7A20--Radformation Software Subscription - Notice of Intent to Sole Source

This is a notice of intent to award a sole source contract and is not a request for quotes. The Department of Veterans Affairs on behalf of NJ VA Medical Center, intend to award a Firm Fixed Price (FFP), sole source action to Name and Contractor Radformation, Inc. Street Address: 261 Madison Ave 9th Floor City, State, Zip: New York, NY 10016 The objective of this action is to provide Radformation Oncology Software Subscription, detailed below, for existing software needed. In accordance with FAR Part 13.106-1(b), it has been determined that only one source is reasonably available due to the requirement for compatibility and therefore limits this requirement to a brand name only procurement. This notice of intent to sole source with justification for brand name only satisfies the public posting requirements of FAR 13.501. Market research was conducted in accordance with FAR part 10; Radformation, Inc. as the manufacturer and has identified themselves as the only vendor authorized to provide this specific Oncology Software Subscription and has expressed interested in fulfilling this requirement. Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer s intended distribution channels. This notice is not a request for quotes; however, all responsible sources may submit a capability statement which shall be considered by the Government. All capability statements must be received by no later than 10:00AM Eastern Standard Time on July 27, 2026. Responses to be submitted to Patricia Tolini, Contracting Officer at patricia.tolini@va.gov. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Statement of Work Radformation Software Subscription Objective The purpose of the Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded Contractor for the provision, installation, integration, upgrade, and implementation of the Radformation software subscription services. This document outlines the technical specifications and services requested by the NJ VA Medical Center for consideration of the purchase of Radformation Software. Background/Justification The NJ VA Medical Center is requesting the purchase of Radformation Software subscription to enhance safety, quality processes, automation, and standardization of patient-specific organ contouring, second check programming, and streamlined documentation for the Radiation Oncology Service. 1. Improved Safety and Quality Radformation s tools automate repetitive and complex tasks, acting as a safety net to prevent human error, which is especially critical in complex treatment planning and quality assurance (QA). Automated plan evaluation: ClearCheck is a one-click tool that automates comprehensive plan checks against departmental standards and clinical guidelines (such as the American Association of Physicists in Medicine (AAPM) TG-275), ensuring consistency and catching errors such as improper dose constraints, small field openings, or potential collisions. Comprehensive QA Management: RadMachine consolidates all machine QA data, from daily linac checks to diagnostic equipment QA, into a single, centralized platform. It sends automated alerts for failed tests and creates detailed reports, ensuring regulatory compliance and freeing up physicists time. Independent Dose Verification: ClearCalc performs fast, independent secondary dose calculations. . This provides an additional layer of verification for treatment plans and increases confidence in accuracy. 2. Increased efficiency and automation The software automates time-consuming tasks, streamlining workflows from planning to billing and freeing up clinical staff to focus on higher-level patient care. Shorter Planning Time: EZFluence automates 3D treatment planning, which can reduce planning time from hours to minutes, even for complex cases. Faster, AI-driven contouring: AutoContour uses deep learning to generate high-quality, review-ready contours for organs-at-risk and target volumes in seconds, saving significant time for dosimetrists and physicians. Efficient Chart Rounds: The Chart rounds module in Clear Check organizes all pertinent patient information, allowing for faster and more streamlined interdisciplinary reviews. Streamlined billing: QuickCode automates billing QA by instantly auditing procedure codes captured in the oncology information system (OIS). This helps prevent missing or incorrect charges and ensures compliance. 3. Enhanced collaboration and standardization By unifying workflows and data on a single platform, Radformation improves communication and standardizes practices across a department or entire network of clinics. Centralized QA and data: RadMachine centralizes QC data across multiple sites and equipment, ensuring a standardized QA process and providing an at-a-glance view of machine performance Improved team communication: With all plan review data available in one place, ClearCheck fosters more effective communication between physicians, dosimetrists, and physicists. This leads to more collaborative decision-making and fewer planning iterations. Vendor-neutral flexibility: Many Radformation products are designed to be vendor-neutral and integrate seamlessly with various treatment planning systems. This allows clinics to standardize their workflows even when using equipment from different manufacturer Project Management / Equipment Implementation Product delivery will be the responsibility of the NJ VA Medical Center project management Point of Contact (POC), and the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices. The Contractor is responsible for the set-up of the equipment; However, the VA Staff in Healthcare Technology Management (HTM) is responsible for connecting the equipment to the VA network. Equipment Specifications All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements for allowable operating system platforms. Auto Contour Product type: AI-driven automated contouring software. Key features: Generates contours for over 290 common anatomical structures in seconds. Uses deep learning to create accurate, clinically validated contours. Supports rigid and deformable image registration. Integrates with DICOM-compliant systems. Has models for multiple modalities, including CT and MR images. System integration: Works seamlessly with most treatment planning and imaging systems, including specific integrations with Varian Eclipse . Regulatory clearance: Holds multiple regulatory clearances, including FDA 510(k) and MDR CE Mark. Clear Check Product type: Automated plan evaluation software. Key features: Performs over 90 automated plan checks. Checks a variety of constraints, including dose, volume, homogeneity, and conformity. Automates documentation and reporting. Features collision checks using customizable LINAC models. System integration: Fully integrated with Varian Eclipse and ARIA, with API options for other applications. ClearCalc Product type: Independent calculation software. Key features: Validates treatment plan accuracy with independent dose calculations. Supports multiple modalities, including photons, electrons, and brachytherapy. Offers various algorithms, from FSPB to the more advanced Raystation. System integration: Part of the Radformation suite and can integrate with Clear Check for reporting. Software / License: The preventative maintenance and repair services shall be completed by the OEM certified service personnel if the NJ VA Medical Center agrees to pay for a Full-Service/Maintenance program. This Software License Agreement (the "Agreement"), by and between the entity ("Customer") named in the Radformation Quote (the "Quote") or electronically agreeing to this Agreement, and Radformation, Inc., a Delaware corporation ("Radformation"), is effective as of the date set forth in the first Quote between Customer and Radformation (the "Effective Date"). In consideration of Radformation s engagement hereunder to provide the Software described in the Quote, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree to the following terms and conditions: Grant of License; Ownership. 2.1. Grant. Radformation hereby grants to Customer a non-exclusive, non-transferable, non-sublicensable, license during the Term to use the Software and Documentation for the Authorized Purpose (the "License"), subject to the terms and conditions of this Agreement. 2.2. Permitted Uses. The License grants Customer the right to: (a) install a single copy, in object code form, of those components of the Software and the Documentation provided on an installed basis, on one or more Licensed Servers (not exceeding the Maximum Number of Licensed Servers). (b) allow Authorized Users (not exceeding the Maximum Number of Concurrent Users, Licensed Delivery Systems, or Licensed Diagnostic Systems) to access and use the Software and Documentation solely for the Authorized Purpose. (c) make one copy of any installed Software and one copy of the Documentation solely for archival purposes, provided that: (i) Customer shall not, and shall not allow any Person to, install or use such copies of the Software unless (and only for so long as) the previously installed Software and Documentation are inoperable and have been uninstalled and deleted; and (ii) all copies of the Software or Documentation made by the Customer include all trademark, copyright, patent, and other Intellectual Property Rights notices contained in the original. All such copies shall be the exclusive property of Radformation, will be subject to the terms and conditions of this Agreement. 2.3. Restrictions. Customer will not, and will not permit any Person to: (a) use the Software or Documentation for any purpose other than the Authorized Purpose or in connection with more than the Maximum Numbers set forth in the applicable Quote; (b) modify, translate, adapt, or otherwise create derivative works or improvements or modification to the Software or Documentation or any part thereof; (c) combine the Software or any part thereof with, or incorporate the Software or any part thereof in, any other programs; (d) reverse engineer, disassemble, decompile, decode, or otherwise attempt to derive or gain access to the source code of the Software or any part thereof, or attempt to do so; (e) remove, delete, alter, or obscure any trademarks or any notices of Radformation s Intellectual Property Rights provided on or with the Software or Documentation; (f) remove, disable, circumvent, or otherwise create or implement any workaround to any copy protection or other security features that the Software may contain, or attempt to do so; (g) except as expressly set forth in Section 2.2, copy the Software or Documentation, in whole or in part; or (h) use the Software or Documentation in violation of any applicable law, regulation, or rule, including without limitation HIPAA. 2.4. Ownership; No Other Rights. As between Radformation and Customer, Radformation owns and shall retain all title and ownership to the Software, the Documentation, and any copies thereof in any form, and all Intellectual Property Rights therein. The Parties acknowledge and agree that this Agreement is a license to use, and not a sale, or contract of sale, for the Software and Documentation. Apart from the limited license rights expressly granted in this Agreement, Customer does not receive any ownership, license or other interest in the Software or the Documentation or any portion thereof, all of which are reserved by Radformation. Customer will promptly notify Radformation if Customer becomes aware of any unauthorized use of the Software or other infringement of Radformation s Intellectual Property Rights and fully cooperate with Radformation, at Radformation s expense, in any legal action taken by Radformation to enforce its Intellectual Property Rights. 2.5. Delivery. Unless otherwise specified in the Quote, Radformation shall deliver the Documentation and those Software components to be installed to Customer for installation by Customer on Licensed Servers. 2.6. Trial Use. If Customer receives the right for a Trial Use of any Software the following terms of this Agreement shall not apply to any Trial Use during the period of the Trial Use specified in the applicable Quote: Section 4.1 (Warranty); Section 5 (Support); Section 9.2 (Radformation Indemnification). SOFTWARE PROVIDED ON A TRIAL USE IS PROVIDED ON AN AS-IS AND AS AVAILABLE BASIS, AND RADFORMATION EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHER (INCLUDING ALL WARRANTIES ARISING FROM COURSE OF DEALING, USAGE, OR TRADE PRACTICE), AND SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, AVAILABILITY, UNINTERRUPTED USE, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. If Customer subsequently converts to a non-Trial Use, this Section 2.6 will no longer apply after the end of the Trial Use period. Use of Software and Documentation 3.1. Verification Required Before Use. Customer acknowledges and agrees it is Customer's responsibility to verify or validate the Software for Customer's use, and that Customer is not relying on Radformation to do so. Customer covenants, as a material term of this Agreement, that before using the Software in connection with diagnosis, treatment planning, providing medical treatment of or to any patient, or any other clinical use, Customer will: (i) run the Software's self-verification and validation process ("Self-Verification"), if any. (ii) perform independent verification and validation, in accordance with the verification and validation processes standard within the radiation therapy and diagnostic field ("Independent Verification"). (iii) Disclose the results of Self-Verification to Radformation and confirm that Customer has performed Independent Verification; and (iv) Determine to Customer's reasonable satisfaction that the Software performs accurately. The above requirement for Self-Verification and Independent Verification must be performed once after installation of the Software and once after installation of each Update provided by Radformation that affects the capabilities and features of the Software that relates to the Authorized Use. 3.2. Customer's Responsibility for Use of Software. Customer is solely responsible and liable for all uses of the Software and Documentation by Customer or any Person obtaining access to the Software or Documentation through Customer. Without limiting the generality of the foregoing: (a) Customer is solely responsible for all diagnoses, treatment plans, and treatments (as well as decisions not to provide treatments) that are developed or performed in connection with use of the Software and/or Documentation. Customer acknowledges and agrees that it is and shall be Customer's obligation to verify the accuracy and applicability for each patient, in each instance, of any treatment plan, treatments or diagnoses made using the Software and/or Documentation, and in general to determine the suitability of the Software and Documentation for Customer's intended use. (b) Customer shall notify Radformation in writing of any material defect Customer believes exists in the Software or Documentation and promptly provide to Radformation all information known or reasonably available to Customer regarding the alleged defect. (c) Customer shall be solely responsible for the supervision, management, and control of its use of the Software, including, but not limited to (a) assuring proper configuration of equipment or devices; (b) establishing adequate operating methods; and (c) implementing procedures sufficient to satisfy its obligations for security under this Agreement, including appropriate action between it and its employees to prevent misuse, unauthorized copying, modification, or disclosure of the Software. (d) With respect to all computer programs and data and hardware not provided by Radformation and to be used or reproduced during Customer's use of the Software, Customer represents that it has all necessary rights to use or reproduce the computer programs and that no use of the Software in connection therewith shall be made that causes an infringement of the right of any Third Party. 3.3. Audit. Radformation may, in Radformation s sole discretion, audit Customer's use of the Software to ensure Customer's compliance with this Agreement, provided that any such audit shall be conducted with at least fifteen (15) days' prior notice, during regular business hours, not more than once annually, and shall not unreasonably interfere with Licensee's business activities. Software Support; Updates 5.1. Software Support. (a) During the Term, Radformation will provide Basic Support as set forth in Exhibit A at no additional charge to Customer. In the event Customer requires support or maintenance services beyond Basic Support, Customer may request Special Support, the terms of which, including any applicable fees, will be agreed to in writing between the Parties. (b) After the Initial Term, Radformation may modify the terms of Basic Support or the applicable fees, provided that (i) Radformation notifies Customer of the modification at least sixty (60) days in advance by submitting a new Exhibit A, (ii) the modified Basic Support includes at a minimum telephone and remote support during Standard Hours (as defined in Exhibit A), and (iii) any modifications to Basic Support or the applicable fees do not take effect until the next Renewal Term. 5.2. Updates. From time to time, Radformation may make available to Customer Updates and/or new Releases of the Software. If the original Software was provided on an installed basis, Customer covenants that Customer shall promptly install all such Updates and new Releases promptly upon receiving notice of and access to such Updates and new Releases. Training Provided / Training Materials 5.1. Included Training a. Radformation shall provide educational materials about Radformation s Software on Radformation s website for the Customer to use. b. Radformation shall provide educational videos about Radformation's software on Radformation s website and YouTube for customers to use. c. Radformation should provide educational remote training sessions at no additional cost when purchasing new access to the Software. Installation 1. Contractor s Responsibilities: a. Based on the approved work schedule, the Contractor shall provide all labor necessary to install and configure the requirements of NJ VA Medical Center. b. The Contractor shall receive and place equipment in the pre-arranged designated areas at the NJ VA Medical Center. c. The Contractor shall unpack and install all equipment in the designated area and dispose of all trash. Disposing of the trash is the responsibility of the Contractor. d. Contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure the product is fully operational in accordance with the manufacturer's operating standards. e. Vendor will coordinate all site visits with the Biomed staff at least 24 hours in advance. f. The vendor will provide all technical information needed to network the medical device, including port and protocols necessary to build, as well as any settings required. g. The vendor will provide at least a 1-year manufacturer's warranty on the device from the date of shipment. h. Vendor will assist NJ VA Medical Center with the integration and configuration of the system into VISTA. i. The Contractor is required to provide all tools, labor, and materials to complete the assembly and installation of the items detailed in this document. j. The Contractor shall have an on-site representative for the duration of assembly and installation to serve as the primary interface with the NJ VA Medical Center staff. 2. Medical Center s Responsibilities: a. Providing access to patient care spaces, hallways, and equipment rooms during normal business hours for implementation of the capital equipment/system installation requirements. b. Providing a single point of contact to work with in planning and implementing the services described. c. Assign additional clinical staff during the equipment transitions d. Provide IT resources during testing and go-live e. Responsible for any structural changes (cabinets, desks, etc.). f. The Customer will be responsible for networking the device on the VA network with assistance provided from the vendor as needed. 3. On-site assembly and installation of items and performance of services identified in this document will take place during hours defined as: 0730 to 1500 (i.e., 7:30 am to 3:00 pm ET), Saturday or Sunday, excluding Federal Holidays 4. High-risk clinical areas may require after-hours installation. 5. The NJ VA Medical Center will provide a staging area for the equipment to be staged before deployment. 3. NARA Records Management Language Clause: The following standard items relate to records generated in executing the contract and should be included in a typical contract: 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. NJ VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. Contractor personnel shall sign VA Form 10-0708 Employee Clearance from Indebtedness before resigning or termination from Contractor working for OBVAMC, and the Facility Records Officer must sign the form. A copy of completed, signed VA Form 10-0708 (Contractor personnel and Facility Records Officer signatures) shall be placed in each competency folder. When information, data, documentary material, records, and/or equipment are no longer required, it shall be returned to [Agency] control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval before engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any subcontractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with OBVAMC policy. 8. The Contractor shall not create or maintain any records containing any non-public OBVAMC information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The OBVAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government, for which OBVAC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. TMS (Talent Management System) course VA 10176: VA Privacy and Information Security Awareness and Rules of Behavior (WBT), VA 4192704: Records Management for Everyone [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] 12. Flow-down of requirements to subcontractors: a. The Contractor shall incorporate the substance of this clause, its terms and requirements, including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of the same. b. Violation by a subcontractor of any provision outlined in this clause will be attributed to the Contractor. Delivery Location Contractor shall deliver all equipment to the: VA Facility Name: NJ VA Medical Center Address: 385 Tremont Ave City, State, Zip code: East Orange, NJ 07018