Performance Evaluation of Triggering Patient-Based Real-Time Quality Control Alarms for Insufficient Remaining Amounts of K^(+),Na^(+),and Cl^(-)Reagents Based on Three Data Truncation MethodsOA

Background:In clinical laboratories,reagent depletion can significantly compromise the accuracy of K^(+),Na^(+),and Cl^(-)measurements,posing risks to patient safety.Patient-based real-time quality control(PBRTQC)has emerged as a valuable tool for early detection of analytical errors.However,the effectiveness of PBRTQC may be influenced using data processing methods.Among these,truncation,tail-retention,and tail-shrinkage are three commonly used data truncation techniques.Despite their potential,the clinical early-warning performance of PBRTQC with these methods under reagent depletion conditions remains unclear.Therefore,this study aims to evaluate the clinical early-warning efficacy of PBRTQC when integrated with these three data truncation methods(truncation,tail-retention,and tail-shrinkage)for K^(+),Na^(+),and Cl^(-)measurements during reagent depletion scenarios.Methods:A controlled experimental design was used with routine patient test results as the control group and simulated reagent depletion scenarios as experimental groups.PBRTQC was applied to integrated datasets processed by the three trun-cation methods.Alarm timeliness rates for detecting abnormal results were evaluated for K^(+),Na^(+),and Cl^(-).Results:Under internal standard solution depletion,the number of samples required for error detection(NPed)for K^(+)using the truncation,tail-retention,and tail-shrinkage methods was 38,10,and 10,respectively.For Na^(+),the NPed was 55,5,and 10,respectively,while for Cl^(-),it was 0,11 and 16,respectively.During diluent depletion,K^(+)and Na^(+)showed 0 with the truncation method but 10 for both the tail-retention and tail-shrinkage methods;Cl^(-)showed 0 with the truncation method but 11 with the tail-retention method and 16 with the tail-shrinkage method.With reference solution depletion,the NPed for K^(+)using the truncation,tail-retention,tail-shrinkage methods was 42,35,and 39,respectively;the NPed for Na^(+)was 135,25,and 25,respectively;and the NPed for Cl^(-)was 140,31,and 36,respectively.Conclusion:During a shortage of reagents,the effectiveness of early warning of the PBRTQC program was the highest with the tail-retention method,followed by the tail-shrinkage method.The truncation method showed the lowest effectiveness with the risk of missed error detection.Considering data variability,the tail-shrinkage method is recommended as the optimal data processing method.