Single Source Justification.pdf

Page 1 of 3 VHAPM Part 813.106 Original Date: 08/30/17 Revision

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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: 36C256-21-AP-2754

1. Contracting Activity: Department of Veterans Affairs, VHA Regional Procurement Office Central, Network Contracting Office 16, 1515 Poydras Street, New Orleans LA 70112

IFCAP: 586-21-3-047-0056

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: WR TestWork Heart Rate Variability Lab is fully automated testing lab that performs a broad range of tests in the search for autonomic neuropathies dysfunctions. The variety of complaints and conditions the bring patients to the autonomic function laboratory are; diabetes, orthostatic hypotension, syncope, tachycardia, shy-draper syndrome, amyloidosis, peripheral autonomic neuropathy, multiple sclerosis, chronic hypotension, causalgia, and hyperhidrosis. The testing provides answers on the severity, pattern, and distribution of autonomic and peripheral nervous disorders, which aids in early detection and proper treatment. The fully autonomic lab includes the Q-Sweat system for quantified sudomotor function testing, small, medium, large 600-hour finger cuffs, WR tilt table with articulating arm (right or left side), and smart hand control for programming angles.

6020 HRV Acquire Heart Rate Variability Testing Lab 6100 CNAP Beat-To-Beat Blood Pressure Acquisition System 6003 Q-SWEAT Measurement System – Quantified Sudomotor Function Testing 5568 Tilt Table Model S1 with Arm 5502 Support Services

The system assists in patient diagnosis to include; heart rate responses to deep breathing, Valsava Maneuver, 30:15 ratio, baroreflex sensitivity including cardiovagal and adrenergic analysis, head-up tilt, quantitative sweat measurements resting and evoked. The testing is also non-invasive, standardized, quantitative and time efficient. System will be installed to include applicable software, and training.

Estimated Amount: $101,900.00

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: WR Medical Electronics is the manufacture for the complete system to include proprietorship for the software (TestWorks 3). The software integrates seamlessly with all testing products to provide physicians the ability to treat patients efficiently. The system provides testing for cardiovagal, sudomotor, adrenergic, QST, and allows for additional systems to be added for testing if needed. No other contractors would be able to recode for the programs and software used. The system allows you to customize reports that are suited to the patient and physicians. The ergonomic designed tilt table allows the user to easily reposition patients with the touch of a button

Page 2 of 3 VHAPM Part 813.106 Original Date: 08/30/17 Revision

0 Eff Date: 0 / /20 with ease from 0 to 70 degrees in 9 seconds. Only authorized technicians from WR Medical Electronics Co can work on the system to adhere to the warranties that would be in place upon installation. They also provide support services.

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

Market research was conducted and only one source was discovered that can accomplish the requirement. The limiting fact for other vendors is the proprietary rights of the software and warranties. Market research was based on internet searches and making phone calls to see what companies would be able to provide the required services for a full autonomic lab.

A search of VETBiz was conducted and determined that no SDVOSBs and VOSBs could provide the items. A search of SBA was conducted and determined that no small business could provide the requested items. Searches of the National Acquisition Center Catalog and GSA Advantage were conducted, and it was determined that no other additional sources were identified under National Acquisition Center/Federal Supply Schedule could provide the requested item. The complete system is commercially offered through the open market. There are no modifications required for the product to be used by the VA. There are no unique laws or regulations that apply for the product to be used for patients of the VA pursuant to the documents received from the service.

A follow-up search was conducted on the National Acquisition Center/Strategic Acquisition Center for the company and product. Neither was listed. WR Medical Electronics or the product was not found on GSA eBuy or GSA Advantage. VIP Search found 75 contractors under NAICS 339112. RFI’s were sent out on VIP, GSA, and posted on SAM.gov. Received the following responses from contractors on the Vendor Information Page (VIP); Academy Medical, Alliant Healthcare, and Geo- Med. They were not able to provide the product. RFI was posted on GSA eBuy (RFQ1496881). Notice was sent to 23 contractors. Five contractors responded; Sustainment Technologies LLC - SDVOSB, Alliant Healthcare Products – SDVOSB, Alliance Tech Medical Inc. – SB, MGC Diagnostics – SB, Claflin Service Company – SB, no quote. Sources Sought Notice published on SAM.gov (36C25621Q1100).

No responses received.

Based on the above market research, WR Medical Electronics is the only manufacturer/distributor for the WR TestWorks Full Autonomic Testing Lab System. The equipment and software are unique to the industry, and specific to WR Medical Electronics. As seen above, RFI’s were posted to seek out possible contractors and products. No viable responses were received. WR Medical Electronics is registered in SAMs as a small business. A sole source letter was provided by the company verifying their proprietorship over said equipment and software. Will submit 2268 with Sole Source Justification for review/approval to purchase direct from WR Medical Electronics.

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.

VHAPM Part 813.106 Page 3 of 3 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

Denise Keyes Shields Date Title: Program Support Assistant

Winston Graber Date Contracting Officer

06/30/2021

WINSTON GRABER Digitally signed by WINSTON GRABER Date: 2021.07.08 11:25:48 -05'00'