36C24623Q0068.docx

36C246-23-Q-0068

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

36C24623Q0068 10-28-2022 WARREN O'BRYANT, Administrative C.O.

757728-7083 11-11-2022

10:00 AM

EST

36246 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X 325412 1250 Employees N/A X Department of Veterans Affairs Central Virginia VA Healthcare System 1201 Broad Rock Boulevard Richmond

VA

23249 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 See CONTINUATION Page

INO NITRIC OXIDE GASEOUS SERVICE

1. Contractor shall provide INO Nitric Oxide Gases by the Hour Service On-Site at the Central Virginia VA Healthcare System accordance with the Statement of Work (SOW).

2. Period of Performance: 01/01/2023 through 12/31/2023.

3. See B.2: For the Schedule of Supplies and Services.

X X X Warren O'Bryant Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C24623Q0068

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SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR: Name: __________________________ / Title: __________________ email: __________________________ / Phone: __________________

b. GOVERNMENT:

Contracting Officer 36C246 Administrative Contracting Officer Mario L. Santiago Warren O’Bryant 757-251-4254 / mario.santiago@va.gov 757-728-7083 / warren.o’bryant@va.gov Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 6 Network Contracting Office 6 100 Emancipation Drive 100 Emancipation Drive Hampton VA 23667 Hampton VA 23667

2. CONTRACTOR REMITTANCE: 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

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. Shall be submitted Electronically To:

Department of Veterans Affairs Financial Services 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:

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B.2 SCHEDULE OF SERVICES

The Contractor shall provide INO Nitric Oxide Gaseous Service to include all cylinders, delivery machines, labor, equipment, tools, materials, supervision and all other items and resources required to provide INO Nitric Oxide Gaseous Service to our patients at Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA 23249. location. The Contractor will respond and be On-Site ready to deliver services at the “requested service time”.

Place of Performance: Central Virginia VA Healthcare System , 1201 Broad Rock Blvd., Richmond, VA 23249.

The Government will issue a single award resulting from this solicitation.

Base Period of Performance: 1 January 2023 through to 31 December 2023

Annual Cost

TOTAL FOR BASE YEAR

Option Year 1: 1 January 2024 through to 31 December 2024

Annual Cost

TOTAL FOR OPTION YEAR - 1 PERIOD

Option Year 2: 1 January 2025 through to 31 December 2025

Annual Cost

TOTAL FOR OPTION YEAR - 2 PERIOD

Option Year 3: 1 January 2026 through to 31 December 2026

Annual Cost

TOTAL FOR OPTION YEAR - 3 PERIOD

Option Year 4: 1 January 2027 through to 31 December 2027

Annual Cost

TOTAL FOR OPTION YEAR - 4 PERIOD

Total Cost for Base Year and All Option Years: $_________________

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Page 1 of

B.5 STATEMENT OF WORK (SOW)

INO Nitric Oxide Gaseous Service

1. GENERAL:

1.1. Product and Services Required: The Department of Veteran Affairs, Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA is requesting INO Nitric Oxide Gaseous Service from January 1, 2023, through December 31, 2023.

The Contractor shall provide Nitric Oxide gaseous include all cylinders, delivery machines, labor, equipment, tools, materials, supervision, and all other items to Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA 23249. The Contractor will respond and be On-Site ready to deliver services at the “requested service time”.

The Contractor and their employees shall possess and maintain all required Department of transportation requirements for the appropriate registration, licensure, and insurance requirements of the State of Registration to operate a commercial vehicle for the delivery of medical and/or other gases. The Contractor shall bear all expenses associated with all licensure requirements. The Contractor shall provide proof of insurance and personnel qualifications.

The Contractor and their employees shall possess and maintain a Commercial Driver’s Licenses (CDL) and hazardous materials endorsement license registration certification and meet all local, State and Federal regulations while operating a commercial vehicle in performance of this contract.

· All gases shall conform to specifications prescribed in the U. S. Pharmacopeia (USP) (https://www.usp.org.) and the U.S. Pharmacopeia: The National Formulary (https://www.worldcat.org.). All medical gas manufacturers and fillers of medical gases shall be registered with the Food and Drug Administration (FDA) (https://www.fda.gov.); and all medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations, Parts 210, 211 and 201 for labeling.

· Cylinders and other containers for gaseous and liquid forms of gases shall comply with the Department of Transportation (DOT) Laws, Codes, and Regulations (https://www.transportation.gov. ) specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current DOT regulations (Title 49-Transportation, Code of Federal Regulations.) Filling, packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

· The pharmaceutical drug INOmax® (nitric oxide) for inhalation (“INOmax”)

· INOmax (nitric oxide) for inhalation portable aluminum cylinders:

· 64693‐002‐02 Size 88, 1963 liters @ STP of nitric oxide gas, 800ppm concentration.

· 64693‐002‐01 Size D, 353 liters @ STP of nitric oxide gas, 800ppm concentration

1.2. Product Specification and Federal Regulations:

1.2.1. All gases shall conform to specifications prescribed in the United States Pharmacopeia and the National Formulary. All medical gas manufacturers and fillers of medical gases shall be registered with the FDA; and all medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations, Parts 210,211 and 201 for labeling.

1.2.2. Federal Specification BB-C101D, Carbon Dioxide (C02) Technical and USP, current edition.

1.2.3. Compressed Gas Association (CGA) Publications G-7 – Compressed Air for Human Respiration, current edition, and ANSI/CGA G-7.1 – Commodity Specification for Air, current edition.

1.2.4. Markings: shall comply with CGA Publication C-7 – Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, current edition.

1.2.5. Cylinders shall be color coded in accordance with CGA Publication C-9 – Standard Color Marking of Compressed Gas Containers Intended for Medical Use, current edition.

1.2.6. Valves shall comply with CGA Safety Bulletin SB-26, current edition and CGA Publication V-1-Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, current edition.

1.2.7. Hydrostatic testing shall be performed in accordance with CGA’s Publication – C-1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, current edition.

1.2.8. Visual inspection shall be performed in accordance with CGA Publication – C-6 – Standards for Visual Inspection of Steel Compressed Gas Cylinders, current edition or C-6.1 – Standards for Visual Inspection of High-Pressure Aluminum Compressed Gas Cylinders, current edition.

1.2.9. Replacement / Repair of Delivery Devices on an as needed basis.

1.3. Authority: FAR Part 13 – Simplified Acquisition Procedures.

1.4. Definitions/Acronyms- Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.1.

1.4.1. ACO: Administrative Contracting Officer

1.4.2. BIOMED: Bio Medical Engineering

1.4.3. CDL: Commercial Driver’s License

1.4.4. CDR: Contract Discrepancy Report

1.4.5. COVID 19: Coronavirus Disease 2019

1.4.5. Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

1.4.6. Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.4.7. COS: Chief of Staff

1.4.8. CPARS: Contractor Performance Assessment Reporting System.

1.4.9. CVHCS: Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA 23249. System located in Richmond, VA

1.4.10. EHR: Electronic Health Records system used by the VA Medical Centers

1.4.11. ENGINEERING: Supervisor or designee.

1.4.12. HIPAA: Health Insurance Portability and Accountability Act

1.4.13. Medical Emergency: a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, Causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.4.14. MOD: Medical Officer of the Day.

1.4.15. Non-Personal Service Contract: means a contract under which the personnel, rendering the services are not subject, tither by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.4.16. OR: Operating Room

1.4.17. PM: Preventive Maintenance Services, which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

1.4.18. POP: Period of Performance.

1.4.19. SICU: Surgical Intensive Care Unit

1.4.20. SOW: Statement of Work.

1.4.21. QA/QI: Quality Assurance/Quality Improvement

1.4.22. QM/PI: Quality Management/Performance Improvement

1.4.23. QASP: Quality Assurance Surveillance Plan

1.4.24. TJC: The Joint Commission.

1.4.25. Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

1.4.26. Veterans Integrated Services Network (VISN): The regional oversight for the VA Medical Centers.

1.4.27. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

1.4.28. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Central Virginia VA Healthcare System, 1201 Broad Rock Blvd, Richmond, VA VA Medical Center.

1.4.29. Veteran Affairs Healthcare System (VAHCS): for purposes of this contract Richmond VA Medical Center is a healthcare system; this term shall mean an organization of multiple people and institutions that deliver healthcare to target populations, such as veterans.

2. SPECIFIC REQUIREMENTS

2.1. The Vendor will provide the following services:

2.1.1. The Contractor shall provide all equipment and Nitric Oxide gases.

2.1.2. The Contractor shall maintain all equipment designed for the Nitric Oxide gas cylinders to include scheduled and preventive maintenance.

2.1.3. The Contract shall provide medical grade tanks to contain Nitric Oxide.

2.1.4. The Contractor shall notify Bio Medical Engineering (Biomed) of maintenance schedules of all Nitric Oxide equipment.

2.1.5. The Contractor shall provide tanks fitted with “time” regulators that record the amount of use in hours and the amount used by volume measured per square inch (PSI).

2.1.6. The Contractor shall monitor inventory and maintain appropriate levels of Nitric Oxide as to prevent any disruption of service.

2.1.7. All products, equipment and services provided under the contract awarded shall be in compliance with all applicable Federal, State and Local regulations.

2.1.8. Valve protection caps for cylinders designed to receive such caps shall be securely attached to the cylinders in a manner to protect the valves from injury during transit and delivery to the purchaser’s receiving area.

2.1.9. Hydrostatic Testing: Retest Date, DOT regulations require retesting of cylinder within three (3) months after scheduled date of shipment to Continental U.S. destinations or within six (6) months after scheduled date of shipment to overseas destinations, cylinders shall be tested.

2.1.10. Cylinder sizes shown in the item description indicate product capacity of the cylinders currently being used. All capacities are approximating, and the Government shall be billed only for the actual amount of gas delivered in accordance with the Federal Food, Drug and Cosmetic Act, the actual contents of the container must appear on the label.

2.1.11. The Contractor shall provide 24/7 Technical and Customer Support (877-566- 9466).

2.1.12. The Contractor shall conduct Test Gas Programs and Monthly System Check- Out Kits.

2.1.13. Emergency Deliveries to include INO Nitric Oxide Gaseous Service Systems: (Delivery Device(s), cylinders, calibration gas, disposable, etc.) on an as needed basis.

Note: Special orders will be initiated by the Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA 23249. System Surgical Service staff with a maximum expected delivery time of twelve (12) hours from the notification time. Notification will come by phone or electronic mail – the primary contract method will be by telephone messaging.

3. QUALIFICATIONS:

3.1. Personnel assigned by the Contractor to perform the services covered by this contract shall possess at the minimum two (2) year of experience to transport Nitric Oxide gases.

3.2. Commercial Driver’s License (CDL) and hazardous materials endorsement licensed and/or certified.

3.2. Personnel assigned by the Contractor to perform the services covered by this contract must be an American citizen (or offer evidence of a naturalization).

3.3. Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English.

4. LICENSING AND TRAINING REQUIREMENTS:

4.1. Personnel assigned by the contractor to perform the required services will have the requisite education and training, and, when required, will be Commercial Driver’s License (CDL) and hazardous materials endorsement licensed and/or certified.

4.2. Contractor is aware of all laws, regulations, policies, and procedures relating to Privacy, Confidentiality and Health Insurance Portability and Accountability Act (HIPAA) and complies with all standards.

4.3. Contractor must ensure that the practice of medicine is consistent with Joint Commission Standards, VA policies and regulations, Veteran Integrated Support Network (VISN) standards, national statutes and regulations, medical record documentation and HIPAA policies.

4.5. Contractor must provide updated licensing, registration, and certification as they are renewed.

5. Non-Personal Healthcare Services: The parties agree that the Contractor and all contractor’s INO Nitric Oxide Gaseous Service shall not be considered VA employees for any purpose.

6. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

7. Inherent Government Functions: Contractor and Contractor’s INO Nitric Oxide Gaseous Service) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

8. No Employee status: The Contractor shall be responsible for protecting Contractor’s personnel providing the INO Nitric Oxide Gaseous Service services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

8.1 Workers’ compensation

8.2 Professional liability insurance

8.3 Health examinations

8.4 Income tax withholding, and

8.5 Social security payments.

9. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractors INO Nitric Oxide Gaseous Service . When a Contractor or Contractor’s INO Nitric Oxide Gaseous Service has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contract INO Nitric Oxide Gaseous Service) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

10. HOURS OF OPERATION

10.1. VA Business Hours: From 7:00 AM to 7:00PM and 7:00PM to 7:00AM, 365 days a year. Deliveries should be delivered 24 hours a day, 365 days of a year due to the emergent nature of the product and services. Holidays are included in the delivery schedule.

10.1.1. Federal Holidays: The following holidays are observed by the Department of Veteran Affairs:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared by the President of the United States to be a national holiday.

11. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

11.1. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

11.4. Performance Standards:

11.4.1. Measure: Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) licensing, registration(s) and certification(s) for contractor’s delivering INO Nitric Oxide Gaseous Service shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: 100% licensing, registration(s) and certification(s) for contractor’s INO Nitric Oxide Gaseous Service shall be provided as they are renewed. Licensing and registration information kept current.

Surveillance Method: Direct observation Frequency: Quarterly

12. Registration with Contractor Performance Assessment Reporting System

12.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $250,000.00 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies.

CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

12.2. Each Contractor whose contract award is estimated to exceed $250,000.00 requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

12.3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

12.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

13. GOVERNMENT RESPONSIBILITIES

13.1. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

7.6.1.1. CONTRACTING OFFICER RESPONSIBILITIES:

CO – Mario L. Santiago, 100 Emancipation Dr. Hampton, VA 23667, 757-728-7013, mario.santiago@va.gov.

ACO – Warren O’Bryant, 100 Emancipation Dr. Hampton, VA 23667. 757-728-7083, warren.o’bryant@va.gov

13.2. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity, or quality of performance of this contract.

13.2.1. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

13.2.2. If contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.1. Contracting Officer Representatives (COR)

13.3. COR Responsibilities:

13.3.1. The COR for this contract is:

Tkethia Houston / Staff Assistant, Medical Service Line / Richmond Health Care Systems / 1201 Broad Rock Boulevard, Richmond, VA 23249 / 804-675-5000 Ext. 14434 / tkethia.houston@va.gov

13.3.2. The 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.

13.3.3. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to enter data that may be collected.

13.3.4. The COR will maintain a record-keeping system of services by electronic storage. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

13.3.5. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

13.3.6. All contract administration functions will be retained by the VA.

14. SPECIAL CONTRACT REQUIREMENTS

14.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

14.2. Billing:

14.2.1. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month.

Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

14.2.1.1. Your firm’s Taxpayer ID Number (TIN)

14.2.1.2. Your firm’s “Remit Address” information

14.2.1.3. The VA Purchase Order (PO) number

14.2.1.4. Your firm’s contact information: (Personal Name, Email, and Phone)

14.2.1.5. Your VA point of contact information: (Personal Name, Email, and Phone)

14.2.1.6. The Period of Performance dates (Beginning and Ending)

14.2.1.7. All discount information if applicable (Percent and Date Terms)

14.2.1.8. Hourly Rate

14.2.1.9. Total price

14.3. Vendor Electronic Invoice Submission Methods:

Invoices will be electronically submitted to the Tungsten website at Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Taxpayer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: https://www.tungsten-network.com/us/support/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafsccshd@va.gov

14.4. Payment Adjustments:

14.4.1. Invoices will be prorated for partial days/hours worked. The contractor shall be paid only for actual work performed onsite. In the event that the Contract provider works a portion of an hour, the government may adjust payments by 15-minute increments. Contract providers shall be responsible for reporting time worked accurately. The Contract shall be paid for actual hours performed.

14.4.2. The contract shall be adjusted (at the end of the period of performance (base or option year) in accordance with actual performance.

14.4.3. If the Government believes that the Running Total stated on an Invoice is incorrect due to a “Run-On” of an INOmeter, the Customer shall notify the Contractor on or prior to the 15th calendar day after the date of the applicable Invoice received from the Contractor’s customer service center at (877-566-9466). The Contractor shall upon reasonable verification of the “Run-On” shall reduce the Running Total by the actual number of hours determined by the Contractor to have been incorrectly recorded.

14.4.4. Running Total of Hours Used: The Contractor shall maintain a running total of the hours of INOtherapy consumed by the Government.

14.4.5. The Running Total will be undated each time the Contractor processes a cylinder of IONMAX collected from the Central Virginia VA Healthcare System, 1201 Broad Rock Blvd., Richmond, VA 23249. System Facility and will be included on each Invoice to and provide when requested by the COR.

15. NO SMOKING POLICY:

15.1. All VHA health care facilities (including CBOCs and HCCs) are smoke-free for patients, visitors, contractors, volunteers, and vendors effective October 1, 2019. The policy applies to cigarettes, cigars, pipes, or any other combustion of tobacco, including but not limited to electronic or e-cigarettes, vape pens or e-cigars.

16. MANDATORY WRITTEN DISCLOSURES:

16.1. Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you are experience-difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

17. POST AWARD ORIENTATION:

17.1. The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual, Part M842.502-70.

18. VHA Supplemental Contract Requirements for Combatting COVID-19 (Updated December 14, 2021):

18.1. Contractor employees who work in or travel to VHA locations must comply with the following:

1. Documentation requirements:

0. If fully vaccinated, shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at-all-times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

18.2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, always, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

18.3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

18.4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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.