P03 Att 1 Single Source Justification MPT to SAT 501-26-3-055-0095 MagView B 4OYs_SIGNED.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 4 Acquisition ID# 36C262-26-AP-4149

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C262-26-AP-4149

1. Contracting Activity: Department of Veterans Affairs, VISN 22, NMVAHCS

Medical Center Funding ID: 501-26-3-055-0095

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

Magview Software license renewal and support. Proprietary software used for our

Selenia Dimensions 3D mammography system.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

MagView is not sold or serviced through any third-party company. MagView warranty is void if non-MagView –authorized person uses any of the diagnostic, maintenance or database tools. The maintenance contract includes upgrades to the software which are not sold through any third party and are not otherwise available unless you have a software maintenance contract in effect. MagView is ACR BI-RADS licensee and as such no other ACR BI-RADS licensee is authorized to sell or service MagView software.

Any lapse in support directly from MagView results in a waving of the right to receive future upgrades from MagView, and any future versions would have to be purchased as they are released.

This software works with our Selenia Dimensions 3D mammography systems. We have two of these systems which we acquired in 2017 for a total of $880,960, both of which require proprietary software, MagView. It is much more economical to just renew the software license rather than do a complete replacement or upgrade of the equipment already purchased in 2017. Due to inflation, prices have gone up significantly since then, so replacing this equipment because we don’t want to renew the software license would be much more expensive than back in 2017. If we renew this software license we won’t have to spend on any new training for clinical staff because the same software will be used. On top of that we would avoid the risk of introducing clinical error as our staff adjust to using a new system.

4. Description of market research conducted and results or statement why it was not conducted:

Effective Date: 12/30/2025 Page 2 of 4

DynaCAD Breast and Patient Hub are not comparable to a full mammography information system because they serve entirely different functions and lack the core components required to manage the end‑to‑end breast imaging workflow. DynaCAD Breast is designed solely as a breast MRI post‑processing platform, providing tools such as lesion segmentation, kinetic curve analysis, and MRI‑specific reporting. It does not include any mammography workflow capabilities, nor does it support patient tracking, follow‑up management, recall letters, regulatory compliance reporting, or patient communication tools. In other words, DynaCAD supports only the interpretive portion of MRI exams and does not provide operational or administrative infrastructure for managing a breast imaging program.

Similarly, Patient Hub solutions such as those offered by Lunit focus primarily on communication, patient tracking, and risk assessment within limited workflows. While these platforms can generate recall letters and help with certain administrative tasks, they lack the built‑in structured BI‑RADS reporting needed for diagnostic mammography, do not support MQSA or HIPAA‑aligned compliance documentation, and offer minimal integration with RIS, PACS, or EHR systems beyond basic messaging functions. They do not manage radiologist interpretation workflows, modality coordination, quality auditing, or comprehensive operational tracking.

Because both DynaCAD and Patient Hub address only narrow segments of the breast imaging process—MRI interpretation in the case of DynaCAD, and patient communication in the case of Patient Hub—they cannot replace or be considered comparable to a fully integrated system that manages the entire clinical, operational, and compliance continuum of mammography services.

Additionally, after reviewing the capabilities of MagView in comparison with PenRad and InsightMed OmniCare, it is clear that MagView remains the only system that fully meets the operational, clinical, and compliance needs of our breast imaging program. While PenRad and InsightMed OmniCare each offer strengths in specific areas, both introduce functional gaps that would significantly affect radiologist workflow, patient engagement, risk assessment, and regulatory readiness. For these reasons, replacing MagView at this time would create measurable clinical and operational disadvantages.

MagView provides an advanced, fully integrated breast imaging ecosystem that includes AI-based image risk assessment, comprehensive genomic and phenotypic risk integration, robust BI‑RADS reporting workflows, deep MQSA compliance tools, enterprise-level EHR integrations, and a modern mobile-first communication framework.

These capabilities together support the entire continuum of breast imaging workflows— from patient intake and risk stratification to radiologist reporting, follow-up management, and audit preparation.

Effective Date: 12/30/2025 Page 3 of 4

PenRad, although the closest true competitor, is notably limited in several areas that are essential to modern breast imaging operations. PenRad does not provide AI-driven image-based risk prediction, which has become increasingly important for identifying high-risk patients and improving early cancer detection. Its genetic module, PenGen, captures family and genetic history but does not integrate genomic results with imaging-based AI and clinical risk factors into a unified risk score as MagView does. PenRad offers patient communication tools such as secure email and a results hotline, but it lacks the mobile-first, SMS-based two-way communication system that MagView delivers. This difference materially affects patient engagement, compliance with recalls, and overall throughput in busy screening environments. PenRad also provides solid BI‑RADS reporting capabilities, but it lacks some of MagView’s high-level automation features, such as auto-next-case workflows, deeper integration with reading room tools, and broader enterprise deployment across multi-site environments.

InsightMed OmniCare excels in patient-facing digital tools, including tablet forms, email-based reminders, and electronic letter generation. However, OmniCare lacks the clinical depth required for radiologist workflows and high-risk patient management. Its reporting features are not as robust or structured as MagView’s BI‑RADS reporting suite, and it does not include any AI-driven image risk tools or genomic integration options. As a result, OmniCare cannot replicate MagView's unified risk ecosystem, which synthesizes AI mammographic analysis, genetic test results, breast density, and clinical data into a consolidated risk profile. In addition, InsightMed’s compliance and MQSA support are more basic and would require supplementing or manual workarounds, increasing the administrative burden on staff. While OmniCare performs well as a patient engagement platform, it does not provide the same level of radiologist workflow automation, enterprise interoperability, or diagnostic support as MagView.

Financially, replacing MagView with PenRad or InsightMed would involve an estimated investment of at least $500,000 due to the need for multiple systems in software licensing plus additional training, migration, and integration costs. The MagView software works with our Selenia Dimensions 3D mammography systems. We have two of these systems which we acquired in 2017 for a total of $880,960. It is much more economical to just renew the software license rather than do a complete replacement or upgrade. Due to inflation, prices have gone up significantly since then, so replacing this equipment because we don’t want to renew the software license would be much more expensive than back in 2017. If we renew this software license we won’t have to spend on any new training for clinical staff because the same software will be used. On top of that we would avoid the risk of introducing clinical error as our staff adjust to using a new system.

However, the larger concern is not the cost of the replacement itself, but the operational and clinical losses that would result. Without AI-based imaging risk, integrated genomic risk scoring, SMS communication, and deep BI‑RADS automation, the breast center would experience reduced efficiency, lower patient follow-up rates, and a less

Effective Date: 12/30/2025 Page 4 of 4 Acquisition ID# 36C262-26-AP-4149 comprehensive framework for risk-based screening. Loss of MagView’s advanced MQSA auditing tools could also increase the workload required to maintain regulatory readiness.

In summary, although PenRad and InsightMed OmniCare offer valuable capabilities, neither system provides the breadth or depth of functionalities required to support a high-performance breast imaging program. MagView remains uniquely positioned to support clinical accuracy, operational efficiency, regulatory compliance, and patient engagement at scale. Due to these significant functional gaps and potential operational risks, MagView is the only platform that fully satisfies current program needs and future strategic direction. Retaining MagView is strongly recommended to avoid workflow disruption, maintain clinical quality standards, and support long-term patient care objectives.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR

12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

EDGAR ALVIZAR Date Contracting Officer

06-15-2026 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466