Quality assurance for point-of-care testing of oral anticoagulation: a large-scale evaluation of the Hemochron Junior Signature Microcoagulation System

• Published in: International journal of laboratory hematology Vol. 31; no. 2; pp. 142 - 150
• Main Authors: MADDOX, J. M., BOGO, P. H., McGREGOR, E., PIPPARD, M. J., KERR, R.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.04.2009
• Subjects: Administration, Oral; Anticoagulants - administration & dosage; Blood Coagulation Tests - instrumentation; Drug Monitoring - instrumentation; Hemochron Junior Signature; Humans; International Normalized Ratio - standards; near-patient-testing; point-of-care; Point-of-Care Systems; quality assurance; Quality Control; warfarin; Warfarin - administration & dosage
• ISSN: 1751-5521; 1751-553X
• DOI: 10.1111/j.1751-553X.2007.01013.x

Summary We report the first large‐scale evaluation of the Hemochron Junior Signature (HJS) Microcoagulation System for community monitoring of oral anticoagulation and establishment of a programme of internal and external quality assurance. Over 1600 HJS results, with a simultaneous venous sample for central analysis, were obtained over a 19 month period. Monitoring of an initial period of HJS results (n = 135) revealed an International Normalized Ratio (INR) over estimation (mean +1.05), with only 27% of results within 0.5 of the central laboratory INR. A correction factor was introduced which reduced the INR bias to +0.07 and improved the percentage of results within 0.5 of the central laboratory INR to 76% (n = 353). A revised correction factor was later introduced to adjust for an under estimation at higher INR values. This changed the INR bias to –0.05, with 76% of results within 0.5 of the central laboratory INR (n = 1174). Local external quality assurance samples were distributed monthly with a total of 791 samples during the study period. 84% of test results were within 15% of the median value (range 73–97% per month). These results emphasize the value of a robust quality assurance programme when using point‐of‐care devices for community monitoring of oral anticoagulation.