A16_CFX_Opus_Single_Source_Justification_BF_1.pdf

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Special Notice of Intent to Sole Source Award
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DOIFFBO240066
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This document is a justification for a sole source award of a contract for the purchase of Bio-Rad CFX 384 and CFX 96 Real Time PCR platforms. The U.S. Fish and Wildlife Service Whitney Genetics Laboratory uses these platforms to conduct environmental DNA testing for invasive carp species as part of its quality assurance project plan. All genetic markers and testing protocols have been validated on the Bio-Rad CFX platform. Maintaining this platform is necessary for consistent data quality and reproducibility of results. Bio-Rad is the original manufacturer of these required devices and has offered discounted pricing of $19,469.65 for the CFX 96 unit and $22,363.14 for the CFX 384 unit, plus trade-in credits. No other vendor was found that could provide equivalent equipment with the original manufacturer's warranty at comparable pricing. The justification recommends awarding a firm fixed price sole source contract to Bio-Rad under the simplified acquisition threshold authority.

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FWS Form 3-0034 (Rev. 10/2020) U.S. Fish and Wildlife Service

1. Description of Need

3. Other Capable Sources

2. Market Research Conducted

Pursuant to FAR subpart 13.106-1(b)(1)(i) and (ii), for purchases not exceeding the Simplified Acquisition Threshold (SAT), Contracting Officers may solicit from only one source if the circumstances deem only one source is reasonably available (e.g., urgency, exclusive licensing agreements, brand name, or industrial mobilization).

Instructions: The information in the text boxes are provided as sample language or to indicate a needed fill-in. Sample language should be removed from the final document. All text boxes require information and shall not be left blank.

SINGLE SOURCE JUSTIFICATION

(UNDER SAT)

JOINT ADMINISTRATIVE OPERATIONS

Acquisitions Operations

4. Barriers to Competition

5. Contractor's Qualifications

6. Determination of Fair and Reasonable Cost

7. Recommendation and Certification by Program Office

Based on the above justification, I recommend this acquisition to be conducted using sole source acquisition procedures. I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

Program / Project Officer

8. Contracting Officer Certification and Approval: Under SAT

Based on the above justification, I hereby certify and approve the use of sole source acquisition procedures under FAR Part 13 for this purchase.

Contracting Officer

Text3: Bio-Rad has offered the lab a $19,469.65 discount on the Opus 96 unit and a $22,363.14 discount on the Opus 384 unit, plus an addition $1,969.72 trade-in value for the 384 Opus and $1,508.54 for the 96 Opus for each old discontinued machine returned to them. We are unaware of any other vendor that can provide this discounted pricing on the updated CFX 384 and CFX 96 Real Time PCR platforms. If there is another vendor that offers this Bio-Rad Opus brand in the CFX platform, that is new and not refurbished or used and has the original equipment manufacturer's warranty, that would be acceptable.
Text2: Currently Bio-Rad is the only manufacturer making and using the CFX platform. The CFX Opus is the replacement for the discontinued CFX Touch Real-Time PCR Detection System that we are currently using and which all of our reagents and markers have been developed and validated on. Bio-Rad provided the research paper, A Model qPCR System Comparability Study: CFX Touch and CFX Opus Real-Time PCR platforms, to demonstrate the equivalence between the two platforms.
Text1: The USFWS Quality Assurance Project Plan (QAPP) for eDNA Monitoring of Bighead and Silver carp has been ongoing at the Whitney Genetics Laboratory (WGL) since 2013. Through this program, the WGL conducts all the USFWS high throughput invasive carp environmental DNA testing for the Great Lakes and Mississippi River watersheds. WGL conducts this work to meet the USFWS Fisheries Program Mission of Managing Aquatic Invasive Species.

All laboratory activities for the carp eDNA monitoring program go through an extensive validation process to ensure a high degree of reproducibility of results from one case to the next, and one year to the next. The Bio-Rad CFX real time qPCR machines used in the WGL have been optimized to be as efficient, reproducible, and sensitive as possible to deliver the highest standard of reliability of laboratory results. All of the genetic markers used at the Whitney Genetics Lab for this monitoring program have been developed and validated on the Bio-Rad CFX platform. To maintain data integrity and reproducibility, this qPCR platform must be used. If our lab switched to a new qPCR platform, a comparability study would need to be completed and the current markers we use would need to be reevaluated and tested on the proposed platform. This may take up to a year to accomplish and would prevent the Whitney Genetics Lab from meeting their Mission of invasive carp eDNA monitoring. There is no guarantee a different qPCR platform would produce a comparable level of data quality and consistent results. We also require that the system be compatible with the CFX Maestro software we are running to analyze the data produced by the Real-Time PCR machines and compatible with the 14 other CFX Bio-Rad machines that are currently in use for the invasive carp monitoring project.

Text4: We have not found another vendor that offers this machines, that are new and has the original equipment manufacturer's warranty or equivalent, than the discounted price with trade-in allowance offered by Bio-Rad.
Text6: Bio-Rad has offered the lab a $19,469.65 discount on the Opus 96 unit and a $22,363.14 discount on the Opus 384 unit, plus and addition $1,969.72 trade-in value for the 384 Opus and $1,508.54 for the 96 Opus for old discontinued machines. We are unaware of any other vendor that can provide this discounted pricing on the updated CFX 384 and CFX 96 Real Time PCR platforms. This is a considerable savings over the pricing found on the GSA Advantage website for the same equipment.
2024-02-06T11:20:44-0600
PATRICK DEHAAN
2024-02-21T11:53:47-0500
WILLIAM FLUHARTY

Text5: They are the original manufacturer of the required devices.

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