Validation of a quality assessment system for blood gas and electrolyte testing

A recently-introduced quality assessment system (Intelligent Quality Management: iQM), was evaluated in routine clinical use at four different hospitals. The iQM technology is designed to replace conventional external liquid controls with software, Process Control (PC) Solutions and Calibration Validation components that continually assess the function of the GEM Premier 3000 (GEM) analyzer and automatically initiate and document corrective actions.

We validated the performance claims of iQM by monitoring quality control (QC) materials at 4 clinical sites while analyzing approximately 10,550 patient samples. We compared iQM-measured QC values to traditional QC results, evaluating the number and type of error flags for patient samples, and used data from control results to calculate the average time to detect an error (ADT) for each analyte.

The calculated ADT was approximately 3 min for all analytes except for sodium (17 min), glucose (11 min), and lactate (5.9 min). Precision of control materials in iQM cartridges was better than from external controls run on traditional analyzers. The iQM system detected errors in 0.46% of actual clinical samples.

The findings from our study confirm that (a) iQM precision in a clinical setting is comparable to that found in previous studies done in a research setting, (b) the improved precision of control material on the iQM is likely because the internal control fluids are sealed and not susceptible to exposure from handling, and (c) the system detects and often corrects errors in specific samples that might not be reported by traditional analytical systems.