Attachment 1-CHY Bulk Liquid Oxygen SOW.doc

442 BULK LIQUID OXYGEN, CHEYENNE VAHCS

STATEMENT OF WORK (SOW)

1. Contract Title 442 Bulk Liquid Oxygen, Cheyenne VAHCS

2. General Background

a. The Cheyenne VA Health Care System uses liquid oxygen for many veteran medical services and therefore has an ongoing requirement for a Contractor to provide medical-grade bulk liquid oxygen. The Government facility owns its bulk oxygen tank system.

b. The Contractor shall make deliveries of medical-grade liquid bulk oxygen throughout the life of the contract. The estimated annual quantities for Cheyenne VAHCS are 33,000 CCF. Contract to be awarded on 10-01-2024.

c. The Government shall award a Firm-Fixed Price contract to the responsible offeror whose quote conforming to the solicitation is deemed the best value.

d. The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the Contractor is responsible for ensuring that all products, bulk tank systems, and services provided under the contract are in compliance with applicable Federal, state, and local regulations. If applicable, the editions in effect as of the date of this solicitation are listed. The Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

· Title 21, Code of Federal Regulations, Parts 210 & 211 – CGMP (Regulations for supplying medical-grade oxygen)

· 29 CFR 1910.104 (Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises)

· 49 CFR - Transportation

· Federal Food, Drug, and Cosmetic Act

· NFPA 55: Compressed Gases and Cryogenic Fluids Code

· NFPA 99: Health Care Facilities Code

· USP 23

· ANSI/CGA M-1 2018 Standard for Medical Gas Supply Systems at Health Care Facilities

e. Acronyms used in this Statement of Work and other parts of the solicitation are as follows:

CCF - 100 cubic feet

CF - Cubic feet

CGA - Compressed Gas Association

CGMP - Current Good Manufacturing Practices

COR - Contracting Officer Representative

FDA - US Food & Drug Administration

GO - Government Owned

NFPA - National Fire Protection Association SCF - Standard Cubic Foot

USP - United States Pharmacopeia

VA - Department of Veterans Affairs

OSHA - US Department of Labor, Occupational Safety & Health Administration

3. Scope The Contractor shall provide all labor, supplies, materials, equipment, supervision, transportation, and other items and services necessary to provide an uninterrupted supply of medical-grade bulk liquid oxygen to the Cheyenne VA Health Care System (VAHCS). This encompasses the Cheyenne VA Medical Center, 2360 East Pershing Boulevard, Cheyenne Wyoming, and any of its affiliated Community-Based Outpatient Clinics (CBOCs).

4. Specific Tasks

a. Ordering

1) The ordering facility shall designate a Point of Contact (POC) and Alternate POC (APOC) responsible for local contract administration procedures. The POC and APOC shall be current (within one year) with Unauthorized Commitment (UAC) and Government Ethics training. POC/APOC responsibilities shall include requesting deliveries and providing specific delivery instructions. The ordering facility shall provide the Contractor with names and contact information of the POC and APOC within 20 days after award of the contract.

2) The Contractor shall deliver medical-grade bulk liquid oxygen bi-weekly, plus any emergency deliveries required. The Contractor shall determine/adjust reoccurring fill dates and initiate delivery requests by accurately monitoring normal consumption. If abnormal consumption surges require consumption from the reserve tank, the Contractor shall fill both tanks when on station. Orders shall be coordinated with the Contractor only by the POC/APOC via fax or e-mail at the address/fax number and contact listed below:

· FAX Number: TBD

· Email Address: TBD

· Department: Facility Management Service

· Name of Contact Person: TBD

· Address: Cheyenne VA Medical Center, 2360 East Pershing Boulevard, Cheyenne Wyoming, 82001

4) The POC shall be authorized to place orders against this contract. The Contracting Officer (CO) shall furnish the Contractor with the names of POCs upon issuing the contract. When a POC is added after award, the CO shall furnish the Contractor with the names of individuals as POCs. POCs are responsible for issuing and administering orders placed under this contract. POCs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized POC. Fulfilling orders from persons other than the CO or POC may result in loss or delay in payment for supplies/services provided under such orders.

b. Emergency Supply Support The Contractor shall, upon contract award, provide a written action plan and protocols in place that shall ensure compliance with the VA’s requirements under the contract in the event of a declared National or State Emergency which affects the Contractor’s ability to perform. The Contractor shall provide annual updates to this plan over the life of the contract. In the event the plan is implemented, the Contractor shall provide notification of implementation of the action plan and protocols within 48 hours of any declared National or State Emergency to the Contracting Officer and POC. In the event of a declared National or State Emergency at the time of award, the Contractor shall submit the written action plan and protocols to the Contracting Officer and POC within 48 hours of award notification.

c. Invoice and payment At the time of delivery, a legibly signed and dated proof of delivery (POD) document must be provided by the Contractor that identifies the tank system level prior to filling, the level after fill, and the quantity delivered in gallons and CCFs, and the purity rating of the product. The driver shall insure that the conversion between gallons and CCF quantity is accurate, so that the numbers listed on the delivery slip are consistent with the details on the resulting invoice to facilitate invoice certification. The invoice that is submitted must match the delivery quantity on the POD document and must be invoiced in CCFs. Consolidated Monthly Invoicing will be via the Tungsten Network (OB10).

5. Performance Monitoring

a. A GOV Point of Contact (POC) will be provided for ordering facility. The POC is responsible for local contract administration issues such as requesting deliveries and providing specific delivery instructions. The Contractor shall be provided with names and contact information of the primary and/or alternate POCs within 20 days after award of the contract for the ordering facility.

b. The Contractor shall contact the VA Contracting Officer on all matters pertaining to the administration of the contract. Only the VA Contracting Officer is authorized to make commitments or issue changes which shall affect the pricing of the contract.

6. Security Requirements The Contractor shall comply with the VA Personal Identity Verification procedures identified in the contract that implement Homeland Security Directive-12 (HSPD-12), Office of Management and Budget (OMB) Guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)

a. The schedule of items shall identify any Government Owned (GO) bulk tank system(s) at the facility. There are two tanks, Main Tank capacity is 1,500 gal (172,650 SCF), and Reserve Tank capacity is 500 gal (57,550 SCF). GO bulk oxygen storage tank systems and appurtenances shall be maintained by the Government at the Government's expense in a manner that ensures compliance with applicable federal and state regulations, standards, and commercial practices. The Government is responsible for providing a pad sufficiently rated by a Certified Project Engineer to support main and reserve tanks filled to full capacity. This includes security fencing, NFPA 55 & 99 code compliance, and safe access for resupply operations.

b. Upon award of the contract, all GO bulk tank systems and materials must be inspected by the Contractor, then annually thereafter. Upon inspection, the Contractor shall immediately notify the Contracting Officer if the Contractor shall not be able to fill the bulk oxygen tank system because of issues related to the tank system, pad, or access to the tank system. The facility shall provide the Contractor reasonable access to the areas where work is required to be performed. Additional issues associated with Government-furnished equipment are the responsibility of the Government. Contractor shall determine the pressure and rate of flow needed at the facility based on VA provided information.

c. Tank Set Points:

· Full Trycock: 142 inches (fills at 130 inches)

· Daily Lox Usage: 8.6 inches

· Reorder Point: 30 inches

· Low Level Alarm: 22 inches

d. The Contractor is responsible for performing minor maintenance on the GO bulk tank systems. Minor maintenance required of the Contractor includes validating that the fittings are securely fastened to the system, testing, minor de-icing, and adjusting alarms as required. Also, the Contractor shall provide documentation and training on how to de-ice the tank system in order to prevent damage (which could void the warranty between the VA and the tank manufacturer). In the event ice build-up occurs that cannot be remedied by the Contractor during regular minor maintenance, the Contractor shall furnish the VA with a quote to remove the ice buildup from the liquid bulk oxygen tank system. After the VA reviews and approves the quote, it may place a stand-alone order to authorize the work. The Government shall be responsible for any follow-on maintenance requirements that are outside of this SOW.

8. Other Pertinent Information or Special Considerations

a. Licensing, Authorization, and Selling Permissions

1) If the Contractor is the manufacturer of the medical grade bulk oxygen being supplied under this contract, it shall annually provide verification that it holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed.

2) If the Contractor is not the manufacturer of the medical grade oxygen being supplied under this contract, the Contractor shall annually provide verification that the manufacturer from which it obtains the medical grade bulk oxygen provided to VA under this contract holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed. In addition, the Contractor shall provide annual updates to any agreements it has with the medical-grade oxygen manufacturer affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor is providing under this contract. In the event of a change in manufacturer, the Contractor shall provide advance notice to the VA prior to the change taking place and shall provide copies of the new medical-grade oxygen manufacturer’s current licenses, permits, certifications or registrations required by the FDA and the states in which this contract is performed. The Contractor shall also provide a copy of its agreement with the new manufacturer demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor intends to provide under this contract.

3) Throughout the term of this contract, Contractor shall maintain all federal, state, and local licenses applicable to the Contractor as well as any required FDA certifications.

b. Liability Insurance Requirements The Contractor shall maintain liability insurance in the amount of $1 million per occurrence and shall provide an annual Certificate of Liability to the VA.

c. Quality Assurance Specifications and Requirements

1) All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA's Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA's labeling regulations (21 CFR Part 201).

2) All liquid bulk oxygen delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (USP).

3) A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include, at a minimum:

· Supplier's name and complete address

· Name of the Product (i.e., Oxygen USP.)

· An Air Liquefaction Statement

· Lot number or other unique identification numbers

· Actual analytical results for full USP monograph testing are an FDA regulation under 21 CRF 211 Subpart E. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

· Test method used to perform the analysis must be based on approved methods from current good manufacturing practice for medical gases guidance. (A statement such as "Meets USP specifications" shall not be acceptable, nor shall "Tested via Servomex" be acceptable, since the specific model number is not provided.)

· Signature of authorized supplier representative and date

4) Material Safety Data Sheets shall be provided to each facility COR upon request.

5) A copy of all inspection reports and training certificates shall be provided to each facility COR upon completing any Contractor-furnished or GO bulk oxygen system inspections that are required and at a minimum done annually and consistent with NFPA 55 and NFPA 99 code requirements.

6) All Contractor-furnished bulk tank systems shall be maintained or repaired in accordance with NFPA 55 Code requirements (Current Edition) and FDA's Current Good Manufacturing Practices (CGMP) Regulations.

d. Conduct of Personnel

1) Contractor/Sub-Contractor employees shall conduct themselves in a professional and/or a socially acceptable manner. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor/Sub-Contractor shall be grounds for denying the employee further access to the VA premises.

2) The Contractor/Sub-Contractor employee(s) shall always wear visible identification on uniform shirt and badge while on the premises. The delivery truck must be clearly and appropriately labeled with Contractor/Sub-Contractor signage when on VA medical facility, Warehouse, and CBOCs.

9. Risk Control The Contractor shall be responsible for all damages to persons or property that occurs because of the Contractor’s fault or negligence.

The Contractor shall provide written procedures and initial in-service training for VA staff on protocols to ensure safety on and around the tank systems at the time of initial filling of any new or upgraded bulk oxygen tank system. The Contractor shall provide additional safety training as needed by the facility to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. The Contractor shall provide 24/7 emergency contact name(s), telephone number(s), fax number(s), and email addresses during training.

10. Place of Performance Since the bulk oxygen tanks are government owned, the Contractor shall deliver all supplies of medical-grade liquid bulk oxygen to the Cheyenne VA Medical Center (VAMC), 2360 East Pershing Boulevard, Cheyenne Wyoming.

11. Period of Performance This is a Base-Plus-Four (4) Option Year requirement. The Period of Performance for this service shall be 10/1/2024 - 9/30/2029, which shall consist of one full year for the Base Contract and four Option Years for contract extension on a year-by-year basis. Option Years shall be reviewed and approved by a VA Contracting Officer prior to execution.

12. Delivery Schedule and Process

a. Bulk deliveries are Monday-Friday, 0700-1600 MT. First delivery shall be on/about 10/15/2024. The delivery driver shall call the Cheyenne VAMC Boiler Plant at 307.778.7334 for tank site access.

b. If for any reason the Contractor is unable to deliver at the agreed upon day or time, the Contractor shall provide 24-hour notice to the POC and must initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries must be monitored by a qualified and trained technical representative that shall be designated by each facility. Contractor shall be provided with names and contact information of primary and backup facility representatives. This applies to all deliveries regardless of time or day of execution.

c. Tank systems(s) shall be filled to maximum functional capacity each time the tank is refilled.

d. At the time of each delivery, the Contractor shall provide to the VA a legible signed and dated document and/or electronic delivery slip that identifies the tank level prior to the fill, after the fill, and the quantity delivered at the time of delivery. This document must be countersigned by the facility representative supervising the delivery. Delivery audits shall be performed by the facility and matched for accuracy. The driver shall convert gallons to ft³ (CF) and CCF quantity and shall list these numbers on the delivery slip to be consistent with the detail on the invoice so to provide accuracy for invoice certification.

e. Emergency delivery shall be provided within 24 hours after receipt of Government notification. Contractor shall respond to the facility POC by either telephone or email within one hour to confirm receipt of emergency notification. Emergency status is determined by the Government when conditions warrant, such as a main bulk tank system damaged by the VA or a system imminent alarm condition, or a system leak that requires a refill in 24 hours. Failure of the Contractor to remain current with the agreed delivery schedule and requirements does not constitute an "emergency" for purposes of charging an emergency fee.

f. Once validated, the facility shall post the facility and Contractor contact names and numbers on the oxygen tank system and at each monitoring point at the facility so that 24/7 supplier staff coverage is assured.

g. The Contractor shall not be required to make non-emergency deliveries on federally observed holidays. When the normal delivery day falls on a federal holiday, the Contractor shall deliver on the workday preceding that holiday. The following holidays are observed by the Federal Government (as well as any other day that is declared a national Holiday per an Executive Order issued by the President):

New Year's Day

Martin Luther King's Birthday (3rd Monday in January)

Presidents Day (3rd Monday in February)

Memorial Day (last Monday in May)

Independence Day (July 4th)

Labor Day (1st Monday in September)

Juneteenth (June 19)

Columbus Day (2nd Monday in October)

Veterans Day (November 11th)

Thanksgiving Day

Christmas Day

Note: If the holiday falls on a Saturday, it is officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it is officially observed on the Monday following the holiday.