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KMID : 0950619950040010075
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Journanl of Allied Health Sciences
1995 Volume.4 No. 1 p.75 ~ p.94
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Registrantion Certificate and Personnel Qualification in CLIA ´88
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Lee Chang-Kyu
Lee Seung-Gwan
Park Jong-Seong
Jung Soo-Kyung
Whang Sun-Chul
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Abstract
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This final rule revises regulations applicable to laboratories and improvements provisions of the Clinical Laborratory Improvement Amendments of 1988 [CLIA], Public Law 100-578. The regulation applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. They specify the performance requirements, based on test complexity and risk factors related to erroneous test results, that apply to laboratories that are subject to CLIA.
We believe that CLIA´88 reflects a shift in public expectations toward fail-safe laboratory testing and the need for additional government oversight in laboratory test quality.
If these new expectations persist, CLIA´88 represents a potential landmark in the course of federal authority and the practice of medicine in the United States.
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KEYWORD
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