Justification and Approval Document_Varian Maintenance_Redacted.docx

CUI

Control Number: JA-FY25-0264

CUI

Control Number:

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division – Southeast (HCD-SE)

2. Nature and/or Description of Action being Approved: This is a request for an individual J&A modified for FAR 13.501 to award a follow-on, sole source, firm-fixed contract to Varian Medical Services, Inc.

3. Description of Supplies/Services: Naval Medical Center Portsmouth (NMCP) has a continuing requirement for non-personal services and maintenance for designated Government-owned Varian Linear Accelerator Radiotherapy Systems hardware and software licensing agreement for associated software. The proposed source is Varian Medical Systems, Inc. (CAGE: 0MAZ9), 3100 Hansen Way, Palo Alto, CA, 94304-1030.

The vendor shall provide unlimited telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, unlimited emergency responses, and remote support (as allowable, via any existing authorized Defense Information Systems Agency (DISA) Business to Business Gateway). Coverage shall be included for all Linear Accelerator Radiotherapy Systems, subsystem components, and assemblies listed in the performance work statement. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The Contractor shall provide all parts, labor, materials, travel, personnel, supervision, and freight for the scheduled (preventive) and unscheduled (corrective) maintenance for all equipment identified in the performance work statement.

The Contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with all US, State, and Local law and regulations, US Navy regulations, instructions, and Joint Commission requirements. The contractor must maintain the system, such that it meets Navy and DHA Cybersecurity requirements.

Total

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Rationale Justifying Use of Authority Cited: Varian Medical Systems, Inc. (Varian) is the OEM of NMC Portsmouth’s TrueBeam Linear Accelerator Radiotherapy System and associated ARIA Oncology Information System and Eclipse Treatment Planning System software. Varian field service engineers directly service the Linear Accelerator; Varian does not authorize any third-party service distributors. Furthermore, Varian has access to technology and software updates required to keep equipment fully functional and to meet all applicable standards and risk mitigation strategy milestones, including Food and Drug Administration (FDA) MedWatch and cybersecurity requirements. Parts and software updates/patches required for repairs are proprietary. Only Varian Medical Systems, Inc. can provide the required services for NMC Portsmouth’s Linear Accelerator Radiotherapy System, in accordance with the OEM recommendations, under a maintenance agreement.

6. Efforts to Obtain Competition: Market research was performed to find as many potential Offerors as practical. A Notice of Intent to Sole Source was published on SAM.gov on 8 May 2025 with responses due by 27 May 2025. No response/capability statements were received. The Market Research Memo and Varian Medical Sole Source Letter dated 5 May 2025 are available for viewing.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: For the reasons set forth in Paragraph 5, DHACA-HCD-SE has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If other potential sources emerge, DHACA-HCD-SE will assess whether competition for future requirements is feasible. J&A 20-00004, dated 24 October 2019, submitted for the current contract N6264520P0002 is available for viewing.

8. Market Research: Market Research was conducted in October 2024 and May 2025. Results from both Market Research Memo’s (MRM) along with acquisition history of prior awards, results of a Notice of Intent to sole source, and a sole source letter received from the vendor were used to make the determination that in order to continue critical non-personal preventive and corrective maintenance services for designated Government-owned Varian Linear Accelerator Radiotherapy Systems hardware and associated software, a sole source to Varian Medical Systems, Inc. would be required. Supporting Documents are available for review.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? No, the legacy contract was a sole source award.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable

b. Additional Information: Defense Logistics Agency (DLA) is working on an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for the procurement of and maintenance service agreements for linear accelerators that DHA Program Executive Officer (PEO) plans to use once available for ordering. Also, once the Varian systems reach end of life NMCP should consider competing the procurement of replacement systems.

10. Interested Sources: To date, no other sources have written to express an interest. A Notice of Intent was published on SAM.gov on 8 May. No responses were received.

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: The Government will use various price analysis techniques to ensure a fair and reasonable price to include comparison of proposed prices to historical prices paid for the same or similar items and comparison of proposed prices with independent Government cost estimate.

14. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

15. Contracting Officer Certification:

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

Review

I have reviewed this justification and find it adequate to support the sole source acquisition.

Concurrence

Approval

Based on the foregoing justification, I hereby approve the procurement of non-personal services for maintenance of designated Government-owned Varian Linear Accelerator Radiotherapy Systems hardware and software licensing agreement with an estimated value of $4,510,000.00 on a sole source basis pursuant to the authority of 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-SE CUI Category: Source Selection Limited Dissemination Control: FED only

Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024