36C25920Q0311-001.docx

36C25920Q0311

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25920Q0311 04-17-2020 Lance Davis 918-577-3838 04-27-2020

1600 (CST)

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401 X X 561210 $41.5 Million N/A X Montana VA Health Care System 1892 Williams Street Fort Harrison MT 59636 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Pharmacy Clean Room Inspection & Testing VAMC Fort Harrison Respond to Soicitation: E-mail to Lance.Davis2@VA.gov as of Date and Time in Block 8 above.

Location of Perfomance as per below PWS.

see 52.212-2 Evaluation of Commercial Intems (below) Must provide with your quote:

1. CETA Certification

2. Price (below price schedule)

3. Technical Capabilities Statement

4. Contract Reference Form Services (attached) See CONTINUATION Page X X Lance Davis

NCO1616L2-5045

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 Performance Work Statement

Page 1 of Page 1 of

PERFORMANCE WORK STATEMENT

Testing and Certification of Pharmacy Sterile Clean Room Montana Veterans Affairs Health Care System (MTVAHCS)

A. GENERAL INFORMATION

1. Title of Service: Testing and Certification of Pharmacy Sterile Compounding Clean Room Suite and Equipment for the Montana Veterans Affairs Health Care System (MTVAHCS).

2. Scope of Work: The contractor shall provide all personnel, supervision, professional expertise, labor, vehicles, lodging, transportation, services, and quality control to ensure all the requirements for performance, evaluation and certification of facility and environmental controls for compounding sterile preparations are performed in a manner that will meet or exceed the requirements to maintain a fully functioning facility in accordance with this Performance Work Statement (PWS).

Offeror shall thoroughly review the specifications and be familiar with the area of coverage prior to submitting their offer in order to be fully aware of the supplies and/or services required. Failure to do so will not relieve the offeror from performing in accordance with this Solicitation and resulting contract; furthermore, additional cost to the Government will not be entertained. This will be a Base Year “Period of Performance” (POP) contract with four one-year Options (which may or may not be exercised).

Locations of Performance:

Fort Harrison VA Medical Center (VAMC) 3687 Veterans Drive Fort Harrison, MT 59636

Equipment:

· Class II B2 Biological Safety Cabinet

· Compounding Aseptic Isolator (CAI) in a Segregated Compounding Area

· Laminar Flow Workbench (two 4-foot sections)

· Ante Room

· Hazardous Sterile Compounding Buffer Room

· Non-hazardous Sterile Compounding Buffer Room

Dr. J Medicine Crow VA Community Based Outpatient Clinic (CBOC) 1775 Spring Creek Lane Billings, Montana 59102

Equipment:

· Compounding Aseptic Isolator in a Segregated Compounding Area

3. Background: MTVAHCS has a requirement for a CETA (Controlled Environment Testing Association) “Certified” contractor to perform numerous testing procedures to establish an industry-based minimum set of criteria appropriate for performance evaluation and certification of facility and environmental controls used for compounding sterile preparations. The contractor being awarded this contract must employ their own CETA Certified Technicians and must provide a copy of that certification with their submitted quote/pricing. The technicians performing the testing/inspections must be employed under the contractor being awarded this contract. All testing/inspections will be in accordance with (IAW) USP (United States Pharmacopeia) standards and procedures.

B. WORK SCHEDULE AND FEDERAL HOLIDAYS

All work shall be conducted during normal business hours Monday thru Friday from 8:00am to 4:30pm excluding Federal Holidays listed below, and any other day declared a federal holiday by the President of the United States.

Christmas Day

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

PRIMARY DUTIES:

Contractor shall perform appropriate tests and procedures to be employed on the various engineering controls for the certification of the cleanroom and equipment. The certification shall be completed in accordance with (IAW) the requirements set forth in the most recent version of the United States Pharmacopeia (USP), to include chapters <797> and <800>, ensuring they are met. The tests appropriate to certify a cleanroom used in sterile compounding are specified in the Certification Application Guide for Sterile Compounding Facilities. The CETA Compounding Isolator Testing Guide defines the purpose, apparatus, procedure, and acceptance criteria for a variety of essential tests, and the guide will be implemented to create a uniform approach for field certifiers to allow consistent and repeatable testing at all facilities.

D. GOVERNMENT RESPONSIBILITIES

1. The facility must ensure CETA certified technicians are using the procedures defined in the CETA Controlled Application Guide.

2. Evaluation of CETA Certified Report and follow-up on any findings.

3. Must review video of the smoke pattern test with certified technician.

4. Any maintenance performed on Primary Engineering Control (PEC) is recorded and maintained for the lifetime of the equipment.

5. PEC and Secondary Engineering Control (SEC) must be recertified ad hoc in the instances of alteration of the room design, equipment movement, repair or replacement, in response to identified problems/trends, in response to changes that could impact the sterile compounding environment, or after corrective action performed.

6. In the event either the entire or part of the current clean room suite/equipment is unusable, an ad hoc certification of contingency PEC and SEC may be required.

7. Appropriate QA monitoring and reporting. Monitor and review the results of viable and non-viable air sampling, critical area surface sampling, air velocity and volume, and room pressure differential in doorways monitoring. Also monitor and review total air changes per hour (ACPH), ACPH from HVAC, and ACPH contributed from PEC.

8. The Government will pay for all contracted services recommended by the contractor and authorized by the Division Manager or Facility Supervisor.

9. The Government will pay for the replacement HEPA filter and supplies necessary for repairs to the PEC provided by the contractor.

10. Notification of Non-Compliance: The COR will notify the Contractor of any detected non-compliance with the foregoing requirements in writing. The Contractor shall take immediate corrective action after receipt of such notice. Such notice, when delivered to the Contractor, shall be deemed sufficient for the purpose of notification. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order ceasing all or part of the work until satisfactory corrective action has been taken. No part of the time lost due to such cessation direction shall be made the subject of claim for extension of time for excess costs or damages by the Contractor.

E. CONTRACTOR RESPONSIBILITIES

1. Technicians performing certification must be CETA certified.

2. Provide a CETA Certified Report and recommendations on any findings. Resampling is required for recertification if the original samples recovered unacceptably high CFU counts or highly pathogenic organisms. The facility is currently electing to comply with the 2008 version of USP <797>. All testing must comply with the 2008 standard until a newer version is published and enforceable, or facility elects to adopt draft USP guidelines early.

3. If viable samples exceed guideline levels, attempt to identify microorganism to the genus level with the assistance of a microbiologist.

4. Develop a process for environmental sampling data evaluation with appropriate staff to determine action levels and any necessary documentation of notification and action plans (Highly pathogenic microorganisms must be immediately remedied regardless of CFU counts.).

5. Recertify PEC and SEC ad hoc in the instances of alteration of the room design or equipment movement, repair or replacement, in response to identified problems/trends, in response to changes that could impact the sterile compounding environment, or after corrective action performed.

6. Certify contingency PEC and SEC ad hoc in the event either the entire or part of the current clean room suite/equipment is unusable.

7. The contractor may be required to conduct an environment sampling following any servicing of facilities and equipment and in response to identified problems with end products or staff techniques. Environmental sampling must be completed two times a year with six-month iterations.

8. Perform testing frequencies in pursuant to USP <797> and USP <800> standards.

9. Each buffer room and ante room has a ceiling-mounted supply HEPA filter (3 total). Each HEPA filter shall be leak tested every 6 months. The facility currently has ports in which the test aerosol can be injected upstream of the HEPA filters. The connection port is a ¾” insert fitting to accept a ¾” I.D. hose. All test equipment shall be decontaminated prior to entering the clean rooms.

10. Must provide a video of the smoke pattern test & it must be reviewed with compounding personnel. The airflow smoke pattern tests described in the CETA CAG standards must be performed in situ and under dynamic conditions to ensure unidirectional air flow is achieved in the PEC while compounding tasks are performed. The smoke test must be of sufficient duration to identify all procedure requirements set forth in USP <797> and CETA CAG standards.

11. Conduct viable air samples, viable surface samples, HEPA Filter Leak Test, Airflow Testing, Non-Viable Particle Counting, total air changes per hour (ACPH), ACPH from HVAC, ACPH contributed from PEC for each area, room pressure differential in doorways and any other necessary testing procedures defined in most current CETA (CAG)-003-2006, CAG-002-2006, USP 797, USP 800 and/or most current industry accepted guidelines.

12. Viable Air Sampling shall be completed with at least 1000 liters of air using an air impaction sampler every 6 months. Passive air sampling is not allowed. Vendor must also include control samples. Viable Air Sampling to occur in the following locations:

a. Each Buffer Room – 2 sampling locations

b. Each Ante-Room – 1 sampling location

c. Each PEC – 7 sampling locations

i. Note that a CAI or CACI requires samples in both main area and pass through area of the PEC

ii. Note that the Laminar Flow Workbench is made up of two 4 foot sections and 1 sample is to be taken in each section.

13. Viable Surface Samples will be collected every 6 months. Vendor must also include control samples. Sampling will occur in the following locations.

a. Each Buffer Room – 6 sampling locations

b. Each Ante-Room – 1 sampling location

c. Each PEC – 7 sampling locations

i. Note that a CAI or CACI requires samples in both main area and pass through area

14. Document date and time of day sampling preformed.

15. Viable air and surface sampling must be done under dynamic conditions.

16. Verify PEC maintaining ISO Class 5 or better conditions for 0.5 micrometers particles under dynamic conditions.

17. Document the number of personnel present in each PEC and SEC during total particle count tests and dynamic airflow smoke pattern tests.

18. Verify buffer areas maintain at least ISO Class 7 & ante-areas at least ISO Class 7 ISO Class conditions for greater or equal to 0.5 micrometers particles under dynamic conditions.

19. Provide certification stickers on PECs indicating a pass or fail result and date of service.

20. Provide certificate of analysis (COA from media manufacturer that must verify devices meet expected growth promotion, pH, and sterilization requirements).

21. The Contractor is responsible for ordering, delivering, changing all HEPA filters and providing any necessary repairs to the PEC. If repairs are needed, the contractor shall provide a proposal for the repairs. At a minimum, the proposal shall break out the price of all parts, labor and travel. A purchase order will be issued outside of the contract for PEC repairs.

22. The Contractor shall be responsible for ensuring all sterile compounding equipment and rooms utilized in sterile compounding are monitored, tested, and certified using the most current procedures or per future changes to procedures in the Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities, FDA rules/guidelines, USP <797>, USP <800>, and/or other customarily accepted industry guidelines/standards.

F. OPERATIONS AND STORAGE AREAS

The Contractor shall confine all operations (including storage of materials) on Government premises to areas authorized or approved by the COR or Contracting Officer. Materials and equipment are not to be stored in other than approved areas. The Contractor shall hold and save the Government, its officers and agents free and harmless from liability of any nature occasioned by the Contractor's performance. Work shall be executed in such a manner as to interfere as little as possible with Pharmacy operations.

G. WORK PERFORMED BY OTHERS ON SITE

The Government may undertake or award other contracts for additional work at or near the site of work for this contract. The Contractor shall fully cooperate with any other contractors and with Government employees and shall carefully adapt scheduling and performance of work, and when direction is needed, it shall be provided by the COR. The Contractor Supervisor shall be responsible for reporting to the COR any problems or questions that may arise with any other personnel on site during the period of performance of this contract. The Contractor employee shall not take it upon themselves to resolve any problems or issues with other on-site contractors or employees, but rather will leave it to the COR to resolve the issue.

H. EMPLOYEE REQUIREMENTS

1. The Contractor shall be responsible to ensure Contractor employees providing work on this contract are fully trained, certified, and completely competent to perform the required work.

2. Labor Force and Equipment: Contractor shall be responsible to provide all labor necessary to meet deadlines. The Contractor will provide all necessary resources to complete the efforts assigned under the scope of this contract.

3. Employee Listing: The Contractor shall maintain and provide the COR a current list of all employees on site including subcontractor personnel. The list shall include the employee’s name, job title, and off-hours contact information.

I. ADDITIONAL REQUIREMENTS

1. PRIVACY STATEMENT: Patient information and physician orders are highly confidential. The contractor is responsible for providing reasonable administrative, technical, and physical safeguards to assure that confidentiality is maintained at all times. Unauthorized disclosure of information regarding any VA patient information or physician information is prohibited and a direct violation of HIPAA regulations. The contractor is responsible for providing a comprehensive program for controlling and maintaining the quality of privacy. The contractor shall comply with all regulations in the HIPAA regulations. The contractor will be liable for any breach of privacy.

B.3 Quality Assurance Surveillance Plan (QASP)

Quality Assurance Surveillance Plan (QASP) Pharmacy Clean Room Testing & Inspection VA Medical Center Fort Harrison MT59636

CONTRACT PERFORMANCE MONITORING:

Monitoring of contractor’s performance shall be demonstrated through Direct Observation. The COR and/or the alternate COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

CONTRACTOR MONITORING BY SERVICE: (QASP)

At the time of contract award, the Contracting Officer will appoint a COR and the alternate COR to assist with the contract monitoring requirements. The COR (and alternate COR if appointed) will monitor such items as quality of service, timeliness of performance, customer service, cost control, and business relations. The COR will ensure that services are performed and be responsible for handling service-related requirements necessary for patient care, the Mission of VHA.

The services provided will be monitored through a variety of mechanisms, including but not limited to:

Observation Random Inspection of services provided

The Government may evaluate the quality of professional and administrative services provided; but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for inspections and/or testing methods), in accordance with FAR 37.401(b).

The delegated COR (and/or alternate COR) will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. Initial communication may be communicated by telephone. After such communication, the COR (and/or alternate COR) will provide a written/electronic statement to the contracting officer along with any supporting documentation regarding the performance failure noted.

A summary evaluation of the contractor performance will be forwarded to the contracting officer annually prior to exercising any option year(s) and could affect positive CPARS (Contract Performance Assessment Reporting System) or other Past Performance Ratings.

PERFORMANCE REQUIREMENTS SUMMARY MATRIX:

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

FORT HARRISON-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Base POP Begin: 08-01-2020 POP End: 07-31-2021

BILLINGS-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Base POP Begin: 08-01-2020 POP End: 07-31-2021

FORT HARRISON-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 1 POP Begin: 08-01-2021 POP End: 07-31-2022

BILLINGS-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 1 POP Begin: 08-01-2021 POP End: 07-31-2022

FORT HARRISON-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 2 POP Begin: 08-01-2022 POP End: 07-31-2023

BILLINGS-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 2 POP Begin: 08-01-2022 POP End: 07-31-2023

FORT HARRISON-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 3 POP Begin: 08-01-2023 POP End: 07-31-2024

BILLINGS-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 3 POP Begin: 08-01-2023 POP End: 07-31-2024

FORT HARRISON-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 4 POP Begin: 08-01-2024 POP End: 07-31-2025

BILLINGS-BIANNUAL (every six months) TESTING AND CERTIFICATION of Pharmacy Clean Room, IAW the PWS and all USP (United States Pharmacopeia) standards and procedures. To be completed in September and March.

Contract Period: Option 4 POP Begin: 08-01-2024 POP End: 07-31-2025

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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 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 32.608-2 of the Federal Acquisition Regulation 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; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 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 ITEMS 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 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause) C.4 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

(a) Definition. For the Department of Veterans Affairs, “Service-disabled veteran owned small business concern or SDVOSB”:

(1) Means a small business concern:

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.101, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been verified for ownership and control pursuant to 38 CFR part 74 and is so listed in the Vendor Information Pages (VIP) database (https://www.vip.vetbiz.va.gov); and

(v) The business will comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size and government contracting programs at 13 CFR part 121 and 125, including the nonmanufacturer rule and limitations on subcontracting requirements in 13 CFR 121.406 and 125.6, provided that any reference therein to a service-disabled veteran-owned small business concern (SDVO SBC), is to be construed to apply to a VA verified and VIP-listed SDVOSB. The nonmanufacturer rule and the limitations on subcontracting apply to all SDVOSB and VOSB set-asides and sole source contracts.

(2) “Service-disabled Veteran” means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(b) General.

(1) Offers are solicited only from eligible service-disabled veteran-owned small business concerns. Only VIP-listed service-disabled veteran-owned small business concerns (SDVOSBs) may submit offers in response to this solicitation. Offers received from concerns that are not VIP-listed service-disabled veteran-owned small business concerns shall not be considered.

(2) Any award resulting from this solicitation shall be made to a VIP-listed service-disabled veteran-owned small business concern that meets the size standard for the applicable NAICS code.

(c) Representation. By submitting an offer, the prospective contractor represents that it is an eligible SDVOSB as defined in this clause, 38 CFR part 74, and VAAR subpart 819.70. Pursuant to 38 U.S.C. 8127(e), only VIP-listed SDVOSBs are considered eligible. Therefore, any reference in 13 CFR part 121 and 125 to a servicedisabled veteran-owned small business concern (SDVO SBC), is to be construed to apply to a VA verified and VIP-listed SDVOSB and only such concern(s) qualify as similarly situated. The offeror must also be eligible at the time of award.

(d) Agreement. Agreement. When awarded a contract (see FAR 2.101, Definitions), including orders under multiple-award contracts, or a subcontract, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size and government contracting programs at 13 CFR part 121 and 125, including the nonmanufacturer rule and limitations on subcontracting requirements in 13 CFR part 121.406 and 125.6, provided that for purposes of the limitations on subcontracting, only VIP-listed SDVOSBs shall be considered eligible and/or “similarly situated” (i.e., a firm that has the same small business program status as the prime contractor). An independent contractor shall be considered a subcontractor. An otherwise eligible firm further agrees to the following:

(1) Services. In the case of a contract for services (except construction), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs.

(2) Supplies or products.

(i) In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs.

(ii) In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted.

(3) General construction. In the case of a contract for general construction, it will not pay more than 85% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs.

(4) Special trade contractors. In the case of a contract for special trade contractors, it will not pay more than 75% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs.

(5) Subcontracting. Any work that a VIP-listed SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, cost of materials is excluded and not considered to be subcontracted. For mixed contracts and additional limitations, refer to 13 CFR 125.6.

(e) Joint ventures. A joint venture may be considered an SDVOSB if the joint venture is listed in VIP and complies with the requirements in 13 CFR 125.18(b), provided that any reference therein to service-disabled veteran-owned small business concern or SDVO SBC, is to be construed to mean a VIP-listed SDVOSB. A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (d) of this clause will be performed by the aggregate of the joint venture participants.

(f) Precedence. For any inconsistencies between the requirements of the SBA program for service-disabled veteran-owned small business concerns and the VA Veterans First Contracting Program, as defined in VAAR subpart 819.70 and this clause, the VA Veterans First Contracting Program requirements have precedence.

(End of Clause) C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran-Owned Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable.