Kenney M L
Clin Chem. 1987 Feb;33(2 Pt 1):328-36.
The U.S. Department of Health and Human Services recently commissioned a comprehensive analysis of the effectiveness and appropriateness of federal clinical regulations. The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and clinical laboratory regulations should be based upon objective data to the maximum extent possible.
美国卫生与公众服务部最近委托对联邦临床法规的有效性和适当性进行了全面分析。分析发现，由于实验室技术的变化和联邦报销政策的改变，许多联邦法规在技术上已经过时，而且许多法规在操作上可能不再必要。由卫生与公众服务部资助的分析所建议的变革包括：基于实验室物理位置的监管分类系统不再合适，应被反映实验室功能的分类系统所取代；应制定一套统一的联邦法规，涵盖所有接受联邦报销或从事州际商业活动的民用实验室；修订后的联邦监管系统应强调人员和检查要求等绩效措施；临床实验室法规应尽可能基于客观数据。
