6515--Consignment | Structural Heart Valves - New Requirement - Pittsburgh | EDA: 07/08/2026 RCN. - SPE 49471 (VA-26-00060187)

NOTICE OF INTENT TO SOLE SOURCE: IAW RFO FAR 5.101 this notice is to advise the public that The Department of Veterans Affairs, Regional Procurement Office East (RPOE), Network Contracting Office 4, intends to award a sole source, Firm-Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ) contract pursuant to RFO FAR 12.102 to Edwards Lifesciences LLC located at 1 Edwards Way, Irvine, CA, 92614, for an ordering period of five (5) years. The Pittsburgh VA Medical Center (VAMC) requires a contract with consignment agreement for structural heart valves.
THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS or QUOTATIONS. Responsible sources that believe they can meet the requirements may give written notification by submitting capability information that clearly demonstrates the capability to provide the following products via consignment. Capability information is required prior to the response due date and time, to establish the ability of the source to meet this requirement. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to fulfill the requirements and must include relevant corporate experience along with the applicable contract number, total contract dollar amount, contract period of performance, details of the relevant products and customer point of contact with corresponding telephone number and email address.
Responses must include following information: 1. Company Name 2. SAM UEI number 3. Company s address 4. Point of Contact information (title, phone number and email address) 5. Business size.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification.
Responses are due by 4:00 pm ET, Friday, June 26, 2026. No submissions will be accepted after this date and time. Responses shall be submitted via email to contact@example.gov. Telephone inquiries will not be accepted.
The NAICS code for this acquisition is 339113 and the size standard is 800 Employees. STATEMENT OF NEED Structural Heart Valves Pittsburgh VA Medical Center University Drive C Pittsburgh, PA 15240
1. SCOPE: The Department of Veterans Affairs (VA), VA Pittsburgh Healthcare System (VAPHS), requires a contract with consignment agreement for the Cardiac Surgery Service. The primary objective of this contract is to standardize the procurement process for obtaining Edwards Lifesciences Structural Heart valves. The agreement aims to ensure an efficient, reliable, and uninterrupted supply of these critical medical devices to support the cardiac surgery service at VAPHS. By establishing this contract, VAPHS will have a consistent, streamlined approach to procuring structural heart valves, thereby enhancing the quality of cardiac care available to veterans. The agreement will encompass the following key components: Provision of Edwards Lifesciences Structural Heart valves of various sizes and specifications. Standardized consignment terms to ensure that necessary inventory levels are maintained without the immediate need for full-front payments. Delivery and logistics management to ensure timely and accurate supply to VAPHS. Documentation and reporting to track usage, manage inventory levels, and facilitate billing and payments. The aim is to improve patient outcomes by providing access to high-quality, reliable structural heart valves, which are essential for the successful treatment of patients with heart valve stenosis. 2. REQUIREMENTS: VAPHS requires Edwards Lifesciences Structural Heart valves in a variety of sizes to accommodate different patient anatomies and clinical needs. Pittsburgh VAPHS estimates a need of 10-15 valves per year. An estimate by type and size is not possible due to differences in patient need. The latest year available, 2025, usage is provided as reference: 2025 Valve Usage Product # Used Aortic Valve 19MM 0 Aortic Valve 21MM 1 Aortic Valve 23MM 2 Aortic Valve 25MM 4 Aortic Valve 27MM 6 Aortic Valve 29MM 0 Mitral Valve, 25MM 0 Mitral Valve, 27MM 0 Mitral Valve, 29MM 0 Mitral Valve, 31MM 0 Mitral Valve, 33MM 2
3. PRODUCT CHANGES/MODIFICATIONS: Recognizing the continual advancements in the field of cardiac surgery and the frequent introduction of new and improved products, the awarded contract may be modified, through mutual agreement of the parties, to include new models of cardiac valves, rings, and bands. These modifications will ensure that VAPHS has access to the latest and most effective products available on the market. Key considerations include: Introduction of New Products: As new models of cardiac valves become available, they may be added to the contract to enhance the range of options provided. Mutual Agreement: Any modifications to include new products will be made through mutual agreement between VA and Edwards Lifesciences, ensuring that both parties are aligned with the changes. Ongoing Assessment: Regular assessments will be conducted to evaluate the need for incorporating new products based on clinical efficacy, physician feedback, and patient outcomes. Implementation Timelines: Agreed-upon modifications will have clearly defined implementation timelines to ensure seamless integration of new products into the inventory. Documentation and Training: Comprehensive documentation and, if necessary, training will be provided for any new products introduced to ensure proper utilization and integration into clinical practice. By accommodating advancements in cardiac surgery technology, this flexible approach ensures that VAPHS continues to provide cutting-edge treatment and maintains the highest standards of patient care. 4. CONSIGNMENT TERMS GENERAL: The Contractor shall provide and maintain an inventory of Edwards Structural Heart Valve products as required. These products shall be placed at VAPHS in the Operating Room on a consignment basis, in accordance with the terms and conditions of this contract and the consignment terms. The Government will be responsible for all expenses related to the safekeeping and use of the consigned items and shall ensure proper storage and security for all items supplied under this agreement. The consignment inventory must be stored in a locked storage cart. INVENTORY PAR LEVEL: Although a par level for the facility will be established initially, it may be adjusted based on real-time demand, changes in clinical requirements, and physician preferences. An initial consignment Inventory level will be mutually determined by the attending Cardiac Surgery Physicians at VAPHS and the contractor. The Inventory level may be adjusted based on need and usage throughout the contract term, subject to mutual agreement between the parties. The Cardiac Surgery Physician will verify and approve the contractor s proposed consignment level to ensure it meets the facility s requirements. A copy of the approved inventory stocking level will be forwarded to the Contracting Officer for the contract file. Initial consignment inventory shall be placed at no expense to the Government in the Operating Room or designated area. The Contractor shall provide a printed inventory list, including product descriptions, part numbers, lot numbers, and expiration dates, to the Contracting Officer Representative and the warehouse department upon delivery of the initial inventory. MAINTENANCE OF INVENTORY: The Contractor shall coordinate all consignment inventories with VA-designated staff. The VA facilities will utilize the Contractor s consignment inventory on a first-in, first-out basis. The Contractor is responsible for removing or replacing the inventory as necessary. To facilitate this action, the Contractor will be granted full access to the inventory, contingent upon prior consultation with the designated VA facilities staff. Before removing or replacing inventory, the Contractor must confer with the VA facility staff. Upon request by VA-designated staff, the Contractor shall remove and replace inventory items that are within 30 days of their expiration date. All inventory maintenance services provided by the Contractor shall be performed at no cost to the Government. SEMI-ANNUAL REVIEW OF INVENTORY: To effectively uphold the ideal inventory PAR Level, VA Staff, along with the contractor's representative, will conduct thorough inspections of the consignment inventory a minimum of twice annually. During these evaluations, the contractor will meticulously analyze actual usage and purchasing patterns, comparing them with the anticipated turnover rate to ensure optimal stock management. The contractor will provide a copy of the inventory list to the VA contracting office. If any audit shows that the actual inventory of consigned products is below the current stock inventory, VA will order and pay for enough products to restore the inventory to the required levels. OWNERSHIP AND LIABILITY: The Contractor retains ownership and title of all items consigned until the Government uses them. The Government does not assume ownership of any items consigned to VA until the items are used and a purchase order is issued under the agreement. The Government will, however, take responsibility for any items damaged or lost while in its care. PURCHASE ORDERS/ORDERING REPLACEMENT INVENTORY: The use of any item is based solely on the patient s diagnosis and need as determined by the attending physician. The contractor shall supply the required products. Payment to the contractor will be made only after the items are implanted or used by the Government. When a valve is implanted or wasted, the facility's designated clinical staff will place a patient-specific surgical prosthetic consult, indicating the model, size, lot, or serial number. The prosthetic purchasing agent (PA) will then issue an individual purchase order (PO) to pay for the used item and to procure its replacement. The VA-designated storage department, Operating Room, is responsible for any inventory discrepancies unless they are due to outstanding deliveries tracked to a specific veteran. Products used will be paid at the prices listed in the Price/Cost Schedule. DELIVERY: The Contractor shall deliver replacement products within two (2) business days after receiving the purchase order. The Contractor will prepay and cover all transportation charges for shipping. ACCEPTANCE OF PRODUCTS: VAPHS physicians will have the responsibility to determine which item to use. Physicians at VAPHS will be authorized to accept products. DEFECTIVE PRODUCTS: The contractor shall replace defective products at no cost to the Government. TECHNICAL SUPPORT: The contractor shall provide a technical support helpline to answer end-user questions and provide consultation on products at no cost to the Government. REPORTS: The contractor shall furnish the Contracting Officer an annual report within 30 days of the contract anniversary date that lists all products purchased from the consignment inventory during the contract period. 5. JUST-in-TIME DELIVERY: This delivery method ensures that products not currently in consignment inventory can be swiftly requested and delivered for surgical use. Occasionally, the physician attending may determine that a different size is required for a specific patient. In such cases, every effort will be made to provide the Contractor with a reasonable lead time to order and/or deliver the requested product to the VA facility. If the product is used, payment will be processed in the same manner as for consignment products (4g). 6. CONTRACT PERIOD: The VA anticipates a five (5) years agreement. The ordering period will begin upon the parties' final signatures. 7. VA STANDARDIZATION PROGRAM: The Department of Veterans Affairs has implemented a department -wide standardization program. As a result, the VA National Acquisition Center (NAC) is issuing national and/or regional contracts and blanket purchase agreements (BPA s) for standardized items. When items in this contract are standardized under any NAC national or regional standardization contract or BPA, they will be removed from this agreement 60 calendar days after the Contractor receives written notice from the VA Contracting Officer. 8. RECALLED AND DEFECTIVE PRODUCTS: The Contractor shall immediately notify the Contracting Officer and Program Point of Contact of any recalls of products or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse the Government for recalled/defective products at no cost. 9. RECONCILIATION AT CONTRACT EXPIRATION: Upon expiration or termination of this contract, the Contractor is responsible for the reconciliation of all consigned items and will, within 15 days of expiration/termination, inventory and pick up all consigned products. VAPHS agrees to return all consignment products in saleable condition (unopened) in the original packaging. The facilities will issue a purchase order for all unreturnable products. VALIDATED USER/CUSTOMER COMPLAINTS: Complaints from specialty service staff regarding lack of technical support will be collected and investigated. Poor performance may cause negative contractor performance ratings to be assigned in the Contractor Performance Assessment Reporting System (CPARS). 10: CONTRACT ADMINISTRATION: The contract will be administered by the Contracting Officer (CO) and by the Contracting Officer s Representative (COR) participating in the consignment agreement, as delegated by the CO. The COR will recommend a modification to the CO if necessary. The CO will approve and process contract modifications as appropriate.