Bissell Michael G
Department of Pathology, The Ohio State University, 4173 Graves Hall, 333 West 10th Avenue, Columbus OH 43210, USA.
Clin Lab Med. 2012 Sep;32(3):525-42. doi: 10.1016/j.cll.2012.06.007. Epub 2012 Jun 29.
Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.
临床毒理学实验室和法医毒理学实验室在高度规范的环境中运作。本文概述了与毒理学实验室认可相关的美国主要法律/监管问题和要求（未深入涉及州和地方法规）。最基本的监管区别涉及实验室的运作目的：临床与非临床。适用的法规以及运作的要求和选项最基本地取决于这一考量，临床毒理学实验室直接受联邦法律约束，包括认可的法定选项，而法医毒理学实验室则受到不同程度的自愿认可或州政府要求的认可。
