SingleSourceJustification_MPT-SAT_20Stereostatic_20Signed_Redacted1.pdf

VHAPM Part 813.106 Page 1 of 2 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 4830

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave. Philadelphia, PA 19104. Requisition # 642 21 4 315 0332.

2. Brief description of supplies required, the intended use and estimated amount: The Corporal Michael J. Crescenz VA Medical Center in Philadelphia is requesting a sole source of Leksell Stereostatic System to supply and outfit the new state of the art Surgical Operating Room for Neuro Surgery, Deep Brain Stimulation program. The Philadelphia VA Medical Center does not currently have the necessary technology to perform these procedures within the medical center.

Leksell Vantage Stereotactic System is a well known coordinated system and a unique center of arc principle. This apparatus is used to help shorten preparation time and lessens the risk of losing parts during cleaning and sterilization. This system will be used for diagnostic and therapeutic procedures providing accurate results with dedicated instruments and solid fixation.

The total estimated contract value of the proposed action is

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

This system is dedicated to minimally invasive stereotactic neurosurgery Leksell Stereotactic System and provides the most precise intracranial neurosurgical results. Exceptional imaging, high platform rigidity and ease of use ensure that critical accuracy requirements are met for this surgical discipline.

The system is designed for easy, versatile and fast operation, Leksell Stereotactic System includes Leksell Coordinate Frame and Leksell Multipurpose Stereotactic Arc. The unique arc employs the center of arc principle for encompassing the surgical target in three dimensions, enabling full access to any intracranial area. In addition, this principle enables limitless trajectories and entry points to be used. These principles are implemented in an even more intuitive and user friendly workflow.

The Leksell Vantage Arc System is made of aluminum and has an elegant click on mechanism for confidence, efficiency and control during surgery and no are no other similar systems that will meet the Philadelphia VA’s requirements.

This Notice of Intent to Sole Source justification shall be posted to Contracting Opportunities upon award in accordance with FAR 5.101

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106 1(b)(2).

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

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

Extensive Market Research was conducted during the Contract Planning Phase of this requirement. The results of that market research are as follows.

A Sources Sought 36C24421Q1126 was posted to Beta.Sam on August 13, 2021 and closed on August 18, 2021. No responses were received. Elekta was contacted and they do not have any existing government indefinite delivery vehicles and no authorized distributors.

Elekta is the only manufacture and distributor of the required Stereostatic System for Philadelphia’s Neuro Surgery, Deep Brain Stimulation program.

A search of the Strategic Acquisition Center (SAC), Medical Surgical Prime Vendor (MSPV), Vendor Information Pages (VIP) and General Service Administration (GSA) websites were also conducted.

There were no responses.

Based on the above, a Notice of Intent to Sole will be posted for three days before awarding a contract to Eleckta Inc.

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.