Question

What are two of the legal aspects of working in a toxicology laboratory?

Answer 1

The home of forensic toxicology is within forensic medicine. This is indeed the case with postmortem toxicology, which represents the oldest area of toxicology and the most established area of forensic toxicology. Education and training in forensic toxicology mainly take the form of workplace learning in a laboratory environment and continuous or targeted training. The basic education of forensic toxicologists is generally in chemistry, biochemistry, pharmacy or medicine. One of the main goals of forensic toxicology is to identify and subsequently quantify a broad range of exogenous substances in biological samples. The legal basis for a medicolegal cause of death investigation differs between countries. The main indications for postmortem toxicological investigation are suspicions, circumstances or autopsy findings that suggest poisoning. The World Anti‐Doping Agency was established in 1999 as an international independent agency composed of, and funded equally by, the sports movement and governments of the world.

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.

FORENSIC TOXICOLOGY LABORATORY GUIDELINES

PREAMBLE
In response to the Guidelines for Federal Workplace Drug Testing Programs recently issued by the U. S. Department of Health and Human Services, the Society of Forensic Toxicologists and the Toxicology Section of the American Academy of Forensic Sciences appointed a joint committee of members to recommend a supplementary set of guidelines for the practice of forensic toxicology. The guidelines, especially with respect to laboratory personnel and operating procedures, may not always be appropriate for other types of forensic toxicology, and the guidelines set forth below represent recommendations of the Society/Academy committee to respond to that issue. These suggestions do not necessarily reflect our opinions about the minimum requirement for any laboratory, and have no regulatory purpose; rather, they are intended to assist laboratories engaged in the practice offorensic toxicology in achieving future goals. The committee has concluded that specific guidelines for the practice of forensic toxicology would be appropriate for three defined areas:

Postmortem Forensic Toxicology, which determines the absence or presence of drugs and their metabolites, chemicals such as ethanol and other volatile substances, carbon monoxide and other gases, metals, and other toxic chemicals in human fluids and tissues, and evaluates their role as a determinant or contributory factor in the cause and manner of death;

Human-Performance Forensic Toxicology, which determines the absence or presence of ethanol and other drugs and chemicals in blood, breath, or other appropriate specimen(s), and evaluates their role in modifying human performance or behavior. (The analysis ofethanol in breath, although important, was not considered by the committee because such tests are not conducted in a laboratory setting);.

Forensic Urine Drug Testing, which determines the absence or presence of drugs and their metabolites in urine to demonstrate prior use or abuse. (Because this subject has been covered by the Department of Health and Human Services Guidelines and by the College ofAmerican Pathologists Accreditation Program, it was not discussed further by the committee and will not be discussed in this document.)

The specific aims ofthe committee, with respect to postmortem and human-performance forensic toxicology, have been to provide detailed guidelines for laboratory practices and to prepare a checklist for self-evaluation that may also serve as an important component of a program designed to prepare a laboratory for accreditation. The committee unanimously agreed that a secondary aim ofits deliberation should be to develop a voluntary accreditation program for laboratories performing postmortem and human-performance toxicology.

SECTIONS

1. Operating Procedures
2. Personnel
3. Samples and Receiving
4. Security and Chain of Custody
5. Analytical Procedures
6. Review of Data
7. Quality Assurance
8. Reporting of Results
9. Safety
10. Comments
11. Appendix
12. Self-Evaluation Checklist