Justifcation for an Exception to Fair Opportunity Only One Capable Source 36A79726N0192.pdf

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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 – ONLY ONE CAPABLE SOURCE

(Implements the provisions and authorities of VA Class Deviation, modeled FAR 16.507-6, “Exceptions to fair opportunity”)

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

This Justification for an Exception to Fair Opportunity is on behalf of the Central Virginia VA Medical Center, located in Richmond, VA, executed by the Veterans Affairs National Acquisition Center located in Hines, Illinois.

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

The activity proposes the issuance of a sole-source delivery order against VA High Tech Medical Equipment (HTME) ID/IQ Contract No. awarded to GE Precision Healthcare LLC. The proposed delivery order is to acquire a ring upgrade from 3 to 5 rings for the Discovery MI PET/CT currently being used at Richmond.

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

The Medical Center requires an upgrade to their GE Discovery MI PET/CT system. To meet the need to upgrade the current Discovery MI PET/CT system from 3 rings to 5 rings at Richmond VA, a specialized set of supplies and services, is essential. The required components include additional PET detector rings with accompanying detector modules and protective enclosures, as well as specialized mounting hardware, enhanced cooling systems, and high-performance cabling and connectors to ensure seamless integration with the existing setup. Upgraded power supplies, advanced data processing units, and expanded storage solutions are also necessary to handle the increased data volume and maintain system performance. Furthermore, updated firmware, advanced imaging software, calibration phantoms, and diagnostic tools are required to ensure optimal functionality and accuracy. Professional installation services and staff training are critical to ensure proper implementation and use of the upgraded system.

Purchase Order No. 652B59012 Estimated Cost: $1,008,011.00

(4) An identification of the exception to fair opportunity (per FAR Subpart 16.507-6(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).

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Only one awardee can provide an upgrade to the Discovery MI PET/CT. It is a an FDA regulated medical device that includes proprietary hardware and software that only the OEM, GE Precision Healthcare, can provide. FDA requires compliance with 100% OEM specifications.

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

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, and there have been no significant changes to the industry or market conditions that would result in changes to the reasonableness of the underlying contract prices.

(6) Any other facts supporting the justification.

The GE Discovery MI PET/CT scan is primarily utilized for detecting, diagnosing, and monitoring various medical conditions, including cancers, cardiovascular diseases, and neurological disorders.

By combining the metabolic insights from PET with the detailed anatomical images from CT, Healthcare providers can achieve more precise diagnoses and tailor treatment plans effectively.

Transitioning from a 3-ring to a 5-ring PET/CT system enhances the scan quality and efficiency, offering several benefits. The 5-ring system expands the axial field of view, leading to faster imaging times and reduced patient exposure to radiation. Additionally, it provides higher resolution images, which improves the accuracy of detecting and characterizing lesions. This advanced technology supports better patient outcomes by enabling earlier diagnosis and more effective monitoring of treatment responses.

(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 of the supplies or services is made.

All prospective delivery orders are completed by all contract holders. Once an order is placed for proprietary equipment, it is generally not possible to compete follow-on acquisitions for upgrades because the system to be upgraded is proprietary in nature. 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 justification is accurate and complete to the best of their knowledge.

(9) Evidence that any supporting data 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.

By signing this justification, the Facility Biomedical Engineer hereby certifies that the justification is accurate and complete to the best of their knowledge.

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(10) A written determination by the approving official that one of the circumstances within the above cited FAR Part applies to the order.

In consideration of the information contained herein, a determination has been made that this requirement meets the FAR exception, “Only One Capable Source.”

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CERTIFICATION AND APPROVAL

(Pursuant to the approval authorities of VA Class Deviation, modeled FAR 16.507-6 (e)(2), “Exceptions to fair opportunity”)

TECHNICAL/REQUIREMENTS CERTIFICATION:

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.

Sanghoon Oh Date Chief Biomedical Engineer Richmond, VAMC

CONTRACTING OFFICER CERTIFICATION:

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

Date

Date

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

Chief HTME Ordering Division VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division

COMPETITION ADVOCATE APPROVAL:

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

Date Head of Contracting Activity

12/22/2025

SANGHOON OH

Digitally signed by SANGHOON

OH

Date: 2025.12.22 07:21:59 -05'00'

1/5/2026ALAINA ANTHONY Digitally signed by ALAINA ANTHONY Date: 2026.01.05 08:32:10 -06'00'

1/6/2026REGINA BLAIR

Digitally signed by REGINA

BLAIR

Date: 2026.01.06 11:23:02 -06'00'

JOY SMITH Digitally signed by JOY SMITH Date: 2026.01.21 15:19:03 -05'00' 1/21/26