Dr Steve Kitchen, Clinical Scientist, Sheffield Hemophila and Thromobosis Centre, Royal Hallamshire Hospital and Scientific Director, UK National External Quality Assessment Scheme (FQAS) for Blood Coagulation, Scientific Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulation, Sheffield, UK. John D Olson, Professor and Vice Chair for Clinical Affairs, Department of Pathology, University of Texas Health Sciences Centre, San Antonio, Texas, USA. F. Eric Preston, Emeritus Professsor of Hematology, University of Sheffield and Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulations, Sheffield, UK.

• Contributors viiForeword xPreface xiiSteve Kitchen John D. Olson & F. Eric PrestonPart 1: General Quality Program1 General quality planning in the hemostasis laboratory 3John D. Olson2 Hemostasis test validation performance and reference intervals: international recommendations and guidelines 12RichardA.Marlar3 Causes of errors in medical laboratories 22Giuseppe Lippi & Emmanuel J. Favaloro4 International standards in hemostasis 32Trevor W. Barrowcliffe & Anthony R. Hubbard5 Sample integrity and preanalytical variables 45Dorothy (Adcock) Funk6 Internal quality control in the hemostasis laboratory 57Steve Kitchen F. Eric Preston & John D. Olson7 External quality assessment in hemostasis: its importance and significance 65F. Eric Preston Steve Kitchen & Alok Srivastava8 The unique challenges of hemostatic testing in children 77M. Patricia Massicotte Mary E. Bauman Vanessa Chan & Anthony K.C. ChanPart 2: Quality in Coagulation Testing9 Initial evaluation of hemostasis: reagent and method selection 95Wayne L. Chandler10 Assay of factor VIII and other clotting factors 105Steve Kitchen & F. Eric Preston11 Application of molecular genetics to the investigation of inherited bleeding disorders 115Stefan Lethagen Morten Dunø & Lars Bo Nielsen12 Detecting and quantifying acquired functional inhibitors in hemostasis 124Bert Verbruggen Myriam Dardikh & Britta Laros-van Gorkom13 Standardization of d-dimer testing 136Guido Reber & Philippe de Moerloose14 Point-of-care testing in hemostasis 147Chris Gardiner Dianne Kitchen Samuel Machin & Ian MackiePart 3: Quality in Testing for Platelet Function and von Willebrand Disease15 Diagnostic assessment of platelet function 159Paquita Nurden Alan Nurden & Martine Jandrot-Perrus16 Laboratory evaluation of heparin-induced thrombocytopenia 174Theodore (Ted) E. Warkentin & Jane C. Moore17 Laboratory evaluation of von Willebrand disease: phenotypic analysis 192Emmanuel J. Favaloro18 Laboratory analysis of von Willebrand disease: molecular analysis 204Anne C. Goodeve & Ian R. PeakePart 4: Quality in Thrombophilia Testing and Monitoring Anticoagulation19 Quality issues in heritable thrombophilia testing 219Isobel D. Walker & Ian Jennings20 Evaluation of antiphospholipid antibodies 233Michael Greaves21 Monitoring heparin therapy 244Marilyn Johnston22 Monitoring oral anticoagulant therapy with vitamin K antagonists 253Armando Tripodi23 Monitoring new anticoagulants 264Elaine Gray & Trevor W. BarrowcliffeIndex 273

Dr Steve Kitchen, Clinical Scientist, Sheffield Hemophila and Thromobosis Centre, Royal Hallamshire Hospital and Scientific Director, UK National External Quality Assessment Scheme (FQAS) for Blood Coagulation, Scientific Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulation, Sheffield, UK. John D Olson, Professor and Vice Chair for Clinical Affairs, Department of Pathology, University of Texas Health Sciences Centre, San Antonio, Texas, USA. F. Eric Preston, Emeritus Professsor of Hematology, University of Sheffield and Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulations, Sheffield, UK.

• Contributors viiForeword xPreface xiiSteve Kitchen John D. Olson & F. Eric PrestonPart 1: General Quality Program1 General quality planning in the hemostasis laboratory 3John D. Olson2 Hemostasis test validation performance and reference intervals: international recommendations and guidelines 12RichardA.Marlar3 Causes of errors in medical laboratories 22Giuseppe Lippi & Emmanuel J. Favaloro4 International standards in hemostasis 32Trevor W. Barrowcliffe & Anthony R. Hubbard5 Sample integrity and preanalytical variables 45Dorothy (Adcock) Funk6 Internal quality control in the hemostasis laboratory 57Steve Kitchen F. Eric Preston & John D. Olson7 External quality assessment in hemostasis: its importance and significance 65F. Eric Preston Steve Kitchen & Alok Srivastava8 The unique challenges of hemostatic testing in children 77M. Patricia Massicotte Mary E. Bauman Vanessa Chan & Anthony K.C. ChanPart 2: Quality in Coagulation Testing9 Initial evaluation of hemostasis: reagent and method selection 95Wayne L. Chandler10 Assay of factor VIII and other clotting factors 105Steve Kitchen & F. Eric Preston11 Application of molecular genetics to the investigation of inherited bleeding disorders 115Stefan Lethagen Morten Dunø & Lars Bo Nielsen12 Detecting and quantifying acquired functional inhibitors in hemostasis 124Bert Verbruggen Myriam Dardikh & Britta Laros-van Gorkom13 Standardization of d-dimer testing 136Guido Reber & Philippe de Moerloose14 Point-of-care testing in hemostasis 147Chris Gardiner Dianne Kitchen Samuel Machin & Ian MackiePart 3: Quality in Testing for Platelet Function and von Willebrand Disease15 Diagnostic assessment of platelet function 159Paquita Nurden Alan Nurden & Martine Jandrot-Perrus16 Laboratory evaluation of heparin-induced thrombocytopenia 174Theodore (Ted) E. Warkentin & Jane C. Moore17 Laboratory evaluation of von Willebrand disease: phenotypic analysis 192Emmanuel J. Favaloro18 Laboratory analysis of von Willebrand disease: molecular analysis 204Anne C. Goodeve & Ian R. PeakePart 4: Quality in Thrombophilia Testing and Monitoring Anticoagulation19 Quality issues in heritable thrombophilia testing 219Isobel D. Walker & Ian Jennings20 Evaluation of antiphospholipid antibodies 233Michael Greaves21 Monitoring heparin therapy 244Marilyn Johnston22 Monitoring oral anticoagulant therapy with vitamin K antagonists 253Armando Tripodi23 Monitoring new anticoagulants 264Elaine Gray & Trevor W. BarrowcliffeIndex 273

Dr Steve Kitchen, Clinical Scientist, Sheffield Hemophila and Thromobosis Centre, Royal Hallamshire Hospital and Scientific Director, UK National External Quality Assessment Scheme (FQAS) for Blood Coagulation, Scientific Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulation, Sheffield, UK. John D Olson, Professor and Vice Chair for Clinical Affairs, Department of Pathology, University of Texas Health Sciences Centre, San Antonio, Texas, USA. F. Eric Preston, Emeritus Professsor of Hematology, University of Sheffield and Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulations, Sheffield, UK.

• Contributors viiForeword xPreface xiiSteve Kitchen John D. Olson & F. Eric PrestonPart 1: General Quality Program1 General quality planning in the hemostasis laboratory 3John D. Olson2 Hemostasis test validation performance and reference intervals: international recommendations and guidelines 12RichardA.Marlar3 Causes of errors in medical laboratories 22Giuseppe Lippi & Emmanuel J. Favaloro4 International standards in hemostasis 32Trevor W. Barrowcliffe & Anthony R. Hubbard5 Sample integrity and preanalytical variables 45Dorothy (Adcock) Funk6 Internal quality control in the hemostasis laboratory 57Steve Kitchen F. Eric Preston & John D. Olson7 External quality assessment in hemostasis: its importance and significance 65F. Eric Preston Steve Kitchen & Alok Srivastava8 The unique challenges of hemostatic testing in children 77M. Patricia Massicotte Mary E. Bauman Vanessa Chan & Anthony K.C. ChanPart 2: Quality in Coagulation Testing9 Initial evaluation of hemostasis: reagent and method selection 95Wayne L. Chandler10 Assay of factor VIII and other clotting factors 105Steve Kitchen & F. Eric Preston11 Application of molecular genetics to the investigation of inherited bleeding disorders 115Stefan Lethagen Morten Dunø & Lars Bo Nielsen12 Detecting and quantifying acquired functional inhibitors in hemostasis 124Bert Verbruggen Myriam Dardikh & Britta Laros-van Gorkom13 Standardization of d-dimer testing 136Guido Reber & Philippe de Moerloose14 Point-of-care testing in hemostasis 147Chris Gardiner Dianne Kitchen Samuel Machin & Ian MackiePart 3: Quality in Testing for Platelet Function and von Willebrand Disease15 Diagnostic assessment of platelet function 159Paquita Nurden Alan Nurden & Martine Jandrot-Perrus16 Laboratory evaluation of heparin-induced thrombocytopenia 174Theodore (Ted) E. Warkentin & Jane C. Moore17 Laboratory evaluation of von Willebrand disease: phenotypic analysis 192Emmanuel J. Favaloro18 Laboratory analysis of von Willebrand disease: molecular analysis 204Anne C. Goodeve & Ian R. PeakePart 4: Quality in Thrombophilia Testing and Monitoring Anticoagulation19 Quality issues in heritable thrombophilia testing 219Isobel D. Walker & Ian Jennings20 Evaluation of antiphospholipid antibodies 233Michael Greaves21 Monitoring heparin therapy 244Marilyn Johnston22 Monitoring oral anticoagulant therapy with vitamin K antagonists 253Armando Tripodi23 Monitoring new anticoagulants 264Elaine Gray & Trevor W. BarrowcliffeIndex 273