Attachment 1 - Brand Name Only Justification.pdf

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RFQ 1232SA25Q0390 - Real-Time PCR Detection System
Solicitation number
1232SA25Q0390
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This document is a Limited Source/Brand Name Justification from the United States Department of Agriculture (USDA) Agricultural Research Service for a CFX Opus 96 Real-Time PCR Detection System. The justification explains the need to purchase a specific scientific instrument due to prior research history and unique technical capabilities. Key system features include precise gene expression analysis capabilities, a compact design with minimal laboratory space requirements, advanced optical detection technologies, and robust software with customizable reporting tools. The USDA is seeking this equipment to maintain research integrity after their original equipment was damaged in a building flood, and they have determined that this specific system is essential to continue their ongoing scientific work with a CRADA (Cooperative Research and Development Agreement) partner.

The document follows Federal Acquisition Regulation 13.106-1(b)(1) for simplified acquisitions, indicating the procurement is for a specialized scientific instrument. Market research confirmed the equipment is available through multiple vendors at similar price points. The justification was prepared by a molecular biologist and will be approved by a contracting officer, with specific sections regarding pricing and recommended sources redacted from the document. The comprehensive technical justification details the system's unique capabilities in gene expression analysis, pathogen detection, and genetic variation studies, emphasizing why this specific equipment is critical for the USDA's research objectives.

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RFQ 1232SA25Q0390 - Terms and Conditions.pdf PDF

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United States Department of Agriculture

Limited Source/Brand Name Justification

FAR 13.106-1(b)(1) – Simplified Acquisitions

Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

USDA-Agricultural Research Service

Supply 2 Section/Contracting Operations Branch/Acquisition and Property Division

800 Buchanan Street, Albany, CA 94710

2. Description of supply or service required to meet the agency’s needs.

CFX Opus 96 Real-Time PCR Detection System-for amplification of DNA/RNA using fluorescence signal capture in real time for quantitative analysis. Used for gene expression analysis, pathogen detection and genetic variation studies.

3. The rationale or circumstances for limiting competition.

Years of proprietary data with our CRADA partner utilized the equipment. To maintain research integrity and reproducibility, the same equipment must be utilized. Original equipment was damaged in a building flood.

In addition, the following characteristics make the equipment unique:

The CFX Opus System

-does not have lid or drawer that extends beyond the footprint of the system nor requires additional operating clearance. This is important because of current and ongoing laboratory space constraints.

-can detect a 1.3-fold change in gene expression. This is very important for the expression analysis of low copy number genes.

-thermal gradient feature enables optimization of multiple temperatures in a single assay. Temperature differences of up to 24°C front-to-back can be created. This is important when optimizing new primers and cycling conditions, saving valuable research time.

-has optics shuttle which independently illuminates and detects fluorescence from each well with the same LED/detector pair per channel. This is important because other similar instruments rely on the use of a passive reference dye (ie ROX dye calibrations) to account for well-to-well variation in fluorescence signal, saving time and money. The system uses six filtered LEDs for illumination and differentially detects emission using six filtered photodiodes (one for each channel plus FRET).

-will continue to run and complete a run if the software is stopped or interrupted. This prevents run data from being lost if there is unintentional interruption of the software. This function is especially valuable for precious or limited samples, whereby all data is not lost for a run that was interrupted.

CFX Opus Software

-allows run results that can be displayed in a customizable configuration so that multiple panes of information may be viewed in a single window. This is important for accurate and streamlined data analysis.

-Reference Gene Selector Tool displays gene stability for selection of ideal reference genes. This is critical for accurate gene expression analysis.

-License for qbasePLUS software permits further gene expression analysis.

-Embedded reports tool can be customized by the user to export run information, data tables, graphs, and analysis parameters in a specified order to PDF or other file formats. This increases the flexibility of data reporting by allowing fast and limitless options for data output and presentation compatible with other software.

-Image export options include DPI selection up to 600DPI, choice of any image size, and color selection using RGB specifications. This allows immediate, publication quality figures to be created from first run data.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

The equipment is available through different vendors. All are within similar price points from one another.

5. Estimated price, including all options, if applicable.

Redacted

6. Recommended source(s).

Redacted

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

Nicole Novak

Nicole Novak, Molecular Biologist

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Michael Hassett

Michael Hassett

Contracting Officer

Notes and Guidance. Delete these Notes prior to finalizing document for signature

For acquisitions greater than the micro-purchase threshold but less than the Simplified Acquisition

Threshold (SAT) the Contracting Officer may solicit from one source only if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand name, etc.). Contracting Officers must document the rationale for soliciting from a single source, including brand name in accordance with FAR 13.106-

1(b)(1)(i) and FAR 13.106-3(b)(3)(i).

Program personnel are advised to work with contracting personnel early on in order to promote and provide for full and open competition to the maximum extent practicable. In circumstances permitting other than full and open competition, program personnel shall provide necessary information to contracting personnel to support and document the circumstances limiting competition through the use of this form

Advance planning. Contracting without providing for full and open competition shall not be justified on the basis of (1) a lack of advance planning by the requiring activity or (2) concerns related to the amount of funds available to the agency or activity for the acquisition of supplies or services.

Brand Name. Items peculiar to one manufacturer can be a particular brand name, product, or feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product or feature is essential to the Government’s requirements and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the Agency’s needs.

Posting. When an acquisition contains brand name specifications, the Contracting Officer shall include the justification required by FAR 13.106-1(b) or 13.501 with the solicitation when synopsizing in the

GPE (actions exceeding $25,000) or displaying in a public place (actions exceeding $15,000 but not expected to exceed $25,000), as required by FAR 5.102(1)(6).

Screening. Before posting the justification, in accordance with FAR 6.305(e) and 24.202, the

Contracting Officer is responsible to redact any information that is exempt from disclosure under

Freedom of Information Act or information proprietary to the contractor.

Signatures. After review and completion by the Program Office and Contracting Officer, the Word document shall be converted to an Adobe PDF file and routed for electronic signatures. Signature blocks shall include dates.

https://www.acquisition.gov/far/part-13#FAR_13_106_1 https://www.acquisition.gov/far/part-13#FAR_13_501

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