Abstract
Background: Patient-based real-time quality control (PBRTQC) enables continuous analytical monitoring using routine patient results; however, the performance of classical statistical process control (SPC) algorithms varies across analytes, and standardized evaluation and optimization strategies remain limited. To address this gap, this study compared three SPC algorithms-moving average (MA), moving quantile (MQ), and exponentially weighted moving average (EWMA)-within a unified preprocessing framework and proposed a composite performance metric for parameter optimization. Methods: Routine patient results from six laboratory analytes were analyzed using a standardized "transform-truncate-alarm" PBRTQC workflow. Simulated systematic biases were introduced for model training, and algorithm-specific parameters were optimized using a composite metric integrating sensitivity, false-positive rate (FPR), and detection delay. Performance was subsequently evaluated on an independent validation dataset. Results: For most analytes, all three SPC algorithms demonstrated robust PBRTQC performance, achieving high sensitivity (generally ≥0.85), very low false-positive rates (<0.002), and rapid detection of systematic bias. EWMA showed more balanced performance for thyroid-stimulating hormone (TSH), with improved sensitivity and shorter detection delay compared with MA and MQ. The proposed composite metric effectively facilitated clinically meaningful parameter optimization across algorithms. Conclusions: Under a unified preprocessing framework, classical SPC algorithms provided reliable PBRTQC performance across multiple analytes, with EWMA offering advantages for more variable measurements. The proposed composite metric supports standardized, practical, and analyte-adaptive PBRTQC implementation in clinical laboratories.