IN-LINE BLOOD/FLUID WARMER DEVICES

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: 972801 Ontario Inc., Caster Medical Systems 274 Poole Drive Oakville Ontario Canada L6H3W4 Nature of Requirements:

IN-LINE BLOOD/FLUID WARMER DEVICES

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 Armed Forces requires an initial purchase of fifty (50) in-line blood/fluid warmer deviceswith an option to purchase an additional one-hundred and fifty (150) over the next three (3) years on an as and when required basis. The in-line blood/fluid warmer will be used to raise the temperature of refrigerated and room-temperature liquids as they are infused into the patient.

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:

GENERAL CHARACTERISTICS

M1 The in-line blood /fluid warmer device must be designed to raise the temperature of refrigerated and room-temperature liquids as they are infused into the patient.

M2 The warmer device must be capable of maintaining the output temperature ofthe infused blood/fluid at 38°C ± 2°C when the liquid temperature input is 10°C and the flow is set to 50 ml/minute.

M3 The warmer unit must be reusable, portable and use a disposable consumable for each patient.

M4 The total weight, including battery and disposable consumable, of the warmer unit must not exceed 1kg.

M4 The unit must use a dry-heat technology system to warm the liquid.

ELECTRICAL CHACTERISTICS

M5 The warmer device must be powered by a rechargeable battery and include a detachable AC power source (110V-240 AC @50-60Hz) to recharge the battery.

M6 With a blood/fluid input temperature of 20°C and a flow rate of 80ml/min, the battery must be capable of providing a minimum 55 minutes of infusion when fully charged.

SECURITY SPECIFICATIONS

The warmer device must have the following security features

M7 Cut-off over heat temperature must not exceed 55°C

M8 Visual and audible alarms in the event of an over-temperature condition.

M9 Prevent and evacuate air trapped in the line.

M10 Visual and audible alarm in the event of trapped air in the fluid path.

M11 Have a mechanism to prevent over pressure reaching the device and the patient.

M12 Audible and/or visible alarm indicator for low battery.

M13 Audible and visual alarm to indicate no heat in the heater plates.

ACCESSORIES

M14 The unit must have a battery charger, built-in or external.

M15 The unit must include a carrying pouch capable of holding the warmer, minimum two (2) disposable infusion sets and battery.

M16 Include two (2), single patient use, disposable sets per fluid warming device.

M17 The unit must come with an IV pole clamp (the IV pole is not included, only provided upon request).

NORMATIVES

M18 AIRWORTHINESS:The device must have approved airworthiness certification under RTCA/DO-160 or similar accepted equivalence for standard environmental test conditions and applicable test procedures for airborne equipment. The Airworthiness certificate will be reviewed by the Canadian Armed Forces Director Technical Airworthiness and Engineering Support (DTAES). The battery used by this device must have airworthiness clearance to be used in fixed and/or rotary wing aircraft.

M19 CSA: Must provide proof the blood/liquid warmer unit complies with Canadian Electrical Safety Standards (CSA) or similar equivalency recognized by Standard Council of Canada.

M20 HEALTH CANADA: Must provide proof the unit has an active licence as a Class 2 medical device granted by Health Canada. The Canadian Armed Forces reserves the right to verify the status of the device licence thru Health Canada’s Medical Device Active Licence Listing.

M21 MANUALS: Must provide a hard or soft copy (PDF) of the user manual with each device purchased and one (1) copy (preferably a soft copy) for the technical authority for the bid evaluation process. English copy is mandatory, French if available. If a French manual is not available the vendor agrees to permit the Canadian Armed Forces to translate the manual to French for its own use at no additional cost.

M22 SERVICE MANUAL: Must provide one (1) copy of the Service Manual (English, electronic preferred) with initial contract and with each call-up.

M23 USER TRAINING: Must provide a user training course for up to four (4) users per device, within two (2) months of delivery of the device. Training will be delivered at the following locations; 19 Wing Comox, Lazo, British Columbia; 1 Field Ambulance, Edmonton, Alberta; 2 Field Ambulance,Petawawa, Ontario; 5 Field Ambulance, Courcelette, Quebec; and Canadian Forces Health Services Training Centre, Borden, Ontario. The Canadian Armed Forces may request additional training on a fee-per-service basis. Training must be delivered in French for locations in Quebec and English for all other locations.

M24 TECHNICAL TRAINING: Must provide technical training to maintain, repair and calibrate the device; such training will be done for a minimum of one (1) Canadian Armed Forces BE Tech for each lot of ten (10) devices purchased. Training will be conducted at Petawawa, Ontario, within sixty (60) calendar days of the request being submitted by the Technical Authority. All cost of training, inclusive of tuition, travel and living expenses are the responsibility of the contractor. The Canadian Armed Forces will be responsible for the travel, accommodations and living expenses associated with sending BE Tech’s on the training.

Must provide technical/service manual with schematics and list of replacement parts when the course is delivered. The level of this course must be equivalent to that given by the manufacturer to their technical supporting engineers.

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

This procurement is subject to the following trade agreement(s)

Agreement on Internal Trade (AIT) North American Free Trade Agreement (NAFTA) World Trade Organization - Agreement on Government Procurement (WTO-AGP)

5. Justification for the Pre-Identified Supplier

The only known supplier of In-Line Blood/Fluid Warmer Devices meeting all the above required technical specifications is Caster Medical Systems. For this reason, it is proposed to negotiate this requirement with Caster Medical Systems.

6. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) 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) World Trade Organization - Agreement on Government Procurement (WTO-AGP) - Article(s) Article XV (b)

7. Period of the proposed contract or delivery date

The final delivery of the equipment must be on December 30th, 2016.

8. Name and address of the pre-identified supplier

Caster Medical Systems 274 Poole Drive Oakville, Ontario L6H3W4 Canada

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 June 27th, 2016 at 2:00 p.m. EST.

11. Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to

Martin Gauthier Supply Officer Public Works and Government Services Canada Scientific, Medical and Photographic Division - PV Portage III - Floor: 6A2 - Room: 48 11 Laurier Street Gatineau, Quebec Canada K1A 0S5

Telephone: 613-404-8642 Facsimile: 819-956-3814 E-mail: martin.gauthier@pwgsc.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.