CLSI POCT14

Point-of-Care Coagulation Testing and Anticoagulation Monitoring, 2nd Edition

This guideline provides recommendations to users and manufacturers of point-of-care coagulation testing devices for monitoring heparin and vitamin K antagonist therapy and for the evaluation of hemostasis, as well as to ensure reliable results comparable with those obtained by routine medical laboratory testing.

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Chairholder: Marcia L. Zucker, PhD, FAACC

Date of Publication: July 27, 2020

Order Code PDF: CLSI POCT14Ed2E
ISBN Number: 978-1-68440-087-4

Order Code Print: CLSI POCT14Ed2
ISBN Number: 978-1-68440-086-7

Edition: Second

Pages: 68

CLSI POCT14 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI POCT14 Abstract

Clinical and Laboratory Standards Institute guideline POCT14—Point-of-Care Coagulation Testing and Anticoagulation Monitoring provides consensus recommendations regarding quality indicators and performance standards for diagnostic coagulation examinations performed in near-patient settings. Point-of-care coagulation testing has evolved to include multiple assays based on traditional laboratory examinations. As with other noncoagulation point-of-care testing (POCT), "near-patient" or "bedside" testing provides examination results more rapidly than can be achieved in hospital or reference laboratory settings. This availability is important in intensive care units, emergency departments, operating rooms, and outpatient clinics, in which immediate diagnostic information may help expedite treatment decisions and positively influence patient compliance with therapy. This guideline provides a composite of applications of coagulation testing and anticoagulation management currently available. It includes performance requirements and clinical applications for point-of-care prothrombin time/international normalized ratio for vitamin K antagonist therapy (ie, oral anticoagulation therapy), as well as activated partial thromboplastin time and activated clotting time to monitor heparin therapy. Precision and accuracy compared with reference methods and clinical anticoagulation targets are presented for specific clinical applications of each type of examination. This guideline also covers the use of these assays for assessing hemostasis, an application that has been underused in POCT to date. POCT14 provides guidance for producing reliable and clinically useful examination results for any POCT setting or personnel.