Custom Surgical Packs RFQ 36C24424Q0957.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

646-24-1-230-0389

36C24424Q0957 08-28-2024

Matthew Wright, matthew.wright6@va.gov 717-673-3842 09-06-2024

4PM EST EDT

36C244

Department of Veterans Affairs

Network Contracting Office 4

1010 Delafield Road

Pittsburgh PA 15240

X

339112

1000 Employees

N/A

X

36C646

See Statement of Work

36C244

Network Contracting Office 4

1010 Delafield Road

Pittsburgh PA 15240

Austin Payment Center

PO Box 149971

Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Solicitation for Custom Surgical Packs

See the Statement of Work on page 5.

See Instructions to Offerors on page 36.

See Evaluation Factors on page 46.

Attached documents and pictures with submission of quote.

See CONTINUATION Page

X X

X 1

Erik Whitaker

Contracting Officer

36C24424Q0957

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 (SOW)

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 52.216-21 REQUIREMENTS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

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 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.11 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.13 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.14 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 25

C.15 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.16 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.17 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

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 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

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: Erik Whitaker Contracting Officer

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh PA 15240

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] after each delivery

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

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 (SOW)

Custom Procedure Packs

VA PITTSBURGH HEALTHCARE SYSTEM

1. Background:

The VA Pittsburgh Healthcare System (VAPHS) is a tertiary referral center for the western half of VA Healthcare—VISN 4. VAPHS proudly serves the Veteran population throughout the tri-state area of Pennsylvania, Ohio, and West Virginia.

The facility must keep an assortment of custom surgical packs on hand to support the clinical need for surgical and invasive procedures. Due to the complexity of surgeries, the contents of each pack will be reviewed yearly.

2. Requirements: “Each Pack Item will be Broken at the end of this document”

Item # Description

1 ANESTHESIA CIRCUIT PACK

2 ANGIOGRAPHY TRAY PACK

3 BASIC ARTHROSCOPY PACK

4 BASIC SET UP PACK

5 BIOPSY/DRAINAGE TRAY

6 CORONARY ANGIO PACK

7 CYSTO BASIC SET UP PACK

8 ENT HEAD-NECK PACK

9 EP DRAPE PACK

10 EYE PACK

11 FOOT AND ANKLE PACK

12 GENERAL LAPAROSCOPY PACK

13 GENERAL LAPAROSCOPY PACK 2

14 INCISION AND LOOP DRAINAGE TRAY PACK

15 IV START KIT

16 KIDNEY PACK

17 LIVER CDS PACK

18 OPEN HEART CDS PACK

19 OR ANGIO PACK

20 PERMANENT PACING DRP PACK

21 PERSONAL CARE KIT #2

22 PLASTIC HAND PACK

23 SHOULDER ARTHROSCOPY PACK

24 SPINE PACK

25 SUTURE TRAY

26 TOTAL HIP PACK

27 TOTAL KNEE PACK

28 ULTRASOUND GUIDED TRAY

29 VA DIALYSIS CATH KIT

30 VA PGH TAVR

31 VASCULAR PACK

32 UNIVERSAL PACK

3. Scope of Work-Related

The Contractor shall provide for each custom procedure pack (CPT). The Contractor shall ensure that the manufacturer and lot number of each component item is traceable. The

Contractor shall provide copies of the standard operating procedures governing batch control, product tracing, component manufacturing lot numbering and written policies and/or procedures on component recalls.

• Sterilization Requirements:

o FDA Registered Organization.

o Adhere to current AORN guidelines for Sterile Processing and Packaging.

o Manufacturer will own all aspects of the sterilization process.

o Compliant with all aspects of 21CFR part 820 Quality System Regulations.

o The sterilization process used shall be validated on an annual basis by the

Association for Advancement of Medical Instrumentation (AAMI. The validation must be sent to the Contracting Officer upon annual inspection.

o Meets Class 8 ISO Requirements with a defect-free rate of at least 99.90%.

o Independent contract laboratories shall perform component bioburden tests, sterility tests, and residual tests.

o Before sterilization, products shall be assembled in controlled environments, accessible, only to authorized personnel with proper attire.

o Pack assembly shall be performed inside an environmentally controlled, limited-access room. The room shall be maintained under positive air pressure and all surfaces cleaned minimally every two hours. The Contractor shall have a sanitation program that monitors levels of microbial contamination regularly. All aspects of the assembly, packaging, and sterilization shall adhere to FDA quality control standards.

The Contractor shall be registered with the FDA.

o The Contractor shall be both responsible and liable for the sterility and quality of the product when properly used and handled by the Government.

o Re-sterilization of any product is prohibited.

o The Contractor must be ISO 13485:2003 and 9001:2008:11135 certified and undergo routine FDA inspections.

o Quality assurance staff shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques, and sterilization methods.

Verification documentation shall be provided with the proposal.

• Component Parts:

The requested components are listed. Other components listed as DO NOT

SUBSTITUTE (denoted with an asterisk in the * column) are required to accommodate procedures. The contractor shall not substitute items marked with either an asterisk or

“DO NOT SUBSTITUTE” without approval from the Contracting Officer. The facilities will be notified of substitutions and must give approval before any substitution is made.

o Those items that cannot be substituted are identified by an asterisk (*) next to the quantity required in the listing of parts in the * column.

o The contractor shall provide all components required for each CPT.

o All packs shall be made of hard plastic base packs and parts to reduce ETO

(Ethylene Oxide) residue and eliminate possible particulate contamination from

Styrofoam. ETO tape/indicator shall be affixed to the outer wrap and pack where applicable. All packs shall be double-wrapped with an additional plastic overwrap.

The overwrap shall be considered a dust cover only.

o Quantitative data shall be provided to demonstrate that the materials for surgical gowns and drapes provide an effective barrier to microbes. The materials shall meet the American Society for Testing and Materials (ASTM) requirements for barrier protection, including blood-borne pathogens, microbial challenge, as well as hydrostatic pressure with resistance to tears, abrasion, and stains. All materials shall be lint-free and meet or exceed the requirements of the National Fire Protection

Regulations for flammability in Part 1610 of the Code of Federal Regulations.

o When specified within a CPT, cloth towels shall be absorbent and either disposable or towels made of 100% cotton, pre-washed with an x-ray detectable loop.

o All CPT components and wrappings shall be latex-free unless specified otherwise by the using facility. All CPTs shall be labeled as “Latex Free” on the outside covering.

• Unavailability of Component Parts:

Should a part become unavailable which will temporarily or permanently delay the production of the pack(s), the Contractor shall immediately notify the Contract Specialist.

All substitutions will be vetted through the End User before changes are submitted. No deletions or substitutions will be made without written authorization from the Contracting

Officer. If the component will be out of stock for a prolonged period and the user service chooses to have the pack assembled without the product, written authorization must be given by the Contracting Officer. The cost of the pack must be adjusted to reflect the change.

• Recalls:

The Contractor shall have a documentation system for component product accountability and lot number recordings for product recalls. The Contracting Officer shall be notified immediately by telephone (with written notice to follow within five (5) calendar days) if one/several CPTs are affected by a product recall. If the recalled component is unavailable for further production of the custom pack(s), no substitutions will be made by the Contractor without the written authorization of the Contracting Officer, with notification and approval of the listed notification group.

• Changes to Composition / Components of CPT(s):

Any participating Healthcare Facility may change individual parts of the pack after thirty

(30) days of usage. Pricing and recommended requested changes will be forwarded to the Contractor by the Contracting Officer. The Contractor shall be requested to consider all part changes and provide a cost estimate for each item to be changed. The cost proposal will include costs plus an estimate for credit for deleted items. Only the

Contracting Officer has the authority to make changes to the contract. Changes will be made by contract modification/supplemental agreement.

o A Pack Change Worksheet shall be utilized for all pack changes. The change form includes all the components, quantity, and manufacturer details for the affected pack.

The sales representative (or equivalent) shall supply the Contracting Officer with the completed change form. With the agreement of the two parties, each shall sign the change form.

o The signed change form shall be forwarded to the Contracting Officer for approval.

Once approved by the Contracting Officer, the Contracting Officer shall issue a contract modification/supplemental agreement; the change shall be submitted to the

Contractor for the next production run of that pack.

o The Contractor shall provide each facility with an electronic inventory report each week which details: the number of packs on order, the current forecast, the three-month average usage, the six-month average usage, the number of packs per case, and the cost of the pack. Trends must be communicated between the sales representative and the Contracting Officer with a mutual determination to adjust inventory levels.

o The arrangement of the parts in the pack/pack shall be coordinated by both the designees and the Contracting Officer. This coordination shall be before production by the Contractor.

• Packaging:

Unless otherwise specified in the specification, the product shall be packed in substantial containers of the type, size, and kind commonly used within the industry for this purpose.

The container(s) shall be constructed to ensure acceptance and safe delivery by common carriers, at the lowest rate, to the point of delivery for each facility. Items shall be packaged adequately to prevent deterioration and damage during shipping, handling, and storage. All packs shall be labeled on the outside as Totally Latex.

o Each pack insert shall have a color-coated label specifying the identification of the specific procedure pack. Also containing the manufactured date of the pack and the expiration date of any dated products. This label, located inside each pack, shall also contain an itemized listing of all components, including quantities.

o All outer packages must contain the complete contract number and delivery order number in addition to the shipping address. The contract number shall be provided upon notice of contract award. A delivery order number will be assigned by each participating facility for the fiscal year, annually or per order, during the life of the contract.

o A packing list/slip shall be enclosed with each shipment indicating the contract number, delivery order number, items and quantity ordered, and items and quantity shipped.

o Any pack determined to be defective (e.g., contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor at the Contractor’s expense. Full credit or replacement shall be made to the Government.

• Production and Supply:

The Government requires the Contractor to undertake production of such quantities of the product as are necessary to reasonably assure the Government of an uninterrupted supply of the product based upon an anticipated monthly usage. The Government may not obligate funds for products in inventory or production whenever the contract is terminated.

The Contractor shall complete component pack changes within thirty (30) days, no longer than forty-five (45) days after written notification by the Contracting Officer. Due to the possible need for changes, the Government shall be obligated to only a thirty (30) day supply of packs manufactured at the time of the change acceptance and not exceeding the current fiscal obligation time. In the event the Government terminates the contract, the Government will not be held responsible for procuring the additional inventory. In the event of component changes in any pack, the Government agrees to purchase up to a maximum of thirty (30) days of usage of the current pack composition before the new pack composition is shipped.

o The Quality Assurance Department shall verify changes and ensure the product meets the Government specification.

o When additions or deletions occur, the Contractor shall provide the Contracting Officer with the costs of each component added or deleted at the time of the change or before written authorization by the Contracting Officer.

o As a fixed-price contract with option years, it is reasonable to expect usage and/or requirements may change during the contract period. The Government reserves the right to negotiate with the Contractor to add and/or delete item(s) to pack components.

• Quality Assurance:

The Custom Sterile manufacturing facilities shall be registered and in good standing with

The Food and Drug Administration and ISO13485:2003 and 9001:2008:11135 certified

(International Organization for Standardization). ISO, CEN (European Committee for

Standardization), AAMI (Association of the Advancement of Medical Instrumentation), and AORN (Association of Operating Room Nurses) are other Industry standards that must be met.

A “Quality system Program” to prevent non-conformances at all product/service stages from design through distribution must be utilized. It is designed to comply with the requirements of ISO13485:2003 and 9001:2008:11135 (International Organization for

Standardization), 21 CFR 820 (Code of Federal Regulations), EN 46001 (European

Nations Quality Standards), and United States regulations regarding the sales and distribution of medical products.

The Custom Sterile Surgical Pack program must provide certain measures in the manufacturing of the kits.

o Product specifications including video images, bills of material, biological evaluations, component specifications, and identification of critical design and process parameters.

These include how the parameter is to be met.

o Production process specifications, including the appropriate equipment specification, production methods, production procedures, and compatibility of the design with current systems and equipment.

o Quality assurance procedures and specifications, i.e., quality plan, including quality assurance checks used and the quality testing apparatus, fixtures, resources, skills, subjective standards, and documentation used.

o Packaging and labeling specifications, including methods and processes used.

o Sterilization requirements and methods.

o Testing requirements and methods.

o The Contractor will meet at least every 3 months with the Contracting Officer discuss any needed changes to the packs and to review quality assurance of packs.

3. Ordering:

Deliveries will be made upon receipt of an individual delivery order issued by the Contracting

Officer.

4. Delivery and Place of Performance Requirements:

All deliveries for this contract shall be FOB Destination only. Deliveries shall be made within forty-eight (48) hours or as needed from receipt of the order.

• Supplier will have a storage facility capable of supplying a product within a business day should an emergent need arise.

Table 1: VA Pittsburgh Healthcare System Sites

VISN Station Address

646-VAPHS, UNIVERSITY DRIVE, C

University Drive C

Pittsburgh, PA 15240-1003

H. John Heinz III Department of Veterans

Affairs Medical Center

1010 Delafield Road

Pittsburgh Pa. 15240

4 Belmont County VA Clinic Ohio Valley Mall

67800 Mall Ring Rd. Suite 215

St. Clairsville Ohio, 43950

4 Westmoreland County VA Clinic 5274 Route 30, Suite 10

Greensburg Pa. 15601

4 Beaver County VA Clinic 300 Brighton Avenue, Suite 110

Rochester Pa. 15070

4 Washington County VA Clinic

Crossroads Center

95 West Beau Street, Suite 200

Washington Pa., 15301

4 Fayette County VA Clinic 627 Pittsburgh Rd. Suite 2

Uniontown Pa., 15401

4 Monroeville VA Clinic 421 Mall Circle Drive

Monroeville Pa., 15146

5. Travel for Installation, Implementation, and Training:

The Government anticipates no additional shipping charges.

6. Hours of Coverage & Federal Holidays:

The VA representative tour of duty, Monday through Friday, excluding federal holidays.

Weekends can be arranged if the need arises to keep the project date on schedule. The contractor shall contact the POC or his/her designee before commencing any work on the premises and provide the proposed schedule for approval by stakeholders.

7. Vendor Credentialing:

Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login symplr.

All on-site contractor representatives agree to follow VA Pittsburgh Policy regarding Vendor

Access across all VA Pittsburgh Campuses and affiliated CBOC Clinics.

(End of SOW)

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

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.216-20 DEFINITE QUANTITY OCT 1995

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 09/20/2024 through 09/19/2027.

(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 $150.00, 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 $50,000.00;

(2) Any order for a combination of items in excess of 1,000,000.00; or

(3) A series of orders from the same ordering office within 10 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 of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 14 days after issuance, with written notice stating the

Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.5 52.216-21 REQUIREMENTS (OCT 1995)

(a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government's requirements do not result in orders in the quantities described as "estimated" or "maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The

Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the

Government activity or activities specified in the Schedule.

(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.

(f) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after 09/19/2027.

(End of Clause)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the

Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after 09/19/2027.

(End of Clause)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR

(APR 1984)

Funds are not presently available for performance under this contract beyond 09/30/2024. The

Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made.

No legal liability on the part of the Government for any payment may arise for performance under this contract beyond 09/30/2024, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

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

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

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

2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided.

This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the

OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.10 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND

VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023)

(DEVIATION)

(a) In an effort to achieve socioeconomic small business goals, VA shall evaluate offerors based on their service-disabled veteran-owned or veteran-owned small business certification status and their proposed use of eligible certified service-disabled veteran-owned small businesses (SDVOSBs) and certified veteran-owned small businesses (VOSBs) as subcontractors.

(b) Eligible and certified service-disabled veteran-owned small businesses offerors will receive full credit, and offerors qualifying as veteran-owned small businesses will receive partial credit for the certified Service-Disabled Veteran-Owned and Veteran-Owned Small Business Status evaluation factor. To receive credit, an offeror must be listed at the time of submission of offers and at time of award, as a certified SDVOSB/VOSB in the SBA certification database on the

SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/

(see 13 CFR 128) and be otherwise eligible in accordance with SBA size standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13

CFR 121, 125 and 128.).

(c) Non-Veteran offerors proposing to use certified SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation factor. Offerors must state in their proposals the names of the certified SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be listed at the time https://veterans.certify.sba.gov/ of submission of offers and at time of award, as a certified SDVOSB/VOSB in the SBA certification database.

(d) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.11 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran-

Owned…