36C25726Q0149_1.docx

Special Notice Special Notice

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs South Texas Veterans HCS 5441 Babcock Rd. STE 302 San Antonio TX 78240

POINT OF CONTACT*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Special Notice – Notice of Intent to Award a Sole Source Procurement

1. This market research notice is being conducted by Network Contracting Office (NCO) 17 VHA Regional Procurement Office-West (RPOW) 5441 Babcock Rd. STE 302, San Antonio, Texas 78240. The Government intends to negotiate solely with Artivion LLC, 1655 Roberts Blvd. NW, Kennesaw, GA, 30144 on a consignment base year plus four option years.

2. Background and Requirement: North Texas Veterans HCS Invasive Cardiology requires On-X Heart at 4500 S. Lancaster Rd., Waco, TX 76711 has requested On-X line products, including On-X Aortic Heart Valve, On-X Mitral Heart Valve, and On-X Ascending Aortic Prosthesis on a consignment basis.

3. Only Artivion LLC is capable of fulfilling this requirement. The On-X mechanical heart valve is the only mechanical heart valve that has been clinically proven (supported by the AHA/ACC) 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 patients. The design features of this valve provide for improved hemodynamics that allow for the benefits of increased strength and reduced pannus formation. Any responses to this notice are requested by 2:00 PM Central Time on Tuesday 12/09/2025.

4. Send responses to Tammy Wilson at Tammy.Wilson5@va.gov.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, Contractors may submit a capability statement, proposal, or quotation which shall be considered by the contracting officer whether to continue with the sole source procurement or to provide for competition.

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government.

The Department of Veterans Affairs, NCO 17 will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) in order to be eligible for award. Interested parties are encouraged to furnish information by email only with Response to this Intent to Sole Source notice. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support this requirement.

DISCLAIMER: This notice complies with the requirements of FAR 5.201 and is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract.

STATEMENT OF WORK

CONSIGNMENT FOR NORTH TEXAS VA MEDICAL CENTER

1. SCOPE:

The VA North Texas Healthcare System (VANTHCS), 4500 South Lancaster Rd, Dallas, TX 75216 intends to procure ON-X Heart Valves under consignment for a base period of date of award and four (4) one-year optional years.

2. REQUIREMENTS:

VANTHCS Invasive Cardiology requires ON-X Heart Valves in various sizes, as appropriate for patient care. While the exact number and size of Valves is unknown, the estimated yearly total is noted below. VA attending physicians have the responsibility for determining which products to use and which will best meet the individual patient's medical needs.

3. PRODUCT CHANGES/MODIFICATIONS:

It is understood that there are continual changes in the field of cardiology, and new and improved products are released to the marketplace every year. Therefore, the awarded contract may be modified, through mutual agreement of the parties, to include new heart valves models.

4. CONSIGNMENT TERMS

a. GENERAL:

The Contractor shall furnish and maintain an inventory of s as required. Products shall be placed in the VANTHCS Cardiology Section on a consignment basis in accordance with the terms and conditions of this contract. The Government will be responsible for proper storage and security for all items supplied.

b. INVENTORY LEVEL:

The initial level of consignment inventory to be placed in the Cardiology Section shall be maintained at the Stock Level Agreement (section 4.c.) quantities. This inventory level may be increased based upon need and usage during the contract term with mutual agreement of the parties. The Cardiology section staff will verify and approve the contractor’s proposed consignment level as acceptable. A copy of the approved inventory stocking level will be forwarded to the Contracting Officer for the contract modification. The Contractor shall not commence any changes until notified in writing by the Contracting Officer.

c. Stock Level Agreement

4.c.1.

Initial consignment inventory shall be placed, at no expense to the Government, in the VANTHCS Cardiology Section. The Contractor shall provide a printed inventory packing list, with description of products and part numbers, to the Contracting Officer’s Representative (COR) and the Contracting Office upon delivery of the initial inventory.

d. MAINTENANCE OF INVENTORY:

The Contractor shall coordinate all consignment inventories with the COR. The VA Cardiology Section will consume the Contractor’s consignment inventory on a first-in, first-out basis. The Contractor shall remove or replace inventory as necessary. The Contractor will be given access to the inventory to remove or replace items as necessary. The COR shall be consulted prior to any inventory being removed or replaced. The COR may request that inventory having less than 90 days to expiration date be removed and replaced. These inventory maintenance services shall be completed at no cost to the Government.

e. MONTHLY REVIEW OF INVENTORY:

To determine appropriate stock levels, the Contractor representative will periodically (no less than once per month) conduct a physical inventory of the consignment inventory. The Contractor shall evaluate the actual usage and purchase volume versus the estimated usage, and review the results with designated Contract Officer Representative. Inventory levels may be adjusted accordingly. A copy of inventory list shall be provided to the VA Contracting Office Representative by the Contractor after each monthly review. In the event any such audit reveals that the actual inventory of consigned products is less than the levels set out in the current stock inventory, the COR will determine and communicate with the Contractor the best solution to get the inventory levels adjusted. It can be either by replacing stock, returning item(s) to the stock or determining if stock has been used. Also consider inventory used and not yet replaced by Prosthetics contracting in the last two weeks.

f. OWNERSHIP AND LIABILITY:

The ownership and title of all consigned items shall remain with the Contractor until item(s) are used by the Government. The Government assumes no ownership for any item(s) stored at the VA on a consignment basis until the item(s) has/have been used.

g. PURCHASE ORDERS/ORDERING REPLACEMENT INVENTORY:

The use of any item is entirely dependent on patient diagnosis and need as determined by the attending physician. The Contractor will be paid only after items are implanted or used by the Government. VANTHCS Prosthetics will issue purchase order to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. Products used will be paid for at prices awarded in the contract.

h. DELIVERY:

The Contractor shall deliver replacement products within 48 hours after receipt of the purchase order. The Contractor shall ship products directly to the North Texas VA Healthcare System at no additional charge.

i. ACCEPTANCE OF PRODUCTS:

VANTHCS physicians will have the responsibility to determine which item to use and Prosthetics staff will have final approval for acceptance of products.

j. DEFECTIVE PRODUCTS:

The Contractor shall submit all recall notices within the last 24 months to the Contracting Officer. VA will review and determine potential impact on clinical need. The Contractor shall replace defective products at no cost to the Government.

5. TECHNICAL SUPPORT:

The Contractor shall provide on-site, in-service training to VA Cardiology Section personnel as needed, as well as when approval has been given to add new products to the contract. The Contractor shall adhere to Vendor or Sale representative contract guidelines while on-site

a. REPORTS:

The Contractor shall furnish the Contracting Officer Representative monthly reports. At minimum, these reports shall list all products purchased from the consignment inventory during that contract period.

6. CONTRACT PERIOD:

The VA anticipates consignment for a base period of date of award estimated January 24, 2026 January 23, 2027 and four (4) one-year optional renewal years expiring January 23, 2030.

7. TECHNOLOGY REFRESH:

All implants offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported by the Contractor.

1. If upgrades of implants become available after award of this contract, the contractor will substitute them for the awarded items according to the following:

2. A list of specific awarded items which shall be updated.

3. Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved.

4. The Contracting Officer Representative will provide the information to the Clinical Product Review Committee for approval. Upon approval, the contract will be modified to acknowledge the updated items.

5. All new products that replace awarded items and released to the market during the term of the contract shall be made available to the Government at a discount price agreed to based on commercial sales practices disclosure. If pricing for new products is unacceptable, the VA will continue to use current products on contract and the Contractor shall be required to continue to supply the contracted item.

8. RECALLED AND DEFECTIVE PRODUCTS:

The Contractor shall notify the Government within three (3) workdays of any notification by the Manufacturer of any removal, recall or modification of supplies required under the contract. In the event of any notice of removal, recall, or modification of supplies, the Contractor shall make available to the Government supplies with specifications and features equal to or in excess of those supplies no longer available.

9. RECONCILIATION AT CONTRACT EXPIRATION:

The Contractor shall reconcile all consigned items and inventory and pickup within 10 days of expiration/termination. VANTHCS agrees to return all consignment products in saleable condition (unopened and undamaged) in the original packaging. The VA will issue a purchase order paying for all unsalable products.

End of Document

Special Notice