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Effective detection of bias and variability using R-value statistics in the even-check method for real-time quality
Noriko Hatanaka1, Yoshikazu Yamamoto1, Eiji Kuramura2
1Department of Clinical Laboratory Science, Faculty of Health Care, Tenri University, Nara, Japan.
Clinica Chimica Acta; International Journal of Clinical Chemistry
|November 20, 2025
Summary
Patient-based real-time quality control (PBRTQC) using the Even Check Method (ECM) with R-value statistics improves systematic error detection. This enhances laboratory reliability and patient safety through more sensitive monitoring and timely corrective actions.
Area of Science:
- Clinical chemistry and laboratory diagnostics.
- Medical device performance and quality control.
- Healthcare quality improvement and patient safety.
Background:
- Patient-based real-time quality control (PBRTQC) aims to improve clinical testing accuracy and patient safety but faces limited adoption.
- The Even Check Method (ECM) uses R-values to detect systematic errors, but its full potential with auxiliary indicators like mean and standard deviation (SD) of R-values is underexplored.
Purpose of the Study:
- To evaluate the effectiveness of incorporating the mean and SD of R-values into ECM for enhanced PBRTQC.
- To assess the sensitivity and timeliness of error detection compared to conventional methods.
- To explore the practical integration of this enhanced monitoring approach into routine laboratory testing.
Main Methods:
- Collected clinical data for 20 laboratory tests before and after analytical equipment replacement.
- Calculated R-values, R-scores, and their mean and SD in real time using patient historical data.
- Compared SDs and coefficients of variation of internal quality control (iQC) samples and R-values pre- and post-equipment replacement.
Main Results:
- Analytical stability improved post-equipment replacement, with reduced SDs and coefficients of variation for iQC and R-values.
- ECM with R-value statistics detected a +3 mmol/L sodium bias earlier and more sensitively than conventional iQC.
- Monitoring mean and SD of R-values enabled detection of both acute and gradual systematic errors, aiding real-time performance evaluation and maintenance scheduling.
Conclusions:
- Integrating mean and SD of R-values into ECM significantly enhances PBRTQC capabilities.
- This improved method enhances systematic error detection, facilitates prompt corrective actions, and supports routine monitoring.
- The approach strengthens laboratory reliability and contributes to improved patient safety.
Keywords:
Data processingEven-check methodLaboratory managementQuality controlReal-time quality controlMore Related Videos
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