Brand Name JA Clearsight Upgrade.pdf

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Hemosphere Clearsight Upgrade
Solicitation number
FA442724Q0177
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About this file

This document is a Justification for Using a Single Source Below the Simplified Acquisition Threshold (SAT) for the procurement of two ClearSight upgrade kits and associated components for the HemoSphere system at the David Grant Medical Center.

The key details are: The requirement is for two ClearSight upgrade kits, including a HemoSphere module, ClearSight Pressure Controller Kit, Heart Reference Sensor, and compatible software. Due to the proprietary nature of the equipment, only the manufacturer Edwards Lifesciences, or its authorized distributor 1st American Medical Distributors, Inc., can provide the required upgrades. Market research confirmed that there are only these two vendors capable of providing the upgrades. The total estimated contract cost is below the SAT. The Contracting Officer has determined that the circumstances of this acquisition deem only a single source is reasonably available.

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Use of a Single Source Below the Simplified Acquisition Threshold (SAT)

CUI//SP-PROCURE

4 Jan 2021 CUI//SP-PROCURE Page 1 of 2

Section A: General Contract Information

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Contracting Activity: 60 CONS

Project/Program Name: PKB - Information Systems (Hemosphere Clearsight Upgrade)

Purchase Request / Local ID Number:

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

Two ClearSight upgrade kits (HEMCSMUPG including PCCVR) and initial in-service. Each upgrade kit includes one of each of the following:

1. Hemosphere module, model HEMCSM10

2. ClearSight Pressure Controller Kit, model PC2K Pressure Controller Cover, model PCCVR-included with

HEMCSMUPG

3. Heart Reference Sensor, model EVHRS

4. Latest Windows software

Section C: Rationale for Soliciting from a Single Source or Brand Name

Due to the proprietary nature of the equipment, only Edwards Life Sciences manufactured upgrade kits can work with the ClearSight Units at David Grant Medical Center. The only vendors identified to sell and install the required upgrade kits are Edwards Lifesciences LLC (manufacturer) or 1st American Medical Distributors, Inc.

Section D: Efforts to Obtain Competition

There is reasonable belief that there will be competition via two vendors for this requirement. A sources sought was posted on SAM.gov and only two sources responded confirming their ability to provide the product, both listed above. No other manufacturer or vendor can upgrade the software for these units.

During market research in FPDS-NG of previous contract actions utilizing "HemoSphere" and "HemoSphere Clearsight" as the requirement description, 30 actions were found. All actions were awarded to Edwards Lifesciences or 1st American Medical Distributors, Inc.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

Due to the proprietary nature of the requirement, the Government has no leverage in precluding this Brand name until the mission partner changes out their equipment.

Use of a Single Source Below the Simplified Acquisition Threshold (SAT)

CUI//SP-PROCURE

4 Jan 2021 CUI//SP-PROCURE Page 2 of 2

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

17-Sep-2024

Typed Name and Rank/Grade of Contracting Officer

MAEKYLA JANE S. ROSENDO, GS-12

Signature of Contracting Officer

ROSENDO.MAEKYLA

JANE.SORIANO.1368765208

Digitally signed by ROSENDO.MAEKYLA

JANE.SORIANO.1368765208

Date: 2024.09.17 16:36:51 -07'00'

File details come from the government source that posted it. Updated .