81 FR 48441 - 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 81, Issue 142 (July 25, 2016)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 81, Issue 142 (July 25, 2016)
| Page Range | 48441-48442 | |
| FR Document | 2016-17441 |
[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)] [Notices] [Pages 48441-48442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17441] ----------------------------------------------------------------------- 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). 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); and on April 30, 2010 (75 FR 22809). 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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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 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 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 November 25, 2008 (73 FR 71858), 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, 585-429-2264 Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615-255-2400 (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc., Aegis Analytical Laboratories) 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 Lab, 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 Fortes Laboratories, Inc., 25749 SW. Canyon Creek Road, Suite 600, Wilsonville, OR 97070, 503-486-1023 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.) [[Page 48442]] Laboratory Corporation of America Holdings, 1904 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 MetroLab-Legacy Laboratory Services, 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) Quest Diagnostics Incorporated, 8401 Fallbrook Ave., West Hills, CA 91304, 818-737-6370 (Formerly: SmithKline Beecham Clinical Laboratories) Redwood Toxicology Laboratory, 3700650 Westwind Blvd., Santa Rosa, CA 95403, 800-255-2159 Southwest Laboratories, 4625 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040, 602-438-8507/800-279-0027 STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800-442-0438 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 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 April 30, 2010 (75 FR 22809). 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. Charles LoDico, Chemist. [FR Doc. 2016-17441 Filed 7-22-16; 8:45 am] BILLING CODE 4160-20-P
![Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices 48441
Responses
Number of Total Hours per Total burden
Instrument/Activity per
respondents responses response hours
respondent
Total .............................................................................. 22,823 ........................ 82,103 ........................ 19,442
Written comments and 2008 (73 FR 75122); and on April 30, and specimen validity tests on urine
recommendations concerning the 2010 (75 FR 22809). specimens:
proposed information collection should A notice listing all currently HHS- HHS-Certified Instrumented Initial
be sent by August 24, 2016 to the certified laboratories and IITFs is Testing Facilities
SAMHSA Desk Officer at the Office of published in the Federal Register
Information and Regulatory Affairs, during the first week of each month. If Dynacare, 6628 50th Street NW.,
Office of Management and Budget any laboratory or IITF certification is Edmonton, AB Canada T6B 2N7, 780–
(OMB). To ensure timely receipt of suspended or revoked, the laboratory or 784–1190 (Formerly: Gamma-
comments, and to avoid potential delays IITF will be omitted from subsequent Dynacare Medical Laboratories)
in OMB’s receipt and processing of mail lists until such time as it is restored to HHS-Certified Laboratories
sent through the U.S. Postal Service, full certification under the Mandatory
commenters are encouraged to submit Guidelines. ACM Medical Laboratory, Inc., 160
their comments to OMB via email to: Elmgrove Park, Rochester, NY 14624,
If any laboratory or IITF has
OIRA_Submission@omb.eop.gov. 585–429–2264
withdrawn from the HHS National
Although commenters are encouraged to Aegis Analytical Laboratories, Inc., 345
Laboratory Certification Program (NLCP)
send their comments via email, Hill Ave., Nashville, TN 37210, 615–
during the past month, it will be listed
commenters may also fax their 255–2400 (Formerly: Aegis Sciences
at the end and will be omitted from the
comments to: 202–395–7285. Corporation, Aegis Analytical
monthly listing thereafter.
Commenters may also mail them to: Laboratories, Inc., Aegis Analytical
This notice is also available on the Laboratories)
Office of Management and Budget, Internet at http://www.samhsa.gov/
Office of Information and Regulatory Alere Toxicology Services, 1111 Newton
workplace. St., Gretna, LA 70053, 504–361–8989/
Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: 800–433–3823 (Formerly: Kroll
Giselle Hersh, Division of Workplace Laboratory Specialists, Inc.,
Summer King, Programs, SAMHSA/CSAP, 5600 Laboratory Specialists, Inc.)
Statistician. Fishers Lane, Room 16N03A, Rockville, Alere Toxicology Services, 450
[FR Doc. 2016–17411 Filed 7–22–16; 8:45 am] Maryland 20857; 240–276–2600 (voice). Southlake Blvd., Richmond, VA
BILLING CODE 4162–20–P 23236, 804–378–9130 (Formerly:
SUPPLEMENTARY INFORMATION: The
Kroll Laboratory Specialists, Inc.,
Mandatory Guidelines were initially
Scientific Testing Laboratories, Inc.;
developed in accordance with Executive
DEPARTMENT OF HEALTH AND Kroll Scientific Testing Laboratories,
Order 12564 and section 503 of Public
HUMAN SERVICES Inc.)
Law 100–71. The ‘‘Mandatory
Baptist Medical Center-Toxicology
Substance Abuse and Mental Health Guidelines for Federal Workplace Drug
Laboratory, 11401 I–30, Little Rock,
Services Administration Testing Programs,’’ as amended in the
AR 72209–7056, 501–202–2783
revisions listed above, requires strict
(Formerly: Forensic Toxicology
Current List of HHS-Certified standards that laboratories and IITFs
Laboratory Baptist Medical Center)
Laboratories and Instrumented Initial must meet in order to conduct drug and
Clinical Reference Lab, 8433 Quivira
Testing Facilities Which Meet Minimum specimen validity tests on urine
Road, Lenexa, KS 66215–2802, 800–
Standards To Engage in Urine Drug specimens for federal agencies.
445–6917
Testing for Federal Agencies To become certified, an applicant DrugScan, Inc., 200 Precision Road,
laboratory or IITF must undergo three Suite 200, Horsham, PA 19044, 800–
AGENCY: Substance Abuse and Mental rounds of performance testing plus an 235–4890
Health Services Administration, HHS. on-site inspection. To maintain that Dynacare,* 245 Pall Mall Street,
ACTION: Notice. certification, a laboratory or IITF must London, ONT, Canada N6A 1P4, 519–
participate in a quarterly performance 679–1630 (Formerly: Gamma-
SUMMARY: The Department of Health and testing program plus undergo periodic, Dynacare Medical Laboratories)
Human Services (HHS) notifies federal on-site inspections. ElSohly Laboratories, Inc., 5 Industrial
agencies of the laboratories and Laboratories and IITFs in the Park Drive, Oxford, MS 38655, 662–
Instrumented Initial Testing Facilities applicant stage of certification are not to 236–2609
(IITF) currently certified to meet the be considered as meeting the minimum Fortes Laboratories, Inc., 25749 SW.
standards of the Mandatory Guidelines requirements described in the HHS Canyon Creek Road, Suite 600,
for Federal Workplace Drug Testing Mandatory Guidelines. A HHS-certified Wilsonville, OR 97070, 503–486–1023
Programs (Mandatory Guidelines). The laboratory or IITF must have its letter of Laboratory Corporation of America
Mandatory Guidelines were first certification from HHS/SAMHSA Holdings, 7207 N. Gessner Road,
mstockstill on DSK3G9T082PROD with NOTICES
published in the Federal Register on (formerly: HHS/NIDA), which attests Houston, TX 77040, 713–856–8288/
April 11, 1988 (53 FR 11970), and that it has met minimum standards. 800–800–2387
subsequently revised in the Federal In accordance with the Mandatory Laboratory Corporation of America
Register on June 9, 1994 (59 FR 29908); Guidelines dated November 25, 2008 Holdings, 69 First Ave., Raritan, NJ
September 30, 1997 (62 FR 51118); (73 FR 71858), the following HHS- 08869, 908–526–2400/800–437–4986
April 13, 2004 (69 FR 19644); November certified laboratories and IITFs meet the (Formerly: Roche Biomedical
25, 2008 (73 FR 71858); December 10, minimum standards to conduct drug Laboratories, Inc.)
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![48442 Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices
Laboratory Corporation of America Quest Diagnostics Incorporated, 8401 DEPARTMENT OF HOUSING AND
Holdings, 1904 Alexander Drive, Fallbrook Ave., West Hills, CA 91304, URBAN DEVELOPMENT
Research Triangle Park, NC 27709, 818–737–6370 (Formerly: SmithKline
[Docket No. FR–5923–N–03]
919–572–6900/800–833–3984 Beecham Clinical Laboratories)
(Formerly: LabCorp Occupational Redwood Toxicology Laboratory, Notice of a Federal Advisory
Testing Services, Inc., CompuChem Committee Meeting: Manufactured
3700650 Westwind Blvd., Santa Rosa,
Laboratories, Inc.; CompuChem Housing Consensus Committee
CA 95403, 800–255–2159
Laboratories, Inc., A Subsidiary of
Roche Biomedical Laboratory; Roche Southwest Laboratories, 4625 E. Cotton AGENCY: Office of the Assistant
CompuChem Laboratories, Inc., A Center Boulevard, Suite 177, Phoenix, Secretary for Housing—Federal Housing
Member of the Roche Group) AZ 85040, 602–438–8507/800–279– Commissioner, Department of Housing
Laboratory Corporation of America 0027 and Urban Development (HUD).
Holdings, 1120 Main Street, STERLING Reference Laboratories, 2617 ACTION: Notice of a Federal Advisory
Southaven, MS 38671, 866–827–8042/ East L Street, Tacoma, Washington Committee Meeting: Manufactured
800–233–6339 (Formerly: LabCorp 98421, 800–442–0438 Housing Consensus Committee (MHCC).
Occupational Testing Services, Inc.;
MedExpress/National Laboratory U.S. Army Forensic Toxicology Drug SUMMARY: This notice sets forth the
Center) Testing Laboratory, 2490 Wilson St., schedule and proposed agenda for a
LabOne, Inc. d/b/a Quest Diagnostics, Fort George G. Meade, MD 20755– teleconference meeting of the MHCC.
10101 Renner Blvd., Lenexa, KS 5235, 301–677–7085, Testing for The teleconference meeting is open to
66219, 913–888–3927/800–873–8845 Department of Defense (DoD) the public. The agenda provides an
(Formerly: Quest Diagnostics Employees Only opportunity for citizens to comment on
Incorporated; LabOne, Inc.; Center for the business before the MHCC.
* The Standards Council of Canada
Laboratory Services, a Division of DATES: The teleconference meeting will
LabOne, Inc.) (SCC) voted to end its Laboratory
be held on August 9, 2016, 10:00 a.m.
MedTox Laboratories, Inc., 402 W. Accreditation Program for Substance to 5:00 p.m. Eastern Daylight Time
County Road D, St. Paul, MN 55112, Abuse (LAPSA) effective May 12, 1998. (EDT). The teleconference numbers are:
651–636–7466/800–832–3244 Laboratories certified through that US toll-free: 1–866–813–5287.
MetroLab-Legacy Laboratory Services, program were accredited to conduct Participant Code: 4325433. Webinar:
1225 NE. 2nd Ave., Portland, OR forensic urine drug testing as required https://zoom.us/j/350303292; Meeting
97232, 503–413–5295/800–950–5295 by U.S. Department of Transportation ID: 350 303 292.
Minneapolis Veterans Affairs Medical (DOT) regulations. As of that date, the FOR FURTHER INFORMATION CONTACT:
Center, Forensic Toxicology certification of those accredited Pamela Beck Danner, Administrator and
Laboratory, 1 Veterans Drive, Canadian laboratories will continue Designated Federal Official (DFO),
Minneapolis, MN 55417, 612–725– under DOT authority. The responsibility Department of Housing and Urban
2088, Testing for Veterans Affairs for conducting quarterly performance Development, Office of Manufactured
(VA) Employees Only testing plus periodic on-site inspections Housing Programs, 451 7th Street SW.,
National Toxicology Laboratories, Inc., of those LAPSA-accredited laboratories Room 9168, Washington, DC 20410,
1100 California Ave., Bakersfield, CA was transferred to the U.S. HHS, with telephone (202) 708–6423 (this is not a
93304, 661–322–4250/800–350–3515
the HHS’ NLCP contractor continuing to toll-free number). Persons who have
One Source Toxicology Laboratory, Inc.,
1213 Genoa-Red Bluff, Pasadena, TX have an active role in the performance difficulty hearing or speaking may
77504, 888–747–3774 (Formerly: testing and laboratory inspection access this number via TTY by calling
University of Texas Medical Branch, processes. Other Canadian laboratories the toll-free Federal Information Relay
Clinical Chemistry Division; UTMB wishing to be considered for the NLCP Service at 800–877–8339.
Pathology-Toxicology Laboratory) may apply directly to the NLCP SUPPLEMENTARY INFORMATION: Notice of
Pacific Toxicology Laboratories, 9348 contractor just as U.S. laboratories do. this meeting provided in accordance
DeSoto Ave., Chatsworth, CA 91311, Upon finding a Canadian laboratory to with the Federal Advisory Committee
800–328–6942 (Formerly: Centinela be qualified, HHS will recommend that Act, 5. U.S.C. App. 10(a)(2) through
Hospital Airport Toxicology DOT certify the laboratory (Federal implementing regulations at 41 CFR
Laboratory) § 102–3.150. The MHCC was established
Register, July 16, 1996) as meeting the
Pathology Associates Medical by the National Manufactured Housing
minimum standards of the Mandatory
Laboratories, 110 West Cliff Dr., Construction and Safety Standards Act
Guidelines published in the Federal
Spokane, WA 99204, 509–755–8991/ of 1974, 42 U.S.C. 5403 (a)(3), as
Register on April 30, 2010 (75 FR amended by the Manufactured Housing
800–541–7891x7
Phamatech, Inc., 15175 Innovation 22809). After receiving DOT Improvement Act of 2000, (Pub. L. 106–
Drive, San Diego, CA 92128, 888– certification, the laboratory will be 569). According to 42 U.S.C. 5403, as
635–5840 included in the monthly list of HHS- amended, the purposes of the MHCC are
Quest Diagnostics Incorporated, 1777 certified laboratories and participate in to:
Montreal Circle, Tucker, GA 30084, the NLCP certification maintenance • Provide periodic recommendations
800–729–6432 (Formerly: SmithKline program. to the Secretary to adopt, revise, and
Beecham Clinical Laboratories; interpret the Federal manufactured
mstockstill on DSK3G9T082PROD with NOTICES
Charles LoDico,
SmithKline Bio-Science Laboratories) housing construction and safety
Quest Diagnostics Incorporated, 400 Chemist. standards in accordance with this
Egypt Road, Norristown, PA 19403, [FR Doc. 2016–17441 Filed 7–22–16; 8:45 am] subsection;
610–631–4600/877–642–2216 BILLING CODE 4160–20–P • Provide periodic recommendations
(Formerly: SmithKline Beecham to the Secretary to adopt, revise, and
Clinical Laboratories; SmithKline Bio- interpret the procedural and
Science Laboratories) enforcement regulations, including
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Document Created: 2016-07-23 02:00:51
Document Modified: 2016-07-23 02:00:51
| 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 | 81 FR 48441 |
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