Portable devices capable of producing immediate results at the point of care continue to evolve to meet the demands of the medical community. Acceptance of clinical coagulation testing traditionally performed by and under the supervision of trained laboratory professionals now being performed by personnel not trained in medical laboratory practice or by patients/caregivers in the home continues to be a challenge. Point-of-care coagulation testing (POC-CT) has been and will continue to be implemented in different sites in a health care facility, such as the catheterization laboratory, operating room, emergency department, intensive care unit, postsurgical recovery room, hemodialysis unit, ambulatory care site, and clinical trial investigation sites. Outside of the hospital setting, limited POC-CT is performed by patients or by their caregivers in the patient’s home.
CLSI’s POCT 14 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. These tests include those used for monitoring vitamin K and heparin. POCT14 also includes recommendations for use of point-of care testing 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 for monitoring direct thrombin inhibitors. Potential assay interferences, including direct oral anticoagulants, 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.