American Society for Veterinary Clinical Pathology
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Madison, WI 53704

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2.7. Hemostatic Testing


2.7.1. Monitoring – see General recommendations

2.7.2. Method Validation – see General recommendations.

Not all of the method validation experiments listed in section 2.1.2. may be applicable to evaluation of coagulation analyzers.  Method validation experiments should be selected or modified as necessary to ensure that new methods/analyzers are functioning satisfactorily to meet the laboratory’s requirements and the manufacturer’s specifications.

2.7.3. Instrumentation – see General recommendations

2.7.4. Personnel Knowledge – see General recommendations

2.7.5. Quality Control for Coagulation – see also General recommendations

a. Assays

i. Platelet count and estimate

ii. Platelet morphology

iii. Platelet function tests (adhesion, aggregations, secretion, PFA100, BMBT, DNA tests)

iv. Platelet antibody tests

v. Activated partial thromboplastin time (APTT)

vi. Prothrombin time (PT)

vii. Thrombin time (TT) or thrombin clot time (TCT)

viii. Fibrinogen concentration

ix. Coagulation factor assay (functional, DNA)

x. Von Willebrand factor assays (quantity ELISA, qualitative CBA, multimere analysis, BMBT, related platelet function assays, )DNA mutation-specific

xi. Fibrin(ogen) degradation products (FDPs) and d-dimer concentrations

xii. Antithrombin activity

xiii. Protein C and S assays

xiv. Thromoboelastography,

xv. Thrombin generation assay

xvi. Fibrinolysis assays

b. Recommendations

i. Individual laboratories must define hours of operation and/or shift in order to accommodate coagulation assays.  Thromboelastography studies should be prearranged prior to the analysis.

ii. Hand-held instruments are calibrated regularly according to manufacturer recommendations. If electronic QC is available, it should be performed as recommended by the manufacturer. External QC is recommended when there is a  change in the lot number of reagent, rotor, etc., a change or damage to instrumentation, or any clinical concern. For benchtop instruments, at least 1 level of control material should be run on instruments each shift if a coagulation profile is requested.  This may be performed prior to or concurrent with testing patient samples.

iii. Patient and control specimens may be tested in duplicate.

iv. Data expressed in % of a pooled sample; Intervals are often provided and % derived from a control is used.


2.7.6. Procedures manual – see General recommendations

2.7.7. Comparison of tests – see General recommendations

2.7.8. Outsourced tests – see General recommendations