STATEMENT OF WORK (Revised- Replaces original SOW in entirety).docx

STATEMENT OF WORK

Medical Grade Bulk Liquid Oxygen

1. General

1.1. The VA North Texas Health Care System has established an ongoing requirement that requires a contractor to provide Medical Grade Bulk Liquid Oxygen. If the Government facility does not own its own bulk oxygen tank system, the Contractor shall provide a contractor-furnished tank system with an appropriate backup system (i.e., reserve tank or cylinder bank). The Contractor shall provide all needed components to support a Food and Drug Administration (FDA) medical grade bulk liquid oxygen tank system in compliance with the National Fire Protection Agency (NFPA) 99: Health Care Facilities Code. Additionally, the Contractor must utilize an off-site, automatic monitoring system (telemetry system) that independently monitors the system and notifies the Contractor when refills are required.

1.2. Location/Facility Requirements: The bulk oxygen tanks are government owned. All supplies of medical-grade liquid bulk oxygen shall be delivered to the Dallas VA Medical Centers: Delivery Location: 4500 S Lancaster Rd, Dallas TX 75216.

Tanks are on Energy Center Circle, Bldg. 70 Off Veterans Drive, call operator to unlock tank, 214-857-1062

1.2.1. The Contractor shall be required to make deliveries of medical-grade liquid bulk oxygen throughout the life of the contract. The estimated quantities are 145,150.00 CCF for the facility annual requirement.

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

1.4. 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. Contractor shall provide 24/7 emergency contact name(s), telephone number(s), fax number(s) and email addresses during training.

2. Acronyms

2.1 This section lists acronyms that are used in this Statement of Work and other parts of the solicitation.

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 USP – United States Pharmacopeia VA – Department of Veterans Affairs OSHA – US Department of Labor, Occupational Safety and Health Administration

3. Government-Furnished Property

3.1. The schedule of items will identify any Government owned (GO) bulk tank system(s) at each facility. GO bulk oxygen storage tank systems and appurtenances will 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.

3.2. Upon award of the contract, all GO bulk tank systems and materials must be inspected by the Contractor at the Contractor's expense. Upon inspection, the Contractor shall immediately notify the Contracting Officer if the Contractor will 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. Each facility will 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.

3.3. The Government will be responsible for annual maintenance and testing of GO property to ensure safety, in accordance with applicable regulations and standards.

3.4. 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.

4. Licensing, Authorization, and Selling Permissions

4.1. 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.

4.2. 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.

4.3. 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.

5. Liability Insurance Requirements

5.1. 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.

6. Ordering

6.1. The medical grade bulk liquid oxygen is ordered through telemetry systems based on automatic monitoring of the bulk liquid oxygen tank system’s established fill point, orders with the contractor are considered to be placed when the telemetry system alerts the contractor that the fill point has been reached. VA facilities may accept the standard fill point established by the Contractor. However, VA Safety and/or Engineering personnel reserve the right to establish different fill point settings for the bulk liquid oxygen tank systems. Any amended fill point settings will be communicated to the Contractor by each facility’s POC.

6.2. In the event telemetry is not used to signal the contractor to initiate a delivery request, orders shall be placed with the Contractor only by the POC through fax or e-mail at the address/fax number and contact listed below:

FAX Number:

Email Address:

Department:

Name of Contact Person:

Address:

6.3. The POC will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of POCs upon issuing the contract. When a POC is added after award, the CO will 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.

7. Delivery of Medical Liquid Bulk Oxygen

7.1. The Contractor shall deliver medical-grade liquid oxygen to the Dallas VA Medical Center: Delivery Locations. 4500 S Lancaster Rd, Dallas TX 75216.

Tanks are on Energy Center Circle, Bldg. 70 Off Veterans Drive, call operator to unlock tank, 214-857-1062

7.2. 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.

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

7.4. 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.

7.5 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.

7.6 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.

7.7 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

7.8 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.

8. Quality Assurance Specifications and Requirements

8.1. 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).

8.2. 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).

8.3. 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 is 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.

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

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.

8.4. 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.

9. Applicable Regulations & Standards

9.1. 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. 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

9.2. Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No. P-6, titled "Standard Density Data, Atmospheric Gases, and Hydrogen," shall be used when necessary to convert the measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to cubic feet to 100 cubic feet.

Calculation based on data in CGA P-6

1 ft³ liquid O2 = 860.6 ft³ gas (Table 1) 1 ft³ liquid O2 = 7.48052 gal (Table 2)

Therefore EXAMPLE:

995-gal (1 ft³) liquid O2 multiplied by the conversion factor of 1115.1 ft³ gas

Total: 114,524.5 ft³ gas divide by 100, and that is what is to be billed.

Gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas multiplied by 100 to get the CCF.

10. Conduct of Personnel:

10.1. 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.

10.2. 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.

11. 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 that a declared National or State Emergency has been declared 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.

12. INVOICE AND PAYMENT

12.1. 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, CFs and CCFs. The driver shall insure that the conversion between gallons, ft³ (CF), and CCF quantity is accurate so that these numbers listed on the delivery slip will be consistent with the details on the resulting invoice in order to facilitate invoice certification. The invoice that is submitted must match the delivery quantity on the POD document and must be invoiced in CFs.