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Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

Authors
 Mi-Ae Jang  ;  Young Ahn Yoon  ;  Junghan Song  ;  Jeong-Ho Kim  ;  Won-Ki Min  ;  Ji Sung Lee  ;  Yong-Wha Lee  ;  You Kyoung Lee 
Citation
 ANNALS OF LABORATORY MEDICINE, Vol.37(3) : 213-222, 2017 
Journal Title
 ANNALS OF LABORATORY MEDICINE 
ISSN
 2234-3806 
Issue Date
2017
MeSH
Accreditation ; Alanine Transaminase/blood ; Aspartate Aminotransferases/blood ; Clinical Chemistry Tests ; Diagnostic Tests, Routine/standards* ; Laboratories, Hospital/standards* ; Quality Control ; Republic of Korea ; Serum Albumin/analysis
Keywords
Quality assurance ; Quality system management ; Standardization, Accuracy ; The Korean Association of External Quality Assessment Service ; The Korean External Quality Assessment Scheme
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.
Files in This Item:
T201701045.pdf Download
DOI
10.3343/alm.2017.37.3.213
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jeong Ho(김정호) ORCID logo https://orcid.org/0000-0003-2479-0548
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/154574
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