Inactive

STATEMENT OF WORK 1. General 1.1. The Department of Veterans Affairs (VA) VISN 6 has a requirement for the distribution and supply of medical-grade liquid bulk oxygen at the Hampton, Virginia VA Medic... STATEMENT OF WORK 1. General 1.1. The Department of Veterans Affairs (VA) VISN 6 has a requirement for the distribution and supply of medical-grade liquid bulk oxygen at the Hampton, Virginia VA Medical Center. 1.2. The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid bulk oxygen for the facilities. The contractor shall also provide a contractor-owned tank and back-up tanks as required. 1.3. The quantities shown in the solicitation schedule are estimates of the facility s annual requirement. There is no express or implied guarantee that these quantities will be purchased. The contract period for this solicitation is for 1 year beginning January 01, 2021 with 4 options. Note that contracts that include the installation of contractor-owned equipment will include a 90 day transition period at the beginning and end of the contract period. 1.4. Prior to first filling, contractor must perform in-service training to include the following facets for contractor 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 VA staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor shall provide 24/7 emergency contact name(s) and telephone number(s). 1.5. 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, latest edition, for contractor 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 COR. Receipt of this written explanation must be signed for by the COR. 1.6. Prior to first filling the contractor shall verify, in writing, the accuracy of all gauges on contractor owned tanks. The Government may choose to exercise this option at its desire. 1.8 The contractor shall provide a digital indicator at the bulk site showing levels and pressure of the bulk tanks. The indicator must be solar powered as there is no electrical power available at the bulk site. Telemetry monitoring will also be required to operate on solar generated power. Telemetry monitoring shall be provided. 2. Acronyms 2.1 This section lists acronyms that are used in this Statement of Work and other parts of the solicitation. CF Cubic feet CGA Compressed Gas Association CGMP Current Good Manufacturing Practices CO Contractor owned COTR - Contracting Officer Technical Representative FDA U.S. Food & Drug Administration NFPA National Fire Protection Association OSHA U.S. Department of Labor, Occupational Safety and Health Administration USP United States Pharmacopeia VA Department of Veterans Affairs 3. Government-Furnished Property 3.1. The Medical Center requires installation of contractor owned equipment and provides a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally, the facility shall provide a facility-maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system. The telemetry system and digital indicator installed by the contractor shall be solar powered. 4. Contractor-Furnished Equipment 4.1. The contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up tank. The bulk system automatically switches between the main and reserve tanks as necessary to maintain optimal levels while allowing for expansion of gas. The contract shall specify if the system being offer has a main and reserve tank, as well as an automatic switching capacity equal to the existing system. Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that will insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve tank shown in the schedule are minimum capacities required. Manifold, 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 contractor shall provide a digital indicator at the bulk site showing levels and pressure of the bulk tanks and it must be solar powered as there is no electrical power available at the bulk site. The telemetry monitoring will also be required to operate on solar generated power. 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 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 bulk oxygen systems for this purpose. 5. Installation of Contractor-Owned Equipment 5.1 Unless otherwise directed by the facility, contractor owned equipment shall be installed within ninety (90) days of the effective date of the contract and shall be connected to the medical gas system by that date. 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 incumbent 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 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. 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 the required contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility site prior to submitting a bid and take other steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting the individuals designated in the solicitation. 5.4. All contractor-owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, the latest edition, NFPA 99 Standard for Health Care Facilities, latest 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. Bulk oxygen is ordered by and delivered to the facility. Information regarding delivery requirements is included in the solicitation schedule. 6.2. The contractor shall deliver medical-grade liquid oxygen on an as required basis for the facility. The contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility and contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. If for any reason the contractor is unable to deliver at the agreed upon day or time, the contractor shall provide 24-hour notice, so that the facility can initiate an alternate backup action. In accordance with the latest VHA Patient Safety Alert, all deliveries shall be monitored by a qualified and trained technical representative that will be designated by each facility. Contractor shall 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. 6.3. Tanks(s) shall 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. 6.4. 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. 6.5. Emergency delivery and/or repairs will be provided within 2 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, 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. Sub-contracting plans established to meet this requirement will be considered during evaluation of proposals. Contractors shall submit any applicable sub-contracting plans with the proposal. 7. Quality Assurance Specifications and Requirements 7.1. All medical gas manufacturers and fillers of medical gases shall 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 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 shall include, at a minimum: a) Supplier s name and complete address b) Name of the 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. is not acceptable.) f) 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.) g) Signature of authorized supplier representative and date. 7.4. Material Safety Data Sheets shall be provided to the facility upon request. 7.5. A copy of all inspection reports shall be provided to the facility upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation. 7.6. All contractors owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, latest edition, and FDA s Current Good Manufacturing Practices (CGMP) Regulations. 8. Applicable Regulations & Standards 8.1 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

Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

STATEMENT OF WORK 1. General 1.1. The Department of Veterans Affairs (VA) VISN 6 has a requirement for the distribution and supply of medical-grade liquid bulk oxygen at the Hampton, Virginia VA Medic... STATEMENT OF WORK 1. General 1.1. The Department of Veterans Affairs (VA) VISN 6 has a requirement for the distribution and supply of medical-grade liquid bulk oxygen at the Hampton, Virginia VA Medical Center. 1.2. The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid bulk oxygen for the facilities. The contractor shall also provide a contractor-owned tank and back-up tanks as required. 1.3. The quantities shown in the solicitation schedule are estimates of the facility s annual requirement. There is no express or implied guarantee that these quantities will be purchased. The contract period for this solicitation is for 1 year beginning January 01, 2021 with 4 options. Note that contracts that include the installation of contractor-owned equipment will include a 90 day transition period at the beginning and end of the contract period. 1.4. Prior to first filling, contractor must perform in-service training to include the following facets for contractor 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 VA staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor shall provide 24/7 emergency contact name(s) and telephone number(s). 1.5. 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, latest edition, for contractor 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 COR. Receipt of this written explanation must be signed for by the COR. 1.6. Prior to first filling the contractor shall verify, in writing, the accuracy of all gauges on contractor owned tanks. The Government may choose to exercise this option at its desire. 1.8 The contractor shall provide a digital indicator at the bulk site showing levels and pressure of the bulk tanks. The indicator must be solar powered as there is no electrical power available at the bulk site. Telemetry monitoring will also be required to operate on solar generated power. Telemetry monitoring shall be provided. 2. Acronyms 2.1 This section lists acronyms that are used in this Statement of Work and other parts of the solicitation. CF Cubic feet CGA Compressed Gas Association CGMP Current Good Manufacturing Practices CO Contractor owned COTR - Contracting Officer Technical Representative FDA U.S. Food & Drug Administration NFPA National Fire Protection Association OSHA U.S. Department of Labor, Occupational Safety and Health Administration USP United States Pharmacopeia VA Department of Veterans Affairs 3. Government-Furnished Property 3.1. The Medical Center requires installation of contractor owned equipment and provides a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally, the facility shall provide a facility-maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system. The telemetry system and digital indicator installed by the contractor shall be solar powered. 4. Contractor-Furnished Equipment 4.1. The contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up tank. The bulk system automatically switches between the main and reserve tanks as necessary to maintain optimal levels while allowing for expansion of gas. The contract shall specify if the system being offer has a main and reserve tank, as well as an automatic switching capacity equal to the existing system. Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that will insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve tank shown in the schedule are minimum capacities required. Manifold, 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 contractor shall provide a digital indicator at the bulk site showing levels and pressure of the bulk tanks and it must be solar powered as there is no electrical power available at the bulk site. The telemetry monitoring will also be required to operate on solar generated power. 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 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 bulk oxygen systems for this purpose. 5. Installation of Contractor-Owned Equipment 5.1 Unless otherwise directed by the facility, contractor owned equipment shall be installed within ninety (90) days of the effective date of the contract and shall be connected to the medical gas system by that date. 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 incumbent 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 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. 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 the required contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility site prior to submitting a bid and take other steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting the individuals designated in the solicitation. 5.4. All contractor-owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, the latest edition, NFPA 99 Standard for Health Care Facilities, latest 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. Bulk oxygen is ordered by and delivered to the facility. Information regarding delivery requirements is included in the solicitation schedule. 6.2. The contractor shall deliver medical-grade liquid oxygen on an as required basis for the facility. The contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility and contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. If for any reason the contractor is unable to deliver at the agreed upon day or time, the contractor shall provide 24-hour notice, so that the facility can initiate an alternate backup action. In accordance with the latest VHA Patient Safety Alert, all deliveries shall be monitored by a qualified and trained technical representative that will be designated by each facility. Contractor shall 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. 6.3. Tanks(s) shall 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. 6.4. 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. 6.5. Emergency delivery and/or repairs will be provided within 2 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, 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. Sub-contracting plans established to meet this requirement will be considered during evaluation of proposals. Contractors shall submit any applicable sub-contracting plans with the proposal. 7. Quality Assurance Specifications and Requirements 7.1. All medical gas manufacturers and fillers of medical gases shall 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 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 shall include, at a minimum: a) Supplier s name and complete address b) Name of the 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. is not acceptable.) f) 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.) g) Signature of authorized supplier representative and date. 7.4. Material Safety Data Sheets shall be provided to the facility upon request. 7.5. A copy of all inspection reports shall be provided to the facility upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation. 7.6. All contractors owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, latest edition, and FDA s Current Good Manufacturing Practices (CGMP) Regulations. 8. Applicable Regulations & Standards 8.1 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