Quality in Laboratory Hemostasis and Thrombosis

1 General Quality Planning in the Hemostasis Laboratory, 1 John D. Olson 2 Hemostasis Test Validation, Performance and Reference Intervals, 9 Richard A. Marlar 3 International Standards in Hemostasis, 19 Trevor W. Barrowcliffe 4 Sample Integrity and Preanalytical Variables, 31 Dorothy M. Adcock 5 Internal Quality Control in the Hemostasis Laboratory, 43 Steve Kitchen, F. Eric Preston, John D. Olson 6 External Quality Assessment in Hemostasis: Its Importance and Signifi cance, 51 F. Eric Preston, Steve Kitchen, Alok Srivastava 7 Initial Evaluation of Hemostasis: Reagent and Method Selection, 63 Wayne L. Chandler 8 Point-of-Care Testing in Hemostasis, 72 Chris Gardiner, Samuel Machin, Ian Mackie 9 Assay of Factor VIII and Other Clotting Factors, 81 Steve Kitchen, F. Eric Preston 10 Application of Molecular Genetics to the Investigation of Inherited Bleeding Disorders, 90 Stefan Lethagen, Marianne Schwartz, Lars Bo Nielsen 11 Standardization of d-dimer Testing, 99 Guido Reber, Philippe de Moerloose 12 Diagnostic Assessment of Platelet Function, 110 Paquita Nurden, Alan Nurden 13 Laboratory Evaluation of von Willebrand Disease: Phenotypic Analysis, 125 Emmanuel J. Favaloro 14 Laboratory Analysis of von Willebrand Disease: Molecular Analysis, 137 Anne Goodeve, Ian Peake vi 15 Dilemmas in Heritable Thrombophilia Testing, 147 Isobel D. Walker, Ian Jennings 16 Evaluation of Antiphospholipid Antibodies, 160 Michael Greaves 17 Monitoring Heparin Therapy, 170 Marilyn Johnston 18 Monitoring Oral Anticoagulant Therapy, 179 Armando Tripodi 19 Monitoring New Anticoagulants, 190 Elaine Gray, Trevor W. Barrowcliffe 20 Detecting and Quantifying Functional Inhibitors in Hemostasis, 198 Bert Verbruggen, Irena Nováková, Waander van Heerde Index, 209 CONTENTS Contributors Dorothy M. Adcock MD Esoterix Coagulation Englewood, Colorado USA Trevor W. Barrowcliffe PhD Formerly National Institute for Biological Standards and Control Potters Bar UK Wayne L. Chandler MD Department of Laboratory Medicine University of Washington Seattle, Washington USA Emmanuel J. Favaloro PhD Department of Hematology Institute of Clinical Pathology and Medical Research Westmead Hospital, NSW Australia Chris Gardiner PhD Hematology Department University College London Hospitals NHS Trust London UK Anne Goodeve PhD Academic Unit of Hematology Henry Wellcome Laboratories for Medical Research Sheffi eld UK Elaine Gray PhD National Institute for Biological Standards and Control Potters Bar UK vii Michael Greaves MD, FRCP, FRCPath School of Medicine University of Aberdeen Aberdeen UK Ian Jennings PhD, CSci UK NEQAS (Blood Coagulation) Rutledge Mews Sheffi eld UK Marilyn Johnston ART Hemostasis Reference Laboratory Henderson Research Centre Hamilton, Ontario Canada Steve Kitchen PhD Sheffi eld Hemophilia and Thrombosis Centre Royal Hallamshire Hospital Sheffi eld UK Stefan Lethagen PhD, MD Copenhagen Hemophilia Center Thrombosis and Hemostasis Unit Department of Hematology Copenhagen University Hospital (Rigshospitalet) Copenhagen Denmark Samuel Machin FRCP, FRCPath Hematology Department University College London Hospitals NHS Trust London and Hemostasis Research Unit Hematology Department University College London London UK CONTRIBUTORS viii Ian Mackie PhD Hematology Department University College London Hospitals NHS Trust London and Hemostasis Research Unit Hematology Department University College London London UK Richard A. Marlar PhD Pathology and Laboratory Medicine Oklahoma City VA Medical Center and Department of Pathology University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma USA Philippe de Moerloose MD Hemostasis Unit University Hospital Geneva Geneva Switzerland Lars Bo Nielsen MD, PhD, DMsc Department of Clinical Biochemistry Copenhagen University Hospital (Rigshospitalet) and Department of Biomedical Sciences University of Copenhagen Copenhagen Denmark Irena Nováková MD, PhD Department of Hematology Radboud University Nijmegen Medical Center Nijmegen The Netherlands Alan Nurden PhD Centre de Référence des Pathologies Plaquettaires Plateforme Technologique d’Innovation Biomédicale Hôpital Xavier Arnozan Pessac France Paquita Nurden MD, PhD Centre de Référence des Pathologies Plaquettaires Plateforme Technologique d’Innovation Biomédicale Hôpital Xavier Arnozan Pessac France John D. Olson MD, PhD Department of Pathology University of Texas Health Science Center San Antonio, Texas USA Ian Peake PhD Academic Unit of Haematology Henry Wellcome Laboratories for Medical Research Sheffi eld UK F. Eric Preston MD, FRCPath, FRCP WHO/WFH EQA Rutledge Mews Sheffi eld UK Guido Reber PhD Hemostasis Unit Department of Internal Medicine University Hospital and Faculty of Medicine Geneva Switzerland Frits R. Rosendaal MD Department of Clinical Epidemiology and Department of Thrombosis and Hemostasis Leiden University Medical Center Leiden The Netherlands Marianne Schwartz PhD Department of Clinical Genetics Copenhagen University Hospital (Rigshospitalet) Copenhagen Denmark CONTRIBUTORS ix Alok Srivastava MD Department of Hematology Christian Medical School Vellore India Armando Tripodi PhD Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Department of Internal Medicine University School of Medicine and IRCCS Maggiore Hospital, Mangiagalli and Regina Elena Foundation Milan Italy Waander van Heerde PhD Central Laboratory for Hematology Radboud University Nijmegen Medical Center Nijmegen The Netherlands