ArticlePractical laboratory medicine2025
Application of sigma-based quality control rules for the efficiency of internal quality control.
Article in Practical laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Toward diagnostically relevant isotope-ratio biomarkers: what does MC-ICP-MS still need for standardized measurements?Analytical and bioanalytical chemistry · 2026Review
- Evaluation of cytokine analytical performance and optimization of quality control strategies using the six sigma model: a multicenter study.Frontiers in medicine · 2026Article
- The Institutional Black Box of Friction Between Digital Agility Demands and Clinical Bureaucracy in Hospital Social Media Management.F1000Research · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Ensuring stability in medical laboratories through quality control (QC) is crucial and requires fitted rules to prevent false alerts and identify errors. This study demonstrates how the introduction of new QC rules to align with individual total allowable error (TEa) affects laboratory efficiency and error detection. Methods: Changes in the performance of 26 biochemical tests before and after applying new internal quality control (IQC) rules were studied. Pre-Phase utilized uniform QC rules (1-3s, 2-2s, 2/3-2s, R-4s, 4-1s, and 12-x) while Post-Phase adopted new QC rules selected using Westgard Adviser (Bio-Rad Inc., USA). Sigma metrics were calculated using TEa and precision and bias from IQC data, compared to the peer group. Efficiency was assessed by comparing QC-repeat rates, turnaround times (TAT), and proficiency test (PT) results. Results: QC-repeats due to violations averaged 5.6 % in the Pre-Phase and decreased to 2.5 % in the Post-Phase. As a result, the rate of out-of-TAT in peak-time decreased from 29.4 % to 15.2 %. In Pre-Phase, 67 of 271 cases exceeded the 2 standard deviation index (SDI) in the PT, which was reduced to 24 cases in Post-Phase. Cases exceeding the 3 SDI significantly decreased from 27 to 4 in the Post-Phase. Conclusion: The introduction of sigma-based rules in the internal quality control process improved laboratory efficiency by reducing QC-repeat, recalibration, and TAT while maintaining quality, demonstrating a valuable balance between efficiency and analytical performance.
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Registered trials
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