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Table of Contents
Preface; Contents; 1: Role and Responsibilities of the Laboratory Director; 1.1 General Responsibilities; 1.2 Personnel; 1.3 Facilities and Safety; 1.4 Test Procedures; 1.5 Quality Management; 1.6 Consultation and Education; 1.7 Communication; 1.8 Operational Management; 1.9 Resources; 1.10 Common Pitfalls; 1.11 Summary and Key Points; References; 2: Collection of Coagulation Specimens; 2.1 Collection of Specimens for Hemostasis Testing; 2.2 Citrate Anticoagulant Concentration; 2.3 Plastic vs. Glass Tubes; 2.4 Collection Techniques; 2.5 Specimen Preparation; 2.6 Specimen Stability
2.7 Problem Detection and Actions2.8 Coagulation Testing on Specimens Other than Citrated Plasma; 2.9 Common Pitfalls; 2.10 Summary and Key Points; References; 3: Instrumentation for the Coagulation Laboratory; 3.1 Laboratory Instruments; 3.1.1 Test Methodologies; 3.1.2 Detection Methods; 3.2 Point of Care Instruments; 3.2.1 Waived PT/INR Instruments; 3.2.2 POC Analyzers Designed for Coagulation Monitoring During Invasive Procedures; 3.2.3 Viscoelastic Analyzers; 3.2.4 Platelet Function Analyzers; 3.3 Platelet Aggregometry; 3.3.1 Light Transmission Aggregometers (LTA)
3.3.2 Multiplate® Analyzer3.3.3 PFA-100®; 3.3.4 Plateletworks®; 3.3.5 VerifyNow™; 3.4 Summary and Key Points; References; 4: Validation of Hemostasis Assays, Analyzers, and Reagents; 4.1 Validation Overview; 4.2 Validation Tools; 4.3 Validation Studies; 4.4 Validation Plan; 4.5 Analyzer Set-up and Utilities; 4.6 Calibration and Calibration Verification; 4.7 Quality Control Ranges; 4.8 Reference Intervals; 4.9 Performance Characteristics; 4.10 Method Comparisons; 4.11 INR; 4.12 Heparin Therapeutic Ranges; 4.13 Instrument Interfaces; 4.14 Reports; 4.15 Implementation Readiness; 4.16 Approval
4.17 "Full" Versus "Partial" Validations4.18 Other Considerations; 4.19 Common Pitfalls; 4.20 Summary and Key Points; References; 5: Hemostasis Screening Assays; 5.1 Hemostasis Screening Assays: Use and Interpretation; 5.2 The CBC; 5.3 The PT Assay; 5.4 The PTT Assay; 5.5 The Mixing Test (Inhibitor Screen); 5.6 The Thrombin Time Assay; 5.7 Fibrinogen Assays; 5.8 D-dimer Assays; 5.9 The Bleeding Time (BT) Test; 5.10 Interpretation of Hemostasis Screening Tests in Patients with Bleeding Disorders; 5.11 Key Points; References; 6: Testing for Inherited Bleeding Disorders
6.1 Qualitative Platelet Disorders6.2 Platelet Aggregation; 6.3 von Willebrand's Disease; 6.4 Assays for vWF; 6.5 vWF Immunoassay; 6.6 Ristocetin Cofactor Activity (vWF Activity) Assay; 6.7 Factor VIII Activity Assay; 6.8 vWF Multimeric Analysis; 6.9 Appropriate Test Ordering for Platelet-Type Bleeding Disorders; 6.10 The Platelet Function Analyzer (PFA)-100®; 6.11 Inherited Coagulation Disorders; 6.12 Factor XIII (Clot Stability) Assay; 6.13 Fibrinogen Activity Assay; 6.14 Alpha2-Antiplasmin Assay; 6.15 Assays for Factor VIII Antibodies (Inhibitor Assays); 6.16 Key Points; References
2.7 Problem Detection and Actions2.8 Coagulation Testing on Specimens Other than Citrated Plasma; 2.9 Common Pitfalls; 2.10 Summary and Key Points; References; 3: Instrumentation for the Coagulation Laboratory; 3.1 Laboratory Instruments; 3.1.1 Test Methodologies; 3.1.2 Detection Methods; 3.2 Point of Care Instruments; 3.2.1 Waived PT/INR Instruments; 3.2.2 POC Analyzers Designed for Coagulation Monitoring During Invasive Procedures; 3.2.3 Viscoelastic Analyzers; 3.2.4 Platelet Function Analyzers; 3.3 Platelet Aggregometry; 3.3.1 Light Transmission Aggregometers (LTA)
3.3.2 Multiplate® Analyzer3.3.3 PFA-100®; 3.3.4 Plateletworks®; 3.3.5 VerifyNow™; 3.4 Summary and Key Points; References; 4: Validation of Hemostasis Assays, Analyzers, and Reagents; 4.1 Validation Overview; 4.2 Validation Tools; 4.3 Validation Studies; 4.4 Validation Plan; 4.5 Analyzer Set-up and Utilities; 4.6 Calibration and Calibration Verification; 4.7 Quality Control Ranges; 4.8 Reference Intervals; 4.9 Performance Characteristics; 4.10 Method Comparisons; 4.11 INR; 4.12 Heparin Therapeutic Ranges; 4.13 Instrument Interfaces; 4.14 Reports; 4.15 Implementation Readiness; 4.16 Approval
4.17 "Full" Versus "Partial" Validations4.18 Other Considerations; 4.19 Common Pitfalls; 4.20 Summary and Key Points; References; 5: Hemostasis Screening Assays; 5.1 Hemostasis Screening Assays: Use and Interpretation; 5.2 The CBC; 5.3 The PT Assay; 5.4 The PTT Assay; 5.5 The Mixing Test (Inhibitor Screen); 5.6 The Thrombin Time Assay; 5.7 Fibrinogen Assays; 5.8 D-dimer Assays; 5.9 The Bleeding Time (BT) Test; 5.10 Interpretation of Hemostasis Screening Tests in Patients with Bleeding Disorders; 5.11 Key Points; References; 6: Testing for Inherited Bleeding Disorders
6.1 Qualitative Platelet Disorders6.2 Platelet Aggregation; 6.3 von Willebrand's Disease; 6.4 Assays for vWF; 6.5 vWF Immunoassay; 6.6 Ristocetin Cofactor Activity (vWF Activity) Assay; 6.7 Factor VIII Activity Assay; 6.8 vWF Multimeric Analysis; 6.9 Appropriate Test Ordering for Platelet-Type Bleeding Disorders; 6.10 The Platelet Function Analyzer (PFA)-100®; 6.11 Inherited Coagulation Disorders; 6.12 Factor XIII (Clot Stability) Assay; 6.13 Fibrinogen Activity Assay; 6.14 Alpha2-Antiplasmin Assay; 6.15 Assays for Factor VIII Antibodies (Inhibitor Assays); 6.16 Key Points; References