title: Regulatory issues in accreditation of toxicology laboratories.
abstract: 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.
authors.affiliation: Department of Pathology, The Ohio State University, 4173 Graves Hall, 333 West 10th Avenue, Columbus OH 43210, USA. Michael.Bissell@osumc.edu
authors.forename: Michael G
authors.initials: MG
authors.lastname: Bissell
mesh_terms: D000068:Accreditation; D035082:Federal Government; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards*; D014116:Toxicology / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States