need to strike an appropriate balance between central direction, prescription vs
letting the trust find its own way, local freedom. However, for the purpose of
Trust-wide implementation, given the size and nature of the agenda and the
varied and developing experience within MT, we believe that it is important that
the plan should serve as a map which addresses the following:
clear aims and objectives with short and long term milestones;
structures in place throughout the organisation accompanied by clear terms
of reference;
supporting infrastructure;
- clear roles, authority and responsibilities, accountability, co-ordination
arrangements;
individual, team (corporate, MT, clinical, improvement teams) and
organisational training and development needs specific to the quality
management/leadership and innovation agendas;
- sources of support and facilitation (internal and external);
- communication strategy;
resource implications of plan.
4. Re-launch clinical governance highlighting recent quality improvement

initiatives (large and small scale) that will illustrate clinical governance in action
eg: ?lung cancer pathway, hospital at home, SCI, other.
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APPENDIX 7: RECOMMENDATIONS - ACTION SET 2
SECOND REPORT & FEEDBACK TO THE TRUST
December 2001
1) It is recommended that the Clinical Governance Sub-committee gives

consideration to the development of an implementation plan that will not
only make explicit but also integrate all aspects of the implementation
process.
2) It is recommended that the current Terms of Reference of the Clinical

Governance Sub-committee are reviewed, the focus of its monitoring
remit (strategic/and or operational) made explicit.
3) It is recommended that the present clinical governance framework is

reviewed in terms of content and coverage to ensure that it reflects the
monitoring remit of the Clinical Governance Sub-committee.
4) It is recommended that the collective development needs of the Clinical

Governance Sub-committee are identified and addressed accordingly.
5) It is recommended that the role and membership of the Best Practice

Development Team are reviewed .
6) It is recommended that the collective development needs of the Best

Practice Development Team are reviewed and met accordingly.
7) It is recommended that the focus of the Risk Management Team's

monitoring remit is made explicit and that the current data set is
reviewed in terms of content and coverage.
8) It is recommended that consideration is given to the merits of appointing

to an operational risk management role in support of the Clinical
Governance Lead, the Risk Management Team and also to provide
specialist support to the directorates/divisions.
9) It is recommended that consideration is given to the development of a

dataset to facilitate regular, collective monitoring of existing training and
development initiatives.
10) It is recommended that consideration is given to the 'cultural' aspects of

accessing library resources and to overcoming 'cultural' barriers to
access in particular.
11) It is recommended that the collective and individual development needs

of the Trust Board are identified and met accordingly.
12) It is recommended that a review of both internal and external

communications is undertaken and the development of an integrated
communication strategy considered.
299
13) It is recommended that an explicit and on-going communication plan is
developed to support the Trust-wide implementation of clinical
governance.
14) It is recommended that current arrangements for training provision in

relation to risk management and its components are reviewed - in the
short term to address the issue of attendance and in the longer term to
inform the development of the Trust training and development strategy.
15) It is recommended that a formal response to Significant Clinical Incident

Review reports from each of the Trust divisions is incorporated as a
feature of the post review audit process.
16) It is recommended that the Significant Clinical Incident Review process

is integrated within the wider risk management process of the Trust.
17) It is recommended that the current mechanisms for reporting clinical

effectiveness and audit activity are reviewed and this information is
incorporated into the regular clinical governance reporting framework.
18) It is recommended that an explicit Trust clinical audit programme is

developed which makes explicit both corporate and divisional priorities
and serves as a framework against which progress may be monitored and
opportunities for synergy identified.
19) It is recommended that consideration is given to the inclusion of a

representative of the IM&T function to the membership of the Clinical
Governance Sub-committee.
20) It is recommended that information on progress against clinical

governance-related aspects of the IM&T action plan is incorporated into
the regular clinical governance reporting framework.
21) It is recommended that consideration is given to the incorporation of the

management and reporting arrangements for user involvement into the
mainstream management arrangements of the Trust.
22) It is recommended that information on the progress of user involvement

initiatives is incorporated into the regular clinical governance reporting
arrangements.
23) It is recommended that the current arrangements through which the

Human Resource issues inform the clinical governance agenda are
reviewed and action taken to achieve greater integration.
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APPENDIX 8: A SELECTION OF INTERVIEW
SCHEDULES / GUIDES
APPENDIX 8a: INTERVIEW CHIEF EXECUTIVE - OCT 2000
1. What do you see as the main objective of clinical governance
2. What changes do you expect to see in the way that the trust works when clinical
governance is embedded
3. If a junior member of staff wanted to know what the trusts vision for clinical
governance is; where would they look it up
4. Accountable officer - what does this mean in practice
5. How did the development plan come into being (involvement)
6. How does the development plan relate to the business plan
7. What is the mechanism for implementation of the development plan (co

ordination, leadership)
8. How is the implementation process being monitored
9. What systems are in place to deliver clinical governance
10. How is the clinical governance agenda communicated to the trust
11. Have the directorate managers had any specific training in relation to clinical
governance
12. Culture change - specific initiatives aimed at this
13. Quality circles
14. What does the trust do particularly well/What could be improved
15. What helps deliver the service/What gets in the way
16. What needs to happen next
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APPENDIX 8b: INTERVIEW TRUST CHAIR
1. What do you see are the main objectives of clinical governance
2. Key elements of clinical governance
3. Newness
4. Your role as Chair
5. Role of trust board
6. Clinical governance - statutory duty for quality - has that made a difference to
the way the board operates, business of the board, thinks about its role and
responsibility (SCI reviews - quality issues explicit)
7. Preparation and training for members; assessment of awareness/understanding

of the implications for them - particularly non-execs
8. Key priorities for the trust in relation to clinical governance
9. How were these determined; role of the trust board in relation to this
10. Systems in place to deliver the clinical governance agenda; systems needed
11. What information tells you that these systems are working effectively
12. Role of clinical governance sub committee
13. Challenges facing the trust in the implementation of clinical governance
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APPENDIX 8c: INTERVIEW CLINICAL GOVERNANCE LEAD - OCT
2000
1. Tell me a bit more about your role in relation to clinical governance
2. Has this changed over time, how
3. Cultural emphasis in the trust; what interventions have been directly aimed at
changing culture
4. Development plan; implementation and monitoring processes
5. Strategic role of clinical governance committee; how is the operational function

discharged
6. Rationale for elements in the clinical governance reporting framework
7. Progress of the Serious Clinical Incident Investigations
8. Overall progress in implementing clinical governance agenda
9. Next steps
303
APPENDIX 8d: INTERVIEW DIRECTOR OF FINANCE - OCT 2000
1. Please tell me about your responsibilities within the trust
2. What do you see as the main objective of clinical governance
3. How is clinical governance different to other quality initiatives
4. What's happened so far around clinical governance in the trust
5. What has been your role in that
6. Where is the trust up to with its development plan
7. Links with business plan
8. Financial implications of clinical governance
9. Implications of clinical governance for managers
10. Rhetoric of policy - raise profile of quality over activity and finance
11. Is this feasible - how could it be achieved
12. Links with controls assurance
13. What needs to happen next
304
APPENDIX 8e: INTERVIEW NON-EXEC DIRECTORS - OCT 2000
1. Can you tell me what you see are the main objectives of clinical governance
2. What differences do you expect to see in the way the trust works when clinical
governance gets to be part of the way things happen
3. Can you think back over the last 18 months and describe what the trust has done
to take the agenda forward
4. If you were asked by a D grade nurse to explain the Trust's vision of clinical
governance what would you say; where would s/he find this written down
5. How do you see your role in relation to clinical governance
6. How has this come about
7. What structures are in place
8. What systems are in place
9. What are the key indicators that tell you that these systems are working
10. Key examples of improvement (not capital developments); what was the catalyst
(part of CQI/problem initiated)
11. Development plan; how did this come about
12. What is the mechanism for implementing this
13. If you asked a front line clinician to describe what the trust was doing about
clinical governance and what their responsibility as a clinician is; what sort of
response do you think you would get
14. What do you think the organisation does particularly well
15. What could it do better
16. What helps deliver the service
17. What gets in the way
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APPENDIX 8f: INTERVIEW DIVISIONAL MANAGERS - SEP 2000
Could you start be telling me about the work of the directorate

• What sort of services do you provide; To whom
• By whom - professional groups, wte, management hierarchy, other agencies
• How is the service delivered / Where - location / When
• How long have you been here - what changes have you seen
• What helps you deliver the service you want to give your clients
• Is there anything that gets in the way of delivering the sort of service you want
to deliver
Directorate
• Strategy and vision - business plan, resources, outputs, environment, technology
• Structure - hierarchy. Main decision/co-ordinating group, other decision groups
• Infrastructure - communications, HR (appraisal, CPD), reporting
• Infrastructure - quality: quality group, quality strategy, quality monitoring, key
quality indicators, reporting
• Infrastructure - clinical audit, risk management, incident reporting, significant
clinical incidents
• People (see service)
• Competencies - and what could be done better
• Culture
Quality improvement
• What initiatives over last 3 years / When did these happen
• What/who was the catalyst for the change. Who was involved - design,
implementation,
• How was the impact evaluated / What was the outcome
• Is there a programme for improvement
Clinical governance
• What do you see as the main objectives of clinical governance - QI, QA, control
• What has the directorate done so far to implement clinical governance
• What is the aim - how developed
• Action plan - key interventions, how developed, how, who, when
will these be implemented - links to business plan and resources
• Action plan interventions - inclusion of education and
involvement, co-ordination mechanisms
(directorate/corporate/clinical governance subcommittee),
feedback and communication, support, leadership
• Baseline assessment of ? what, ?existing quality systems such as
clinical audit, CRM, CPD, knowledge management complaints
What has been the response of clinicians - assessed

Changes in the way the directorate works
Significant clinical incident investigations
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APPENDIX 8g: FOCUS GROUP NON-EXECUTIVE DIRECTORS - SEP
2001
General role
• How do you see your role as non-execs
• Strategy/policy - formulation/monitoring
- what stage involved in strategy/policy development process
- away days to focus on strategy
• Each have a lead focus/ Written objectives
• What sort of preparation and training have you had specifically for your role as
non-exec - anything on-going
Clinical governance
• Preparation for role in relation to clinical governance agenda - education,

training; briefings
• What impact has clinical governance had on your role as non-exec

- corporate accountability for quality - what has this meant in practice
- how does the statutory duty for quality impact on your role
- what tells you that you are discharging that duty
• What specific information do you get to enable you to discharge your

responsibilities in relation to clinical governance - how were info needs
identified
• Do you feel able to challenge the executive team around this agenda
• Where do you think the trust is currently with clinical governance - structures,
processes. What tells you that clinical governance is going forward
• What information tells you that systems are in place and working
risk register/risks managed
- clinical audit - closing the loop
- programme of QI activity
- appraisal / CPD
• What's new about clinical governance
• Has there been any team building as a board development - new executive team
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APPENDIX 8h: INTERVIEW PRIMARY CARE DIVISION MANAGERS
Role of manager
• How long in this post
• Key areas of responsibility
• To whom are you accountable; how is this discharged (? Div manager)
Department
• Strategy - business plan, objectives for this year, quality strategy - objectives
• Structure - decision making group, hierarchy, quality group
• Infrastructure:
Decision making
Problem solving
Communications, regular meetings, mechanisms for feedback up and down
Appraisal, training, PDPs
Clinical audit, risk management, incident reporting
Complaints
R&D
Access to evidence (library, hardware, skills in EBP)
NICE guidance, NSF; how is this introduced if relevant
User involvement
• People - see service
• Culture
Recent improvements (eg: ICPs,)
Quality improvement
• Key quality indicators
• What initiatives over last 3 years
• When did these happen
• What/who was the catalyst for the change
• Who was involved - design, implementation, evaluation, (multi-disciplinary)
• How was the impact evaluated
• What was the outcome
• Sustained after initiative
Clinical governance
• Vision:
> What do you see as the main objectives of clinical governance (QI, QA,
control);
> What do you see as the key elements of clinical governance
> Do you see clinical governance as something new
'r What sort of differences in the service do you expect to see when clinical
governance becomes a way of life
'r What is your role as a manager in relation to clinical governance
•r Specific lead (eg: clinical governance committee)
308
• What has the department done so far to implement clinical governance
Strategy
Is there a written plan
What are the key objectives 01 /02 and beyond
- How were these identified
Who was involved in development, how
- How does this link with the business plan,
- Are there timescales for action,
- How will these be monitored
- What are the critical success factors
- Have resources been allocated
- Reporting mechanisms; feedback to staff, feedback up the hierarchy
- Was there a baseline assessment of existing quality systems?
Structure:
Clinical governance lead; co-ordinating group; clinical governance
action plan (key objectives)
Infrastructure:
- Leadership arrangements
- Accountability
- Reporting mechanisms
- Co-ordination mechanisms (clinical audit, complaints, risk management
Awareness raising
- Training for clinical governance, CQI
- Education - CPD
- Involvement; identification of issues, development, implementation,
monitoring,
- Communication and feedback
- Appraisal
- Improvement
- Support
- Multidisciplinary approaches
People:
What have been the response of clinicians to clinical governance - has this been
assessed
Competencies -
Key competencies for clinical governance - existing/to be developed
Culture -
Involvement, multidisciplinary working, CQI, customer focus
What helps you deliver the service / What gets in the way
309
APPENDIX 8i: FOCUS GROUPS DISTRICT NURSES/HEALTH VISITORS
1. Please write down what clinical governance means to you
2. What's been happening in the trust to take clinical governance forward
3. Early road shows; what since
4. Anything more locally
5. If not attended road shows, how have you heard about clinical governance
6. What changes have you noticed in the way you work as a result of clinical
governance
7. What elements get most attention/least attention
8. How does clinical audit happen; what feedback do you get from incident
reports; how are complaints handled - are these discussed in the staff meetings
9. What do you think you think needs to be done differently/happen to make

clinical governance a reality
310
APPENDIX 8j: INTERVIEW ACTING DIVISIONAL MANAGER - MAY 01
Division/Locality
• Strategy - business plan, objectives for this year, quality strategy - objectives
• Structure - decision making group, hierarchy, quality group
• Structure - other groups apart from PCG nurses and PAMS
• Infrastructure:
Decision making; problem solving
Communications, regular meetings, mechanisms for feedback up and down
Appraisal, training, PDPs
Clinical audit, risk management, incident reporting, complaints (and
integration system)
R&D
Access to evidence (library, hardware, skills in EBP)
NICE guidance, NSF; how is this introduced if relevant
User involvement
• People - see service
• Culture: Recent improvements (eg: ICPs,) and CQI, multidisciplinary
working, customer focus
Quality improvement
• Key quality indicators
• What initiatives over last 3 years
• When did these happen
• What/who was the catalyst for the change
• Who was involved - design, implementation, evaluation, (multi-disciplinary)
• How was the impact evaluated
• What was the outcome
• Sustained after initiative
Clinical governance
• Vision:
> What do you see as the main objectives of clinical governance (QI, QA,
control);
> What do you see as the key elements of clinical governance
> Do you see clinical governance as something new
> What sort of differences in the service do you expect to see when clinical
governance becomes a way of life
> What was your role as community manager in relation to clinical governance
> Specific lead
• What has the locality done so far to implement clinical governance

Strategy
Is there a written plan
- What are the key objectives 01/02 and beyond
- How were these identified
- Who was involved in development, how
- How does this link with the business plan,
311
- Are there timescales for action,
How will these be monitored
What are the critical success factors
- Have resources been allocated
- Reporting mechanisms; feedback to staff, feedback up the hierarchy
- Was there a baseline assessment of existing quality systems?
Structure:
- Locality group
- Locality lead
Infrastructure:
- Leadership arrangements
- Accountability
- Co-ordination mechanisms (clinical audit, complaints, risk management
Awareness raising
Training for clinical governance, CQI
- Education - CPD
- Involvement; identification of issues, development, implementation,
monitoring,
- Communication and feedback
Appraisal
- Improvement
Support
- Multidisciplinary approaches
People:
What have been the response of clinicians to clinical governance - has this been
assessed
Competencies -
Key competencies for clinical governance - existing/to be developed
Culture -
Involvement, multidisciplinary working, CQI, customer focus
What helps you deliver the service
What gets in the way
What has got in the way of taking clinical governance forward
Divisional clinical governance forum

- Clinical governance lead for division
- Co-ordinating group; TOR
- Key objectives
- Translated into action plan
- Role of group chair - preparation; training
- Role of members - preparation; training
- How will the agenda be formulated
312
- Link/integrate with other structures internally and externally (trust
corporate and divisional; PCG)
Serious clinical incidents
• How do you get to hear that incidents have occurred and are being investigated
• How do you get the information around action sets arising from the review
• How is this actionned locally
• Have you had any SCI on your patch
• Tell me about the incident; how are the recommendations being implemented
313
THESIS REFERENCES
Ahire, S. Golhar, D. Waller, M. (1996). Development and Validation of TQM

Implementation Constructs. Decision Sciences. 27(1) 23-56
Alexander, J. Weiner, B. Bogue, R (2001). Changes in the Structure, Composition,

and Activity of Hospital Governing Boards, 1989-1997: Evidence from Two National
Surveys. The Millbank Quarterly. 79(2)253-279
Anderson, D. Ackerman-Anderson, L. (2001). Beyond Change Management. San

Francisco: Jossey-Bass
Anderson, E. Adams, D. (1997). Evaluating the Success of TQM Implementation::

Lessons from Employees. Production and Inventory Management Journal. Fourth
Quarter. 1-6
Anderson, J. Rungtusanatham, M. Schroeder, R (1994). A Theory of Quality

Management Underlying The Deming Management Method. Academy of Management
Review. 19 (3) 472-509
Arndt, M. Bigelow, B. (1995). The implementation of total quality management in

hospitals: How good is the fit? Health Care Management Review. 20(4) 7-14
Arrington, B. Gautam, K. McCabe, W. (1995). Continually Improving Governance.

Hospital & Health Services Administration. 40 (1) 95-110
Asubonteng, P. McCleary, K. Munchus, G. (1996). The evolution of quality in the

US health care industry: an old wine in a new bottle. International Journal of Health
Care Quality Assurance. 9 (3) 11-19
Audit Commission. (1995). Taken on Board. London: HMSO
BAMM. (1998). Clinical Governance in the new NHS. Stockport: BAMM
Bate, P. (1994). Strategies for Cultural Change. Oxford: Butterworth-Heinemann
Bate, P. (2000). Synthesizing Research and Practice: Using the Action Research
Approach in Health Care Settings. Social Policy and Administration. 35 (4) 478-493
Bate, P. Kahn, R Pyle, A. (2000). Culturally sensitive structuring: An action

research-based approach to organization development and design. Public
Administration Quarterly. Winter. 445-470
314
Bate, P. Robert, G. (2002). Studying Health Care "Quality" Qualitatively: The
Dilemmas and Tensions Between Different Forms of Evaluation Research Within the
U.K. National Health Service. Qualitative Health Research. 12(7)966-981
Beckford, J. (1998). Quality: a critical introduction. London: Routledge
Beckhard R. Harris, R. (1897). Organizational Transitions. Reading Mass:

Addison-Wesley Publishing
Berger,A. (1998). Why doesn't audit work? British Medical Journal. 316 875-76
Berwick, D. (1989). Continuous Improvement as an Ideal in Health Care. The New

England Journal of Medicine. 320, (1) 53-56
Berwick, D. (1996). A primer on leading the improvement of systems. British

Medical Journal. 312,619-622
Berwick, D. Godfrey, A. Roessner, J. (1990). Curing Health Care. San Francisco:

Jossey-Bass
Bickman, L. Rog, D. (1998). Introduction. In: Bickman, L. Rog, D. (eds).

Handbook of Applied Social Research Methods. Thousand Oaks: Sage
Black, S. Porter, L. (1996). Identification of the Critical Factors of TQM. Decision

Sciences. 27(1)1-21
Bloor, K. Maynard, A. (1998). Clinical Governance: Clinician, heal thyself?

London: Institute of Health Services Management.
Blumenthal, D. Kilo,C. (1998). A Report Card on Continuous Quality Improvement.

The Milbank Quarterly. 76, (4) 625-648
Boaden, R. (1996). Is total quality management really unique? Total Quality

Management. 7 (5) 553-570
Boaden, R. (1997). What is total quality management... and does it matter? Total
Quality Management. 8 (4) 153-171
Boerstler, H. Foster, R. O'Connor, O'Brien, J. Shortell, S, Carmen, J. Hughes, E.

(1996). Implementation of Total Quality Management: Conventional Wisdom versus
Reality. Hospital and Health Services Administration. 41 (2) 143-159
Brown, L. (1993). Social change through collective reflection with Asian

nongovernmental development organizations. Human Relations. 46 (2) 249-273
Brown, M. (1993). Why does total quality fail in two out of three tries? Journal of
Quality and Participation. March. 80-89
315
Cameron, K. Barnett, C. (2000). Organization Quality as a Cultural Variable: an
Empirical Investigation of Quality Culture, Processes, and Outcomes. In: Cole, R.
Scott, W. (2000). (eds). The Quality Movement and Organization Theory. California:
Sage
Carnall, C. (1999). Managing Change in Organizations. London: Prentice Hall
Carver, J. (1990). Boards that make a difference. San Francisco: Jossey-Bass
Checkland, P. Scholes, J. (1990). Soft Systems Methodology in Action. Chichester:

John Wiley & Sons
CHI website - www.chi.nhs.uk
Conduit, D. Morgan, A. Willetts, J. (1999). Clinical Governance in the NHS Trusts:

results of an early baseline assessment in the Trent Region. Journal of Clinical
Governance. 7 121-123
Crosby, P. (1979). Quality Is Free. New York: Penguin Books
Cummings, T. Worley, C. (2001). Organization Development and Change. Australia:

South Western College Publishing
Cunningham, J. (1993). Action Research and Organizational Development. London:

Praeger
Dale, B. (1994). Managing Quality. New York: Prentice Hall
Dale, B. Boaden, R. (1994). A generic framework for managing quality

improvement. In Dale, B. (ed). Managing Quality. New York: Prentice Hall
Dale, B. Boaden, R. Lascelles, D. (1994). Total Quality Management: an overview.

In: Dale, B. (1994) (ed). Managing Quality. Hertfordshire: Prentice Hall
Dale, B. Cooper, C. (1994). Total Quality Management: Some Common Mistakes

Made By Senior Management. QWTS. March. 4-11
Dash, D. (1999). Current Debates in Action Research. Systemic Practice and Action
Research. 12(5)457-492
Davies, HTO. Mannion, R. (1999). Clinical Governance: Striking a Balance

Between Checking and Trusting. York: Centre for Health Economics
Davies, HTO. Nutley, S. Mannion, R. (2000). Organisational culture and quality of

health care. Quality in Health Care. 9 111-119
316
Davis, T. (1997). Breakdowns in Total Quality Management: An Analysis with
Recommendations. InternationalJournal of Management. 14(1) 13-22
Dawson, S. (1992). Analysing Organisations. London: The MacMillan Press Ltd
Day, P. Klein, R. (2002). Who nose best? Health Service Journal. 112 (5799) 26-
29
Dean, J. Bowen, D. (1994). Management Theory and Total Quality: Improving

Research and Practice through Theory Development. Academy of Management
Review. 19 (3) 392-418
Deming, W.E. (1986). Out of Crisis. Cambridge: Cambridge University Press
Department of Health. (1997). 'The new NHS Modern: Dependable'. London:

HMSO
Department of Health. (1998). A First Class Service. London: HMSO
Department of Health. (1999). HSC 1999/065. Clinical Governance: Quality in the

new NHS. London
Department of Health. (2000). The NHS Plan. A plan for investment; a plan for
reform. London: The Stationary Office
Dewar, S. (1999). Clinical Governance Under Construction. London: King's Fund
Dobbs, M. (1994). Continuous Improvement as Continuous Implementation:

Implementing TQM in Santa Ana. Public Productivity and Management Review. 18
(1) 89-100
Donaldson, L. (1998). Commentary: Clinical Governance and Service Failure in the

NHS. Public Money and Management. Oct-Dec 10-11
Donaldson, L. (1999). Clinical governance - medical practice in a new era. The

Journal of the MDU. 15(2)7-9
Donaldson, L. Muir Gray, J. (1998). Clinical Governance: a quality duty for health
organisations. Quality in Health Care. 7 (Supplement) 37-44
Drucker, P. (1989). The Practice of Management. Heinemann Professional.
Dunphy, D. (1996). Organizational Change in Corporate Settings. Human Relations.

49(5) 541-551
Dunsire, M. (1978). Implementation in a Bureaucracy. Oxford: Martin Robertson
317
Easton, G. Jarrell, S. (2000). Patterns in the Deployment of Total Quality
Management: An Analysis of 44 Leading Companies. In: Cole, R. Scott, W (2000).
(eds). The Quality Movement and Organization Theory. California: Sage
Eden, C. Huxham, C. (1996). Action Research for the Study of Organizations. In:
Clegg, S. Hardy, C. Nord, W. (eds). Handbook of Organization Studies. London:
Sage
Elden, M. Chisholm, R. (1993). Features of Emerging Action Research. Human

Relations. 46(2) 275-298
Elliot, J. (1991). Action Research for Educational Change. Buckingham: Open

University Press
Ellis, R Whittington, D. (1993). Quality Assurance in Health Care: A Handbook.

London: Edward Arnold
Elmore, R (1978). Organizational models of social program implementation. Public

Policy. 26 185-228
Faulkner, W. (1951). Requiem for a Nun. Cited in: Ratcliffe, S (ed). The Oxford
Dictionary of Thematic Quotations. Oxford: The Oxford University Press
Feigenbaum, A. (1991). Total Quality Control. New York: McGraw-Hill
Ferlie, E. (1997). Large-scale organizational and managerial change in health care: a

review of the literature. Journal of Health Services Research and Policy. 2 180-189
Firth-Cozens, J. (1999). Clinical governance development needs in health service

staff. British Journal of Clinical Governance. 4 (4) 128-134
Flood, R (1993). Beyond TQM. Chichester: John Wiley
Foster, M. (1972). An Introduction to the Theory and Practice of Action Research in

Work Organizations. Human Relations. 25 (6) 529-556
Gann, M. Restuccia, J. (1994). Total Quality Management in Health Care: A View of

Current and Potential Research. Medical Care Review. 51 (4) 467-500
Garside P. (1998). Organisational context for quality: lessons from the fields of
organisational development and change management. Quality in Health Care. 7
(Supplement) 8-15
Gersick, C. (1991). Revolutionary Change Theories: A multilevel exploration of the

punctuated equilibrium paradigm. Academy of Management Review. 16(1) 10-36
318
Ghobadian, A. Gallear, D. (1997). TQM and organization size. International Journal
of Operations and Production Management. 17 (2) 121 -163
Gioia, D. Chittipeddi, K. (1991). Sensemaking and sensegiving in strategic change

initiation. Strategic Management Journal. 12433-448
Glover, J. (1993). Achieving the Organizational Change Necessary for Successful

TQM. The International Journal of Quality and Reliability Management. 10 (6) 47-64
Goh, P. Ridgway, K. (1994). The implementation of total quality management in

small and medium sized manufacturing companies. TQM Magazine. 6 (2) 54-60
Goodman, N. (1998). Clinical governance. British Medical Journal. 317.1725-7
Goodman, N. (2002). Clinical governance: vision or mirage? Journal of Evaluation

in Clinical Practice 8 (2) 243-249
Goodstein, L. Burke, W. (1991). Creating Successful Organization Change.

Organizational Dynamics. 19(4)5-17
Grainger, K. Hopkinson, R. Barrett, V. Campbell, C. Chittenden, S. Griffiths, R

Low, D. Parker, J. Roy, A. Thompson, T. Wilson,T. (2002). Implementing clinical
governance - results of a year's programme of semi-structured visits to assess the
development of clinical governance in West Midlands Trusts. British Journal of
Clinical Governance. 7 (3) 177-186
Grant, R Shani, R Krishnan, R (1994). TQM's challenge to management theory

and practice. Sloan Management Review. 35 (2) 25
Greenwood, D. Levin, M. (1998). An Introduction to Action Research: Social

research for social change. Thousand Oaks: Sage
Greenwood, D. Whyte, W. Harkavy, I. (1993). Participatory action research as a

process and as a goal. Human Relations 46 (2) 175-92
Gunn, L. (1978). Why is Implementation So Difficult? Management Services In

Government. 33 169-176
Hackett, M. Spurgeon, P. (1999). Culture, leadership, and power: the key to

changing attitudes and behaviours in trusts. Clinician in Management. 8 27-32
Hackman, J. Wageman, R (1995). Administrative Science Quarterly. 40 309-342
Hallett, L. Thompson, M. (2001). Clinical governance: a practical guide for

managers. London: e map Public Management.
319
Halligan, A. (1999). How the National Clinical Governance Support Team plans to
support the development of clinical governance in the workplace. Journal of Clinical
Governance. 7 Decppl55-157
Hamada, T. (2000). Quality as a Cultural Concept: Messages and Metamessages. In:

Cole, R. Scott, W. (2000). (eds). The Quality Movement and Organization Theory.
California: Sage
Hamel, G. (2001). Revolution vs. Evolution: You Need Both. Harvard Business
Review. 150-125
Harrison, S. (2000). Lewis Gunn and 'perfect implementation1. Clinician in

Management. 949-50
Hart, M. (1996). Improving the quality of NHS out-patient clinics: the applications
and misapplications of TQM. The International Journal of Health Care Quality
Assurance. 9(2)20-27
Hart E. Bond, M. (1995). Action Research for Health and Social Care.
Buckingham: Open University Press
Hawkins, P. (1997). Organizational Culture: Sailing Between Evangelism and

Complexity. Human Relations. 50(4)417-440
Hedrick, T. Bickman, L. Rog, D. (1993). Applied Research Design. Newbury Park :

Sage
Hewer, P. Lugon, M. (2001). Clinical governance - putting it into practice in a trust.

Clinical Governance Bulletin. 2(1) 8-9
Hill,M. (1997). The Policy Process. London: Prentice Hall
Hill, S. Wilkinson, A. (1995). In search of TQM. Employee Relations. 17 (3) 8-25
Hittinger, R. (2001). Implementation of clinical governance in a teaching trust.

Clinical Governance Bulletin. 2(1)9-11
Hogwood, B. Gunn, L. (1984). Policy Analysis for the Real World. Oxford: OUP
Holland, K. Fennell, S. (2000). Clinical governance is "ACE" - using the EFQM
Excellence Model to support baseline assessment. International Journal of Health Care
Quality Assurance. 13 (4) 170-177
Holt, P. (1999). The Rhythm of quality management. British Journal of Health Care
Management. 5 (6) 242-246
320
Hopkinson, R. (1999). Clinical governance: putting it into practice in an acute trust.
Clinician in Management 8 81-88
Huws, R. (2000). Implementing clinical governance. Clinician in Management. 9 39-

43
Ichniowski, C. Shaw, K. (2000). Quality Improvement Practices and Innovative

HRM Practices: New Evidence on Adoption and Effectiveness. In: Cole, R. Scott, W.
(2000). (eds). The Quality Movement and Organization Theory. California: Sage
lies, V. Sutherland, K. (2001). Managing Change in the NHS. London: NCCSDO
Internal Trust Document (1999). The Clinical Governance Report
Internal Trust Document (2000a). The Clinical Governance Development Plan
Internal Trust Document (2000b). The Human Resource Strategy
Jackson, S. (2001). Successfully implementing total quality management tools within

healthcare: what are the key actions? International Journal of Health Care Quality
Assurance. 14(4)157-163
Jen kins, W. (1978). Policy Analysis: A Political and Organisational Perspective.

London: Martin Robertson
Joss, R Kogan, M. (1995). Advancing Quality. Buckingham: Open University

Press
Joss, R. Kogan, M. Henkel, M. (1994). Total Quality Management in the National

Health Service. Final Report of an Evaluation. Brunei University: Centre for the
Evaluation of Public Policy and Practice.
Juran, J. (1988). Juran on Planning for Quality. New York: The Free Press
Kanji, G. (1996). Implementation and pitfalls of total quality management. Total

Quality Management. 7(3) 331-343
Kanji, G. Barker, R (1990). Implementation of total quality management. Total

Quality Management 1 (3) 375-389
Katz, A. (1993). Eight TQM pitfalls. Journal for Quality and Participation.
July/August 24-27
Kerrison, S. Packwood, T. Buxton, M. (1994). Monitoring Medical Audit. In:

Robinson, R. Le Grand, J. (eds) (1994). Evaluating the NHS Reforms. Newbury:
Policy Journals
321
Kim, P. Johnson, D. (1994). Implementing total quality management in the health
care industry. Health Care Supervisor. 12(3) 51-57
Klein, R. (1995). Big Bang Health Care Reform - Does It Work?: The Case of
Britain's 1991 National Health Service Reforms. The Millbank Quarterly Review. 73
(3) 299-337
Klein, R. (1998). Can policy drive quality. Quality in Health Care. 7 (Supplement)
51-53
Kochan, T. Rubenstein, S. (2000). Human Resource Policies and Quality: From

Quality Circles to Organizational Transformation. In: Cole, R. Scott, W. (2000).
(eds). The Quality Movement and Organization Theory. California: Sage
Kolesar, P. (1993). Vision, Values, Milestones: Paul O'Neill Starts Total Quality at
Alcoa. California Management Review. Spring 133-165
Kolesar, P. (1995). Partial Quality Management. Production and Operations

Management. 4(3) 195-200
Kotter, J. (1990). A Force for Change. New York: The Free Press
Kotter, J. (1996). Leading Change. Boston: Harvard Business School Press
Kovner, A. (1990). Improving Hospital Board Effectiveness: An Update. Frontiers

of Health Services Management. 6 (3) 3-27
Krishnan, R. Shani, A. Grant, R. Baer, R. (1993). In search of quality

improvement: Problems of design and implementation. 7 (4) 7-20
Kritchevsky, S. and Simmons, B. (1991). Continuous Improvement: Concepts and

Applications for Physician Care. Journal of the American Medical Association. 266
(13) 1817-1823
Lane, J. (1987). Implementation, accountability and trust. European Journal of

Political Research. 15(5) 527-546
Latham, L. (1996). Cancer Services: What Shropshire People Say. Shropshire Health
Authority
Latham, L. Freeman, T. Walshe, K. Spurgeon, P. Wallace, L. (2000). Clinical

governance in the West Midlands and South West Regions: early progress in NHS
Trusts. Clinician in Management. 9(2)83-91
Ledford, G. Morhman, S. (1993). Self-Design for High Involvement: A Large-Scale

Organizational Change. Human Relations. 46(1) 143-173
322
Lewin, K. (1951). Field Theory in Social Science. New York: Harper & Row
Lewis, S. Saunders, N. Fenton, K. (2002). The magic matrix of clinical governance.

British Journal of Clinical Governance. 7(3) 150-153
Lillrank, P. Shani, R. Kolodny, H. Stymme, B. Figuera, J. Liu, M. (1998).

Learning from the success of continuous improvement programs: an international
comparative study. Research in Organizational Change and Development. 11 47-71
Lincoln, Y. Guba. E. (1985). Naturalistic inquiry. Beverly Hills: Sage
Lipsky, M. (1980). Street-level Bureaucracy: Dilemmas of the individual in public

services. New York: Russell Sage Foundation.
Lloyd, A. (2001). Role of the Chief Executive in Clinical Governance: Some

Practical Guidelines. In: Lugon, M. Seeker-Walker, J. (2002). Advancing Clinical
Governance. London: The Royal Society of Medicine Press Limited.
Lovelock, C. (1992). Managing Services. London: Prentice-Hall
Lugon, M. Seeker-Walker, J. (1999). Clinical Governance: Making it Happen.

London: The Royal Society of Medicine Press
Mann, R. Kehoe, D. (1995). Factors affecting the implementation and success of

TQM. The International Journal of Quality and Reliability Management. 12(1)11
Marris, P. (1993). The Management of Change. In: Mabey, C. and Mayon-White, B.

(eds). Managing Change. Second edition. London: Paul Chapman
Marshall, C. Rossman, G. (1998). Designing Qualitative Research. Thousand Oaks:

Sage
Maxwell, J. (1998). Designing a Qualitative Study. In: Bickman, L. Rog, D. (eds).

Handbook of Applied Social Research Methods. Thousand Oaks: Sage
Maxwell, R. (1984). Quality assessment in health. British Medical Journal. 288

1470-1471
Mays, N. Pope, C. (1995). Qualitative Research: Rigour and qualitative research.

British Medical Journal. 311 109-112
Mays, N. Pope, C. (2000). Assessing quality in qualitative research. British Medical

Journal. 320 50-2
McLaughlin, C. Kaluzny, A. (1990). Total quality management in health: Making it

work. Health Care Management Review. 15(3) 7-14
323
McTaggart, R. (1994). Participatory Action Research: issues in theory and practice.
Educational Action Research. 2 (3) 313-337
Meyer, A. Goes, J. Brooks, G. (1995). Organizations Reacting to Hyperturbulance.

In: Huber, G. Click, W (1995). Organizational Change and Redesign. Oxford: Oxford
University Press
Meyer, J. (2001). Action Research. In: Fulop, N. Alien, P. Clarke, A. Black, N.

(eds). Studying Organisation and Delivery of Health Services. London: Routledge
Miles, M. Huberman, A. (1994). Qualitative Data Analysis. Thousand Oaks: Sage
Miles, R. (1997). Leading Corporate Transformation. San Francisco: Jossey-Bass
Mintzberg, H. (1979). The Structuring of Organizations. London: Prentice-Hall
Morgan, C. Murgatroyd, S. (1994). Total Quality Management in the Public Sector.

Buckingham: Open University Press
Morgan, G. (1986). Images of Organization. California: Sage
Moss, F. (1995). Risk management and the quality of care. In: Vincent, C. (ed)
(1995). Clinical Risk management. London: BMJ
Motwani, J. Sower, V. Brashier, L. (1996). Implementing TQM in the health sector.

Health Care Management Review. 21(1) 73-82
Mullins, L. (1999). Management and Organisational Behaviour. London: Financial

Times Pitman Publishing
Nadler, D. Tush man, M. (1995). The Challenge of Discontinuous Change. In:

Nadler, D. Shaw, R. Walton, A. (eds). Discontinuous Change. San Francisco: Jossey-
Bass
Newall, D. Dale, B. (1991). The introduction and development of a quality

improvement process: a study. International Journal of Production Research. 29 (9)
1747-1760
Nicholls, S. Cullen, R. O'Neill, S. Halligan, A. (2000). Clinical governance its origins

and foundations. British Journal of Clinical Governance. 5 (3)172-178
Nicholls, S. Cullen, R. O'Neill, S. Halligan, A. (2000). Clinical governance: its

origins and foundation. Clinical Performance and Quality Health Care. 8 (3)172-178
Nwabueze, U. Kanji, G. (1997). The implementation of total quality management in

the NHS: how to avoid failure. Total Quality Management. 8 (5) 265-280
324
Oakland J. Porter, L. (1994). Cases in Total Quality Management. Oxford:
Butterworth-Heinemann
Oakland, J. (1995). Total Quality Management. Oxford: Butterworth - Heinemann
Olian, J. Rynes, S. (1991). Making Total Quality Work: Aligning Organizational

Processes, Performance Measures and Stakeholders. Human Resource Management.
30 (3) 303-333
Ovretveit, J. Aslaksen, A (1999). The Quality Journeys of Six Norwegian Hospitals.

Oslo: Norwegian Medical Association
Ovretveit, J. (1992). Health Service Quality. Oxford: Blackwell Scientific

Publications
Ovretveit, J. (1998). Proving and improving the quality of national health services:
past, present and future. In: Spurgeon, P. (ed). The New Face of the NHS. Second
edition. London: The Royal Society of Medicine Press
Ovretveit, J. (1999). Integrated Quality Development in Public Healthcare. Norway:

Norwegian Medical Association
Packwood, T. Pollitt, C. Roberts, S. (1998). Good Medicine? A case study of

business process re-engineering in a hospital. Policy and Politics. 26 (4) 401-415
Parsons, W. (1995). Public Policy. Cheltenham: Edward Elgar.
Pasmore, W. Friedlander, F. (1981). An action research program for increasing

employee involvement in problem-solving. Administrative Science Quarterly. 27,
343-362
Patton, M. (1999). Enhancing the Quality and Credibility of Qualitative Analysis.

Health Services Research. 34 (5) 1189-1208
Patton, M. (2002). Qualitative Research and Evaluation Methods. Thousand Oaks:
Sage
Pendlebury, J. Grouard, B. Meston, F. (1998). Successful Change Management.
Chichester: Wiley
Pettigrew, A. Ferlie, E. McKee, L. (1992). Shaping Strategic Change. London: Sage
Peters T. Waterman, R. (1982). In Search of Excellence. London: Pan Books
Pollitt, C. (1990). Doing business in the temple? Managers and quality assurance in
the public services. Public Administration. 68 (4) 435-452
325
Pollitt, C. (1993). The Struggle for Quality: the case of the National Health Service.
Policy and Politics. 21 (93), 161-170
Pollitt, C. (1996). Business approaches to quality improvement: why are they hard for
the NHS to swallow. Quality in Health Care. 5 104-110
Porter, L. Parker, A. (1993). Total quality management - the critical success factors.
Total Quality Management. 4(1) 13-22
Povey, B. (1996). Continuous Business Improvement. London: McGraw-Hill
Powell, T. (1995). Total Quality Management as Competitive Advantage: A Review

and Empirical Study. Strategic Management Journal. 16 15-37
Rand, J. (1994). Learning comes before ownership. Journal for Quality and
Participation. July/August. 64-68
Reger, R. Gustafason, L. Demaire, S. Mullane, J. (1994). Reframing The

Organization: Why Implementing Total Quality Is Easier Said Than Done. Academy
of Management Review. 19(3) 565-584
Robinson, J. Akers, J. Artzt, E. Poling, EL Galvin, R. Alia ire, P. (1991). An open

letter: TQM on the campus. Harvard Business Review. 69 (6) 94-95
Robson, C. (1993). Real World Research. Oxford: Blackwell
Robson, C. (2000). Small-Scale Evaluation. London: Sage
Romano, C. (1994). Report Card on TQM. Management Review. Jan. 22-25
Sabatier, P. (1986). Top-down and bottom-up approaches to implementation

research: a critical analysis and suggested synthesis. Journal of Public Policy. 6 21-48
Santayaner, G. (1905). The Life of Reason. Cited in: Ratcliffe, S (ed). The Oxford
Dictionary of Thematic Quotations. Oxford: The Oxford University Press
Saraph, J. Benson, P. Schroeder, R. (1989). An instrument for measuring the critical

factors of quality. Decision Sciences. 20810-829
Scally, G. Donaldson, L. (1998). Clinical governance and the drive for quality
improvement in the new NHS in England. British Medical Journal. 317 61-65
Scotland, A. (1998). Clinical governance in the new NHS: an agenda for personal and
organisational development. Clinician in Management. 7 138-141
326
Scott, W. Cole, R. (2000). The Quality Movement and Organization Theory. In:
Cole, R. Scott, W. (2000). (eds). The Quality Movement and Organization Theory.
California: Sage
Shea, C. Ho well, J. (1998). Organizational Antecedents to the Successful

Implementation of Total Quality Management: A Social Cognitive Perspective.
Journal of Quality Management. 3(1) 3-24
Short, P. Rahim, M. (1995). Total quality management in hospitals. Total Quality

Shortell, S. Levin, D. O'Brien, J. Hughes, E. (1995). Assessing the Evidence on

CQI: Is the Glass Half Empty or Half Full. Hospital and Health Services
Administration. 40 (1) 4-24
Shortell, S. O'Brien, J. Carmen, J. Foster, R. Hughes, E. Boerstler, H. O'Connor,

E. (1995). Assessing the Impact of Continuous Quality Improvement/Total Quality
Management: Concept versus Implementation. Health Services Research. 30 (2) 377-
401
Silverman, D. (2000). Doing Qualitative Research: A Practical Handbook. London:

Sage
Sitkin, S. Sutcliffe, K. Schroeder, R. (1994). Distinguishing Control from Learning

in Total Quality Management: A Contingency Perspective. Academy of Management
Review. 19 (3) 537-564
Snape, E. Redman, T. (1995). Managing human resources for TQM: possibilities and
pitfalls. Employee Relations. 17(3) 42-51
Snowberger, M. (1996). TQM - why and how it was implemented at Gilbarco. GEC
Journal of Research. 13(2) 80-86
Spencer, B. (1994). Models of Organization and Total Quality Management: A

Comparison and Critical Evaluation. Academy of Management Review. 19 (3) 446-
471
Sproull, L. Hofmeister, K. (1986). Thinking About Implementation. Journal of

Spurgeon, P. (1999). Organisational Development: from a reactive to a proactive

process. In: Mark. A. Dopson, S. (eds) Organisational Behaviour in Healthcare. :
London: MacMillan Business
327
Spurgeon, P. Latham, L. (2003) (In press). Pursuing Clinical Governance Through
Effective Leadership. In Dopson, S. Mark, A. (eds). Leading Healthcare Organisations.
Basingstoke: Macmillan
Stamatis, D. (1994). Total Quality Management and Project Management. Project

Management Journal. XXV (3) 48-54
Sutherland, D. Dawson, S. (1998). Power and quality improvement in the new NHS:
the roles of doctors and managers. Quality in Health Care. 7 (Supplement) 16-23
Tata, J. Prasad, S. (1998). Cultural and structural constraints on total quality

management implementation. Total Quality Management. 9(8) 703-710
Taylor, D. (1996). Quality and professionalism in health care: a review of current

initiatives in the NHS. British Medical Journal. 312 626-629
Taylor, W. (1996). Sectoral differences in total quality management implementation:

the influence of management mind-set. Total Quality Management. 7(3) 235-248
Teixeira, A. (1999). How to navigate the sea of quality management literature.

Strategic Change. 8143-151
The Conference Board. (1993). Does Quality Work? A Review of Relevant Studies.
New York: The Conference Board.
Thomas, M. (2002). The evidence base for clinical governance. Journal of

Evaluation in Clinical Practice 8 (2) 251-254
Thomson, R. (1998). Quality to the fore in health policy - at last. British Medical
Journal. 317,95-96
Tush man, M. O'Reilly, C. (1996). Ambidextrous Organizations: Managing

Evolutionary and Revolutionary Change. California Management Review. 38 (4) 8-
30
Umbdenstock, R. Hageman, W. Amundson, B. (1990). The Five Critical Areas for

Effective Governance of Not-for-Profit Hospitals. Hospital & Health Services
Administration. 35 (4) 481-492
Van de Ven, A. Poole, M. (1995). Explaining Development and Change in

Organizations. Academy of Management Review. 20(3) 510-540
Van Meter, D. Van Horn, C. (1975). The policy implementation process: a

conceptual framework. Administration and Society. 6 445-488
328
Wakefield, D. Wakefield, B. (1993). Overcoming the Barriers to Implementation of
TQM/CQI in Hospitals: Myths and Realities. QRB. March 83-88
Wall, A. (1999). Review: Clinical governance: Making it Happen. Health Service

Journal. 109(5654)30-31
Walsh, P. (1995). Overcoming chronic TQM fatigue. The TQM Magazine. 7(5)58-
64
Walshe, K. (1997). NICE ideas on quality. Health Service Journal. 18 Dec. 20
Walshe, K. (1998a). Cutting to the heart of quality. Health Management. 2 (4) 20-21
Walshe, K. (1998b). Clinical governance: what does it really mean? HSMC

Newsletter. 4 (2) 1-2
Walshe, K. (1998c). The reliability and validity of adverse-event measures of the

quality of healthcare. PhD thesis. University of Birmingham.
Walshe, K. (1999). Baseline assessment for clinical governance: issues, methods and
results. Journal of Clinical Governance. 7 166-171
Walshe, K. (2000a). Systems for clinical governance: evidence of effectiveness.

Journal of Clinical Governance. 8 174-180
Walshe, K. (2000b). Clinical governance: a review of the evidence. Health Services

Management Centre: University of Birmingham
Walshe, K. Dineen, M. (1998). Clinical risk management: making a difference?

Birmingham: The NHS Confederation.
Walshe, K. Freeman, T. Latham, L. Wallace, L. Spurgeon, P. (2000). Clinical

governance: from policy to practice. Birmingham: Health Services Management
Centre
Weick, K. Quinn, R. (1999). Organizational Change and Development. Annual

Review of Psychology. 50. 361-386
Weiner, B. Alexander, J. (1993). Hospital Governance and Quality of Care: A

Critical Review of Transitional Roles. Medical Care Review. 375-409
Weiner, B. Shoetree, S. Alexander, J. (1997). Promoting Clinical Involvement in

Hospital Quality Improvement Efforts: The Effects of Top Management, Board, and
Physician Leadership. Health Services Research. 32 (4) 491-510
329
West, J. Berman, E. Milakovich, M. (1993). Implementing TQM in Local
Government: The Leadership Challenge. Public Productivity and Management
Review. XVI1 (2) 175-189
Whalen, M. Rahim, M. (1994). Common barriers to implementation of a TQM

program. Industrial Management. 36 (2) 19-21
Wilkinson, A. (1995) Re-examining quality management. Review of Employment

Topics. 3 187-211
Wilkinson, A. Witcher, B. (1993). Holistic total quality management must take

account of political processes. Total Quality Management. 4 (1) 47-56
Williams, W. (1980). The Implementation Perspective. Berkeley: University of

California Press
Wilson, D. (1992). A Strategy of Change. London: Routledge
Winter, M. (1999). Clinical governance - getting beyond a new management mantra?

Healthcare Quality. 26-29
Witcher, B. (1995). The Changing Scale of Total Quality Management. Quality

Management Journal. Summer 9-29
Wolman, H. (1981). The Determinants of Program Success and Failure. Journal of

Public Policy. 1 (4) 433-464
Wright, J. Smith, M. Jackson, D. (1999). Clinical governance: principles into

practice. Journal of Management in Medicine. 13 (6) 457-465
Yin, R. (1994). Case Study Research: Design and Methods. Thousand Oaks: Sage
Yin, R. (1999). Enhancing the Quality of Case Studies in Health Services Research.
Health Services Research. 34 (5) 1209-1224
Yong, J. Wilkinson, A. (1999). The state of total quality management: a review. The
International Journal of Human Resource Management. 10(1)137-161
Yong, J. Wilkinson, A. (2001). Rethinking total quality management. Total Quality

Management. 12 (2) 247-258
Yusof, S. Aspinwall, E. (1999). Critical success factors for total quality management
implementation in small and medium enterprises. Total Quality Management. 10
(4&5) S803-809
330
Yusof, S. Aspinwall, E. (2000a). Total quality management implementation
frameworks: comparison and review. Total Quality Management. 11(3) 281-294
Yusof, S. Aspinwall, E. (2000b). A conceptual framework for TQM implementation

forSMEs. The TQM Magazine. 12(1)31-36
Yusof, S. Aspinwall, E. (2000c). Critical success factors in small and medium

enterprises: survey results. Total Quality Management. 11 (4/S&6) S448-462
Zabada, C. Rivers, P. Munchus, G. (1998). Obstacles to the application of total

quality in health-care organizations. Total Quality Management. 9(1) 57-66
Zairi, M. (1994). Measuring Performance for Business Results. London: Chapman

and Hall
331

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CLINICAL GOVERNANCE

A STUDY OF IMPLEMENTATION; A STUDY OF CHANGE

LINDA ANN LATHAM

Health Services Management Centre

This unpublished thesis/dissertation is copyright of the author and/or third

Any use made of information contained in this thesis/dissertation must be in

'A framework through which NHS organisations are accountable for

my grandmother and a fellow traveller

To Professor Peter Spurgeon for his experienced supervision, support

1.1 The emergence of clinical governance 1

2.4 Making sense of clinical governance 17

3.3 Total Quality Management - the concept 38

3.4 Implementing Total Quality Management 50

3.5 TQM and CQI in health care - a general overview 66

3.6 Experimenting with TQM in the UK National Health Service

3.7 Chapter summary 74

4.4 Change management 85

4.5 Chapter summary 98

5.1 Introduction 100

5.3 Research strategy 106

5.4 Action research 109

5.5 Data collection and data management 115

5.6 Research in action 118

5.7 Research quality 127

5.8 Chapter summary 131

6.1 Introduction 132

6.2 A vision and a strategy for clinical governance 132

6.3 Structures to support a developing agenda 136

6.4 Systems and Processes 154

6.5 People 173

6.6 Organisational culture 176

6.7 Chapter summary 180

7.1 Introduction 182

7.9 Chapter summary 209

8.1 Introduction 210

8.5 Clinical governance: the implementation process in the

8.5.1 Clinical governance implementation - a late start 222

8.6 Chapter summary 227

9.1 Introduction 228

9.4 Limitations 281

9.5 Further research 284

9.6 Chapter summary 285

CHAPTER 10 CONCLUSION 287

CHAPTER 1 INTRODUCTION AND OVERVIEW OF THESIS

CHAPTER 2 LITERATURE REVIEW - CLINICAL GOVERNANCE

CHAPTER 3 LITERATURE REVIEW - TOTAL QUALITY

CHAPTER 4 LITERATURE REVIEW - CHANGE AND CHANGE

CHAPTER 6 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION

CHAPTER 7 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION

CHAPTER 9 DISCUSSION OF RESULTS

Appendix! Typologies of TQM implementation 291

Appendix 2 Framework for transformational change 294

Appendix 3 Eight stage process for change 295

Appendix 4 Ten keys to effective change management 296

Appendix 5 Action research - a model for practice 297

Appendix 6 Recommendations - action set 1 298

Appendix 7 Recommendations - action set 2 299

Appendix 8 A selection of interview schedules/guides 301

INTRODUCTION AND OVERVIEW OF THESIS