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Assuring the quality of health care in the European Union: a case for action

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Helena Legido-Quigley Martin McKee

Ellen Nolte Irene A Glinos

on Health Systems and Policies

European

Observatory Studies Series No 12

SIXTH FRAMEWORK PROGRAMME

ASSURING THE QUALITY OF HEALTH

CARE IN THE EUROPEAN UNION

A case for action

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

Helena Legido-Quigley, Martin McKee, Ellen Nolte, Irene A Glinos

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

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the European Observatory on Health Systems and Policies concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the European Observatory on Health Systems and Policies in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the European Observatory on Health Systems and Policies to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the European Observatory on Health Systems and Policies be liable for damages arising from its use. The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the European Observatory on Health Systems and Policies.

ISBN 978 92 890 7193 2

Printed in the United Kingdom by MPG Books Ltd, Bodmin, Cornwall

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).

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

Contents

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

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 tables, figures and boxes

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

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 Laboratory Accreditation Cooperation IMC Irish Medical Council INFARMED National Institute of Pharmaceuticals and Medicines (Portugal) INSALUD National Institute of Health (Spain) IOM Institute of Medicine (of the National Academies) (United States) IQWiG Institute for Quality and Efficiency (Germany) ISO International Organization for Standardization ISQSH Irish Society for Quality and Safety in Healthcare ISQua International Society for Quality in Health Care (Inc.) (Australia) IT Information technology JCAHO Joint Commission on Accreditation of Healthcare Organizations

(United States) KAKuG Law on Health Care Institutions (Austria) KBV National Association of Statutory Health Insurance Physicians

(Germany) KCE Health Care Knowledge Centre (Belgium) KESY Central Health Council (Greece)

List of abbreviations

x Assuring the quality of health care in the European Union

KFOA King’s Fund Organizational Audit (United Kingdom) KTQ Cooperation for Transparency and Quality in Health Care (Germany) KZI Care Institutions Quality Act (Netherlands) LOK-GLEM(s) Local Medical Evaluation Groups (Belgium) LQS Regional Offices for Quality Assurance (Germany) MHRA Medicines and Healthcare Products Regulatory Agency (England

(United Kingdom)) MRI Magnetic resonance imaging MRSA Methicillin-resistant staphylococcus aureus NAM National Agency for Pharmaceutical Medicines (Finland) NBHW National Board of Health and Welfare (Sweden) NCAS National Clinical Assessment Service (England (United Kingdom)) NCCHTA National Coordinating Centre for Health Technology Assessment

(England (United Kingdom)) NCQA National Centre for Quality Assessment in Health Care (Poland) NHIF National Health Insurance Fund (Bulgaria, Romania) NHS National Health Service (Greece, Norway, Portugal, Spain, England

(United Kingdom)) NIA National Insurance Administration (Norway) NIAZ Netherlands Institute for Accreditation of Hospitals NICE National Institute for Health and Clinical Excellence (England and

Wales Department of Health) NIP National Indicator Project (Denmark) NIVEL Netherlands Institute for Health Services Research NPSA National Patient Safety Agency (England (United Kingdom)) NRES National Research Ethics Service (England (United Kingdom)) NSAI National Standards Authority of Ireland NTPF National Treatment Purchase Fund (Ireland) NVZ Dutch Hospital Association NZa Dutch Healthcare Authority OECD Organisation for Economic Co-operation and Development RIZIV-INAMI National Institute for Sickness and Disability Insurance (Belgium) SACHI State Agency for Compulsory Health Insurance (Latvia) SALAR Swedish Association of Local Authorities and Regions SBU Swedish Council on Technology Assessment in Health Care SEMC Standards of Efficient Medical Care (Czech Republic) SGB Social Code Book (Germany) SGL State General Laboratory (Cyprus) SIQUAS VRQ Italian Society for Quality Health Care SMC Supreme Medical Council (Bulgaria) SPRI Swedish Institute for Health Services Development STAKES National Research and Development Centre for Welfare and Health

(Finland) TEO National Authority for Medico-Legal Affairs (Finland)

TQM Total quality management URML Regional Medical Unions (France) VAT Value-added tax WGBO Medical Treatment Contracts Act (the Netherlands) WHO World Health Organization WKCZ Clients’ Right of Complaint Act (the Netherlands) WMCZ Participation by Clients of Care Institutions Act (the Netherlands) WTZi Admission of Care Institutions Act (the Netherlands) ZOM Zorg op Maat project: experimental cross-border health care project

in the Meuse-Rhine border region (Netherlands)

List of abbreviations

Ms. Helena Legido-Quigley, Research Fellow in Public Health, London School of Hygiene & Tropical Medicine, London

Professor Martin McKee, Professor of European Public Health, London School of Hygiene & Tropical Medicine, and Research Director, European Observatory on Health Systems and Policies, London

Dr Ellen Nolte, Senior Lecturer in Public Health, London School of Hygiene & Tropical Medicine, and Senior Research Fellow, European Observatory on Health Systems and Policies, London

Ms. Irene A Glinos, Researcher, Observatoire Social Européen, Brussels, and University of Maastricht, Maastricht

About the authors

It gives me great pleasure to introduce and recommend this publication on Assuring the quality of health care in the European Union. It comes at an important time in the policy debate on health care and the role of the European Union (EU). Health systems and health policies across the EU are becoming more interconnected than ever. This is a result of many factors, including movement of patients and professionals (facilitated by rulings of the European Court of Justice), common public expectations across Europe, dissemination of new medical technologies and techniques through information technology (IT), and the enlargement of the EU. This increased interconnection raises many health policy issues, not least that of quality and access to health care and it is clear that the ability of European citizens to obtain health care of high quality throughout the EU is emerging as an important policy issue. The European Commission (EC) Directorate-General for Research is committed to research that informs policy and this published work is a clear example of how such research can feed into the policy process, such as the EC’s deliberations on a Community framework for the application of patients’ rights in cross-border health care. At the same time it is evident that the richness of European research is clearly illustrated by the array of contributors involved, and I would like to congratulate the authors on this achievement.

This publication grew out of the research carried out within the Europe for Patients project (2004–2007), one of the first to be supported under the Scientific Support to Policies Activity of the EU 6th Framework Programme for Research (FP6). Europe for Patients was an initiative to provide scientific underpinning and the evidence base needed by EU policy-makers to take concerted and coordinated action to allow Europe’s citizens (or patients) to benefit from enhanced mobility in Europe.

Foreword I: The European experience

Kevin McCarthy Public Health Research, European Commission

xiv Assuring the quality of health care in the European Union

The Scientific Support to Policies Activity under FP6 targeted research to serve the formulation and implementation of EU policies. The objective was to help to create over time a more efficient environment for policy research in the EU, providing policy actors throughout the EU with a facility to access relevant Community research, reinforcing the link between research and policy, making it stronger, more responsive and more coherent than before.

This approach has now become mainstream in the “Health Theme” under the EU 7th Framework Programme for Research (FP7, 2007–2013). The intention is that European public health research will aim to provide the necessary basis both for informed policy decisions on health systems and for more effective strategies of health promotion, disease prevention, diagnosis and therapy. These activities are part of the 3rd pillar of the Health Theme under the Specific Programme “Co-operation” of FP7 that is entitled “Optimizing the delivery of health care to European citizens”. Loosely referred to as “public health research”, this pillar will contribute to the policy debate at European level by seeking to provide the framework to develop new research methods and generate the necessary scientific basis to underpin informed policy decisions by Member States on health systems and on more effective and efficient evidence-based strategies of health promotion and disease prevention.

I believe this book will provide policy stakeholders throughout the EU with better insight and evidence for enhancing policy decisions – ultimately for the benefit of all European citizens. It should also demonstrate that first-class research leads to high-quality policies. EU research funding is ideally placed to serve the needs of policy-makers in this domain and I look forward to further results and policy contributions from such projects under the new direction provided for in FP7.

Geographic variation in quality of health care: the United States’ experience

In the last few years, increasing awareness of variations in the quality of health care across geographic areas has helped propel a quality improvement movement. This important book documents concerns with variations across European nations, analyses quality measurement, assurance, and improvement efforts in various European countries, and sets forth an agenda for ensuring that everyone has access to high-quality care regardless of where they live or travel.

Similar enquiries are ongoing in the United States. Four recent reports document extensive variation in quality and costs across states within the United States. State-by-state reports on quality by the Agency for Healthcare Research and Quality (AHRQ), along with the state scorecard on health system performance by the Commonwealth Fund Commission on a High Performance Health System, constitute a rich database to inform state and national health policy and stimulate further research and analysis of the determinants of, and interrelationships among, quality, health outcomes, access, cost, and equity dimensions of performance (AHRQ 2006; Cantor et al. 2007). A United Health state report card focusing on health outcomes and public health adds to this rich database (United Health Foundation 2007) and more recently, Martin and colleagues have documented broad variations in health expenditure across states (Martin et al. 2007).

Several conclusions from these recent studies stand out.

• Health care access, quality, costs and efficiency vary widely across the United States. The range of performance is often two- to threefold or greater on various key indicators.

Foreword II: The United States’ experience

Karen Davis Commonwealth Fund, New York

xvi Assuring the quality of health care in the European Union

• Leading states consistently out perform lagging states on multiple indicators and dimensions. The patterns indicate that federal and state policies and local and regional health systems make a difference.

• Across states, better access is closely associated with better quality. States with the highest rates of uninsured residents tend to score highest on measures of preventive and chronic disease care, as well as other quality indicators.

• There are significant opportunities to reduce costs as well as to improve access to and quality of care. Higher quality is not associated with greater spending across states (Davis and Schoen 2007).

• All states have significant room to improve. States can learn from best practices and policies that contribute to benchmark levels of health system performance.

In the United States, as in Europe, benchmarks set by leading geographic regions show there are broad opportunities to improve and achieve better and more affordable health care. With health costs rising faster than incomes and straining family, business, state and federal budgets, and with startling evidence of variable quality and inefficient care, all states and nations have much to gain from aiming higher.

Comparable databases on which to assess international variations in quality need considerable further development but important work is shedding insight into variations across countries. For 10 years, Commonwealth Fund international health policy surveys of the public, sicker adults and health care professionals have compared select aspects of health system performance in five to seven countries (Davis et al. 2007). Again, significant variations exist, although some systematic patterns persist. The United States, with its market-based health system and limited role for regulation of the health system systematically scores lowest among the countries compared, most recently including Australia, Canada, Germany, the Netherlands, New Zealand, and the United Kingdom, as well as the United States (Schoen et al. 2007).

An Organisation for Economic Co-operation and Development (OECD) international working group on health care quality is developing and expanding a database on comparable clinical quality indicators (Hussey et al. 2004). Important work by Nolte and McKee is expanding our understanding of variations in mortality amenable to medical care (Nolte and McKee 2003; Nolte and McKee 2008). All of these resources are an important foundation from which to promote greater understanding of promising strategies for meeting and raising benchmark standards of care.

xvii

In the United States, the quality improvement movement is being advanced by a growing acceptance of the need for transparency regarding quality and cost performance by health care providers, and the importance of accountability for results and proper stewardship of resources at national, regional, and local levels.

The quality improvement agenda starts with better data on benchmark levels of performance on key indicators, for example the level achieved by the top decile of hospitals, physicians, health care organizations or geographic areas. Knowing how one stands, who the top performers are and the best practices leading to peak performance are key to improvement. This requires greater openness, collaboration and resources devoted to improvement. The United States is watching the nations that have established organizations devoted to developing, synthesizing and disseminating comparative effectiveness information on prescription drugs, devices and procedures.

Activated, informed patients are also key to quality improvement, which can be facilitated with a philosophy of shared decision-making and access to information and tools to assist patients in this role. Similarly, an engaged and motivated professional commitment to high standards of quality and continuous quality improvement – through the actions of physicians and other health professionals and their professional societies – is crucial to success.

But all sectors of society will need to make quality improvement a priority to narrow variations and improve overall levels of performance. The United States lags markedly behind other countries because it has not committed sufficient resources to health information technology (Schoen et al. 2006). Other strategies that need to be part of a multifaceted approach to quality improvement include better technical assistance, changes in the organization and delivery of care, and at least in the United States context, financial incentives that reward better results. For other countries, a greater array of regulatory and other governmental strategies may also be effective.

Achieving a shared goal of a high-performance health system requires, most of all, a commitment to learning both from variations within countries and across nations. This book is an important starting point in identifying the array of strategies to measure, assure and improve quality across European countries. It needs to be followed by systematic mining of data on variations in performance, and research to better understand the multiple determinants of health outcomes, quality, access, equity and cost.

Foreword II: The United States’ experience

Austria

Ms. Ursula Fronaschuetz, Department of Quality Management and Health Economics, Austrian Federal Ministry of Health and Women, the Ministry of Health, Austria

Dr Guido Offermanns, Assistant Professor at the University of Klagenfurt/ Austria, Faculty of Management and Economics, Department of Public, Non- Profit and Health Management, Austria

Dr Esther Thaler, Managing Director, ÖQMed – Austrian Society of Medical Quality Assurance and Quality Management LLC, Vienna, Austria

Belgium

Ms. Rita Baeten, Policy Analyst, European Social Observatory, Brussels, Belgium

Ms. Leen Meulenbergs, Advisor to the Minister of Health, Belgium

Mr Pascal Meeus, Ministry of Health, Belgium

Bulgaria

Dr Lidia Georgieva, Associate Professor, Senior Advisor Head of Health Risk Management, Marsh EOOD, Sofia, Bulgaria

Ms. Svetla Tsolova, Associate Research Fellow, Index Foundation, Sofia, Bulgaria

Contributors

xix

Cyprus

Dr Annita Anastassiadou, Coordinator, European Integration Sector, Ministry of Health Cyprus, Cyprus

Dr Mamas Theodorou, Associate Professor of Health Policy, Cyprus Open University, Cyprus

Czech Republic

Dr Aleš Bourek, Head of University Center for Healthcare Quality, Masaryk University Medical Faculty, Czech Republic

Ms. Lenka Grohova, International Department, Czech Medical Chamber, Czech Republic

Ms. Milena Kalvachova, Ministry of Health, Department of Health Care, Czech Republic

Denmark

Dr Jan Mainz, Professor, University of Southern Denmark, Hojbjerg, Demark

Dr Thomas Schiøler, Chief Project Officer, the Danish Healthcare Quality Assessment Programme, National Board of Health, Denmark

Ms. Gunilla Svensmark, Consultant, Danish Nurses’ Organization, Denmark

Estonia

Mr Ain Aaviksoo, CEO, Director of Health Policy Program, PRAXIS Center for Policy Studies, Tallinn, Estonia

Dr Maris Jesse, Health Policy Analyst, PRAXIS Center for Policy Studies, Tallinn, Estonia

Finland

Dr Risto Pomoell, Ministerial Counsellor, Ministry of Social Affairs and Health, Finland

Dr Juha Teperi, National Research and Development Centre for Welfare and Health, Finland

Contributors

xx Assuring the quality of health care in the European Union

France

Dr Charles Bruneau, Scientific Advisor, French National Authority for Health, La Plaine Saint-Denis, France

Mr Christophe Debout, President of the French Nurses Association ANFIIDE, France

Mr Pascal Garel, Chief Executive, HOPE, Brussels, Belgium

Germany

Professor Reinhard Busse, Professor and Director, Department of Health Care Management, Berlin University of Technology, and Associate Head of Research Policy, European Observatory on Health Systems and Policies, Berlin, Germany

Professor Dr Günter Ollenschläger, Director, Agency for Quality in Medicine, Berlin, Germany

Professor Doris Schiemann, Fachhochschule Osnabrück (University of Applied Sciences), Faculty of Business Management and Social Sciences, Osnabrück, Germany

Dr Susanne Weinbrenner, Research Officer, Department of Health Care Management, Berlin University of Technology, Berlin, Germany

Greece

Mr Nykos Polyzos, Associate Professor, Financial Management of Health and Welfare Units, Kalamata’s Technical University (TEI), Greece

Hungary

Mr Zoltán Balogh, President of Association and Official Delegate, Hungarian Nursing Association, Hungary

Dr Eva Belicza, Senior Fellow at Health Services Management Training Centre, Semmelweis University, Budapest, Hungary

Dr Laszlo Gulácsi, Chair Professor, Health Economics Research Centre, Corvinus University, Budapest, Hungary

Republic of Ireland

Dr Ian Callanan, Head of Clinical Audit, St. Vincent’s Healthcare Group, Dublin, Republic of Ireland

xxi

Dr Breeda Howley, Lecturer, UCD School of Nursing, Midwifery & Health Systems, Republic of Ireland

Dr Jim Kiely, Chief Medical Officer Department of Health and Children, Hawkins House, Republic of Ireland

Professor Miriam Wiley, Head of the Health Services Research and Information Division at the Economic and Social Research Institute, Republic of Ireland

Italy

Dr Luigi Bertinato, Director of International Health & Social Affairs Office, Veneto Region, Venice, Italy

Professor Piera Poletti, Director, CEREF, Padova, Italy

Professor Julita Sansoni, Director of Nursing Area, Department of Public Health, University of Rome “La Sapienza”, Italy

Dr Simonetta Scaramagli, Medical Doctor, Local Health Unit 10, Veneto Region, Venice, Italy

Latvia

Mr Girts Brigis, Medical Academy of Latvia, Latvia

Lithuania

Dr Ramune Kalediene, Dean of the Faculty of Public Health, Kaunas University of Medicine, Lithuania

Dr Ramune Navickiene, State Inspectorate of Medical Audit by the Ministry of Health Care, Lithuania

Luxembourg

Ms. Marie-France Liefgen, Vice-president ANIL, Luxembourg

Dr Susanne Michel, Director Health Consulting, United Kingdom

Malta

Dr Natasha Azzopardi Muscat, Director General, Strategy and Sustainability, Ministry of Health, the Elderly and Community Care, Valletta, Malta

Contributors

xxii Assuring the quality of health care in the European Union

The Netherlands

Dr Cule Cucic, Programme Director, CBO Dutch Institute for Healthcare Improvement, Utrecht, the Netherlands

Mr Willem Kistemaker, CBO Dutch Institute for Healthcare Improvement, Utrecht, the Netherlands

Professor Niek Klazinga, Professor of Social Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands

Ms. Eveline Klein-Lankhorst, Research Assistant, London School of Hygiene and Tropical Medicine, London, United Kingdom

Mr Benno van Beek, Senior Advisor, Knowledge and Innovation Department, CBO Dutch Institute for Healthcare Improvement, Utrecht, the Netherlands

Poland

Ms. Basia Kutryba, ESQH President, National Center for Quality Assessment in Health Care, Krakow, Poland

Ms. Halina Wasikowska, National Centre for Quality Assessment in Health Care, Poland

Portugal

Dr Francisco Alpendurada, Medical Doctor, Royal Brompton Hospital, London, United Kingdom

Mr Antonio Manuel V. A. Silva, Director, International Affairs, Ordem dos Enfermeiros, Portugal

Dr Suzana Parente, Portuguese Society for Quality in Healthcare, Lisbon, Portugal

Romania

Dr Cassandra Butu, Public Health Expert, National School of Public Health, Romania

Dr Victor Olsavszky, Head of WHO Country Office, Romania

Dr Gabriela Scintee, Public Health Expert, Center for Health Policies and Services, Romania

xxiii

Professor Dr Cristian Vladescu, Professor of Public Health, Timisoara Medical University, Romania

Slovakia

Dr Darina Sedlakova, Head of WHO Country Office, Slovakia

Slovenia

Dr Tit Albreht, Adviser to the Director, Institute of Public Health of the Republic of Slovenia, Ljubljana, Slovenia

Ms. Elizabeta Bobnar Najžer, Medical Chamber of Slovenia, Slovenia

Professor Dr Andrej Robida, Medical Faculty and Faculty for Health Sciences, University of Maribor, Slovenia

Ms. Eva Turk, Researcher, Institute of Public Health of the Republic of Slovenia, Ljubljana, Slovenia

Spain

Dr José Mª Amate, Head of Unit, Health Technology Assessment Agency Institute of Health Carlos III, Ministry of Health & Consumers Affairs, Spain

Ms. Isabel de la Mata, Health Counsellor, Spanish Permanent Representation to the EU, Spain

Dr Juan Garcia-Caballero, Preventive Medicine Services, Hospital La Paz, Madrid, Spain

Ms. Maria Lluch, Project Coordinator, London School of Economics and Political Science, London, United Kingdom

Professor Angel Otero, Department of Public Health, Autonomous Universty of Madrid, Spain

Dr Rosa Suñol Sala, Director, Avedis Donabedian Foundation, Barcelona, Spain

Sweden

Ms. Ewa Axelsson, Doctoral Candidate in Medical Law Faculty of Law, Uppsala University, Sweden

Contributors

Dr Michael Bergstrom, Global Knowledge Explorer, Change Agent, Project Director, Swedish Association of Local Authorities and Regions, Stockholm, Sweden

Mr Karl-Henrik Lundell, Medical Director, Jönköping Health Care District, Vice President Swedish Forum for Quality in Health Care, Sweden

Ms. Anette Richardson, Adviser, Swedish Association of Health Professionals, Sweden

United Kingdom

Dr Jason Christopher, General Practitioner in Tower Hamlets, London, United Kingdom

Dr Helen Hogan, Research Fellow/Specialist Registrar Public Health, London School of Hygiene & Tropical Medicine, London, United Kingdom

Dr Lorelei Jones, Research Fellow, London School of Hygiene and Tropical Medicine, London, United Kingdom

Dr David Somekh, Vice President, European Society for Quality in Healthcare, Whitwell, United Kingdom

Mrs Maggie Somekh, Kingates Farm, Isle of Wight, United Kingdom

Professor Kieran Walshe, Professor of Health Policy and Management, University of Manchester, Manchester, United Kingdom

International

Professor Elias Mossialos, European Observatory on Health Systems and Policies (London hub), London School of Economics and Political Science, London, United Kingdom

Dr Josep Figueras, Director, European Observatory on Health Systems and Policies, Brussels, Belgium

Mr Willy Palm, Dissemination Development Officer, European Observatory on Health Systems and Policies, Brussels, Belgium

Assuring the quality of health care in the European Unionxxiv

This volume is one of a series of books produced by the European Observatory on Health Systems and Policies. The work that it reports was collected within the Europe for Patients project of the European Union’s 6th Framework Programme. We are especially grateful to Mr Kevin McCarthy, from DG Research, and Mr Nick Fahy, from DG Sanco, for their continuing and wide-ranging support of this work. We are also grateful to our collaborators in this project, led by Magdalene Rosenmöller. They include Rita Baeten, Elias Mossialos, Sherry Merkur, Maria Lluch, Angela Dunbar, Yves Jorens, Michael Coucheir, Ain Aaviksoo, Maris Jesse, Ruta Kruuda1, Jim Jamison, Patricia Clark, Tit Albreht, Rade Pribakovic, Eva Turk, Luigi Bertinato, Dario Zanon, Francesco Ronfini, Simonetta Scaramagli, Ilaria Passarani, Willy Palm and Josep Figueras. Ellen Nolte is funded by a Personal Award Scheme Career Scientist Award from the National Institute for Health Research (England).

Charles Shaw also provided valuable insights on quality across Europe as a whole. We would like to thank our external reviewer, Kieran Walshe, whose comments were particularly helpful.

We would also like to thank those that helped with searching for information and summarizing the results of documents written in German, Italian and French. These are Rosemary Quigley, Florian Marx, Cristina Legido-Quigley and Stephane Mino-Vercellio.

We are especially grateful to the production team in the European Observatory, past and present, including Francine Raveney, Giovanna Ceroni, Jonathan North, Nicole Satterley and Caroline White, and for the administrative support provided by Sue Gammerman.

1 Deceased

Acknowledgements

The research reported in this publication was supported by the European Commission’s Directorate General for Research, as part of the Europe for Patients project, undertaken within the Scientific Support for Policies component of the 6th Framework Programme.

Assuring the quality of health care in the European Unionxxvi

The European Union (EU) is built on the concept of four freedoms: free movement of goods, services, people and capital. To make these freedoms realizable the EU has, over many years, enacted laws to ensure, first, that goods and services provided across borders are of an appropriate quality (exemplified by the European Commission (EC) safety mark on many goods) and, second, that freedom for people to move is not constrained by their health (by ensuring that they can obtain health care when outside their home country).

The challenge now facing the EU’s legislators is how to ensure that these two goals are fully aligned. While many of the elements required to deliver high- quality health care are subject to European standards, such as the licensing of pharmaceuticals and certain technical aspects of health technology, there is still much to be done to ensure that European Union citizens can be confident that any care they receive outside their own Member State will be safe and of high quality.

This book asks the question: can the citizens of the EU be assured of receiving high-quality care if they need health care beyond their national frontiers? It forms part of the Europe for Patients project, which was undertaken within the EU’s 6th Framework Programme for Research (FP6).

The first part of the book is divided into three chapters. The first presents an overview of the concept, nature, methods and players involved in the assessment of quality of care, thus identifying the main issues surrounding quality of care and providing the conceptual basis for the rest of the book. The second focuses on those strategies for promoting quality of care that already exist within the EU as well as on those being considered for the future. It draws on a large amount of material, summarized in Chapter 4, which provides a description of the mechanisms to ensure quality of care in each EU Member State.

Preface

xxviii Assuring the quality of health care in the European Union

The third chapter presents the issues pertaining specifically to quality of care when care is delivered in a cross-border setting, that is, when patients travel to be treated outside their home country. The chapter is divided into four parts. Before entering the discussion on quality of care, it is necessary to explain what we understand by cross-border care and to introduce the different categories of mobile patients that we have identified. The first part of the chapter presents a taxonomy of five patient types that constitute a useful way to conceptualize patient mobility and to understand the motivations and arrangements by which people use health care services outside their home country. The second part focuses on quality of health care in cross-border settings from the patient’s perspective, based on patient surveys and interviews that highlight the needs, expectations and satisfaction of those who have experienced cross-border care. The third part complements this by examining quality of cross-border care from a functional perspective to identify what mechanisms are in place to ensure quality of care and fluid communication between health professionals in projects that link providers, purchasers and health authorities on both sides of a border. This part is based on descriptions of projects in the literature and, where available, the opinions and experiences of involved stakeholders are presented. The final part presents an overview of the needs, in terms of assurance of quality, of each of the five patient types.

The fourth chapter collates brief descriptions of the systems to enhance quality of care that have been established in each of the EU’s 27 Member States.

Finally, the fifth chapter introduces a 2-step logic which, if adopted by policy- makers, could ensure that patients receive high-quality health care when they are treated abroad. This chapter concludes that there is considerable variation between and within EU Member States in the approaches they have taken and the extent to which they have implemented programmes to ensure quality of care. However, while we have been able to assemble a number of descriptions of systems already in place, with very few exceptions there is a remarkable lack of evaluative research that can provide information on whether the systems that exist are effective, or even in many cases how widely implemented they are in practice.

Quality of care: definitions

The literature on quality of care in health systems is very extensive and at the same time difficult to systematize. Depending on the disciplinary paradigm, quality can be understood in diverse ways, using different terms, labels and models. Where there seems to be agreement is that there is no consensus on how to define quality of care and that the lack of a common systematic framework is, to a considerable extent, due to the diversity in the language used to describe this concept (Blumenthal 1996; Brook, McGlynn and Cleary 1996; Saturno, Gascón and Parra 1997; Evans et al. 2001; Shaw and Kalo 2002; Suñol and Bañeres 2003). This chapter reviews the most frequently used definitions of quality of care that have been proposed so far and examines how quality can be assessed, using the available literature. An understanding of the core concepts, dimensions, measurement tools and the players involved in the decision-making processes is key to assessing quality assurance systems that exist within the European Union (EU).

Drawing on the seminal work of Avedis Donabedian, the first step in assessing the quality of care involves defining what is meant by quality (Donabedian 1988). Yet, as indicated above, there are many possible definitions. The choice of which one to adopt will to some extent depend on the level of analysis or specific context. Consequently, different definitions may be acceptable depending on their intended use, as well as the nature and scope of the responsibilities of the person who is defining them (Donabedian 1988). There is, however, a risk that failure to accept certain general principles within Europe will make

Chapter 1

Quality of care: an overview

2 Assuring the quality of health care in the European Union

it much more difficult to define consistent frameworks for measurement. It is also important to recognize that the definitions of quality of care are constantly evolving. Initially, the definition and assessment of quality was within the purview of health professionals and health service researchers. However, there is a growing recognition that the preferences and views of patients, the public and other key players are also relevant (Brook, McGlynn and Cleary 1996; Shaw and Kalo 2002).

Table 1.1 provides an overview of the most frequently applied definitions of quality of care, as identified in the literature. These definitions demarcate the boundaries of quality, while a second set of definitions, presented below, more clearly distinguishes the various dimensions of the concept.

Table 1.1 Definitions of quality of care

Author/Organization Definition

Donabedian (1980) Quality of care is the kind of care which is expected to maximize an inclusive measure of patient welfare, after one has taken account of the balance of expected gains and losses that attend the process of care in all its parts.

IOM (1990) Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.

Department of Quality of care is: Health (UK) (1997) • doing the right things (what)

• to the right people (to whom)

• at the right time (when)

• and doing things right first time.

Council of Europe Quality of care is the degree to which the treatment dispensed (1998) increases the patient’s chances of achieving the desired results and diminishes the chances of undesirable results, having regard to the current state of knowledge.

WHO (2000) Quality of care is the level of attainment of health systems’ intrinsic goals for health improvement and responsiveness to legitimate expectations of the population.

Notes: IOM: Institute of Medicine; WHO: World Health Organization.

The definitions put forward by Avedis Donabedian and by the Institute of Medicine (IOM) have been particularly influential. Thus, Donabedian defined quality as “the ability to achieve desirable objectives using legitimate means”, while quality of care was defined as “that kind of care which is expected to maximize an inclusive measure of patient welfare, after one has taken account

of the balance of expected gains and losses that attend the process of care in all its parts” (Donabedian 1980). He argued that before assessing quality of care it is necessary to define whether monetary cost should enter the definition of quality. He thus distinguished a “maximalist” specification from an “optimalist” specification of quality. The maximalist specification ignores monetary costs and defines the highest quality as the level that can be expected to achieve the greatest improvement in health. In contrast, in the optimalist specification of quality, very expensive interventions that do not achieve a great improvement in health would be avoided (Evans et al. 2001). Initially, Donabedian defined quality of care from a maximalist perspective, while later he opted for the concept of value, with quality defined as the maximum that is possible given the inputs that are available.

One other very influential definition of quality of care is that proposed by the IOM in the United States and which has been adopted by a range of (mostly American) organizations including the United States Department of Health and Human Services, the Joint Commission on Accreditation of Healthcare Organizations and the National Committee for Quality Assurance, as well as regulatory bodies such as the Health Care Financing Administration (now Centers for Medicare & Medicaid Services) (Edinger 2000). Already in 1974 the IOM had commented on quality assurance, stating that its “primary goal … should be to make health care more effective in bettering the health status and satisfaction of a population, within the resources which society and individuals have chosen to spend for that care”. When reviewing this early work later, the IOM realized that “quality of care” had not been defined. It also acknowledged that the method of reviewing and assuring quality depended on how quality of care was defined (IOM 1990).

Therefore, in a 1990 report, the IOM authors reviewed over 100 definitions and parameters of quality of care according to the presence or absence of 18 dimensions (IOM 1990). Based on this review, the authors arrived at a definition of quality of care that considers 8 of the 18 dimensions identified. Consequently, quality of care was defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (IOM 1990).

The definition:

• includes a measure of scale;

• encompasses a wide range of elements of care with reference to health services;

• identifies both individuals and populations as targets for quality assurance efforts;

Quality of care: an overview

4 Assuring the quality of health care in the European Union

• is goal oriented, making a distinction within the health care goals depending on whether they emanate from government, patients, administrators, health care practitioners or other participants in the health care system;

• recognizes the importance of outcomes without specifying for whom, thus allowing the possibility of differing perspectives on which values of quality are most important;

• highlights the importance of individual patients’ and society’s preferences and values and implies that the patients have been taken into account in health care decision- and policy-making;

• underlines the constraints placed on professional performance by the state of technical, medical and scientific knowledge, implying that the State is dynamic and that the health care provider is responsible for using the best knowledge base available.

It is important to note that compared to the definition developed by Donabedian, the IOM definition narrows the goal from improving total patient welfare to improving health outcomes (Evans et al. 2001). At the same time, it shifts the focus from patients to individuals and populations, hence allowing quality of care also to incorporate health promotion and disease prevention and not just cure and rehabilitation. It also adds “desired outcomes” to the definition so as to emphasize the need to consider the perspective of the recipients of services, and by highlighting that care should be “consistent with current professional knowledge” it implies that the standards of the service also need to be defined.

Dimensions of quality of care

As noted above, several authors and/or organizations have defined quality of care by describing the concept according to a set of dimensions (Table 1.2). The most frequently used dimensions include (in descending order of frequency): effectiveness, efficiency, access, safety, equity, appropriateness, timeliness, acceptability, patient responsiveness or patient-centredness, satisfaction, health improvement and continuity of care. These dimensions are, however, neither comprehensive nor mutually exclusive.

The dimensions of effectiveness and efficiency are included in all definitions of quality of care analysed here. Effectiveness refers to the extent to which the intervention in question produces the intended effects (Maxwell 1992; Witter and Ensor 1997). Efficiency, in contrast, refers to the extent to which objectives are achieved by minimizing the use of resources (WHO 2000). The goal is to maximize the output for a given input, or conversely to minimize the input for a given level of output, for example by comparing the unit cost associated

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with the intervention with the unit cost elsewhere for the same intervention or service (Maxwell 1992).

Access (to care) is also an important dimension in all definitions of quality of care considered in the literature, except for the one put forward by the IOM (IOM 2001). Access can, in very simple terms, be operationalized as the proportion of a given population in need of health services that can obtain them (WHO Regional Office for Europe 1998). It is important to note that access has been attributed different meanings by different authors (Saturno, Gascón and Parra 1997). However, the common concern is to quantify whether a health service or treatment is available to the person needing it, at the time it is needed.

Safety refers to the reduction of risk and forms an important component of several definitions. According to the IOM, patient safety is “freedom from accidental injury due to medical care, or medical errors”, with medical error being defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim…[including] problems in practice, products, procedures, and systems” (Kohn, Corrigan and Donaldson 2000).

Table 1.2 Dimensions of quality of care

Donabedian Maxwell Department Council of IoM JCAHO (1988) (1992) of Health Europe (2001) (2006) (UK) (1997) (1998)

Effectiveness X X X X X X Efficiency X X X X X X Access X X X X X Safety X X X X Equity X X (X) X Appropriateness X X X X Timeliness X X X Acceptability X X Responsiveness Respect Respect Choice Patient- Information centred- ness Satisfaction (X) X

Health improvement X X

Continuity X

Other Technical Efficacy Availability competence Prevention/ Relevance early detection

Sources: Donabedian 1988; Maxwell 1992; Department of Health 1997; Council of Europe 1998; IOM 2001; JCAHO 2006. Notes: IOM: Institute of Medicine: JCAHO: Joint Commission on Accreditation of Healthcare Organizations.

Quality of care: an overview

� Assuring the quality of health care in the European Union

Patient safety has traditionally been considered as one among many dimensions of quality of care, but it is increasingly being seen as absolutely key to quality overall. As a consequence, the policy debate concerning patient safety has developed in parallel to mainstream quality of health care initiatives. It is therefore important to reiterate that patient safety forms a dimension of quality of health care.

Equity, as a separate, if related, dimension is also included in some classifications. This is different from, but often confused with, equality. Equity implies considerations of fairness so that, in some circumstances, individuals will receive more care than others to reflect differences in their ability to benefit or in their particular needs.

The next sets of dimensions most frequently mentioned refer to the extent to which care meets the medical, social and aspirational needs of patients. These dimensions are: appropriateness (how the treatment corresponds to the needs of the patient); timeliness (receiving treatment within a reasonable time frame); acceptability (how humanely and considerately the treatment is delivered); responsiveness to patients or patient-centredness (consideration of individual patients’ and society’s preferences and values); satisfaction (how the treatment and the improvement in the patient’s health meets her/his expectations); and continuity of care (the connectedness between stages along the patient pathway). As will be seen later, continuity of care is regarded as the most important concern by those patients who are receiving care abroad.

An overriding dimension mentioned specifically by Maxwell is that of relevance (Maxwell 1992). It refers to the optimal overall pattern and balance of services that could be achieved, taking into account the needs and wants of the population as a whole. The Council of Europe also includes two notions that are not included by the other definitions considered here, namely those of efficacy and assessment. Efficacy constitutes for the individuals in a defined population the probable benefit of a given medical technique for a specific medical problem, in ideal circumstances, and as such is a rather more limited element of effectiveness. Assessment refers to the degree to which effective health care has been implemented and achieved and results have been attained (Council of Europe 1998).

The choice of dimensions to measure quality of care is critical as it will influence the health care policies adopted. Thus, (Shaw and Kalo 2002) underline the key challenge for every country to recognize these diverse but legitimate expectations and to reconcile them in a responsive and balanced health system.

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Levels of quality of care

There are different levels at which quality of care can be addressed. Here we present four possible approaches to classifying levels of quality of care, ranging from broad concepts to Donabedian’s thorough and comprehensive analysis, and concluding with a framework that looks at different levels of regulation as applied to patient safety.

Saturno and colleagues distinguish three levels of quality that relate to the delivery of care (Figure 1.1) (Saturno, Gascón and Parra 1997). The first level refers to a general concept of quality and is applicable to any service, product or institution in the health system. The second level is applicable to a specific group of services, while the third level refers to a specific product or service that is provided in health institutions.

The Council of Europe (1997) proposed an approach that takes account of the different administrative and organizational tiers of the health care system, emphasizing the need to improve the quality of care at each level of service delivery (Figure 1.2), including: central (country, district); local (hospital, local or regional organization for home care, collaboration practices, etc.); unit (practice team, hospital unit); and individual level (individual health care provider).

The approach proposed by Donabedian considers four levels at which quality may be assessed (Figure 1.3). It takes account of the actors involved in the process of care (providers, patients, communities) as well as the setting in which health care takes place. This classification not only distinguishes different levels of quality but also identifies specific elements that define quality at that level. At the core he places the care provided by practitioners and other providers. These are further defined by two elements of performance: technical performance and the management of interpersonal relationships. The former depends on

Specific product or service

Specific group of health services

Any service, product or institution in a given health system

Figure 1.1 Levels of analysis in the concept of quality

Quality of care: an overview

Source: Adapted from Saturno, Gascón and Parra 1997.

� Assuring the quality of health care in the European Union

the knowledge and judgement used in arriving at the appropriate strategies of care and on the skills needed to implement those strategies. It is assessed in comparison with best practice. The second element relates to the way in which technical care is implemented and on which its success depends, an element that is often ignored in assessments of quality of care.

The second level involves the amenities of care, focusing on the desirable attributes of the settings in which care is provided. The third level refers to the actual implementation of care, responsibility for which is shared between the provider and the patient. The final level refers to the care received by the community as a whole and considers issues of social distribution of levels of quality. Thus, according to Donabedian, the definition of quality becomes either narrower or more expansive, depending on how the concept of health and related responsibilities are being defined (Donabedian 1988).

Figure 1.2 Organizational levels of quality improvement in health care

Indivdual level

Unit level

Central level

Local level

Care provided by individual practitioners and other providers

Amenities: attributes of the care setting

Community setting

Implementation of care

Figure 1.3 Levels at which quality may be assessed

Source: Adapted from Council of Europe 1997.

Source: Adapted from Donabedian 1988.

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A different approach was taken by Braithwaite, Healy and Dwan (2005), who proposed a framework for analysis that is based on regulation, its different levels and its applicability to patient safety. Their main argument derives from the concept of responsive regulation “which maintains that regulators are more likely to succeed by using mechanisms that are responsive to the context, conduct, and culture of those being regulated”. Escalating sanctions can be invoked “that is, soft words before hard words, and carrots before sticks” (Braithwaite, Healy and Dwan 2005). The authors illustrate the concept by means of a regulatory pyramid that stretches from regulation to market mechanisms, with examples relating to patient safety across the spectrum (Figure 1.4). The base of the pyramid is formed by market mechanisms (e.g. payments to incentivize quality), followed by voluntarism (e.g. clinical protocols), self-regulation (e.g. industry standards) and meta-regulation (e.g. compulsory incident reporting), with command and control at the apex of the pyramid (e.g. criminal penalties).

Assessing quality of care

The preceding sections have presented a range of systematic approaches to defining and classifying quality of care. Yet, the various concepts and models say little about how actually to assess quality. Donabedian pioneered this work by proposing that we can measure the quality of health care by evaluating its

Quality of care: an overview

Command and control

Meta-regulation

Self-regulation and voluntarism

Market mechanisms

Figure 1.4 Regulatory pyramid and health care safety and quality mechanisms

Source: Adapted from Braithwaite, Healy and Dwan 2005.

10 Assuring the quality of health care in the European Union

structure, processes and outcomes as adapted from the concept of input–process– output in industrial manufacturing (Shaw and Kalo 2002). He argued that “good structure increases the likelihood of good process, and good process increases the likelihood of good outcome” (Donabedian 1988).

Donabedian defined structure (or input) as the attributes of the settings in which care occurs and the resources needed for health care. This would include material resources (facilities, capital, equipment, drugs, etc.), intellectual resources (medical knowledge, information systems) and human resources (health care professionals). Process denotes the use of resources in terms of what is done in giving and receiving care. This can be classified into patient-related processes (intervention rates, referral rates, etc.) and organizational aspects (supply with drugs, management of waiting lists, payment of health care staff, collection of funds, etc.). Outcomes describe the effects of health care on the health status of patients and populations and comprise final outcomes such as mortality, morbidity, disability or quality of life, as well as intermediate outcomes, for instance, blood pressure, body weight, personal well-being, functional ability, coping ability, improved knowledge and others.

However, Donabedian also argued that before assessing quality one must decide (Donabedian 1988):

• whether to adopt a maximal or optimal specification of quality;

• how health and our responsibility for it is to be defined;

• whether the assessment is to involve the performance of practitioners only or also to include that of patients and the health care system; and

• whether the amenities and the management of the interpersonal process between patient and provider are to be included in addition to technical care.

Shaw and Kalo (2002) have explored Donabedian’s approach further and identified the dimensions of quality of care that correspond to each category (Table 1.3). Donabedian’s approach to describing and evaluating the quality of care has been accepted widely and is possibly one of the very few points of consensus in the field of quality of care. In reality, however, it appears that the three components are rarely analysed in a comprehensive manner. Traditionally, efforts to assess quality were founded on structural measures of health care, such as recognition of professional qualifications and experience, approval of drugs and medical devices, and radiation dosage reduction. More recently, the focus has shifted towards developing measures of process and outcome.

However, there is a long-standing debate in the literature about the relative merits of process and outcome measures. Brook and colleagues (2000) argue that process data often provide a more sensitive measure of quality than outcome data, since a poor outcome does not necessarily result from a failure in the provision of care (Brook, McGlynn and Shekelle 2000). In addtion, physicians usually define quality of care in terms of process (Brook, McGlynn and Cleary 1996). Outcomes are more generally perceived as poor measures of quality of care as they are only partially attributable to health services and may be more strongly influenced by other factors such as nutrition, environment, lifestyle or socioeconomic circumstances. Thus, outcomes of patients receiving the same treatment reflect to some extent patient characteristics rather than factors under the control of health care providers. Also, the interval between an intervention and its ultimate outcome may be lengthy and it may be difficult to attribute many outcomes of interest to the provision of particular services.

Similarly, Wareham and colleagues (2001) noted that “[m]easuring the outcome of care would intuitively appear to be the final arbiter, but outcomes are not necessarily the best measures of quality”. This is because outcomes do not capture all elements of performance but only permit an inference about the quality of the processes and structures of care (Wareham, Pencheon and Melzer 2001). Also, echoing Brook, McGlynn and Shekelle (2000), the authors contend that poor outcomes do not always imply poor quality of care. Furthermore, outcomes can be difficult and costly to measure and their measurement is subject to statistical uncertainty.

This issue is further highlighted by Mant and Hicks (1995) who, taking the example of thrombolysis for myocardial infarction, showed that it would take

Quality of care: an overview

Table 1.3 Dimensions in the assessment of quality of care

Dimension of quality of care

Structure (Input) How resources are allocated in terms of time, place and responsiveness to the needs of populations (access) Fairness in sharing costs and benefits (equity)

Process How the resources are applied (stewardship) Use of time and resources (efficiency) Avoidance of waste (economy) Reduction of risk (safety) Evidence-based practice (appropriateness) Patient-focused care (continuity) Public/patient information (choice, transparency, accountability)

Outcome Population health (health improvement) Clinical outcome (effectiveness) Meeting expectations of public and workforce (cost–benefit)

Source: Shaw and Kale, 2002.

12 Assuring the quality of health care in the European Union

many years to detect a difference in outcome between two hospitals offering the treatment to very different proportions of patients, yet a measure of process (uptake of the intervention) would identify the difference rapidly (Mant and Hicks 1995). At the same time, Mant (2001) noted that outcome measures are attractive as they are important in their own right, whereas a process measure by itself is usually of little intrinsic interest to those receiving the intervention. Also, it can be argued that outcome measures capture the sum of “all aspects of the processes of care and not simply those that are measurable or measured” (Mant 2001).

A rarely discussed issue is whether an “optimal” assessment of quality of care is being pursued or whether the cost of assessment is considered in the equation. Ideally, any system of assessment would include elements of structure, process and outcome as they examine different aspects of the care provided in health systems while using process and outcome measures on their own may be misleading.

Conceptual framework

This book addresses the question of whether patients moving within the European Union can be assured that they will obtain high-quality care. To do so we begin by developing a conceptual framework to enable systematic assessment of existing quality of care strategies in the EU. The framework is described in more detail below, with the findings of the actual analysis presented in detail in Chapter 2 of this book. Chapter 3 seeks to present the issues pertaining to quality of care when care is delivered in a cross-border setting, that is, when patients travel to be treated outside their home country. Finally, Chapter 4 describes the policies to promote quality of care in each EU Member State, based on the approach to analysing the policy process as developed by Walt and Gilson, which distinguishes the context within which policies are being made, the actual process of policy development and the key actors involved in that process (Walt and Gilson 1994). Where possible the conceptual framework outlined below has been applied, which includes health system, organizational and clinical quality assessment schemes. Based on the evidence compiled here, Chapter 5 concludes the volume, proposing steps that policy-makers at both national and European levels should undertake to ensure that citizens of Europe crossing national borders can be assured of receiving high-quality care.

The brief review presented in the preceding sections illustrates that there are many different perspectives on health care quality. For the purposes of this book we chose as a starting point the definition developed by the IOM detailed

previously, since it has probably the widest currency in both policy and academic literature (Lohr 1990):

Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.

It is important to recognize that this definition emerged within a United States paradigm from which the notion of “access” was excluded. In contrast, the European context requires stressing the inclusion of the word “populations”, recognizing that a high-quality service should be one that does not disadvantage particular groups within a population in need of care.

As for the dimensions of quality of care, we select those that appear to be most relevant for policy development: effectiveness, acceptability, appropriateness, satisfaction, and patient or care experience. While, as noted above, “patient safety” is considered to be an integral element of quality, because it is developing a separate existence in some places, we also include those initiatives that focus on it.

In line with work by Øvretveit (2001), we distinguish levels at which policy development takes place: the health system (or macro) level, the organizational (meso) level and the clinical (micro) level. Thus, policies operating at the health system level include national legislation and regulation, patient safety, registration and licensing of pharmaceuticals and medical devices, health technology assessment (HTA) and training and continuing education of professionals. At an organizational or service level, there are organizational quality assessment schemes and clinical quality assessment schemes. The boundaries between these two categories are somewhat blurred (Øvretveit 2001; Øvretveit and Gustafson 2002). However, organizational quality assessment schemes are directed at the evaluation of organizations providing care and cover a wide variety of mechanisms, which can be separated into compulsory and voluntary. Voluntary mechanisms are normally carried out by professional organizations while those that are compulsory are often carried out by governments or agencies acting on their behalf. Clinical quality assessment schemes involve, amongst other factor, practice guidelines, quality indicators and information systems, quality circles, medical specialty peer review, patient surveys, clinical governance and audit processes. These often involve the development of new organizational structures, processes, measurement tools or methods (Walshe 2003).

Chapter 2 applies this framework to examine, in detail, quality of care strategies that have been adopted in the EU Member States.

Quality of care: an overview

Introduction

There is a wide range of national and international organizations addressing issues of quality of care and these have influenced the development of regional, national and international quality of care strategies across Europe. Among the most influential are the United States-based JCAHO and the IOM, as well as the International Society for Quality in Health Care (ISQua). At European level, influential bodies include the European Society for Quality in Healthcare (ESQH), the Council of Europe and the World Health Organization (WHO) Regional Office for Europe. In addition, the Cochrane Collaboration has played a major part in ensuring availability of the evidence on which quality care is based, including a considerable volume of work on the effectiveness of strategies for changing clinical practice.

In 1995 the Council of Europe established a committee of experts to examine the issue of quality in health care, with a subsequent report developing recommendations on “Dimensions of Quality Improvement Systems” (Council of Europe 1998). This provided a framework to compare the activities being undertaken in different countries. In 1998, health ministers agreed to collaborate on quality in the health sector; and the Austrian Federal Ministry of Health and Women’s Affairs published a summary of quality policies in EU Member States, followed by a similar summary of policies in the then candidate countries in 2001. In May 2000, the EU adopted a new health policy, taking into account the recent legal and political developments of the 1998 review.

Chapter 2

Quality of care strategies in the European Union

1� Assuring the quality of health care in the European Union

The 2000 strategy introduced the concept of diffusing best practice in health care (Shaw and Kalo 2002).

In 2008, the European Commission envisages certain non-legislative proposals relevant to quality of health care. The main initiatives planned are (European Commission 2007):

• a Communication and Council Recommendation on Patient Safety and Quality of Health Services (November 2008);

• a Green Paper on Health Professionals in Europe and launch of a High Level Reflection Process on Health Professionals in Europe (4th Quarter 2008);

• a proposal for improving patient safety by prevention and control of health care-associated infections (December 2008).

The two primary objectives of the initiative on Patient Safety and Quality of Health Services are (European Commission 2007):

• to support Member States in ensuring the highest possible levels of patient safety throughout EU health systems by providing necessary and relevant practical and legal tools and mechanisms for the Member States, as well as the key stakeholders, to take appropriate actions to improve safety and quality of care; and

• to improve EU citizens’ confidence that they have sufficient information available on the safety of EU health systems.

It is important to note that the development of policies on quality of health care within the EU has been complicated by, on the one hand, the clear statement in successive European treaties that health care is the responsibility of Member States, yet, on the other hand, the fact that health care delivery involves people, goods and services whose characteristics are regulated at European level. As a consequence, and as we will see below, there is a wide legislative spectrum from those areas that are addressed exclusively at European level through to areas where some or all countries have adopted common solutions, to those where arrangements are entirely local matters. The same is true of initiatives developed by health care providers, ranging from purely local approaches to those that have been adopted across many countries (Figure 2.1). A detailed description of the approaches to promotion of quality of health care adopted by individual countries is contained in Chapter 4.

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Health systems quality assessment

The following paragraphs summarize those strategies for promoting quality of care already in existence within the EU.

Legislation and policies on quality of care

There is considerable variation between and within European Union Member States in the approaches each has adopted and the extent to which legislative measures to ensure quality of care have been implemented. To some extent, this variation reflects the prevailing view in each country about whether health care quality is a legitimate matter for legislation or for other measures such as voluntary agreements. This is a question that is unresolved and which will almost certainly be determined by specific national circumstances; the absence of legislation should not necessarily be seen as a weakness. A closer look at what has been done by the various Member States does, however, reveal some commonalities. Three broad categories emerge. The first category consists of those Member States that do not have any legislation on quality of care, or national policies on quality. The second category includes those countries that have only recently either enacted legislation or implemented policies relating to quality of care. The third category includes those countries that have a long tradition of enacting legislation and/or implementing quality of care strategies. Within the third category two subcategories can be identified. The first includes those that have had systems in place for a considerable period that are now firmly embedded and where major reform is not envisaged. The second includes those where there is also a long tradition of activities to promote quality of

Quality of care strategies in the European Union

Consistency

Diversity

Mutual recognition e.g. medical training

Harmonization e.g. biotechnology

Open method of coordination

EU initiated

Guidelines by European

specialist societies

International Organization for Standardization

Peer review

Provider initiated

Figure 2.1 A conceptual model of strategies for health care quality in Europe

1� Assuring the quality of health care in the European Union

care but where major reforms are envisaged or are in progress due to perceived limitations of the existing systems.

The first category includes Bulgaria, Cyprus, Estonia, Greece, Hungary, Malta, Luxembourg, Latvia, Poland, Portugal, Romania and Slovakia. Although these countries have some initiatives in place, these are not systematically applied at national level. For example, various efforts have taken place in Greece since the mid-1990s to initiate quality of care activities. In 1996 and in 2001, the then ministers of health established National Committees for Quality on Health Care, while a facility for a proposed Institute of Quality and Accreditation in Health Care Services has been built. The 2001 Committee produced, in 2002, an in-depth report that recommended ways to enhance quality of care. However, with changes of government, as well as a lack of financial support, few of the proposed activities have taken place.

In Estonia, the establishment of a quality assurance system was first identified as a priority during the Estonian Health Care Project (1995–1998), funded by the World Bank and the Government of the Netherlands (World Bank 2001). The project included development of a policy on quality of health care. A report was presented to the Estonian Government for approval but was later rejected due to a lack of clarity about funding of the measures proposed. Following its rejection, a quality working group was initiated by the Ministry of Social Affairs and the Central Sickness Fund (Estonian Health Insurance Fund since 2000), together with the Medical and Nursing Associations (Shaw and Kalo 2002). Although the proposal was not approved, Estonian health care institutions have used it as a basis for quality-related activities (Kaarna and Kalda 2005). The first official mention of quality of health care was in the Health Services Organization Act of 2001. The Act required the Minister of Social Affairs to set standards for accessibility and quality of health services. It also established minimum standards for health care professionals and health care providers (Kaarna and Kalda 2005).

In Hungary, it was in the early 1990s when quality assurance first became a priority for the Government, leading to the enactment of several government resolutions, decrees and orders related to quality (Gulácsi 2001). The first regulation was the Law on Health Care (1997), which provided a legal basis for internal and external quality management systems. The Law stated that each health care organization was required to establish an internal system and it also defined some minimum quality standards and set out in detail the rights of patients. However, at the time of writing, Hungary has not yet developed a specific policy on quality of health care. It has been reported that policy-makers were more interested in quality of health care during the 1990s than in the new

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millennium. A survey carried out in 107 hospitals clearly shows that the level of quality-related activity was lower in 2005 than in 2000 (Gulácsi 2006).

In Luxembourg, the first developments establishing a framework for quality in health service delivery took place in 1998. The Law on hospital establishments (28 August 1998, published 18 September 1998) was changed to integrate the option that hospitals are given 2% of their annual hospital budget on the condition and achievement of defined quality measures. However, participation of hospitals in this endeavour was on a voluntary basis.

In Bulgaria, the Health Act passed in 2004 referred to a few quality improvement strategies. The Act set out standards for different medical specialties, outlined the responsibilities of the 28 regional health centres and the Ministry of Health in controlling the competencies of medical specialists and monitoring the quality of care, and included a process for patient complaints and appeals (Avdeeva and Georgieva 2007). The process of health care reform is widely accepted to have been difficult. Several years after the initial reform, many problems persist. Quality of care remains one of the most significant challenges facing the health care system, and it has been especially difficult to improve quality in rural areas.

In Cyprus, one element of current reforms initiated by the Ministry of Health involves the introduction of a system of quality assurance, which will seek to identify areas for improvement, formulate guidelines for best practice and evaluate the delivery of care. The Ministry of Health has established a quality assurance committee, the National Committee for Quality Assurance and Risk Management, which includes representatives from all branches of the Ministry of Health. It envisages a process whereby all hospitals in Cyprus would be accredited with an international body, and has developed an action plan to strengthen quality assurance in all health facilities. The Ministry of Health supports quality initiatives through its funding of the Committee but there is a consensus that its achievements have been limited.

In Romania, quality of care is not regulated by a specific act, but Law 95/2006 includes some references to quality of care in each sector of the health care system, for instance, hospitals, laboratories, primary care facilities, etc. For instance, the Law specifies that hospitals need to be accredited based on standards that are to be elaborated by the Ministry of Public Health.

Turning to the second category, that is, countries that have recently adopted quality of care laws and related measures, we find that several of the new Member States, namely the Czech Republic, Lithuania and Slovenia, as well as the Republic of Ireland, fall into this category. In some cases, the accession process has acted as a stimulus to develop these policies.

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20 Assuring the quality of health care in the European Union

In 2000 the Government of the Czech Republic adopted a National Quality Policy in Decree No. 458. This defined a package of methods designed to improve quality of products, services and activities. The main objectives of the Decree included: development of a national accreditation system; assurance of quality in public services; standardization; staff training and retraining; and creating a system of quality assurance.

Measures related to quality of care in Lithuania include a system of licensing (based on the International Organization for Standardization (ISO) ISO 9000 standard) for health care and pharmaceutical organizations (introduced in 1995); provision for medical audit in health facilities, since 1998; a system of accreditation of health care institutions, dating from 1999, and a Health Care Quality Assurance Programme, proposed in 2004. This programme, based on a concept developed two years earlier, seeks to direct health care more clearly towards the needs of patients and the public; to improve quality and safety; and to develop health care quality management. However, the majority of measures envisaged have not been implemented due to lack of funds.

In the Republic of Ireland, in the late 1990s, three major reports into health services were published, leading to a major review of the organization and delivery of care. This process culminated in 2001 with the publication of a national health strategy, “Quality and fairness, a system for you”. This strategy recommended a radical reorganization of the health services in the Republic of Ireland, proposing the abolition of the 11 regional health boards and their replacement by a centralized, unified health authority (the Health Service Executive (HSE)) that would deliver primary, secondary and continuing care. In tandem with this new authority an equivalent oversight body was proposed to regulate the standard health care services delivered by the HSE. This authority, the Health Information and Quality Authority (HIQA) was established on an interim basis in March 2005. Its role is to ensure the delivery of high-quality services based on evidence of best practice, to design and monitor standards of care provision, to conduct HTAs and to advise on and regulate elements of health care information processes. In initial discussions, it was envisaged that it would also incorporate the Irish Health Services Accreditation Board (IHSAB) and the National Cancer Registry.

In Slovenia, quality has risen higher on the health policy agenda following proposals for health care reforms in 2003. The current emphasis is on connecting the elements already in place and adding the missing links, so as to create a framework for sustained quality improvement (DRMED 2007). This is being operationalized by means of an expert committee within the Ministry of Health and the appointment of a national coordinator for quality in general practice. However, it is reported that neither have received adequate financial

support. At the time of writing, new legislation on quality and safety is being prepared. The Ministry of Health supports the creation of a national institution for quality and safety in health care, with mandatory reporting by health care providers. However, the approaches proposed by the Ministry have not so far been well received by health professionals, with support concentrated among those already actively involved in quality-related activities.

Finally, the third category consists of countries with a well-established tradition of quality of care legislation and related measures. As noted above, these can be further divided into those that have had policies in place for some time and are anticipating only minor reforms – France, Finland, Germany, Italy, Spain and Sweden – and those that have a long tradition of quality strategies but are going through major reforms to reorganize their systems (Austria, Belgium, the Netherlands, the United Kingdom/England and Denmark).

Quality assurance activities in Finland started in the early 1980s, when professional groups became engaged in different quality assurance projects, and these expanded during the 1990s. In 1994 a National Policy on Quality for Health Care was approved. One year later the first National Recommendation on Quality Management was published. In 1998 a quality strategy was proposed for public services and in 1999 recommendations on Quality Management for Health Services provided and purchased by municipalities was introduced (Outinen 2003).

In France, growing concern about the quality of care emerged in the 1980s and early 1990s following a series of incidents exposing undesirable practices in health care services. As a result, the Government embarked on a series of reforms which saw the creation in 1990 of the National Agency for the Development of Medical Evaluation (ANDEM) and the Hospital Act No. 91-748 of 31 July 1991, in which assessment of care became mandatory (de Pouvourville 1997). Other initiatives comprise dissemination of practice guidelines, lengthening general practice training periods, the development of medical information systems and piloting networks of health care providers to improve coordination and continuity of care. These were (partly) formalized in the context of the 1996 “Juppé reform” of the French health care system that also established the Agency for Accreditation and Evaluation of Health Care (ANAES), which replaced ANDEM (Sandier, Paris and Polton 2004). In October 2004, the role of ANAES was subsumed under the newly created National Authority for Health (HAS) that also resumes the roles of the Commission on Transparency and the Economic Committee for Medical Products (CEPS) (created in 1999), among others (Haute Autorité en Santé).

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22 Assuring the quality of health care in the European Union

In Germany, systematic quality assurance programmes addressing selected topics were introduced for the first time in the mid-1970s at regional level by the State Chambers of Physicians (Birkner 1998; Ollenschläger, Marshall and Qureshi 2004). At national level, professional self-regulation, with monitoring of technical safety and hygiene, was, until the end of the 1980s, regarded as sufficient to ensure quality of health care (Busse and Riesberg 2004). In the mid-1990s, “quality in health care” became a priority topic both in professional self-administration and health policy at state level – focussing on the use of quality management programmes, clinical guidelines, and quality indicators (Helou, Schwartz and Ollenschläger 2002). Subsequently, it became more prominent in the national policy debate (Allen and Riemer Hommel 2006) and quality requirements for in- and outpatient care have progressively been transformed from a voluntary activity to a legal obligation, and, from 2000, successive measures to improve the quality of care were introduced.

In Sweden, the Health and Medical Services Act (1982:763) explicitly stipulates that quality of health care shall be guaranteed and systematically and continuously developed. The Act is primarily directed at health care providers. It does not confer any explicit rights on patients to receive good-quality health care, but it sets out obligations for providers to deliver health care of high quality. In the 1980s, quality assurance activities started in Sweden and the first National Strategy on Quality was developed in 1990, initiated by the Government. In 1994 the National Board of Health and Welfare issued a further set of regulations on quality assurance, subsequently revised in 1997 and in 2005. These regulations state that all health services in Sweden must include a system for continuous, target-oriented quality improvement.

Spain and Italy represent examples of countries where, although quality improvement is mostly promoted by the national Ministry of Health, regional governments have responsibility for introducing and implementing policies on quality of health care. Thus, in Spain responsibility for health care has been devolved to the 17 Autonomous Regions since 2002, leading to 17 different policies on quality of care. For example, Catalunya, Andalucia and Madrid have implemented accreditation of hospitals; Aragon and Cantabria are using the European Foundation for Quality Management model (EFQM); and Navarra is implementing its own quality management programme (Comite Editorial RCA 2004). In Italy, the national Government provides general guidelines but regional governments are entirely responsible for quality of the care provided in their territories. As a result, there are essentially 20 regional health care systems with marked differences in strategies on quality. There are, however, three principle sources of national guidance on quality, derived from the National Reform Act passed in 1992. These refer to accreditation, quality assurance and

citizens’ rights. Based on this legal framework, the regions approve their own regulations.

Austria, Belgium, the Netherlands, the United Kingdom/England and Denmark have introduced highly regulated strategies to ensure quality of care, with polices characterized by a “top-down” approach. In Austria, a key step in the process of promoting quality was the amendment of the Law on Health Care Institutions (KAKuG) in 1993, which established a legal framework for the implementation of quality assurance in hospitals (Hofmarcher and Rack 2001). Further reforms were introduced in 2005, including the Law on the Quality of Health Care Services, which sets out the responsibilities for quality of care by the different actors. The objective of the 2005 health care system reform involves promoting closer cooperation of the inpatient (hospital) and outpatient sectors (hospital clinics, doctors in private practice).

In 1993, the Danish Ministry of Health and the Danish National Board of Health introduced a National Strategy for Quality Improvement in Health Care, based on the principle of “bottom-up” quality improvement. Between 1993 and 2000, a wide range of initiatives were introduced within the framework of this strategy, although these were largely local, ad hoc and informal activities. In 2003 the Danish Ministry of Health and the National Board of Health developed a 3-year National Strategy for Quality Improvement that consciously sought to overcome the problems encountered with the previous strategy. This specified that quality improvement should be related to clinical pathways and should use set standards and indicators. That same year, as part of the new strategy, a Danish Health Care Quality Assessment Programme was proposed.

In the Netherlands it is predicted that, following recent reforms, health care delivery will change considerably over the next decade. The health care reforms have resulted in an increase in market competition and a decrease in government control. It can be envisaged that some care providers will focus on specific markets, whilst others will focus on enhanced quality. Two laws define the framework for individual providers and care institutions: the Individual Health Care Professions Act (BIG, Wet op de beroepen in de individuele gezondheidszorg) enacted in 1993 and the Care Institutions Quality Act (KZI, Kwaliteitswet Zorginstellingen) passed in 1996. Legislation stipulates that the primary responsibility for quality lies with health care providers and professionals (Dutch Department of Health 2005). An evaluation of the Health Care Quality Law carried out in 2002 showed that little progress had been made by health care institutions towards implementing a structured quality system. Following recommendations made in late 2002, the Minister of Health announced specific measures to make quality management compulsory. This

Quality of care strategies in the European Union

24 Assuring the quality of health care in the European Union

envisaged a move from a supporting role to a more controlling position (den Exter et al. 2004).

In Belgium, after years of maintaining a predominant focus on cost-containment, assessment of quality of care is now gaining more attention. Whereas the traditional way of assuring quality was through specific licensing standards, mainly for health care institutions, the responsible authorities have more recently been seeking to strengthen quality assurance by means of accreditation of care providers, peer review and audit. Several laws, such as the Hospital Act and the Health Insurance Act, incorporate quality improvement initiatives.

Patient safety

In the last 20 years, the issue of patient safety has become recognized increasingly as a key element of overall quality. The United States has been a pioneer in this area, with the publication of two influential studies. The first was the Harvard Medical Practice Study, in 1991 (Leape et al. 1991), which showed that adverse events occurred in 3.7% of hospitalizations and that 27.6% of the adverse events could be attributed to errors.

The second, and most influential study published to date, was carried out by the IOM in 2000, entitled To err is human: building a safer health system. This study estimated that between 44 000 and 98 000 people died in United States hospitals each year as a result of medical errors that could have been prevented. This figure was greater than that for those who died each year from motor vehicle accidents (43 458), breast cancer (42 297) or AIDS (16 516) (Kohn, Corrigan and Donaldson 2000). This report received worldwide attention. The following year the English National Health Service (NHS) published the pioneering report, An organisation with a memory, which estimated that about 10% of admissions to NHS hospitals were associated with adverse events causing harm to patients, affecting more than 850 000 patients a year (Department of Health 2000).

Both the Luxembourg and British Presidencies of the EU in 2005 identified patient safety as a key theme. In 2005 an expert panel of the Council of Europe prepared a recommendation on patient safety which was adopted by the Committee of Ministers in 2006 (Council of Europe 2006).

The High Level Group on Health Services and Medical Care, a committee set up for taking forward the Communication COM (2004) 301 of 20 April 2004 on patient mobility, has proposed a range of ways in which European action could support Member States, potentially forming the basis of a European strategy for patient safety that would reflect the actions proposed by WHO’s Global Alliance for Patient Safety (see Box 2.1) (Bertinato, 2005).

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Despite its growing visibility on the policy agenda, patient safety has not yet been translated into tangible action in all Member States. It has been recognized that interventions to avoid errors in health care are particularly successful when they act at all levels of the system. Current debates on patient safety place the prime responsibility for most adverse events on deficiencies in system design, organization and operation rather than on negligence or poor performance by individual providers or individual products (Department of Health 2000).

A recent European study on patient safety found that in 2005 only Denmark, Germany, Spain, the Netherlands and the United Kingdom had established specific institutional structures to ensure patient safety; with the systems implemented by Denmark and the United Kingdom being judged as the most adv

Основные сведения

Организация Всемирная организация здравоохранения (ВОЗ / WHO)

Тип документа Publications

Дата принятия 1 января 2008 г.

Источник Всемирная организация здравоохранения