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미국 임상병리검사소 법제에 관한 연구(Ⅱ) : 실력데스트 및 정도관리를 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 保健科學論集 Vol.21 No.1
With the passage of the Clinical laboratory Improvement Amendments of 1988, Congress has profoundly influenced laboratory testing practices in the U. S. Media stories leading to the passage of CLIA '88 raised the public's concern about inaccurate and imprecise results for certain laboratory tests. CLIA's main areas of interest and controversy include the effects on health care of the personnel standards and test complexity categories, and the costs of laboratory certification, proficiency testing, and quality control measures. The conventional approach to clinical testing standards seeks to assure quality by regulating the laboratory analytical process. However, little empirical evidence is available to support or refute this model, which has been used during the past 25years. The goal is to create a regulatory framework that is not burdensome, incorporating equitable requirements and maintaining timely access to testing at a reasonable cost while ensuring that all laboratories have personnel with the technical ability and skills to provide quality results.