36C26123Q0270_1.docx

36C26123Q0270

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

662-23-1-051-0148 36C26123Q0270 06-27-2023 Alex Hernandez N/A 07-13-2023 15:00

PDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas

NV

89086 X 339113 750 Employees N/A X Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA San Francisco Health Care System 4150 Clement St.

San Francisco

CA

94121-1545 00261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas

NV

89086

Department of Veterans Affairs In Accordance with Consignment Agreement Instructions

See CONTINUATION Page

CONTRACTOR TO PROVIDE EDWARDS LIFE SCIENCES HEART VALVES OR

EQUAL CONSIGNMENT AGREEMENT FOR THE VA SAN FRANCISCO

HEALTHCARE SYSTEM, SAN FRANCISCO, CA

**SEE STATEMENT OF WORK AND PRICE SCHEDULE IN SECTION B

FOR REQUIREMENT.

OFFEROR MUST PROVIDE ALL SUPPORTING DOCUMENTS AND COMPLY

WITH ALL ITEMS IN EACH EVALUATION FACTOR AS OUTLINED IN

SECTION E.

THIS IS A BLANKET PURCHASE AGREMENT CONSIGNMENT AND ALL

PRICING SHALL BE DONE IN ACCORDANCE WITH THE PRICE SCHEDULE

CONTAINED IN SECTION B.

PERIOD OF PERFORMANCE:

FIVE YEAR ORDERING PERIOD

662-23-1-051-0148 X Victoria Torres Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Victoria Torres Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

STATEMENT OF WORK:

1.0 INTRODUCTION:

1. Background. The Department of Veterans Affairs (VA) has identified the Edwards Lifesciences and the following items Inspiris Aortic Heart Valve, MC3 Annuloplasty, Mitral Annuloplasty rings, Mitris Mitral Heart Valve, and the Intuity Elite Heart Valves, or equal as candidate items for consolidated contracting through the Prosthetics Clinical Management Program. The purpose of consolidated contracting is to obtain user uniformity and quality products. The items listed under “SCHEDULE OF SUPPLIES/SERVICES" are not on a national contract.

2. Salient Characteristics –

A) COMPLETE GENERIC IDENTIFICATION –

Salient Characteristics are based on the manufacturer Edwards for aortic valves, inspiris (durability) and intuit (shorter operation); mitral valves: Resilia (durability), and Physio II (complete ring for repair)

B) APPLICABLE MODEL/MAKE/CATALOG NUMBER –

BT528743 /ST 554345

EDWARDS INSPIRIS RESILIA AORTIC VALVE OR EQUAL

· INSPIRIS RESILIA Aortic Valve, Model 11500A (mm): 19, 21, 23, 25, 27, 29 Or Equal

· Built on proven performance and durability of the Carpentier-Edwards Perimount Valve Design

· Resilia Tissue is treated with special Integrity preservation technology that effectively eliminates free aldehydes, protecting and preserving the tissue resulting in:

· Improved Anti-Calcification

· Improved sustained Hemodynamic Performance

· Dry Storage, ready to use, no rinsing required.

· V-fit Technology incorporates two novel features for future valve in valve procedures:

· Fluoroscopically visible labeled size marking at each commissure

· Expansion zone

· Flexible, radiopaque cobalt chromium alloy wire-form

· Three independent leaflets matched for thickness and elasticity

· Fabric covering stent: Polyester cloth

· Valve sewing ring: Silicone Rubber

· Low profile design specific to the aortic position

· Storage Temperature: 10 °C to 25 °C (50-77 °F)

EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

· Edwards MC3 Tricuspid Annuloplasty Ring, Model 4900 (mm): 26, 28, 30, 32, 34, 36 Or Equal

· Rigid ring for remodeling the tricuspid annulus

· Constructed of titanium alloy covered with woven polyester cloth

· 3D shape mimics the tricuspid annulus, corresponds to the anatomical contour

· Incomplete ring to avoid the sensitive conduction system anatomy

· Corrects annular dilatation, increases leaflet coaptation, reinforces annular suture lines, and prevents further dilatation of the annulus

· Downward angle in the septal region to help reduce the stress on sutures and the risk of ring dehiscence.

CARPENTIER-EDWARDS PHYSIO II MITRAL ANNULOPLASTY RING

· Carpentier-Edwards Physio II Mitral Ring, Model 5200 (mm): 24, 26, 28, 30, 32, 34, 36, 38, 40 Or Equal

· Angled holder with single cut release improves visualization and line-of-sight to the mitral valve

· Indicated for use in patients with mitral valve insufficiency

· Constructed of three Cobalt Chromium Bands Separated by polyester film Strips.

· Sewing cuff constructed of silicone rubber covered with woven polyester cloth.

· Evolves from the native D-shape to a more circular shape to accommodate the pathological changes in mitral annular dimensions

MITRIS RESILIA MITRAL VALVE

· MITRIS RESILIA Mitral Valve, Model 11400M (mm) 25, 27, 29, 31, 33

· Built on proven performance and durability of the Carpentier-Edwards Perimount valve design

· Resilia Tissue is treated with special Integrity preservation technology that effectively eliminates free aldehydes, protecting and preserving the tissue resulting in: o Improved Anti-Calcification performance

· Improved sustained Hemodynamic Performance

· Dry Storage, ready to use, no rinsing required.

· Nitinol Stent posts fold down to 55 degrees allowing for ease of implant; Stents return to original position when valve is implanted.

· Anterior segment of Sewing ring Marked “A” to facilitate orientation of the valve

· Good visibility under fluoroscopy for easy identification of the landing zone for future Transcatheter interventions.

· Low profile stent posts do not obstruct blood flow through the Left Ventricular Outflow Tract

· Sewing Cuff: Silicone Rubber covered with woven polyester cloth

· Storage Temperature: 10 °C to 25 °C (50-77 °F)

EDWARDS INTUITY ELITE RAPID DEPLOYMENT AORTIC VALVE SYSTEM-

· Edwards Intuity Elite Rapid Deployment Aortic Valve, Model 8300KITB (mm): 19, 21, 23, 25, 27

· Rapid deployment aortic valve system combining proven pericardial valve technology with innovations in transcatheter heart valves

· Built on the proven performance and long-term durability of the Perimount valve design

· Low supra-annular profile facilitates use with any aortotomy and provides excellent clearance from the coronary ostia

· Therma fix processed tissue treatment, matched leaflets, flexible alloy wire-form, stainless steel frame and textured sealing cloth help to create Excellent hemodynamic performance

· Delivery system provides streamlined procedures through rapid valve preparation and innovative balloon design helping to save time during procedures and streamline concomitant procedures

3. Purpose and Objectives. The purpose of this solicitation is to establish supply sources that will provide the contracted items for Prosthetics and Sensory Aids Services at the Department of Veterans Affairs San Francisco Medical Center (SFVAMC). The objectives are to ensure availability and consistency of product for ease of usage and to obtain volume-based, committed use pricing.

4. Agreement Duration. The base agreement period will be for a five-year ordering period.

5. Agreement Effective Date. The effective date of the agreement shall be date of award.

6. Multiple Award. This solicitation will result in a five-year (5) firm fixed-priced consignment agreement.

2.0 EXTENT OF OBLIGATION:

1. The Contractor shall furnish all supplies listed in Part I, Supplies/Services and Prices/Costs on a consignment basis to the SFVAMC in accordance with the terms and conditions of this consignment agreement. Items as listed shall be placed at the VA Medical Center, 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 VA Physician’s prescription that has been provided by the prescribing VA Facility. The solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113, with a small business size standard of 800 employees.

2. Estimated Quantities. See Schedule of Supplies for estimates by line item. There is no expressed or implied guarantee that the estimated quantities will be purchased under this agreement. The only guarantee is the minimum guarantee elsewhere in this solicitation. Actual quantities may exceed or be less than those represented.

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

4. Consignment Agreement – An agreement for a specified period of time 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 the purposes of this agreement, use of item(s) or used item(s) shall be defined as “implanted, opened, or lost”.

The Government assumes no liability for any item(s) assigned to the SFVAMC on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. 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 (implanted) or the package is opened by the VA. Contractor agrees to accept the Government Purchase Card as the preferred method of payment.

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

5. Network Contracting Office (NCO) 21 contracting officers and purchasing agents are authorized to issue orders under this agreement.

6. The Certification and Accreditation requirements do not apply, and that a Security Accreditation Package is not required.

7. 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. The COR and/or the Contracting Officer will be the only medical centers personnel authorized to request services under this agreement.

8. The Contractor shall deliver FOB destination, the supplies on an as needed basis when requested by the Contracting Officer or his/her designee. Only the Contracting Officer or designee will be authorized to coordinate and request consignment items direct from the Contractor.

9. Contractor Selection by Medical Center. Ordering Procedures: As a multiple award, blanket purchase agreement (BPA) vehicle, calls are governed by FAR 13.303-5(c) & (d), which provides that each awardee must be given a fair opportunity to be considered for each order exceeding $3500, unless a statutory exception applies.

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

10. Quarterly Reports: Contractor shall furnish the Contracting Officer a Quarterly Usage/Saving Report. This information shall be used to report the expenditures express report required by the Federal Procurement Data System (FPDS). Which captures the amounts expended through the BPA and subtract from the total awarded ceiling.

3.0 DELIVERY:

1. DELIVERY REQUIREMENTS. The Contractor shall deliver FOB destination, the supplies on an as needed basis when requested by the Contracting Officer or his/her designee. 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 VA staff additional accessory items (i.e., sizers, handles and trays) that are handled, but not implanted for the consigned products in this Agreement.

Based on case scheduling, Contractor may be required to have additional accessory set(s) for the implant procedures at no additional cost to the Government.

4.0 CONSIGNMENT AGREEMENT:

1. INITIAL INVENTORY: The products listed under the "SCHEDULE OF SUPPLIES/SERVICES” represent the products that must be available for the initial inventory. The initial inventory required for each product is shown in the "SCHEDULE OF SUPPLIES/SERVICES". 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. The contractor agrees to coordinate with the COR to maintain the inventory level of product at all times. 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 periodically (no less than bi-annually) conduct a physical inventory of the consignment inventory and notify the COR if any discrepancy and any outdated items. 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 the Contracting Officer/purchasing agent will issue an order with an associated purchase order (PO) 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) days. Replacement products will be shipped/delivered FOB Destination directly to the requesting location at no additional cost to the Government. The PO will serve as authorization for 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: 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 SFVAMC is not liable for devices that are allowed to expire. These services will be completed at no additional cost to the Government.

9. EXPIRATION/TERMINATION OF AGREEMENT: Upon expiration/termination of the agreement, the SFVAMC 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 10:30 AM and 4:00PM Monday through Friday.

11. UNIT PRICING:

The unit price for each item/implant shall remain the same, as identified in Part I, Supplies/Services and Prices/Costs, throughout the term of this Agreement.

12. INITIAL INVENTORY LEVELS:

An initial consignment inventory is indicated in the schedule; 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. 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 VA Medical Center. 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 and/or damaged or cannot be re-sterilized, the item will be purchased by the medical center. The Government will not be liable for damage due to acts of God, e.g. earthquakes.

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. 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 SFVAMC 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 Supplies/Services and Prices/Costs are used, a purchase order will be placed by the Contracting Officer/Purchasing Agent with the Contractor within 48-72 hours of its use, at the price listed in Supplies/Services and Prices/Costs. 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.

21. PAYMENT PROCEDURES:

Contractor must accept the Government Purchase Card as a form of payment in accordance with procedures outlined in the Continuation of SF 1449 section.

22. INVENTORY SIGN IN/OUT PROCESS:

The SFVAMC 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:

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. 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 the award, VA 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 will be available twenty-four (24) hours a day on technical issues. Contractor must return telephone calls for assistance within a reasonable time of the medical center’s telephone call to the contractor. Upon request, the vendor must provide names of the 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 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 immediately be taken by the contractor or manufacturer:

a. Notify Chief, Surgical Services, San Francisco VA Medical Center, 4150 Clement St, CA 94121, 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:

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

8.0 SPD 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 SPD before delivering product to Surgical Suite, so that SPD 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 VA 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 Acquisition and Material Management Service, 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 VA 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 VA Security Service. The VA 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 VA Healthcare System facilities, except in designated areas.

(END STATEMENT OF WORK)

Price/Cost Schedule.

This is a Blanket Purchase Agreement. Accordingly, all quantities in the price schedule are estimates and the maximum amount is not a guarantee. Funds are obligated via call orders issued against this Agreement. No individual purchase under this agreement will exceed the Simplified Acquisition Threshold ($250,000.00). The value of all orders that may be placed against this Contract during its 5-year period.

Minimum Value: $0.00 Maximum Value: TBD (All funds are subject to the availability of funds per clause 53.232-19) This is not an option year contract. The period of performance for this contract is Date of Award through five (5) years. The tables listed on the price schedules are to be used to annotate Contractor’s price quotes. Quantities of each line item are broken out separately by year in order to allow.

DESCRIPTION PRODUCT PART NO.

YEAR 1 – PRICES OFFERED TO THE GOVERNMENT

YEAR 1

YEAR 2 – PRICES OFFERED TO THE GOVERNMENT

YEAR 2

YEAR 1&2

YEAR 3 – PRICES OFFERED TO THE GOVERNMENT

YEAR 3

YEARS 1-3

YEAR 4 – PRICES OFFERED TO THE GOVERNMENT

YEAR 4

YEARS 1-4

YEAR 5 – PRICES OFFERED TO THE GOVERNMENT

YEAR 5

ALL YEARS

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii)…