P03 JNA 499-B59040 Signed.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 23, Minneapolis, MN VAHCS 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-0022 as awarded to Philips.

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

This request is for upgrade of the existing Philips Epiq 7 ultrasound systems for 12 units that have reached their end-of-life cycle. The Philips EPIQ Elite advanced for general imaging is a premium diagnostic ultrasound system featuring an uncompromised level of clinical performance and the latest diagnostic applications and clinical packages. It offers Multi-Modality Query Retrieve that allows for the viewing of DICOM CT, Mammography, NM, MRI and ultrasound images and can be reviewed while live imaging. It also offers NetLink/DICOM 3.0 provides network print and store, commit, modality worklist, DICOM Query and Retrieve, and structured reporting for adult and pediatric echo, vascular, and OB/GYN. The upgrade will include hardware and software, required to bring the entire system to conformance.

The total estimated value is $ 983,248.62.

(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-0022. The equipment was originally procured in FY2015-2017, utilizing full competition via the February Consolidation. The items were subsequently procured under Delivery Order Number VA797H-15-J-0183, VA797A-17-J-0689, VA797A-17-J-0697, VA797A-17-J-0694, VA797A-17-J-0691, VA797A- 17-J-0696, VA797A-17-J-0698, VA797A-17-J-0699, VA797A-17-J-0700, VA797A-17-J-0693, VA797A-17-J-0701, VA797A-17-J-0690. This upgrade will provide current technology without requiring additional specialized site preparation.

The original equipment manufacturer (OEM), Philips, 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. The OEM is the only organization capable of owning trade information about the system and as such is the only one qualified to provide and perform the upgrade, with the expectation that the systems will continue operating as expected in a safe manner.

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(5) A determination by the Contracting Officer is that the anticipated cost to the Government will be fair and reasonable. Philips Healthcare IDIQ contract VA797H-17-D-0022.

All items are currently on Philips Healthcare DIQ Contract No. VA797H-17-D-0022. 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 steps to remove or overcome any barriers that led to the exception of fair opportunity before any subsequent acquisition of 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 required activity 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 has 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 required 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 logical follow-on on FAR exception 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.

Digitally signed by COLEMAN MCCARTHY Date: 2025.07.07 09:13:35 -05'00'

Coleman McCarthy Date Biomedical Engineer, Healthcare Technology Management

VISN 23

CONTRACTING OFFICER CERTIFICATION:

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

Ann English VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division

Regina Blair Chief HTME Ordering Division/Chief HTME Contracting 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.

Joy M. Smith Head Contracting Activity Strategic Acquisition Center and National Acquisition Center

COLEMAN MCCARTHY