Drug Testing

Please download the PDF at the bottom of the page to see the tables. ------------------------------ 1. Advance Contract Award Notice

An Advance Contract Award Notice (ACAN) is a public notice indicating to the supplier community that a department or agency intends to award a contract/issue a standing offer for goods, services or construction to a pre-identified supplier/offeror, thereby allowing other suppliers/offerors to signal their interest in bidding, by submitting a statement of capabilities. If no supplier/offeror submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier/offeror.

2. Definition of the requirement

Commercial testing laboratories services are required to provide drug urinalysis for Correctional Service Canada (CSC) for an initial period of three (3) years, for the period from March 1, 2014 to February 28, 2017 and two (2) optional one (1) year extensions. Expert Testimony and Technical Support services are also required.

The Urinalysis Program, as part of the Corrections and Conditional Release Act (CCRA) and Regulations (CCRR) is designed to assist CSC in contributing to institutional and public security and safety by detecting and deterring usage of intoxicants by offenders in correctional facilities and in the community. The Urinalysis Program is intended to supplement, not replace, other means by which an inmate or offender’s use of illicit substances can be detected and deterred. The purpose of this requirement is to assure that the testing of urine specimens provided by inmates and offenders is performed in an accurate, secure and timely manner.

The requirement is limited to Canadian goods and/or services.

3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)

Any interested Offeror must demonstrate by way of a statement of capabilities that it meets the following five (5) Minimum Essential Requirements (MER):

MER 1: The Offeror must provide a copy of the certificate or a signed letter from the Substance Abuse and Mental Health Services Administration (SAMHSA) under the direction of the Research Triangle Institute (RTI) stating that the Offeror holds a valid accreditation from SAMHSA.

MER 2: The Offeror must provide its Standard Operating Procedures for the seven drug classes specified in Group 1, alcohol in Group 2, volatiles in Group 3 and LSD in Group 4:

• GROUP 1 - Drugs

Drugs to be screened by a recognized immunoassay technique and confirmed by gas chromatography / mass spectrometry (GC/MS) or liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) technique

CLASS OF DRUGS CUT-OFF LEVEL (ng/mL) DRUG / METABOLITE NAME Screening Confirmation THC (Cannabinoids) 50 15 11-nor-delta-9-THC-9- carboxylic acid Cocaine 150 (Benzoylecgonine) 100 (Benzoylecgonine) Benzoylecgonine Opiates 300

300 (as morphine or codeine equivalents)

10 300

300

10 Morphine Codeine

Hydrocodone Hydromorphone Oxycodone

(6-monoacetyl morphine)

Methadone 100 100 Methadone metabolite (EDDP) Phencyclidine 25 25 Phencyclidine (PCP) Amphetamines 500 (methamphetamine equivalents) 250 (as amphetamine and/or methamphetamine + 100 ng/ml) d, l-Amphetamine d, l-Methamphetamine MDMA/MDA/MDEA Benzodiazepines 100 (as nitrazepam equivalents) 50 Oxazepam Temazepam Nordiazepam

Alprazolam Lorazepam Triazolam

Bromazepam Flurazepam Clonazepam

• GROUP 2 - Alcohol

To be screened by an enzyme technique and confirmed by Gas Chromatography (GC)

CLASS OF DRUGS CUT-OFF LEVEL (ng/mL) DRUG / METABOLITE NAME Screening Confirmation Alcohol 20 20 Ethyl alcohol (ethanol)

• GROUP 3 – VOLATILES

Volatile testing must exceed the following reporting limit

Volatile Solvent Reporting Limit (µg/L) Acetone 5000 Butanone (Methyl Ethyl Ketone) 500 Chloroform 10 Chloroethane (ethyl chloride) 20 1,4-Dichlorobenzene 20 Dichloromethane 50 1,2-Dichloropropane 10 Diethyl ether 100 Ethyl acetate 100 Hexane 200 Toluene 20 Methyl isobutyl ketone (MIBK) 500 Methyl tert-butyl ether 20 Trichloroethylene 10 1,1,1-trichloroethane 10 Tetrachloroethylene 10 Tetrachloromethane (Carbon tetrachloride) 10 1,1,1,2-tetrachloroethane 10 o-Xylene 10 m+p-Xylene 10

• GROUP 4 – Lysergic Acid Diethylamide (LSD)

The screening cut off level is at 0.2 ng/mL and confirmation cut-off level is 0.1ng/mL.

MER 3: The Offeror must provide two examples of litigation packages that would be provided to a legal hearing or court system demonstrating the steps in the process of drug testing from specimen collection to the final report. One example package provided must be for a normally concentrated urine specimen positive for a drug or drugs and the second example package must be provided for a dilute urine specimen (as defined in the CSC dilution protocol) positive for a drug or drugs.

Correctional Service of Canada dilution protocol

Review of the CSC Urinalysis Program demonstrates that intentional dilution and / or adulteration of urine specimens is a significant problem. The Offeror is required to screen all urine specimens for dilution by creatinine analysis using the SAMHSA Guidelines creatinine cut-off concentration.

Whenever the urine creatinine concentration is 1.003, the specimen is treated as a non-dilute specimen. If the specific gravity is less than or equal to 1.003, the laboratory must proceed in the following “dilution protocol” manner.

Screening for cannabinoids in dilute specimens will be by a commercial immunoassay with a screening cut-off value of 20 ng/mL. Other drugs listed in the attached table are to be screened by an immunoassay method. The confirmatory cut-off values for each drug or metabolite will be the validated limit of quantitation (LOQ) for that drug of metabolite by GC/MS analysis as stated, or at the values shown in the table. Every GC/MS assay has to have a calibrator at LOQ or 40% of the normal cut-off concentration.

Technical changes may occur to the cut-off values and will be reflected in the Commissioner’s Directives throughout the course of the Requirement.

Screening – Confirmation LOQ* (ng/ml)

Amphetamine100 100 Benzodiazepine50 50 Cannabinoid (THC)20 6 Cocaine15 15 Methadone50 50 Opiates120 120 Phencyclidine5 5

* The confirmation LOQ numbers are subject to change upon method revalidation.

MER 4: The Offeror must confirm that all testing will be conducted at a single laboratory site and specify the laboratory site.

MER 5: The Offeror must certify that all senior laboratory staff (at the level of a Responsible Person or Alternate Responsible Person (as defined by SAMHSA)) must be working at least 75% of the time (0.75 FTE) at the single laboratory site.

4. Applicability of the trade agreement(s) to the procurement

This procurement is subject to the Agreement on Internal Trade (AIT).

This procurement consists of services which are excluded from the application of the North American Free Trade Agreement (NAFTA) as per Annex 1001.1b-2, Class H3, Inspection Services (incl. Commercial testing and laboratory services except medical/dental), subclass H300C – Commercial Testing Laboratory Services, and for protecting public order reasons under the World Trade Organization – Agreement on Government Procurement (WTO-AGP) (Article XXIII, Paragraph 2).

5. Comprehensive Land Claims Agreement(s)

This procurement is subject to the following Comprehensive Land Claims Agreements (CLCA) as a portion of the Work will be delivered or conducted within CLCA areas: - Tlicho Land Claims; & - Nunavut Land Claims

6. Justification for the Pre-Identified Offeror

The CSC urinalysis program requires that all testing be performed according to rigorous forensic standards as found in a forensic toxicology laboratory. CSC has mandatory performance specifications that must be met: the SAMHSA certification. Any laboratory bidding to offer this service must have SAMHSA certification at the time of Offer submission. Gamma-Dynacare Medical laboratories is the only known SAMHSA certified lab in Canada at this time (see the Federal Register Vol. 78, No 173 dated September 6, 2013).

7. Government Contracts Regulations Exception

The following exceptions to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - "only one person is capable of performing the work".

8. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under the: o Agreement on Internal Trade (AIT): “Where there is an absence of competition for technical reasons and the goods or services can be supplied only by a particular supplier and no alternative or substitute exists.”

9. Period of the proposed Standing Offer

The proposed initial period of the Standing Offer is three years, from March 1, 2014 to February 28, 2017 and two (2) optional one (1) year extensions.

10. Cost estimate of the proposed Standing Offer.

The estimated value of the Standing Offer, including options, is $10,000,000 (GST/HST extra).

11. Name and address of the pre-identified Offeror

Gamma-Dynacare Medical Laboratories 115 Midair Court Brampton, Ontario L6T 5M3

12. Offeror’s right to submit a statement of capabilities

Offeror who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

13. Closing date for a submission of a statement of capabilities

The closing date and time for accepting statements of capabilities is December 20, 2013 at 2:00 p.m. EST.

14. Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to: François Pageau Supply Specialist Scientific Commodities and Projects Division - SC Science Procurement Directorate Public Works and Government Services Canada Tel. : 819-956-3563 Fax : 819-997-2229 PDPIII 11C1-41, 11 Laurier, Gatineau Qc K1A 0S5 francois.pageau@tpsgc-pwgsc.gc.ca Government of Canada