P03_Stryker RF Generator BNO Justification MPT to SAT.pdf

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

Last Updated: 02/01/22 Page 1 of 2

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: 36C260-23-AP-3787

JOFOC ID: 2023-08-08T11:10:04

1. Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration, Regional

Procurement Office West, Network Contracting Office 20 on behalf of VISN 20, Puget Sound VA Medical Center.

Network Contracting Office 20 (V4CONT) 1601 E. Fourth Plain Blvd Bldg. 17, Suite B428 Vancouver, WA 98661

2237#: 496-23-3-241-0089

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

Brand Name Only request for two (2) Stryker Radiofrequency (RF) Generators and associated accessories for use in Veteran Patient pain reduction procedures at Puget Sound VAMC Interventional Pain Clinic.

Estimated Amount: $106,200.38

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

The Avanos systems were initially selected due to the large spherical lesion that it is able to create using the cooled technology (much larger than conventional RF lesions, which is thought to improve care, as it is able to address more small, peripheral nerves). This technology requires a very large 18 gauge introducer needle to be driven through the patients’ tissues, subsequently resulting in increased use of numbing medications and conscious sedation medications, ultimately increasing the patient’s risk for falls and respiratory depression, as well as delayed discharges and increased nursing time. Physicians on the interventional team have declined to use the Avanos RF Generator due to the increased pain experienced by the Veteran Patient (as a result of the large gauge needles) in comparison to a lower pain level for Veteran Patients when the Stryker RF Generator is used for this same procedure.

The Stryker RF Generator machine is the only machine compatible with their patented bifurcated needle, “Venom”. This needle allows the interventionalist to obtain a similar lesion as the Avanos Coolief, but using a smaller gauge introducer, which is more comfortable for the patient - gauges as small as 20 and 22 are available for Stryker Venom, which are much more comfortable than the 18 gauge for Avanos’ large burn Coolief technology. Stryker Venom needles can be used in areas of lower tissue depth (closer to the skin surface, helpful for small nerves such as those involved in https://www.acquisition.gov/?q=/browse/far/13

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

Last Updated: 02/01/22 Page 2 of 2 carpal tunnel), with decreased risk of full thickness dermal lesions/skin burns. Additionally, the needles and probes used with the Avanos Coolief RF Generator are significantly more expensive and have less use cycles per needle and probe during Veteran Patient procedures as compared to the Stryker RF Generator machine.

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

Unrestricted/Open Market BNOE Sources Sought/RFI was issued 7/12/2023 (ended 7/18/2023) and received responses from three (3) SDVOSB vendors that are authorized by Stryker to provide the requested equipment for this procurement. Stryker representative, Stephan Sparkman provided a list of five (5) SDVOSB vendors that are authorized to provide the requested Stryker equipment.

Large Business Avanos responded to the RFI offering their Avanos Coolief RF Generator, however due to the Veteran Patient pain outcomes exceeding the pain outcomes as found during clinical use at the Puget Sound VAMC, the Avanos Coolief RF Generator does not meet the technical specifications required by the facility end users regarding patient comfortability and pain level experienced. Per above it was found that the Stryker RF Generator is the only one with the “Venom” technology. This will be a 100% small business set-aside Brand Name Only requirement, competed between Stryker Small Business authorized distributors.

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.

Name: Michael Allred Date Title: Contracting Officer (ME II, NCO 20) https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466