- •In the United States, the type of laboratory accreditation required by a toxicology laboratory depends on the purpose of the laboratory's testing menu: clinical versus forensic.
- •Like all clinical laboratories, clinical toxicology laboratories are subject to direct federal regulatory requirements for Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification, classified as waived, moderate, or high-complexity testing operations.
- •CLIA requirements include on-site inspections and acceptable participation in proficiency testing, which may be met by achieving accreditation from an agency with CLIA-deemed status.
- •Forensic toxicology laboratories are CLIA-exempt under federal regulations but nonetheless subject to all applicable state and local regulatory requirements, which typically mandate independent laboratory accreditation.
- •Such accreditation is provided by the College of American Pathologists, American Board of Forensic Toxicology, American Society of Crime Lab Directors, and Substance Abuse and Mental Health Services Administration National Laboratory Certification Program.
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Department of Health and Human Services, Centers for Medicare & Medicaid Services. Part 493 Laboratory requirements, clinical laboratory improvement amendments of 1988, subpart A, sec. 493.2, definitions, 42CFR493.2, revised as of October 1, 2004.
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Disclosure: The author is the current chair of the College of American Pathologists' Toxicology Resource Committee, which oversees all CAP proficiency testing in toxicology and therapeutic drug monitoring.
