SOW_for_Oxygen_Support_(rv1).docx

STATEMENT OF WORK

1. General

1.1 The 11 Medical Group (11 MDG) Joint Base Andrews, MD has a requirement to rent and procure medical-grade owned bulk liquid oxygen system in support of facilities 1060 and 1045 (Malcolm Grow Ambulatory Care Center). The contractor shall provide a contractor-owned tank with an appropriate back-up system (i.e. reserve tank or cylinder bank) and liquid bulk oxygen.

1.2 The quantities are estimates of the facility’s annual requirements. There is no express or implied guarantee that these quantities will be purchased. Please note that agreements that include the installation of contractor-owned equipment will include a 30 day transition period at the beginning and end of the BPA period.

1.3 The contractor shall perform in-service training to include the following facets for contractor owned and government owned systems: the refill procedure, any preventive maintenance support requirements that may be needed from the medical center systems, and an explanation of all the volume alarm and low pressure set-points. The contractor will provide written procedures and training for 11 MDG staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor will provide 24/7 emergency contact name(s) and telephone number(s).

1.4 Written verification shall be presented through the use of a qualified third party expert per National Fire Protection Association (NFPA) 99 Standard for Health Care Facilities for contractor owned and government owned systems. Any code deficiencies in the Medical Center’s existing system, as defined by NFPA 50 “Bulk Oxygen System”, must be identified by the contractor. A detailed explanation of these deficiencies must be presented in writing to the government representative.

1.5 The contractor shall install 3000 Gallon Main system and 300 Gallon Reserve system to building 1060 and 500 Gallon system to building 1045 within the Pressure Chamber in support of Malcolm Grow Medical Clinic and Surgery Center (MGMCSC). The estimate monthly usage for the 3000 Gallon Main system and 300 Gallon Reserve system is 1,000,000 cf and the 500 Gallon system is 23,500 cf.

1.6 The contractor will verify system is operational meeting National Fire Protection Agency requirements located in NFPA 55 Compressed Gases and Cryogenic Fluids Code (2016 edition) and NFPA 99 Health Care Facilities Code (2018 edition) in support of Malcolm Grow Medical Clinic and Surgery Centers supply of bulk gas systems.

1.7 The contractor shall verify, in writing, the accuracy of all gauges on contractor owned tanks.

2. Contractor-Furnished Equipment

2.1 Contractor owned tanks, the contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that will insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the using facilities. Manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility’s gas system shall be furnished by the contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

2.2 All equipment and materials required to perform on the contract shall be provided by the contractor. Contractor owned equipment shall be installed, inspected, and maintained by the contractor without additional cost to the Government (i.e., all installation, inspection, and maintenance costs shall be included in the contract’s monthly equipment rental fee). Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

3. Installation of Contractor-Owned Equipment

3.1 Unless otherwise directed by the using facility, contractor owned equipment shall be installed by the effective date of the BPA and shall be connected to the medical gas system on that date; provided that the contractor shall be allowed a maximum of thirty days after receipt of notice of award to complete installation. If the contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor so as to avoid interruption of gas supply.

3.2 Upon expiration or termination of the contract and if the contractor is not awarded a follow- on contract, the contractor shall remove contractor owned equipment at no cost to the Government. To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract’s monthly equipment rental fee and bulk oxygen contract price for scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to transition period. For any partial month, the contractor shall prorate the monthly equipment rental fee accordingly. The contractor shall continue to provide and maintain its equipment during this transition period.

3.3 All contractor owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, NFPA 99 Standard for Health Care Facilities, and FDA’s Current Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all U.S. Department of Labor, Occupational Safety and Health Administration USP (OSHA) standards and applicable safety requirements, including proper signage and use of personal protective equipment.

4. Delivery of Medical Liquid Bulk Oxygen

4.1 Bulk oxygen is ordered by and delivered to the individual ordering facility. The contractor shall deliver medical-grade liquid oxygen within the time-frame specified in the schedule. The time-frame identified may be either the number of calendar days after receipt of the Government’s order, the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point, or other specified ordering and delivery methods. If the time frame for contractor delivery is not identified in the facility requirements, the contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility and contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. If for any reason the contractor is unable to delivery at the agreed upon day or time, the contractor will provide 24-hour notice to the government representative, so that the facility can initiate an alternate backup action. Contractor will be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution.

4.2 Tanks(s) will be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the COR.

4.3 At the time of each delivery, contractor must provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the facility representative supervising the delivery.

4.4 Emergency delivery will be provided within 24 hours after receipt of Government notification. Contractor must respond to the facility by either telephone or email within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government. Facility Representative shall notify the contractor when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak. Failure of the contractor to remain current with agreed delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.

5. Quality Assurance Specifications and Requirements

5.1 All medical gas manufacturers and fillers of medical gases must be registered with U.S. Food & Drug Administration (FDA) as drug manufacturers. 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).

5.2 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 (U.S.P.).

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

a) Supplier’s name and complete address

b) Name of the Product (i.e. Oxygen U.S.P.)

c) An Air Liquefaction Statement where appropriate

d) Lot number or other unique identification number

e) Actual analytical results for full U.S.P. monograph testing.

f) Test method used to perform the analysis.

g) Signature of authorized supplier representative and date.

5.4 Material Safety Data Sheets shall be provided to the facility.

5.5 A copy of all inspection reports shall be provided to the facility upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation.

5.6 All contractor owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA’s Current Good Manufacturing Practices (CGMP) Regulations.

6. Contractor Owned Cylinders

6.1 This section applies to all contractor owned cylinders that are provided under this contract as a back-up system to a primary bulk oxygen system.

6.2 Laws and Regulations: Cylinders and other containers for gaseous and liquid forms of gases shall comply with the Department of Transportation (DOT) specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current and subsequent updates to DOT regulations (Title 49-Transportation, Code of Federal Regulations). Packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

6.3 Marking: In addition to marking required by the aforementioned laws and regulations, marking shall comply with American National Standards Z48.1-1954 (R 1971), "Method of Marking Portable Compressed Gas Containers to Identify the Material Contained."

6.4 Valves: Valves shall comply with Compressed Gas Associates Standard CGA-V-1 (11th Edition, 2003), "Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections." 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. Refer to 49 CFR 173.301(g)).

6.5 Color Coding: All cylinders shall be color coded in accordance with the Compressed Gas Association Pamphlet CGA C-9-1988, “Standard Color Marking of Compressed Gas Containers Intended for Medical Use.”