Attachment-Statement of Work for OKC Bulk Oxygen and Tank Rental.pdf

Statement of Work for Medical-Grade Liquid Bulk Oxygen for

Oklahoma City VA Health Care System

1. General

1.1 Prior to first filling, contractor must 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 VA 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).

1.2 Prior to first filling, and annually thereafter, alarm set-point testing and written verification must be presented using a qualified third-party expert per NFPA 99, 2015 Edition for contractor owned and government owned systems. Any code deficiencies in the Medical Center’s existing system, as defined by NFPA 55, Standard for

Compressed Gases and Cryogenic Fluids Code, 2013 Edition, must be identified by the contractor. A detailed explanation of these deficiencies must be presented in writing to the facility Point of Contact (POC). Receipt of this written explanation must be signed for by the POC.

1.3 Prior to first filling, and annually thereafter, the contractor must verify, in writing, the accuracy of all gauges on contractor owned tanks. If the gauge(s) are government owned, contractor will provide, if requested after award, a written proposal with price to verify accuracy of the gauge(s). The individual facility may choose to accept this proposal at its desire.

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 CO – Contractor owned

COT - Contracting Officer Representative

FDA – U.S. Food & Drug Administration GO – Government owned

NFPA – National Fire Protection Association

OSHA – U.S. Department of Labor, Occupational Safety and Health Administration

USP – United States Pharmacopeia

VA – Department of Veterans Affairs

3. Government-Furnished Property

3.1 The solicitation schedule will identify the bulk oxygen storage tank(s) at each facility as being either GO

(Government Owned) or CO (Contractor Owned). Government owned bulk oxygen storage tanks and appurtenances will be maintained by and at the expense of the Government in a manner that will insure compliance with applicable regulations, standards and normal good practices.

3.2 Each Government facility that requires installation of contractor owned equipment shall provide a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally, each facility shall provide access to an electrical power source and hook-up to a facility- maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system.

4. Contractor-Furnished Equipment

4.1 For those facilities listed in the schedule as having 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 order, 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.

4.2 All equipment and materials required to perform on the contract (other than what is specifically listed in section 3, Government-Furnished Property) 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 for the applicable facility.) 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.

5. Installation of Contractor Owned Equipment

5.1 All contractor owned equipment shall be installed in accordance with NFPA 55: Compressed Gases and

Cryogenic Fluids, 2013 Edition, NFPA 99 Standard for Health Care Facilities, 2015 Edition, and FDA’s Current

Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

6. Delivery of Medical Liquid Bulk Oxygen

6.1 Bulk oxygen is ordered by and delivered to the Oklahoma City VA Health Care System (OKC), 921 N.E. 13th

Street, Oklahoma City, OK 73104.

6.2 The contractor shall deliver medical-grade liquid oxygen within the timeframe specified in the schedule for each facility. The timeframe 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 re-order 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 deliver at the agreed upon day or time, the contractor will provide 24-hour notice to the POC, so that the facility can 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 will be designated by each facility.

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.

6.3 Tanks 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 POC.

6.4 At the time of each delivery, contractor must provide a legibly 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.

6.5 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 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.

7. Applicable Regulations & Standards

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, equipment 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 supplying medical grade oxygen

29 CFR 1910.104 OSHA Standards for the installation of bulk oxygen systems on industrial and institutional consumer premises

49 CFR – Transportation

Federal Food, Drug, and Cosmetic Act, Chapter V

NFPA 55: Standard for Compressed Gases and Cryogenic Fluid Code, 2013 Edition NFPA 99: Standard for Health

Care Facilities, 2015 Edition

U.S.P. 23: US Pharmacopoeia & National Formulary – current edition

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 measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to 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:

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

1 gal liquid O2 = 860.6 ft³ gas

7.48052

1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas

8. Contractor Owned Cylinders

8.1 Laws and Regulations: Cylinders and other containers for gaseous and liquid forms of gases shall comply with the Department of Transportation 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.

8.2 Marking: In addition to marking required by the laws and regulations, marking shall comply with the

Handbook of Compressed Gases, Chapter 10.

8.3 All unauthorized or inapplicable markings, tags, and labels shall be removed. When shipment is by commercial carrier, shipping tags complying with Federal Standard 123G dated 6/6/1997 shall be attached to each cylinder to be protected by the valve protection cap. The contract data markings required by the applicable standard shall be applied to one side of the tag and the identification markings on the reverse side. Consignee markings may be omitted when shipment is by contractor's truck.

8.4 Valves: Valves shall comply with Compressed Gas Associates Standard CGA-V-1 (13th Edition, 2013), "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)).

8.5 Color Coding: All cylinders shall be color coded in accordance with the Compressed Gas Association Pamphlet

CGA C-9-2004, “Standard Color Marking of Compressed Gas Containers Intended for Medical Use.”

8.6 The contractor shall be responsible for all testing required by regulation of contractor owned cylinders at no additional cost to the Government.

8.7 All services which are required at every filling of a shall cylinder to comply with applicable regulations, specifications, and normal good practices. Such services are of the type normally provided in the supply of medical cylinder gases, and shall include, but not be limited to: tags indicating cylinder is "Full," In Use," or "Empty";

inspection, testing, evaluation, and cleaning services required at each filling; pin-indexing, when required, and attachment of Government-furnished warning tags, when required. The contractor is responsible for all maintenance and testing of contractor-owned cylinders.

9. Government Owned Cylinders

9.1 Government owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either government-owned or contractor-owned, without authorization.

10. Contractor’s Liability

10.1 The contractor assumes full responsibility for and shall indemnify the Government for any and all loss or damage whatsoever kind and nature to any and all Government property, including any equipment, supplies, accessories, or parts furnished while in custody and care for storage, repairs, or services to be performed under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor or any employee, agent , or representative of Contractor or subcontractor.

10.2 The contractor shall hold harmless and indemnify the Government against any and all liability, claims, and cost of whatsoever kind and nature for injury to or death of any person or persons and for loss or damage to any property occurring in connection with or in any way incident to or arising out of the occupancy, use, service, operations, or performance of work under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor, or any employee, agent or representative of Contractor or subcontractor.

10.3 Nothing in the above paragraphs shall be considered to preclude the Government from receiving the benefits of any insurance the Contractor may carry which provides for indemnification for any loss, destruction, or damage to Government property. The Contractor shall do nothing to prejudice the Government’s right to recover against third parties for any loss, destruction, or damage to Government property and upon the request of the Contracting

Officer shall, at the Contractor’s expense, furnish to the Government all reasonable assistance and cooperation

(including assistance in prosecution of suit and the execution of instruments of assignment in favor of the

Government) in obtaining recovery.

11. Smoking Policy

11.1 Except in designated areas smoking is strictly prohibited inside and, on the patios or balconies of all buildings and within 25 feet of all openings of all buildings. It is also prohibited inside all VA Healthcare System vehicles.

“Smoking” is defined as the burning of any cigarette, cigar or other tobacco product.