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Tytuł:
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Application of a six sigma model to the evaluation of the analytical performance of serum enzyme assays and the design of a quality control strategy for these assays: A multicentre study.
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Autorzy:
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Liu Q; Department of Laboratory Medicine, The Second People's Hospital of Lianyungang, Lianyungang, PR China.
Chen X; Department of Laboratory Medicine, Xuzhou Medical University Affiliated Hospital of Lianyungang, Lianyungang, PR China.
Han J; Department of Laboratory Medicine, Wuxi Branch of Ruijin Hospital, Wuxi, PR China.
Chen Y; Department of Laboratory Medicine, Nantong Hospital of Traditional Chinese Medicine, Nantong, PR China.
Wang M; Department of Laboratory Medicine, Suqian First Hospital, Suqian, PR China.
Zhao J; Department of Laboratory Medicine, Wuxi Maternal and Child Health Hospital, Wuxi, PR China.
Liang W; Department of Laboratory Medicine, The Second People's Hospital of Lianyungang, Lianyungang, PR China.
Yang F; Department of Laboratory Medicine, The Second People's Hospital of Lianyungang, Lianyungang, PR China. Electronic address: .
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Źródło:
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Clinical biochemistry [Clin Biochem] 2021 May; Vol. 91, pp. 52-58. Date of Electronic Publication: 2021 Feb 20.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: Tarrytown, NY : Elsevier Science
Original Publication: [Toronto] Canadian Society of Clinical Chemists.
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MeSH Terms:
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Models, Theoretical*
Total Quality Management*
Enzyme Assays/*standards
Laboratories/*standards
Humans ; Multicenter Studies as Topic
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Contributed Indexing:
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Keywords: Analytical performance; Quality goal index; Serum enzymes; Six sigma
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Entry Date(s):
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Date Created: 20210222 Date Completed: 20210707 Latest Revision: 20210707
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Update Code:
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20240105
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DOI:
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10.1016/j.clinbiochem.2021.02.004
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PMID:
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33617847
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Background: Six medical testing laboratories at six different sites in China participated in this study. We applied a six sigma model for (a) the evaluation of the analytical performance of serum enzyme assays at each of the laboratories, (b) the design of individualized quality control programs and (c) the development of improvement measures for each of the assays, as appropriate.
Methods: Internal quality control (IQC) and external quality assessment (EQA) data for selected serum enzyme assays were collected from each of the laboratories. Sigma values for these assays were calculated using coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts were generated using these parameters. IQC design and improvement measures were defined using the Westgard sigma rules. The quality goal index (QGI) was used to assist with identification of deficiencies (bias problems, precision problems, or their combination) affecting the analytical performance of assays with sigma values <6.
Results: Sigma values for the selected serum enzyme assays were significantly different at different levels of enzyme activity. Differences in assay quality in different laboratories were also seen, despite the use of identical testing instruments and reagents. Based on the six sigma data, individualized quality control programs were outlined for each assay with sigma <6 at each laboratory.
Conclusions: In multi-location laboratory systems, a six sigma model can evaluate the quality of the assays being performed, allowing management to design individualized IQC programs and strategies for continuous improvement as appropriate for each laboratory. This will improve patient care, especially for patients transferred between sites within multi-hospital systems.
(Copyright © 2021 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)
