List of figures. List of tables. Abbreviations and acronyms

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1 Preface List of figures List of tables Abbreviations and acronyms vii xv xix xxiii I Introduction and methods 1 General introduction Introduction Themotivesforthisresearch Riskmanagement Definitionofriskmanagement Reasonsforriskmanagementinhospitals Risk management in literature and the risk management framework Background HealthcareintheNetherlands CatharinaHospital Overview Overviewofthethesis Theresearchpathofthethesis Risk and quality management Introduction Standardsandauditsasrequirements Processdeviationsandriskmanagement Caresystems Risk management as a differentiationofqualitymanagement Introduction Importantdefinitions Qualitysystematdepartmentallevel ix

2 x Contents Centralqualitysystematmanagementlevel Quality-orientatedorganisation Modelforqualitypolicyinahospital Risk management: definitions and tools Introduction Definitions Models to explain the cause-effect path of incidents and complications Model for the development of process deviations which can lead todamage Model for the development of incidents and complications Framework for effectiveriskmanagement Introduction: the risk management framework Processmodel Failure Mode and EffectsAnalysis(FMEA) CriticalIncidentInterview(CII) CausalTreeAnalysis(CTA) Eindhoven Classification Model of system failure (ECM) IncidentReportingandManagementSystem(IRMS) Complication and Incident Reporting and Management System (CIRMS) Legalaspectsofincidentandcomplicationregistration II Results and analysis 4 Prospective and retrospective approach in the OR: FMEA and CIIs Introduction Processmodel CreationoftheORprocessmodel ORprocessmodel Conclusionsandrecommendations FMEA UseoftheFMEA ResultsoftheFMEA Conclusionsandrecommendations CIIs UseoftheCIIs

3 xi ResultsoftheCIIs Conclusionsandrecommendations ComparingtheFMEAresultswiththeCIIresults Real-time approach in the OR: IRMS Introduction UseoftheIRMS Experiences with and recommendations about ECM and CTA ResultsoftheIRMS Analysisconclusionsandrecommendations Risk management adjustments in the OR: trial by error? Introduction Initiative towards the further development of the IRMS into a quality system NewIRMSprotocol Expansion of the IRMS with occupational health and safety incidents UsingthenewIRMSprotocol Allocationofstructuralprocessfailuretocriticalpoints Considerations about (possible) further research into the precise natureanddimensionofproblems Design and implementation of process and system improvements toremovestructuralfailure Discussion Conclusionsandrecommendations Risk management in the Haemodialysis department Introduction Processmodel DescriptionoftheHaemodialysisprocesses Results,conclusionsandrecommendations CIIs Approach Results,conclusionsandrecommendations FMEA Approach Results,conclusionsandrecommendations Conclusionsandrecommendations

4 xii Contents CIIsorFMEAorboth? Conclusions and recommendations regarding improvements Conclusions and recommendations regarding risk management. 239 III Conclusions and recommendations 8 Conclusions and recommendations Introduction Risk management methods used Risksobserved Reflections about this research Nearfuture Bibliography 271 A Persons who contributed to or participated in this research 287 B Contents CD-ROM 289 C FMEA participants manual 291 D Classification used during the Haemodialysis FMEA 299 E The Eindhoven Classification Model of system failure (ECM) 301 F Problems found during the creation of the Haemodialysis process model 309 G Results of the Haemodialysis CIIs 313 H Results of the Haemodialysis FMEA 333 I The final IRMS reporting form (including the possibility to report Arbo incidents) 347 J The number of doctors and employees who reported one or more incidents 351 Summary 353 Samenvatting 355 Acknowledgements 357 Curriculum vitae 359

5 xiii Author index 361 Subject index 365

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