Application of the six sigma model to evaluate the analytical performance of serum lipid analytes and design quality control strategies: A multi-centre study.
Qian Liu, Yu Lin, Fang Yang, Yaping Dai, Huan Hang, Menglin Wang, Ming Hu, Fumeng Yang
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引用次数: 0
Abstract
BackgroundThe six sigma model is widely used in laboratory quality management. For the first time, this study introduced total allowable error (TEa) from WS/T403-2024 and 'desirable' biological variation (BV) as dual quality goals to evaluate serum lipid analytes in six laboratories and develop individualized quality control (QC) strategies.MethodsWe collected internal quality control (IQC) and external quality assessment (EQA) data to calculate sigma values for each serum lipid analyte. Normalized sigma method decision charts were employed, and the Westgard sigma rule flow chart with batch size plus the quality goal index (QGI) guided individualized QC strategies and improvement plans.ResultsUnder the same quality goal, different QC concentrations produced varying sigma values. Sigma values also differed significantly between the two quality goals. When WS/T403-2024 was applied, all analytes except triglycerides (TGs) showed lower sigma values than under 'desirable' BV. Normalized sigma method decision charts effectively highlighted these differences. Based on the Westgard sigma rule flow chart with batch size and QGI, individualized QC strategies were created, and priority improvement measures were proposed for analytes with sigma values below six.ConclusionsThe six sigma model is a valuable tool for laboratory quality management, guiding laboratories to enhance the detection capabilities of serum lipid analytes through targeted QC strategies and improvement measures.
期刊介绍：
Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine.
Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals.
Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).
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