title: Issues and trends in the regulation of office-based clinical laboratories.
abstract: Office-based clinical laboratories are the least regulated of all laboratories as a result of familiar forces in the politics of the regulation of medicine. This article discusses the evolution of these regulations and summarizes the applicability and intent of federal and state rules. Counterbalancing forces in the present political and medical environment tending simultaneously toward greater and lesser regulation are discussed.
mesh_terms: D000553:Ambulatory Care / Q000331:legislation & jurisprudence; D002567:Certificate of Need / Q000331:legislation & jurisprudence; D019411:Clinical Laboratory Techniques / Q000592:standards; D007753:Laboratories / Q000331:legislation & jurisprudence*; D007883:Legislation, Medical; D008004:Licensure; D008318:Malpractice / Q000331:legislation & jurisprudence*; D008484:Medicaid / Q000331:legislation & jurisprudence*; D006278:Medicare / Q000331:legislation & jurisprudence*