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The Vale of Leven Hospital Inquiry Report the Rt Hon Lord Maclean Chairman the Vale of Leven Hospital Inquiry Report the Rt Hon Lord Maclean Chairman

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The Vale of Leven Hospital Inquiry Report the Rt Hon Lord Maclean Chairman the Vale of Leven Hospital Inquiry Report the Rt Hon Lord Maclean Chairman The Vale of Leven Hospital Inquiry Report Inquiry Report Hospital Leven of The Vale The Vale of Leven Hospital Inquiry Report The Rt Hon Lord MacLean Chairman MacLean Hon Lord The Rt The Rt Hon Lord MacLean Chairman The Vale of Leven Hospital Inquiry Report The Rt Hon Lord MacLean Chairman Laid before the Scottish Parliament by the Scottish Ministers under section 26 of the Inquiries Act 2005. November 2014 SG/2014/211 © Crown copyright 2014 ISBN: 978-1-78412-843-2 Published on behalf of The Vale of Leven Hospital Inquiry by APS Group An online version of the Report is available at www.valeoflevenhospitalinquiry.org email: [email protected] APS Group Scotland DPPAS10898 (11/14) Contents Page Chairman’s letter to the Cabinet Secretary ix Foreword x How to read the Report xii Chapter 1 Introduction 1 Chapter 2 How the Inquiry worked 17 2.1 Inquiry procedures 18 2.2 Inquiry organisation and administration 30 Chapter 3 Healthcare Associated Infection and Clostridium difficile 35 3.1 Healthcare Associated Infection 36 3.2 Antibiotics and the bowel flora 36 3.3 C. difficile – what is it? 37 3.4 How C. difficile is spread 38 3.5 Laboratory diagnosis of C. difficile infection 39 3.6 Precautions against occurrence and spread of C. difficile infection 43 3.7 Treatment of C. difficile infection 44 3.8 Conclusion 45 Chapter 4 The number of patients with CDI and those who died 47 4.1 Discovery of the problem 48 4.2 Number of CDI cases 49 4.3 Number of C. difficile deaths 51 4.4 Conclusion 53 Chapter 5 C. difficile infection rates and undeclared outbreaks 55 5.1 Definition of an outbreak 56 5.2 The number of CDI results 57 5.3 Wards with CDI patients – the early period 64 5.4 Wards with CDI patients – the focus period 71 5.5 Conclusion 77 iii The Vale of Leven Hospital Inquiry Report Chapter 6 National structures and systems 79 6.1 Relevant parties and agencies 80 6.2 Systems 81 6.3 Accountability and monitoring 83 6.4 Health Improvement, Efficiency, Access and Treatment (HEAT) Targets and CDI guidance 85 6.5 The review system 86 6.6 Healthcare Environment Inspectorate 87 6.7 Conclusion 91 6.8 Recommendations 93 Chapter 7 National policies and guidance 95 7.1 National guidance on the prevention and control of C. difficilebefore 2008 96 7.2 The role of Health Protection Scotland in developing guidance on C. difficile 101 7.3 Developments from June 2008 onwards 103 7.4 Was the guidance on HAI adequate? 104 7.5 The provision of C. difficileguidance 104 7.6 The monitoring of the implementation of guidance 105 7.7 Conclusion 106 7.8 Recommendations 107 Chapter 8 Changes in services at the Vale of Leven Hospital from 2002 109 8.1 Prolonged uncertainty 110 8.2 Shaping the Future 111 8.3 Lomond Integrated Care Model 111 8.4 A new strategy 112 8.5 The Vision for the Vale 114 8.6 Conclusion 116 8.7 Recommendations 116 Chapter 9 The creation, leadership and management of the Clyde Directorate 117 9.1 The dissolution of NHS Argyll and Clyde 118 9.2 Integration 118 9.3 Impact of integration on the Vale of Leven Hospital (VOLH) 120 9.4 Leadership of the Clyde Directorate 122 9.5 The leadership of Mrs den Herder 122 9.6 Other managers in the Clyde Directorate 126 9.7 Conclusion 129 9.8 Recommendations 130 iv Contents Chapter 10 Clinical governance 131 10.1 National policy 132 10.2 Clinical governance in NHS Greater Glasgow and Clyde 133 10.3 Clinical governance structures at divisional level 135 10.4 Clinical governance in the Clyde Acute Directorate 140 10.5 Clinical governance in the Rehabilitation and Assessment Directorate 146 10.6 Reporting from the Clyde Sector 149 10.7 The Clinical Governance Committee and NHS Greater Glasgow and Clyde 150 10.8 Changes in clinical governance since 2008 151 10.9 No non-executive director for Clyde 152 10.10 Conclusion 152 10.11 Recommendations 152 Chapter 11 The experiences of patients and relatives 153 11.1 Sources of evidence 154 11.2 The patients’ and relatives’ expectations 155 11.3 Patient care 156 11.4 The patients’ and relatives’ view on staffing 158 11.5 Communication 159 11.6 Ward fabric and cleanliness 162 11.7 Infection prevention and control issues 164 11.8 Conclusion 168 11.9 Recommendations 168 Chapter 12 Nursing care 169 12.1 The Nursing and Midwifery Council Code of Conduct 171 12.2 Use of nursing experts 172 12.3 Overall view of nursing experts 175 12.4 Record keeping 176 12.5 Nursing aspects of infection prevention and control 180 12.6 Isolation issues specific to ward F 189 12.7 Nursing assessments and care planning in the focus period 191 12.8 Nursing notes and charts in the focus period 198 12.9 Pressure damage in the focus period 205 12.10 Nursing care in the early period 210 12.11 Staffing issues and care 210 12.12 Overall conclusions on nursing care 213 12.13 Recommendations 214 v The Vale of Leven Hospital Inquiry Report Chapter 13 Antibiotic prescribing 217 13.1 Antimicrobial policy and prudent prescribing 218 13.2 The 2008 Action Plan 221 13.3 Significant failures in implementation and monitoring 223 13.4 The Antimicrobial Management Team 224 13.5 Conclusion 226 13.6 Recommendations 227 Chapter 14 Medical care 229 14.1 Inquiry medical experts 230 14.2 Record keeping 231 14.3 Medical staffing 232 14.4 Medical management of CDI 240 14.5 Do Not Attempt Resuscitation orders 247 14.6 Antibiotic prescribing 248 14.7 The process for testing for C. difficile toxin 255 14.8 Overall conclusion 262 14.9 Recommendations 262 Chapter 15 Infection prevention and control 263 15.1 The constitution of an Infection Control Team 265 15.2 The Infection Control Team for the VOLH 266 15.3 The infection prevention and control management structure 270 15.4 Implementation of policies and training 272 15.5 The Infection Control Manager 280 15.6 The Nurse Consultant 284 15.7 The infection control committee structure 286 15.8 Reporting within the infection control committee structure 294 15.9 The failure of the committee structure 298 15.10 Surveillance systems 301 15.11 Failure to identify outbreaks 306 15.12 Role of the Microbiologists 320 15.13 The Infection Control Doctor 326 15.14 Knowledge of Dr Biggs’ failure as Infection Control Doctor 331 15.15 The secondment issue 335 15.16 The reporting of C. difficile data to Health Protection Scotland and the Public Health Protection Unit 341 15.17 Statistical Process Control Charts 343 vi Contents 15.18 The VOLH Laboratory accreditation 345 15.19 Risk registers 346 15.20 Hygiene, environment and audits 349 15.21 Changes after June 2008 361 15.22 Conclusion 367 15.23 Recommendations 368 Chapter 16 Death certification 371 16.1 Form of death certificate 372 16.2 The 1999 guidance on death certification and VOLH practice 372 16.3 Accuracy in death certification in the VOLH 374 16.4 Updated guidance 375 16.5 Collation, analysis of data and future changes 376 16.6 Conclusion 378 16.7 Recommendations 379 Chapter 17 Investigations from May 2008 381 17.1 The Independent Review 382 17.2 Vale of Leven Internal Investigation Report 382 17.3 Outbreak Control Team Investigation 386 17.4 Conclusion 390 17.5 Recommendations 391 Chapter 18 Experiences of C. difficile infection within and beyond Scotland 393 18.1 The 027 strain 394 18.2 The Stoke Mandeville, and Maidstone and Tunbridge Wells reports 395 18.3 The NHS Greater Glasgow and Clyde response to Stoke Mandeville, and Maidstone and Tunbridge Wells 397 18.4 NHS Quality Improvement Scotland response 398 18.5 The response to the Stoke Mandeville, and Maidstone and Tunbridge Wells reports by Health Protection Scotland 399 18.6 The Scottish Government response 404 18.7 The Northern Health and Social Care Trust, Northern Ireland 404 18.8 Ninewells Hospital, Dundee 406 18.9 Comparison between the VOLH, Stoke Mandeville, and Maidstone and Tunbridge Wells 407 18.10 Conclusion 409 18.11 Recommendations 410 Chapter 19 Conclusion and Recommendations 411 vii The Vale of Leven Hospital Inquiry Report Appendices AP1 Patients for whom individual expert reports were commissioned 420 AP2 The Inquiry Team 421 AP3 Core Participants and their legal representation 423 AP4 Expert witnesses instructed by the Inquiry 424 AP5 Witnesses who gave oral or written evidence 431 AP6 Organisations which provided documentary evidence 433 AP7 Acronyms 434 AP8 List of figures and tables 436 AP9 Timeline of investigations prior to the Inquiry 439 viii Chairman’s letter to the Cabinet Secretary Chairman’s letter to the Cabinet Secretary The Vale of Leven Hospital Inquiry Third Floor, Lothian Chambers, George IV Bridge, Edinburgh, EH1 1RN Website: valeoflevenhospitalinquiry.org Email: [email protected] Phone: (0131) 240 6809 Fax: (0131) 225 6710 Cabinet Secretary for Health and Wellbeing St Andrew's House Regent Road EDINBURGH EH1 3DG November 2014 On 21 August 2009, I was appointed by the then Cabinet Secretary for Health and Wellbeing to hold a public inquiry into the occurrence of Clostridium difficile infection at the Vale of Leven Hospital from 1 January 2007 onwards, in particular between 1 December 2007 and 1 June 2008, and to investigate the deaths associated with that infection. The Terms of Reference were very wide-ranging and I have addressed these, I hope, comprehensively, as can be seen from the Report which I now present to you.
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