SOW Balboa Medical Gas 11-28-22.pdf

STATEMENT OF WORK

Naval Medical Center San Diego

Bulk Medical-Grade Gases

Introduction/Scope

The effort required hereunder shall be performed in accordance with this statement of work and all other terms and conditions set forth herein. The contractor shall supply bulk medical-grade cylinder gases and service to the Naval Medical Center San Diego (NMCSD) and its Branch Clinics throughout San Diego CA. The gases include, but are not limited to, are compressed Medical Air USP, Oxygen USP, Carbon Dioxide USP, Nitrogen NF, Nitrous Oxide USP, Helium USP, and specialty medical gas mixtures.

The contract items shall be ordered by and delivered to the Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, Ca. 92134-5000. The quantities shown in the schedule are estimates of the activity's annual requirements. There is no express or implied guarantee that these quantities will be purchased. The solicitation also requires the contractor to fill government owned cylinders, will provided contactor owned (C) cylinders, will be servicing the facility with a combination of both (C/G).

Government Technical Representatives

A Contracting Officer Representative (COR) and Alternate Contracting Officer Representative (ACOR) has been designated in the contract for the ordering facility. The COR is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR/ACOR 's specific responsibilities will be provided to the contractor and COR/ACOR at the time of contract award. Within 15 days after notification of contract award, the contractor shall meet with the COR to ensure mutual understanding of facility requirements relating to the ordering method and specific details of any delivery instructions that are included in the solicitation schedule. The facility COR shall forward a written copy of the mutual agreement signed by both parties to the Naval Medical Center National Acquisition Center Contracting Officer for incorporation into the contract by written modification within 30 days after contract award. If agreement cannot be reached between the contractor and COR regarding any issue, the matter shall be referred to the Contracting Officer for resolution.

Contingency/ Emergency

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 NMCSD staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor will provide 24h emergency contact name(s) and telephone number(s).

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, 2002 Edition for contractor owned and government 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 Technical advisory. Receipt of this written explanation must be signed for by Technical advisory.

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 Government may choose to exercise this option at its desire.

Contacts from the facility to the contractor concerning emergency situations must be responded to within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency.

Product Specification

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

In addition, the following specifications are incorporated into the solicitation and resulting contracts:

a. Federal Specification BB-A-1034B, Air, Compressed, for Breathing Purposes

b. Federal Specification BB-C-101B, Carbon Dioxide (CO2) Technical and USP

c. Compressed Gas Association (CGA) Publications G-7-CompressedAirfor

Human Respiration, ANSI/CGA G-7.1- Commodity Specification for Air

All products, equipment, and services provided under the contracts awarded under this solicitation shall be in compliant with all applicable Federal, State, and local regulations.

Delivery Requirements

The delivery time is specified in the schedule for each facility; the number of days specified shall be the number of calendar days after receipt of order. The schedule lists delivery instructions that are unique to each facility. Contractor must be within 55 miles and must be able to deliver gases within 24 hours upon ordering, if needed. FOB point is destination. All transportation charges for cylinders shall be included in the price of gas. Additional charges such as delivery fees, hazardous materials fees. fuel surcharges. etc.. Shall NOT be billed to or collected from the facilities for orders received under this contract.

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

Non-Repairable Government Property

Prior to disposing of non-repairable government-owned cylinders, parts, fittings, and appurtenances, the contractor shall contact ordering (owning) activity. Contractor shall make disposition in accordance with the ordering activities instructions.

Contractor shall not charge any additional types of fees, other than those specified above in paragraph 4:2, for the return on non-repairable cylinders to the ordering activities.

Cylinders and other Containers 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 DOT regulations (title 49-Transportation, Code of Federal Regulations), Filling, packaging, labeling, ect, for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

Marking

In addition to marking required by the laws, and regulations, marking shall comply with CGA Publications C-7- Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, dated 03/21/04.

Color Coding

Cylinders shall be in color coded in accordance with CGA Publications C-9-Standard Color Marking of Compressed Gas Containers Intended for Medical Use, dated 10/13/04

Valves

Valves shall comply with CGA Safety Bulletin SB-26 and CGA Publication V-1

Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated 12/31/00. 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. 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.

HYDROSTATIC TESTING

Retest Date

If applicable DOT regulations would require retesting of cylinder within three (3) months after scheduled date of shipment to continental U.S destination, or within (6) months after scheduled date of shipment to overseas destination, cylinder shall be rested.

Contractor will be required to retest any Government-owned cylinder when requested by ordering activity, regardless of scheduled retest data.

Method

Cylinder Sizes Cylinder sizes shown below indicate the product capacity of those currently being used. All capacities are approximate, and the Government shall be billed based on cylinder size delivered. In accordance with the Federal Food Drug and Cosmetic act. The actual contents of the container must appear on the label.

Gaseous Cylinders Sizes: An B C D E H T & M

Government-owned cylinders which are eligible for extended hydrostatic retest period, testing by modified hydrostatic method, or visual inspection in. lieu of hydrostatic testing, shall be serviced by the most economical means which will comply with the Department of Transportation regulations (49 CFR 173.34) unless otherwise specified by the ordering activity.

When modified or reduced DOT test requirements are contingent upon past usage of the cylinders, a written statement from the ordering activity indicating that the cylinders have been used exclusively for a specific gas may be considered acceptable evidence of the cylinder’s eligibility for modified testing or inspection.

Hydrostatic testing shall be performed in accordance with CGA's Publication-.C-1 Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated 12/01/96.

Visual inspection shall be performed in accordance with the applicable CGA Publications C-6- Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated 1/1/93 or C-6.1 - Standards for Visual Inspection of High Pressure Aluminum Compressed Gas Cylinders, dated 4/1/95.

The contractor shall be responsible for all testing of contractor-owned cylinder at no additional cost to the Government. The government shall pay for the hydrostatic testing of government-owned cylinders.

Cylinder Sizes

Cylinder sizes shown in the item description indicated product capacity of the cylinder currently being used. All capacities are approximate, and the Government shall be billed4 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.

Cylinder Sizes

Cylinder sizes shown below indicate the product capacity of those currently being used.

All capacities are approximate and the Government shall be billed based on cylinder size delivered. In accordance with the Federal

Food Drug and Cosmetic Act the actual contents of the container must appear on the label.

Gaseous Cylinders Sizes: An B C D E H T & M.

Installation of Temp liquid oxygen system:

Contractor shall install and fill a temp liquid oxygen system to the Naval Medical Center San Diego and perform all the proper permitting and inspection of the temp system prior to properly permitting and performing all the inspections of the installation of the 9000 gallon main liquid oxygen tank and the 500 gallon reserve tank.

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.

Lost or Damaged Contractor-Owned cylinders

For each contractor-owned cylinder lost or damaged beyond repair while in Government possession, the Government shall pay the Contractor the replacement value, less the allocable rental paid for that cylinder. These cylinders shall become Government property. If any lost cylinder is located within 30 calendar days 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, fewer rentals computed in accordance with section 8 of this Statement of Work.

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.

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. Density and data volume measurement equivalents printed in CGA Publication P-6 Standard Density Data, Atmospheric Gases and Hydrogen, dated 3/8/00 shall be used with necessary to convert measurement of these gases from one form to another: for example, from cubic feet to gallons.

Cylinders picked up by contractors’ truck: ordering activities shall notify the contractor of the number and type of empty cylinders ready for return. No rental charges shall be applied to any cylinder five days (Saturdays, Sundays and Holidays excluded) after the ordering activity has notified the contractor. The day the contractor is notified is excluded from the five day period.

If the contractor is verbally notified of empty cylinders, the ordering activity will document the notification by making a record of the date, time and contractor's representative contacted.

Cylinders returned by carrier: Ordering activities returning empty contractor-owned cylinders will immediately notify the contractor in writing of quantity and size of cylinders and the date they were turned over to the carrier. Rental charges shall not be applied after the date cylinders are picked up the common carrier.

Contractor-Furnished Equipment

For contractor owned Tanks, the contractor shall provide, install, and maintain bulk Liquid Oxygen, Nitrogen NF, and Nitrous Oxide UPS tanks with appropriate back-up system (s).

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 capacity and reserve system should meet 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 the pressure and rate of flow adequate to supply the system.

Each liquid storage container shall have an outlet that allows access for testing the purity of the gas.