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Standards and regulations are important drivers of toxicology lab processes and SOPs. Some are broad enough to apply to all or most kinds of tox labs - and indeed, often most labs of any kind - and others are discipline-specific. Below is a guide to the main standards and regulations that are of concern for different tox labs, broken down by lab type:

Standards and regulations help ensure any type of laboratory provides meaningful results, and it is certainly no different for any of the various types of tox labs. Meeting and/or exceeding these is a prime consideration, and in fact is one of the compelling drivers for the decision to use a dedicated software to manage data processing. A Laboratory Information Management System (LIMS) and Laboratory Information System (LIS) are two terms used to describe such a system, with the difference being that the latter term tends to be more commonplace in medical settings. Today's LIMS and LIS share features and functionality to such a degree that the distinction has all but disappeared, and the terms are merely a function of usage.[1]

The Toxic Substances Control Act of 1976 gives the Environmental Protection Agency (EPA) (established in 1970) the power to ban or restrict the manufacture or use of any chemical that it deems hazardous. The Act also authorizes the EPA to require testing of potentially harmful chemical substances already on the market. The Federal Insecticide, Fungicide, and Rodenticide Act requires that all pesticides distributed in the United States be registered.

The Occupational Safety and Health Administration (OSHA), created in 1971, is responsible for regulating safety in the workplace. OSHA uses both epidemiological and animal studies to make regulatory decisions regarding toxins. Finally, the Consumer Products Safety Commission (CPSC) is responsible for maintaining a clearinghouse of information about the hazards associated with the use of consumer products.[2]

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Forensic tox labs are provided guidelines by the Society of Forensic Toxicologists (SOFT), Society of Toxicological and Forensic Chemistry (GTFCh), TIAFT (The International Association of Forensic Toxicologists), American Board of Forensic Toxicology, Inc. (ABFT) and the toxicology section of the American Academy of Forensic Sciences (AAFS), among others, and may be regulated by SAMHSA (the US Substance Abuse and Mental Health Services Administration, administered through HHS) and/or CAP (College of American Pathologists). Forensic LIMS will want to support data transfer that meets the National Institute of Justice’s (NIJ) Forensic Information Data Exchange (FIDEX) standards.[3] In a clinical setting, HIPAA, CLIA and HITECH regulations apply in most cases, along with National Academy of Clinical Biochemistry (NACB) standards or ACB (Association of Clinical Biochemists), GCLP (Good Clinical Laboratory Practices) and any applicable state and local laws. Outside of that, your tox lab may be subject to 21 CFR part 11, ISOs and others. All are guided by GLP/GALP. In some applications, standards and regs may address timeliness of results in addition to analytical methods and procedures. Since there are a number of varieties of forensic labs, areas of regulation and standards may be broken down into particular areas:
  • Forensic toxicology
  • Workplace drug testing
  • Driving under the influence of alcohol/drugs
  • Clinical toxicology (poisoning in emergency medicine,substitution programs)
  • Point-of-care testing
  • An overlap area (brain death, drugs of abuse, sexual assault cases)[4]

Aquatic and environmental toxicology labs test to National Pollutant Discharge Elimination System (NPDES) US EPA standards, as specified in permits issued by the EPA, who also regulate permits for stormwater, water treatment, wastewater, pesticides, animal feed and other areas. The aquatic tox lab may use WET tests (whole effluent toxicity) and other direct aquatic toxicity tests.[5]

Even though standards and regulations for each type of tox lab may vary, most major Laboratory Information Management Systems (LIMS) will support any/all of them fully, with the added benefit of providing easy and swift retrieval of necessary records during audits.[3]

LabLynx LIMS for Toxicology Solution Compliance

Your LabLynx solution for Toxicology is configured specifically for your type of toxicology lab, as well as your own specific preferences. Overall, LabLynx supports these regulations and standards, along with others that may apply:

  • HIPAA
  • CLIA
  • HITECH
  • CAP
  • GLP/GALP
  • 21 CFR part 11
  • 40 CFR 3
  • National Academy of Clinical Biochemistry (NACB)
  • ACB (Association of Clinical Biochemists)
  • GCLP (Good Clinical Laboratory Practices)
  • Society of Forensic Toxicologists (SOFT)
  • Society of Toxicological and Forensic Chemistry (GTFCh)
  • TIAFT (The International Association of Forensic Toxicologists)
  • American Board of Forensic Toxicology, Inc. (ABFT)
  • Toxicology section of the American Academy of Forensic Sciences (AAFS)
  • SAMHSA
  • SETAC
  • ISOs
  • Others (state, local, etc.)
  • "Laboratory information management system". Wikipedia. 28 October 2016. https://en.wikipedia.org/wiki/Laboratory_information_management_system. Retrieved December 17, 2016. 
  • "Animals and Alternatives in Testing: History, Science, and Ethics, Ch. 3 Toxicology and Toxicity Testing". Johns Hopkins Bloomberg School of Public Health. http://caat.jhsph.edu/publications/animal_alternatives/chapter3.html. Retrieved December 19, 2016. 
  • 3.0 3.1 "What Constitutes a Good Forensics LIMS?". Scientific Computing. 10/04/2011. https://www.scientificcomputing.com/article/2011/10/what-constitutes-good-forensics-lims. Retrieved December 19, 2016. 
  • Joris Penders, Alain Verstraete (3 May 2006). "Laboratory guidelines and standards in clinical and forensic toxicology". ResearchGate. https://www.researchgate.net/publication/225749577_Laboratory_guidelines_and_standards_in_clinical_and_forensic_toxicology. Retrieved December 19, 2016. 
  • "Toxicity Testing Laboratory". Marinco Bioassay Laboratory. 2009. http://www.toxicitylab.com/content/laboratory/toxicity_testing.php. Retrieved December 19, 2016. 
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