Clinical Chemistry and Laboratory Medicine (CCLM)
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Mapping point-of-care performance using locally-smoothed median and maximum absolute difference curves
1Point-of-Care Testing Center for Teaching and Research (POCT·CTR), Pathology and Laboratory Medicine, School of Medicine, University of California, Davis, CA, USA
Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 49, Issue 10, Pages 1637–1646, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2011.655, October 2011
Background: The goal is to introduce visual performance mapping efficient for establishing acceptance criteria and facilitating decisions regarding the utility of hospital point-of-care devices. This approach uniquely reveals the quality of performance locally, as opposed to globally.
Methods: After presenting theoretical foundations, this study illustrates the approach by applying it to six hospital glucose meter systems (GMSs) using clinical multi-center (n=2767) and multi-system (n=613, n=100) observations.
Results: LS MAD curves identified breakouts, that is, points where the locally-smoothed median absolute difference (LS MAD) curve exceeds the recommended error tolerance limit of 5 mg/dL (0.28 mmol/L). LS maximum absolute difference (MaxAD) breakthroughs, which occur where the LS MaxAD curve exceeds the 99th percentile of MaxADs from x=30–200 mg/dL (1.67–11.10 mmol/L), showed extreme error locations. A multi-sensor interference- and hematocrirt-correcting GMS displayed a flat LS MAD curve until it reached a breakout of 179 mg/dL (9.94 mmol/L) and generated breakthroughs that could affect bedside decision-making, but less erratically than other systems with inadequate performance for hospital critical care. We discovered Class I (meter high, reference low) and Class II (converse) discrepant values in some systems. Class I errors could lead to inappropriate insulin dosing and hypoglycemic episodes in tight glucose control.
Conclusions: LS MAD-MaxAD curves help assess the performance of point-of-care testing. Visual mapping of systematic and random errors locally over the entire analyte measurement range in a single integrated display is an advantage when considering the adverse impact of zones of poor quantitative performance on specific clinical applications, threshold-driven bedside decisions and the care of critically ill patients.
Keywords: bandwidth; breakout; breakthrough; discrepant value; erroneous result; glucose meter; International Standards Organization (ISO) 15197; tight glucose control (TGC); tolerance limit; visual logistics
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