2. JA_Redacted.pdf

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

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C244-21-AP-4298

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104. PR: 642-21-4-315-0322.

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

The estimated value of the proposed action is .

This is a Brand Name requirement for the Magventure Depression Transcranial Magnetic Stimulation (TMS) System to be located at the Philadelphia VA Medical Center. This equipment will be utilized in the Behavioral Health Clinic to treat Veterans suffering from major depressive disorder that have failed to receive satisfactory improvement from traditional antidepressant medication.

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

Before the FDA approval, the required treatment time per session was up to 37 minutes. The new treatment form, which is known as Theta Burst Stimulation (TBS), offers one significant advantage: Time. The Magventure Depression TMS System is non-invasive and does not require any anesthesia and there is no recovery period, and is free from common antidepressant drug side effects, allowing Veterans to immediately get back to their usual activities

The requested equipment is shown below:

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

VHAPM Part 813.106 Page 2 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

ITEM NO. DESCRIPTION QUANTITY UNIT COST

OR STOCK NO.

9016A0031 1 MagVenture Depression Therapy System 1 EA with Express TMST based on MagPro R30 Magnetic Stimulator.

9016e0537 2 2 MagVenture OCD treatment package. 1 EA Provides critical treatment for OCD.

3 Enhanced Warranty Platinum 24 2 YEAR Months.

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

All of the mandatory contract vehicles, the Strategic Acquisition Center (SAC) and Medical Surgical Prime Vendor (MSPV), resulted in no findings. The Vendor Information Pages (VIP) was searched using NAICS 339112 and keyword Magventure resulted in no findings. However upon further Market Research and confirmation from the Original Equipment Manufacturer (OEM) Magventure (Small Business), there is one authorized distributor: Fidelis (SDVOSB).

During Market Research, a Request for Information (RFI 36C24421Q1170) was posted to SAM.gov from August 24, 2021 to August 26, 2021 4PM ET. One response was received from authorized distributor Fidelis (SDVOSB). An authorized distributor letter was submitted in Fidelis s response, and they are verified as an authorized distributor from the OEM.

The response from Fidelis confirms the Government s request can be acquired from the Open Market.

The Non-Manufacturer Rule (NMR) was examined to determine if this procurement could be a Service-Disabled Veteran Owned Small Business Set-Aside or Veteran Owned Small Business Set- Aside. Although all four requirements for the NMR were met, there is not reasonable expectation that two or more SDVOSB s or VOSB s can meet the Government s requirement, because there is only one authorized SDVOSV distributor for the OEM. The strategy is to post a Small Business Set- Aside and allow for competition between the OEM Magventure (Small Business) and their one authorized distributor Fidelis (SDVOSB).