Federal Register - March 1, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices
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 10071 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 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.
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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
7841190. Formerly: GammaDynacare 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, 5043618989/
8004333823. Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.
Alere Toxicology Services, 450
Southlake Blvd., Richmond, VA
23236, 8043789130. 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, 8004456917
Cordant Health Solutions, 2617 East L
Street, Tacoma, WA 98421, 800442
0438. Formerly: STERLING Reference Laboratories Desert Tox, LLC, 5425 E Bell Rd., Suite 125, Scottsdale, AZ 85254, 602457
5411/6237485045
DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800
2354890
Dynacare , 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519
6791630. Formerly: GammaDynacare Medical Laboratories ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662
2362609
Laboratory Corporation of America Holdings, 7207 N Gessner Road, Houston, TX 77040, 7138568288/
8008002387
Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ
08869, 9085262400/8004374986.
Formerly: Roche Biomedical Laboratories, Inc.
Laboratory Corporation of America Holdings, 1904 TW Alexander Drive, Research Triangle Park, NC 27709, 9195726900/8008333984.
PO 00000
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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, 8668278042/
8002336339. Formerly: LabCorp Occupational Testing Services, Inc.;
MedExpress/National Laboratory Center LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS
66219, 9138883927/8008738845.
Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.
Legacy Laboratory Services Toxicology, 1225 NE 2nd Ave., Portland, OR
97232, 5034135295/8009505295
MedTox Laboratories, Inc., 402 W
County Road D, St. Paul, MN 55112, 6516367466/8008323244
Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612725
2088
Testing for Veterans Affairs VA
Employees Only, Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800328
6942. Formerly: Centinela Hospital Airport Toxicology Laboratory Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888
6355840
Quest Diagnostics Incorporated, 400
Egypt Road, Norristown, PA 19403, 6106314600/8776422216.
Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories Redwood Toxicology Laboratory, 3700
Westwind Blvd., Santa Rosa, CA
95403, 8002552159
U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755
5235, 3016777085. Testing for Department of Defense DoD
Employees Only The following laboratory is voluntarily withdrawing from the National Laboratory Certification Program effective March 15, 2021:
Quest Diagnostics Incorporated, 1777
Montreal Circle, Tucker, GA 30084, 8007296432. Formerly: SmithKline Beecham Clinical Laboratories;
SmithKline Bio-Science Laboratories The Standards Council of Canada SCC voted to end its Laboratory Accreditation Program for Substance
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