Ann Lab Med 2017; 37(3): 213-222  https://doi.org/10.3343/alm.2017.37.3.213
Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories
Mi-Ae Jang, M.D.1,*, Young Ahn Yoon, M.D.2,*, Junghan Song, M.D.3, Jeong-Ho Kim, M.D.4, Won-Ki Min, M.D.5, Ji Sung Lee, Ph.D.6, Yong-Wha Lee, M.D.1, and You Kyoung Lee, M.D.1
Department of Laboratory Medicine and Genetics1, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon; Department of Laboratory Medicine2, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan; Department of Laboratory Medicine3, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam; Department of Laboratory Medicine4, Yonsei University College of Medicine, Seoul; Department of Laboratory Medicine5 and Clinical Trial Center6, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence to: Yong-Wha Lee
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
Tel: +82-32-621-5943
Fax: +82-32-621-5944
E-mail: lywmd@schmc.ac.kr
You Kyoung Lee
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
Tel: +82-32-621-5941
Fax: +82-32-621-5944
E-mail: cecilia@schmc.ac.kr
*These two authors contributed equally to this manuscript.
Received: August 23, 2016; Revised: September 30, 2016; Accepted: December 23, 2016; Published online: May 1, 2017.
© The Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests.
Methods: We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP.
Results: Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different.
Conclusions: These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing.
Keywords: The Korean Association of External Quality Assessment Service, The Korean External Quality Assessment Scheme, Quality assurance, Quality system management, Standardization, Accuracy


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