S02. Attachment D.2 - Single Source Justifcation - 36C25625Q1044.pdf
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- Attached to
- NovaSure RF Controller and Fluent Fluid Management System Pro System FLT 200 Federal contract opportunity
- Solicitation number
- 36C25625Q1044
About this file
This document is a Single Source Justification (SSJ) for the Department of Veterans Affairs, specifically Network Contracting Office 16 (NCO 16), seeking to acquire the NovaSure RF Controller (Mode 10) and Fluent® Fluid Management System from Hologic, Inc. The devices are clinically specialized and proprietary, designed exclusively for advanced gynecologic procedures including diagnostic and operative hysteroscopy and endometrial ablation. The justification emphasizes the systems' unique capabilities, such as real-time volume differential monitoring, dual peristaltic pump management, and integration with hysteroscopic morcellators, which are classified by Hologic as non-interchangeable and not compatible with third-party accessories.
The procurement is a 100% Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside with a Solicitation Number 36C25625Q1044, targeting a small business size standard of 1,000 employees under NAICS code 339112. Market research across federal acquisition resources like eCMS, GSA eLibrary, and VetCert found no alternative sources offering functionally equivalent systems that could meet the clinical, technical, and patient safety requirements. Consultation with clinical stakeholders validated that only the OEM's system meets procedural standards and integrates safely with current surgical protocols, with attempts to substitute non-OEM systems deemed unacceptable due to potential patient safety risks.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| S02. Attachment D.1 Final Invoice Memo.pdf | ||
| S02. 36C25625Q1044.pdf |
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT
Revision: 01 Effective Date: 11/15/2024 Page 1 of 3
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)
(Brand Name)
Acquisition Plan Action ID:
1. Contracting Activity:
Network Contracting Office 16 (NCO 16), located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 in support of the G.V.
(Sonny) Montgomery Department of Veterans Affairs Medical Center, 1500 East Woodrow Wilson Avenue Jackson, MS 39216-5116
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
The supplies required include the NovaSure RF Controller (Mode 10) and Fluent® Fluid Management System. These clinically specialized and proprietary devices are designed exclusively by Hologic, Inc. for advanced gynecologic procedures. The intended use includes diagnostic and operative hysteroscopy as well as endometrial ablation. These systems are vital for providing automated, real-time monitoring of fluid volumes, ensuring precise control of fluid inflow and outflow, and integrating with hysteroscopic equipment to maintain safe fluid pressure and streamline procedural efficiency.
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
The NovaSure RF Controller (Mode 10) and Fluent® Fluid Management System are proprietary, clinically specialized devices designed exclusively by Hologic, Inc. for advanced gynecologic procedures, including diagnostic and operative hysteroscopy and endometrial ablation. These systems are uniquely capable of:
Providing automated, real-time volume differential monitoring between irrigation inflow and outflow, which is essential for maintaining uterine distention and preventing fluid overload complications during hysteroscopy.
Using dual peristaltic pumps to independently manage inflow and outflow, ensuring precise control throughout the procedure.
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