Justification and Approval - AGFA - Redacted.pdf

AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution’s core technology, database structure, and application logic are owned by AGFA. The AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution requires the VA to procure specialized support, security, and technical integration for the reasons specified below:

Exclusive Vendor Support and Training: AGFA does not authorize third-party companies to support their systems. The maintenance, technical support, and system-level access required to manage these servers are restricted to AGFA, ensuring that only certified personnel work on the technology.

Complex, Integrated Ecosystem: AGFA servers and operating systems are heavily customized, closed-loop environments rather than generic, open-source platforms, and they use proprietary grid computing technology to manage real-time imaging data.

Only Source Requirement: Due to the specialized nature of the software, servers, and operating system, AGFA is listed as the only source for the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution support, meaning that alternative vendors do not possess the necessary training or access to provide support/maintenance for their solution infrastructure.

System Integrity and Data Security: The proprietary design ensures that the high volume of archived data (sometimes over 247 terabytes) remains secure and that the system components, such as workstations, scanners, and servers, function specifically with each other without interference from uncertified software, maintenance, or hardware.

The AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution is critical for the VA because it provides real-time, enterprise-wide radiation dose monitoring, and it is considered irreplaceable due to its ability to aggregate data across multiple, diverse, and legacy imaging systems, eliminating the need for manual, site-specific reporting, and offering specialized, high-accuracy dosimetry for patients. More importantly, putting AGFA software on a new operating system and servers would not be feasible option for the VA due to dependencies on existing technology, strict hardware licensing, and specialized, low-level drivers that are not designed for modern operating system security standards. AGFA frequently stops releasing updated drivers when a new operating system is released, particularly for older scanners or imaging digitizers such as those used by the VA. Existing AGFA software often requires Kernel-type drivers, which have newer operating systems (like Windows 10/11) block to improve system security and stability.

The AGFA infrastructure, servers, and other imaging software throughout VA use USB security dongles (license keys). If a user attempts to move to a new workstation, they may find the license is locked to the original machine or that the dongle is "retired" and cannot be activated on new hardware. AGFA servers, particularly those used in their radiology Picture Archiving and Communication System (PACS) and imaging solutions (like IMPAX), are considered proprietary because they are designed as closed systems where only AGFA-authorized personnel, software, and hardware can fully support and interact with the technology. Also, the server software is tightly coupled with specific, certified workstation hardware that has been uniquely configured by AGFA.

There are 27 VAMC’s currently using the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution. AGFA is the only distributor that maintains a Memorandum of Understanding/Interconnection Security Agreement with the VA, which significantly improves remote system access, security, and efficiency during the implementation and support of the application. No other brand name software solution can integrate or will be interoperable or compatible with the current AGFA software solution, servers, and operating system. Specifically, the current AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution communicates through source code that is based on AGFA proprietary data. The VA currently utilizes the AGFA DoseMonitor and REM Registry - Enterprise Dose Management solution and has a dose tracking contract involving AGFA DoseMonitor that has been in place since 2021. This existing product provides the VA with dose tracking and software capabilities that are installed on a VLAN located in the Cleveland data center. The initial contract provided Dose Aggregation to Cleveland and ten (10) Sites. As part of a VA Innovator’s Network (iNET) initiative, sixteen (16) additional sites were added, and the VA REM Registry was developed and based in the Cleveland VA data center. The AGFA DoseMonitor and REM Registry – Enterprise Dose Management contract aggregates patient dose tracking for 27 VAMCs. Dose Aggregation and REM Registry require enterprise dose management to provide the means for vendor agnostic dose tracking of these VAMCs. The resulting AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management software licenses will provide a platform to integrate Dose Aggregation and REM Registry within the Oracle Cerner electronic health record. No other software can provide this communication capability without the OEM’s source code.

Additionally, only AFGA can provide the necessary maintenance support as it is the only source able to maintain the propriety source code required for software updates, security patches, bug fixes, and technical support. No other firm currently has the capability of developing and issuing software maintenance support for the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management software due to their inability to be interoperable and compatible with the software.

The VA needs these software licenses and maintenance because they are currently the only software licenses and maintenance that are interoperable and compatible with the current AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution. If the VA were to purchase new software licenses and maintenance support, the VA would then need to purchase a new operating system and servers. Transitioning to a different vendor would necessitate replacing and reconfiguring VAMC server integrations, incurring costs exceeding . Failure to procure the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution would result in the discontinuation of the REM Registry, as a new software solution would not be compatible or interoperable with the existing AGFA solution, thereby diminishing the VA's capacity to monitor and optimize radiation exposure, which would adversely affect Veteran health. Additionally, a new Enterprise

Dose Management system would require significant duplication of time and costs required to redevelop, reconfigure, and implement any alternative. Ultimately, if the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management software licenses and maintenance support are not purchased, the VA will experience significant disruptions in diagnostic imaging services since AGFA’s imaging equipment is proprietary, and the company provides critical software updates, patches, and information security certifications. A loss of maintenance support could lead to security vulnerabilities and software failures. Moreover, consolidating data from across the VA has significantly advanced the VA’s ability to optimize radiation doses, and the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution serves as a valuable resource when assessing cases involving higher radiation exposure.

6. Efforts to Obtain Competition: Recent market research conducted, detailed in paragraph eight of this document, has confirmed that no additional sources have emerged that can meet the Government’s requirements without the need for multiple procurements or an undetermined amount of customization to one or more commercial products. There is no competition anticipated for this acquisition. Procurement data does not include any unnecessary requirements that may inhibit competition. The solicitation will be made publicly available, along with this justification in accordance with FAR 6.301(b)(2) and 5.201(c)(3). Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.101. Any quotes received shall be evaluated. The Request for Quotation will be sent to AGFA directly via email.

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 competition in future actions.

8. Market Research: The Government’s technical experts conducted market research in October 2025 by interacting with other VAMCs, Veterans Integrated Service Networks (VISN) and the VHA National Health Physics Program. Similar products researched were Ignyte Group, ProAqCT, and Radimetrics. These products could not meet VA’s need due to not being compatible with the current AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution.

Ignyte Group: AGFA integrates DoseMonitor with its existing Picture Archiving and Communication System (PACS), whereas Ignyte (Change Healthcare) provides a browser-based solution that is not currently compatible with the existing AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution, differing primarily in vendor focus and integration approach, with AGFA offering its own dose management tools.

ProAqCT: AGFA’s solution integrates with their broader enterprise imaging platform and uses PACSHealth's DoseMonitor product for data acquisition and analytics.

Conversely, ProAqCT is a standalone solution that uniquely incorporates automated image quality monitoring alongside dose tracking and would require significant customization, configuration, and transition costs to implement if the VA were to switch from AGFA’s proprietary software solution.

Radimetrics: While the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution emphasizes its interoperability and data integration capabilities within existing workflows, Radimetrics, for effective implementation, would require a robust validation process and a multidisciplinary team to ensure accuracy and reliability of data collection which would then require significant interoperability/transition costs if the VA were to switch from AGFA’s proprietary software solution.

Any new product’s server and data solution would have to be aggregated, sorted, and plugged into a new system, and the data could not be pushed together without having to rebuild. Furthermore, the current AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution communicates through a source code that is based on AGFA’s proprietary data. Also, discussions with representatives from other VAMCs and VISNs have resulted in a consensus that AGFA is the only authorized and delegated source with assigned authority to distribute and manage the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution.

On January 21, 2026, the Government’s technical expert contacted PACSHEALTH directly, and the company confirmed that AGFA is the only distributor of the AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management solution.

As a result, it was determined that the required AGFA DoseMonitor Aggregation and REM Registry – Enterprise Dose Management software licenses and maintenance must be procured on a sole source basis from AGFA.

9. Other Facts: None.

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.

Fair and Reasonable Cost Determination

I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable compared to historical prices paid for the same or similar items. In addition, prices will be compared to catalog pricing for the software if available.

Finally, if necessary, the proposed pricing will be compared to the Independent Government Cost Estimate.

Contracting Officer Certification/Approval

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