Six Sigma in Action: Evaluating Its Practicality in a Multi-Analyzer Laboratory under CLIA 2024 Guidelines.

IF 1 4区 医学 Q4 MEDICAL LABORATORY TECHNOLOGY
Humeyra Ozturk Emre
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引用次数: 0

Abstract

Objective: The stricter Clinical Laboratory Improvement Amendments (CLIA) 2024 guidelines introduced narrower Total Allowable Error (TEa) limits, posing challenges for clinical laboratories in maintaining analytical quality. This study evaluated the effectiveness of Six Sigma metrics in assessing the performance of routine biochemical tests using these updated criteria.

Methods: This retrospective study analyzed the internal quality control (IQC) data for 22 biochemical analytes across four instruments in a high-throughput laboratory. Performance was assessed using Sigma metrics calculated based on the CLIA 88 and CLIA 2024 criteria, with classifications into poor (<3 Sigma), acceptable (3-6 Sigma), and excellent (>6 Sigma) categories. İnstrument-specific variability and control levels (normal and pathological) were also analyzed.

Results: Under the CLIA 2024 guidelines, only 22.16% of the analytes achieved excellent performance (>6 Sigma), compared to 49.43% under CLIA 88. No significant differences were observed between instruments, indicating consistent analytical performance across platforms. Normal control levels (Control Level 1) exhibited greater variability (median Sigma: 4.76, range: 1.19-13.34) compared to pathological controls (Control Level 2) (median Sigma: 4.72, range: 1.22-10.22), reinforcing the impact of control level differences on analytical precision. CRP, CK, and Bilirubin were the highest-performing tests, consistently maintaining high Sigma values above the acceptable threshold. In contrast, Albumin, Urea, and GGT exhibited the lowest Sigma performance.

Conclusions: The transition to stricter CLIA 2024 guidelines significantly affects the analytical performance of biochemical tests, highlighting vulnerabilities in routine laboratory operations. Adopting advanced automation, tailored QC protocols, and modern analytical tools is essential to enhance diagnostic precision and ensure compliance with evolving regulatory demands.

六西格玛在行动:根据CLIA 2024指南评估其在多分析仪实验室的实用性。
目的:更严格的临床实验室改进修正案(CLIA) 2024指南引入了更窄的总允许误差(TEa)限制,为临床实验室保持分析质量带来了挑战。本研究使用这些更新的标准评估了六西格玛指标在评估常规生化测试性能方面的有效性。方法:本回顾性研究分析了高通量实验室四种仪器中22种生化分析物的内部质量控制(IQC)数据。使用基于CLIA 88和CLIA 2024标准计算的西格玛指标评估绩效,并将其分为差(6西格玛)类别。İnstrument-specific变异和控制水平(正常和病理)也进行了分析。结果:在CLIA 2024指南下,只有22.16%的分析物达到优异性能(bbb6 Sigma),而在CLIA 88下为49.43%。仪器之间没有观察到显着差异,表明不同平台的分析性能一致。与病理对照组(控制水平2)(Sigma中位数:4.72,范围:1.22-10.22)相比,正常对照水平(控制水平1)表现出更大的变异性(Sigma中位数:4.76,范围:1.19-13.34),强化了控制水平差异对分析精度的影响。CRP, CK和胆红素是表现最好的测试,始终保持高Sigma值高于可接受的阈值。相比之下,白蛋白、尿素和GGT表现出最低的Sigma性能。结论:过渡到更严格的CLIA 2024指南显著影响生化检测的分析性能,突出了常规实验室操作的脆弱性。采用先进的自动化、定制的QC协议和现代分析工具对于提高诊断精度和确保符合不断变化的监管要求至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Annals of clinical and laboratory science
Annals of clinical and laboratory science 医学-医学实验技术
CiteScore
1.60
自引率
0.00%
发文量
112
审稿时长
6-12 weeks
期刊介绍: The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.
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