Rapid JA-Redacted.pdf

Rapid Enterprise Solution and Support VA-26-00060052

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for a firm-fixed-price contract to provide brand name Rapid enterprise software and support for the VA National Telestroke Program (NTSP). The proposed source for this procurement is iSchemaView, Inc. (iSchemaView), 405 El Camino Real, No. 601, Menlo Park, CA 94025.

3. Description of Supplies or Services: The VA NTSP requires enterprise-wide licensing, implementation, maintenance, and operational support for the Rapid advanced imaging and clinical decision support platform, scaled to support a baseline capacity of 6,000 patients per year. VA requires a solution that is U.S.

Food and Drug Administration (FDA)-cleared, artificial intelligence (AI)-enabled platform that analyzes Computed Tomography (CT) and magnetic resonance imaging to deliver real-time identification of large-vessel occlusions (LVO) and other critical stroke indicators, perfusion processing capabilities, and is integrated with VA imaging and telehealth infrastructure. Rapid is currently deployed and operating within the VA environment under a current Authority to Operate (ATO). This effort provides for the licensing, continued sustainment, and enterprise-wide expansion of that existing deployment across additional NTSP Telestroke sites during the period of performance.

The solution shall, at a minimum, automatically detect LVO strokes at the point of computed tomography/computed tomography angiography image acquisition;

instantly alert and mobilize the appropriate care team; enable secure remote consultation between stroke-site clinicians and hub-based telestroke neurologists;

and integrate seamlessly with existing picture archiving and communication system (PACS)/radiology infrastructure and applicable state and federal health reporting networks. These capabilities support the efficient care coordination and streamlined workflow integration essential to time-sensitive stroke management. Under this effort, the Contractor shall provide all required software licenses, configuration, and implementation services across NTSP sites; system integration with VA imaging infrastructure; and ongoing technical sustainment. Services include enterprise configuration and deployment, system and cybersecurity compliance support, performance monitoring, platform updates, algorithm enhancements, and vendor-managed maintenance. The Contractor shall also conduct integration activities to ensure compatibility with VA network architecture and clinical workflows, and shall provide technical assistance, onboarding, and training to VA clinical, imaging, and administrative personnel at all participating NTSP locations. The solution shall provide a consistent, secure, and clinically validated enterprise solution that enables

Rapid Enterprise Solution VA-26-00060052

VA clinicians to rapidly interpret advanced imaging, coordinate emergent care, and improve outcomes for Veterans experiencing stroke symptoms.

The platform is presently integrated end-to-end with the VA's clinical imaging and telehealth ecosystem. Rapid is currently deployed and interoperating at 10 VA Medical Centers (VAMC) and is architected to scale across the NTSP's 80+ Telestroke sites using the same validated integration pattern. Rapid is presently deployed at the following VA medical centers: Phoenix VA Health Care System (Carl T. Hayden VAMC); John D. Dingell VAMC (Detroit); Veterans Health Indiana (Richard L. Roudebush VAMC); Kansas City VAMC; Hunter Holmes McGuire VAMC (Richmond); Louisville VAMC (Robley Rex); VA Palo Alto Health Care System (Palo Alto Division); Michael E. DeBakey VAMC (Houston); Birmingham VAMC; and James A. Haley Veterans' Hospital (Tampa). Rapid ingests studies directly from VA PACS and radiology modalities through established Digital Imaging and Communications in Medicine routing, returns AI-generated results into the clinical viewing and telestroke consultation workflow, and exchanges data with VA systems through pathways that have already been engineered, tested, and accredited. This integration operates under a current ATO and has been validated against VA Office of Information and Technology (OIT) security and network configuration requirements, including VA's identity, access, and boundary-protection controls.

The period of performance consists of one, 12-month base period and two, 12-month option periods with optional tasks to add patient capacity to support program growth. The total estimated price of the proposed action, inclusive of all options, is

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Revolutionary Federal Acquisition Regulation Overhaul (RFO) 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 NTSP requires an FDA-cleared, AI-enabled platform that automatically detects large-vessel occlusions and other critical stroke indicators at the point of CT/CTA acquisition, has perfusion processing capabilities, alerts and mobilizes the care team in real time, and delivers results into the telestroke consultation workflow on clinician mobile devices. Rapid is the only FDA-cleared solution identified through market research that meets this complete set of minimum functional requirements. Based on the market research described in Section 8, only iSchemaView is capable of meeting the Government's requirements. Rapid is a proprietary, FDA-cleared advanced imaging and clinical decision support platform exclusively developed, owned, and maintained by iSchemaView. No other entity possesses the rights or technical knowledge to modify, support, maintain, update, or integrate the software. As the sole developer, iSchemaView alone holds the proprietary knowledge of Rapid's algorithmic models, system architecture, data-processing pipelines, and interoperability protocols necessary to ensure accurate imaging analysis, reliable performance, and compliant cybersecurity integration within the VA environment. Rapid's interoperability within the VA environment is the product of substantial, existing integration work that cannot be replicated by another vendor without duplicative cost and operational risk.

Since Rapid’s algorithmic models, data-processing pipelines, and interoperability protocols are proprietary to iSchemaView, no third party can interface a competing platform to these same VA systems or reproduce Rapid’s established data exchange without the cooperation and proprietary technical knowledge that only iSchemaView possesses. Any alternative solution would require building new interfaces to VA PACS/radiology infrastructure and the VA Electronic Health Record, re-engineering and re-testing every data-exchange pathway, before the replacement could process a single clinical case. Throughout that period, the standardized, real-time imaging interpretation on which the NTSP depends would be degraded or interrupted, directly affecting time-sensitive acute stroke care. Introducing a different platform would fragment that interoperability, forcing site-by-site re-integration and revalidation and creating inconsistencies in clinical workflow across the telestroke network. Maintaining Rapid therefore preserves both the existing technical investment and the seamless, enterprise-wide interoperability essential to the program's mission.

Replacing the existing infrastructure would be cost prohibitive, would result in unacceptable delays, and would place patient care at risk if another provider were chosen for this requirement. The procurement, integration and sustainment of any other stroke imaging and clinical decision support solution is estimated to take a minimum of 20-24 months and would result in an estimated cost of at least

This estimated cost to replace the existing solution includes the extensive development, configuration, integration, migration, hardware replacement, and personnel re-training efforts for a new solution These estimated costs and time are based upon previous acquisition history of development and configuration efforts of similar size and scope, and would not be recovered through competition. The existing Rapid platform would need to be maintained until the new software solution is integrated and available. The impact of any such disruption falls directly on Veteran patient care. Stroke is a time-critical emergency in which every minute of delay results in the loss of brain tissue and a measurable reduction in the likelihood of recovery. Rapid's real-time, automated detection of large-vessel occlusions and its seamless integration into the NTSP's imaging and consultation workflow directly enable the rapid diagnosis, care-team mobilization, and treatment decisions on which Veteran outcomes depend. Any degradation, delay, or interruption in this capability during a transition to an alternative platform would slow image interpretation and emergent care coordination across the telestroke network, increasing the risk of permanent disability or death for Veterans presenting with acute stroke. Maintaining the existing, fully integrated Rapid solution ensures uninterrupted continuity of this life-critical capability and preserves the quality and timeliness of acute stroke care for Veterans nationwide.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. In accordance with RFO 6.301(b)(2) and 5.201(c)(3), this justification shall be posted with solicitation. Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with RFO 5.301.

Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research on commercially available advanced imaging and clinical decision support platforms to determine whether future acquisitions can be competed. As part of this effort, VA will monitor developments in AI based stroke detection solutions, evaluate emerging vendors, and reassess whether existing products are updated, or if other new market entrants can meet NTSP’s enterprise-level functional, technical, and cybersecurity requirements. The Government will also evaluate opportunities to reduce reliance on proprietary components, challenge restrictive data rights where applicable, and encourage industry innovation through continuous market engagement.

8. Market Research: Market research was conducted in 2026 by VA technical and acquisition personnel to determine whether alternative sources could meet VA’s requirements. The market research included review of commercially available products, vendor outreach, evaluation of technical documentation, and assessment of system capabilities in clinical and cybersecurity domains. Solutions such as Viz.ai and InteleViewer were examined as part of this analysis. While Viz.ai offers certain AI based stroke detection features, it does not provide the full spectrum of proprietary algorithmic capabilities, enterprise scalability, VA-required cybersecurity compliance, or system-to-system interoperability needed to support deployment across NTSP’s 80+ Telestroke sites. InteleViewer, although a functional diagnostic image viewer, lacks FDA-cleared AI-based analysis modules, perfusion processing capabilities, and the advanced workflow automation required to support NTSP’s mission-critical clinical operations. Additionally, neither Viz.ai nor InteleViewer can integrate with the existing solution currently integrated in VA nor do they offer compatibility with VA OIT security and network configuration requirements.

Rapid software is a proprietary software product; therefore, only iSchemaView can provide the subscriptions and sustainment support required by VA. The Rapid software is manufactured by a sole proprietary company, iSchemaView, and no other entity, other than its sole reseller, Lovell Government Services, Inc (Lovell), is authorized to sell, service, or maintain this software. The contracting office contacted iSchemaView directly to 1) verify its authorized resellers, and 2) confirm if its resellers can comply with limitations on subcontracting requirements applicable to a Service-Disabled Veteran-Owned Small Business (SDVOSB)/Veteran-Owned Small Business (VOSB) set-aside or sole-source action under VA Acquisition Regulation (VAAR) clauses 852.219-73, 852.219-74, 852.219-75, and 852.219-76. In response, iSchemaView confirmed that it has one reseller, Lovell; however, it also indicated that its reseller cannot meet the limitations on subcontracting requirements.

Based on this market research, no alternative vendor or solution was identified that could meet VA's technical, clinical, operational, or cybersecurity requirements. Since the required product is proprietary to iSchemaView and available only through the OEM or its single reseller, which cannot meet limitations-on-subcontracting requirements, neither a set-aside nor a sole-source award to any small business of any socioeconomic category is feasible. As a result, the Government determined that only iSchemaView is capable of providing the highly specialized Rapid solution and associated support services necessary for the NTSP enterprise deployment.

9. Other Facts: None

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of the Rapid enterprise-wide licensing, implementation, maintenance, and operational support for the VA NTSP on an other than full and open competition basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.