FAR6_JA_OVER_SAT Edwards Lifesciences Consignment_redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C252-26-AP-2806

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C252-26-AP-2806

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office (NCO)

12, 115 South 84th Street, Suite 101, Milwaukee, WI 53214-1476, in support of Edward Hines Jr. VA Medical Center located at 5000 S. 5th Avenue, Hines, IL 60141-3030.

2237: 578-26-3-051-4456

2. Nature and/or Description of the Action Being Approved: This action seeks approval to award a new firm fixed price contract to Edwards Lifesciences LLC for specialized cardiovascular surgical implants—including aortic and mitral valves, annuloplasty rings, and bands—provided under a consignment agreement. This is a standalone contract and not a modification to any existing award.

The contractor will maintain an on site consignment inventory to ensure immediate availability for scheduled and emergent cardiac procedures. Payment will be made only for items implanted. No unpriced options are included.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The requirement includes Edwards Lifesciences cardiovascular implants such as the KONECT system (11060A), INSPIRIS RESILIA Aortic Valve (11500A), MITRIS RESILIA Mitral Valve (11400M), annuloplasty systems (4600, 4900T), and Physio/Physio Flex/Physio Tricuspid rings (5200M, 5300M, 6200T). These devices contain patented RESILIA tissue technology and specific design profiles required for complex cardiac procedures and compatibility with Hines’ established surgical protocols.

The estimated contract value is based on two primary cost components: the annual consignment inventory value maintained onsite by the contractor and the estimated annual usage cost associated with projected implant consumption. The contractor will maintain a consigned inventory valued at approximately per year to ensure immediate availability for scheduled and emergent cardiovascular surgical procedures at Edward Hines Jr. VA Medical Center, resulting in an estimated five year inventory value of . The annual usage cost—representing the value of implants actually used and invoiced—is estimated at per year, with a total projected five year usage cost of .

The estimated value will be finalized through negotiation. Consistent with commercial practice, the contractor will sustain an on site consignment stock, with payment made only upon implantation. The anticipated period of performance is five years. The requirement is authorized under 38 U.S.C. § 8123 and VHA Directive 1081.01(1).

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

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by RFO 6.103-1;

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Acquisition ID#: 36C252-26-AP-2806

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Edwards Lifesciences LLC is the only firm capable of providing the supplies described in Section III without the Veterans Health Administration experiencing substantial duplication of cost and unacceptable delays. This determination is supported by 38 U.S.C. § 8123 and VHA Directive 1081.01(1).

The required implants are patented, proprietary devices manufactured exclusively by Edwards Lifesciences. Their unique anatomical designs, RESILIA tissue technology, and compatibility with Hines’ standardized surgical procedures make them clinically necessary and not interchangeable with other products.

No other manufacturer produces valves or annuloplasty systems that meet these clinical and procedural requirements. Substitution would require retraining, revalidation of surgical techniques, and revised protocols, resulting in significant unrecoverable duplication of cost and unacceptable delays to patient care.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Market research included reviews of SCMC, SAM.gov, NAC catalogs, and the National Strategic Source Listing. No alternate manufacturers, distributors, or VetCert listed SDVOSBs/VOSBs capable of supplying the required Edwards implants were identified.

A sources sought notice was not issued because the procurement is conducted under 38 U.S.C. § 8123 and VHA Directive 1081.01(1), which allow acquisition of surgical implants without regard to other procurement laws, including public notice requirements. No additional potential sources were identified.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO determines that the anticipated costs will be fair and reasonable. Price analysis will include comparison with recent VA Indefinite Delivery Contracts and open market purchase history for the same Edwards implants. Although certified cost or pricing data is not required for a sole manufacturer, commercial pricing information will be used to support negotiation.

The CO will evaluate historical VA pricing, commercial consistency, and the industry standard consignment model before finalizing pricing.

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 per RFO Part 10 and VAAR 810.001 70, including review of the SBA SBS database for VetCert listed SDVOSBs/VOSBs.

No small businesses were identified as capable sources. All federal databases reviewed (SCMC, SAM.gov, NAC, NSS) confirmed Edwards Lifesciences as the sole manufacturer of the required devices.

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Acquisition ID#: 36C252-26-AP-2806

38 U.S.C. § 8123 and VHA Directive 1081.01(1) permit implant purchases without regard to competition or synopsis requirements, a public notice was not issued. BAA/TAA do not apply to acquisitions made under this authority.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The implants are proprietary, patented devices with no equivalent alternatives. No specifications or competitive purchase descriptions can be developed due to the unique clinical requirements and the exclusive nature of Edwards Lifesciences’ technology.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Edwards Lifesciences, LLC, 1 Edwards Way, Irvine, CA 92614

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 agency will continue to monitor the market for new FDA approved alternatives; however, none currently exist.

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.

Christine Flynn Date Implant Coordinator Edward Hines Jr. VA Medical Center

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

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

Stacy Massey Date Contracting Officer Network Contracting Office 12

CHRISTINE FLYNN Digitally signed by CHRISTINE FLYNN Date: 2026.06.30 08:19:13 -05'00'

STACY MASSEY Digitally signed by STACY MASSEY Date: 2026.06.30 08:35:35 -05'00'

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Acquisition ID#: 36C252-26-AP-2806

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Parris Weidenbach Date Branch Chief, Supply Team

Scott Ivy Date Division Manager

Paul Lauro Date Director of Contracting

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Daryl Berg Date Executive Director, RPO Central VHA Head of Contracting Activity (HCA)

PARRIS WEIDENBACH Digitally signed by PARRIS WEIDENBACH Date: 2026.06.30 10:35:06 -05'00'

SCOTT IVY Digitally signed by SCOTT IVY Date: 2026.06.30 11:00:18 -05'00'

JAMES HEDMAN Digitally signed by JAMES HEDMAN Date: 2026.06.30 14:17:26 -05'00'

07/07/2026

DARYL BERG

Digitally signed by DARYL

BERG

Date: 2026.07.07 11:40:55 -05'00'