36C24624Q0570_1.docx

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GENERAL INFORMATION

SET-ASIDE

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Kim Pauley kim.pauley@va.gov kim.Pauley@va.gov 757-728-7189

PLACE OF PERFORMANCE

1100 Tunnel Road

Asheville NC

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The following must be met for the upcoming medical oxygen and equipment needed by Charles George Veterans Administration Medical Center.

It is the intention of the government to procure medical oxygen for medical facility.

If your company can provide this product per the SOW, please respond ASAP no later than March 15, 2024 @ 9:00 am to kim.pauley@va.gov with technical documentation to fulfill this need.

This contract is all-inclusive. Prospective offerors should read the requirements carefully to ensure a complete understanding of the contract requirements to ensure their proposal includes all expenses and costs associated with performance related to the contract. The Government will not reimburse offerors due to a failure on the offeror’s part to consider all costs associated with performance on this requirement.

The Government seeks a Base Year plus four(4) option years (B+4) with the following period(s) of Performance (PoP):

Summary of Requirements The Contractor shall be responsible for the delivery medical grade liquid bulk oxygen and Oxygen Storage Tanks to the Asheville VAMC. At a minimum, the contractor shall be responsible for providing all (to include, but not limited to) project management, labor, equipment, materials, hardware, software, special tooling, and transportation to ensure the successful performance of all requirements contained within this Statement of Work.

Bulk Oxygen

The contractor shall be responsible for the delivery medical-grade liquid oxygen. The contractor shall deliver all liquid oxygen orders within 24 hours of receiving request from the COR or Alternate COR’s. Additionally, a mutually agreeable delivery schedule for the filling of tanks may be established between the COR and the Contractor.

Tank(s) shall be filled to maximum functional capacity at each refilling within the limits of available funding at the delivery order level and or allowable variations IAW the defined terms of this contract.

Prior to first filling the contractor will verify, in writing, the accuracy of all gauges on contractor owned tanks. The Government may choose to exercise this option at its desire.

At the time of each delivery, contractor should 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 will be counter-signed by the facility representative supervising the delivery.

Prior to first filling, and annually thereafter, alarm set-point testing and written verification should be presented through the use of a qualified third-party expert per NFPA 99, latest edition, for contractor owned systems. Any code deficiencies in the Medical Center’s existing system, as defined by NFPA 50, 1.3.3, “Bulk Oxygen System”, must be identified by the contractor. A detailed explanation of these deficiencies must be presented in writing to the COR. Receipt of this written explanation must be signed for by the COR.

The contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the COR 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 shall provide 24-hour notice to the COR via email, so that the facility can initiate an alternate backup action. In accordance with the latest VHA Patient Safety Alert, all deliveries will 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.

Emergency delivery and/or repairs shall be provided within two (2) 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.

Prior to first filling, contractor should perform in-service training to include the following facets for contractor 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. 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).

Contractor-Furnished Equipment

The contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate backup tank. The bulk system automatically switches between the main and reserve tanks as necessary to maintain optimal levels while allowing for expansion of gas. Through the duration of the contract, the contractor will be liable for the integrity, suitability, and safety of contractor owned tank(s) that will ensure compliance with applicable regulations, standards, and normal good practices. The tank capacity and reserve tank shown in the schedule are minimum capacities required. Manifold, 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 will be furnished by the contractor, without cost to the Government. The contractor shall provide a digital indicator at the bulk site showing levels and pressure of the bulk tanks and it must be solar powered as there is no electrical power available at the bulk site. The telemetry monitoring will also be required to operate on solar generated power. The manifold or liquid converter will deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container should have an outlet that allows access for testing the purity of the oxygen.

All contractor-owned equipment shall be installed and maintained in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, the latest edition, NFPA 99 Standard for Health Care Facilities, latest 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.

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

The contractor will provide a digital indicator at the bulk site showing levels and pressures of the bulk tanks. The indicator must be solar powered as there is no electrical power available at the bulk site. Telemetry monitoring will also be required to operate on solar generated power. Telemetry monitoring may be provided.

Should the existing tanks be deemed unserviceable, the Asheville VAMC requires installation of contractor owned equipment and provides a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally, the facility will provide a facility-maintained alarm system. The contractor will perform the hook-up of contractor owned equipment to the facility- maintained alarm system. The telemetry system and digital indicator installed by the contractor should be solar powered. If the contractor’s equipment replaces equipment already in use, the exchange of equipment will be accomplished without interruption of gas supply to the using facility. Contractor- installed equipment should remain the property of the contractor and will be removed upon termination of the contract, at the Contractor’s expense, when directed by the COR and in full cooperation with any succeeding contractor so as to avoid interruption of gas supply.

No guarantee is given or implied that data included in the schedule regarding contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required contractor owned tanks and appurtenances.

Transition/Continuity of Services

To permit orderly transition from one contractor to another or in the event that the government elects to replace contractor owned equipment with government owned equipment, the incumbent contractor should continue to honor the contract’s monthly equipment rental fee and bulk oxygen contract price for a maximum of ninety days beyond the scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to the ninety-day transition period. For any partial month, the contractor will prorate the monthly equipment rental fee accordingly and will continue to maintain its equipment during this transition period.

Quality Assurance Specifications and Requirements

All medical gas manufacturers and fillers of medical gases shall be registered with 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).

All liquid bulk oxygen delivered under the contract shall be medical-grade, meeting or exceeding the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.).

A valid certificate of analysis will be provided with each delivery of liquid oxygen. The certificate will 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. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

f) Test method used to perform the analysis. (A statement such as “Meets U.S.P.

specifications” is not acceptable; nor would “Tested via Servomex” be acceptable since the specific model number is not provided.)

g) Signature of authorized supplier representative and date.

Material Safety Data Sheets will be provided to the facility COR upon request.

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

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

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 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 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 Edition NFPA 99: Standard for Health Care Facilities, 2002 Edition U.S.P. 23

Sources Sought Notice