P03 - JOFOC_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 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: 36C252-21-AP-3089

1. Contracting Activity: Department of Veterans Affairs, VISN 12, William S. Middleton

Memorial Veterans Hospital, Great Lakes Acquisition Center, 607-21-3-969-0272.

2. Brief description of supplies/services required and the intended use/estimated amount: This is a justification for a new, firm fixed price procurement with Medtronic Sofamor Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132-1703 for its OsteoCool Radiofrequency (RF) Ablation System. The estimated amount is .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The William S. Middleton Memorial Veterans Hospital Radiology Service is requesting a OsteoCool RF Ablation System. This system will be in support of the facility’s new Cancer Treatment Center (CTC) patients and is a new program. The OsteoCool RF Ablation System is intended for ablation of benign bone tumors such as osteoid osteoma and for the palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. It is also intended for coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. The OsteoCool RF Ablation System is the only cool tipped bone ablation unit used for predictable outcomes. This ablation system has a wide range of ablation scenarios to meet patient and procedural needs. The system tracks temperature and power output to reduce risk of thermal damage to adjacent structures. The system monitors impedance and automatically pauses ablation before charring can occur. The system automatically halts RF energy delivery once ablation time is complete. OsteoCool RF ablation probes can be used for: simultaneous ablation of adjacent or multiple levels in the spine, simultaneous ablation using two probes, such as bipedicular spine tumor ablation, ablation using one probe, 4.7 mm, 10 mm, 15 mm, and 20 mm active tip sizes, multiple introducer gauge options, and track ablation.

4. Description of market research conducted and results or statement why it was not conducted: A VIP search of NAICS 339112 and the keyword “OsteoCool” (brand name) produced zero results. Another search of NAICS 339112 and keyword “Medtronic” (brand name) produced one result for a Service-Disabled Veteran-Owned Small Business

(SDVOSB).

Similar searches were conducted on ECAT, GSA Advantage, Interagency Contract Directory (ICD), and VA’s Supply Chain Master Catalog (SCMC). Zero results were returned.

The CO contacted the manufacturer to determine if it authorizes any small businesses – including Veteran-Owned Small Businesses (VOSBs) or SDVOSBs – to distribute this product. The manufacturer responded that the “OsteoCool RF Ablation is only sold by Medtronic in the US, with the exception of a few small geographic areas where Medtronic does not have a Sales Representative available.”

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 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

This justification is also to be posted with an Intent to Sole Source notification to Industry along with any resulting award. At this time, the VA Rule of Two is not met for VOSBs, SDVOSBs, or any other socio-economic small businesses or small businesses.

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.

____________________________ 6/7/2021 Jim Hedman Date Contracting Officer