Redacted J and A IC mapping syst.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Page 1 of 4 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:____36C263-21-AP-2918_______________________________________

1. Contracting Activity: US Department of Veterans Affairs, NCO 23, 4801 Veterans Drive, St. Cloud MN 56303-2099. Ordering Activity: US Department of Veterans Affairs, Iowa City VA Healthcare System, 601 Highway 6, West, Iowa City, IA 52246-2208.

2237 Number: 636-21-3-4154-0146

2. Nature and/or Description of the Action Being Processed: This is a Brand Name Only justification for the St. Jude/Abbott Mapping system. This is an upgrade from Precision to Ensite which is requested to support EP procedures. The upgrade includes the following options that will enhance EP procedures that can be performed on the existing unit that we are requesting to be upgraded:

Efficiency from a redesign platform, decreased signal to noice platform, addresses bipolar blindness, ability to capture data faster, reduction in connections for set up (prevents damage unusable cables, incorrect pinning for catheters), efficiency of staff time in set up and upgrade which would provide additional magnetic navigation which will increase the efficiency of procedure duration as mapped images of the heart are more efficiently and accurately captured. This allows for increase in access to care to increase the capacity of the EP lab and expansion. The upgraded system has a new amplifier and catheter connections. It will eliminate artifact which is inaccurate electrogram readings on our catheter signals.

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

ENSITE SYSTEM-01 EnSite X EP System Upgrade H702601 Ensite Live View Dynamic Display License Kit EX904-UPG EnSite X EP System Assurance Premium Service Plan

Period of Performance: One-time delivery

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

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

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Iowa City VA Medical Center currently has the St. Jude/Abbott Precision Mapping System. The current legacy operating system platform is 10 years old. The equipment was purchased in 2016 and first utilized in 2019. The upgrade will allow for the St. Jude/Abbott system to be utilized for an additional 2 -4 years . The Iowa City VA would get an additional estimated ten years, however there are unforseeables, which is why the assurance premium plan which allos for all future upgrades to software and equipment is included. As a result, it may be longer than an additional ten years. The upgrade is for the St. Jude equipment; therefore, other mapping systems would not be compatible. Other EP mapping systems cannot be applied to St. Jude/Abbott.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Other vendors were researched, however as the Iowa City VA is looking for an upgrade to the existing system, it is more cost effective to purchase an upgrade in lieu of an entirely new system. No other system is compatible with the existing system in place in Iowa City. Market research has demonstrated that there are at least 2 small business authorized distributors for this Abbott Laboratories system, therefore the procurement will be a brand name only procurement competed amongst authorized small business distributors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: By competing this procurement as a brand name only small business set aside, it is anticipated that there will be sufficient competition to provide competitive pricing based on market research received.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A VIP search using NAICS 334510 yielded 198 matches of which 178 were SDVOSBs. GSA was contacted to complete a GSA Rapid Review Research form, which resulted in zero matches. NAICS 334510 has an SBA class waiver, however SB must meet the criteria of 13 CFR 121.406. A beta.SAM RFI/Sources Sought notice was posted on 05/18/21 and closed on 5/24/21

Other Facts Supporting the Use of Other than Full and Open Competition: This is a software upgrade to an existing system located at the Iowa City VA HCS.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Biosense Webster, Abbott Laboratories, Metro Medical, Marathon Medical, SpecOps.

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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: This procurement will be a Brand Name Only (Abbott Laboratories) small business set aside as market research has demonstrated sufficient small business interest. The Iowa City VA will need an additional mapping system with the addition of a third lab that is in its design phase for variety in cases. At this juncture, no other mapping system can upgrade Iowa City’s current system and the competing vendor (BioSense Webster) does not run on Windows 10. The only other firm that Iowa City is aware of is ‘Rythmia’ from Boston Scientific, which does not offer contact force ablation catheters. Contact force allows Iowa City staffers to know when they are touching heart tissue before ablating.

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.

Date

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

a. 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.

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Revision 11 Date: 02/11/2021

b. 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.