P03 PG_PART806.3_ATCH1_FAR6_JA_OVER_SAT_BC SIGNED.pdf

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C241-25-AP-2236

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-25-AP-2236

1. Contracting Activity: RPOE, NCO 1 on behalf of Department of Veterans Affairs, VISN 1, VA Connecticut 2237: 689-25-2-7441-0199

2. Nature and/or Description of the Action Being Processed: This will be a sole source firm fixed price purchase order for a Base plus four-year service agreement for three Ethicon NeuWave Microwave Ablation Systems located at West Haven, Togus and West Roxbury VA Medical Centers within VISN 1. Each site has one system. The systems are in operating rooms and interventional radiology labs used to destroy liver tumors via heat generated by microwave energy. It is critical that this system be maintained up to OEM specifications and put on regular maintenance intervals to ensure proper functionality. Due to the complexity of the equipment only the OEM Ethicon is allowed to service their equipment.

Total Annual Price: $50,561.40 Price per system/location: $16,853.80 Base plus four option years: $252,807.00

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

Microwave Ablation Systems is critical for the Surgical and Radiology Services. In order to withhold the high standard of patient care at West Haven, Togus and West Roxbury VA Medical Centers within VISN 1, the system needs to be maintained properly. Specialized maintenance will result in higher patient care and will greatly eliminate patient care issues associated with the equipment. Only the OEM, Ethicon, has the knowledge and expertise to complete corrective and preventative maintenance on these devices. As such, no other supplies or services will meet the agency’s needs.

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

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

a. 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

b. 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;

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Acquisition ID#: 36C241-25-AP-2236

( ) (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):

Ethicon is the sole manufacture of the NeuWave Microwave Ablation System. Ethicon does not authorize any third party vendors service their equipment.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Current pricing is being compared to the current VISN 1 NeuWave Ablation Service Contract PO 36C24122P0677 set to expire 5/31/2025.

7. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: No one other than the OEM Ethicon can service their equipment. The OEM provided a sole source letter stating such.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: An intent to sole source will be posted on SAM.gov. It is anticipated that the intent to sole source will not be challenged. In the event that it is, we will change our acquisition strategy.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: n/a

10. 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: At this time, there are no actions that can be taken to remove or overcome barriers that lead to the Other Than Full and Open Competition. The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future action to be competed; however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

11. 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.

Vinnie Defrancesco VISN 1 Deputy Healthcare Technology Manager

VHA, VISN 1

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

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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Acquisition ID#: 36C241-25-AP-2236

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

Ashley Kenyon Contracting Officer

RPOE, NCO 1

a. 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.

Sheryl Anthony Branch Chief, Commercial Team 3

RPOE, NCO 1