    [Federal Register Volume 90, Number 84 (Friday, May 2, 2025)]
    [Notices]
    [Pages 18860-18862]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2025-07627]

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    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Substance Abuse and Mental Health Services Administration

    Current List of HHS-Certified Laboratories and Instrumented
    Initial Testing Facilities Which Meet Minimum Standards To Engage in
    Urine and Oral Fluid Drug Testing for Federal Agencies

    AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

    ACTION: Notice.

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    SUMMARY: The Department of Health and Human Services (HHS) notifies
    Federal agencies of the laboratories and Instrumented Initial Testing
    Facilities (IITFs) currently certified to meet the standards of the
    Mandatory Guidelines for Federal Workplace Drug Testing Programs
    (Mandatory Guidelines) using Urine and the laboratories currently
    certified to meet the standards of the Mandatory Guidelines using Oral
    Fluid.

    [[Page 18861]]

    FOR FURTHER INFORMATION CONTACT: Anastasia Flanagan, Division of
    Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B,
    Rockville, Maryland 20857; 240-276-2600 (voice);
    Anastasia.Flanagan@samhsa.hhs.gov (email).

    SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
    (HHS) publishes a notice listing all HHS-certified laboratories and
    Instrumented Initial Testing Facilities (IITFs) in the Federal Register
    during the first week of each month, in accordance with Section 9.19 of
    the Mandatory Guidelines for Federal Workplace Drug Testing Programs
    (Mandatory Guidelines) using Urine and Section 9.17 of the Mandatory
    Guidelines using Oral Fluid. If any laboratory or IITF certification is
    suspended or revoked, the laboratory or IITF will be omitted from
    subsequent lists until such time as it is restored to full
    certification under the Mandatory Guidelines.
        If any laboratory or IITF has withdrawn from the HHS National
    Laboratory Certification Program (NLCP) during the past month, it will
    be listed at the end and will be omitted from the monthly listing
    thereafter.
        This notice is also available on the internet at https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list.
        HHS separately notifies Federal agencies of the laboratories and
    IITFs currently certified to meet the standards of the Mandatory
    Guidelines using Urine and of the laboratories currently certified to
    meet the standards of the Mandatory Guidelines using Oral Fluid.
        The Mandatory Guidelines using Urine were first published in the
    Federal Register on April 11, 1988 (53 FR 11970), and subsequently
    revised in the Federal Register on June 9, 1994 (59 FR 29908);
    September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644);
    November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April
    30, 2010 (75 FR 22809); January 23, 2017 (82 FR 7920); and on October
    12, 2023 (88 FR 70768).
        The Mandatory Guidelines using Oral Fluid were first published in
    the Federal Register on October 25, 2019 (84 FR 57554) with an
    effective date of January 1, 2020, and subsequently revised in the
    Federal Register on October 12, 2023 (88 FR 70814).
        The Mandatory Guidelines were initially developed in accordance
    with Executive Order 12564 and section 503 of Public Law 100-71 and
    allowed urine drug testing only. The Mandatory Guidelines using Urine
    have since been revised, and new Mandatory Guidelines allowing for oral
    fluid drug testing have been published. The Mandatory Guidelines
    require strict standards that laboratories and IITFs must meet in order
    to conduct drug and specimen validity tests on specimens for Federal
    agencies. HHS does not allow IITFs to conduct oral fluid testing.
        To become certified, an applicant laboratory or IITF must undergo
    three rounds of performance testing plus an on-site inspection. To
    maintain that certification, a laboratory or IITF must participate in a
    quarterly performance testing program plus undergo periodic, on-site
    inspections.
        Laboratories and IITFs in the applicant stage of certification are
    not to be considered as meeting the minimum requirements described in
    the HHS Mandatory Guidelines using Urine and/or Oral Fluid. An HHS-
    certified laboratory or IITF must have its letter of certification from
    HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility
    has met minimum standards. HHS does not allow IITFs to conduct oral
    fluid testing.

    HHS-Certified Laboratories Approved To Conduct Oral Fluid Drug Testing

        In accordance with the Mandatory Guidelines using Oral Fluid
    effective October 10, 2023 (88 FR 70814), the following HHS-certified
    laboratories meet the minimum standards to conduct drug and specimen
    validity tests on oral fluid specimens:
        At this time, there are no laboratories certified to conduct drug
    and specimen validity tests on oral fluid specimens.

    HHS-Certified Instrumented Initial Testing Facilities Approved To
    Conduct Urine Drug Testing

        In accordance with the Mandatory Guidelines using Urine effective
    February 1, 2024 (88 FR 70768), the following HHS-certified IITFs meet
    the minimum standards to conduct drug and specimen validity tests on
    urine specimens:

    Dynacare*, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780-784-
    1190, (Formerly: Gamma-Dynacare Medical Laboratories)

    HHS-Certified Laboratories Approved To Conduct Urine Drug Testing

        In accordance with the Mandatory Guidelines using Urine effective
    February 1, 2024 (88 FR 70768), the following HHS-certified
    laboratories meet the minimum standards to conduct drug and specimen
    validity tests on urine specimens:

    Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-
    8989/800-433-3823, (Formerly: Kroll Laboratory Specialists, Inc.,
    Laboratory Specialists, Inc.)
    Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236,
    804-378-9130, (Formerly: Kroll Laboratory Specialists, Inc., Scientific
    Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories,
    Inc.)
    Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS
    66215-2802, 800-445-6917
    Desert Tox, LLC, 5425 E Bell Rd, Suite 125, Scottsdale, AZ, 85254, 602-
    457-5411/623-748-5045
    DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-
    235-4890
    Dynacare*, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-
    1630, (Formerly: Gamma-Dynacare Medical Laboratories)
    ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655,
    662-236-2609
    LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS
    66219, 913-888-3927/800-873-8845, (Formerly: Quest Diagnostics
    Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division
    of LabOne, Inc.)
    Laboratory Corporation of America Holdings, 7207 N Gessner Road,
    Houston, TX 77040, 713-856-8288/800-800-2387
    Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ
    08869, 908-526-2400/800-437-4986, (Formerly: Roche Biomedical
    Laboratories, Inc.)
    Laboratory Corporation of America Holdings, 1904 TW Alexander Drive,
    Research Triangle Park, NC 27709, 919-572-6900/800-833-3984, (Formerly:
    LabCorp Occupational Testing Services, Inc., CompuChem Laboratories,
    Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical
    Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche
    Group)
    Laboratory Corporation of America Holdings, 1120 Main Street,
    Southaven, MS 38671, 866-827-8042/800-233-6339, (Formerly: LabCorp
    Occupational Testing Services, Inc.; MedExpress/National Laboratory
    Center)
    MedTox Laboratories, Inc., 402 W County Road D, St. Paul, MN 55112,
    651-636-7466/800-832-3244
    Minneapolis Veterans Affairs Medical Center, Forensic Toxicology
    Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088.
    Testing for Veterans Affairs (VA) Employees Only

    [[Page 18862]]

    Omega Laboratories, Inc.*, 2150 Dunwin Drive, Unit 1 & 2, Mississauga,
    ON, Canada L5L 5M8, 289-919-3188
    Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA
    91311, 800-328-6942, (Formerly: Centinela Hospital Airport Toxicology
    Laboratory)
    Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-
    5840
    U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St.,
    Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for
    Department of Defense (DoD) Employees Only

        The following laboratory is voluntarily withdrawing from the
    National Laboratory Certification Program effective January 10, 2025:

    Laboratory Corporation of America, 1225 NE 2nd Ave., Portland, OR
    97323, 503-413-5295/800-950-5295, (Formerly: Legacy Laboratory Services
    Toxicology MetroLab)

        * The Standards Council of Canada (SCC) voted to end its Laboratory
    Accreditation Program for Substance Abuse (LAPSA) effective May 12,
    1998. Laboratories certified through that program were accredited to
    conduct forensic urine drug testing as required by U.S. Department of
    Transportation (DOT) regulations. As of that date, the certification of
    those accredited Canadian laboratories continued under DOT authority.
    The responsibility for conducting quarterly performance testing plus
    periodic on-site inspections of those LAPSA-accredited laboratories was
    transferred to the U.S. HHS, with the HHS' NLCP contractor continuing
    to have an active role in the performance testing and laboratory
    inspection processes. Other Canadian laboratories wishing to be
    considered for the NLCP may apply directly to the NLCP contractor just
    as U.S. laboratories do.
        Upon finding a Canadian laboratory to be qualified, HHS will
    recommend that DOT certify the laboratory as meeting the minimum
    standards of the current Mandatory Guidelines published in the Federal
    Register. After receiving DOT certification, the laboratory will be
    included in the monthly list of HHS-certified laboratories and
    participate in the NLCP certification maintenance program. DOT
    established this process in July 1996 (61 FR 37015) to allow foreign
    laboratories to participate in the DOT drug testing program.

    Anastasia D. Flanagan,
    Public Health Advisor, Division of Workplace Programs.
    [FR Doc. 2025-07627 Filed 5-1-25; 8:45 am]
    BILLING CODE 4160-20-P