Evolis Twin Plus

Solicitation number 6D063-132296/A

Publication date

Closing date and time 2014/02/18 15:00 EST


    Description
    Trade Agreement: NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama
    Tendering Procedures: Generally only one firm has been invited
    to bid
    Attachment: None
    Non-Competitive Procurement Strategy: Exclusive Rights
    Comprehensive Land Claim Agreement: No
    Vendor Name and Address: 
    BIO-RAD LABORATORIES (CANADA) LIMITED
    2403 Guénette
    Montréal Quebec
    Canada
    H4R2E9
    Nature of Requirements: 
    Marlene Hall
    Supply Specialist
    Telephone:  204 984-6423
    E-mail:  marlene.hall@pwgsc-tpsgc.gc.ca
    
    File No.: 6D063-132296/A
    
    
    
    TITLE:	EVOLIS Twin Plus
    Public Works and Government Services Canada (PWGSC), on behalf
    of Public Health Agency Canada (PHAC), intends to negotiate with
    Bio-Rad Laboratories (Canada) Ltd. for the provision of an
    EVOLIS Twin Plus System.
    
    
    DEFINITION OF REQUIREMENT
    The Public Health Agency of Canada has a requirement for the
    supply, delivery, installation and training of one (1) EVOLIS
    Twin Plus System.
    
    The National Laboratory for HIV Reference Services (NLHRS)
    represents Canada's premier reference laboratory for HIV and
    HTLV testing in support of testing programs conducted by
    provincial ministries of health and the Canadian Blood Services.
    Our role is to strengthen the country's capacity to diagnose,
    detect and characterize HIV infection, which threatens the
    public health system and blood supply. Our reference diagnostic
    testing program and Reference Material, Proficiency testing and
    External Quality Control program supports national and
    international stakeholders. As well, our Surveillance program is
    at the leading edge of new and novel HIV and Hepatitis C (HCV)
    testing due to its reference diagnostic and technical capacity
    and we have the ability to rapidly 'alert' public health and
    blood screening agencies of potential new threats. The
    surveillance studies focus on a number of various risk groups
    which include, intravenous drug users, men who have sex with
    men, street youth, aboriginal and people from endemic countries.
    These surveillance studies are critical in tracking the spread
    of the virus. This allows epidemiologists to see which groups
    are at higher risk, where prevention programs are needed and
    which prevention programs are working successfully, resulting in
    more efficient use of funding. We have extensive experience in
    molecular and serological testing, from a variety of sample
    types, for HIV-1 and HIV-2 as well as other human retroviruses
    (Human T-cell Leukemia Virus (HTLV-I, HTLV-II), SIV and
    endogenous retroviruses (ERVs)). Sample types can include but
    are not restricted to whole blood, cell pellets, plasma,
    formalin fixed and frozen tissue and dried blood spots (DBS).
    Our laboratory is also actively involved in the development and
    optimization of new and innovative technologies.  
    
    The NLHRS has a need for a fully automated enzyme immunoassay
    (EIA) processor, specifically the EvolisTM Twin Plus System from
    Bio-Rad to improve efficiency and reduce variability in sample
    testing. 
    Current diagnostic testing and projects testing samples from
    national surveillance studies require the manual application of
    tests with the number of samples ranging from hundreds to
    thousands which must be tested in a timely manner. These assays
    have numerous steps and involve incubations of various times,
    some ranging from 5 minutes to 60 minutes. Due to the strict
    time requirements and hands-on work, a technician is limited
    both in the number of samples they can run in a day and the
    amount of other work they can accomplish. The variation between
    runs is also increased because of differences in technicians and
    technique. In the current absence of an automated system this
    requirement addresses the ability to perform these tests as
    close to an automated fashion as possible.  The ability of this
    instrument to: support different functions such as aliquoting,
    diluting and archiving; running  many samples from primary
    containers; run multiple assays at the same time; and
    automatically recording and monitoring Quality Control
    functions, will increase the through-put and efficiency of the
    lab, reduce worker fatigue and injury, and aid in meeting ISO
    15189 accreditation requirements.
    
    The EVOLIS Twin Plus system from Bio-Rad Laboratories is the
    only system on the market that can meet the mandatory
    specifications This system has obtained Class IV Medical Device
    licensing from Health Canada for In Vitro Diagnostic Devices
    (IVDD) which allows it to be used for automated processing of
    tests that diagnose transmissable blood born pathogens in blood
    and blood products for transfusions or tissues for
    transplantation.
    
    To change the workflow in order to accommodate for the
    automation of another instrument would be costly and time
    consuming. It would also require the use of HIV and HCV positive
    samples for validation which are precious and hard to come by in
    sufficient volumes. We found no other Health Canada approved
    Class IV medical device on the market with automation from
    sample input to result in a closed system that can accommodate
    the throughput needed by the NLHRS that also allows for complete
    traceability for our ISO 15189 accreditation requirements.
    
    
    SECURITY REQUIREMENT
    There is a security requirement associated with this requirement.
    
    
    PERFORMANCE/ CRITERIA/OBJECTIVES/SPECIFICATIONS
    Any interested supplier must demonstrate by way of a statement
    of capabilities that its product meets the following mandatory
    requirements:
    
    1.	Due to the pathogenicity of HIV this instrument must be a
    Health Canada approved Class IV
    	medical device
    	a.	An excerpt from Medical Devices Regulations (SOR/98-282)
    PART 2 IN VITRO 
    		DIAGNOSTIC DEVICES (IVDD): Use with respect to Transmissible
    Agents 
    		(http://lois-laws.justice.gc.ca/eng/regulations/SOR-98-282/page
    -23.html#h-68):
    		An IVDD that is intended to be used to detect the presence of,
    or exposure to, a 
    		transmissible agent in blood, blood components, blood
    derivatives, tissues or organs to 
    		assess their suitability for transfusion or transplantation is
    classified as Class IV.
    
    2.	The instrument must have an integrated QC program to monitor
    reagent lot numbers and to trace 	
    	events (monitor for errors in process), this complete
    traceability is required to comply with our 
    	lab's ISO 15189 accreditation requirements.
    
    3.	The Instrument must have a compact design (must be small
    enough to fit on lab bench) 
    
    4.	The instrument must be a closed system and must not be
    required to be placed in a biological 
    	safety cabinet.
    
    5.	The Instrument must be fully automated, from the beginning of
    the process (direct sample input) 
    	to the end result. The instrument must be able to perform a
    pre-dilution step automatically without 	
    	any manual manipulation beforehand.
    
    6.	The instrument must be able to load up to 144 samples.
    
    7.	The instrument must be able to run 3 full 96-well plates in a
    day.
    
    8.	The Instrument must have the capacity to incubate at
    different temperatures (RT, 37°C, 40°C) 
    	with shaking capacity.  Incubation times must be programmable.
    
    9.	The instrument must have greater than one (>1) incubator to
    allow for different temperature and 
    	shaking options.
    
    10.	The Instrument must have a  washer manifold capable of
    washing flat, U and V-shaped plates
    
    11.	The Instrument must have a sample dispenser with a minimum
    volume of 10uL up to 1,000uL. 
    	This minimum volume is critical considering that limited
    volumes of samples will be used.
    
    12.	The instrument must be able to verify pipetting accuracy
    with different methods (Capacitive, and 
    	Barometric) to alert when potential mishandling of samples
    and/or reagents has occurred.
    
    13.	The instrument must use disposable tips to eliminate
    carryover contamination. 
    
    14.	The Instrument must have an absorbance reader for single or
    dual wavelength and have a filter 
    	wheel with 450, 492 and 620 filters
    
    15.	The Instrument must have the capability to:
    	a.	perform plate dilutions 
    	b.	distribute primary samples and reagents directly from
    original containers 
    	c.	accept a wide range of primary tube sizes
    
    16.	The instrument must be able to archive samples to
    microplates and be able to link with sample 
    	storage inventory.
    
    
    JUSTIFICATION FOR PRE-IDENTIFIED SUPPLIER
    Bio-Rad Laboratories (Canada) Ltd. is the only known supplier
    that can provide an EVOLIS Twin Plus System that meets all of
    the mandatory performance specifications.
    
    
    TRADE AGREEMENTS
    The following limited tendering reasons pertain to this
    requirement:
    
    Government Contract Regulations, Part 1, Section 6(d) only one
    person is capable of performing the contract.
    
    Government on Internal Trade (AIT), Article 506-12(b) where
    there is an absence of competition for technical reasons and the
    goods or services can be supplied only by a particular supplier
    and no alternative or substitute exists;
    
    North American Free Trade Agreement (NAFTA), 1016.2(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;
    
    
    DELIVERY DATE
    The equipment must be delivered on or before March 31, 2014, FOB
    destination.
    
    
    PRE-IDENTIFIED SUPPLIER
    Bio-Rad Laboratories Ltd.
    2403 Guénette
    Montréal, Quebec
    H4R 2E9
    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.

    Contract duration

    Refer to the description above for full details.

    Trade agreements

    • Canada-Panama Free Trade Agreement
    • Agreement on Internal Trade (AIT)
    • Canada-Colombia Free Trade Agreement
    • Canada-Peru Free Trade Agreement (CPFTA)
    • North American Free Trade Agreement (NAFTA)

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    Contact information

    Contracting organization

    Organization
    Public Works and Government Services Canada
    Address
    11 Laurier St, Phase III, Place du Portage
    Gatineau, Quebec, K1A 0S5
    Canada
    Contracting authority
    Hall, Marlene
    Phone
    (204) 984-6423 ( )
    Fax
    (204) 983-7796
    Address
    PO Box 1408, Room 100
    167 Lombard Ave.
    Winnipeg, Manitoba, R3C 2Z1

    Buying organization(s)

    Organization
    Public Health Agency of Canada
    Address
    130 Colonnade Road
    Ottawa, Ontario, K1A 0K9
    Canada
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    Summary information

    Notice type
    Advance Contract Award Notice
    Language(s)
    English, French
    Region(s) of delivery
    Manitoba
    Commodity - GSIN
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