Field Steam Sterilizers

Trade Agreement: CETA / WTO-AGP / CPTPP / NAFTA / CFTA / FTAs with Peru / Colombia / Panama / Korea Tendering Procedures: All interested suppliers may submit a bid Non-Competitive Procurement Strategy: Prices and/or Sources Fixed by Government Regulations Comprehensive Land Claim Agreement: No Vendor Name and Address: Fort Defiance Industries LLC 2411 Maremont Pkwy Loudon Tennessee United States 37774 Nature of Requirements:

***ACAN Amendment 1 is issued to correct the closing under article 12.***

Field Steam Sterilizers

W6369-19A045/A Granger, Dominique Telephone No. - (343) 550-1633 ( )

Line 1, Field Steam Sterilizers

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 Department of National Defence has a requirement for the supply of four (4) fully functional model P2131 Field Sterilizer units or equivalent Field Sterilizer Units with accessories. This requirement also includes an option to purchase up to an additional four (4) units with accessories within 36 months of contract award date to support both domestic and deployed operational requirements. 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 Field Sterilizer Unit meets the following requirements: As Canada is a member of the North Atlantic Treaty Organization (NATO) and the Government of Canada is a signatory to NATO Standardization Agreement (STANAG) 2906 - Essential Physical Requirements and Performance Characteristics of Field Type High Pressure Steam Sterilizers, the Fort Defiance Industries model P2131 Field Sterilizer or equivalent must have the following capabilities:

M.1 The device must meet the requirements of NATO Standardization Agreement (STANAG) AMedP-1.13: Essential Physical Requirements and Performance Characteristics of Field Type High Pressure Steam Sterilizers.

M.2 The device must have a valid, active, medical device license issued by Health Canada. Proof of licensure must be included with the bid submission. The Canadian Armed Forces reserves the right, at its discretion, to verify the validity of the device license through Health Canada’s Medical Device Active License Listing website https://health-products.canada.ca/mdall-limh/index-eng.jsp

M.3 The device must meet or exceed ANSI/AAMI ST8:2013 - Hospital Steam Sterilizers http://my.aami.org/store/?navItemNumber=1338.

GENERAL CHARACTERISTIC

The device MUST: M.4 Be a self-contained unit, the sterilizer enclosure acts as the shipping container, with endcaps which close securely to protect the sterilizer during transport but open securely to act as an integral stand once in location. M.5 Be capable of being carried by a Maximum of six (6) personnel, incorporating handles to assist with moving. M.6 Include a Micro-processor controlled sterilizer cycles that permits the operator to select the cycle and walk away M.7 Incorporate pre and post vacuum dynamic air removal M.8 Include alarm functions which are designed to abort a cycle in the event of abnormal operating conditions M.9 Include programmable sterilization cycles depending on the kind of items to be sterilized, including at least one cycle to inactive causative agents of spongiform encephalopathies (prions). M.10 Include a fully automated sterilization cycles, preprogrammed for: i. Immediate use ii. Textiles iii. Wrapped instruments iv. Bowie Dick and vacuum leak test M.11 Have data logging capability, allowing the operator to verify sterilization temperature, time and pressure during the sterilization cycle

PHYSICAL SPECIFICATIONS The Sterilizer Unit MUST: M.12 Have a Sterilization temperature of 270 degrees Fahrenheit (132 degrees Celsius) for all cycles M.13 Have a Maximum working pressure of 40 pounds per square inch M.14 Have a door that includes a safety preventing the cycle to start unless the door is closed and latched. M.15 Have a Maximum weight of 325 pounds

The Water Recovery System MUST: M.16 Provide the means by which the sterilizer unit is able to create pre and post cycle vacuum M.17 Have a minimum water storage capacity of 6 US gallons (22 litres) M.18 Allow the sterilizer to run a minimum of 100 cycles before requiring water to be added M.19 Have a maximum weight of 180 pounds 4. Applicability of the trade agreement(s) to the procurement

This procurement is subject to the following trade agreement(s): o Canadian Free Trade Agreement (CFTA) o North American Free Trade Agreement (NAFTA) o World Trade Organization - Agreement on Government Procurement (WTO-AGP)

5. Justification for the Pre-Identified Supplier The Fort Defiance Industries model P2131 Field Sterilizer unique technical feature is that it is the only self-contained, transportable, Field Sterilizer unit capable of programmable, micro-processor controlled, sterilization cycles offering data logging capability thus ensuring the Government of Canada is in compliance with its NATO obligations. 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 work".

7. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under

o Canadian Free Trade Agreement (CFTA) Article513 (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;

o North American Free Trade Agreement (NAFTA) Article 1016 2. An entity may use limited tendering procedures in the following circumstances and subject to the following conditions, as applicable: (b) where, for works of art, or for reasons connected with the protection of patents, copyrights or other exclusive rights, or proprietary information or where there is an absence of competition for technical reasons, the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists The procedural elements of CCFTA/CPFTA/CCOFTA are considered to be fulfilled through compliance with the procedural requirements of NAFTA. o World Trade Organization Agreement on Government Procurement (WTO-AGP)

Article XIII - Limited Tendering (b, iii.)

Where 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: ? due to an absence of competition for technical reasons; The procedural elements of CPTPP are considered to be fulfilled through compliance with the procedural requirements of WTO-AGP.

8. Ownership of Intellectual Property

There are not IP terms.

9. Period of the proposed contract or delivery date

The equipment must be delivered before March 29, 2019.

10. Name and address of the pre-identified supplier

Fort Defiance Industries (FDI) 2411 Maremont Parkway Loudon, TN 37774

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 February 28, 2019 at 2:00 p.m. (EDT).

13. Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to

Dominique Granger Supply Specialist Public Works and Government Services Canada Commercial Consumer Products Directorate 140 O'Connor Street, 7th floor L'Esplanade Laurier (LEL), East Tower Ottawa, Ontario, K1A 0R5

Telephone: 343-550-1633 E-mail address: Dominique.granger@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.