P03.FAR 13.5 Sole Source Justification - Over SAT - NeuroStar TMS - Redacted.pdf

VHAPG Part 806.3 OFOC Revision: 03 Effective Date: 04/15/24 Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon Veterans Affairs Medical Center (VAMC), 1700 South Lincoln Avenue, Lebanon, PA 17042.

Purchase Request Number:

2. Nature and/or Description of the Action Being Processed: This procurement is for a new Brand Name Only five (5) Year, firm-fixed-priced IDIQ contract for the Neuronetics Inc., NeuroStar Transcranial Magnetic Simulation (TMS) Treatment Sessions, with full-service preventative maintenance to be used for the existing NeuroStar TMS Therapy System located in Behavioral Health and Sciences Department at the Lebanon VAMC.

The Lebanon VAMC currently utilizes the Neuronetics NeuroStar TMS System to address the Behavioral Health and Science population with a diagnosis of depression.

Neuronetics is the original equipment manufacturer (OEM) of the NeuroStar TMS Therapy System. In order to maintain continuity and keep the warranties and maintenance services, it is required to procure Neuronetics NeuroStar TMS Treatment Sessions and receive ongoing preventative maintenance for the TMS Therapy System.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed period of performance for the five (5) year IDIQ awarded contract will start on or around 3 April 2025 through 2 April 2030.

A minimum quantity of eight hundred (800) TMS Treatment Sessions (Item Number: CSM 500) will be ordered per year, in addition to the annual full-service preventative maintenance.

Task Order Requirements:

Multiple Delivery Order may occur within fiscal years.

Each Delivery Order must comply with the delivery requirements stated in S .

The total estimated value of the contract (Base plus 4 Ordering Periods) is:

4. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. This procurement is for a Brand Name Only (5) Year IDIQ contract in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

Competition is restricted on this procurement for the reason below:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This is a new Brand Name Only requirement for a highly specialized service and required treatment sessions that is specific to only Neuronetics, Inc., NeuroStar TMS Treatment Sessions.

On November 11, 2024, the Program Analyst received a Sole Source priority letter from Steve Furlong the Vice President, Chief Financial officer from Neuronetics Inc., stating that: “The NeuroStar Advanced Therapy System, SenStar Connect, Treatment Links, and Accessories are exclusively manufactured for and distributed in the United States by Neuronetics, Inc. For our government customers who wish to work with a Service-Disabled Veteran Owned Small Business (SDVOSB), we have a Product Distribution Agreement with to support that procurement preference.

Accordingly, Neuronetics Inc., OEM, Large Business, and capable of providing the supplies and services described in Section III above.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contact was made by the Program Analyst with the OEM, Neuronetics Inc., for a sole proprietary vendor certification, as well as vendors who are authorized distributors.

The Contract Specialist posted a "Sources Sought Notice" 36C24425Q0115 to beta.SAM on November 14, 2024, thru November 20, 2024, seeking feedback and information from any potential vendors. The results produced zero (0) possible vendors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost is fair and reasonable based on previous contract pricing.

Current Contracts Neurostar TMS Treatment Sessions for the VA owned Neuronetics Inc., Model CSM500, and Full-service maintenance on VA Owned Neurostar TMS Therapy System were referenced.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A search of FPDS historical

Acquisition ID#:

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Medical technology is continuously being reviewed and considered.

When a superior piece of technology is identified, the Lebanon VAMC will consider new vendors to overcome any barriers to competition.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.