A-390 Implementation of the New GEM Hemochron 100 Point-of-care Coagulation System for Heparin Monitoring During Cardiopulmonary Bypass Procedures

Abstract Background The Ohio State University Wexner Medical Center has monitored the administration of unfractionated heparin (UFH) during cardiopulmonary bypass (CPB) procedures with activated coagulation time test, using Hemochron Signature Elite (Elite) instrument (Werfen) ACT+ cartridge. An assessment was conducted to evaluate performance newest model, GEM 100 (Werfen), upgrade current instruments. Methods Precision and Comparison studies were nine systems. Each analyzed two levels directCHECK liquid quality control, five replicates, over four days. Method study compared results from one system's result, against average result reported three This methodology repeated in multiple groups, different All tests performed assay, which is sensitive UFH 1–6 IU/mL. Results Precision: instruments yielded: Level 1 CV ≤ 9.5%, 2 2.5%. Comparison: Total datasets 66; range 94–902 seconds; estimated bias at 300, 420, 480 second clinical decision points 1.6, 3.2, 4.1 seconds respectively; correlation (r) 0.97; slope 1.01; across systems 6.0%. Conclusion new system demonstrated acceptable agreement CPB, maintaining existing procedural target times. consistent manufacturer's package insert, as well previously published data. Based on performance, have been implemented into our surgical suites.