Yuping Zeng1, He He2, Ken Qin3, Mei Zhang2, Zhenmei An4, Hengjian Huang5. 1. West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China; Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China. 2. Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China. 3. Health Management Center, West China Hospital of Sichuan University, Chengdu, China. 4. Department of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, China. 5. Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China. Electronic address: huanghenjian@sina.com.
Abstract
BACKGROUND: A sigma-metric run size nomogram is used to recommend quality control (QC) strategies to reduce patient risks. Herein, we aimed to evaluate the sigma performance of 8 enzymes and apply multistage bracketed statistical QC (SQC). METHODS: Sigma performance of alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), creatine kinase (CK), amylase (AMY), and lipase (LIP) were determined. Daily workload of each test was estimated and expected reporting QC intervals were designed. Per the nomogram, "start-up" and "monitor" QC rules were determined from sigma performance. SQC was finally applied, followed by quality improvement. RESULTS: Sigma metrics were as follows: 5.26 (ALT), 4.80(AST), 5.25(GGT), 3.36(ALP), 4.71(LDH), 15.45(CK), 10.77(AMY), and 3.70 (LIP). "Start-up" rules were MR N2, MR N4, MR N2, MR N4, MR N4, 1:2.5 s N1, 1:3 s N1, and MR N4, and "monitor" QC rules were 1:2.5 s N1, 1:3 s N2, 1:2.5 s N1, MR N4, 1:3 s N2, 1:3 s N1, 1:3 s N1, MR N2 for 8 enzymes, respectively. CONCLUSION: Multistage bracketed SQC is determined by sigma performance. Risk monitoring is significant during assaying to reduce patient risks and improve quality.
BACKGROUND: A sigma-metric run size nomogram is used to recommend quality control (QC) strategies to reduce patient risks. Herein, we aimed to evaluate the sigma performance of 8 enzymes and apply multistage bracketed statistical QC (SQC). METHODS: Sigma performance of alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), creatine kinase (CK), amylase (AMY), and lipase (LIP) were determined. Daily workload of each test was estimated and expected reporting QC intervals were designed. Per the nomogram, "start-up" and "monitor" QC rules were determined from sigma performance. SQC was finally applied, followed by quality improvement. RESULTS: Sigma metrics were as follows: 5.26 (ALT), 4.80(AST), 5.25(GGT), 3.36(ALP), 4.71(LDH), 15.45(CK), 10.77(AMY), and 3.70 (LIP). "Start-up" rules were MR N2, MR N4, MR N2, MR N4, MR N4, 1:2.5 s N1, 1:3 s N1, and MR N4, and "monitor" QC rules were 1:2.5 s N1, 1:3 s N2, 1:2.5 s N1, MR N4, 1:3 s N2, 1:3 s N1, 1:3 s N1, MR N2 for 8 enzymes, respectively. CONCLUSION: Multistage bracketed SQC is determined by sigma performance. Risk monitoring is significant during assaying to reduce patient risks and improve quality.