S02 - 36C246-23-Q-0068 - INO NITRIC OXIDE GASES.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

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

Central Virginia VA Healthcare System

1201 Broad Rock Boulevard

Richmond VA 23249

Network Contracting Office 6

100 Emancipation Drive

Hampton VA 23667

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 1

Warren O'Bryant

Contracting Officer

36C246-23-Q-0068

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES

B.3 STATEMENT OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION

SYSTEMS (NOV 2021)

C.3 52.216-18 ORDERING (AUG 2020)

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

C.5 52.216-21 REQUIREMENTS (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 25

C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

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

C.12 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVIELLANCE PLAN (QASP)

D.2 CONTRACTOR CERTIFICATION: Immigration and Nationality Act of 1952, As Amended

D.3 PAST PERFORMANCE SURVEY

D.4 DEPARTMENT OF VETERANS AFFAIRS (VA) NATIONAL RULES OF BEHAVIOR 52

D.5 CONTRACTOR CONFLICT OF INTEREST CERTIFICATION STATEMENT

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (NOV 2021)

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

1998)

E.3 SPECIFIC INSTRUCTIONS TO OFFERORS REGARDING REQUEST FOR QUOTE

PREPARATIONS AND SUBMISSION

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.7 VAAR 852.273-73 EVALUATION - HEALTH-CARE RESOURCES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

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:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly 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:

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:

AMENDMENT NO DATE

mailto:mario.santiago@va.gov mailto:mohamed.shakur@va.gov

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

LINE

ITEM

Description Qty. Unit Unit Cost Total

Annual Cost

0001 INO Nitric Oxide Gaseous Service by hour

2,978 Hours $ $

TOTAL FOR BASE YEAR $

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

Description Qty. Unit Unit Cost Total

Annual Cost

1001 INO Nitric Oxide Gaseous Service by

TOTAL FOR OPTION YEAR - 1 PERIOD $

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

Description Qty. Unit Unit Cost Total

Annual Cost

2001 INO Nitric Oxide Gaseous Service by

TOTAL FOR OPTION YEAR - 2 PERIOD $

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

Description Qty. Unit Unit Cost Total

Annual Cost

3001 INO Nitric Oxide Gaseous Service by

TOTAL FOR OPTION YEAR - 3 PERIOD $

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

Description Qty. Unit Unit Cost Total

Annual Cost

4001 INO Nitric Oxide Gaseous Service by

TOTAL FOR OPTION YEAR - 4 PERIOD $

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

B.3 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:

https://www.usp.org/ https://www.worldcat.org/ https://www.fda.gov/ https://www.transportation.gov/

• 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.

1.4.1. 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

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.

http://www.cpars.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.

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.

mailto:tkethia.houston@va.gov

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.

https://www.tungsten-network.com/us/support/ https://dvagov.sharepoint.com/sites/VHAProcurement/RPOC/BIT/Shared%20Documents/Cardiology%20(Onsite)%20Services/vafsccshd@va.gov

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:

a. Documentation requirements:

1) 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.

https://www.va.gov/covid19screen/ https://www.va.gov/covid19screen/

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

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

PRODUCTS AND COMMERCIAL SERVICES

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

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

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL

ITEMS

NOV 2021

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER

RIGHTS AND REQUIREMENTS TO INFORM

EMPLOYEES OF WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-9 PERSONAL IDENTITY VERIFICATION OF

CONTRACTOR PERSONNEL

JAN 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT

MAINTENANCE

OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.224-1 PRIVACY ACT NOTIFICATION APR 1984

52.224-2 PRIVACY ACT APR 1984

52.227-14 RIGHTS IN DATA- GENERAL MAY 2014

52.227-17 RIGHTS IN DATA -SPECIAL WORKS DEC 2007

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

NOV 2021

52.237-3 CONTINUITY OF SERVICES JAN 1991

852.204-70 PERSONAL IDENTITY VERIFICATION OF

CONTRACTOR PERSONNEL

MAY 2020

(End of Clause)

(End of Addendum to 52.212-4) http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

(a) Definitions. As used in this clause—

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C.

3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures. (1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of Clause)

C.3 52.216-18 ORDERING (AUG 2020)

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

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

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

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the

Government deposits the order in the mail.

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

(3) If sent electronically, the Government either—

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

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

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

(End of Clause)

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

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than , the Government is not obligated to purchase, nor is the

Contractor obligated to furnish, those supplies or services under the contract.

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

(1) Any order for a single item in excess of than the hours listed in the Schedule of Services page (2,978).

(2) Any order for a combination of items in excess of or than the hours listed in the Schedule of Service page (2,978).

(3) A series of orders from the same ordering office within seven (7) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection

52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within three (3) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

C.5 52.216-21 REQUIREMENTS (OCT 1995)

(a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government's requirements do not result in orders in the quantities described as

"estimated" or "maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

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

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

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

Government activity or activities specified in the Schedule.

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

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified…