Justification.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Brand Name Only

Acquisition Plan Action ID: 36C246-20-AP-1206

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Richmond VA Medical

Center, 1201 Broad Rock Blvd., Richmond, VA 23249 | 652-20-3-165-0089

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Hunter Holmes McGuire VA Medical Center is seeking to obtain a brand-name superDimension Navigation System including Illumisite/Fluoroscopic technology. That will aid with their Interventional Pulmonology Lung Cancer Screening Dept. to minimize invasive procedures while accessing difficult-to-reach areas of the lung, aiding in the diagnosis of lung disease. The current endoscopic tools and catheters used at the Richmond VAMC will interface with the Navigation System to help the physician in guiding the tools through the pulmonary tract.

The estimated value of the proposed action is

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The required system will be a unique, all-in-one product that can be used in a variety of procedures such as; deep brain, back surgery, anterior neck, posterior neck, frontal sinus and other ENT surgeries. There are other specific Navigation Systems on the market, but none that provide the versatility of the superDimension Navigation including llumisite/Fluoroscopic technology. This system will reduce the needed amount of equipment and associated costs for maintaining separate navigation systems.

This new Illumisite platform is the only ENB system on the market that has Fluoroscopic Navigation Technology (FN) and continuous navigation all in one. This system directly accounts for CT to body divergence by doing a new local registration over the lesion and then sending that new positional data back to the tower allowing the virtual target to move to the precise lesion location increasing the sampling accuracy.

The Illumisite/Fluoroscopic technology:

• the superDimension™ iLogic™ Navigation System (the “iLogic™ System”) including Fluoroscopic Navigation Technology is a sole source product, manufactured, sold and serviced exclusively by Covidien Sales LLC, a Medtronic company. No division of Covidien Sales LLC, nor any other company, makes or services a similar or competing product.

• the ILLUMISITE™ Navigation System, including Fluoroscopic Navigation Technology is a sole source product, manufactured, sold and serviced exclusively by Covidien Sales LLC, a Medtronic company. No division of Covidien Sales LLC, nor any other company, makes or services a similar or competing product.

4. Description of market research conducted and results or statement why it was not conducted:

On May 05, 2020, researched GSA Advantage for “Navigation System Manufacturers” and “Medical Navigation Systems”, results showed a list of GPS navigation systems. A Global Positioning System,” which in turn is an interconnected system of satellites and receivers that allows for the precise pinpointing of locations anywhere on or directly above the earth does not meet the requirement. Further research was conducted using other sources, such as FPDS showed some past purchases with “superDimension” and “Navigation System”, as keywords.

One result showed a purchase to Asheville VA Medical Center back in August 2019.

On May 05, 2020, I reached out to a Sales representative for COVIDIEN SALES LLC dba SUPER DIMENSION. I asked if there were any SDVOSB/VOSBs or any other small business authorize to distribute their products. They had three (3) SDVOSB, (Veterans’ Healthcare Supply Solutions, Synergy Biomed, and Icon), found on VIP were authorized to distribute Medtronic products and can meet the requirement. He also provided a sole source letter to the superDimension Navigation System with the Illumisite/Fluoroscopic technology, that it is only available via manufacturer Medtronic and is a sole source product, manufactured, sold and serviced exclusively by Medtronic.

Sources Sought 36C24620Q0320 was posted on May 11, 2020 to May 14, 2020 with three

(3) SDVOSB replies. Veterans’ Healthcare Supply Solutions, Synergy Biomed, and Icon with capabilities of fulfilling the Richmond VAMC standardize requirement for this Super Dimension Navigation System Including Illumisite/Fluoroscopic technology. The NMR does not apply. A class waiver does exist for NAICS Code 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing allowing the requirement to be set-aside for SD/VOSB and/or SB’s. The Contracting Officer has determined it would benefit the government to solicit as Brand Name Only, Firm-Fixed Price, Open Market, SDVOSB set-aside.