May 25, 2007

CLSI Publishes Guideline for Toxicology and Drug Testing in the Clinical Laboratory

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a new edition of its document, Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline--Second Edition (C52-A2). It is designed to aid the clinical laboratorian in developing procedures for the efficient and reliable analysis of clinical and forensic specimens to qualitatively and/or quantitatively determine the presence of drugs of abuse and other commonly encountered drugs. This guideline addresses forensic drug testing applications, such as workplace, criminal justice system, and rehabilitation settings, and clinical drug testing as typically undertaken for the diagnosis and treatment of emergency room patients. Its primary objective is to ensure that high quality standards are maintained within both of these important areas of clinical laboratory analysis.

This guideline addresses the most common specimen types used for toxicology testing, including serum and plasma, whole blood, and urine. Topics addressed in the guideline include:

specimen collection and processing;

methods of analysis;

quality assurance; and

the reporting and interpretation of results.

Because the results of forensic analyses have obvious potential for use as evidence in legal proceedings, information is provided relating to forensic procedures used to safeguard the identity of the specimen, document the chain of custody, and ensure proper use of analytical results.

The previous editions of this guideline focused extensively on forensic testing conducted to detect drug abuse. The guideline has been expanded to include drug testing for clinical purposes. This document replaces Urine Drug Testing in the Clinical Laboratory; Approved Guideline (T/DM8-A).

For additional information on CLSI or for further information regarding this release, visit our website at or call +610.688.0100.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.