title: Quality assurance in changing times: proposals for reform and research in the clinical laboratory field.
abstract: 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.
mesh_terms: D003365:Costs and Cost Analysis; D005380:Financing, Government / Q000331:legislation & jurisprudence; D007753:Laboratories / Q000191:economics / Q000592:standards*; D007883:Legislation, Medical / Q000639:trends*; D013677:Medical Laboratory Science / Q000639:trends; D011786:Quality Control; D012107:Research Design; D014481:United States