36C25525Q0301.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* EDWARDS OPEN HEART CONSIGNMENT

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 66048

SOLICITATION NUMBER* 36C25525Q0301

RESPONSE DATE/TIME/ZONE 04-11-2025 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 Memorial Veterans' Hospital

800 Hospital Drive

Columbia, MO 65201

DESCRIPTION

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses.

Responses to this notice shall include:

1. Company Name

2. Address

3. Point of Contact

4. Phone, Fax, and Email

5. UIE number

6. Must provide a capability statement that addresses the organizations qualifications and ability to perform the work in the Statement of Requirements.

See Attached:

1. Statement of Work

Please respond if you can provide.

All responses due by 10:00 am CST, Friday, April 11, 2025 Denise Maynard Contract Specialist denise.maynard@va.gov Network Contracting Office 15

See attached document: Statement of Work

Statement of work: Edwards Open Heart Valves

1. GENERAL INFORAMTION

a. Background: The Department of Veteran Affairs (VA) has identified the Mitral Resilia Vavles and Inspiris Resilia aortic Vavles with Physio II Mitral Annuloplasty rings as an immediate need.

Contractor agrees to furnish and maintain an inventory of Mitral Resilia valves, Inspiris Resilia Aortic Vavles and Physio II Mitral Annuloplasty rings. Solely for Harry S Truman Memorial Veterans Hospital (HSTMVH)’s own use at Premises as set forth in the attached Schedule A (“Products”) as detailed in the stock levels column of the Schedule of Supplies at the (HSTMVH) in Columbia Missouri (“Premises”). Products will be placed in the facility on a consignment basis (“Consigned Products”) in accordance with the terms and conditions of this contract, upon receipt of a no-charge stocking order. The Contractor will assign a representative to the premises to initiate and inventory the consignment inventory monthly.

mailto:denise.maynard@va.gov

b. Purpose and Objectives: The purpose of this solicitation is to establish supply sources that will provide the contracted items for our Surgery Services Department at the HSTVA. The objectives are to ensure the availability and consistency of products for ease of usage and to obtain volume-based, committed use pricing.

c. Agreement Duration: The base agreement period will be for on year, with four one-year option periods that may be exercised by the Government.

d. Award by Item: Award/s will be made by product item. All relevant items must be included in the offer/s. As detailed in the solicitation each offeror is required to offer their complete product line. The intended scope of this agreement includes all current and future product line items. The solicitation details the pricing information required to be submitted for those line items. Prices will be established for each of the product line items. VA recognizes that this market is not static, and we need to have access to state-of-the-art technology.

Therefore, in addition to the items initially agreed upon, the scope of this agreement includes all items which become available during the agreement which are in the product line. New or modified items within the awarded product line may be added to or deleted from the agreement later in accordance with paragraph 5.0 Technology Refresh.

2.0 Extent of Obligation

The Contractor shall furnish all supplies listed in B.3 Price/Cost Schedule and Attachment A Items Edwards Mitrial, Inspiris and Physio II Mitral rings. With Consignment Agreement delivery, to the HSTMVH in accordance with the terms and conditions of this Statement of Work. Items as listed shall be placed at the HSTMVH, stocked in a secured area agreed upon by the Contractor and Contracting Officer’s Representative(s) (COR’s) and as described by the product labeling, at no expense to the Government. The Contractor shall provide all items in strict conformance to the HSTMVH Physician’s prescription that has been provided by the prescribing HSTMVH Facility.

These are commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized.

CONTRACTOR REQUIREMENTS

3.0 Technical Requirements/Tasks:

Contractor shall provide THS Mitral, Inspiris and Phyisio II Mitral Aortic Prosthetic Heart Valves for immediate use. Periodic Adjustment Replenishment (PAR) is included). These valves are as follows, Item # Description/Part Number* PAR Unit

MITRIS RESILIA VALVE

11400M25 25 MM VALVE 1 EA

11400M27 MITRIS RESILIA Mitral Valve, 27MM 1 EA

11400M29 MITRIS RESILIA Mitral Valve, 29MM 1 EA

11400M31 MITRIS RESILIA Mitral Valve, 31MM 1 EA

11400M33 MITRIS RESILIA Mitral Valve, 33MM 1 EA

INSPIRIS RESILIA AORTIC VALVE

11500A19 Inspiris Resilia Aortic Valve, 19mm 1 EA

11500A21 Inspiris Resilia Aortic Valve, 21mm 1 EA

11500A23 Inspiris Resilia Aortic Valve, 23mm 1 EA

11500A25 Inspiris Resilia Aortic Valve, 25mm 1 EA

11500A27 Inspiris Resilia Aortic Valve, 27mm 1 EA

11500A29 Inspiris Resilia Aortic Valve, 29mm 1 EA

PHYSIO II MITRIAL

ANNULOPLASTY RING

5200M24 Physio II Mitral Annuloplasty Ring 24M 1 EA

5200M26 Physio II Mitral Annuloplasty Ring 26M 1 EA

5200M28 Physio II Mitral Annuloplasty Ring 28M 1 EA

5200M30 Physio II Mitral Annuloplasty Ring 30M 1 EA

5200M32 Physio II Mitral Annuloplasty Ring 32M 1 EA

5200M34 Physio II Mitral Annuloplasty Ring 34M 1 EA

5200M36 Physio II Mitral Annuloplasty Ring 36M 1 EA

5200M38 Physio II Mitral Annuloplasty Ring 38M 1 EA

5200M40 Physio II Mitral Annuloplasty Ring 40M 1 EA

MC3 TRICUSPID ANNULOPLASTY

SYSTEM

4900T26 MC3 Tricuspid Annuloplasty System 26T

1 EA

4900T28 MC3 Tricuspid Annuloplasty System 28T

1 EA

4900T30 MC3 Tricuspid Annuloplasty System 30T

1 EA

4900T32 MC3 Tricuspid Annuloplasty System 32T

1 EA

4900T34 MC3 Tricuspid Annuloplasty System 34T

1 EA

4900T36 MC3 Tricuspid Annuloplasty System 36T

1 EA

4.0 DELIVERY:

1. DELIVERY REQUIREMENTS. The Contractor shall deliver FOB destination, the supplies on an as needed basis when requested by the Contracting Officer, COR, and Logistics and Prosthetics purchasing agents. Only the Contracting Officer or designee will be authorized to coordinate and request consignment items direct from the contractor.

2. JUST-IN-TIME DELIVERY. Normal delivery time is within 48 hours after receipt of order Monday through Friday. Urgent delivery is upon receiving notification no later than 9:00 AM local time the day before delivery, the awardees shall supply to appropriate facility personnel all required items by 10:30 AM the following day. Orders must be received and delivered five (5) days per week in these situations. Orders may be made orally, faxed, e-mailed, written or by delivery order.

3. ADDITIONAL ACCESSORY ITEMS. If needed, the Contractor shall provide, at no additional cost to the Government, to the HSTMVH staff additional accessory items (i.e., sizers, handles and trays) that are handled, but not implanted for the consigned products in this Agreement.

Contractor may be required to have additional accessory set(s) for the implant procedures at no additional cost to the Government. This would be to provide in case of damaged/mishandled items. If damage occurs due to the Government, costs may be reimbursed to the Contractor.

a. The deliverables will be the implant systems themselves. After initial stock is brought on board replacement stock purchased through Prosthetics will need to be delivered within 14 business days from the day the contractor receives the purchase order.

3. Contractor Selection by Medical Center. Ordering Procedures:

After award, individual orders for these highly specialized items will be based on the unique circumstances of each procedure, considering individual patient needs and physician training.

4.0 CONSIGNMENT AGREEMENT DELIVERY:

1. INITIAL INVENTORY: The products listed on the “Initial Inventory Schedule Attachment A” represent the products that must be available for the initial inventory. The initial inventory required for each product is shown in the Initial Inventory Schedule Attachment A. However, this level may be changed by written notification of the Contracting Officer. The Contractor shall place the products at the designated location(s) within the time specified, or if no time is specified, no later than ten (10) calendar days after receipt of the fully executed contract. Each facility will provide adequate space/shelving for stocking these products. The contractor shall provide a complete listing of model and part numbers to the Contracting Officer’s Representative (COR) upon delivery of the initial inventory.

2. INVENTORY LEVEL: All consignment inventories will be coordinated with the COR. The contractor agrees to coordinate with the COR to always maintain the inventory level of product. At no time shall the number of products held on consignment fall below the minimum quantity specified without the concurrence of the COR. If it is discovered that the stock quantities fall below the agreed minimum stock level, the contractor must replenish the stock level with like quantities of items within 48 hours at no additional expense to the Government.

3. INVENTORY MANAGEMENT: The designated contractor’s representatives assigned to the facility will conduct a monthly physical inventory. This inventory shall be conducted with the facility POC and/or the COR. A copy of the inventory will be maintained by the facility POC and provided to the COR and Contracting Officer. At a minimum, the report will contain stock utilization and levels and recalled/outdated items found and removed. The excess unused items will be returned to the contractor at the end of the term of the agreement without reimbursement or other expense to the Government, provided that such items are in unopened and undamaged condition.

4. REPLACEMENT PRODUCTS: The facility will withdraw products from the consignment stock on a first-in-first-out basis. After each procedure, but no later than seven (7) business days after such procedure, an order (Delivery order for over $10,000.00 or a purchase card for $100,000.00 or less) will be placed listing the products used and the vendor shall replace these products within the time specified. If no time is specified, delivery shall be within five (5) calendar days. Replacement products will be shipped/delivered to FOB Destination directly to the requesting location at no additional cost to the Government. A purchase card order or Delivery Order will serve as authorization for the delivery of replacement items and payment for the item(s) used.

5. PRODUCT STERILIZATION: The contractor shall replace any accessory items such as handles, trays and sizers that are handled, but not implanted, at no additional cost to the Government. The handled items shall be shipped periodically upon written request by the COR at no additional cost to the Government. The contractor does not re-sterilize products.

6. ALTERATION OF QUANTITIES: The contractor agrees that the total quantity of items furnished under the agreement can be changed at any time during the effective period of the agreement. The contractor agrees that from time to time, the contracting officer may change the number of items on consignment by written request. Any such changes shall be mutually agreed upon and the Contracting Officer providing a change modification request.

7. DEFECTIVE PRODUCTS: The contractor shall replace defective products according to the delivery schedule of the agreement at no additional cost to the Government, unless the facility has misused or lost the product.

8. EXPIRING INVENTORY: Inventory having less than 30 days sterility/expiration date must be removed and replaced. The contractor shall provide a list of all the expired products to the COR. The HSTMVH is not liable for devices that are allowed to expire. These removal/replacement services will be completed at no additional cost to the Government.

9. EXPIRATION/TERMINATION OF AGREEMENT: Upon expiration/termination of the agreement, the HSTMVH will reconcile all consignment stock units. The contractor will remove all unused items at the end of the effective period of the agreement without reimbursement or other expense to the Government, provided that such items are in unopened and undamaged condition.

10. DELIVERY SCHEDULE: The vendor shall contact the COR (or COR designee) at the VA to coordinate the delivery of the products. Delivery of the products shall be during normal working hours, between 6:30 AM and 4:00 PM Monday through Friday.

11. UNIT PRICING:

The unit price for each item/implant shall remain the same throughout the term of this Agreement, as identified in the Price/Cost Schedule.

12. INITIAL INVENTORY LEVELS:

An initial consignment inventory is indicated in Attachment A Items; however, this level may be changed by written mutual written notification of the Contractor and the Contracting Officer. Initial consignment inventory shall be placed in the participating Medical Center(s) within ten (10) calendar days after receipt of Notice of Award.

13. CONSIGNMENT ITEM OWNERSHIP/TITLE:

The Contractor shall maintain ownership of all consigned items furnished under this Agreement, until such time that the Government uses (implants) the consigned item.

14. GOVERNMENT SAFEGUARDING OF ITEMS ON GOVERNMENT PREMISES:

The Government is responsible for storing the consignment items and for using the items as indicated by product labeling, as they are needed. Once used, the Government orders a replacement and is invoiced at the agreed price for the used product. The Government will provide proper storage and security for all items supplied hereunder and is responsible for all expenses incidental to the safekeeping and security of items on Government premises.

15. CONTRACTOR LIABILITY:

The Government shall be held responsible for any consignment item that has been without question damaged, misused, or lost by Government. If the Contractor damages the item, or the item is defective, it shall be replaced by the Contractor, with no re-stocking fees of any kind assessed upon the HSTVA Medical Center. The determination as to whether the Government was undeniably negligent related to the damage, misuse or loss of consignment items shall be decided by mutual agreement between the Contractor and the Contracting Officer, based on evidence presented.

Disagreements thereafter shall be settled in accordance with the Disputes Clause.

16. CONSIGNMENT EXPIRATION/TERMINATION:

All unused, unopened and undamaged items will be returned to the Contractor at the end of the term of this agreement, or cancellation of this agreement, without reimbursement or any additional expense to medical center. Contractor shall be responsible for all shipping costs associated with their return.

17. MODIFICATIONS:

Changes to the agreement will be made with mutual consent of both parties. Changes will be made in writing and signed by the Contractor and the Contracting Officer. Neither CORs nor HSTMVH staff have the authority to make changes to the agreement. The only Government official authorized to make changes to the Agreement is the Contracting Officer.

18. CONSIGNMENT ITEMS ROTATION:

Contractor shall remove and/or replace items from consignment inventory as necessary. If items have 30 days or less remaining before the sterility expiration date, they must be replaced. The Contractor shall advise the COR prior to any inventory item(s) being removed or replaced; upon removal or replacement of that item, the COR will sign receipt for that item. The Contractor shall perform these services at no cost to the Government.

19. PAYMENT/REPLACEMENT:

As consignment items listed under the Price/Cost Schedule are used, payment will be made by purchase card (if $100,000.00 or less) or Delivery Order (if over $100,000.00) the Contracting Officer/Prosthetics Purchasing Agent to the Contractor within 48-72 hours of its use, at the price listed in the Price/Cost Schedule. This purchase order will authorize payment for the used item(s) and will also authorize delivery of the replacement item(s). The purchase order shall be referenced on the invoice and delivery ticket for the replaced items. All replacement items shall be delivered within five (5) business days from receipt of purchase order. Replacement of consignment items is through the Contractor’s Customer Service department by providing a purchase/delivery order number including model, size and serial number used, for the consignment items and quantities needed. Contractor will be paid only after consigned item(s) is/are used (implanted) by the Government, at the replacement cost indicated in this agreement. Purchase orders and/or Government credit card may be issued/used for reordering and payment.

20. PAYMENT PROCEDURES:

Contractor must accept the Government Purchase Card as a form of payment for orders $100,000.00 or less. Orders over $100,000.00 will be paid through Delivery Order issued by the Contracting Officer.

21. INVENTORY SIGN IN/OUT PROCESS:

The HSTMVH will develop an inventory accountability process, whereby each consigned item shall be accounted for. Contractor shall log each item that they place or remove from the consignment inventory; the item’s disposition shall be logged, dated and double signed (Contractor’s signature and the COR’s signature or COR’s designee). COR will log the item’s disposition each time an item is removed from inventory. This log sheet shall consist of (at a minimum) the following information:

a. Date

b. Item Description

c. Item serial number (or identification number)

d. Description of item disposition (Narrative stating what happened to the item)

e. Printed Name and Title of person who placed or removed the item

f. Signature of item “e” above

g. Counter signature (including Printed Name and Title) if required

22. CONTRACTOR INVENTORY CHECKS:

Contractor shall periodically (at least twice per year) conduct a physical inventory (audit) of the consignment items. Inventory results shall be furnished to the COR.

23. SPECIAL IMPLANT NEEDS:

Occasionally specific patients may require a special implant not available from the consignment inventory. These items will be purchased from any contractor whose pricing is deemed to be fair and reasonable following all Government rules and regulation as they pertain to the acquisition of supplies. Special use items that become routinely used may be added to this agreement by a mutually agreed upon modification issued by the Contracting Officer.

24. DEFECTIVE CONSIGNMENT ITEMS/GUARANTEE:

Contractor shall replace defective consignment items or related supplies at no charge to the Government. The consignment items shall be subject to the terms and conditions specified in the warranty information for each individual item. All items will be in proper working condition as required by applicable quality standards.

5.0 TECHNOLOGY REFRESH:

1. All implants, instruments, and accessories 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 in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of award are not acceptable.

2. If upgrades of implants, or supplies become available after award of this agreement, the contractor and Government shall mutually agree to adding replacement items for the awarded items.

3. The contractor will provide to the contracting officer the following information:

(1) A list of specific awarded items which shall be updated.

(2) 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 will provide the information to the Program Office for approval. Upon approval, the agreement will be modified to acknowledge the updated items.

5. Upon mutual agreement, new products may replace awarded items during the term of this Agreement. If pricing for new products is unacceptable, medical centers will continue to use current products on agreement and contractor will be required to continue to supply the agreement items.

6.0 ON-SITE PERSONNEL REQUIREMENT:

Contractor shall endeavor to have qualified personnel available within 120 minutes (2 hours) of reasonable request by the medical center. The technical representative will provide technical information of the contractor’s products. At the time of request, HSTMVH will provide the contractor with a list of contact information for that implant device and a list of medical centers that provide clinic follow-up care. Technical support will be available twenty-four (24) hours a day on technical issues. Contractor must return telephone calls for assistance within two (2) hours of the Medical Center’s telephone call to the contractor. Upon request, the contractor must provide names of the contractor representatives covering the Medical Center. If the contractor fails to provide the above information or the needed support the agreement may be terminated.

Upon award, contractor shall inform CORs of appropriate contractor representative contacts and their phone numbers.

7.0 PRODUCT MODIFICATION, REMOVAL OR RECALL:

If any product awarded under this solicitation requires modification, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:

a. Notify Chief, Surgical Services, Columbia MO VA Medical Center, 800 Hospital Dr, Columbia MO 65203 in writing, by the most expeditious manner possible. Provide two copies of the notification, which shall include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the agreement number assigned as a result of an award on this solicitation.

(2) Reasons for modifications, removal or recall.

(3) Necessary instructions for return for credit, replacement or corrective action.

b. A copy of the notification in a. above shall be provided to:

Chief of Prosthetics Columbia MO VA Medical Center

800. Hospital Dr.

Columbia, MO 65203

c. The Contracting Officer shall be provided a copy of the notification in a. above.

8.0 Sterile Processing Service (SPS) SUPPORT:

i. All items delivered to the medical center shall be accompanied by a complete inventory listing to include lot numbers and expiration dates.

ii. Vendor or designee shall visit SPS before delivering product to Surgical Suite, so that SPS can verify the inventory list and ensure that the condition of the packaging is intact and are labeled as being sterilized.

iii. No items shall be marked miscellaneous.

9.0 TRAINING:

Contractor shall provide on-site, in-service training to HSTMVH staff as needed.

12.0 NATIONAL PROVIDER IDENTIFIER (NPI) INFORMATION REQUIRED:

All Contractors and health care practitioners who provide billable health care services to the Department of Veterans Affairs, VHA, shall obtain a National Provider Identifier (NPI) as required by the Health

Insurance Portability and Accountability Act (HIPPA) National Provider Identifier Final Rule, administered by the Centers for Medicare and Medicaid Services (CMS). This rule establishes assignment of a 10-digit numeric identifier for health care practitioners, intended to replace the many identifiers currently assigned by various health plans. Each practitioner needs only one NPI, valid for all employers and health plans. The NPI may be obtained via a secure website at: https://nppes.cms.hhs.gov/NPPES

13.0 AGREEMENT ADMINISTRATION DATA:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this agreement. The Contractor shall communicate with the Contracting Officer on all matters pertaining to agreement administration. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, or quality of performance of this agreement. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the agreement price to cover any increase in costs incurred as a result thereof.

14.0 ID BADGES/PARKING/SMOKING POLICY:

a. CONTRACTOR SIGN-IN – Contractor personnel shall report to Supply Chain Management Service (Logistics), before visiting the facilities, to sign-in and receive a contractor’s security badge.

b. BADGES – All Contractor personnel are required to wear identification (ID) badges during the entire period during which they are on HSTMVH grounds. ID badges must show an identification picture, name of the individual, and the represented company.

c. PARKING – It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the HSTMVH Security Service. The HSTMVH will not invalidate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

d. SMOKING – Smoking is not permitted within or around the HSTMVH Healthcare System facilities, except in designated areas.

(END STATEMENT OF WORK)