Redacted JandA_Redacted.pdf

VHAPG Part 806.3 OFOC Page 2 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C24E-26-AP-0176

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO

6.103-2;

(X ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO

6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Co-Principal Investigator for the multisite IRB (VA CSDR 1I01CX003005-01) project will be with the Vascular Imaging Lab (VIL) at the University of Washington. The Biomolecular Imaging Center (BMIC), also at the University of Washington, will provide site-specific scanning for this study

The University of Washington Vascular Imaging Laboratory (VIL) has developed software tailored for atherosclerosis imaging and conducted several studies in atherosclerosis imaging and clinical trials using these software tools. The combination of the software tools and demonstrated expertise of the VIL in successfully conducting atherosclerosis MRI studies is unique. The following are the software and processes of VIL that are necessary for successful completion of this project:

Detailed documentation of standard operating procedures for software development and maintaining the software life cycle has been established. Software development contributes to core products. The first is the Vascular Trials System (VTS) which is a 21 CFR part 11 (FDA) compliant trial management system for imaging-based trials of vascular therapies. The second is the iCafe toolbox, a series of artificial intelligence and image processing tools for quantifying intracranial vasculature features through automated artery centerline tracing, multi-sequence registration and image reformation and visualization. The third is CASCADE, a dedicated software tool for vessel wall MRI analysis, consisting of algorithms for multispectral display and registration, automated segmentation, and visualization. Fourth is MOCHA, a novel multi-contrast, multi-time point intracranial and extracranial vessel wall analysis software for measurement of different arterial segments of the intracranial vasculature and carotid arteries.

This study will use these core products for data analysis and quantification. VIL has the necessary expertise to conduct imaging clinical trials using quantitative measurements of atherosclerosis using these software and processes. Detailed and precise quantitative measurements that the VIL lab can provide are critical to meeting the goals of this study.

VHAPG Part 806.3 OFOC Page 3 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C24E-26-AP-0176

The analytical capabilities of VIL and its MRI methods and expertise implemented at the associated BMIC MRI center make the UW site uniquely positioned to meet the needs of this multisite study. VIL and BMIC also have access to the patient population for this study and have demonstrated expertise in conducting multiple vessel wall MRI studies similar to the needs for this study. Considering these unique capabilities, the IRB has required the Seattle Site and the University of Washington as the sole source for this study. The use of any other vendor�s services would be unacceptable because other sites do not have the necessary resources and expertise to conduct the requisite research for this study. If the University of Washington cannot be used, our study aims cannot be met.

6. 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 RFO Part 5 and, if not, which exception under RFO Part 5 applies):

An intent to sole source, 36C24E26Q0014, was posted on 2/9/2026 and closed on 2/23/2026 with no responses received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

Once the proposal is received, the proposal prices will be subject to price analysis and negotiations may be conducted if the Contracting Officer determines negotiations necessary.

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 and included reviewing the SBA Small Business Search (SBS) database, System for Award Management (SAM) and the sources found in the Veterans Health Administration (VHA) Procurement Hierarchy chart per Federal Acquisition Regulation (FAR) and Veterans Affairs Acquisition Regulation (VAAR).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None.

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

None.

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:

End users will continue to monitor the market to ensure that barriers are overcome for future requirements as they are identified.