P03 JA 36C257-2-6-AP-0900 Redacted v2.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$9M under RFO FAR12

Effective Date: 12/30/2025

REVISION: 02

Acquisition ID#: 36C257-26-AP-0900

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH RFO FAR 12

Acquisition Plan Action ID: 36C257-26-AP-0900 JOFOC: FY26 - NCO 17 - 581

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Service Network 17, North Texas Veteran Health Care System (NTXVHCS), 4500 S. Lancaster Rd. Dallas TX, 75216 Network Contracting Office 17 Regional Procurement Office-West 124 E HWY 67 Suite 100 Duncanville, TX 75137.

Purchase Request Number 2237: 549-26-1-085-0004.

2. Nature and/or Description of the Action Being Processed: The VA NTXVHCS requests a Single Award Indefinite Delivery Indefinite Quantity (IDIQ) contract for issuance of a Consignment Agreement as a Delivery Method for a base year with four one-year option periods to procure Artivion ON-X mechanical heart Valves with Artivion, Inc. Artivion will be responsible for maintaining agreed inventory levels and will retain ownership of the material until the VA uses an item. At which time, the VA will make payment for the used item. This procurement is for mechanical heart valves in accordance with RFO FAR Subpart Part 12 Acquisition of Commercial Products and Commercial Services and specifically RFO FAR 12.201-1 (b) acquisitions valued over the SAT. This is a written justification and approval of the justification as described in RFO FAR 6.104-1.

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

Consignment Agreement as a delivery method is for the procurement of Artivion ON-X mechanical heart valves and components. The estimated total value for the expected usage is Redacted. The period of performance will be as follows:

Base Year: 06/29/2026 through 05/28/2027 Option year 1: 06/29/2027 through 05/28/2028 Option year 2: 06/29/2028 through 05/28/2029 Option year 3: 06/29/2029 through 05/28/2030 Option year 4: 06/29/2030 through 05/28/2031

4. Statutory Authority Permitting Restricted Competition:

The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41

U.S.C. § 1901 and is implemented by RFO FAR 12.201-1 (b) acquisitions valued over the SAT on this procurement. Competition is restricted on this procurement for the reason below:

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

( ) Unusual and Compelling Urgency

Effective Date: 12/30/2025

REVISION: 02

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

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

Artivion is the only vendor that manufactures and provides the –mechanical heart valves required to fulfill this need. These heart valves are the only mechanical heart valves that work with existing VA owned instrumentation proven to be safe with a lower INR (1.5-2.0) compared to all other mechanical heart valves which require a higher INR (2.0-3.0). This lower anticoagulation goal reduces the bleeding risk to VA patients. The design features of this valve provide for improved hemodynamics that allow increased strength and reduced pannus formation.

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This IDIQ with a Consignment Agreement as a delivery method is approved by the Head of Contracting Activity in accordance with VA Acquisition Manual Subpart M816.770(c).

Consignments agreements allow the VA to keep several of these short shelf-life items in the facility without having to buy them until they are used. The items requested meet the strict requirements of quality and functionality for clinical heart surgery procedures.

This IDIQ with a Consignment Agreement as a delivery method is most advantageous to the Government since the mechanical heart valves proper storage (refrigeration, freezing in nitrogen) is essential for maintaining integrity of the valves and the Vendor retains the expertise and responsibility to maintain the mechanical heart valves in working condition. The mechanical heart valves will be available at a moment’s notice to Physicians.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The requesting service, Doctors and Artivion staff discussed feasibility to execute this Consignment Agreement. Artivion is the only vendor willing to enter into a contract of this nature for these products at this time. The Government will continue to assess the feasibility of other sources to meet this clinical need, if it is discovered that there are other vendors that will enter into this type of a contract with the VA, the facility is willing to try those products or enter into a contract competitively.

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

Reasonable: The Contracting Officer will determine the prices fair and reasonable prior to contract award. The Contracting Officer is anticipating using comparison of currently proposed prices to prices paid on previous procurements. In addition, the prices will be compared to the Independent Government estimate.

Effective Date: 12/30/2025

REVISION: 02

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

Market Research Was Not Conducted: Market research done in GSA Advantage, GSA eLibrary, SAC and NAC contracts database resulted in no hits. A sources sought notice was posted to Contract Opportunities from 12/1/2025 – 12/9/2025 with no responses. An FPDS search found that recent orders for these mechanical heart valves have been ordered through Artivion Inc. A search was done in ADDS UP, which confirmed that only Artivion Inc. can provide the mechanical heart valves.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other facts apply.

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

Artivion , Inc.

1655 Roberts Blvd NW Kennesaw, GA 30144-3632 Size standard: Large business

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 Government will continue to monitor the availability of other sources to support the acquisition of mechanical heart valves and support components. The effort also includes assessment of other sources that can be used to support appropriate levels of supply inventories, minimize patient risk, and offer an advantageous cost benefit.

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.

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