A16-20230622_CFX_Opus_Single_Source_Justification_1.pdf
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- Attached to
- Special Notice of Intent to Sole Source Award
- Solicitation number
- DOIFFBO230122
About this file
This document is a single source justification for the acquisition of an updated CFX 384 Real Time PCR platform from Bio-Rad. The US Fish and Wildlife Service's Whitney Genetics Laboratory requires the CFX 384 Real Time PCR platform for continuity of data in its invasive carp environmental DNA monitoring program for the Great Lakes and Mississippi River watersheds. All genetic markers and tests used by the laboratory in this program have been developed and validated on Bio-Rad's CFX qPCR platform. Maintaining use of this platform is necessary to ensure reproducibility of results and prevent interruptions to monitoring that could occur if a new platform required revalidation of markers. As Bio-Rad is the original manufacturer of the CFX platform and provided documentation demonstrating equivalence between the existing and updated models, no other capable sources were identified. The acquisition is associated with Special Notice of Intent to Sole Source Award DOIFFBO230122 from the Department of the Interior Fish and Wildlife Service.
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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: The updated CFX 384 Real Time PCR platform is required for continuity of data. |
| Text2: Currently Bio-Rad is the only manufacturer making and using the CFX qPCR platform. The CFX Opus is the replacement for the discontinued CFX Touch Real-Time qPCR 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. |
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.
| Text4: The updated CFX 384 Real Time PCR platform is required for continuity of data. | |
| Text6: The updated CFX 384 Real Time PCR platform is required for continuity of data. | |
| 2022-12-12T11:44:41-0600 | |
| PATRICK DEHAAN |
| 2023-06-29T08:39:14-0500 | |
| JOHN SKOGEN |
Text5: They are the original manufacturer of the required devices.
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