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미국 임상병리검사소 법제에 관한 연구(Ⅰ) : 인허가 및 직원 자격 기준을 중심으로
이창규,이승관,박종성,정수경,황선철 高麗大學校 倂設 保健大學 保健科學硏究所 1995 保建科學硏究論集 Vol.4 No.1
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.