A-195 Improving the efficiency of quality control with an integrated PBRTQC system based on patient risk

Abstract Background Recent advances in information technology have led to a renewed interest in patient-based real-time quality control (PBRTQC) as an alternative to internal quality control (IQC). However, as regulations mandate IQC in many countries, PBRTQC can only be run separately. The extra labor PBRTQC brings for laboratory staff can lower enthusiasm and impede wide adoption. Therefore, laboratories need a more efficient system integrating the IQC with PBRTQC to implement the methods. Methods A QC system that integrates the IQC with PBRTQC was proposed (Figure.1) . The integrated system states that there is no fixed schedule for IQC; instead, alarms generated by the PBRTQC model were verified with QC. The maximum average number of patients with unacceptable analytical errors (MaxANPTE) was proposed as the critical metric to benchmark the efficiency of the integrated PBRTQC system to the classic IQC system based on a modified Parvin patient risk model for laboratories not running under the bracketed continuous mode. The historical data of serum sodium (Na), chloride (Cl), alanine aminotransferase (ALT), and creatinine (CREA) from Zhongshan Hospital, Fudan University, in 2019 was used for simulation. The efficiency of the integrated system incorporating the simple PBRTQC model and the more advanced regression-adjusted real-time quality control (RARTQC) model were compared with the classic IQC system. Results In most cases, the integrated system incorporating RARTQC models outperformed the classic system, where they could reduce QC events by up to 45%, 98%, 100%, and 86% for ALT, Na, Cl, and CREA, respectively. In an extreme case, the RARTQC model for Cl can run with no false alarm and still achieve superior quality assurance than the twice-daily IQC system. Two design procedures for the integrated systems were proposed: the Quality First Design Procedures (QFDP), which maintains the QC cost while improving quality assurance, and the Cost First Design Procedures (CFDP), which maintains the quality assurance while reducing the cost of QC materials. Conclusion The study demonstrated the improvement of efficiency of the integrated PBRTQC system over the classic IQC system. These insights can help laboratories make informed decisions on adopting PBRTQC models and provide evidence for revising regulations on IQC.