Hemovigilance (eBook)

An Effective Tool for Improving Transfusion Safety

René R. P. De Vries, Jean-Claude Faber (Herausgeber)

eBook Download: PDF

2012
John Wiley & Sons (Verlag)
978-1-118-33806-3 (ISBN)

Infos

* Hemovigilance is a 'quality process' which aims to improve quality and increase safety of blood transfusion, by surveying all activities of the blood transfusion chain, from donors to recipients.

Hemovigilance programmes have now been in existence for over 15 years, but many countries and centers are still at the development stage. This valuable resource brings together the main elements of such programmes and shows the different types of models available. A general introduction includes Chapters on hemovigilance as a quality tool for transfusion as well as concepts of and models for hemovigilance. The core of the book describes how Hemovigilance systems have been set up and how they work in hospitals, blood establishments, and at a national level. These Chapters are written according to a structured template: products and processes, documentation of jobs, monitoring and assessment, implementation and evaluation of measures for improvement, education and training.  Chapters on Hemovigilance at the International level, Achievements and new developments complete the picture.

Hemovigilance is above all a practical guide to setting up and improving hemovigilance systems, whilst raising awareness for reporting adverse events and reactions.

This is the first international book on hemovigilance, assembling all the vital issues in one definitive reference source - essential reading for all staff involved in the transfusion process.

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* Hemovigilance is a "e;quality process"e; which aims to improve quality and increase safety of blood transfusion, by surveying all activities of the blood transfusion chain, from donors to recipients. Hemovigilance programmes have now been in existence for over 15 years, but many countries and centers are still at the development stage. This valuable resource brings together the main elements of such programmes and shows the different types of models available. A general introduction includes Chapters on hemovigilance as a quality tool for transfusion as well as concepts of and models for hemovigilance. The core of the book describes how Hemovigilance systems have been set up and how they work in hospitals, blood establishments, and at a national level. These Chapters are written according to a structured template: products and processes, documentation of jobs, monitoring and assessment, implementation and evaluation of measures for improvement, education and training. Chapters on Hemovigilance at the International level, Achievements and new developments complete the picture. Hemovigilance is above all a practical guide to setting up and improving hemovigilance systems, whilst raising awareness for reporting adverse events and reactions. This is the first international book on hemovigilance, assembling all the vital issues in one definitive reference source - essential reading for all staff involved in the transfusion process.

Autor

Professor René R.P. De Vries, Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands and President of the European Haemovigilance Network. Dr Jean Claude Faber, Director of the Blood Transfusion Service, Luxembourg Red Cross, Luxembourg. The editors are experts in the field of haemovigilance. Both are members of the Board of the International Haemovigilance Network (IHN) and of the International Society of Blood Transfusion (ISBT) Working Party on Haemovigilance.

Inhalt

Hemovigilance: An Effective Tool for Improving Transfusion Safety 3
Contents 7
List of Contributors 10
Foreword 14
PART 1 General Introduction 15
CHAPTER 1 Introduction 17
Why did we produce this book? 17
Who would want to read or consult this book? 17
What can you expect to find in this book? 17
How to use this book? 18
References 18
CHAPTER 2 Hemovigilance: A Quality Tool for the Blood Transfusion Chain 19
History of blood transfusions 19
Introducing hemovigilance 19
Blood components 20
Quality system 20
Adverse reactions in recipients 21
Adverse reactions or complications in donors 21
Legal framework 21
Summary 22
Hemovigilance in the blood establishment and the hospital: The blood transfusion chain (Part 2) 22
Establishing a hemovigilance system (Part 2, Section 2.1) 22
Hemovigilance systems at three levels (Parts 3 and 4) 22
Results and achievements (Part 5) 24
New developments: Vigilance of alternatives for and appropriateness of transfusion and tissue-/bio-vigilance (see Part 6) 24
Appendices 25
References 25
CHAPTER 3 Concepts and Models 26
Introduction 26
Scope 26
Products and processes 26
Recipients and donors 26
“Hot and cold” hemovigilance 27
Report all adverse events/reactions or only the serious ones? 27
Data on more than just blood components? 27
Structure 27
Integration in quality systems 27
Integration in other patient safety activities 27
International collaboration 28
Reporting structure 28
Governance 28
Centralized or not 29
Legal status 29
Passive or active 29
Rapid alert system 29
References 30
PART 2 Hemovigilance of the Blood Transfusion Chain (Blood Establishment and Hospital) 31
SECTION 2.1 Setting up a Hemovigilance System 33
CHAPTER 4 Setting Up or Consolidating a System for Donor Hemovigilance at the Level of a Blood Establishment 35
Introduction 35
Products and processes 35
Introduction 35
Processes 35
Complications related to blood donation (donor adverse reactions) 36
Introduction 36
Definitions and classification of complications of blood donation 36
What is known: Complication statistics and risk factors 37
Reporting limitations 37
Causes 37
Specific complications and long-term complications 38
Serious (severe) and non-serious 38
Recognizing and treating complications related to blood donation 39
Recording and vigilance 39
Errors (adverse incidents) in donor care* 39
Blame-safe reporting 40
Learning opportunities 40
Donor post-donation information 41
Counseling and procedures relating to unexpected findings 42
Prerequisites and requirements 42
Preparation 43
Digital or paper? 43
Access to information 43
Implementation timetable 44
Standard Operating Procedures (SOPs) 44
Documentation of jobs: Tasks and responsibilities 44
Monitoring and assessment 44
Data validation 44
Ongoing complications monitoring 45
Denominator 46
Training and assessment 47
Implementation, evaluation of measures for improvement, and performance indicators 47
Concluding remarks 48
References 48
CHAPTER 5 Preparation of Blood Components 50
Introduction 50
Products and processes: Standards, specifications, and documentation 52
Products 52
Standards and specifications 52
Documentation 54
Processes 54
Documentation of jobs: Tasks and responsibilities 58
Monitoring and assessment 59
Blood product quality control 59
Audits 62
Periodical reports 63
Implementation and evaluation of measures for improvement 63
Training and assessment 64
References 64
CHAPTER 6 Establishment of Hemovigilance for the Testing, Storage, Distribution, Transport, and Issuing of Blood and Blood Components: The Example of Greece 66
Introduction 66
Establishment of the Coordinating Haemovigilance Centre 66
National hemovigilance network 67
Flow chart of information 67
Quality issues and hemovigilance procedures for testing, storage, distribution, transport, and issuing 68
Testing for transfusion transmissible Infections (TTIs) 68
Traceability studies and look-back procedures 70
Blood group serology-compatibility 70
Storage, release, distribution, and issuing of blood components 71
Storage requirements 72
Release of blood components 72
Distribution and transport 72
Issuing 73
References 73
CHAPTER 7 Medical Decision, Ordering, Administration of Component, and Monitoring of the Patient 75
Introduction 75
Medical decision and ordering 75
Products and processes 76
Jobs and responsibilities 78
Monitoring and assessment 79
Implementation, training, and evaluation of measures for improvement 79
Blood administration and monitoring 83
Monitoring and assessment 83
Conclusions 85
References 86
SECTION 2.2 How the System Works 89
CHAPTER 8 Blood Donation: An Approach to Donor Vigilance 91
Introduction 91
Goals of donor vigilance 92
Process cycle 92
Gather data 92
Analyze 94
Insights, conclusions, and priorities 94
Interventions 94
Implement interventions 94
Assess interventions and create new baselines 94
Blood donation process 95
Data 97
Data management 97
Data validation 100
Denominators 100
Analysis and reporting 102
Publication 106
Design interventions 108
Education/Information 109
Limit on volume of blood collected 109
Muscle tensing exercises (applied muscle tensing, physical counter-pressure maneuvers) 109
Restoration of plasma volume 109
Reducing needle-related injuries 109
Implement intervention 110
Summary 110
References 111
CHAPTER 9 Preparation of Blood Components 113
Introduction 113
Products and processes: Standards, specifications, and documentation 114
Starting material: Whole blood donation or apheresis bags with stored information on donor clearance, donor traceability, and the donation process itself 115
Machinery and information technology including hardware and software 117
Quality management 118
Documentation and analysis of deviations and errors in the preparation of blood components 119
Risk management 119
Documentation of jobs: Tasks and responsibilities, training and assessment 121
Monitoring and assessment 122
Implementation and evaluation of measures for improvement 123
Conclusion 125
References 126
CHAPTER 10 Testing, Issuing, and Transport of Blood Components 127
Introduction 127
Testing 127
Screening process for transfusion transmitted infections (TTIs) 128
Bacterial quality control testing and hemovigilance issues 131
Blood group serology: Compatibility 132
Issuing and transport 135
Issuing components 135
Transportation 137
Transportation of blood components 137
Chain of traceability 137
Quality requirements 137
References 138
CHAPTER 11 Clinical Activities: Medical Decision-making, Sampling, Ordering Components, Administration, and Patient Monitoring 140
Introduction 140
Reporting of error-based adverse incidents to hemovigilance systems 141
Categories of errors relating to clinical activities 142
Decision to transfuse 143
Case 1 144
Case 2 144
Case 3 145
Case 4 145
Case 5 145
Case 6 145
Case 7 145
Undertransfusion 145
Sample collection 146
Wrong Blood in Tube (WBIT) 147
Case 1 147
Case 2 147
Ordering components 147
Special requirements not met (SRNM) 148
Case 1 148
Case 2 148
Case 3 148
Administration 149
Case 1 149
Case 2 149
Patient monitoring 150
National Comparative Audits of blood transfusion, UK 150
Under-reporting 151
Initiatives to improve clinical transfusion activities 151
Transfusion education and training initiatives in the UK 151
Professional responsibility 153
Future hemovigilance 154
Conclusions 155
References 155
PART 3 National or Regional Hemovigilance Systems 159
CHAPTER 12 The French Hemovigilance Network: From the Blood Scandal to Epidemiologic Surveillance of the Transfusion Chain 161
Introduction 161
The blood scandal 161
Epidemiologic surveillance 163
The French hemovigilance system 164
The Transfusion Incident Report form 164
Severity grade and imputability levels 165
Traceability 165
Communication of results 165
Selected results from 1994 to 2009 166
Conclusion 170
Acknowledgements 170
References 172
CHAPTER 13 The Japanese Hemovigilance System 173
History of the Japanese Hemovigilance System 173
Legal basis 174
Setting up the hemovigilance system 174
Governance of the hemovigilance system 175
Adverse events to be reported/ reporting system 175
Concept and methodology of Japanese hemovigilance 176
Data analysis and feedback 177
Evaluation of hemovigilance system 177
Look-back studies 177
Errors and near-misses 177
Adverse reactions 178
Adverse reactions in donors 178
Adverse reactions in recipients 178
Data and trends 178
Results of data utilization for prevention and evaluation 179
Usefulness of data from our hemovigilance system 179
Advantages and limitations of Japanese hemovigilance system 180
Moving towards evidence-based hemovigilance 181
References 181
CHAPTER 14 Setting up a National Hemovigilance System: SHOT 182
The origins of Serious Hazards of Transfusion (SHOT) 182
Getting SHOT started 183
Type of events to be reported 183
Additional SHOT reporting categories 183
Imputability 186
Scope and reporting system 186
Impact of the European Union (EU) Blood Directive on SHOT reporting 187
Participation 188
Governance 188
SHOT’s relationship with other professional bodies 189
Infrastructure and budget 190
Accountability 190
The launch of SHOT 190
The first year of SHOT, and the first report 191
Subsequent annual SHOT reports and SHOT recommendations 191
What would we have done differently? 192
References 192
CHAPTER 15 The Dutch Hemovigilance System: Transfusion Reactions in Patients (TRIP) 194
Introduction 194
Participation 195
Reports received 195
Transfusion reactions and incidents from 2003 up to 2009 196
Severity of transfusion reactions 197
Relationship to the blood transfusion (imputability) 198
Variation among hospitals 198
Numbers of transfusion reactions in relationship to numbers of supplied blood components 199
Obligatory reports of serious adverse events in the transfusion chain 200
Comments on some categories of transfusion reactions and incidents 200
Transfusion Related Acute Lung Injury (TRALI) and the Dutch “male-only plasma” measure 200
Anaphylactic transfusion reaction 201
Other allergic reactions 201
Transfusion Associated Circulatory Overload (TACO) 201
Incidents in the transfusion chain 201
Incorrect blood component transfused 201
Other incidents 202
Near-misses 202
General considerations and conclusions 203
References 204
CHAPTER 16 Regulatory, Public Health, and International Aspects of Hemovigilance in Canada 205
Introduction 205
Overview of hemovigilance in Canada 205
Canada’s blood system: The importance of hemovigilance 206
Hemovigilance in Canada: Key elements 206
Scope and governance of the hemovigilance system in Canada 207
Evolution of Canada’s hemovigilance system 208
Transfusion Transmitted Injuries Surveillance System (TTISS) 208
National Working Party for Data Review (NWPDR) 210
Transfusion Errors Surveillance System (TESS) 212
Targeted surveillance/research for high-risk populations and emerging pathogens 214
Further enhancement of TTISS, TESS surveillance systems 215
International linkages and Canada’s roles 215
Building on the hemovigilance system within Canada’s National Health Care System: Biovigilance 216
Acknowledgements 217
References 217
CHAPTER 17 Setting up and Implementation of the National Hemovigilance System in Italy 218
Introduction 218
Governance 219
Use of a computerized system 219
Framework 220
SARs 220
SAEs 220
TTI surveillance in blood donors 220
ARs in blood donors 221
Aims and responsibilities 221
References 222
CHAPTER 18 The Australian Hemovigilance System 223
Introduction 223
The blood sector and context for hemovigilance programs in Australia 223
Examples from Australian regional hemovigilance systems 225
Serious Transfusion Incident Reporting (STIR) system 225
Queensland Incidents in Transfusion (QiiT) 226
South Australia: BloodSafe 227
New South Wales Blood Watch 227
Australian national hemovigilance arrangements 227
Australian Red Cross blood service data 228
Data from other sources 229
Communication/reporting 229
Lessons learned from implementing hemovigilance in Australia 229
Research opportunities in hemovigilance 229
Conclusions/future directions 231
Acknowledgments 232
References 232
CHAPTER 19 Biovigilance in the United States 234
History of biovigilance development 234
Transfusion recipient surveillance 235
Blood donation surveillance 237
Transplantation Transmission Sentinel Network (TTSN) 238
The future of biovigilance in the US 239
Acknowledgement 239
References 239
CHAPTER 20 Arab Hemovigilance Network 240
Introduction 240
Introducing the Arab Hemovigilance Network 241
Hemovigilance policies 241
Basic clinical and organizational guidelines and requirements for effective hemovigilance in all hospitals 242
Establishing a regional system (the AHN) 242
Scope and procedure 243
Objectives of the program 244
Reporting process of the program 245
Conclusion 246
References 246
PART 4 Hemovigilance at the International Level 247
CHAPTER 21 Hemovigilance in the European Community 249
Introduction 249
Council of Europe 249
European Union 249
Legal framework set by Community legislation 251
Directive 2002/98/EC4 251
Directive 2004/33/EC5 253
Directive 2005/61/EC6 254
Directive 2005/62/EC7 256
Transposition by Member States 257
Difficulties encountered 257
Reporting experiences11–13 258
Rapid alert 261
Role of ECDC 263
Future of European hemovigilance 264
Conclusions 264
References 265
CHAPTER 22 International Collaboration 267
Introduction 267
International Hemovigilance Network 268
Working Party on Hemovigilance of the International Society of Blood Transfusion 269
Global Steering Committee for Hemovigilance (GloSCH) 270
Objectives of international collaboration between organizations 271
References 273
CHAPTER 23 Hemovigilance in Developing Countries 274
Introduction 274
Blood system level 274
Production segment 276
Blood donors 276
Blood donations 277
Testing 277
Processing 277
Storage and transportation 278
Usage segment 278
Vigilance of donors, recipients, and products/processes in developing countries 279
Donor vigilance 279
Patient hemovigilance 279
Product and process vigilance 281
Proceeding with HV in developing countries 281
Hemovigilance: From basic to comprehensive 282
Prerequisites for setting up HV 282
A final consideration 284
WHO and hemovigilance 284
Framework 284
Aims and responsibilites 285
WHO BTS 286
WHO publications 287
WHO and hemovigilance with special emphasis on developing countries 288
WHO response to make HV a reality in its member states 289
GloSCH: A worldwide HV initiative 289
References 290
PART 5 Achievements 293
CHAPTER 24 Achievements Through Hemovigilance 295
Introduction 295
Methods 297
Longitudinal analysis using UK data 298
General recommendations 299
Specific recommendations 299
Results 302
Problems and risks identified by hemovigilance 302
Actions and measures triggered by hemovigilance 306
Outcomes and achievements through hemovigilance 310
Conclusions 313
Acknowledgements 314
References 315
PART 6 Developments 317
CHAPTER 25 Vigilance of Alternatives for Blood Components 319
Introduction 319
Autologous blood transfusion techniques 320
Predeposit 320
Hemodilution 321
Peri-operative cell salvage (POCS) 322
Possible problems with autologous blood collection 323
Iron 325
Hemostatic fibrin sealants 325
Erythopoietin (EPO) 326
Aprotonin 327
Tranexamic acid 327
Recombinant VIIa 327
Hemovigilance of alternatives 328
References 333
CHAPTER 26 Surveillance of Clinical Effectiveness of Transfusion 336
Introduction 336
Why we transfuse blood components 336
Benefits 336
Risks 336
What is meant by hemovigilance 337
What hemovigilance can tell us 337
What hemovigilance does not tell us 337
Information that would show how transfusion treatment influences the health of a population 337
Definitions and data quality 338
Transfusion and survival in a population 338
Hemovigilance in the future 338
References 339
CHAPTER 27 Biovigilance 340
Definition of biovigilance and surveillance 340
Background of need 341
Coordinating public health and approach to risk 342
Biovigilance in the United States: Efforts to bridge a critical gap in patient safety and donor health 342
AEs associated with HCT/P in the US 345
Solid organ AE report in the US 347
Development of Vigilance and Surveillance (V& S) systems for HCT/P and organs
Emerging threat assessment: Looking to the future and beyond known transfusion/ transplantation-related events 351
Mandates for a Comprehensive Biovigilance Program and Future Challenges 352
Conclusions 353
References 354
Appendices 355
APPENDIX A Glossary 357
APPENDIX B Proposed Standard Definitions for Surveillance of Non Infectious Adverse Transfusion Reactions 365
APPENDIX C ISBT Working Party on Haemovigilance 374
Index 383

Rezensionen

"This is a thoroughly fascinating read and will make you
eager to implement or enhance your current hemovigilance efforts. I
recommend it." (Doody's, 26 April
2013)

Produkt-Details

• Erscheint lt. Verlag: 11.7.2012
• Sprache: englisch
• Themenwelt: Medizinische Fachgebiete ► Innere Medizin ► Hämatologie
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Schlagworte: Blood • blood components • Blood Transfusion • Bluttransfusionen • Chain • Concepts • contributors • der kreek • Donor • Establishment • Faber • Hämatologie • Hämatologisches Labor • Hämatologie • Hämatologisches Labor • Hematology • hemovigilance • Introduction • laboratory hematology • Level • List • marijtvan • Medical Science • Medizin • Part • quality • section • System • Transfusion • XII
• ISBN-10: 1-118-33806-5 / 1118338065
• ISBN-13: 978-1-118-33806-3 / 9781118338063