Radiopharmaceutical Inventory for Nuclear Medicine (RAIN) System Control Number VA-26-00024441

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 with Mystic Ventures Group LLC (Mystic) 105 white City CT, Canton, Georgia 30115, for an enterprise Radiopharmaceutical Inventory for Nuclear Medicine (RAIN) Solution and services, including maintenance, installation, interfacing, implementation, data migration, and training.

3. Description of Supplies or Services: VA, Veterans Health Administration (VHA), National Radiology Program Office requires a full-service Radiopharmaceutical Inventory for Nuclear Medicine (RAIN) system to ensure the quality, safety, and operational support of radiopharmaceuticals for Veteran care for 135 sites.

Currently, VA's 135 nuclear medicine sites operate a mix of disparate RAIN solutions, including standalone software systems, networked systems, and manual paper-based processes. In the past, all of these contracts were awarded to three companies throughout VA. Over the years, they were all acquired and are now part of one company, Mirion. These solutions have been acquired with different levels of functionality and VA is now standardizing into one enterprise system. This acquisition will replace that fragmented environment with a single, standardized enterprise RAIN solution deployed across all sites, enabling centralized auditing, consistent data capture, and national-level reporting. To do so, VA requires a proven, standardized, scalable radiopharmaceutical inventory for Nuclear Medicine system with centralized auditing capability. A modern, full-spectrum management system will support this effort, allowing VA to realize radiopharmaceutical acquisition and delivery methods and lifecycle management efficiencies. This software will ensure that the correct patient receives the correct exam, the correct radiopharmaceutical, and the correct dosage. In addition, the enterprise system will maintain records in accordance with Nuclear Regulatory Commission (NRC) 10 C.F.R regulatory requirements and allows for reports to be generated at the local, Veteran Integrated Service Network (VISN), and National levels. These enterprise level reports will allow National Health Physics Program (NHPP) to ensure that patient radiation dose is within acceptable limits and allows for cross-comparison to ensure that radiation dose is maintained as low as reasonably achievable. It also tracks radiation dose from acceptance to disposal to ensure safety of patients, staff, and the general public. A modern system will also facilitate enterprise-wide integration and data sharing with systems supporting the Electronic Health Records Management (EHRM), National Radiology Program (NRP) and NHPP programs.

VHA requires a vendor to furnish and install an enterprise Radiopharmaceutical Inventory for Nuclear Medicine Solution and services. The proposed Radiopharmaceutical Inventory for Nuclear Medicine System will enable nuclear medicine technologists, radiologists and nuclear medicine physicians, radiation safety officers, and clinical staff to better manage the VHA radiation safety programs in Nuclear Medicine. This effort requires Contractor services to furnish and install an enterprise RAIN Solution and maintenance services. The VA requires a solution that provides accurate data to improve auditing and patient care. Additionally, VA requires a modern RAIN system in support of EHRM efforts. The Enterprise RAIN project will allow for standardization of VA Nuclear Medicine services and oversight/analytics capabilities for the NRP and NHPP. The current environment of the non-standardized procurement and deployment of RAIN systems throughout the VA prevents the capture and analysis of data on a national level.

Currently, reporting is disparate and there is no single source to gather enterprise level reports for NHPP and NRPP for compliance, review, and auditing measures. In order to develop a national report, each site would need to run a local report and send it to the national program office. There are many risks and flaws with this process. Primarily, there are still some VAs that have paper process or software systems on stand-alone systems. They have no effective way to compile and transmit a report or guarantee that they are all pulling the data in the same way. This could lead to inconsistencies with the data presented and analyzed on the national level.

The Period of Performance shall be one 12-month base period, with four 12-month option periods for service along with optional tasks for Federal Electronic Health Record Transition Services, additional training, and additional sites. The overall Period of Performance shall not exceed 60 months.

It is expected that the full enterprise installation to all 135 sites will take at least three years to install with an additional two years to complete the EHRM integration.

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 (FAR) Overhaul (RFO) FAR VA Deviation Subpart 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: BioDose/NMIS is the only commercially available product that meets VA’s minimum requirements for an enterprise-wide RAIN system. Mystic Ventures is the only authorized reseller of BioDose/NMIS to the government.

The new national system will allow for national reports to be pulled in the same manner across all sites from a central office staff member. This will ensure that all data is able to be collected and that it is gathered in the same way to prevent inaccuracies. Failure to install an enterprise RAIN solution will result in not having patient demographics transferred to and from the EHR, Electronic Healthcare Record. This introduces a significant risk to patient care if the wrong patient is identified because their appointment and patient information is not transferred to the RAIN solution. Additionally, a lack of an enterprise system removes the ability for NRP and NHPP to seamlessly perform audits and pull reports across the enterprise.

Any service or maintenance performed by a third-party vendor, other than Mystic Field Service Technician Affiliates, would render null and void any existing warranty and be unsupported by Mystic.

Failure to award to the sole authorized source would either (a) preclude VA from acquiring the only product on the market that meets its requirements, or

(b) result in an unwarranted and unsupported deployment, neither of which is acceptable for a system that directly affects patient safety, radiation dose tracking, and NRC regulatory compliance across the VA enterprise.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition.

7. Actions to Increase Competition: 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: The Government’s technical experts conducted market research from September 2025 through February 2026 to ascertain the ability of vendors in the Radiopharmaceutical Systems market to meet the VA’s requirements.

Specifically, the Government’s technical experts interviewed knowledgeable individuals in the industry and Government. The Government's technical experts also reviewed similar vendors and products that could potentially meet the RAIN requirement, including Siemens, Hermes Medical Solutions, Sun Nuclear, and LabLogic Systems. Capability statements were requested from each, and none were able to provide a solution meeting VA's enterprise requirements. Siemens provides imaging equipment and post-processing software but does not offer a radiopharmaceutical inventory management system. Hermes Medical Solutions delivers nuclear medicine image processing and dosimetry software centered on post-acquisition image analysis, rather than radiopharmaceutical inventory, ordering, or lifecycle tracking from acceptance through disposal. Sun Nuclear provides radiation therapy quality assurance and patient dosimetry products, but does not offer a nuclear medicine radiopharmaceutical inventory solution. LabLogic Systems offers nuclear medicine software, but its product does not meet VA's enterprise scalability, centralized national reporting, and EHRM integration requirements.

Additionally, in November 2026 a Request for Information (RFI) was posted to SAM.gov resulting in one (1) one response from Mystic Ventures Group LLC (Mystic). VA’s technical experts reviewed the RFI response and determined it to meet the RAIN solution requirements. Mystic Ventures Group was determined to be a certified Service-Disabled Veteran Owned Small Business (SDVOSB) via use of the Veteran Small Business Certification (VetCert) database.. Market research was also conducted by utilizing the National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Governmentwide Acquisition Contract (GWAC) Find Provider Tool and the General Servies Administration (GSA) Multiple Award Schedule (MAS) eLibrary. The Find Provider Tool and eLibrary did not show Mystic to hold a basic contract on either. Based on the market research results, it is determined that no other vendor could meet the requirements and this will be issued on a sole source basis to Mystic.

Historically, there were three vendors that sold commercial-off-the-shelf (COTS) solutions that would meet the VA’s needs. However, one vendor, Mirion, has purchased the competition and there is currently only one vendor that provides a solution, BioDose/NMIS, to meet VA’s requirements. Mystic Ventures is the authorized SDVOSB reseller of this product.

On May 15, 2026, Mystic states the company is the exclusive end provider of BioDose/NMIS software and services and the sole company capable of performing installation and maintenance services. Because Mystic is the sole authorized reseller of BioDose/NMIS, no other vendor can provide the required solution.

9. Other Facts: None