Quality in Laboratory Hemostasis and Thrombosis
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...
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| Main Authors: | , , |
|---|---|
| Format: | eBook |
| Language: | English |
| Published: |
Newark
John Wiley & Sons, Incorporated
2013
Wiley-Blackwell |
| Edition: | 2 |
| Subjects: | |
| ISBN: | 9780470671191, 047067119X, 9781118543467, 1118543467 |
| Online Access: | Get full text |
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Table of Contents:
- Introduction -- Sample acquisition (specimen collection) -- Transportation of whole blood specimens to the laboratory -- Specimen Processing -- Stability and storage of plasma samples -- Controlled thawing of frozen plasma samples -- Conclusion -- References -- 6 Internal quality control in the hemostasis laboratory -- Introduction -- IQC materials -- Frequency of IQC testing -- Acceptable limits for IQC -- Storage and processing of IQC results -- Out of limits IQC results -- Accreditation and regulatory bodies -- Conclusion -- References -- 7 External quality assessment in hemostasis: its importance and significance -- Overview -- Target values -- The evaluation of laboratory performance -- Monitoring results: the role of the laboratory -- The educational role of EQA -- Additional advantages of EQA programs -- Recent developments -- Establishing EQA programs in developing countries -- The need and the challenges -- The establishment of an EQA program in India: a successful model -- Samples for EQAS -- Assignment of target value -- Profile of participants -- Range of tests offered -- The program and its impact -- Extension to other developing countries -- References -- 8 The unique challenges of hemostatic testing in children -- Introduction -- Normal hemostasis -- Developmental hemostasis -- Pediatric reference ranges: challenges and deviations -- Local pediatric reference range development -- The effect of the assay method -- Test sampling -- Preanalytical variables -- Analytical variables -- Postanalytical variables -- Global hemostasis parameters -- Thrombophilia testing -- When is thrombophilia testing indicated in children -- Monitoring currently administered anticoagulants -- Unfractionated heparin -- Low molecular weight heparin -- Vitamin K antagonists -- POC INR monitoring -- New anticoagulants in children -- Conclusion -- References
- Pitfalls and limitations of the inhibitor assay -- Inhibitors against other clotting factors -- Conclusion -- References -- 13 Standardization of D-dimer testing -- Introduction -- Heterogeneity of D-dimer containing fragments -- Specificity of monoclonal antibodies directed to D-dimer motif -- Calibrators for D-dimer assays -- Standardization of D-dimer assays -- Harmonization of D-dimer assays -- Problems in daily practice -- Reference material for D-dimer assays -- Conclusion -- References -- 14 Point-of-care testing in hemostasis -- Introduction -- Monitoring of oral anticoagulation -- Quality assurance of point-of-care INR monitors -- Patient self-monitoring of oral anticoagulation -- aPTT testing -- aCT -- Thrombin time -- Low molecular weight heparin monitoring -- D-dimer -- Thrombelastography -- Management of POCT services -- Conclusion -- References -- PART 3 Quality in Testing for Platelet Function and von Willebrand Disease -- 15 Diagnostic assessment of platelet function -- Bleeding time -- Prothrombin consumption -- Platelet counting and morphology -- The platelet function analyzer -- The VerifyNow and point-of-care tests -- Platelet aggregometry -- Platelet secretion -- Flow cytometry -- Clot retraction -- Signaling pathways -- In vitro studies on thrombus formation -- Requiring specialist procedures, this can be studied under static or flow conditions. -- Platelet adhesion to collagen and other adhesive proteins under static conditions -- Thrombus formation on immobilized collagen under flow conditions -- Platelet procoagulant activity -- New technologies -- Proteomics and genomics -- Gene sequencing -- References -- 16 Laboratory evaluation of heparin-induced thrombocytopenia -- HIT syndrome -- Central paradigm of HIT [5] -- Key concepts in HIT
- PART 2 Quality in Coagulation Testing -- 9 Initial evaluation of hemostasis: reagent and method selection -- Introduction -- Instrument selection -- Evaluation of the method -- Prothrombin time method selection -- Minimum evaluation, prothrombin time -- Activated partial thromboplastin time method selection -- Minimum evaluation, activated partial thromboplastin time assay -- Fibrinogen method selection -- Minimum evaluation, fibrinogen assay -- Thrombin time method selection -- Minimum evaluation, thrombin time -- Whole blood viscoelastic assays -- Minimum evaluation, viscoelastic assays -- References -- 10 Assay of factor VIII and other clotting factors -- Pretest variables -- One-stage assay of factor VIII:C or factor IX:C -- Assays in the presence of strong lupus anticoagulant -- One-stage assay components -- Factor assays in the presence of severe deficiency -- Assay of elevated factor VIII:C -- Two-stage clotting assay for FVIII:C -- Chromogenic assay for factor VIII:C in plasma -- Factor VIII:C and FIX:C assays following clotting factor infusions -- References -- 11 Application of molecular genetics to the investigation of inherited bleeding disorders -- Hemophilia A and B -- The genes and their mutations -- Most common mutations -- Other rare bleeding disorders -- Internal quality control -- External quality assessment -- Reporting -- References -- 12 Detecting and quantifying acquired functional inhibitors in hemostasis -- Introduction -- Clinical manifestations of hemostasis inhibitors -- Screening tests for inhibitor detection -- Differential classification of inhibitors -- Assay of inhibitors against individual coagulation factors -- Assay principle -- Available methods -- Reagents -- Equipment -- Method -- Evaluation of test results -- Expected values -- Improved sensitive assay -- Assay characteristics
- Intro -- Quality in Laboratory Hemostasis and Thrombosis -- Contents -- Contributors -- Foreword -- Preface -- PART 1 General Quality Program -- 1 General quality planning in the hemostasis laboratory -- Introduction -- The principles -- Elements of quality in the hemostasis laboratory -- The tools -- Six Sigma -- Lean -- Error detection and correction -- Internal quality control -- Quality assurance -- External quality assessment -- The application of the tools in the laboratory -- Quality system essentials -- Summary -- References -- 2 Hemostasis test validation, performance, and reference intervals: international recommendations and guidelines -- Hemostatic test validation concepts -- Limits -- Protocol -- Continued performance of coagulation/hemostasis assays -- Internal quality control -- External quality assessment -- Reference interval -- Appendix: Standards and guideline developing organizations -- Statistics -- Acknowledgments -- References -- 3 Causes of errors in medical laboratories -- Overview on medical errors -- Diagnostic errors: the laboratory scenario -- The definition of laboratory error -- Exploring the iceberg of laboratory errors -- Preanalytical errors -- Specific preanalytical issues related to coagulation testing -- Dealing with preanalytical errors -- Analytical errors -- Postanalytical errors -- Conclusion -- References -- 4 International standards in hemostasis -- Introduction -- International standards and international units -- Units of activity -- International units -- Establishment of international standards -- Heparin and LMW heparin -- Thromboplastins -- Coagulation factors and inhibitors -- Factor VIII -- Factor IX -- von Willebrand factor -- Fibrinogen -- Thrombin -- Other coagulation factors and inhibitors -- Fibrinolysis standards -- References -- 5 Sample integrity and preanalytical variables
- Several concepts directly relate to issues of laboratory testing and the interpretation of test results. -- Stoichiometric PF4: heparin ratios and high heparin inhibition -- Iceberg model -- Timeline of HIT immune response -- Serum versus plasma -- Positive control reagents -- Evaluation of pretest probability -- Platelet activation assays -- Platelet aggregation assays -- Washed platelet activation assays: serotonin-release assay (SRA) and heparin-induced platelet activation HIPA) test -- Whole blood impedance aggregometry -- PF4-dependent enzyme-immunoassays -- PF4-dependent particle-based immunoassays (rapid assays) -- Particle gel immunoassay -- Particle immunofiltration assay -- Instrumentation-based immunoassays -- Fluid-phase immunoassays -- Sepharose G fluid-phase EIA -- Gold nanoparticle-based fluid-phase EIA lateral-flow immunoassay) -- Approach of the McMaster platelet immunology laboratory -- References -- 17 Laboratory evaluation of von Willebrand disease: phenotypic analysis -- Introduction and background -- Fundamental problems with the phenotypic evaluation of vWD -- Phenotypic assays used in the diagnosis of vWD -- Sensitive and specific laboratory assays for vWD -- A diagnostic laboratory process for vWD -- Recommendations and conclusions -- Acknowledgments -- References -- 18 Laboratory analysis of von Willebrand disease: molecular analysis -- Introduction -- Type 3 VWD -- Type 2 VWD -- Type 2A VWD -- Type 2B VWD -- Type 2M VWD -- Type 2N VWD -- Type 2 VWD summary -- Type 1 VWD -- Mutation analysis -- Point mutations -- Large deletions and duplications -- Mutation analysis in VWD -- Missing mutations and too many mutations -- Prenatal diagnosis -- Internal quality control -- External quality control -- External quality assessment -- Reporting -- Nomenclature -- Report inclusions -- References
- PART 4 Quality in Thrombophilia Testing and Monitoring Anticoagulation