P03 SSJ US Vascular_s__Redacted.pdf

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6515--NEW - Vasculab GSX doppler system Notice of intent to sole source
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36C26123Q0957
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This document contains a single source justification for the acquisition of a Vasculab GSX blood flow diagnostic device. The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21 requires this device for vascular surgeons to perform diagnostic imaging and determine decreased blood flow that increases the risk of limb loss. The justification cites the Vasculab as the only system that provides superior diagnostic results, in-depth and accurate vascular images, real-time data to diagnose and treat vascular insufficiency, and the ability to run solely on battery eliminating noise that can interfere with measurements. Market research found no other suppliers through various government databases and confirmation from the original equipment manufacturer, US Vascular Inc., that they do not use distributors and sell directly to end users.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C261-23-AP-4274

1. Contracting Activity: Department of Veterans Affairs, NCO 21 at 855 M St, Suite 1020, Fresno, CA

93721 on behalf of VISN 21, VA Sierra Nevada Medical Center

PR: 654-23-3-055-0178

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

Vasculab GSX (Blood flow diagnostic device) /

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

The Society of Vascular Surgeons requires vascular surgeons perform diagnostic imaging on blood flood flow to determine decreased blood flow that increases the risk of loss of limb. This imaging reduces the risk of medical complication that can lead to permanent physical disability and in some instances can lead to loss of life.This is an non-invasive doppler system that can be used for testing arterial blood flow to limbs, using Photoplethasomography, which allows identification of capillary fill of digits hands/feet to prevent limb amputation is used to rule out thoracic outlet syndrome.

The vascular surgeons trialed the Vasculab and systems. The physicians have experience with Simeons and feel that Vasculab had the superior diagnostic results that would result in superior diagnostic care that would help prevent the progression of vascular dysfunction leads to amputation. The physicians determined that the Vasculab monitor provided more indepth and accurate vascular images than the monitors. The vascular surgeons fill the Vasculab monitor will help provide the data that is needed to diagnose and treat vascular insufficiency in real time to reduce the morbidity and mortality associated with periphal vascular disease. Other manufacturers have older platforms, whereas US Vascular is continually optimizing the VascuLab system with software updates, at no charge for 7-years.

The VascuLab is the only system that is able to run solely on battery, thus eliminating A/C noise. This is critical when listening to high frequency sound waves needed for measuring turbulent blood flow.

VascuLab is the only system that has post-processing of all signals. VascuLab’s PVR and PPG signals are superior in sensitivity and stability than other models. This is critical when measuring arterial pressures and determining if blood flow to the limb is adequate or compromised. The Vasculab system is the only system felt to provide the diagnostic results to needed to properly diagnose and treat vascular insufficiency.

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

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

GSA Advantage was reviewed, searching for the vascular doppler system. No significant results could be found. GSA eLibrary was reviewed, with no significant results being returned. The NAC was searched, with no results being relevant to the needed requirement. The SCMC had no relevant results. SEWP was reviewed with no significant results.

FPDS was reviewed, where award 36C24421P0622 was found , awarded to US Vascular Inc (small business) on 08/16/2021 in the amount of for a Vasculab 4040 GSX.

SAM.Gov was reviewed, where a solicitation and sole source justification was found. RFQ 36C24421Q0875 was reviewed, where NCO 4 issued a sole source RFQ for the same Vasculab device to US Vascular Inc. The sole source justification included information that the OEM (US Vascular Inc), does not utilize any distributors and only sells directly to the end-user.

A phone call was made to the OEM (US Vascular Inc) on 07/06/2023, where a sales representative confirmed that US Vascular does not utilize distributors and sells exclusively to the end user.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mathew Czeshinski Date Contracting Officer

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