Jang Mi Ae, Yoon Young Ahn, Song Junghan, Kim Jeong Ho, Min Won Ki, Lee Ji Sung, Lee Yong Wha, Lee You Kyoung
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.
Ann Lab Med. 2017 May;37(3):213-222. doi: 10.3343/alm.2017.37.3.213.
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.
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.
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.
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.
医学实验室在医疗保健中发挥着核心作用。许多实验室正在采取更具针对性和严格的质量体系管理方法。在韩国，韩国实验室认可计划（KLAP）和韩国外部质量评估计划（KEQAS）所开展的实验室标准化工作可能促进了实验室性能的改善，但尚无基础研究证明实验室标准化是有效的。我们分析了KEQAS的结果，以确定有或没有KLAP的实验室之间的显著差异，并确定实验室标准化对诊断测试准确性的影响。
我们分析了2010年至2013年KEQAS参与者关于白蛋白、谷丙转氨酶、谷草转氨酶和葡萄糖等临床化学测试的数据。作为评估实验室之间性能偏差的统计参数，我们比较了有或没有KLAP的两组之间的4年变异指数评分（VIS）。
与没有KLAP的组相比，有KLAP的组在所有临床化学测试中4年VIS的几何平均值显著更低（P<0.0001）；这种差异证明了对认可实验室提供的标准化服务有高度信心。两组（认可和未认可）中每项测试均值的置信区间没有重叠，表明两组的均值有显著差异。
这些结果证实了实践标准化与测试结果的准确性密切相关。我们的研究强调了建立诊断测试标准化系统的必要性。
