P09 SOW surgical draft.pdf

Statement of Work (SOW)

1.0 INTRODUCTION:

1. Background. The Department of Veterans Affairs (VA) has identified the Edwards

Lifesciences and the following Surgical heart valve and annuloplasty ring items: INSPIRIS RESILIA Aortic Heart Valve, Magna Ease Pericardial Aortic Bioprosthesis, Mitral/Tricuspid Annuloplasty System, Physio II Mitral Annuloplasty Ring, Magna Mitral Ease Pericardial Valve, MITRIS RESILIA Mitral Valve, as an immediate need for our Surgery Services Department at Veterans Integrated Service Network (VISN) 01 locations. The ring's design aims to offer post-surgery support following annuloplasty. It keeps the natural valve annulus from distending excessively by maintaining a set maximum size while adjusting to the mitral annulus's movement during the cardiac cycle. For easy implantation, the ring comes with a holder. The INSPIRIS RESILIA aortic valve combines elements from the reliable Edwards PERIMOUNT and Magna Ease aortic valve platforms to improve the ease of implantation. This need is specifically for our Cardiac Vascular Program to ensure that uninhibited treatment is provided for our cardiac patients. The purpose of this contract is to obtain user uniformity and quality products.

2. 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 Veterans Integrated Service Network (VISN) 01 locations. The objectives are to ensure the availability and consistency of products for ease of usage.

3. Period of Performance. The contract period will be 5 years from date of award.

4. Agreement Effective Date. The effective date of the agreement shall be the date last signed by the parties after the date of award.

5. Contract Type. This will be a Blanket Purchase Agreement with a Consignment Agreement delivery.

2.0 EXTENT OF OBLIGATION:

1. The Contractor shall furnish all supplies listed in B.3 Price/Cost Schedule and Attachment A Items (Surgical Heart Valves) to VISN 01 locations in accordance with the terms and conditions of this consignment agreement. Items as listed shall be placed at VISN 01 locations, 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. These are commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation.

2. Estimated Quantities. See B.3 Price/Cost Schedule for pricing and the Attachment A Items for estimated quantity. There is no expressed or implied guarantee that the estimated quantities will be purchased under this agreement. The only guarantee is for the purchase of the minimum guaranteed amount stated in the Price/Cost Schedule. Actual quantities may exceed or be less than those estimated in the Price/Cost Schedule, as itemized in Attachment A Items.

3. Exclusions. Agreements resulting from this solicitation will not preclude VISN 01 locations from purchasing items from non-contract sources.

4. Consignment Agreement – An agreement for a specified period during which the Contractor provides an item to the Government, reimbursement for which is made only if and when the Government makes use of the item. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. For this agreement, the use of item(s) or used item(s) shall be defined as “implanted, opened, damaged or lost due to the Government’s negligence.”

The Government assumes liability for any item(s) assigned to the VISN 01 locations on a consignment basis upon delivery. Title for the consigned items shall remain with the agreement or until the items are used.

Payment for items furnished under the agreement is applicable only when such items are used as described above. Contractor agrees to accept the Government Purchase Card as the preferred method of payment for purchase $10,000.00 or under. A Delivery Order will be used for purchases greater than $10,000.00. When a Delivery Order is used, invoices must be submitted by the Contractor for payment.

The contractor shall assign a representative to the facility to initiate and oversee the consignment inventory.

5. Contracting Officers and Logistics and Prosthetics purchasing agents are authorized to issue orders under this agreement.

Contracting Officer’s Representative (COR) - Individual or Individuals designated by the Contracting Officer to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed agreement. This definition is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the agreement.

Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

6. 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.

7. Semi-Annual Reports: Contractor shall furnish the Contracting Officer a Semi-Annual Usage/Saving Report upon request. This information shall be used to report the expenditures express report required by the Federal Procurement Data System

(FPDS).

3.0 DELIVERY:

1. DELIVERY REQUIREMENTS. The Contractor shall deliver FOB destination, freight prepaid and charged back the supplies on an as needed basis when requested by the Contracting Officer COR, and Logistics and Prosthetics purchasing agents through a purchase order. 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 to the to VISN

01 staff additional accessory items (i.e., sizers, handles and trays) that are handled, but not implanted for the consigned products in this Agreement as mutually agreed upon by the parties.

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.

4.0 CONSIGNMENT AGREEMENT:

1. INITIAL INVENTORY: The products listed on Attachment A Items represent the products that must be available for the initial inventory upon receipt of a no charge purchase order.

The initial inventory required for each product is shown in Attachment A Items. 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 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.

Following the purchase of each consigned Product, VA shall promptly issue to Contractor an order pursuant to Section 4 below, thereby fully replenishing the Consignment Inventory. 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 upon receipt of an order.

3. INVENTORY MANAGEMENT: The designated contractor’s representatives assigned to the facility will conduct a semi-annual 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/expired 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 $10,000.00 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, freight prepaid and charged back 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. The handled items shall be shipped periodically upon written request by the COR at no additional cost to the Government. 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: Contractor shall remove and replace all expired consigned

Products at no cost to VISN 01 locations. These services will be completed at no additional cost to the Government.

9. EXPIRATION/TERMINATION OF AGREEMENT:

Upon expiration/termination of the agreement, VISN 01 locations and the contractor 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 no items are missing and 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 and no charge purchase order.

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 VISN 01 Medical Centers. The determination as to whether or not the Government was negligent 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. GOVERNMENT LIABILITY:

The Government assumes no liability for any items assigned to the participating medical center on a consignment basis until such time as a requirement for the item exists, a consignment item is used, and a purchase (delivery) order is placed against this consignment agreement. If an item has been opened by the Government, lost and/or damaged or cannot be re-sterilized, the item will be purchased by the Medical Center.

17. 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 other than payment for any consigned Products that are lost, missing or damaged. Contractor shall be responsible for all shipping costs associated with their return.

18. 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 VISN 01 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.

19. CONSIGNMENT ITEMS ROTATION:

Contractor shall remove and/or replace items from consignment inventory as necessary.

Such items may have 30 days or less remaining before the sterility expiration date. 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.

20. PAYMENT/REPLACEMENT:

As consignment items listed under the Price/Cost Schedule are used, payment will be made by purchase card (if $10,000.00 or less) or Delivery Order (if over $10,000.00) by the Contracting Officer/Purchasing Agent with 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 (as defined above) by the Government, at the replacement cost indicated in this agreement. Delivery orders and/or Government credit card may be issued/used for reordering and payment.

21. PAYMENT PROCEDURES:

Contractor must accept the Government Purchase Card as a form of payment for orders $10,000.00 or less. Orders over $10,000.00 will be paid through Delivery Order issued by the Contracting Officer.

22. INVENTORY SIGN IN/OUT PROCESS:

VISN 01 locations will develop an inventory accountability process, whereby each and every 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

23. 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.

24. 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 modification issued by the Contracting Officer.

25. 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. Warranty means that the product warranty has to be for the purpose described in the product labeling as prescribed and/approved by the FDA. All items will be in shipped and in and 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 FDA approved, announced for marketing purposes, commercially 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 unless otherwise mutually agreed upon.

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. Upon request 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 at a mutually agreed upon price.

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 the award, VISN 01 will provide the vendor with a list of contact information for that implant device and a list of medical centers that provide clinic follow-up care. Technical support shall 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 vendor must provide names of the contractor representatives covering the Medical Center. If the vendor fails to provide the above information or the needed support the agreement will be terminated.

Upon award, contractor shall inform CORs of appropriate contractor representative contacts and provide 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 be taken by the contractor or manufacturer:

a. Notify Chief, Surgical Services, Saint Louis VA Medical Center, 915 N. Grand Blvd., Saint Louis, MO 63106, in writing. Provide two copies of the notification, which shall include, but not be limited to the following:

(1) Complete item description and/or identification.

(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 Saint Louis VA Medical Center 915 N. Grand Blvd.

Saint Louis, MO 63106

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. If requested, 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 VISN 01 staff as needed. Such training and education will be provided at no additional charge at VISN 01 locations or other appropriate venue identified by Contractor. The provision of training and education may include coverage by Contractor of meal, lodging and travel expenses for VISN 01 staff as permitted.

10.0 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 to the extent mutually agreed upon by the Contractor. 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.

11.0 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 VISN 01 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 VISN 01 Security Service. VISN 01 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 VISN 01 Healthcare System facilities, except in designated areas.