(PCR) Bio-threat Identification System

Trade Agreement: Canadian Free Trade Agreement (CFTA)
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: 
Clermark Inc
154 Forrest Ridge Crt
Welland Ontario
Canada
L3C0C2
Nature of Requirements: 

(PCR) Bio-threat Identification System

W6399-17KC24/A
Littlefield, Mike
Telephone No. - (613) 545-8058 (    )
Fax No. - (613) 545-8067 (    )

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 

Polymerase Chain Reaction (PCR) Bio-threat Identification System

The Department of National Defence (DND) has a requirement to expand their current fleet of Polymerase Chain Reaction (PCR) Bio-threat Identification Systems located in Trenton, Ontario. The Biofire RAZOR EX is a ruggedized, field-deployable system for the detection and identification of biological warfare agents (BWAs). The system enables portable and reliable testing for BWAs using PCR Technology and the ability to test for multiple threats in a single run.

DND’s immediate requirement consists of, but are not limited to, the following:
-Twenty-four (24) complete RAZOR EX kits, in accordance with the configuration of NSN 6665-01-588-4381 
-One-hundred twenty-five ( 125) Canadian 10-Target Pouch kits (pouch, swabs, syringes) in accordance with the configuration of NSN 6665-01-627-1050
-One-hundred twenty-five (125) RAZOR SIM 10 kits in accordance with the configuration of NSN 6665-01-624-4065
-A Manufacturer Recommended Spare Parts List
-Operator/Maintenance Manuals
-In-Service Support (ISS) for a period of two years

DND’s optional requirement consists of, but are not limited to, the following:
Within 24 months of contract award
-Up to four (4) RAZOR EX kits in accordance with the configuration of NSN 6665-01-588-4381; (Within twenty-four (24) months of Contract Award)
-One (1) year of additional ISS;
-One (1) training serial;
-Up to quantity one-hundred forty ( 140) Canadian 10-Target Pouch kits (NSN 6665-01-627-1050);
-Up to quantity fifty (50) RAZOR Training Pouches (NSN 6550-01-565-5396);
-Up to quantity one-hundred forty (140) RAZOR SIM 10 Kit (NSN 6665-01-624-4065);
-Up to quantity fifty (50) RAZOR BA 3 Target Kit (NSN 6550-01-552-8454);
-Up to quantity fifty (50) RAZOR Food Screen 3 Target Kit (NSN 6550-01-565-5395);
-Up to quantity fifty (50) RAZOR Water Screen 3 Target Kit (NSN 6665-01-565-7365).

Within 36 months of contract award
-One (1) year of additional ISS;
-One (1) training serial;
-Up to quantity one-hundred forty ( 140) Canadian 10-Target Pouch kits (NSN 6665-01-627-1050);
-Up to quantity fifty (50) RAZOR Training Pouches (NSN 6550-01-565-5396);
-Up to quantity one-hundred forty (140) RAZOR SIM 10 Kit (NSN 6665-01-624-4065);
-Up to quantity fifty (50) RAZOR BA 3 Target Kit (NSN 6550-01-552-8454);
-Up to quantity fifty (50) RAZOR Food Screen 3 Target Kit (NSN 6550-01-565-5395);
-Up to quantity fifty (50) RAZOR Water Screen 3 Target Kit (NSN 6665-01-565-7365).

Within 48 months of contract award
-One (1) year of additional ISS;
-One (1) training serial;
-Up to quantity one-hundred forty ( 140) Canadian 10-Target Pouch kits (NSN 6665-01-627-1050);
-Up to quantity fifty (50) RAZOR Training Pouches (NSN 6550-01-565-5396);
-Up to quantity one-hundred forty (140) RAZOR SIM 10 Kit (NSN 6665-01-624-4065);
-Up to quantity fifty (50) RAZOR BA 3 Target Kit (NSN 6550-01-552-8454);
-Up to quantity fifty (50) RAZOR Food Screen 3 Target Kit (NSN 6550-01-565-5395);
-Up to quantity fifty (50) RAZOR Water Screen 3 Target Kit (NSN 6665-01-565-7365).

Within 60 months of contract award
-One (1) year of additional ISS;
-One (1) training serial;
-Up to quantity one-hundred forty ( 140) Canadian 10-Target Pouch kits (NSN 6665-01-627-1050);
-Up to quantity fifty (50) RAZOR Training Pouches (NSN 6550-01-565-5396);
-Up to quantity one-hundred forty (140) RAZOR SIM 10 Kit (NSN 6665-01-624-4065);
-Up to quantity fifty (50) RAZOR BA 3 Target Kit (NSN 6550-01-552-8454);
-Up to quantity fifty (50) RAZOR Food Screen 3 Target Kit (NSN 6550-01-565-5395);
-Up to quantity fifty (50) RAZOR Water Screen 3 Target Kit (NSN 6665-01-565-7365).

Security Provisions for Canadian Supplier:

(1) The Contractor/Offeror must, at all times during the performance of the Contract/Standing Offer, hold a valid Designated Organization Screening (DOS), issued by the Canadian Industrial Security Directorate (CISD), Public Works and Government Services Canada (PWGSC).

(2) The Contractor/Offeror personnel requiring access to sensitive work site(s) must EACH hold a valid RELIABILITY STATUS, granted or approved by CISD/PWGSC.


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

Any interested supplier must demonstrate by way of a statement of capabilities that its product/equipment/system meets the following requirements: 

General
This specification outlines the operational performance and technical requirements for the Polymerase Chain Reaction Bio threat Identification System (PCRBIS).

Definitions

Detection Limit The minimum concentration of the pathogen in the sample at which the instrument will detect and identify said pathogen.

Simultaneous Testing done in parallel for multiple pathogens or agents via the preparation and administration of a single sample and a single test run.
 
Acronyms
cfu  Colony Forming Units
ml  Millilitre
PCR  Polymerase Chain Reaction
PCRBIS  PCR Bio threat Identification System
pfu  Plaque Forming Units
VAC  Volts, Alternating Current  
VDC  Volts, Direct Current

Operational Requirements
The PCRBIS must:

(a) Use a Polymerase Chain Reaction (PCR)-based technology as its means of detection and identification;
(b) Be designed to be portable; 
(c) Be colored black or olive drab for its main exterior components and;
(d) Accommodate swab, liquid, culture, and powder samples.

Technical Requirements

Analysis and Identification
The PCRBIS must;

(a) Have an analysis time of thirty (30) minutes or less;
(b) Have control analyses to avoid false negatives;
(c) Have a detection limit of 100 cfu/ml or better for bacteria;
(d) Have a detection limit of 1000 pfu/ml or better for viruses; and,
(e) Test for and identify up to ten (10) targets simultaneously.

 
Physical
The PCRBIS must;

(a) Weigh 12 lb. or less (including battery); 
(b) Adhere to following dimensional constraints;
 Width 12" or less;
 Depth 6" or less; and,
 Height 8" or less.

Temperature
The PCRBIS must:
(a) Perform analyses in temperatures ranging (as a minimum) from 0 to +40o C; and,
(b) Be storable in temperatures ranging (as a minimum) from -33 to +70o C.

Shelf Life
The PCRBIS reagents must have a shelf life of at least 6 months, from date of shipment.

Test and Identification
The PCRBIS must test for and identify the following bacteria and viruses:

(a) Bacteria:
i. Bacillus Anthrax
ii. Brucella spp
iii.  Coxiella
iv.  Francisella Tularensis
v. Yersinia Pestis.

(b) Viruses:
i. Variola
ii. Venezuelan Equine Encephalitis

Data and Diagnostics
The PCRBIS must;

(a) Have a self-diagnostics system which monitors for system faults;
(b) Store data for at least 60 analyses;
(c) Export data reports to a PC; and,
(d) Have a means of communicating with a PC.

Power
The PCRBIS must;

(a) Be powered by 110-220 VAC;
(b) Be powered by 24 VDC;
(c) Be powered by rechargeable batteries; 
(d) Complete at least four (4) full (i.e. test for up to 10 different agents simultaneously) runs on a single charge; and,
(e) Include a battery charger.

Consumables
The PCRBIS must include a complete kit of consumables with instrument (i.e. buffer solution, droppers, swabs, tubes and any other items required for the execution of the tests).

Carrying Case
The PCRBIS must come equipped with a rigid-plastic, foam-lined carrying case, with the following:
(a) Adequate space for;
i. Instrument;
ii. Batteries, charger, DC and AC adapters;
iii. Cables and connectors;
iv. Consumables;
v. Operating manual; and,
vi. Any other items required for the operation of the PCRBIS

(b) Pre-cut holes and slots for the items list in (a)
(c) A carrying handle
(d) Water and dust resistant in compliance with IP67


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

This procurement is subject to the following trade agreement(s): 
a. Canadian Free Trade Agreement (CFTA)

5. Justification for the Pre-Identified Supplier 

Company "Clermark Inc." is the only authorized distributor of BIOFIRE RAZOR EX Instruments in Canada.  Thus, according to the purchasing policies of Government Contracts, PSPC proposes to award the contract to "Clermark Inc.", that is, to our knowledge, the only company able to provide the required goods. 
 
6. Government Contracts Regulations Exception(s) 

The following exception(s) to the Government Contracts Regulations is (are) invoked for this procurement under subsection 6(d) " only one person is capable of performing the contract".

 
7. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under the section of the trade agreement(s) specified:
Canadian Free Trade Agreement (CFTA)
Chapter Five - Government Procurement
Article 513: Limited Tendering
1. Subject to paragraphs 2 and 3, and provided that it does not use this provision for the purpose of avoiding competition among suppliers or in a manner that discriminates against suppliers of any other Party or protects its own suppliers, a procuring entity may use limited tendering in the following circumstances:
(b) if the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist for any of the following reasons:
(iii) due to an absence of competition for technical reasons.

North American Free Trade Agreement (NAFTA)
Exempt under NAFTA Annex 1001.1b-1, Section B

World Trade Organization - Agreement on Government Procurement (WTO-AGP)
Exempt under WTO-AGP Annex 4, Goods

Comprehensive Economic and Trade Agreement (CETA)
Exempt under CETA Annex 19-4, Goods

8. Period of the proposed contract or delivery date 

a. The equipment must be delivered and initial training must be performed before 31 March 2019.

9. Cost estimate of the proposed contract 

a. The estimated value of the contract, is $2,200,000.00 (GST/HST extra) including options to purchase additional units at a later date. 

10. Name and address of the pre-identified supplier 

Clermark Inc.
356 Hillsboro Pvt,
Kanata, Ontario
K2M 3B1

11. 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.

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

The closing date and time for accepting statements of capabilities is August 16, 2018 at 2:00 p.m. EST. 

13. Inquiries and submission of statements of capabilities 

Inquiries and statements of capabilities are to be directed to: 

Name:  Mike Littlefield
Title:   Supply Specialist
                Public Services and Procurement Canada
                Acquisitions Branch
Address:  86 Clarence Street, 2nd Floor
  Kingston, Ontario, K7L 1X3
Telephone:  (613) 545-8058
Facsimile:  (613) 545-8067
E-mail address: mike.littlefield@pwgsc-tpsgc.gc.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.