P03 Vevo F2 Ultrasound FAR 13.5 Final Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 4

53296 - UHF46x: 46 MHz UHFx Series Transducer 1 EA 53297 - UHF57x: 57 MHz UHFx Series Transducer 1 EA VS-20084 - Vevo Imaging Station 1 1 EA 53610 - Vevo Animal Monitor Mouse Platform 1 EA 53611 - Vevo Animal Monitor Rat Platform 1 EA VS-12055 - Vevo Compact Dual (Med. Air & O2) Anesthesia System (Tabletop Version) 1 EA 10414 - "H" Type Regulator 1 EA 11830 - "H" Type Medical Air Regulator 1 EA 11301 - 12.5 mm Bain Circuit (for Rat Anesthesia) 1 EA 11486 - 9 mm Bain Circuit (for Mouse Anesthesia) 1 EA 53214 - Foot Pedal Assembly for Vevo 3100/F2 1 EA 12353 - Introductory 2-Day On-Site User Training 1 EA 12370 - Vevo System Installation (United States) 1 EA

Vevo Customer Care: Access to exclusive online video tutorials, webinars, imaging guides/protocols, software updates, technical/scientific support 1 EA

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Fujifilm remains the only vendor on the market with available high frequency imaging machinery for ultrasound-based imaging of small animals. The equipment purchased, the Vevo F2 imaging system, also required highly specialized maintenance and and repair services offered by Fujifilm. There is no additional duplication of cost or unacceptable delays anticipated. The Vevo F2 system is a unique instrument that is able to use ultrasound imaging to measure, in a high resolution, structures within small animals such as the the heart, lung, blood vessels, liver, and kidney. The purpose for this is to better understand in our research studies what effect our various treatments have on the structure and

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 4 function of the aforementioned organs and tissues. Importantly, ultrasound imaging is routinely used in humans too, and having the option for this technique is particularly important because it will inform us on what to measure in humans. The supplies needed for this equipment will be provided 100% from the vendor and will include a large console for the ultrasound imager, the probes that will be used for imaging, the computer system for acquiring images, and the stands for placing small animals on with anesthetization equipment for imaging. This instrument is unrivaled in its function and therefore cannot be substituted for additional instruments from other vendors. Additionally, service and maintenance can only be provided by the vendor due to the specialized nature of the equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research techniques included reviewing current literature and available animal ultrasound offerings described by competing sources. This included evaluation of primarily veterinary ultrasound machines from NVET, Clarius, and GE. The technologies, and particularly post-processing capabilities, provided by Fujifilm and the Vevo F2 system are not available from the other companies. Additionally, the high resolution capabilities for cardiac imaging, in particular, and 3D imaging are not available from the other companies. Fujifilm’s Vevo platform remains the gold standard for ultrasound imaging in small animals for research purposes, and the competitors identified above primarily develop machines with limited capabilities for focused clinical applications in veterinary medicine. No company could be found that specifically developed a research-focused ultrasound machine for use in small animals besides Fujifilm.

Specifically, Fujifilm is the exclusive and only manufacturer of in vivo high-frequency (20MHz+) linear micro-array ultrasound machines for animal use.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The costs are anticipated to be fair and reasonable based on comparison of the quote to the Independent Government Cost Estimate (IGCE), comparative evaluation of quote received from DSI and a fair and reasonable determination will be documented prior to award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research was conducted based on talking to knowledgeable individuals in trade shows and similar work enviornments. Results are that the requested brand name, FUJIFILMS Vevo F2 system will meet all needs for the service now and years to come. FUJIFILMS is the only manufacturer and distributor of the product.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No company could be found that specifically developed a research-focused ultrasound machine for use in small animals besides Fujifilm. Specifically, Fujifilm is the exclusive and only manufacturer of in vivo high-frequency (20MHz+) linear micro-array ultrasound machines for animal use.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

FUJIFILM VisualSonics Corporation 21919 30th Drive SE Bothell, WA 98021

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Department of Veterans Affairs will continue to seek vendors capable of providing medical