BRAND NAME JUSTIFICATION REDACTED.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-23-AP-1589

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Services

Network 10, Network Contracting Office 10, 3140 Governors Place Boulevard, Suite 210, Kettering, OH 45409, on behalf of requirements for the Aleda E. Lutz VA Medical Center, 1500 Weiss Street, Saginaw, MI 48602. Brand Name Justification.

[VA Form 2237: 655-23-2-059-0102]

2. Brief Description of Supplies/ Services required and the intended use/Estimated

Amount: The Aleda E. Lutz VA Medical Center, Department of Urology, has a brand name requirement for the Fujifilm Healthcare Corporation’s Arietta 65, a diagnostic ultrasound system, and associated components and support. The requirement is for one (1) Arietta 65 System (P/N: H6234157), three (3) small prostate biplane probes (P/N: H7887794), six (6) endocavity probes (P/N: H4320584), two (2) urology probes (P/N: H1248547), one (1) KIT- DK SpaceOar (P/N: H5982202), eleven (11) trays (P/N: H6029237), installation (P/N:

H230248), four days of clinical training (P/N: H230248), twelve (12) months of the standard warranty (P/N: H4862335), and shipping (P/N: H6234555). The Arietta 65 System will be used by urologists for real-time ultrasound imaging to diagnose and treat patients at the Aleda E. Lutz VA Medical Center. The total estimated price of the Arietta 65 System and associated components is $

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Aleda E. Lutz VA Medical Center in Saginaw, Michigan, requires specific brand name (only) supplies to standardize medical equipment and to ensure the compatibility between existing VA medical equipment at Saginaw and the Lieutenant Colonel Charles S. Kettles VA Medical Center in Ann Arbor, Michigan. The Fujifilm Healthcare Corporation’s Arietta 65 System and components is required by VA urologists in Saginaw due to its confirmed compatibility with the Ann Arbor VA’s existing Philips-UroNav Fusion Biopsy System, which combines/fuses patient magnetic resonance imaging (MRI) images with urology ultrasound images needed for biopsies. The MRI images are performed at the Ann Arbor VA and the images/data can be transmitted electronically between VA medical centers through the Arietta 65 System due to software proprietary to the Fujifilm Healthcare Corporation. The urologists at the Saginaw VA require the capability to perform prostate biopsies and treat prostate cancer within their facility which is only made possible by the compatibility between the two systems (Arietta 65 and UroNav Fusion Biopsy systems). The standardization of equipment between the Saginaw and Ann Arbor VA facilities will enable the sharing of information and education between the VA providers, clinical, and maintenance staff, which creates efficiencies benefitting VA patient care. The procurement of the Arietta 65 System will allow for a more seamless transition of care

Last Updated: 02/01/22 Page 2 of 3 between Saginaw Urology and Ann Arbor subspecialty Urology based on the integration of the MRI imaging systems between the facilities. Gaps in the compatibility of systems can result in repeat testing; delays in care between sites; and the loss of images or image quality, which could delay cancer treatment care. Furthermore, the Arietta 65 System has a greater image quality due to the system’s total pixel count (1,440,000 pixels) as compared to other similar systems in the commercial marketplace. The enhanced image quality of the Arietta 65 System enables VA staff to more accurately detect lesions and lesion characteristics. As such, only the Fujifilm Healthcare Corporation’s Arietta 65 System and components will satisfy the requirements of the Aleda E. Lutz VA Medical Center.

4. Description of market research conducted and results or statement why it was not conducted: The VA’s Vendor Information Pages (VIP) database was searched using NAICS 334510, which resulted in the identification of 180 Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB) concerns. The VIP database was also searched using NAICS 334510 and keyword “Ultrasound” and resulted in the identification of 11 SD/VOSB concerns. The Small Business Administration (SBA) Dynamic Small Business Search database was searched using NAICS 334510 and keyword “Urology” which resulted in the identification of four (4) small business concerns. The GSA Advantage website was searched but yielded no results for the required supplies. The VA’s National Acquisition Center (NAC) Contact Catalog Search Tool (CCST) was searched and developed one existing contract, 36F797-21-D-0031, with a line item for the Arietta 65 Digital Ultrasound System. After consultation with the requiring service, it was learned not all of the required items can be fulfilled using the NAC contract. The VA obtained and reviewed a market research quote from Fujifilm Healthcare Corporation, the original equipment manufacturer (OEM) of the Arietta 65 System. The Federal Procurement Data System-Next Generation (FPDS-NG) website and the VA’s Electronic Contract Management System (eCMS) was searched and yielded one existing contract and delivery order for similar required items, Contract VA797H-17-D-0010 Delivery Order 36C250-23-F-0244. The delivery order was awarded to Fujifilm Healthcare Corporation for the procurement of Arietta trays and probes in December 2022. The VA reached out to a sales representative with Fujifilm Healthcare Corporation to ascertain whether or not the requirements of the Aleda E. Lutz VA Medical Center could be fulfilled under Contract VA797H-17-D-0010.

The OEM contact indicated the VA requirements require an open market solicitation. A sources sought notice was published in the Government Point of Entry (GPE (SAM.gov)) seeking all eligible sources to determine the ideal procurement strategy. Sources Sought Notice 36C25023Q0290 was posted to the GPE between 1 February 2023 and 6 February 2023. The notice listed each of the items required by the Aleda E. Lutz VA Medical Center.

At the close of the notice, the following vendors conveyed interest in the form of capability statements and email responses: Salvadorini Consulting LLC (SDVOSB), ASAP Cargo Van Service LLC (Small Business), BK Medical Holding Inc. (Large Business), and Defense Venture Holdings LLC (SDVOSB). The VA contacted Fujifilm Healthcare Corporation to find out if there are authorized resellers of the required ultrasound equipment. A sales representative provided the VA with the business names of three small business concerns:

Aviate Enterprise, Inc. (SDVOSB), ThunderCat Technology, LLC (SDVOSB), and Avenue Healthcare (Small Business). All SDVOSB concerns identified in the market research searches were verified in the SBA’s Veteran Small Business Certification (VetCert) database.

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Market research pursuits led the VA to conclude there is a reasonable expectation offers will be received from two or more eligible SDVOSB concerns and award will be made at a fair and reasonable price. The market research findings support an open market SDVOSB set aside in accordance with 38 U.S.C. § 8127(d).

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-

1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Network Contracting Office 10