Part 12 Over SAT JA 12639526Q0180 redacted.pdf

United States Department of Agriculture Justification to Restrict Competition

Identification Number:

Rev. 11/6/2025

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) 12.102 (b), the following justification documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requesting Agency:

USDA, APHIS, MRPBS, VS, D&B, CVB

1920 Dayton Ave Ames, IA 50010

Contacting Agency:

USDA, APHIS, MRPBS AAMD

250 Marquette Avenue, Suite 410 Minneapolis, MN 55401

The USDA proposes the use of other than full and open competition for the procurement of supplies manufactured by Becton Dickinson Biosciences (BD Biosciences).

(2) Nature and/or description of the action being approved.

This J&A authorizes and approves the award of a sole-source, fixed price, 90 day delivery, new contract for the manufacture or procurement of a spectral flow cytometer with cell imaging capabilities, a critical piece of scientific equipment which measures fluorescent emission spectra from stained samples allowing for the rapid and accurate measurement of specific live cell populations within a mixed sample as well as being capable of visualizing the cells.

The spectral flow cytometer needs to be purchased to ensure the laboratory is capable of testing regulatory samples which are submitted to the laboratory, enhance the laboratory’s capabilities to produce and develop new reagents used in regulatory testing, and support the ongoing research efforts focused on finding alternatives to animal testing.

The suggested contractor is:

BD Biosciences 34 Maple St.

Milford MA 01757

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The contract will supply a spectral flow cytometer machine with the capability of capturing images of the cells. This machine will have 5-lasers, come with an instrument table, detergent solution concentrate, calibration beads, Trucount Absolute Counting Tubes IVD, and a setup MSB 150 test.

In addition the contract will include an extended warranty, covering 2 years of service for the instrument, 3 free copies of compatible analysis software already present and approved for use on the campus that the laboratory is located at (FlowJo software), a computer capable of operating the instrument in a standalone configuration (no network connection) which supports exports compatible with the FlowJo analysis software, onsite setup, initial on-site training for staff who will be using the instrument, and technical support for the install.

Estimated Value-$398,370.00

For additional specifics please see statement of work.

(4) Identify the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. 1901 - FAR 12.201-1, Simplified Procedures.

>SAT, ≤ $9 million, using FAR 12.201-1, Simplified procedures - 41 U.S.C. 1901

(5) Demonstrate that the proposed contractor's unique qualifications or the nature of the acquisition requires using the authority cited.

The acquisition of the spectral flow cytometer must be restricted to BD Biosciences due to several unique qualifications and characteristics exclusive to their product. First, the flow cytometer uses proprietary software which is compatible with the analysis software already integrated into our existing laboratory workflow since the USDA APHIS CVB program is co-located with ARS which already uses Becton Dickinson products and their patented FlowJo analysis software. This ensures that data generated on the flow cytometer is compatible with the already present analysis software allowing for seamless data transfer and compatibility which is crucial to maintain workflow and operational efficiency.

Additionally, the FACSDiscover A8 model offers required features such as real-time cell imaging technology, spectral flow cytometry, and 78 fluorescence APD detectors which are not available on other spectral flow cytometers on the market. Specifically, BD Biosciences is the only company to offer orthogonal frequency domain multiplexing with electronic and optical components. This unique technology makes it possible to produce images without a camera, enabling real-time imaging of all the events. They also offer full spectrum optics, next generation QC and system aware spectral unmixing that manages spread by adapting to instrument performance and sample conditions in real time. The fluorescence detectors in BD FACSDiscover A8 Cell Analyzer are spectral arrays of 78 fluorescence APD detectors paired with algorithmically optimized filter bandwidths covering the full spectrum. This combination of requirements is uniquely available with the FACSDiscover A8 system.

(6) Provide a description of efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by Part 5 and, if not, which exception under Part 5 applies.

The market was surveyed for this specific type of equipment. The following firms were identified:

BD Biosciences Thermo Fisher Scientific, and Agilent. Upon review by SME, the technical specifications provided by Thermo Fisher Scientific and Agilent did not meet the laboratory’s requirements.

Flow-cytometry instruments which meet the laboratory’s requirements are made to order and are not sold by resellers. This limits the available sources to the manufacturers of flow-cytometry machines. Several of the laboratory’s requirements are unique features to the BD Biosciences instrument which were not available in machines that could be provided by either of the other two manufacturers.

(7) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer has determined the anticipated cost to the Government for the supplies covered by this J&A will be fair and reasonable based upon a comparison of rates from market research of similar products.

(8) A description of the market research conducted, and the results or a statement of the reason Market Research was not conducted.

Market research was conducted to verify the availability of comparable spectral flow cytometers from other vendors. This included analyzing product specifications and discussing product capabilities and options with potential vendors. The responses and findings confirmed that no other flow cytometers met our required compatibility and performance criteria.

(9) Any other facts supporting use of other than full and open competition, such as:

Several additional factors support the use of this justification for a sole-source contract with BD Biosciences.

The proposed contractor already has and maintains other equipment on the same campus, this also provides the possibility of saving money and time by utilizing combined maintenance contracts.

Additionally, the data analysis software and its licensing scheme allows for the use of already approved and in place IT systems minimizing IT delays and saving the government money. This proprietary software (FlowJo) and the unique technical specifications prevent the formulation of a competitive solicitation that could be addressed by other vendors, and transitioning to an alternate source would require significant time, and financial investments leading to delays and operational risks.

(10) A listing of the sources, if any, that expressed an interest in the acquisition in writing.

At this time, we know of only 5 companies which manufacture spectral flow cytometer machines (BD Biosciences, Agilent, Thermo Fisher Scientific, Sony Corporation, and Cytek Biosciences).

From our initial research, only BD Biosciences, Agilent, and Thermo Fisher Scientific offered spectral flow cytometers with 4+ laseers.

In response to the inquiry of what Flow Cytometer machines were available from their company, Agilent and Thermo Fisher Scientific expressed an interest in providing a flow cytometer although none of the available machines were able to meet our work requirement.

• Agilent: Although Agilent demonstrated the capability of providing a spectral flow cytometer with many of the same features as the BD FACSDiscover A8, the cytometer discussed was Opteon, a spectral cytometer with a 5-laser setup but did not have the technology at this time to provide imaging of the cells passing through the laser. This does not meet our work requirements.

• Thermo Fisher Scientific demonstrated the capability of providing a spectral flow cytometer with a 6-laser configuration and a 4-laser traditional configuration with the ability to take pictures but had not integrated the capabilities of both into one instrument. As we require a spectral flow cytometer with the ability to take pictures of the cells passing through the machine, this does not meet our work requirements.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition of the supplies or services required.

Restricted competition for scientific instruments is commonly required due to software compatibility between vendors, software licensing terms, as well as unique technical specifications.

We will conduct regular market research and engage with industry to identify new sources and emerging technologies as we investigate increasing our laboratory capabilities. However, it is unlikely that these efforts will overcome industry wide proprietary software and unique technical specifications, or unique emerging technologies which have no competitors at the time of purchase.

(12) Certifications & Approvals

Technical / Requirements Personnel Certification I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Katherine Turnbull Date Veterinary Medical Officer

Contracting Officer’s Certification I certify that the data supporting the recommended use of other than full and open competition accurate and complete to the best of my knowledge and belief.

Name Date Contracting Officer

Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition, including all possible options. Delete reviews/approvals that are not needed.

Competition Advocate (greater than $900,000 but not exceeding $20M).

I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity, I hereby approve this justification. If required, my approval constitutes clearance for submission to the Head of the Contracting Activity (HCA).

Name of Chief of the Contracting Office (COCO) Date Competition Advocate

HCA (greater than $20M but not exceeding $90M).

I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as Head of the Procuring Activity, I hereby approve this justification. If required, my approval constitutes clearance for submission to the Senior Procurement Executive (SPE).

May 29, 2026

Name of HCA Date Head of Contracting Activity (HCA) United States Department of Agriculture

SPE of the Agency ($90M and over).

I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, as the Senior Procurement Executive, I hereby approve this justification.

Name of SPE Date Senior Procurement Executive (SPE) United States Department of Agriculture

Legal Review and Concurrence (when required - see AGAR 4001.402-2)

I have reviewed this justification and deem it legally sufficient.

Name of Attorney Date Office of General Counsel