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Quality assurance in drug testing laboratories.

M L Smith1, W E Bronner, E T Shimomura

  • 1Office of the Armed Forces Medical Examiner, Armed Forces Institute of Pathology, Washington, DC.

Clinics in Laboratory Medicine
|September 1, 1990
PubMed
Summary

Federal drug testing regulations ensure high-quality results and may expand to the private sector. A robust quality assurance (QA) program is crucial for the success of certified drug testing laboratories (DTLs).

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Area of Science:

  • Forensic Science
  • Regulatory Affairs

Background:

  • Current drug testing programs for federal agencies, including the Department of Defense, are subject to specific regulations.
  • Many quality assurance (QA) actions are mandated by these existing regulations.

Purpose of the Study:

  • To examine the current state of drug testing regulation and QA practices.
  • To discuss the potential expansion of these regulations into the private sector.
  • To consider the future of drug testing and the role of certified laboratories.

Main Methods:

  • Review of existing federal regulations for drug testing programs.
  • Analysis of mandated QA actions within these regulations.
  • Discussion of trends and potential future developments in drug testing.

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Main Results:

  • Drug testing is regulated for federal programs, with QA actions often mandated.
  • A trend towards continued regulation for high-quality results is anticipated, possibly including private sector testing.
  • The number of mandated drugs for federal testing may increase.

Conclusions:

  • The success of certified drug testing laboratories (DTLs) hinges on avoiding past program failures.
  • A comprehensive quality assurance (QA) program is identified as the most critical factor for future success in drug testing.