approved JEFO Over SAT_CO Memorandum_PO 499-B49001.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 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 Omaha NE Department of Veterans Affairs (VA) Medical Center and will be executed by the VA National Acquisition Center, NAC, 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 VA HTME ID/IQ Contract VA797H-17-D-0022 awarded to Philips North America LLC for the Philips XPER Cath Lab Upgrade. The requested purchase is an upgrade from the existing Philips Xper Flex Cardio system to the Philips Xper IM with Hemodynamic system. The current Xper system is at end of life and an upgrade is needed to continue cardiac monitoring. This will include associated hardware upgrades that are affected by the upgrade. The requested software upgrade and associated hardware upgrades are manufactured specifically for the originally requested XPER. There are no other systems with the ability to integrate with the existing Philips Allura FD20 in the Cath Labs, IntelliSpace Cardiovascular (ISCV), VistA, and CPRS.

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

Estimated value: $282,172.63. A fully funded PO/obligation is provided with this request.

Upgrade to the Philips Xper IM with Hemodynamic (hemo) system is $282,172.63. Xper IM with Hemo system is designed to enhance the interventional cardiology workflow and improve communication. Xper IM would allow the clinical staff to be able to continue monitoring all of the patient vital signs, analyze physiological parameters and display calculation results without needing to leave the control room/sterile area. Xper IM provides tools for reporting, scheduling, inventory, and data management. With the Interventional Hemo System, Xper IM can offer advanced hemodynamic measures to the Cath labs such as interactive heart diagrams to aid the clinical team in quickly performing pullbacks and changing pressure labels. The Xper IM is compatible with the interventional systems Omaha has in the Cath Labs – Philips Allura Xper FD20. This system is needed to continue cardiac Cath lab, ablation, and pacemaker/defibrillator procedures since it provides patient hemodynamic monitoring and provides a record of the procedure for both cardiac cath labs. In order to maintain facility interoperability and cross coverage, this upgrade is necessary.

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(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).

Only one such awardee is capable of providing the supplies or services. The manufacturer has released an upgrade. The original equipment manufacturer (OEM), Philips, is the only contractor who can provide the upgrade due to the proprietary nature of the software upgrade. 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 system continues 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.

(6) All items are currently on Philips IDIQ contract VA797H-17-D-0022. All items are priced at or below the contract price, previously determined to be fair and reasonable at the time of contract award. Although there have been changes to the industry and market conditions due to supply chain shortages and inflation, the prices remain stable and consistent with the awarded contract price. Any other facts supporting the justification.

N/A

(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.

At this time, there are no actions that can be taken to remove or overcome barriers that led to the exception to fair opportunity. All future requirements will be addressed on a case-by-case basis.

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

I hereby determine that the anticipated cost/price to the Government for this contract action will be fair and reasonable and that this Justification is accurate and complete to the best of my knowledge and belief.

(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 governments minimum requirements.

(10)A written determination by the approving official that one of the circumstances

3 | P a g e in (b)(2)(i)(A) through (E) 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) because the supplies or services are unique or highly specialized, as Siemens Medical Solutions, USA, Inc. is the only contractor capable of providing their proprietary equip

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.

Date Wendy Reyes VAMC Omaha, NE

VISN 23 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.

James Sullivan Date Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Post Award Division

John Lewandowski Date Chief VA National Acquisition Center – Hines High-Tech Medical Equipment Post Award Division

VHAMINReyesW Typewritten Text 06/05/2024