European SIXTH FRAMEWORK PROGRAMME on Health Systems and Policies ASSURING THE QUALITY OF HEALTH CARE IN THE EUROPEAN UNION A case for action Helena Legido-Quigley Martin McKee Ellen Nolte Irene A Glinos Observatory Studies Series No 12 Assuring the quality of health care in the European Union The European Observatory on Health Systems and Policies supports and promotes evidence- based health policy-making through comprehensive and rigorous analysis of health systems in Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues. The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine. Assuring the quality of health care in the European Union A case for action The European Observatory on Health Systems and Policies supports and promotes evidence- based health policy-making through comprehensive and rigorous analysis of health systems in Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues. The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Helena Legido-Quigley, Martin McKee, Ellen Nolte, Irene A Glinos Investment Bank, the Open Society Institute, the World Bank, the London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine. SIXTH FRAMEWORK PROGRAMME Keywords: QUALITY ASSURANCE, HEALTH CARE - methods DELIVERY OF HEALTH CARE - standards NATIONAL HEALTH PROGRAMS - standards HEALTH POLICY INTERNATIONAL COOPERATION EUROPEAN UNION UNITED STATES © World Health Organization 2008, on behalf of the European Observatory on Health Systems and Policies Address requests about publications to: Publications, WHO Regional Office for Europe, Scherfigsvej 8 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office web site (http://www.euro.who.int/pubrequest). All rights reserved. The European Observatory on Health Systems and Policies welcomes requests for permission to reproduce or translate its publications, in part or in full. 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ISBN 978 92 890 7193 2 Printed in the United Kingdom by MPG Books Ltd, Bodmin, Cornwall Contents List of tables, figures and boxes vii List of abbreviations viii About the authors xii Foreword I: The European experience xiii Foreword II: The United States’ experience xv Contributors xviii Acknowledgements xxv Preface xxvii Chapter 1 Quality of care: an overview 1 Quality of care: definitions 1 Dimensions of quality of care 4 Levels of quality of care 7 Assessing quality of care 9 Conceptual framework 12 Chapter 2 Quality of care strategies in the European Union 15 Introduction 15 Health systems quality assessment 17 Organizational quality assessment 29 Clinical quality assessment 35 Chapter 3 Patients, quality of care and cross-border care in the European Union 41 Introduction 41 Methodology 42 I: The users of cross-border health care: mobile patients 43 vi Assuring the quality of health care in the European Union II: Patient experiences: different aspects of quality in cross-border care 50 III: Mechanisms for ensuring quality of care and communication between 64 providers Chapter 4 Policies to promote quality of care in EU Member States 77 Introduction 77 Methodology 78 Austria 80 Belgium 84 Bulgaria 90 Cyprus 94 Czech Republic 97 Denmark 100 Estonia 105 Finland 109 France 112 Germany 116 Greece 121 Hungary 125 Republic of Ireland 128 Italy 135 Latvia 139 Lithuania 141 Luxembourg 144 Malta 148 The Netherlands 150 Poland 157 Portugal 160 Romania 162 Slovakia 166 Slovenia 169 Spain 173 Sweden 178 United Kingdom 183 Chapter 5 Conclusions 191 Meeting the needs of Europe’s citizens 192 References 199 List of tables, figures and boxes Tables Table 1.1 Definitions of quality of care 2 Table 1.2 Dimensions of quality of care 5 Table 1.3 Dimensions in the assessment of quality of care 11 Figures Figure 1.1 Levels of analysis in the concept of quality 7 Figure 1.2 Organizational levels of quality improvement in health care 8 Figure 1.3 Levels at which quality may be assessed 8 Figure 1.4 Regulatory pyramid and health care safety and quality mechanisms 9 Figure 2.1 A conceptual model of strategies for health care quality in Europe 17 Boxes Box 2.1 Action areas of WHO’s Global World Alliance for Patient Safety (2004) 25 Box 2.2 Patient safety initiatives in Denmark and the United Kingdom 26 Box 2.3 The Dutch visitatie mode 38 Box 3.1 Typology of mobile patients 44 Box 4.1 Functions of the Czech Republic Centre for Health Care Quality 97 Box 4.2 Key elements of the Irish reform programme 129 Box 4.3 Lithuanian Health Quality Assurance Programme 2005–2010 142 List of abbreviations AEZQ Agency for Quality in Medicine (Germany) AFSSAPS Agency for the Safety of Health Products (France) AIDS Acquired immunodeficiency syndrome ANAES Agency for Accreditation and Evaluation of Health Care (France) ANDEM National Agency for the Development of Medical Evaluation (France) BÄK Federal Chamber of Physicians (Germany) BIG Individual Health Care Professions Act (the Netherlands) BMA British Medical Association BMGFJ Federal Ministry for Health and Women’s Affairs (Austria) BQS Federal Office for Quality Assurance (Germany) CAF Common Assessment Framework (Finland) CBO Dutch Institute for Healthcare Improvement CEPS Economic Committee for Medical Products (France) CIS State Claims Agency (Republic of Ireland) CME Continuing medical education CMT Centre for Medical Technology Assessment (Linköping University, Sweden) COLD Chronic obstructive lung disease CoPh National College of Physicians (Romania) CQI Continuous quality improvement CT Computed tomography CYS Cyprus Organization for the Promotion of Quality DACEHTA Danish Centre for Health Technology Assessment DGEC-SECM Department for Medical Evaluation and Control (Belgium) DHIF District Health Insurance Fund (Romania) DIHTA Danish Institute for Health Technology Assessment DIMDI German Institute for Medical Documentation and Information EA European Co-operation for Accreditation EC European Commission List of abbreviations ix EFQM European Foundation for Quality Management EGQM European Good Quality Management model EHIC European Health Insurance Card EHIF Estonian Health Insurance Fund EIQA Excellence Ireland Quality Authority ELOT Greek Standards Organization EMEA European Medicines Agency EPA-PM European Practice Assessment Practice Management framework ESQH European Society for Quality in Healthcare EU European Union FAGG-AFMP Federal Pharmaceuticals and Health Products Agency (Belgium) FPS Federal Public Service (Public Health, Food Chain Safety and Environment) (Belgium) G-BA Federal Joint Committee (Germany) GMC General Medical Council (England (United Kingdom)) GP General practitioner HAS National Authority for Health (France) HIQA Health Information and Quality Authority (Republic of Ireland) HKZ Foundation for Harmonisation of Quality Review in Health Care and Welfare (Netherlands) HOPE Standing Committee of the Hospitals of the European Union HSE Health Service Executive (Republic of Ireland) HTA Health technology assessment ICH Irish Clearing House IGZ Health Care Inspectorate (Netherlands) IHSAB Irish Health Services Accreditation Board IKAS Institute for Quality and Accreditation in Health Care (Denmark) ILAC International