Attachment 1 STATEMENT OF WORK 6-30-2026.docx

STATEMENT OF WORK

Medical Grade Gases & Cylinder Rentals

1.0 BACKGROUND:

1.1 A new contract for medical grade gases and cylinder rentals is needed to adequately support the Research and Development Department at the Atlanta VA Medical Center. The gases to be purchased include but are not limited to Liquid Nitrogen- various types and purity including but not limited to refrigerated, NF, High Purity, Carbon Dioxide - various types and purity including but not limited to Medical Grade, Oxygen. The contract items will be ordered by and delivered to the locations listed in the schedule as described below. The quantities shown in the schedule are estimates of each activity’s annual requirements. In accordance with FAR 52.216-22, the volumes or amounts shown are estimates only and impose no obligation on the VA, except for the guaranteed minimum as specified elsewhere in the documentation.

2.0 SPECIFICATIONS:

2.1 All medical gases shall conform to specifications prescribed in the United States Pharmacopeia and the National Formulary.

2.2 All medical gas manufacturers and fillers of medical gases shall be registered with the FDA; and all medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations, Parts 210, 211 and 201 for labeling.

2.3 The following specifications are incorporated:

2.3.1 Federal Specification BB-C-101D, Carbon Dioxide (CO2) Technical and USP, current edition.

2.3.2 Compressed Gas Association (CGA) Publications G-7 – Compressed Air for Human Respiration, current edition, and ANSI/CGA G-7.1 – Commodity Specification for Air, current edition.

2.4 All products, equipment, and services provided under the contracts awarded under this solicitation shall be in compliance with all applicable Federal, state, and local regulations. All applicable licenses/certifications/insurance or other required documentation shall be provided to the Government Point of Contact and the Contracting Officer within 10 days after the contract award.

2.4.1 LICENSING, AUTHORIZATION, AND SELLING PERMISSIONS

2.4.1.1 If the Contractor is the manufacturer of the medical gases it places into the medical gas cylinders being supplied under this contract, it shall provide verification on an annual basis (initial submission is within ten calendar days after award), that it holds current licensing, permits, certifications, or registrations required by the FDA and the states in which this contract is performed.

2.4.1.2 If the Contractor is not the manufacturer of the medical gases that are placed into medical gas cylinders being supplied under this contract, the Contractor must provide evidence of the medical gas manufacturer’s current licenses, permits, certifications, or registrations required by the FDA in the states in which this contract is performed, as well as an executed copy of the resellers agreement within ten (10) calendar days of contract award affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the medical gas and to rent the medical gas cylinders that the Contractor is providing under this contract. In addition, the Contractor shall provide annual updates to any agreements it has with the medical gas manufacturer and medical gas cylinder provider affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the medical gas and to rent the medical gas cylinders that the Contractor is providing under this contract. In the event of a change in the manufacturer, the Contractor shall provide a minimum of 30 days advance notification, or at the time it is known, to VA of the change in manufacturer, and shall provide evidence of the new medical gas 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 signed agreement with the new manufacturer demonstrating that the Contractor has authorization by the manufacturer to resell the medical gases and to rent the medical gas cylinders that the Contractor intends to provide under this contract.

2.4.1.3 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. Contractor must also provide, annually, verification that the manufacturer from which it obtains the medical gases placed into the medical gas cylinders 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.

2.4.2 Material Safety Data Sheets shall be provided to the facility COR upon request at no additional charge.

2.5 The following are the expected needs:

2.5.1 Gas Needs

2.5.1.1 Liquid Nitrogen- various types and purity including but not limited to refrigerated, NF, High Purity, and high pressure (standard pressure expectation is 350 PSI)

2.5.1.2 Carbon Dioxide - various types and purity including but not limited to Medical Grade, Liquified

2.5.1.3 Oxygen (compressed gas)

2.5.2 Delivery requirements (unless specifically addressed in Section 3.0 below)

2.5.2.1 Delivery to Research Lab between working hours 8:00 am to 4:30pm unless otherwise noted in 3.0

2.5.2.2 When delivering tanks the contractor is required to swap out and take old tanks

2.5.2.3 If needed, the Government POC may request to skip scheduled tank delivery per location with 24-hour notice

2.5.2.4 Delivery is required directly to different lab locations, with the ability add additional lab locations

2.5.2.5 Delivery Receipt to be given to lab managers at point of delivery

2.5.2.6 There will be 30 days between award of contract and award effective/start date.

3.0 SPECIFIC DELIVERY REQUIREMENTS

3.1 The contractor shall provide all labor, material and supplies necessary to supply medical grade gases to the Atlanta Veterans Administration Healthcare System (AVAHCS), 1670 Clairmont Road, Decatur, GA 30033.

3.2 The contract items will be ordered and delivered to the AVAHCS, Research Department, located on the 5th floor clinical addition. The supply systems will be located at the existing Research 4th, 5th, and 12th floors 1670 Clairmont Road, Decatur, GA 30033.

3.3 The quantities shown on the Pricing Schedule are estimated annual requirements. ‘In accordance with FAR 52.216-22, the volumes or amounts shown are estimates only and impose no obligation on the VA, except for the guaranteed minimum as specified elsewhere in the documentation.

3.4 The contractor will provide contractor owned cylinders or will be servicing the facility with a combination of both Government owned and Contractor owned cylinders.

3.4.1 The contract shall include all required components of the supply system to include fittings, values, pressure relief values, and other components to provide a useable system.

3.5 Preventative maintenance on both Government owned and Contractor owned cylinders to include one hour annual training on proper filling procedures for personnel onsite.

3.6 The Gases must be maintained to ensure uninterrupted supply of to the Medical Research Department of Veterans Healthcare System.

3.7 Schedule of Deliverables:

3.7.1 FOB point is destination.

3.7.2 Deliveries shall be made on a twice per month basis, on the first and third full weeks of each month (24 deliveries annually) unless otherwise noted.

3.7.3 Delivery is required to the point of use.

3.7.4 There are four (4) delivery points:

Rooms 12C188; 4A125; 4A150; 5A138.

Atlanta VA Health Care System (Research Department) Attn:

1670 Clairmont Road Decatur, Georgia 30033 Office:

Cell:

3.7.5 Government POC will communicate in writing to the contractor which delivery point is needed to the contractor.

3.7.5.1 Potential for interaction with patients is minimal in common area hallways leading from the Loading Dock to service elevators.

3.7.5.2 Deliveries of refills shall be made Monday thru Friday (excluding holidays which are listed below) between the hours of 8 AM-4:30 PM. If a Holiday falls on the specified delivery dates, then immediate delivery arrangements need to be made with POC.

3.7.5.3 At the time of each delivery, the contractor shall provide signed and dated invoices. Document will be counter-signed by the facility representative supervising the delivery.

4.0 OTHER REQUIREMENTS

4.1 Performance Period: Five year IDIQ with no options. There will be 30 days between award of contract and start of performance.

4.2 Estimated quantities

8 cylinders per month

96 cylinders per year

4 cylinders per month

48 cylinders per month

4 cylinders per month

48 cylinders per month

(Oxygen Medical) 12 cylinders per day

12 cylinders @ 365 days = 4380

(Carbon Dioxide Anaerobic Grade) 12 units per day each

12 cylinders @ 365 days = 4380

4 units per day each 4 cylinders @ 365 days = 1460

4.3 Hours and Holidays

4.3.1 FEDERAL HOLIDAYS OBSERVED:

New Year’s Day Labor Day

Martin Luther King Day Columbus Day

President’s Day Veterans Day

Memorial Day Thanksgiving Day

Juneteenth Christmas Day

Independence Day

4.4 CYLINDERS AND OTHER CONTAINERS

4.4.1 Laws and Regulations

4.4.1.1 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 DOT regulations (Title 49-Transportation, Code of Federal Regulations.)

4.4.1.2 Filling, packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

4.4.2 Marking: In addition to marking required by the aforementioned laws and regulations, marking shall comply with CGA Publication C-7 – Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, current edition.

4.4.3 Color Coding: Cylinders shall be color coded in accordance with CGA Publication C-9 -- Standard Color Marking of Compressed Gas Containers Intended for Medical Use, dated current edition.

4.4.4 Valves

4.4.4.1 Valves shall comply with CGA Safety Bulletin SB-26 current edition and CGA Publication V-1 -- Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, current edition.

4.4.4.2 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.

4.4.4.3 For liquid containers, all fittings must be permanently brazed to prevent their removal. In addition, each container should contain a 360-degree cryoband applied at the top of the container with the drug product name repeated around the entire container.

4.4.5 Cylinder Sizes: Cylinder sizes shown in the item description indicate product capacity of the cylinder currently being used. All capacities are approximate, and the Government shall be billed only for the actual amount of gas delivered. In accordance with the Federal Food, Drug and Cosmetic Act, the actual contents of the container must appear on the label.

4.4.6 Individual Agency Ownership of Cylinders: 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 of the ordering agency.

4.4.7 Lost or Damaged Contractor-Owned Cylinders: For each contractor-owned cylinder lost or damaged beyond repair while in the Government’s possession, the government shall be liable to the contractor for each contractor-owned cylinder that is lost or damaged beyond repair while in the government’s possession and that the government’s liability shall not exceed the prevailing market rate.

4.4.7.1 These cylinders shall become Government property.

4.4.7.2 If any lost cylinder is located within 30 calendar days after payment by the Government, it may be returned to the Contractor by the Government, and the Contractor shall pay to the Government an amount equal to the replacement value, less rental during the period lost.

4.4.7.3 Any costs paid to the contractor should be done via a bilateral contract modification with appropriate release of claims language.

4.4.8 Method of Shipment: Empty Government-owned cylinders that are picked up from an ordering facility for re-fill or servicing shall be transported according to the Department of Transportation Regulations, using normal commercial practice to prevent damage to cylinders.

4.4.9 Transportation of Cylinders: All transportation charges for empty government-owned and contractor-owned cylinders from the ordering facility to the contractor’s facility shall be at the expense of the contractor.

4.4.10. Cylinder Inventory Audits

4.4.10.1 The Facility POC will conduct at a minimum, an annual review of inventory to reconcile the number of cylinders on hand in comparison to the number of cylinders held on the delivery ticket. The annual cylinder inventory audit must occur for each site within 45 calendar days of the end of each year of the ordering period. An inventory report will be provided to the CO and the FCLO.

4.4.10.2. Annual inventory audits require a minimum one day and vendor representative for service area of approximately 50,000 sq feet.

4.4.10.3. Contractor must be present until audit is completed in its entirety. Audits may be performed outside of normal business hours (at no additional cost to the Government). The Government POC will only sign complete audits that are mutually agreed upon.

4.4.10.4. Each facility must approve the final amount /number of missing / damaged cylinders (LOU). If discrepancies ensue, the Contractor must return at a mutually agreed upon date to redo the audit (at no additional expense). If the facility is unable to reschedule within 90 days, the facility must honor the audit findings.

4.5 Price of services for government-owned and contractor-owned cylinders

4.5.1 The price for the gas shall include the furnishing, at no additional cost, of all services which are required at each and every filling of a cylinder to comply with applicable regulations, specifications, and normal good practices.

4.5.1.1 Such services 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, when required, and attachment of Government-furnished warning tags, when required.

4.5.1.2 Attaching oxygen cylinders to manifold systems, when required, shall also be performed by the lab staff and/or Biosafety to be on side to hook up the tanks as needed.

4.5.1.3 The contractor is responsible for all maintenance and testing of contractor-owned cylinders.

5.0 Network: Computer / VA Network access is not required.