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1 Role and Responsibilities of the Laboratory Director |
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1 | (18) |
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1.1 General Responsibilities |
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3 | (8) |
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11 | (1) |
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1.3 Facilities and Safety |
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12 | (1) |
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12 | (1) |
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13 | (1) |
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1.6 Consultation and Education |
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14 | (1) |
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14 | (1) |
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1.8 Operational Management |
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14 | (1) |
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15 | (1) |
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15 | (1) |
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1.11 Summary and Key Points |
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16 | (3) |
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16 | (3) |
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2 Collection of Coagulation Specimens |
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19 | (14) |
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2.1 Collection of Specimens for Hemostasis Testing |
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19 | (1) |
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2.2 Citrate Anticoagulant Concentration |
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19 | (4) |
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2.3 Plastic vs. Glass Tubes |
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23 | (1) |
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2.4 Collection Techniques |
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23 | (3) |
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26 | (1) |
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26 | (1) |
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2.7 Problem Detection and Actions |
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26 | (4) |
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2.8 Coagulation Testing on Specimens Other than Citrated Plasma |
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30 | (1) |
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30 | (1) |
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2.10 Summary and Key Points |
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31 | (2) |
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31 | (2) |
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3 Instrumentation for the Coagulation Laboratory |
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33 | (12) |
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3.1 Laboratory Instruments |
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33 | (2) |
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33 | (1) |
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34 | (1) |
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3.2 Point of Care Instruments |
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35 | (5) |
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3.2.1 Waived PT/INR Instruments |
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35 | (1) |
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3.2.2 POC Analyzers Designed for Coagulation Monitoring During Invasive Procedures |
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36 | (2) |
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3.2.3 Viscoelastic Analyzers |
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38 | (1) |
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3.2.4 Platelet Function Analyzers |
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39 | (1) |
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3.3 Platelet Aggregometry |
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40 | (1) |
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3.3.1 Light Transmission Aggregometers (LTA) |
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40 | (1) |
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3.3.2 Multiplate® Analyzer |
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40 | (1) |
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40 | (1) |
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41 | (1) |
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41 | (1) |
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3.4 Summary and Key Points |
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41 | (4) |
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42 | (3) |
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4 Validation of Hemostasis Assays, Analyzers, and Reagents |
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45 | (24) |
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45 | (1) |
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46 | (1) |
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47 | (1) |
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47 | (1) |
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4.5 Analyzer Set-up and Utilities |
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47 | (1) |
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4.6 Calibration and Calibration Verification |
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47 | (1) |
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4.7 Quality Control Ranges |
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48 | (2) |
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50 | (2) |
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4.9 Performance Characteristics |
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52 | (4) |
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56 | (2) |
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58 | (4) |
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4.12 Heparin Therapeutic Ranges |
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62 | (1) |
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4.13 Instrument Interfaces |
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62 | (1) |
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62 | (1) |
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4.15 Implementation Readiness |
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63 | (2) |
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65 | (1) |
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4.17 "Full" Versus "Partial" Validations |
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65 | (1) |
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4.18 Other Considerations |
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65 | (1) |
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65 | (1) |
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4.20 Summary and Key Points |
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66 | (3) |
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66 | (3) |
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5 Hemostasis Screening Assays |
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69 | (14) |
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5.1 Hemostasis Screening Assays: Use and Interpretation |
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69 | (1) |
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69 | (1) |
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70 | (3) |
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73 | (1) |
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5.5 The Mixing Test (Inhibitor Screen) |
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74 | (1) |
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5.6 The Thrombin Time Assay |
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74 | (1) |
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75 | (1) |
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75 | (1) |
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5.9 The Bleeding Time (BT) Test |
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76 | (1) |
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5.10 Interpretation of Hemostasis Screening Tests in Patients with Bleeding Disorders |
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77 | (3) |
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80 | (3) |
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80 | (3) |
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6 Testing for Inherited Bleeding Disorders |
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83 | (16) |
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6.1 Qualitative Platelet Disorders |
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83 | (2) |
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85 | (3) |
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6.3 von Willebrand's Disease |
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88 | (1) |
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89 | (1) |
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89 | (1) |
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6.6 Ristocetin Cofactor Activity (vWF Activity) Assay |
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89 | (1) |
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6.7 Factor VIII Activity Assay |
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90 | (1) |
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6.8 vWF Multimeric Analysis |
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91 | (1) |
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6.9 Appropriate Test Ordering for Platelet-Type Bleeding Disorders |
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91 | (1) |
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6.10 The Platelet Function Analyzer (PFA)-100® |
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92 | (1) |
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6.11 Inherited Coagulation Disorders |
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92 | (1) |
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6.12 Factor XIII (Clot Stability) Assay |
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93 | (1) |
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6.13 Fibrinogen Activity Assay |
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94 | (1) |
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6.14 Alpha2-Antiplasmin Assay |
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95 | (1) |
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6.15 Assays for Factor VIII Antibodies (Inhibitor Assays) |
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95 | (1) |
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96 | (3) |
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97 | (2) |
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7 Testing for Acquired Platelet Disorders |
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99 | (12) |
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7.1 Platelet Counting Methods |
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99 | (2) |
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99 | (1) |
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7.1.2 Automated Platelet Counters |
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100 | (1) |
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7.2 Platelet Antibody Testing |
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101 | (4) |
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7.2.1 Immune-Mediated Thrombocytopenia |
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101 | (1) |
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102 | (1) |
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7.2.3 Platelet Antibody Tests |
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102 | (1) |
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7.2.4 Testing for Heparin-Dependent Antibodies |
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103 | (1) |
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7.2.5 Clinical Utility of Platelet Antibody Tests |
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104 | (1) |
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7.3 Platelet Function Testing |
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105 | (2) |
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7.3.1 Myeloproliferative Disorders |
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105 | (1) |
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105 | (1) |
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106 | (1) |
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7.3.4 Cardiovascular Surgery |
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107 | (1) |
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7.4 Summary and Key Points |
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107 | (4) |
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108 | (3) |
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8 Acquired Coagulation Disorders and TTP |
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111 | (6) |
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8.1 Liver Disease and Vitamin K Deficiency |
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111 | (1) |
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112 | (1) |
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8.3 Antibodies to Coagulation Factors |
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112 | (2) |
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8.4 Abnormal Fibrinolysis |
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114 | (1) |
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8.5 Thrombotic Thrombocytopenic Purpura |
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114 | (1) |
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8.6 Summary and Key Points |
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115 | (2) |
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116 | (1) |
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9 Testing for Inherited and Acquired Thrombotic Disorders |
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117 | (18) |
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9.1 Pathophysiology of Thrombosis |
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118 | (1) |
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9.2 The Inherited Thrombotic Disorders |
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119 | (1) |
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9.3 General Principles of Thrombosis TESTING |
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120 | (3) |
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9.4 Laboratory Testing Strategy for Inherited Thrombosis |
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123 | (1) |
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9.5 Utility of Inherited Thrombosis Testing |
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124 | (1) |
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9.6 Laboratory Tests for Inherited Thrombosis |
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125 | (1) |
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9.7 Activated Protein C Resistance Assay |
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125 | (1) |
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9.8 Factor V Leiden DNA Test |
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126 | (1) |
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9.9 Prothrombin Gene Mutation Assay |
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126 | (1) |
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126 | (1) |
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127 | (1) |
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127 | (2) |
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129 | (1) |
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9.14 Laboratory Testing for Other Inherited Thrombotic Disorders |
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129 | (1) |
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9.15 The Acquired Thrombotic Disorders |
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129 | (1) |
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9.16 Anticardiolipin Antibody Assay |
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130 | (1) |
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9.17 Lupus Anticoagulant (LA) Assay |
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131 | (1) |
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9.18 Utility of Laboratory Thrombosis Testing |
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132 | (1) |
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133 | (2) |
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134 | (1) |
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10 Monitoring of Anticoagulant Therapy |
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135 | (38) |
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10.1 Monitoring Anticoagulant and Antiplatelet Therapy |
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135 | (4) |
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139 | (7) |
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10.2.1 Mechanism of Action |
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139 | (1) |
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10.2.2 Rationale for Laboratory Monitoring |
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140 | (1) |
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140 | (2) |
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10.2.4 INR and Calibration |
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142 | (2) |
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144 | (1) |
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10.2.6 Evaluation of Discrepant INRs |
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144 | (1) |
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10.2.7 Therapeutic Monitoring |
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145 | (1) |
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10.3 Unfractionated Heparin |
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146 | (8) |
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10.3.1 Mechanism of Action |
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146 | (2) |
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10.3.2 Rationale for Laboratory Monitoring |
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148 | (1) |
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10.3.3 Heparin-Induced Thrombocytopenia |
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149 | (1) |
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150 | (1) |
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10.3.5 Anti-Xa Heparin Assay Basics |
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151 | (1) |
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152 | (2) |
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10.3.7 Therapeutic Monitoring |
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154 | (1) |
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10.4 Low-Molecular-Weight Heparin |
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154 | (2) |
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10.4.1 Mechanism of Action |
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154 | (1) |
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10.4.2 Rationale for Laboratory Monitoring |
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155 | (1) |
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10.4.3 Therapeutic Monitoring |
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156 | (1) |
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156 | (1) |
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10.5.1 Mechanism of Action |
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156 | (1) |
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10.5.2 Rationale for Laboratory Monitoring |
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156 | (1) |
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10.5.3 Therapeutic Monitoring |
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157 | (1) |
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157 | (1) |
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10.6.1 Mechanism of Action |
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157 | (1) |
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10.6.2 Therapeutic Monitoring |
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157 | (1) |
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157 | (1) |
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10.7.1 Mechanism of Action |
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158 | (1) |
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10.7.2 Rationale for Laboratory Monitoring |
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158 | (1) |
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10.7.3 Therapeutic Monitoring |
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158 | (1) |
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158 | (2) |
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10.8.1 Mechanism of Action |
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158 | (1) |
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10.8.2 Ecarin Clotting Time Basics |
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159 | (1) |
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10.8.3 Plasma-Diluted Thrombin Time Basics |
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159 | (1) |
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10.8.4 Therapeutic Monitoring |
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160 | (1) |
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160 | (1) |
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10.9.1 Mechanism of Action |
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160 | (1) |
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10.9.2 Therapeutic Monitoring |
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161 | (1) |
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161 | (5) |
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10.10.1 Other Anticoagulants |
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161 | (1) |
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10.10.2 Antiplatelet Agents |
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161 | (1) |
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10.10.3 Mechanisms of Action |
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162 | (1) |
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10.10.4 Basics of Platelet Function Testing |
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162 | (1) |
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10.10.5 Rationale for Laboratory Testing |
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162 | (3) |
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10.10.6 Therapeutic Monitoring |
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165 | (1) |
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10.11 Effects of Anticoagulants on Hemostasis Tests |
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166 | (1) |
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166 | (1) |
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10.13 Summary and Key Points |
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166 | (7) |
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169 | (4) |
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11 Pharmacogenetic Testing for Anticoagulant and Antiplatelet Therapies |
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173 | (10) |
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173 | (1) |
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11.2 Pharmacogenetic Testing for Warfarin |
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173 | (3) |
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11.3 Pharmacogenetic Testing for Clopidogrel |
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176 | (7) |
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179 | (4) |
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12 Coagulation Testing and Transfusion Medicine |
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183 | (18) |
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12.1 Essential Coagulation Assays |
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183 | (4) |
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184 | (1) |
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12.1.2 Partial Thromboplastin Time |
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184 | (1) |
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12.1.3 Fibrinogen Concentration |
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184 | (1) |
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12.1.4 Prothrombin Time and Partial Thromboplastin Time Mixing Studies |
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185 | (1) |
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186 | (1) |
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186 | (1) |
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12.1.7 Thromboelastography |
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186 | (1) |
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12.2 Transfusion Medicine Tools: Blood Components |
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187 | (4) |
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187 | (2) |
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12.2.2 Fresh Frozen Plasma (FFP) |
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189 | (1) |
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190 | (1) |
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12.3 Clinical Scenarios and Case Studies |
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191 | (5) |
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12.3.1 Dilutional Coagulopathy |
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191 | (5) |
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12.4 Emerging Issues in Transfusion Medicine and Anticoagulation |
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196 | (1) |
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12.4.1 Reversing New Oral Anticoagulants (NOACs) |
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196 | (1) |
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12.5 Summary and Key Points |
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197 | (4) |
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198 | (3) |
Index |
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201 | |