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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2017.1
- 수록면
- 213 - 222 (10page)
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초록· 키워드
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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.
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참고문헌 (14)
참고문헌 신청
/ 1992 / Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period /
Burnett D / 2006 / ISO 15189:2003--quality management, evaluation and continual improvement / Clin Chem Lab Med 44 : 733 ~ 739
Cho HI / 1999 / Twenty-years of experiences in external quality assurance in Korea / Southeast Asian J Trop Med Public Health 30 (S3) : 32 ~ 38
Forsman RW / 1996 / Why is the laboratory an afterthought for managed care organizations? / Clin Chem 42 : 813 ~ 816
Gershy-Damet GM / 2010 / The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region / A
Burnett D / 2006 / ISO 15189:2003--quality management, evaluation and continual improvement / Clin Chem Lab Med 44 : 733 ~ 739
Cho HI / 1999 / Twenty-years of experiences in external quality assurance in Korea / Southeast Asian J Trop Med Public Health 30 (S3) : 32 ~ 38
Forsman RW / 1996 / Why is the laboratory an afterthought for managed care organizations? / Clin Chem 42 : 813 ~ 816
Gershy-Damet GM / 2010 / The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region / A
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