36C25818Q9719-003.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA258-18-AP-1135

1. Contracting Activity: Department of Veterans Affairs, VISN22 G, SAVAHCS, TUCSON, AZ

678-18-3-071-0202 MEDTRONIC ELECTROSURGICAL GENERATORS

2. Nature and/or Description of the Action Being Processed:

This is a Brand Name only Justification for Medtronic Electrosurgical generators Specifically:

Valleylab FT10 Energy Platform Bovie and carts. Only this brand will work as the VA currently has existing Medtronic generators and the new equipment must match the existing equipment. The Operating Room currently uses these surgical generators for all surgical specialties. This brand generator is essential because it meets the needs of our surgeons who are already familiar with this device. Consumable products are already being used on existing generators. that are compatible with this device.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

10 EA Medtronic Brand Name Generator FT10 MFN# VLFT10GEN 16 EA Medtronic Brand Name Cart for FT10 MFN# VLFTCRT Vendor will take for trade in the following and offer a trade in value:

10EA ForceFXCS MFN#VLESUOTP

4. Statutory Authority Permitting Other than Full and Open Competition:

Per FAR6.302-1(c) Application for Brand Name Descriptions.

The VA previously purchased Medtronic Electrosurgical Generators FT10 using PO# 678A70167 This facility requires additional generators that are the same brand and the machines are interchangeable to different areas/surgenos depending on usage. These units have patented vessel sealing technology that is not available from other manufaturers. If different manufacturer was used it could affect Surgical Outcomes for Veterans and substancially delay the procurement to determine compatability with current equipment amount of training needed and what to do with current equipment with active lifespan.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Medtronic has patented and trademarked abilities

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought was posted to FBO 6/19/2018 ID# 36C25818Q9451 and specified the VA was looking for Medtronic generators and would have trade ins.

OFOC SOP Revision 08 Page 2 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This is a COTS item and pricing can be compared to VA NAC contract pricing if only one vendor submits a quote. It is anticipated that several vendors will submit quotes and quotes will be determined far and reasonable based on competition per FAR 13.106-3(a)(1)

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted and is on the market research forms. The VA found that two or more SDVOSB concerns can meet this need.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The energy platform is an integrated solution for open and laparoscopic electrosurgical procedures.

This platform provides the operating room with one energy system for electrosurgical and tissue fusion needs and gives surgeons the ability to deliver precisely controlled energy and improved tissue effect. In the past, operating rooms needed separate pieces of equipment to achieve different tissue effects: monopolar, bipolar and vessel sealing. This unit combines all three into one easy-to-use platform, making setup simpler. It offers the surgeon a wide range of options, including electrosurgical cutting and coagulation, bipolar functionality and Ligasure tissue fusion.

The Valleylab FT10 energy platform has optimized vessel sealing performance with Ligasure devices.

High-speed, closed-loop control continuously monitors the electrical properties of the tissue and utilizes an advance vessel sealing algorithm to apply a proportionate amount of energy based on composition and size of the vessels being sealed. This reduces the need for manual bar settings on the Valleylab FT10 generator.

We currently have these units in use at SAVAHCS. It is not conducive to the surgical team to have various electrosurgical units in the operating room. Keeping consistent in all surgical suites is mandatory.

Not only will these units provide standardization among the surgical standard of care, they offer additional benefits which will reduce the amount of equipment in our surgical suites. This newer and improved surgical generator will allow the surgical team to use other disposable equipment that would usually require a second generator.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: This is listedin the Contract file Market research report.

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:

The VA will continue to conduct Market Research to determine if Other than Brand Name items are able to be ustilized for future procurements.

OFOC SOP Revision 08 Page 3 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

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. J&A info from Requestin Facility in briefcase

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

Prepared by Contracting Specialist, Theresa Hamilton

14. 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.

Contracting Officer-

a. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Chief-

Theresa L.

Hamilton 520729

Digitally signed by Theresa L. Hamilton 520729 Date: 2018.09.16 13:00:05 -07'00'

Jeremy J.

Parker 624395

Digitally signed by Jeremy J. Parker 624395 Date: 2018.09.16 13:03:53 -07'00'

KELLY M.

Griego 185769

Digitally signed by KELLY M. Griego 185769 Date: 2018.09.16 13:23:49 -07'00'