JA Varian SSA - 12.20.2024 Signature - Redacted.pdf

CONTROL NUMBER VA-24-00080875

JUSTIFICATION FOR A SOLE SOURCE AWARD

FOR CERTAIN COMMERCIAL ITEMS

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

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 to be issued to Varian Medical Systems, Inc. (Varian) for software, hardware, maintenance, and training support.

3. Description of Supplies or Services:

The proposed action is for Varian Software Support Agreement (SSA) which will allow for upgrades, training, technical support, and a full Varian Eclipse Calculation Workstation refresh for the Saint Louis Veterans Affairs Health Care System Diagnostic Imaging Service. The Saint Louis Veterans Affairs Health Care System currently utilizes the Varian TrueBeam Linear Accelerator (Linac) radiotherapy system with a complimentary Software System for digital oncology, which efficiently manages patient and technical information to enhance operational performance. This Software System includes Varian Aria which is a comprehensive treatment information management system that transfers treatment planning data to the treatment machine for radiation treatment of cancer patients. Aria is essential for entering radiation prescriptions, registering patients, scheduling appointments, uploading documents, and reviewing images and treatment records. The Software System also includes Varian Eclipse which is a radiotherapy treatment planning system used to create treatment plans based on prescribed dose and tumor information.

The period of performance for this proposed action consists of one, 12-month base period and four 12-month option periods. The total estimated value of the proposed action is , which is inclusive of the base and option periods.

4. Statutory Authority:

The statutory authority permitting other than full and open competition is 41 U.S.C.

1903 as implemented by the Federal Acquisition Regulation (FAR) 13.501, entitled “Special Documentation Requirements”.

5. Rationale Supporting Use of Authority Cited Above: The St. Louis VA Health Care System (STLVAHCS) purchased the Varian TrueBeam Linac radiotherapy system in December 2016 for . Due to room modifications, construction requirements, and the Covid-19 pandemic, the installation was delayed until May 2020. The TrueBeam system is a Linac designed for precise cancer treatment

Varian Software Service Agreement VA-24-00080875 techniques with built-in safety features to ensure patient wellbeing. The system is complemented by Eclipse treatment planning software, revolutionizing treatment planning workflows, and ARIA Oncology Information System facilitating clinical and workflow needs. The ARIA system automates cancer staging and toxicity management, while Eclipse software sets new standards in radiation therapy.

Software Service Agreements (SSA) are necessary for upgrades and patches for ARIA and Eclipse software.

When evaluating different linear accelerators such as the TrueBeam Linac system, important considerations include the cost of replacement, maintenance needs, and the availability of software and hardware upgrades for both the Linac system itself and its associated components used for diagnosis, treatment planning, and therapy delivery. The average replacement cost for a new Linac is estimated to cost $4M based on previous acquisition history.

Varian Medical Systems, Inc. is the exclusive manufacturer of the current VA owned TrueBeam Linac equipment that requires maintenance and support at the St. Louis VA Medical Center. The Aria and Eclipse systems, along with their specifications and software, are proprietary to Varian. Only technicians employed by Varian have the authorization to maintain the equipment and software platform at the medical center.

In addition, Varian is the only provider capable of installing software upgrades and firmware patches for their products. These upgrades are essential for keeping up with new safety features, software platform upgrades, and Operating System (OS) upgrades. The service contract includes coverage for these upgrades, as well as the required upgrades for Varian's Linac console computer systems.

Varian's service and support training, procedures, and documentation are proprietary and the intellectual property of Varian. Varian does not provide training to third-party service providers and may terminate a service agreement if parts or labor are purchased from a non-affiliated party.

Therefore, choosing an alternative source for maintenance would require the complete replacement of the entire existing VA owned equipment currently in use at the STLVAMC, due to the unique and customized nature of Varian's products.

This acquisition is necessary in order to keep the VA owned equipment and system updated and compliant. Not upgrading poses a risk of performance issues or outages impacting VA’s ability to provide patient care for Veterans facing potentially life-threatening cancer diseases.

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. Additionally, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201 and the ordering activity will make publicly available the justification along with the solicitation in accordance with FAR 13.501(a)(1)(iv). Any proposals that are received shall be evaluated.

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 December 2023 to November 2024 to determine if other sources could meet the VA's needs. While Elekta, MIM, and RaySearch were identified as potential alternatives, they all would require replacement of the existing VA owned hardware environment, as none of these alternatives could provide replacement parts or support upgrades and patches of the existing software required to run on VA’s hardware. Varian has made it clear that only they can provide and install upgrades and firmware patches for their products. These upgrades are essential to stay current with safety features, software platform upgrades, and operating system updates. Varian's service contracts cover these necessary upgrades, including those for their Linac console computer system, which is integral to the software service agreement. An intent to sole source was issued to SAM.gov 36C24524Q0367 on March 18, 2024, with a deadline to respond to the sole source notice by March 25, 2024. This intent to sole source received (0) vendor replies.

Furthermore, a sources sought notice was posted to the SAM.gov website on May 8, 2024, to identify all sources that can provide all hardware and software support on the currently fielded VA owned Linac and Varian Aria/Eclipse environment. The deadline to respond to the source’s sought notice was May 17,2024. There were 0 responses received from the sources sought notice.

In December 2023 through November 2024, Market research was also conducted in Federal Procurement Data System (FPDS). The results indicate contracts for service for preventive maintenance and software were solely performed through Varian Medical system. Finally, CS confirmed with Varian that they are the only source that can provide the required hardware and software support services and that they do not have any current Government contracts that can be ordered from.

9. Other Facts: N/A

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 sole source, firm-fixed-price contract action in accordance with FAR 13.5, Simplified Acquisition procedures and accordance with 13.501, entitled “Special Documentation Requirements” will be fair and reasonable based on comparison of proposed prices from the IGCE and Market Research provided by the customer. Further price analysis will be conducted, and subsequent negotiations held as necessary. Additionally, price discounts will be sought.

Contracting Officer Certification/Approval

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

Approval

In my role as the procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of the Varian software, hardware, maintenance and training support 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.