scope:

This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg, activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration). POCT14 also includes recommendations for use of point-ofcare testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed.

The intended users of this guideline are manufacturers, regulatory organizations, and health care professionals. Recommendations are provided on how to assess accuracy and precision of traditional coagulation assays, as well as how to assess clinical safety and effectiveness. This guideline does not cover other hemostasis assays such as viscoelastic tests, either thromboelastometry or thromboelastography, or POC platelet function tests.