Final Updated Bulk Oxygen SOW 18 NOV 2022.docx

Statement of Work (SOW) Medical Grade Liquid Bulk Oxygen for RMR VA Medical Center

1. Scope of Work

1.1 The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid bulk oxygen and tank rental for the Rocky Mountain Regional VA Medical Center (RMRVAMC) 1700 N Wheeling St, Aurora, CO 80045. This will be for a Base Year and Four (4) Option Years.

1.2 The quantities shown in the Schedule of Supplies and Services are estimates of the RMRVAMC’s annual requirements. There is no express or implied guarantee that these quantities will be purchased. Please note that if this contract includes the installation of contractor-owned equipment it will include a transition period at the beginning and end of the contract.

1.3 The contractor must perform in-service training to include the following facets for contractor owned: the refill procedure, any preventative maintenance support requirements that may be needed form the medical center 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. The contractor will provide 24/7 emergency contact names and phone numbers. Facility Emergency POC’s are as follows:

Larry Williams (720) 857-2502\Cell 720-287-9085 larry.m.williams@va.gov AUS Email Group vhaechscmscontractingliaisons@va.gov FMS Group vhaechfmssupervisors@va.gov

1.4 annual alarm set point testing and written verification must be presented using a qualified 3rd party expert per NFPA 99, 2002 edition for contractor owned systems. Any code deficiencies in the “system as defines 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 VA Medical Center. Receipts of the written explanation will be signed for by the POC.

2. Government Furnished Equipment

2.1 Each government facility that require installation of contractor owned equipment shall provide a suitable location and foundation for the installation of the contractor owned bulk oxygen tanks.

3. Contractor Furnished Equipment

3.1 the contractor shall provide, install, and maintain bulk oxygen tanks with appropriate backup systems. Through the duration of the contract, the contractor shall be liable for the integrity, suitability and safety of contractor owned tanks that will ensure compliance with applicable regulations, standards, and normal good practices. The tank capacity and reserve system shown in the schedule are minimum required by using facility. Manifold, liquid converter, alarm switch, regulator, valves, level indicator and any other devices or connections required for proper tie-ins with the facilities 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 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.

3.2 All equipment and materials required to perform on the contract (other than what is specifically listed in section 2, Government Furnished Property) shall be provided by the contractor. Contractor owned equipment shall be installed, inspected, and maintained by the contractor without any additional cost to the Government. (i.e., all inspection and maintenance costs shall be included in the contract’s monthly storage tank lease fee.) contractor owned equipment shall be kept in good operating condition and appearance with applicable regulations, standard and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

4. Installation of Contractor Owned Equipment & Transition Plan

4.1 Unless otherwise directed by the using facility, contractor owned equipment shall be installed prior to 30 APR 2023 and shall be connected to the medical gas system on that date. If the contractor’s equipment replaces equipment already in use, the exchange of equipment shall be completed without interruption of the bulk oxygen gas supply to the facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination/end of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor so to avoid interruption of the bulk oxygen gas supply at the end of the contract.

4.2 All contractor owned equipment shall be installed in accordance with NFPA 50: standard for bulk oxygen systems at consumer sites, 2001, NFPA 99 Standard for Health Care Facilities, 2002 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

5. Contractors Responsibility

5.1 Responsibility for Government Property. The contractor assumes full responsibility for and shall indemnify the government for all loss or damage of whatsoever kind and nature to all government property. This includes any equipment, supplies, accessories, or parts furnished while in the contractor's 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.

5.2 . Damage to Government Property from causes other than Contractor's Negligence. Nothing in the above paragraphs shall be considered to preclude the government from receiving the benefits of any insurance the contractor may carry that provides for indemnification for any loss of, destruction of or damage to property in the care of the contractor where such loss of destruction or damage is to government property. The contractor shall do nothing to prejudice the government's right to recover against third parties for any loss of, destruction of or damage to government property and upon the request of the contracting officer shall, at the government'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.

6. Delivery of Medical Liquid Bulk Oxygen

6.1 Oxygen is provided from a contracted bulk liquid storage tank system that consists of a 6000-gallon main tank and a 1500-gallon reserve tank that is piped throughout the main hospital. The current set points for both tanks are as follows:

· Full TryCOCK: Main 318 and Reserve 135

· Reorder Point: Main 126 and Reserve 54

· Low Level Alarm” Main 62 and Reserve 24

The oxygen is to be monitored 24 hours a day 7 days a week by contractor’s designated staff.

6.2 The contractor shall deliver medical-grade liquid oxygen weekly as determined by staff during normal business hours. In the case that the delivery day falls on a federal holiday delivery should me made day prior and weather interferes with delivery, then the delivery shall be made the next business day. Bulk deliveries will be made to the existing bulk oxygen storage located outside of FMS Building L on the north end of the campus. In the case of an emergency, in which the facility becomes non-operational, the RMRVA requires a bulk tank delivery within 24 hours.

Normal Business Hours are between 8:00 a.m. and 4:00 p.m. Monday through Friday, excluding the Federal Holidays listed below.

New Years’ Day

Columbus Day

Any other day specifically designated by Federal Statute, Executive Order, and /or Presidential Proclamation shall be excluded

Normal Business Hour contact information:

Larry Williams (720) 857-2502\Cell 720-287-9085 larry.m.williams@va.gov AUS Email Group vhaechscmscontractingliaisons@va.gov FMS Group vhaechfmssupervisors@va.gov

6.3 Tanks will be filled to the maximum functional capacity at each refilling procedure unless otherwise specifies in the facility requirements or as agreed upon in a written document signed and dated by a Contracting representative.

6.4 At each delivery contractor must provide a legible signed and dated written document that identifies the tank level prior to fill and the level afterwards and the quantity delivered. This document must be counter signed by the facility representative supervising the delivery. Please provide documents to following:

Larry Williams (720) 857-2502\Cell 720-287-9085 larry.m.williams@va.gov AUS Email Group vhaechscmscontractingliaisons@va.gov

6.5 Emergency deliveries will be provided within 2 hours after receipt of Government notification. Contractor must respond to the facility by telephone within 1 hour to confirm receipt of emergency notification to ascertain the nature of 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 and emergency for purposes of charging an emergency delivery fee.

6.6 in the event of any natural disaster or potential disaster activity representing a threat to the contractor will be requesting an immediate dispatch of their truck to top off the main oxygen tank within 24 hours of pending disaster.

7. Quality Assurance Specifications and Requirements

7.1 All medical gas manufactures and fillers of medical gases must 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).

7.2 All liquid bull oxygen delivered under 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).

7.3 A Valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate should include at a minimum below:

a. Supplier’s name and complete address

b. Name of 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., it is not acceptable)

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

g. Signature of authorized supplier representative and date

7.4 Material Safety Data Sheets shall be provided to the facility

7.5 A copy of all inspection reports shall be provided to the facility upon completion of any contractor owned bulk oxygen system inspections that are required by regulation. Also send reports to Larry Williams (720) 857-2502\Cell 720-287-9085 larry.m.williams@va.gov AUS Email Group vhaechscmscontractingliaisons@va.gov FMS Group vhaechfmssupervisors@va.gov

7.6 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.

8. Applicable Regulations & Standards

8.1 The following is a list 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 this contract follow applicable Federal, State and Local regulations. If applicable the editions in effect as of the date of this solicitation ae 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

NGPA 99 Standard for Health Care Facilities 2002 Edition

U.S.P. 23

8.2 Offerors (or subcontractor manufacturer per paragraph 9 of this SOW) must be licensed in State of Colorado to distribute Medical Grade Oxygen as required by the Code of Colorado Regulations, State Board of Pharmacy 3 CCR 719-1 Section 15.00.00 Wholesalers

9. Licensing, Authorization, and Selling Permissions

9.1. If the Contractor is the manufacturer of the medical grade bulk oxygen being supplied under this contract, it shall annually provide verification that it holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed.

9.2. If the Contractor is not the manufacturer of the medical grade oxygen being supplied under this contract, the Contractor shall annually provide verification that the manufacturer from which it obtains the medical grade bulk oxygen 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. In addition, the Contractor shall provide annual updates to any agreements it has with the medical-grade oxygen manufacturer affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor is providing under this contract. In the event of a change in manufacturer, the Contractor shall provide advance notice to the VA prior to the change taking place, and shall provide copies of the new medical-grade oxygen 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 agreement with the new manufacturer demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor intends to provide under this contract. Annual updates of the agreement by the contractor that it remains an authorized reseller is required.

9.3. 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. A state license from a subcontractor manufacturer will satisfy the licensing requirement.