Application of Risk-based Quality Control Procedures in Special Protein Testing Projects

Song Yuyin; Xu Hua; Chen Jia

doi:10.3969/j.issn.1004-5775.2025.23.016

Abstract：Objective:Based on the Westgard Sigma rules for batch length analysis,a statistical quality control procedure was designed for the special protein testing project of the Laboratory Department at Panjin Liaoyang Baoshihua Hospital.Methods:From June 2023 to November 2023,the special protein testing project at Panjin Liaoyang Baoshihua Hospital were selected as the imprecision,the average deviation of the interlaboratory quality assessment data reported to the National Health Commission Clinical Laboratory Center for the special protein projects as the bias,and the acceptable range of the interlaboratory quality assessment evaluation criteria set by the National Health Commission Clinical Laboratory Center as the allowable total error for the project,the Sigma(σ)metric values for each project were calculated.The Westgard Sigma rules for analyzing batch lengths were used to design appropriate statistical quality control procedures for each project.Results:Anti-streptolysin O,rheumatoid factor,immunoglobulin G,immunoglobulin M,immunoglobulin A,complement C3,and complement C4 projects showed σ＞6.Using the 13s rule,two control levels,and a batch size of 1 000 patient samples,the statistical quality control program for C-reactive protein and prealbumin projects had a σ greater than 5.Using the 13s/22s/R4s rule,two control levels,and a batch size of 450 patient samples,the statistical quality control program was implemented.Conclusion:Using Westgard Sigma rules for analysis batch length can help laboratories design risk-based statistical quality control procedures,thereby better controlling the testing process and reducing patient risk.