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 jefferson.mann@va.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…