Hemovigilance

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.

List of Contributors, viii Foreword, xii

Part 1 General Introduction

1 Introduction, 3
Ren´e R.P. de Vries

2 Hemovigilance: A Quality Tool for the Blood Transfusion Chain, 5
Ren´e R.P. de Vries

3 Concepts and Models, 12
Ren´e R.P. de Vries and Jean-Claude Faber

Part 2 Hemovigilance of the Blood Transfusion Chain (Blood Establishment and Hospital)

Section 2.1: Setting up a Hemovigilance System

4 Setting Up or Consolidating a System for Donor Hemovigilance at the Level of a Blood Establishment, 21
Johanna Wiersum-Osselton, Wim de Kort, Tanneke Marijt-van der Kreek, and Jeroen de Wit

5 Preparation of Blood Components, 36
Tomislav Vuk

6 Establishment of Hemovigilance for the Testing, Storage, Distribution, Transport, and Issuing of Blood and Blood Components: The Example of Greece, 52
Constantina Politis

7 Medical Decision, Ordering, Administration of Component, and Monitoring of the Patient, 61
Mickey B.C. Koh, Ramir Alcantara, Mark Grumbridge, and Ai Leen Ang

Section 2.2: How the System Works

8 Blood Donation: An Approach to Donor Vigilance, 77
Peter Tomasulo, Madhav Erraguntla, and Hany Kamel

9 Preparation of Blood Components, 99
Erhard Seifried, Reinhard Henschler, Juergen Luhm, Thea Mueller-Kuller, Hans-Ulrich Pfeiffer, Walid Sireis, and Markus M. Mueller

10 Testing, Issuing, and Transport of Blood Components, 113
Constantina Politis

11 Clinical Activities: Medical Decision-making, Sampling, Ordering Components, Administration, and Patient Monitoring, 126
Clare Taylor

Part 3 National or Regional Hemovigilance Systems

12 The French Hemovigilance Network: From the Blood Scandal to Epidemiologic Surveillance of the Transfusion Chain, 147
Philippe Renaudier

13 The Japanese Hemovigilance System, 159
Hitoshi Okazaki, Naoko Goto, Shun-ya Momose, Satoru Hino, and Kenji Tadokoro

14 Setting up a National Hemovigilance System: SHOT, 168
Hannah Cohen and Lorna M. Williamson

15 The Dutch Hemovigilance System: Transfusion Reactions in Patients (TRIP), 180
Martin R. Schipperus, Johanna Wiersum-Osselton, Pauline Y. Zijlker-Jansen, and Anita J.W. van Tilborgh-de Jong

16 Regulatory, Public Health, and International Aspects of Hemovigilance in Canada, 191
Peter R. Ganz and Jun Wu

17 Setting up and Implementation of the National Hemovigilance System in Italy, 204
Giuliano Grazzini and Simonetta Pupella

18 The Australian Hemovigilance System, 209
Erica M. Wood, Lisa J. Stevenson, Simon A. Brown, and Christopher J. Hogan

19 Biovigilance in the United States, 220
D. Michael Strong, Barbee Whitaker, Matthew J. Kuehnert, and Jerry A. Holmberg

20 Arab Hemovigilance Network, 226
Salwa Hindawi, Magdy Elekiaby, and Gamal Gabra

Part 4 Hemovigilance at the International Level

21 Hemovigilance in the European Community, 235
Jean-Claude Faber

22 International collaboration, 253
Paul F.W. Strengers

23 Hemovigilance in Developing Countries, 260
Jean-Claude Faber

Part 5 Achievements

24 Achievements Through Hemovigilance, 281
Jean-Claude Faber and F´atima Nascimento

Part 6 Developments

25 Vigilance of Alternatives for Blood Components, 305
Dafydd Thomas

26 Surveillance of Clinical Effectiveness of Transfusion, 322
Brian McClelland and Katherine Forrester

27 Biovigilance, 326
Jerry A. Holmberg, Matthew J. Kuehnert, and D. Michael Strong

Appendices

Appendix A Glossary, 343

Appendix B Proposed standard definitions for surveillance of non infectious adverse transfusion reactions, 351

Appendix C Standard for surveillance of complications related to blood donation, 360

Index, 369