Quality in Laboratory Hemostasis and Thrombosis
Second Edition
Edited by
Steve Kitchen, Clinical Scientist, Sheffield Haemophilia and Thrombosis 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 Haematology, University of Sheffield and Director, WHO and WFH International External Quality Assessment Programs for Blood Coagulations, Sheffield, UK
The hemostasis laboratory has a vital role in the diagnosis and management of patients with familial and acquired hemorrhagic and thrombotic disorders. Rapid changes in the number and complexity of tests in this discipline have presented challenges for laboratories, as they develop quality programs for the oversight of this testing.
Quality in Laboratory Hemostasis and Thrombosis has been completely revised and updated to reflect the changing process of managing quality. The second edition provides information on all aspects of testing, from pre-analytic to analytic and result reporting, in addition to external quality assurance. Chapters throughout the book include the development of global guidelines for methods, as well as the preparation of international standard plasmas and reagents.
Designed to capture the elements of quality at all levels of the practice of laboratory hemostasis and thrombosis, this book will guide the reader through the development of a quality program to support all activities in the hemostasis laboratory, both simple and complex.
Titles of related interest
Lee: Textbook of Hemophilia, 2e (2010)
ISBN 9781405169141
Federici: Von Willebrand Disease: Basic and Clinical Aspects, 1e (2011)
ISBN 9781405195126
Ma: Hemophilia and Hemostasis: A Case Based Approach to Management, 2e (2012)
ISBN 9780470659762
Table of Contents
Contributors, vii
Foreword, x
Preface, xii
Steve Kitchen, John D. Olson, & F. Eric Preston
Part 1: General Quality Program
1 General quality planning in the hemostasis laboratory, 3
John D. Olson
2 Hemostasis test validation, performance, and reference intervals: international recommendations and guidelines, 12
Richard A. Marlar
3 Causes of errors in medical laboratories, 22
Giuseppe Lippi & Emmanuel J. Favaloro
4 International standards in hemostasis, 32
Trevor W. Barrowcliffe & Anthony R. Hubbard
5 Sample integrity and preanalytical variables, 45
Dorothy (Adcock) Funk
6 Internal quality control in the hemostasis laboratory, 57
Steve Kitchen, F. Eric Preston, & John D. Olson
7 External quality assessment in hemostasis: its importance and significance, 65
F. Eric Preston, Steve Kitchen, & Alok Srivastava
8 The unique challenges of hemostatic testing in children, 77
M. Patricia Massicotte, Mary E. Bauman, Vanessa Chan, & Anthony K.C. Chan
Part 2: Quality in Coagulation Testing
9 Initial evaluation of hemostasis: reagent and method selection, 95
Wayne L. Chandler
10 Assay of factor VIII and other clotting factors, 105
Steve Kitchen & F. Eric Preston
11 Application of molecular genetics to the investigation of inherited bleeding disorders, 115
Stefan Lethagen, Morten Dunø, & Lars Bo Nielsen
12 Detecting and quantifying acquired functional inhibitors in hemostasis, 124
Bert Verbruggen, Myriam Dardikh, & Britta Laros-van Gorkom
13 Standardization of d-dimer testing, 136
Guido Reber & Philippe de Moerloose
14 Point-of-care testing in hemostasis, 147
Chris Gardiner, Dianne Kitchen, Samuel Machin, & Ian Mackie
Part 3: Quality in Testing for Platelet Function and von Willebrand Disease
15 Diagnostic assessment of platelet function, 159
Paquita Nurden, Alan Nurden, & Martine Jandrot-Perrus
16 Laboratory evaluation of heparin-induced thrombocytopenia, 174
Theodore (Ted) E. Warkentin & Jane C. Moore
17 Laboratory evaluation of von Willebrand disease: phenotypic analysis, 192
Emmanuel J. Favaloro
18 Laboratory analysis of von Willebrand disease: molecular analysis, 204
Anne C. Goodeve & Ian R. Peake
Part 4: Quality in Thrombophilia Testing and Monitoring Anticoagulation
19 Quality issues in heritable thrombophilia testing, 219
Isobel D. Walker & Ian Jennings
20 Evaluation of antiphospholipid antibodies, 233
Michael Greaves
21 Monitoring heparin therapy, 244
Marilyn Johnston
22 Monitoring oral anticoagulant therapy with vitamin K antagonists, 253
Armando Tripodi
23 Monitoring new anticoagulants, 264
Elaine Gray & Trevor W. Barrowcliffe
Index, 273
