Hemostatis Analyzer System

Trade Agreement: NONE
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: 
Haemonetics Canada LTD
125 Summer street
Boston Massachusetts
United States
02110
Nature of Requirements: 

Hemostatis Analyzer System

W7719-215522/A
Cook, Wayne
Telephone No. - (613) 401-0623 (    )
Fax No. - (613) 687-6656 (    )
E-mail: wayne.cook@pwgsc-tpsgc.gc.ca

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 
a) The Department of National Defence (DND) is looking to Procure 1 Automated Viscoelastic Hemostatic Analyzer Instrument - TEG 6s Hemostasis Analyzer System with the following accessories delivered by 31 January 2021: 
i. HMN-118332-00 Barcode scanner, USB
ii. HMN-118034-00 Printer, USB
iii. HMN-118035-00 Printer Paper, USB
iv. HMN-TEG1VALIDATION Analyzer Validation Calculation and Certification
b) The following Consumables Items, with the latest expiration dates:
i. HMN-07-601 Global Haemostasis Cartridge - Citrated: K, KH, RT, FF 10/CA
ii. HMN-07-615 PlateletMapping® ADP Cartridge 10/CA
iii. HMN-07-650 QC Level 1 cartridge - TEG 6s Cartridges 10/CA
iv. HMN-07-651 QC Level 2 cartridge - TEG 6s Cartridges 10/CA
v. HMN-07-662 Abnormal QC Vial Test Kit 12/CA
c) The Contractor must be able to provide the following services for the Automated Hemostatic Analyzer System:
i. Instrument Installation one month after delivery:
1. The Contractor must provide on-site installation service for the TEG 6s Instrument and its software. The Contractor must ensure that the installed items are correctly adjusted, calibrated, and serviced such that the equipment is ready for operational use. 
ii. Training one month after delivery:
1. The Contractor must provide on-site training at DRDC - TRC including necessary materials for the proper use of the Hemostasis Analyzer within one month after delivery of instrument. The training must contain as a minimum: preparing reagents and supplies, running instrument software, performing calibration, quality control, method setup, sample analysis, and user maintenance. 
2. All Contractor related costs associated with the performance of the training (inclusive of the training manuals, reference manuals, reference materials, documentation, tuition and contractors travel and living expenses) must be included in the price of the contract.
d) Service Plan:
i. The Contractor must provide an annual service plan for the TEG 6s Instrument which includes:
1. Service calls with on-site response within 24 hours.
2. Unlimited access to a support centre for concerns.
3. Yearly service contract that includes annual Preventative Maintenance of the device and all required repairs/updates. All travel, parts and labour are included.
e) Options:
i. The Contractor must provide the following options:
1. Two additional one year options for the software support and maintenance service.
2. Consumables specific to the TEG 6s instrument on an “as and when required” basis, for three, one year options after contract award via a task authorization. These are outlined in points F to K, but could also include unspecified consumables that may be required at a later date.
f) The Hemostatic Analyzer must be a bench-top instrument and meet the following specifications.  The instrument:
i. must automatically monitor and continuously record the viscoelastic changes of whole blood from the start of coagulation to the end of fibrinolysis.
ii. must have the ability to measure multiple coagulation pathways and functions such as extrinsic and intrinsic pathways.
iii. must analyze the functional activities of blood cellular elements in conjunction with plasma components such as platelet and fibrinogen.
iv. must be insensitive to shock and vibration. 
v. must include a computerized system that can control the analyzer to perform quality control, data collection, data analysis and reporting.
vi. must be fully automated: no sample preparation / handling; no test preparation; automatic aspiration and detection of blood sample.
vii. should require volume of blood no more than 500 µL to run sufficient duplicates or tests with minimum blood collection.
viii. must be Health Canada licensed.
ix. must have at least 4 channels for multiple analyses to accommodate four types of tests involving intrinsic and extrinsic coagulation pathways, functional fibrinogen and heparin, respectively).
x. must be bench-top as in size or configuration  for convenient use on a laboratory workbench and portable for carry and transportation by hand (<10 lbs.) .
xi. must include installation kit, on-site set-up, calibration and training.
xii. must meet CSA approved electronic power standard (i.e., 110-120 V, 60 Hz).
xiii. must be cartridge based and include the test for true Platelet function.
xiv. requires no human attention to complete assays after sample introduction.

3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
a. Must automatically monitor and continuously record the viscoelastic changes of whole blood from the start of coagulation to the end of fibrinolysis.
b. Must have the ability to measure multiple coagulation pathways and functions such as extrinsic and intrinsic pathways.
c. Must analyze the functional activities of blood cellular elements in conjunction with plasma components such as platelet and fibrinogen.
d. Must be insensitive to shock and vibration
e. Must include a computerized system that can control the analyzer to perform quality control, data collection, data analysis and reporting.
f. Must be fully automated: no sample preparation / handling; no test preparation; automatic aspiration and detection of blood sample.
g. Should require volume of blood no more than 500 µL to run sufficient duplicates or tests with minimum blood collection.
h. Must be Health Canada licensed.
i. Must have at least 4 channels for multiple analyses to accommodate four types of tests involving intrinsic and extrinsic coagulation pathways, functional fibrinogen and heparin, respectively).
j. Must be bench-top as in size or configuration for convenient use on a laboratory workbench and portable for carry and transportation by hand (<10 lbs.).
k. Must include installation kit, on-site set-up, calibration and training.
l. Must meet CSA approved electronic power standard (i.e., 110-120 V, 60 Hz).
m. Must be cartridge based and include the test for true Platelet function.
n. Requires no human attention to complete assays after sample introduction.
o. LANGUAGE.  All training and materials must be provided in English.
p. SECURITY

 The Canadian Designated Security Authority (Canadian DSA) for industrial security matters in Canada is the Industrial Security Sector (ISS), Public Works and Government Services Canada (PWGSC), administered by International Industrial Security Directorate (IISD), PWGSC. The Canadian DSA is the authority for confirming Contractor/Subcontractor compliance with the security requirements for foreign suppliers. The following security requirements apply to the foreign recipient Contractor/Subcontractor incorporated or authorized to do business in a jurisdiction other than Canada and delivering outside of Canada the services listed and described in the subsequent contract/subcontract. 
1. The Foreign recipient Contractor/Subcontractor must be from a Country within the North Atlantic Treaty Organization (NATO), the European Union (EU) or from a country with which Canada has an international bilateral security instrument. The Contract Security Program (CSP) has international bilateral security instruments with the countries listed on the following PWGSC website: http://www.tpsgc-pwgsc.gc.ca/esc-src/international-eng.html. 
2. The Foreign recipient Contractor/Subcontractor must, at all times during the performance of the contract/subcontract, hold an equivalence to a valid Designated Organization Screening (DOS), issued by the Canadian DSA as follows: 
i. The Foreign recipient Contractor/Subcontractor must provide proof that they are incorporated or authorized to do business in their jurisdiction. 
ii. The Foreign recipient Contractor/Subcontractor must not begin the work, services or performance until the Canadian Designated Security Authority (DSA) is satisfied that all contract security requirement conditions have been met. Canadian DSA confirmation must be provided, in writing, to the foreign recipient Contractor/Subcontractor in an Attestation Form, to provide confirmation of compliance and authorization for services to be performed. 
iii. The Foreign recipient Contractor/Subcontractor must identify an authorized Contract Security Officer (CSO) and an Alternate Contract Security Officer (ACSO) (if applicable) to be responsible for the overseeing of the security requirements, as defined in this contract. This individual will be appointed by the proponent foreign recipient Contractor’s/Subcontractor’s Chief Executive officer or Designated Key Senior Official, defined as an owner, officer, director, executive, and or partner who occupy a position which would enable them to adversely affect the organization’s policies or practices in the performance of the contract/subcontract. 
iv. The Foreign recipient Contractor/Subcontractor must not permit access to Canadian restricted sites, except to its personnel subject to the following conditions: 
a. Personnel have a need-to-know for the performance of the contract/subcontract; 
b. Personnel have been subject to a Criminal Record Check, with favourable results, from a recognized governmental agency or private sector organization in their country as well as a Background Verification, validated by the Canadian DSA; 


c. The Foreign recipient Contractor/Subcontractor must ensure that personnel provide consent to share results of the Criminal Record and Background Checks with the Canadian DSA and other Canadian Government Officials, if requested; and 
d. The Government of Canada reserves the right to deny access to Canadian restricted sites to a foreign recipient Contractor/Subcontractor for cause. 
3. CANADA PROTECTED information/assets provided or generated pursuant to this contract/subcontract must not be further provided to a third party Foreign recipient Subcontractor unless: 
a. written assurance is obtained from the Canadian DSA to the effect that the third-party Foreign recipient Subcontractor has been approved for access to CANADA PROTECTED information/assets by the Canadian DSA; and 
b. written consent is obtained from the Canadian DSA, if the third-party Foreign recipient Subcontractor is located in a third country. 
4. The foreign recipient Contractor/Subcontractor requiring access to Canadian restricted sites, under this contract/subcontract, must submit a Request for Site Access to the Chief Security Officer of the Department of National Defence Canada. 
5. In the event that a Foreign recipient Contractor/Subcontractor is chosen as a supplier for this contract/subcontract, subsequent country-specific foreign security requirement clauses must be generated and promulgated by the Canadian DSA, and provided to the Government of Canada Contracting Authority, to ensure compliance with the security provisions, as defined by the Canadian DSA, in relation to equivalencies. 
6. Subcontracts which contain security requirements are NOT to be awarded without the prior written permission of the Canadian DSA. 
7. All Subcontracts awarded to a third party foreign recipient are NOT to be awarded without the prior written permission of the Canadian DSA in order to confirm the security requirements to be imposed on the subcontractors. 
8. All Subcontracts awarded by a third party foreign recipient are NOT to be awarded without the prior written permission of the Canadian DSA in order to confirm the security requirements to be imposed on the subcontractors. 


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. Government Contracts Regulations Exception(s) 

a. 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”.

6. Period of the proposed contract or delivery date 

Requirement Reference  Delivery date
A to B Before 31 January 2021
C Within one month after delivery of deliverable A to K., but before 31 March 2021
D For two additional one-year options
E For three one-year options

7. Cost estimate of the proposed contract 

a) The estimated value of the contract, including option(s), is $256,053.66 x (GST/HST extra). 

8. Name and address of the pre-identified supplier 

Haemonetics Corporation
125 Summer Street
Boston, MA 02110

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 December 18, 2020 at 2:00 p.m. EST. 

11. Inquiries and submission of statements of capabilities 

Inquiries and statements of capabilities are to be directed to: 

Wayne Cook
Supply Specialist
PWGSC, Petawawa Acquisitions
101 Menin Rd. Garrison Petawawa
Building S-111 Rm C-114
Petawawa, Ontario
K8H 2X3
Telephone: 613-401-0623
Facsimile: 613-687-6656
E-mail: wayne.cook@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.