2- Performance Work Statement Bulk Oxygen 36C24821Q0565.docx

Bulk Oxygen Performance Work Statement

1. General

1.1 The West Palm Beach VA Medical Center (VAMC) has a requirement for a Florida Licensed Bulk Oxygen Contractor to supply medical grade bulk oxygen services to the medical center. The VA contractor shall provide all needed components to support a Food and Drug Administration (FDA) certified bulk oxygen main supply system for medical gas in accordance with National Fire Protection Agency (NFPA) 99. The need involves the rental of a primary tank for the West Palm Beach VAMC location with a capacity of 6000 gallons and rental of a reserve tank with a 1500-gallon capacity. Contractor shall include all required components of the bulk oxygen supply, connection to VAMC’s existing oxygen system, preventive maintenance, annual training, inventory management of the bulk systems, and all necessary documentation. The contractor shall have an off-site monitoring system (telemetry system) that will allow the contractor to independently monitor the system and refill requirements. The supply systems shall be located at the existing location at the VAMC in West Palm Beach, Florida. In order to ensure uninterrupted supply of oxygen to the medical center, the contractor’s business must be physically located within a 1- hour drive to the West Palm Beach VA Medical Center (VAMC).

1.2 The quantities shown in the solicitation price schedules are estimates of the annual requirements. There is no expressed or implied guarantee that these quantities will be purchased. Please note that contract shall include the installation of contractor-owned equipment will include a 90- day transition period at the beginning and end of the contract period.

1.3 Prior to first filling, contractor shall 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 shall provide written procedures and training for designated 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).

1.4 Prior to first filling, and annually thereafter, alarm set-point testing and written verification shall be presented through the use of 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 Contracting Officer Representative (COR). Receipt of this written explanation must be signed for by the COR or designee.

1.5 Prior to first filling, and annually thereafter, the contractor shall verify, in writing, the accuracy of all gauges on contractor-owned tanks.

2. Acronyms BOP — Federal Bureau of Prisons CCF — 100 cubic feet CF — Cubic feet CGA — Compressed Gas Association CGMP — Current Good Manufacturing Practices CO — Contractor owned 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

3. Government-Furnished Property The solicitation schedule will identify the bulk oxygen storage tanks as being contractor owned. VAMC West Palm Beach requires installation of contractor-owned equipment and has a suitable location and foundation for the installation of the contractor-owned bulk oxygen tanks with access to an electrical power source and hook-up to a facility-maintained alarm system. The contractor shall perform the hook-up of contractor-owned equipment to the facility-maintained alarm system.

4. Contractor-Furnished Equipment

4.1 The contractor shall provide, install and maintain both a 6000 gallon and a 1500-gallon bulk oxygen tank with appropriate back-up system(s). Throughout 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 shown in the schedule are 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 VAMC West Palm Beach. The manifold or liquid converter shall deliver gas at a pressure and rate of 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.

4.2 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. (i.e., all installation, inspection and maintenance costs shall be included in the contract's monthly equipment rental fee for the facility.) Contractor-owned equipment shall be kept in safe optimum operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

5. Installation of Contractor-Owned Equipment

5.1 Unless otherwise directed, the contractor-owned equipment shall be installed by the effective date of the contract and shall be connected to the medical gas system on that date; provided: that the contractor shall be allowed a maximum of ninety days after receipt of notice of award to complete installation. If the contractor's equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor so as to avoid interruption of gas supply.

5.2 To permit orderly transition from one contractor to another, the contractor shall 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 incumbent’s 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.

5.3 All contractor-owned equipment shall be installed and maintained 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.

6. Delivery of Medical Liquid Bulk Oxygen

6.1 The contractor shall deliver medical-grade liquid oxygen Monday-Friday (with the exception federal or training holidays) between the hours of 0800 and 1630 to the West Palm Beach VAMC. 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 the facility. Contractor shall be available to make emergency deliveries within 1 hour of notification as required or as mission dictates at no additional cost to the government. 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. 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.

6.2 Both contractor-owned tanks will be filled and maintained at maximum functional capacity at each refilling procedure unless otherwise specified in the requirements or as agreed upon in a written document signed and dated by the COR. Contractor must be certified to perform and complete NFPA annual inspections of bulk liquid oxygen system.

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

7. Quality Assurance Specifications and Requirements

7.1 All medical gas manufacturers 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 bulk oxygen delivered under the contract shall be medical-grade and shall meet or exceed all industry standards and Federal regulations.

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

7.4 Safety Data Sheets shall be provided to the facility COR upon request.

7.5 A copy of all inspection reports shall be provided to the facility COR within 30 days upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation. A schedule listing all annual and semi-annual inspections by date for the life of the contract shall be provided once the contract is awarded.

8. 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 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.

9. Product Specifications 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:

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.

10. Qualifications: The contractor performing under this contract shall be licensed in the state of Florida and possess all required certifications and accreditations. The qualifications of contractor personnel are subject to review by the VA Chief of Staff and approval by VA Facility Director.

11. Personnel Policy: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel: worker's compensation professional liability insurance health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

12. Modification: In accordance with FAR 52.212-4(c), changes may only be made by a written modification which is formally executed by the contractor and the Contracting Officer.

Performance Requirements Summary

Task

ID

Indicator

Standard

Remedy

Standard Deliveries of Medical Grade Liquid Bulk Oxygen and maintenance of equipment

Timelines

Mon-Fri 0800 - 1630

97%

Direct Observation; 100% Inspection Satisfactory Or Unsatisfactory

Noted in quarterly reports

Emergency deliveries made to WEST PALM BEACH VAMC within 1 hour of order

Timelines

Delivery arrives with 1 hour of order

100%

Direct Observation; 100% Inspection Satisfactory Or

Accurate Invoicing for WEST PALM BEACH VAMC

Vendor billing price matches contract price

Accurate monthly invoicing

97%

100% Inspection

Satisfactory Or

B.6 PRICE SCHEDULE

PERIOD OF PERFORMANCE: BASE YEAR- 04/1/2021 – 3/31/2022

PRICE

TOTAL

PRICE

PERIOD OF PERFORMANCE: OPTION YEAR ONE (1) 04/1/2022 – 3/31/2023

PRICE

TOTAL

PERIOD OF PERFORMANCE: OPTION YEAR TWO (2) 04/1/2023 – 3/31/2024

PRICE

TOTAL

PERIOD OF PERFORMANCE: OPTION YEAR THREE (3) 04/1/2024 – 3/31/2025

PRICE

TOTAL

ANNUAL

TOTAL

PERIOD OF PERFORMANCE: OPTION YEAR FOUR (4) 04/1/2025 – 3/31/2026

PRICE

TOTAL

SUMMARY