83 FR 19076 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 83, Issue 84 (May 1, 2018)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 83, Issue 84 (May 1, 2018)
| Page Range | 19076-19077 | |
| FR Document | 2018-09178 |
[Federal Register Volume 83, Number 84 (Tuesday, May 1, 2018)] [Notices] [Pages 19076-19077] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09178] ----------------------------------------------------------------------- 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 Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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 http://www.samhsa.gov/workplace. FOR FURTHER INFORMATION CONTACT: Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice). SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines 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 were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug [[Page 19077]] Testing Programs,'' as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies. 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. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards. In accordance with the Mandatory Guidelines dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens: HHS-Certified Instrumented Initial Testing Facilities Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780-784- 1190, (Formerly: Gamma-Dynacare Medical Laboratories). HHS-Certified Laboratories ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624 844-486-9226. 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.). Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock, AR 72209-7056, 501-202-2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center). Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 66215-2802, 800-445-6917. 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. 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). 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.). MedTox Laboratories, Inc., 402 W County Road D, St. Paul, MN 55112, 651-636-7466/800-832-3244. Legacy Laboratory Services--MetroLab, 1225 NE 2nd Ave., Portland, OR 97232, 503-413-5295/800-950-5295. Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088, Testing for Veterans Affairs (VA) Employees Only. National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661-322-4250/800-350-3515. One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888-747-3774, (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory). Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800-328-6942, (Formerly: Centinela Hospital Airport Toxicology Laboratory). Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509-755-8991/800-541-7891x7. Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635- 5840. Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800-729-6432, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610-631-4600/877-642-2216, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 95403, 800-255-2159. STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800-442-0438. 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 (Federal Register, July 16, 1996) 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. Dated: April 26, 2018. Carlos Castillo, Committee Management Officer, SAMHSA. [FR Doc. 2018-09178 Filed 4-30-18; 8:45 am] BILLING CODE 4162-20-P
![19076 Federal Register / Vol. 83, No. 84 / Tuesday, May 1, 2018 / Notices
3. Referral to Treatment (Yes/No) 11. [For client] Did the program Yes/No
10. [For grantee] Did this client get provide the following: (Asked of client 12. [For client] Indicate the degree to
screened and referred to treatment for at follow up) which you agree or disagree with each
an opioid use disorder or an alcohol use a. HIV test—Yes/No of the following statements by using:
disorder? Yes/No i. If yes, the result was—Positive/ Strongly Disagree, Disagree, Neutral,
a. If yes, did they receive an FDA- Negative/Indeterminate/Don’t know Agree, Strongly Agree, Not Applicable
ii. If the result was Positive were you
approved medication for the a. The use of technology accessed
connected to treatment services—
treatment of opioid use disorder or through (insert grantee or program
Yes/No
alcohol use disorder? Yes/No b. Hepatitis B (HBV) test—Yes/No name) helped me
i. If yes, specify the FDA-approved i. If yes, the result was—Positive/ i. Communicate with my provider
medication (methadone, Negative/Indeterminate/Don’t know ii. Reduce my substance use
buprenorphine, naltrexone, ii. If the result was Positive were you
extended-release naltrexone) for iii. Manage my mental health
connected to treatment services— symptoms
opioid use disorder. Yes/No
ii. If yes, specify the FDA-approved iv. Support my recovery
c. Hepatitis C (HCV) test—Yes/No
medication (naltrexone, extended- i. If yes, the result was—Positive/ 13. [For client] To what extent has
release naltrexone, disulfiram, Negative/Indeterminate/Don’t know this program improved your quality of
acamprosate) for alcohol use ii. If the result was Positive were you life? (To a Great Extent, Somewhat, Very
disorder. connected to treatment services— Little, Not at All)
TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN
Responses Total Burden Total
Number of
SAMHSA tool per number of hours burden
respondents respondent responses per response hours
Baseline Interview Includes SBIRT Brief TX, Referral to
TX, and Program-specific questions ................................ 179,668 1 179,668 0.60 107,801
Follow-Up Interview with Program-specific questions 1 ....... 143,734 1 143,734 0.60 86,240
Discharge Interview with Program-specific questions 2 ....... 93,427 1 93,427 0.60 56,056
SBIRT Program—Screening Only ....................................... 594,192 1 594,192 0.13 77,245
SBIRT Program—Brief Intervention Only Baseline ............. 111,411 1 111,411 .20 22,282
SBIRT Program—Brief Intervention Only Follow-Up 1 ........ 89,129 1 89,129 .20 17,826
SBIRT Program—Brief Intervention Only Discharge 2 ........ 57,934 1 57,934 .20 11,587
CSAT Total ................................................................... 885,271 ........................ 1,269,495 ........................ 379,037
Note: Numbers may not add to the totals due to rounding and some individual participants completing more than one form.
1 It is estimated that 80% of baseline clients will complete this interview.
2 It is estimated that 52% of baseline clients will complete this interview.
Send comments to Summer King, SUMMARY: The Department of Health and FOR FURTHER INFORMATION CONTACT:
SAMHSA Reports Clearance Officer, Human Services (HHS) notifies federal Giselle Hersh, Division of Workplace
5600 Fishers Lane, Room 15E57–B, agencies of the laboratories and Programs, SAMHSA/CSAP, 5600
Rockville, Maryland 20857, OR email a Instrumented Initial Testing Facilities Fishers Lane, Room 16N03A, Rockville,
copy to summer.king@samhsa.hhs.gov. (IITF) currently certified to meet the Maryland 20857; 240–276–2600 (voice).
Written comments should be received standards of the Mandatory Guidelines SUPPLEMENTARY INFORMATION: The
by July 2, 2018. for Federal Workplace Drug Testing Department of Health and Human
Summer King, Programs (Mandatory Guidelines). Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Statistician. A notice listing all currently HHS- Initial Testing Facilities (IITF) currently
[FR Doc. 2018–09146 Filed 4–30–18; 8:45 am] certified laboratories and IITFs is certified to meet the standards of the
BILLING CODE 4162–20–P published in the Federal Register Mandatory Guidelines for Federal
during the first week of each month. If Workplace Drug Testing Programs
any laboratory or IITF certification is (Mandatory Guidelines). The Mandatory
DEPARTMENT OF HEALTH AND suspended or revoked, the laboratory or Guidelines were first published in the
HUMAN SERVICES IITF will be omitted from subsequent Federal Register on April 11, 1988 (53
lists until such time as it is restored to FR 11970), and subsequently revised in
Substance Abuse and Mental Health
full certification under the Mandatory the Federal Register on June 9, 1994 (59
Services Administration
Guidelines. FR 29908); September 30, 1997 (62 FR
Current List of HHS-Certified If any laboratory or IITF has 51118); April 13, 2004 (69 FR 19644);
Laboratories and Instrumented Initial withdrawn from the HHS National November 25, 2008 (73 FR 71858);
Testing Facilities Which Meet Minimum Laboratory Certification Program (NLCP) December 10, 2008 (73 FR 75122); April
amozie on DSK30RV082PROD with NOTICES
Standards To Engage in Urine Drug during the past month, it will be listed 30, 2010 (75 FR 22809); and on January
Testing for Federal Agencies 23, 2017 (82 FR 7920)
at the end and will be omitted from the The Mandatory Guidelines were
monthly listing thereafter. initially developed in accordance with
AGENCY: Substance Abuse and Mental
Health Services Administration, HHS. This notice is also available on the Executive Order 12564 and section 503
internet at http://www.samhsa.gov/ of Public Law 100–71. The ‘‘Mandatory
ACTION: Notice.
workplace. Guidelines for Federal Workplace Drug
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![Federal Register / Vol. 83, No. 84 / Tuesday, May 1, 2018 / Notices 19077
Testing Programs,’’ as amended in the ElSohly Laboratories, Inc., 5 Industrial Phamatech, Inc., 15175 Innovation
revisions listed above, requires strict Park Drive, Oxford, MS 38655, 662– Drive, San Diego, CA 92128, 888–
standards that laboratories and IITFs 236–2609. 635–5840.
must meet in order to conduct drug and Laboratory Corporation of America Quest Diagnostics Incorporated, 1777
specimen validity tests on urine Holdings, 7207 N. Gessner Road, Montreal Circle, Tucker, GA 30084,
specimens for federal agencies. Houston, TX 77040, 713–856–8288/ 800–729–6432, (Formerly: SmithKline
To become certified, an applicant 800–800–2387. Beecham Clinical Laboratories;
laboratory or IITF must undergo three Laboratory Corporation of America SmithKline Bio-Science Laboratories).
rounds of performance testing plus an Holdings, 69 First Ave., Raritan, NJ Quest Diagnostics Incorporated, 400
on-site inspection. To maintain that 08869, 908–526–2400/800–437–4986, Egypt Road, Norristown, PA 19403,
certification, a laboratory or IITF must (Formerly: Roche Biomedical 610–631–4600/877–642–2216,
participate in a quarterly performance- Laboratories, Inc.). (Formerly: SmithKline Beecham
testing program plus undergo periodic, Laboratory Corporation of America Clinical Laboratories; SmithKline Bio-
on-site inspections. Holdings, 1904 TW Alexander Drive, Science Laboratories).
Laboratories and IITFs in the Research Triangle Park, NC 27709,
applicant stage of certification are not to Redwood Toxicology Laboratory, 3700
919–572–6900/800–833–3984, Westwind Blvd., Santa Rosa, CA
be considered as meeting the minimum (Formerly: LabCorp Occupational
requirements described in the HHS 95403, 800–255–2159.
Testing Services, Inc., CompuChem
Mandatory Guidelines. A HHS-certified Laboratories, Inc.; CompuChem STERLING Reference Laboratories, 2617
laboratory or IITF must have its letter of Laboratories, Inc., A Subsidiary of East L Street, Tacoma, Washington
certification from HHS/SAMHSA Roche Biomedical Laboratory; Roche 98421, 800–442–0438.
(formerly: HHS/NIDA), which attests CompuChem Laboratories, Inc., A US Army Forensic Toxicology Drug
that it has met minimum standards. Member of the Roche Group). Testing Laboratory, 2490 Wilson St.,
In accordance with the Mandatory Fort George G. Meade, MD 20755–
Guidelines dated January 23, 2017 (82 Laboratory Corporation of America
Holdings, 1120 Main Street, 5235, 301–677–7085, Testing for
FR 7920), the following HHS-certified Department of Defense (DoD)
laboratories and IITFs meet the Southaven, MS 38671, 866–827–8042/
800–233–6339, (Formerly: LabCorp Employees Only.
minimum standards to conduct drug
Occupational Testing Services, Inc.; * The Standards Council of Canada
and specimen validity tests on urine
MedExpress/National Laboratory (SCC) voted to end its Laboratory
specimens:
Center). Accreditation Program for Substance
HHS-Certified Instrumented Initial LabOne, Inc. d/b/a Quest Diagnostics, Abuse (LAPSA) effective May 12, 1998.
Testing Facilities 10101 Renner Blvd., Lenexa, KS Laboratories certified through that
Dynacare, 6628 50th Street NW, 66219, 913–888–3927/800–873–8845, program were accredited to conduct
Edmonton, AB Canada T6B 2N7, 780– (Formerly: Quest Diagnostics forensic urine drug testing as required
784–1190, (Formerly: Gamma- Incorporated; LabOne, Inc.; Center for by U.S. Department of Transportation
Dynacare Medical Laboratories). Laboratory Services, a Division of (DOT) regulations. As of that date, the
LabOne, Inc.). certification of those accredited
HHS-Certified Laboratories MedTox Laboratories, Inc., 402 W Canadian laboratories will continue
ACM Medical Laboratory, Inc., 160 County Road D, St. Paul, MN 55112, under DOT authority. The responsibility
Elmgrove Park, Rochester, NY 14624 651–636–7466/800–832–3244. for conducting quarterly performance
844–486–9226. Legacy Laboratory Services—MetroLab, testing plus periodic on-site inspections
Alere Toxicology Services, 1111 Newton 1225 NE 2nd Ave., Portland, OR of those LAPSA-accredited laboratories
St., Gretna, LA 70053, 504–361–8989/ 97232, 503–413–5295/800–950–5295. was transferred to the U.S. HHS, with
800–433–3823, (Formerly: Kroll the HHS’ NLCP contractor continuing to
Minneapolis Veterans Affairs Medical
Laboratory Specialists, Inc., have an active role in the performance
Center, Forensic Toxicology
Laboratory Specialists, Inc.). testing and laboratory inspection
Laboratory, 1 Veterans Drive,
Alere Toxicology Services, 450 processes. Other Canadian laboratories
Minneapolis, MN 55417, 612–725–
Southlake Blvd., Richmond, VA wishing to be considered for the NLCP
2088, Testing for Veterans Affairs
23236, 804–378–9130, (Formerly: may apply directly to the NLCP
(VA) Employees Only.
Kroll Laboratory Specialists, Inc., contractor just as U.S. laboratories do.
National Toxicology Laboratories, Inc.,
Scientific Testing Laboratories, Inc.; Upon finding a Canadian laboratory to
1100 California Ave., Bakersfield, CA
Kroll Scientific Testing Laboratories, be qualified, HHS will recommend that
93304, 661–322–4250/800–350–3515.
Inc.). DOT certify the laboratory (Federal
Baptist Medical Center-Toxicology One Source Toxicology Laboratory, Inc.,
Register, July 16, 1996) as meeting the
Laboratory, 11401 I–30, Little Rock, 1213 Genoa-Red Bluff, Pasadena, TX
minimum standards of the Mandatory
AR 72209–7056, 501–202–2783, 77504, 888–747–3774, (Formerly:
Guidelines published in the Federal
(Formerly: Forensic Toxicology University of Texas Medical Branch,
Register on January 23, 2017 (82 FR
Laboratory Baptist Medical Center). Clinical Chemistry Division; UTMB
7920). After receiving DOT certification,
Clinical Reference Laboratory, Inc., 8433 Pathology-Toxicology Laboratory).
the laboratory will be included in the
Quivira Road, Lenexa, KS 66215– Pacific Toxicology Laboratories, 9348 monthly list of HHS-certified
2802, 800–445–6917. DeSoto Ave., Chatsworth, CA 91311, laboratories and participate in the NLCP
amozie on DSK30RV082PROD with NOTICES
DrugScan, Inc., 200 Precision Road, 800–328–6942, (Formerly: Centinela certification maintenance program.
Suite 200, Horsham, PA 19044, 800– Hospital Airport Toxicology
Laboratory). Dated: April 26, 2018.
235–4890.
Dynacare*, 245 Pall Mall Street, Pathology Associates Medical Carlos Castillo,
London, ONT, Canada N6A 1P4 519– Laboratories, 110 West Cliff Dr., Committee Management Officer, SAMHSA.
679–1630, (Formerly: Gamma- Spokane, WA 99204, 509–755–8991/ [FR Doc. 2018–09178 Filed 4–30–18; 8:45 am]
Dynacare Medical Laboratories). 800–541–7891x7. BILLING CODE 4162–20–P
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Document Created: 2018-05-01 00:24:03
Document Modified: 2018-05-01 00:24:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice). | |
| FR Citation | 83 FR 19076 |
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