Trade Agreement: NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama
Tendering Procedures: Generally only one firm has been invited to bid
Non-Competitive Procurement Strategy: Exclusive Rights
Comprehensive Land Claim Agreement: No
Vendor Name and Address:
DNA Genotek Inc.
2 Beaverbrook Road
Ottawa Ontario
Canada
K2K1L1
Nature of Requirements:
Medical Supplies
45045-150077/A
Mirfatahi, Kaveh
Telephone No. - (613) 668-2618
Fax No. - (819) 956-3814
1.Advance Contract Award Notice (ACAN)
An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier 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.
2.Definition of the requirement
The Canadian Health Measures Survey (CHMS) has a requirement for the supply of 595 saliva sample collection kits for DNA testing and 3 DNA extraction kits for delivery to Ottawa, Ontario. The requirement includes proof of quality control testing for each saliva kit lot production.
This contract also includes the option to purchase an additional 7000 saliva sample collection kits and 35 additional DNA extraction kits in the two-year period following contract award.
3.Criteria for assessment of the Statement of Capabilities
Any interested supplier must demonstrate by way of a statement of capabilities that its product meets the following requirements:
Mandatory specifications
•Receptacle funnel must be wider than the collection tube. The minimum width of the receptacle funnel is 3 cm.
•The receptacle funnel must be securely attached to the collection tube.
•To limit chemical reagent exposure, the saliva collection device and reagent vessel must consist of a single unit.
•The collection tube must be resistantto breakage and leakage during transportation by mail (as assessed by impact testing, drop testing and vacuum testing).
Quality control and assurance:
•The manufacture must be ISO 13485 certified.
•The manufacture must be registered with US FDA or Health Canada.
•Saliva collection kit must meet the European Union Certification as an in-vitro diagnostic (CE-IVD) or have a Canadian or US equivalent.
Specimen storage:
•Must demonstrate that the collected saliva specimens can be stored in the collection tube for a minimum of 5 years at ambient temperature ((20-21°C) 23 kb band on an agarose gel electrophoresis and no DNA band smearing for more than 90% of thesamples).
oThe saliva collection kit must contain reagents (preservatives) that can prevent microbial growth and DNA degradation
DNA extraction/purification:
•The collection kit must be compatible with all of the following DNA purification methods: ethanol precipitation, magnetic beat based extraction, spin columns.
•DNA purification must be performed with non-proprietary chemistry.
DNA quality and quantity:
•The collected DNA sample must have an absorbance ratio A260/280 > 1.6.
•Mean yield > 50µg of purified DNA per sample.
•The collected sample must have a presence of DNA fragments > 23 kb.
•The purified DNA must be usable in all of the following downstream applications: PCR, genotyping, and sequencing.
4. Applicability of the trade agreement(s) to the procurement
This procurement is subject to the following trade agreement:
Agreement on Internal Trade (AIT)
North American Free Trade Agreement (NAFTA)
5. Justification for the Pre-Identified Supplier
The only known supplier of a saliva sample collection kit for DNA testing meeting all required technical specifications is Oragene-DNA self-collection kit from DNA Genotek Inc. For this reason, it is proposed to negotiate directly with the OEM, DNA Genotek Inc., Kanata, Ontario, Canada.
6. Exclusions and/or Limited Tendering Reasons
The following exclusions and/or limited tendering reasons are invoked under the:
Agreement on Internal Trade (AIT) - Article 506.12 (b)
North American Free Trade Agreement (NAFTA) - Article 1016.2 (b)
7. Period of the proposed contract or delivery date
The product must be delivered on or before April 8th, 2016.
8.Name and address of the pre-identified supplier
DNA Genotek Inc.
2 Beaverbrook Road
Kanata, Ontario K2K 1L1
Canada
Tel.: (866) 813-6354 Fax: (613) 723-5057
9. Suppliers' right to submit a statement of capabilities
Suppliers 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.
10. Closing date for a submission of a statement of capabilities
The closing date and time for accepting statements of capabilities is March 29th, 2016 at 2:00 pm EST.
11. Inquiries and submission of statements of capabilities
Inquiries and statements of capabilities are to be directed to:
Kaveh Mirfatahi
Intern Officer
Public Works and Government Services Canada
Scientific,Medical and Photographic Division - PV
Portage III - Floor: 6A2 - Room: 32
11 Laurier Street
Gatineau, Quebec
Canada
K1A 0S5
Telephone: 613-668-2618
Facsimile: 819-956-3814
E-mail: k••••••••@•••••.••.ca
Delivery Date: Above-mentioned
You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.
An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.
Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, 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.
The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.
The Crown retains the right to negotiate with suppliers on any procurement.
Documents may be submitted in either official language of Canada.
