iQM: A New Concept for Quality Control

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Abstract
Intelligent quality management (iQM) is proposed on IL’s GEM Premier 3000 as an alternative to traditional QC (internal controls). The theoretic aspects of this concept have been evaluated by Westgard, who has demonstrated the potential value of an increase in the frequency of control testing. However, the concept has not been evaluated in a field study compared with traditional QC. The goal of this study was to assess, under laboratory conditions, the performance of iQM and to validate the proposed concept. The evaluation was performed in a multicenter field approach in 3 hospital laboratories. Analytes included blood gases (pCO2, pO2), pH, electrolytes (Na+, K+, Ca++), metabolic substrates (glucose, lactate), and hematocrit. A total of 850 whole blood samples (arterial and venous) covering the range of physiopathologic variations were tested. The following ranges give the minimum and maximum values of the CVs obtained in the 3 laboratories. Good CVs were obtained for blood gases (0–4.5%), electrolytes (0.4–2.3%), and substrates (2.3–5.0%). Comparing the results obtained with iQM cartridges with those from a reference analyzer, a good relationship was found in all cases. The authors verified that iQM cartridges confirm non-iQM cartridges performance. To make sure that iQM does not bypass errors, all messages from analyzers were registered and evaluated. A total of 177 internal QCs were measured during the study. No QC failure detected by reference analyzer or internal QC led to an iQM false negative. The iQM system ran 9,065 checks and, in 21 cases (0.25%), an iQM error was detected. To validate iQM corrective actions, the authors compared the next sample result of the GEM Premier 3000 with the reference analyzer. There were no significant differences between the GEM Premier 3000 and the reference analyzer results, demonstrating that the corrective actions had cleared the detected errors. Error detection and correction durations ranged from 1 to 13 minutes and did not interfere with analyzer use. The data demonstrate the effectiveness of the iQM system to detect and repair malfunctions that could have an impact on blood gas results. Real-time corrective actions enhance quality control, especially in locations with a personnel turnover. Taking into consideration Westgard’s validation of iQM technology and the results obtained in this work, the authors conclude that traditional daily QC can be abandoned in routine POCT. The iQM system can be used both in laboratories and in point-of-care locations. In the latter case, the main advantage for the laboratory is a reduction in human interventions required in intensive care units.

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