B-265 A Large Multisite Study of Beckman Coulter clinical chemistry performance demonstrates a significant majority of assays are eligible to use less QC

Abstract

The scientific literature contains sparse data on analytical method performance, especially across multiple sites There is little publicly available information about broad analytical performance of methods or instruments. To get a better understanding of assay performance, we collected routine long-term performance data and assessed it using analytical Sigma metrics From mid-2023 and through 2025, we collected and analyzed individual instrument performance for Beckman Coulter clinical chemistry assays in the US, as well as a handful in Canada. 164 instruments were assessed from 66 different laboratories. Multiple types of controls were used, from Bio-Rad to Technopath to Thermo-Fisher MAS. Peer comparison study reports from all three control vendors were accessed for each instrument. CLIA 2025 proficiency testing criteria goals were used as performance goals. Where CLIA does not set criteria, we used goals from other global sources. Cumulative mean and SD from control data were used to estimate imprecision. Peer comparison reports were used to assess bias against the cumulative peer group mean. The standard Westgard analytical Sigma-metric was calculated from the data for all available control levels. Medians and averages of the Sigma metrics were calculated. Westgard Sigma Rules were used to identify appropriate QC procedures for tests. As the analytical Sigma-metric increases, the number of rules required decreases. The study reveals that laboratories experience a range of performance when using Beckman Coulter biochemistry instruments. The median laboratory of the study population has nearly 70% of its clinical chemistry menu at 4, 5, and 6 Sigma, and thus are able to optimize and reduce QC rules. The average laboratory is almost 75% optimizable. The greatest number of methods for median and average customers is 6 Sigma. The vast majority of clinical chemistry methods in these laboratories are achieving good, excellent and world class quality. Over 91% of the assays run by the median lab are acceptable or better, demonstrating market-leading performance. Labs in the study have the opportunity to reduce their current QC practices and implement reduced Westgard Sigma Rules. The typical laboratory employs the 1:2s control rule with 2 controls and generates 9% false rejection. For 6 Sigma methods, Westgard Sigma Rules recommend switching to 1:3s with 2 controls instead, which generates less than 1% false rejection. This would reduce outliers by more than 90%, implying significant practical savings can be realized through analytical Sigma metrics and subsequent QC optimization.