Attachment 1 Single Source Justification MPT to SAT_Signed25.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 36C244 24 AP 0135

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: 36C244 24 AP 0135

1. Contracting Activity: Department of Veterans Affairs, VISN 04, VA Pittsburgh Healthcare, University Drive C, Pittsburgh. PA 15240. Purchase Request Number 646 25 1 233 0014

2. Brief description of the supplies required and the intended use and estimated amount: Surgical Services at the University Drive Campus in Pittsburgh is requesting new Brand Name Only requirement for one (1) Fluent System, one (1) Novasure RF Controller Model 10, one (1) Myosure Device, and one (1) Fluent Pack.

The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators. The Fluent® Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. The Fluent Fluid Management System is designed to be used in operating room, ambulatory surgical center, and physician’s office environments. The NovaSure endometrial ablation (EA) procedure can reduce or stop menstrual bleeding. It works by permanently removing the endometrium, or the lining of the uterus (the part that causes the bleeding), with a quick delivery of radiofrequency energy.

Estimated Amount: $49,852.78

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Unique features of the Aquilex system: One integrated system with a fluid pump capable of 800 mL/min inflow. Two integrated vacuum pumps: One for the under buttock drape and scope outflow capable of producing up to 125 mmHg of suction. One for the MyoSure system capable of producing up to 500 mmHg of suction. Automatic lumen calibration to optimize intrauterine pressure for achieving and maintaining distention and visualization. Dual scale technology means there is a scale for the supply hooks and one for the canisters for accurate deficit measurements.

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

The Contract Specialist posted a “Sources Sought Notice” 36C24425Q0020 to GSA eBuy on October 10th, 2024, thru October 17th, 2024, seeking feedback and information, from any potential vendors.

The sources sought did not provide any potential vendors with a federal supply schedule contract. A second “Sources Sought Notice” 36C24425Q0020 was posted to SAM.gov from October 29th, 2024, thru November 1st, 2024. The results produce two vendor responses BHPE LLC and DGA Medical LLC, both Service Disabled Veteran Owned Small Businesses which produced an authorized distributor letter from Hologic and is capable with fulfilling this requirement.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C244 24 AP 0135

The Department of Veterans Affairs, National Acquisition Center Contract Catalog Search tool, Strategic Acquistion Center Contract Catalog, Contract Directory and GSA Advantage websites were searched. There are no existing government contracts. Search SBA VetCert and verified responses BHPE LLC and DGA Medical LLC, both Service Disabled Veteran Owned Small Businesses.

There is not an existing waiver to the non manufacturing rule under NAICS 33912 therfore this requirement will be competed on the Open Market as a Total Small Business Set Aside, to BHPE LLC (SDVOSB) and DGA LLC (SDVOSB), Authorized Distributors and any other small businesses that may be capable of fulfilling this requirement.

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.

Andrew Taylor Contracting Offcer

ANDREW TAYLOR

Digitally signed by ANDREW

TAYLOR

Date: 2024.11.14 14:58:52 -05'00'