Final SOW Liquid O2.pdf

DEPARTMENT OF VETERAN AFFAIRS

STATEMENT OF WORK

IN-HOUSE LIQUID OXYGEN

1. GENERAL

1.a. The Lebanon VA Medical Center is seeking a contractor to provide an on-station medical gas fill site for liquid oxygen (Contractor-provided 40-liter to 48-liter liquid stationary reservoir tanks located in Building 1). These stationary units must accommodate approximately 4,000 to 8,000 pounds of usage per month, depending on need of the hospital. In addition, the VA intends to utilize 100 Contractor provided liquid portable oxygen canisters to be placed in two

(2) or more buildings at the VA Medical Center, Lebanon, PA, 17042. Ten (10) of these portable canisters must be high flow tanks. Twice per week each stationary reservoir tank will require a complete fill. These tanks are used to fill the 100 portable canisters which are used by patients. Services included in the price of medical gas: the bidder’s price for the medical gas shall include the furnishing, at no additional cost, all services which are required at each and every filling of a cylinder to comply with the applicable regulations, specifications, and normal good practices. Such services shall include but are not limited to: Tags or gauges (identifying cylinders as “full” or “in use”), inspection, testing, and evacuation. If

Current breakdown for liquid oxygen stationary tanks is as follows:

Building 1, Room 15:

Ten (10) 40 to 48-liter Penox (Pin index) and/or Puritan Bennett base tanks

All equipment provided must be compatible with the equipment used in our home oxygen system. The current system is Penox, Puritan Bennett, or comparable. All medical gas shall be clearly labeled with the contents of the cylinder. All contractor-furnished equipment must be visibly marked with its own serial number for tracking purposes. The VA and vendor share responsibility in tracking all liquid portable units.

1.b. The usage shown in the solicitation schedule is an estimate for the facility’s annual requirements. There is no express or implied guarantee that the usage will be purchased. The base contract period for a contract awarded under this solicitation will be March 27, 2025, through March 26, 2026. Unless otherwise directed by the using activity, contractor owned equipment shall be provided by the first day of the contract period and shall be filled and ready for use on that date, provided that the contractor is allowed a minimum of thirty (30) days after receipt of notice of award to begin performance. If Contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of medical gas supply to the using activity. Contract awarded under the solicitation will include four (4) one-year option periods which may be exercised by the Government if required.

1.c. A Contracting Officer Representative (COR) may be designated after award. The COR is responsible for contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR’s specific responsibilities will be provided to the contractor and COR at the time of contract award. Within 15 days after contract award, the contractor shall contact the COR to finalize the ordering method and clarify the specific details of any delivery instructions that are included in the solicitation schedule. If agreement cannot be reached between the contractor and COR regarding any issue, the matter shall be referred to the Contracting Officer for resolution.

1.d. Prior to first filling, contractor must perform in-service training if required 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 precautionary and emergency measures as well as low pressure set points if required. The Contractor will perform a visual inspection of valves and regulators for periodic maintenance and repair on contractor and government owned cylinders. A visual inspection should be performed before each use to detect any damage, cracks, corrosion, or other defects. Recommended valve and regulator maintenance schedules will be conducted in accordance with OSHA and NFPA 99. This is due to long term maintenance or replacement periods varying with the types of gases used and the length of use and conditions of usage.

1.e. The contractor will provide written procedures and training to VA staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the on-site refilling process. Contractor will provide 24/7 emergency contact name(s) and telephone number(s).

1.f. Any code deficiencies in the Medical Center’s existing system must be identified by the contractor if required. 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.

1.g. 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 verification that pressure gauges on regulators are correct for the pressure of the gas cylinder used.

2. Contractor-Furnished Equipment

2.a. The contractor shall provide and maintain 100 liquid portable canisters, and liquid stationary tanks. Through the duration of the contract, the contractor shall 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 capacities shown in the schedule are minimum capacities required by the using facilities. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each container shall have an outlet that allows access for testing the purity of the medical gas.

2.b. 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 tanks for this purpose.

2.c. Contractor provided equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering activity. Contractor provided equipment shall be maintained by the contractor and shall be removed by the contractor when directed by the ordering activity and shall remain in full cooperation with the succeeding contractor to avoid interruption of medical gas supply.

3. Provision of Contractor-Owned Equipment

3.a. Unless otherwise directed by the using activity, contractor owned equipment shall be installed/delivered and ready for use by the first day of the contract period provided that the contractor shall be allowed notice of time to complete the installation. If Contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using activity. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering activity. Contractor installed equipment shall be maintained by the contractor and removed by the contractor when directed by the ordering activity and in full cooperation with the succeeding contractor to avoid interruption of gas supply.

3.b. To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract’s monthly equipment rental fee and gases/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 shall prorate the monthly equipment rental fee accordingly.

The contractor shall continue to provide and maintain its equipment during this transition period.

3.c. 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 required contractor owned tanks and appurtenances.

3.d. All contractor’s owned equipment shall be installed in accordance with OSHA, NFPA 99 Standard for Health Care Facilities, 2002 Edition, and FDA’s Safe Device Act Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

4. Deliveries

4.a. Delivery is to be made two times per week on Tuesday and Friday and should be set up on an automatic fill schedule. All delivery tickets will be signed by the Oxygen Technicians or Respiratory Staff and then forwarded to the COR for processing. Off-schedule, (not regularly scheduled Tuesday and Friday) emergency deliveries will be made by the contractor in accordance with paragraph 4d below. 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 COR, 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.

4.b. 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.c. 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.d. 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 (not part of this contract), 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.a. All medical gas manufacturers and fillers of medical gases must be registered with FDA as drug manufacturers. All gases/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.b. All gases/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.c. A valid certificate of analysis shall be provided with each delivery of gases/oxygen. The certificate shall include, at a minimum if required:

• Supplier’s name and complete address

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

• An Air Liquefaction Statement where appropriate

• Lot number or other unique identification number

• 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.)

• 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.)

• Signature of authorized supplier representative and date.

5.d. Material Safety Data Sheets shall be provided to the facility COR at first fill and upon request.

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

6. Applicable Regulations & Standards

6.a. Additional Laws and Regulations: Cylinders and other containers for gaseous and liquid forms of gasses shall comply with Department of Transportation specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current 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.b. 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 follow 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.

49 CFR – Transportation

Federal Food, Drug, and Cosmetic Act

NFPA 55: Compressed Gases and Cryogenic Fluids Code

NFPA 99: Standard for Health Care Facilities, 2002 Edition

U.S.P. 23

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

6.c. 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 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.

7. Contractor Owned Cylinders

7.a. 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.

7.b. 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."

7.c. All unauthorized or inapplicable markings, tags, and labels shall be removed. When shipment is by commercial carrier, shipping tags complying with Federal Standard 123F dated 5/15/91 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.

7.d. Agencies may order gases under stock numbers differing from those in the List under Section B; containers shall be marked with the number used on the purchase order.

7.e. 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)).

7.f. 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.” Anesthesia gases: Cylinder for use on anesthesia machines shall be color coded in accordance with US Department of Commerce, “Simplified Practice

Recommendations R175-14 of the Bureau of Standards” will be acceptable on Contractor owned cylinders.

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

7.h. Transportation: Transportation of empty cylinders will be made at the expense of the contractor. Pickup will be made within five (5) days after notification by the Government.

7.i. All products, equipment, and services provided under the contract awarded under this solicitation shall follow all applicable Federal, state, and local regulations.

7.j. The bidder's price shall include the furnishing of, at no additional cost, all services which are required at each and every filling of a 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 and every filling; pin-indexing safety system, and attachment of Government-furnished warning tags, when required. Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the contractor at no additional cost. In addition to services listed in this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders. Cylinder condition must be at or above good condition. All cylinders must be painted with no loose chips, where contact with other cylinders will cause paint flakes to fall off. Cylinder must be clean of any debris (i.e., Dirt or Mud) to include bottom. Identification of Distributor must be visible on all cylinders.

8. Term of Contract

The contract is effective from date of award through March 26, 2026, plus four (4) additional one-year option periods ending March 26, 2030. Service/Supplies shall not be performed by the Contractor after March 26 of any year until the Contracting Officer authorizes such services by exercise of option year(s).

Performance Period: The Government is requesting one base period of one year and four option periods of one year.

Base Period: 27 March 2025 thru 26 March 2026 Option Period 1: 27 March 2026 thru 26 March 2027 Option Period 2: 27 March 2027 thru 26 March 2028 Option Period 3: 27 March 2028 thru 26 March 2029 Option Period 4: 27 March 2029 thru 26 March 2030

9. Payment

9.a. The VAMC agrees to reimburse the Contractor for resources furnished at the price listed in the schedule of contract. The Contractor will be paid monthly, upon receipt of invoice. The invoice shall contain at a minimum: The Contractor’s name, address, items, price, and Purchase order number.

9.b. Invoicing Procedures

The method of payment is certified invoice.

9.c. Invoice Remittance

The Contractor shall submit all invoices electronically at the following site:

https://authentication.tungsten-network.com/

10. Administration

The contractor shall contact the Contracting Officer on all matters pertaining to the administration of this contract. Only the Contracting Officer is authorized to make changes that will affect the price, quantity, quality, or delivery terms of this contract.

11. Use of Cell Phones

11.a. A sign posted in every entryway and lobby will state the following, “Cell phone usage is permitted except for posted areas.”

11.b. Use of cell phones and personal electronics is not allowed within six feet of any active medical device for any reason, even if signs are not posted.

12. Deliveries will be made to:

Lebanon VA Medical Center 1700 S. Lincoln Ave Lebanon PA 17042 Building 1, Room 15

13. Delivery Commitment

• Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

• PERSON’S AUTHORIZED TO PLACE ORDERS: In addition to the Contracting

Officer’s Technical Representative (COR), VA may submit names of authorized government personnel to request requirement to fill cylinders after award. Only these named personnel have the authority to request requirement of medical gases.

• The services/supplies specified herein may be changed by written modification when contract is awarded. The modification will only be prepared by the VA Contracting Officer prior to becoming effective and approved.

14. SPECIAL CONTRACT REQUIREMENTS: Qualification of Offerors: The offeror shall be licensed by the city in which they are located.

15. Acronyms

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 DOD – Department of Defense DOT – Department of Transportation FDA – U.S. Food & Drug Administration GO – Government-Owned IHS – Indian Health Service NFPA – National Fire Protection Association OGA – Other Government Agency (Other than VA) OSHA – U.S. Department of Labor, Occupational Safety and Health Administration USP – United States Pharmacopeia VA – Department of Veterans Affairs