[Federal Register Volume 89, Number 2 (Wednesday, January 3, 2024)]
[Notices]
[Pages 382-383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28882]


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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 using 
Urine or Oral Fluid (Mandatory Guidelines).

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

SUPPLEMENTARY INFORMATION: In accordance with section 9.19 of the 
Mandatory Guidelines, a notice listing all currently HHS-certified 
laboratories and IITFs is published in the Federal Register during the 
first week of each month. 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    If any laboratory or IITF has withdrawn from the HHS National 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/resources/drug-testing/certified-lab-list.
    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 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); and on January 23, 2017 (82 FR 7920).
    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.
    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

[[Page 383]]

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 dated 
October 25, 2019 (84 FR 57554), 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 dated 
January 23, 2017 (82 FR 7920), 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 dated 
January 23, 2017 (82 FR 7920), 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, 1225 NE 2nd Ave., Portland, OR 
97232, 503-413-5295/800-950-5295, (Formerly: Legacy Laboratory Services 
Toxicology MetroLab)
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
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
Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 
610-631-4600/877-642-2216, (Formerly: SmithKline Beecham Clinical 
Laboratories; SmithKline Bio-Science Laboratories)
US 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 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 will continue 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 (61 FR 37015) as meeting the 
minimum standards of the Mandatory Guidelines published in the Federal 
Register on January 23, 2017 (82 FR 7920). 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.

Anastasia D. Flanagan,
Public Health Advisor, Division of Workplace Programs.
[FR Doc. 2023-28882 Filed 1-2-24; 8:45 am]
BILLING CODE 4160-20-P