P03-JNA 652B59001-Signed.pdf

1 | P a g e

DEPARTMENT OF VETERAN AFFAIRS

Office of Acquisition and Logistics

National Acquisition Center P.O. Box 76 Hines, IL 60141

Justification for an Exception to Fair Opportunity FAR 16.505(b)(2)(i)(B) – Only one capable source

(1) Identification of the agency and the contracting activity.

This Justification for an Exception to Fair Opportunity is on behalf of the Richmond VA Medical Center, located in Richmond, VA and will be executed by the Department of Veterans Affairs (VA) National Acquisition Center (NAC-36A797) located in Hines, IL.

(2) Nature and/or description of the action being approved.

The activity proposes the issuance of a sole source delivery order against Indefinite Delivery Indefinite Quantity (IDIQ) contract 36H79724D0005 awarded to Varian Medical Systems to acquire RapidArc Additional Licenses and Eclipse Desktops.

(3) A description of the supplies or services required to meet the agency’s needs, including the estimated value.

Richmond VA Medical Center requires Additional Rapid Arc Licenses and Eclipse Desktops for the current Varian Medical Systems Linear Accelerators. Currently, Richmond VA Medical Center has Eclipse calculation (physics and dosimetry) licenses and Eclipse non-calculator (physician workstation) licenses. However, due to increased use of the Eclipse system by

, additional licenses and workstations are needed. The estimated price for this requirement is $379,285.00.

(4) An identification of the exception to fair opportunity (see 16.505(b) (2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualification or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g. in terms of scope, period of performance, or value).

Varian Medical Systems (Varian) is the only manufacturer qualified to provide the required equipment.

Varian’s Additional Licenses and Eclipse workstations are vital as they are uniquely qualified to meet the station’s needs. The technology necessary to manufacture the licenses and workstations is a trade secret and only available from the Original Equipment Manufacturer (OEM), Varian. Moreover, per FDA requirements, the hardware must meet the manufacturer’s bill of materials exactly. As such, only one such awardee, Varian Medical Systems, can provide the required supplies.

In addition, it is imperative to have the safest and most efficient total system to treat patients. Although other linear accelerator companies exist, no other company can seamlessly integrate with the station’s existing equipment while fully meeting the needs of the station. If an alternative vendor is selected, Richmond VA Medical Center would transition to a dual-system environment, necessitating significant negative changes in clinical workflow. In fact, quality, functionality, and synchronization will be dramatically decreased if the station attempted to integrate another manufacturer’s linear accelerator licenses and workstations with the existing Varian equipment. As such, this requirement meets the exception to fair opportunity pursuant to FAR 16.505(b)(2)(i)(B) – Only one capable source.

2 | P a g e

(5) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

All items are currently on the Varian Medical Systems IDIQ contract 36H79724D0005. The contracting officer for the resultant order has determined the prices offered to be fair and reasonable for this justification for an exception to fair opportunity. All items are priced at or below the contract price, which was previously determined fair and reasonable at time of contract award.

(6) Any other facts supporting the justification.

Richmond VA Medical Center utilizes highly specialized linear accelerators to deliver radiotherapy to adequately control disease. The current system must be able to accurately reproduce simulated therapy using Aria and Eclipse software and related hardware. Richmond VA Medical Center currently operates Varian TrueBeam systems integrated with Varian's ARIA and Eclipse software. Eclipse (

) and Aria ), work seamlessly together to streamline the treatment process and integrate with the current Varian linear accelerators.

(7) A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

Future requirements will be handled on a case-by-case basis and all attempts will be made to provide fair opportunity to all contract holders when appropriate.

(8) The contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

By signing this justification, the Contracting Officer hereby certifies that the justifications are accurate and complete to the best of their knowledge.

(9) Evidence that any supporting data that is the responsibility of the technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

The technical information contained in the proposal was reviewed and certified by the facility Biomedical Engineering and clinical end user and determined to meet the Government’s minimum requirements. By signing this justification, the requiring activity hereby certifies that the justification is accurate and complete to the best of their knowledge.

(10) A written determination by the approving official that one of the circumstances in (b)(2)(i)(A) through (F) of this section applies to the order.

Based on the information contained herein, a determination has been made that this requirement meets the exception at FAR 16.505(b)(2)(i)(B) as only one contract holder can provide the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. All awardees were given a fair opportunity to be considered for the original order.

3 | P a g e

CERTIFICATION AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(9), I certify that any supporting data that is my responsibility and which forms a basis for the justification is complete and accurate to the best of my knowledge and belief.

Joshua Brady

Biomedical Engineer

CONTRACTING OFFICER CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(8), I certify that the justification is complete and accurate to the best of my knowledge and belief.

La Torsha Jackson Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division

JOSHUA BRADY Digitally signed by JOSHUA BRADY Date: 2025.05.06 12:09:08 -04'00'

LA TORSHA

JACKSON

Digitally signed by LA

TORSHA JACKSON

Date: 2025.05.06 11:16:54 -05'00'