S02 36C26125Q0242.pdf

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

662-25-1-051-0428

36C261-25-AP-0253

36C26125Q0242 02-21-2025

Shelley Self 702-791-9000 02-28-2025

12:00 PST

00261

Department of Veterans Affairs Network Contracting Office 21

X

Y

339113

800 Employees

N/A

See Delivery Schedule

00261

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Stryker Target 360 Coil Consignment Indefinite Delivery Indefinite Quantity (IDIQ) Contract for the VA San Francisco Healthcare System

**See Statement of Work and attached Price Schedule for requirement.**

Period of Performance: Date of Award through Five (5) Years

Please follow instructions in Section E of this RFQ.

Respondents shall fill out attached Price Schedule and indicate delivery/completion timeframe.

Please submit your quote to Shelley.Self2@va.gov no later than the due date/time shown in Box 8 above. Any questions must be received 72 hours prior to this closing period.

See CONTINUATION Page

X 1

Mathew B. Czeshinski Contracting Officer

36C26125Q0242

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..24

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

None

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 Mathew B. Czeshinski

VA Sierra Pacific Network (VISN 21)

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] See Statement of Work

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.

VA - FSC Tungsten

Http://www.fsc.va.gov/einvoice.asp

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

1.0 INTRODUCTION:

1. Background. The Department of Veterans Affairs (VA) has identified the Stryker Target 360

Coil, 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 on the Inventory Schedule Attachment are not on a national contract.

2. 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 Healthcare System (VASFHCS). The objectives are to ensure availability and consistency of product for ease of usage and to obtain volume-based, committed use pricing.

3. Agreement Duration. The agreement period will be for five (5) one-year ordering periods.

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

5. Award by CLIN Item. Award/s will be made by CLIN 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 these 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 course of 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 at a later date in accordance with paragraph 5.0 Technology Refresh.

6. Single Award. This solicitation will result in a minimum of one (1) firm fixed-priced consignment agreement.

2.0 EXTENT OF OBLIGATION:

1. The Contractor shall furnish all supplies listed in the attached Price/Cost Schedule 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) (CORs) 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. 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. Agreements resulting from this solicitation will not preclude VA from purchasing items from non-contract sources.

4. 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 CORs 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. 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 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 IDIQ 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 delivery 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 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 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 the attached Price/Cost Schedule, 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:

a. Date of receipt of property

b. Ownership of property

c. Description of property

d. Quantity

e. Value of property

f. Agreement number

g. Record of orders placed for property used during agreement period and receiving official

h. Acknowledgement of receipt of unused property returned to owner

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 regulations 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:

**CHANGE**

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:

Chief of Prosthetics San Francisco VA Medical Center 4150 Clement St San Francisco, CA 94121

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.

10.0 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

11.0 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.

12.0 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)

See attached document: SCHEDULE.

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

ALL

VA San Francisco Healthcare System 4150 Clement Street San Francisco, CA 94121

ALL

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from The CONTRACT AWARD DATE through The END OF THE FIFTH

YEAR AFTER THE CONTRACT AWARD DATE.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than THE PRICE OF THE LOWEST PRICED CONTRACT LINE ITEM NUMBER, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $25,000.00;

(2) Any order for a combination of items in excess of $150,000.00; or

(3) A series of orders from the same ordering office within 1 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part…