Brand_Name_Justification_Letter_Signed_Redacted.pdf

Single Source Justification (Simplified Acquisition)

20 Apr 2017 Page 1 of 1

Section A: General Contract Information

Contracting Activity: 60th Contracting Squadron

Project/Program Name: Galil Visual-ICE Cryoablation System

Section B: Description of the Supplies/Services Required

The Galil Visual-ICE Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The product uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Tumor ablation is achieved by repeated freeze and thaw cycles with both freezing and thawing contributing to cell death. Generally, multiple freeze-thaw cycles are used to achieve complete destruction of the target tissue. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of a heating element inside the cryoablation needle which can be energized to cause thawing. The system also controls the heating element inside the needles to provide active helium-free thawing and track cauterizing.

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

The Galil Visual-ICE Cyroablation System is the only cryoablation system on the market which provides post-freeze track ablation/cauterization. By capitalizing on this technology, the physician is able to significantly reduce the risk of bleeding/ hemorrhaging while removing the needles. Bleeding/hemorrhaging is one of the greatest risk associated with cryoablation and by reducing this risk, we provide our cancer patients with the level of care that is expected at a high reliability institution.

Without bleeding, the patient is released approximately 2-4 hours post-procedure. However, if bleeding/hemorrhaging occurs, the patient will likely be admitted to the intensive care unit in the facility, resulting in deterioration in health as well as additional health-care associated cost/man hours.

Section D: Efforts to Obtain Competition

There are no similar items on the market.

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

Extensive market research will be performed for future requirements.

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 Typed Name and Rank/Grade of Contracting Officer

Dantzler, Jennifer, MSgt

Signature of Contracting Officer

DANTZLER.JENNIFER.RENEE.

1027952026

Digitally signed by

DANTZLER.JENNIFER.RENEE.1027952026

Date: 2018.01.12 08:39:44 -08'00'