Optimizing laboratory quality with sigma metrics: Application of CLIA 2024 total allowable error guidelines.

IF 1.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2026-06-24 DOI:10.1177/00045632261466864

Anurag Sankhyan, Onjal Kamlakar Taywade, Sumita Sharma

{"title":"Optimizing laboratory quality with sigma metrics: Application of CLIA 2024 total allowable error guidelines.","authors":"Anurag Sankhyan, Onjal Kamlakar Taywade, Sumita Sharma","doi":"10.1177/00045632261466864","DOIUrl":null,"url":null,"abstract":"<p><p>BackgroundStatistical quality control continues to serve as the cornerstone for ensuring the accuracy and reliability of laboratory investigations. The current research aimed to evaluate the performance of biochemistry parameters using Six Sigma metrics in light of revised CLIA (Clinical Laboratory Improvement Amendments) total allowable error (TEa) 2024 guidelines, to guide the application of appropriate quality control strategies.MethodsQuality control data for 20 chemistry parameters analyzed on the Fully Automated Biochemistry analyzer were evaluated using Six Sigma methodology. Internal quality control (IQC) and external quality assessment scheme (EQAS) data from December 2023 to May 2024 were collected. Coefficient of variation (%), bias (%) and TEa based on CLIA and Ricos biological variation guidelines were used to calculate sigma metrics. All quality control data were entered and analyzed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA).ResultsThe laboratory showed excellent (≥6 sigma) performance for direct bilirubin and HDL-cholesterol. Albumin, alkaline phosphatase, aspartate transaminase, cholesterol, glucose, iron, potassium, total iron-binding capacity and triglycerides achieved minimum sigma performance standard (>3) at one level. However, the other chemistry parameters did not meet the minimum sigma performance standard across all assay range.ConclusionThe laboratories need to reassess the performance of various biochemical parameters to redefine quality control protocols as the CLIA 2024 guidelines have tightened the total allowable error goals.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261466864"},"PeriodicalIF":1.1000,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Clinical Biochemistry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/00045632261466864","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

BackgroundStatistical quality control continues to serve as the cornerstone for ensuring the accuracy and reliability of laboratory investigations. The current research aimed to evaluate the performance of biochemistry parameters using Six Sigma metrics in light of revised CLIA (Clinical Laboratory Improvement Amendments) total allowable error (TEa) 2024 guidelines, to guide the application of appropriate quality control strategies.MethodsQuality control data for 20 chemistry parameters analyzed on the Fully Automated Biochemistry analyzer were evaluated using Six Sigma methodology. Internal quality control (IQC) and external quality assessment scheme (EQAS) data from December 2023 to May 2024 were collected. Coefficient of variation (%), bias (%) and TEa based on CLIA and Ricos biological variation guidelines were used to calculate sigma metrics. All quality control data were entered and analyzed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA).ResultsThe laboratory showed excellent (≥6 sigma) performance for direct bilirubin and HDL-cholesterol. Albumin, alkaline phosphatase, aspartate transaminase, cholesterol, glucose, iron, potassium, total iron-binding capacity and triglycerides achieved minimum sigma performance standard (>3) at one level. However, the other chemistry parameters did not meet the minimum sigma performance standard across all assay range.ConclusionThe laboratories need to reassess the performance of various biochemical parameters to redefine quality control protocols as the CLIA 2024 guidelines have tightened the total allowable error goals.

查看原文本刊更多论文

用Sigma指标优化实验室质量：CLIA 2024总允许误差指南的应用。

背景-统计质量控制仍然是确保实验室调查准确性和可靠性的基石。本研究旨在根据修订后的CLIA（临床实验室改进修正案）总允许误差（TEa） 2024指南，采用六西格玛指标评价生化参数的性能，以指导适当的质量控制策略的应用。方法：在全自动生化分析仪上分析的20个化学参数的质量控制数据采用六西格玛方法进行评估。收集了2023年12月至2024年5月的内部质量控制（IQC）和外部质量评估方案（EQAS）数据。采用基于CLIA和Ricos生物变异指南的变异系数（%）、偏倚（%）和TEa计算sigma指标。使用Microsoft Excel （Microsoft Corporation, Redmond， WA， USA）输入并分析所有质量控制数据。结果-实验室对直接胆红素和高密度脂蛋白胆固醇表现优异（≥6西格玛）。白蛋白、碱性磷酸酶、天冬氨酸转氨酶、胆固醇、葡萄糖、铁、钾、总铁结合能力和甘油三酯在一个水平上达到最低sigma性能标准（>3）。然而，其他化学参数不符合所有分析范围的最低西格玛性能标准。结论：由于CLIA 2024指南收紧了总允许误差目标，实验室需要重新评估各种生化参数的性能，以重新定义质量控制方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

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).