A05_JA for Under SAT EVOS M5000 redacted.pdf

United States Department of Agriculture Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number: 12639526Q0236

Rev. 3/4/26

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR

12.102 (a), the following documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requisition Number: 1174469

Requesting Activity Agency: Animal Plant Health Inspection Service (APHIS), Veterinary Services (VS), Foreign Animal Disease Diagnostic Laboratory (FADDL), North American Foot and Mouth Disease Vaccine Bank (NAFMDVB) and National Animal Veterinary Vaccines and Countermeasures Bank (NAVVCB)

Contracting Activity: Animal Plant Health Inspection Service (APHIS), Marketing and Regulatory Programs Business Services (MRPBS), Acquisition and Asset Management Division (AAMD).

(2) Estimated Value:

Item Name/Model: EVOS M5000SV Imaging System (See listing below) Manufacturer: Thermo Fisher Scientific

Item Number

Part Number Description Quantity Estimated

Price 0001 A65468 EVOS M5000 Imaging System with Stage View. Bundle includes: (1.1) AMF5000SV – EVOS M5000 Imaging System with integrated digital imaging capabilities; (1.2) ZGEXSCEVOSM5000 – Rapid Exchange Program providing a 2-year expedited instrument replacement service to minimize downtime; and (1.3) A40109 – Digital SmartStart remote onboarding and installation assistance to facilitate system setup and user training.

2 $52,772.94

0002 AMEP5010 Phase Contrast Objective Bundle – Includes 4X, 10X, and 20X long working distance (LWD) phase contrast objectives for routine imaging of samples at multiple magnifications.

2 $10,152.00

0003 AMEP4983 40X Long Working Distance Phase Contrast Objective – High-resolution 40X objective (0.65 NA, 1.79 mm working distance) for detailed higher magnification imaging.

2 $6,219.00

0004 AMEP5016 Fluorescence Light Cube Bundle – Includes DAPI, GFP, and Texas Red fluorescence filter cubes for multichannel imaging of commonly used fluorophores.

2 $21,127.00

0005 AMEP4619 Holder Pack – Includes vessel holders (AMEP-VH001 and VH010) for securely mounting compatible sample vessels during image acquisition.

2 $0.02

(3) Brief Description of Supplies or Services

The NAFMDVB and the NAVVCB are establishing critical laboratory workflows that support stockpiling efforts. The laboratory requires routine monitoring of cell lines for health, confluency, cytopathic effect, and contamination. The Invitrogen EVOS M5000 Imaging System provides high resolution brightfield and fluorescence imaging allowing the detection of cell morphological changes that are central to Foot and Mouth Disease Virus (FMDV) propagation, titration, and virus neutralization assays. The integrated automated imaging helps to reduce user-to-user variability and improves reliability of assay results. In an FMDV outbreak, this instrument would allow for greatly enhanced turnaround time and increased confidence in results used for vaccine matching, potency testing, and other response related assays.

(4) Suggested Source

Life Technologies Corporation 5781 Van Allen Way Carlsbad, CA 92008

(5) Justification for Restricting Competition and the Basis for that Decision.

A. Explain the unique qualifications/characteristics of the proposed contractor or product and why no other contractor or product/service can meet the Government's need.

After completion of the market research for microscope imaging systems, the Invitrogen EVOS M5000 Imaging System from ThermoFisher is the only product that meets laboratory needs. The EVOS M5000 integrates multi-channel fluorescence, transmitted light, phase contrast, and true-color imaging, all within a single fully integrated benchtop system. The system features a 3.2 MP monochrome CMOS sensor with 2048×1536 resolution, optimized for high sensitivity and low-light quantitative imaging. Additionally, the EVOS M5000 includes automatic focus (sub-micron precision), z-stacks, single-click multichannel capture, time-lapse imaging, and plate scanning capabilities. The proprietary Stage View tracks stage positions manually; areas of interest can be saved and revisited even after power down. The EVOS M5000 is plug-and-play: no alignment, assembly, or calibration required.

This instrument is currently installed and operational in adjacent laboratory sections within the same facility. Procuring the EVOS M5000 guarantees continuity and allows for a seamless transition as the software application is already approved by security.

Moreover, the proprietary nature of the hardware and software means that no other manufacturer can provide the Invitrogen EVOS M5000 Imaging System that match the exact specifications and integration capabilities of the ThermoFisher microscope imaging system.

B. Describe market research conducted and the results or the reason why no market research was conducted.

Market research was conducted to verify the availability of comparable microscopes/imaging systems from other vendors. Market research consisted of searching USDA wide contracts, GSA Advantage, System for Award Management, procurement Co-Pilot, GSA’s Market Research as a Service, SBA’s Dynamic Small Business Search tool, and the interment. The (x) and x (x) were identified as potential alternatives. The table below summarizes key features of each imaging system.

EVOS M5000 x x Fluorescence imaging 4-color sensitive Up to 5-channel None

Transmitted light/true Color Color + phase contrast Multi-mode contrasting Yes Camera High-sensitivity mono Not specified Color megapixel Autofocus, Z-stack, time-lapse

Fully automated Limited AI autofocus Not included

Stage tracking Proprietary maps Not included Not included Onboard analysis tools Counting, confluency AI counting/confluency Confluency only Ease of use/setup Plug and play, no calibration Intuitive interface Easy

LED illumination/filter quality

Hard coated Unspecified LED

Ability to connect to USDA networks

Yes Unknown No

Findings from the market research show that the EVOS M5000 is the only product that aligns with laboratory needs. The x has most required features, but the use of AI will require additional approvals and may pose a security concern, therefore this is not an option at this time. The x does not offer most of the advanced features to meet laboratory needs.

The open market will be pursued to purchase the instruments. Purchasing through the IDIQ was explored during market research. The current IDIQ has the old instrument model (AMF5000) on the contract, and the newest instrument model (AMF5000SV) is not on contract. The IDIQ is in the process of being updated to include the most current model, however, the timeline for when this update will be complete is unclear. Additionally, the requirement in its entirety is not available IDIQ. Use of the IDIQ would pose a risk as it would fragment the order of these critical instruments and accessories.

Certifications & Approvals

(6) 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.

Biological Scientist

(7) 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. I hereby approve this justification.

Contracting Officer