Sources Sought Heart Valves.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* Heart Valves

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 66048

SOLICITATION NUMBER* 36C25525Q0248

RESPONSE DATE/TIME/ZONE 03-14-2025 10:00am CENTRAL TIME, CHICAGO, USA

ARCHIVE 45 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339113

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office (NCO) 15

3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Contracting Officer

Denise Maynard denise.maynard@va.gov

PLACE OF PERFORMANCE

ADDRESS Harry S. Truman Veterans'Hospital

800 Hospital Drive

Columbia, MO 65201-5275

DESCRIPTION

Statement Of Need

In the spirit of the Federal Acquisition Streamlining Act, The Harry S. Truman VA Medical Center would like to enter into a cooperative Memorandum of Understanding (MOU) with Edward Life Sciences, LLC for a consignment agreement. A consignment agreement for the items that this vendor will provide offers cost savings, improved inventory management, timely availability, enhanced patient care, reduced paperwork and administrative tasks, and flexibility compared to ordering items individually every time.

This Consignment Agreement with Edward Life Sciences, LLC will be for SAPIEN 3 Transcatheter Heart Valve THV with certitude system. Under this agreement, the Contractor shall provide two delivery methods to The Harry S. Truman VA Medical Center. The first delivery method shall be “Just in Time” which is a demand forecasting process where you order just enough product to meet specific needs without overstocking and the second method is consignment delivery for consigned stock inventory denoted on a PAR level inventory schedule.

Pricing under this consignment agreement for Edward Life Sciences, LLC consigned items shall be consistent with the pricing reflected in the established inventory list that accompanies this MOU.

A PAR level inventory will be established based on this list for all consigned items that are stocked on the shelf at:

Department of Veterans Affairs Harry S. Truman VA Medical Center 800 Hospital Drive Columbia, MO 65201

DELIVERY, ORDERING, INVENTORY AND RETURNS

Delivery Tickets/Packaging:

All deliveries shall contain the following information.

• Name and Address of Supplier

• Name and Address of Receiver

• Product Number, Product Description and Quantity Shipped

• Serial numbers and or expiration date if applicable

• Customer PO number and Sales Order number

Orders:

For items consigned to the Harry S. Truman VA Medical Center, the Government will utilize the Post Consignment/Inventory consult and submit to Prosthetics after a consigned item is used by the facility, who will forward to the appropriate contracting activity to issue an order for payment and if needed, initiate the shipment of the replacement item.

Inventory:

There are two types of inventories covered under this consignment agreement - (1) Consigned Stock Inventory, and (2) Consigned JIT Inventory. The contractor agrees to accept the VA Government

Purchase Card as the preferred method of payment for inventory used. Delivery Orders will be issued when deemed appropriated by the VA. The Prescribing Physicians are responsible for selection of items to be used and will have the final approval for acceptance of those products.

Consigned Stock Inventory:

Consigned stock inventory is contractor owned inventory consigned to the Harry S. Truman VA Medical Center on a PAR level inventory schedule for use by VA staff on an as needed basis.

Contractor will be paid only after consigned items are used by the Government, at the replacement cost indicated in the base contract. The Contractor agrees to deliver replacement items within (48) hours after receipt of an order. Replacements will be shipped/delivered FOB Destination. Delivery Orders for replacement items will be faxed or emailed through the Contractor’s designated Customer Service department. Orders will provide model, size, serial number and expiration date if applicable for the product and quantities used. In no event will patient PII or PHI be transmitted via email without approved encryption. Any patient information should be faxed or redacted if emailed.

The Logistics Department at the Harry S. Truman VA Medical Center will maintain the consigned stock inventory locally always showing all transactions and the total value of consigned inventory during the terms of the agreement. The Contractor will be allowed to have access to the consigned inventory upon a minimum of 24-hour advance notice to the facility POC. It is recommended that contractor’s personnel conduct a quarterly inventory. The contractor shall conduct at least once per six months, a physical inventory with the facility POC and or COR. A copy of inventory will be maintained by the facility POC and provided to the COR and Contracting officer.

Age of Inventory: The Harry S. Truman VA Medical Center will utilize Contractor’s product on a first-in, first-out basis to the maximum extent practical. Harry S. Truman VAMC Staff may request that Inventory having less than 90 days sterility/expiration date be removed and replaced. A list of all products having an expiration date of less than 90 days will be provided to the COR at the Harry S. Truman VAMC. These replacement services will be completed at no additional cost to the Government. The Harry S. Truman VAMC is not liable for devices that are allowed to expire if not removed when requested. Government will be responsible for replacing items that have been misused or lost.

PAR levels may be changed, removed or added as well as non-consigned inventory added to the agreement upon mutual agreement of the parties. Any such changes must be requested by the Program Office and will be made by written modification to the agreement by a Contracting Officer.

Returns:

Unused (Unopened and Undamaged) items will be returned to the Contractor at the end of the effective period of this consignment agreement without reimbursement or other financial obligations to the Harry S. Truman VA Medical Center. Unused items will be removed from the facilities by the Contractor within thirty (30) days after written notification of completion or cancellation of this consignment agreement.

Consigned JIT Inventory:

Consigned JIT Inventory is contractor-controlled inventory kept with the contractor but available as if it was on hand at the Medical Center. These items may be requested on a “Just in Time” basis at the contracted prices. The Harry S. Truman VA Medical Center will call the sales representative when surgery is scheduled to discuss the case, make a product selection from Contractor’s product line and inform the sales representative of the surgery date and time. The sales representative will transport the implants, instrumentation sets, auxiliary products and backup components necessary for surgery to the designated site at the scheduled time. Contractor will be paid only after consigned items are used by the Government, at the replacement cost indicated in the base contract.

CONTRACTOR RESPONSIBILITIES

a) The Contractor agrees to maintain the specified quantities set forth under an agreed upon schedule at all times during the term of this consignment agreement by promptly replacing like quantities of items that may be used, thus assuring instant availability of all items specified by the Harry S. Truman VA Medical Center covered under this agreement. All deliveries shall be coordinated through the Contracting Officer issuing the delivery order and facility point of contact or designee.

b) Contractor will remove or replace consigned inventory as necessary when inspected by the Contractor or upon request by the Harry S. Truman VA Medical Center Staff such as defective or expired items. These replacement services will be completed at no cost to the Government.

c) The Contractor shall notify the facility point of contact within one (1) business day for nonemergency Orders and within four (4) hours of an emergency Order if any parts/materials cannot be delivered in accordance with the individual order delivery requirements. To ensure that the correct items are shipped, the Contractor shall not substitute items without prior approval by the facility POC. Instances where the Contractor cannot meet the Government’s requirement(s), the Contractor shall notify the facility POC of the shortest delivery period available.

d) If applicable, Contractor shall provide on-site, in-service training to Prosthetic personnel, the same as what is provided to commercial customers.

VA RESPONSIBILITIES

a) VHA Clinicians determine the prosthetic needs of patients as a part of their clinical care and follow-up with the patient to ensure the necessary device(s) are purchased to achieve the optimal clinical outcomes. Clinicians, in consultation with the patient, will decide what device is medically necessary to best meet the need(s) of the patient. When requesting the device, clinicians are required to provide information to the Prosthetic and Sensory Aids Services

(PSAS)

staffs in the form of a patient consult via the Computerized Patient Record System. When considering which device will be provided to the patient, clinicians should consult with the PSAS staff at the medical center for guidance regarding those prosthetic appliances and sensory aids on the Prosthetic National Strategic Source Contracts awarded by the VA.

Prosthetic and Sensory Aids Services (PSAS) are responsible for:

i. Ensuring all requests for the purchase of prosthetic appliances and sensory aids, above the micro-purchase threshold, are entered into the eCMS Planning Module in accordance with the established timelines/standards to include an invoice and other appropriate documentation.

ii. Ensuring all requests for the purchase of prosthetic appliances and sensory aids, below the micro-purchase threshold, are directed to the appropriate purchasing unit.

iii. Working with the prescribing clinician to ensure consult contains all pertinent information.

e.g., quantity, delivery date and location, and any other special requirements.

LIABILITY

The ownership and title of all consigned items shall remain with the Contractor until such a time said item(s) are used. The Government is liable only for those items used by the Harry S. Truman VA Medical Center. At the end of the agreement period, unused (unopened and undamaged) items shall be returned to the Contractor without reimbursement or other expenses to the Government. Purchase/Delivery orders will be issued for all unreturned products, including any lost, damaged, stolen or missing consigned inventory. The Government is responsible for storing the consigned inventory and using them as indicated by product labeling. The Government will provide proper storage and security for supplied item(s) and is responsible for expenses incidental to safekeeping within the Government premises. The Government assumes responsibility for any lost, damaged, stolen or missing product.

LIABILITY EXCLUSION

Neither party shall be liable for any failure or delay in the performance of this Contractual Agreement under extra ordinary circumstances beyond control of each party, i.e., acts of God, including but not limited to earthquake, fire, flood, and the like, wars, embargoes, accidents, and any other acts or order of any government or governmental agency are deemed to be beyond control of said parties.

ALTERATION OF QUANTITIES & TECHNOLOGY REFRESH

The Contractor Agrees that the total quantity of items furnished under this Agreement can only be changed by mutual agreement with the Contracting Officer. The Contractor also agrees to inform the facility of any technology refresh of products and if requested by the COR, replace the existing items with the newer models. Any changes due to technology refresh must also be done by mutual agreement with the Contracting Officer in accordance with the base contract.

CANCELLATION

a) This agreement may be terminated by either party by giving thirty (30) day written notice.

When so doing as directed, the Contractor will remove all unused products furnished for stock at a participating facility within thirty (30) days upon expiration of this agreement or upon receipt of written notice of cancellation. Upon the expiration of this consignment agreement, the VA shall reconcile all consignment stock units as follows:

Return stocks are in saleable conditions (unopened and undamaged package) for credit against the Consignment Stock Level; and/or

Issue purchase/delivery order for all unreturned stock, including any lost, damaged, stolen or other missing stocks.

SECURITY REQUIREMENTS:

The VA’s C&A requirements as well as the Security Accreditation Package are not required for this agreement. At no time is VA sensitive information i.e., patient PHI or PII to be transmitted verbally or electronically to the Contractor. The CO will ensure all sensitive information will be redacted or excluded from orders to the Contractor.

Contractor’s Personnel Security Requirements:

All contractor employees who require access to the Harry S. Truman VA Medical Center’s campus must follow the Medical Center Policy for those requesting access. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

Contractor Responsibilities:

The contractor shall prescreen all personnel to ensure they maintain a U.S. citizenship or valid legal status that allows personnel to work within the United States and its Territories. All such personnel shall be able to read, write, speak, and understand the English language.

The Contractor is responsible for adhering to the policies and procedures regarding security and reporting any suspected violations and security.

Substitutions: It is expected that the Contractor shall maintain a local Company Representative to perform under this agreement, however, when such personnel are substituted for any reason, Contractor is to notify the VA’s appointed COR/POC prior to any visit to conduct company business at a participating facility.