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Clinical Governance 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of Birmingham Birmingham B152TT February 2003 University of Birmingham Research Archive e-theses repository This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder. o ao (A) 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 3.7 Chapter summary 74 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 4.5 Chapter summary 98 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 5.8 Chapter summary 131 CHAPTER 6 132 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION CORPORATE ACTIVITY: CONTENT 6.1 Introduction 132 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 6.7 Chapter summary 180 CHAPTER 7 182 RESULTS: CLINICAL GOVERNANCE IMPLEMENTATION - CORPORATE ACTIVITY: PROCESS 7.1 Introduction 182 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 7.9 Chapter summary 209 CHAPTER 8 210 RESULTS: CLINICAL GOVERNANCE - A DIVISIONAL VIEW 8.1 Introduction 210 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 8.6 Chapter summary 227 CHAPTER 9 DISCUSSION OF RESULTS 228 9.1 Introduction 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
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