P03 JEFO FUJIFILM HEALTHCARE 612B59013 LFO 1-13-26 rgb.pdf

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DEPARTMENT OF VETERANS AFFAIRS

Office of Acquisition and Logistics National

Acquisition Center P.O. Box 76

Hines, IL 60141

Justification for an Exception to Fair Opportunity Logical Follow-On

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 VISN 21, VAMC Northern California Healthcare system and will be executed by the Veterans Affairs National Acquisition Center (NAC) located in Hines, Illinois.

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

This activity proposes to issue a sole-source delivery order as a logical follow-on against Indefinite Delivery/Indefinite Quantity (IDIQ) Contract No. VA797H-17-D-0020 as awarded to FujiFilm Healthcare Americas Corp.

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

This request is for the upgrade of the existing FujiFilm Persona RF Premium Plus system to include five (5) additional x-ray detectors. This will include all computer hardware and software in addition to x-ray detecting components.

The total estimated value is $363,520.75

(4) An identification of the exception to fair opportunity (per FAR Subpart 16.507-6(b)(3)) 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).

The resulting delivery order will be issued on a sole-source basis as a logical follow-on to Contract VA797H-17-D-0020. The equipment was originally procured in FY2024, utilizing full competition via the September Consolidation. The items were subsequently procured under Delivery Order Number 36A79725N0329. This upgrade will provide current technology while maintaining components of the original system, without requiring additional specialized site preparation.

The original equipment manufacturer , FujiFIlm Healthcare Americas Corp, is the only contractor who can provide the upgrade and as such is a logical follow-on to the original contract, due to the need to operate with existing OEM’S components and the proprietary nature of the hardware and software.

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The OEM is the only vendor that owns the trade information about the system and is the only one qualified to provide and perform the upgrade, with the expectation that the system continue operating as expected in a safe manner.

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

All items are currently on IDIQ Contract No. VA797H-17-D-0020. Even though there have been increases to the industry and market changes because of the COVID-19 pandemic, the prices under the IDIQ contract remain the same from when they were awarded. The quoted price for each item is at or below the IDIQ not-to- exceed contract price, and the IDIQ contract pricing has been determined fair and reasonable by a contracting officer in accordance with FAR Subpart 15.4.

(6) Any other facts supporting the justification.

This is a medical device which received FDA 510K medical device certification in the specific configuration which the OEM manufactured it. This information is known only to the OEM.

(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 schedule holders.

(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 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’s Biomedical Engineer 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 listed within the above cited FAR Part applies to the order.

Based on the information contained herein, a determination has been made that this requirement meets the FAR exception for logical follow-on since the planned acquisition is a follow on to the original delivery order and the contract holders were given a fair opportunity to be considered for the original delivery order, via competition.

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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.

Prasad Manda Date Chief Biomedical Engineer Northern California Healthcare System, Sacramento VAMC

CONTRACTING OFFICER CERTIFICATION:

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

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

Regina G. Blair Date Chief HTME Ordering Division VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division