JA - Patient Hub Redacted_Redacted.pdf

Brand Name Patient Hub Software Licensing, Maintenance, and Technical Support Control Number VA-26-00004764

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement Operations Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for a sole source firm-fixed-price contract, for Patient Hub software licensing, maintenance, and technical support directly awarded to Lunit Americas Inc., 3500 188th Street SW, Suite 335, Lynnwood, WA, 98037.

3. Description of the Supplies or Services: VA, Health Service Area (HSA) 2.3 requires Patient Hub software licensing, maintenance, and technical support for mammography tracking and patient notification platform services. Patient Hub is a proprietary software solution developed and maintained exclusively by Lunit Americas Inc., and is currently integrated within the VA HSA 2.3 breast imaging clinical workflow at all seven of the following VA Healthcare System locations for mammography patient tracking, results notification, and recall management: Bay Pines VA Healthcare System, Miami VA Healthcare System, North Florida/South Georgia Veterans Health System, Orlando VA Healthcare System, VA Caribbean Healthcare System, James A. Haley Veterans' Hospital, and West Palm Beach VA Healthcare System. The software supports breast imaging programs used to track screenings and diagnostic mammography, breast ultrasound, and breast magnetic resonance imaging examinations; manage patient follow-up and recall notifications; and support compliance with American College of Radiology (ACR) and VA mammography quality standards. Continuity of this software is essential to maintain compliance with VA mammography policy directives and ACR accreditation requirements and to avoid disruption to Veteran patient care. The base period of performance shall be October 1, 2026, to September 30, 2027, with three 12-month option periods, to be exercised at the discretion of the open competition for this acquisition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.103-1 entitled “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this requirement is Lunit Americas Inc., 3500 188th Street SW, Suite 335, Lynnwood, WA, 98037. Based on market research, as described in Section 8 of this justification, it has been determined that only Patient Hub has the capability to meet this requirement.

Patient Hub is a proprietary software solution developed, owned, and maintained exclusively by Lunit Americas Inc., built on a proprietary data architecture and database schema essential to the VA HSA 2.3 breast imaging clinical workflow. It is currently deployed, fully integrated, and customized within the breast imaging environment at all seven HSA 2.3 VA Healthcare System locations, where it contains patient tracking histories, recall notification records, ACR compliance documentation, and examination workflow data. No other software product can access, migrate, or interface with this proprietary data environment without complete system replacement, which would require full data migration, interface redevelopment, revalidation, and reauthorization under VA's Authority to Operate (ATO) process.

Beyond its data environment, Patient Hub is currently interfaced with existing HSA 2.3 clinical systems, including Hologic mammography acquisition systems (via Hologic AppSync) and Nuance PowerScribe radiology reporting systems. These interfaces were developed specifically for Patient Hub and are not transferable to any alternative product, so replacing the software would require redevelopment and retesting of all clinical interfaces at significant cost and risk. The estimated cost of installing and implementing a different breast imaging management system is approximately $210,000.00, including VA staff costs during implementation and radiologist costs for retraining and efficiency impacts and roughly 6 months to complete. These technical dependencies carry direct compliance and safety consequences. HSA 2.3 breast imaging programs must maintain ACR accreditation and comply with VA mammography quality directives, both of which mandate continuous, uninterrupted patient tracking and recall notification. Any gap in system availability or patient tracking capability during a transition to an alternative product would place HSA 2.3 ACR accreditation status at risk and could result in non-compliance with VA mammography policy. Most critically, Patient Hub manages the tracking and recall notification of Veterans with abnormal mammography findings requiring follow-up. A disruption to this system, whether from software transition, data migration failure, or interface incompatibility, creates a direct patient safety risk, as Veterans requiring timely follow-up could be lost to follow-up during any transition period.

No other vendor possesses this knowledge base, and onboarding an alternative would require a significant learning curve and transition risk. Failure to procure continued maintenance would result in unsupported mainframe software, preventing delivery of critical security patches and fixes and exposing Veteran-facing applications to system outages, delays in benefits processing, and disruption of essential mission services.

This would cover the expenses for testing, transitioning, deployment, and training associated with the new product.

No other commercially available mammography tracking and patient notification software product is compatible or interoperable with the existing Patient Hub installation currently in operation across HSA 2.3 without significant disruption to Veteran patient care, clinical operations, and ACR accreditation compliance.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this document. This effort did not yield any additional sources that could provide replacement for the required Patient Hub software licensing, maintenance, and technical support. However, it was determined that limited competition is available among authorized resellers. Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: In order to remove or overcome barriers to competition in future acquisitions for this requirement, the Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: Market research was conducted by HSA 2.3 Radiology Service clinical and IT subject matter experts to identify commercially available mammography patient tracking and recall notification software products capable of satisfying the Government's requirements without replacing the existing Patient Hub implementation.

The research reviewed available mammography information system and breast imaging tracking software products, including but not limited to those offered by breast imaging software vendors such as MagView, PenRad, and Viztek. While other mammography information system products exist in the commercial marketplace, none can provide the specific Patient Hub product, its proprietary data environment, its existing VISN 8 clinical integrations, or its established VA ATO documentation.

Based on this research, the Government's technical experts determined that no alternative product can access or interface with the existing Patient Hub proprietary patient tracking database and historical data currently residing within the VISN 8 implementation, replicate the existing clinical system interfaces with Hologic AppSync and Nuance PowerScribe without complete redevelopment, maintain uninterrupted patient recall notification services for Veterans with pending or active follow-up requirements during a system transition, or satisfy VA ATO requirements within the required timeframe given the complexity of the existing integrated environment.

Adopting any alternative product would require complete replacement of the existing system, including full data migration, interface redevelopment, staff retraining, and reauthorization, which is operationally impractical within the required period of performance and would introduce unacceptable patient safety risk.

Furthermore, market research confirmed that Patient Hub is available exclusively from Lunit Americas Inc., and that no other vendor can provide this specific proprietary software product. Based on all market research efforts, the Government's technical experts determined that only Patient Hub software, obtained through Lunit Americas Inc., can provide the software licensing and support services required to maintain continuity of breast imaging patient tracking operations across VISN 8.

Additional market research was conducted by the Contract Specialist in September 2026 using the National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Governmentwide Acquisition Contract Provider Lookup Tool. This search revealed no NASA SEWP vendors offer Patient Hub, including Service-Disabled Veteran-Owned Small Business resellers.

On August 21, 2026, the Contract Specialist contacted Lunit via email to request the names of any authorized resellers, along with any Federal Supply Schedules or Governmentwide Acquisition Contracts held by the company. On August 24, 2026, Lunit's Customer Service Manager responded that the company has no authorized resellers and holds no Federal Supply Schedules or Governmentwide Acquisition Contracts.

Based on this market research, Lunit is the only known vendor capable of satisfying HSA 2.3's requirement; therefore, this action will be solicited to Lunit Americas, Inc. on a sole-source basis via Contracting Opportunities.

9. Other Facts: None.

10. Technical/Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

11. determine that the anticipated price to the Government for this contract action will be fair and reasonable based on comparing the quote to the Independent

12. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.