Regulatory Issues in Accreditation of Toxicology Laboratories

被引：3

作者：

Bissell, Michael G. ^{[1
,2
]}

机构：

[1] Ohio State Univ, Dept Pathol, Columbus, OH 43210 USA

[2] Ohio State Univ, Wexner Med Ctr, Columbus, OH 43210 USA

来源：

CLINICS IN LABORATORY MEDICINE | 2012年 / 32卷 / 03期

关键词：

CLIA '88; CAP FUDT; ABFT/LAP; ASCLD/LAB; SAMHSA NLCP;

D O I：

10.1016/j.cll.2012.06.007

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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.

引用

页码：525 / +

页数：19