Atch 3 - Bulk Oxygen SOW Revised 6Dec2022.pdf

STATEMENT OF WORK (SOW)

FOR

USP MEDICAL-GRADE LIQUID OXYGEN STORAGE TANK

Revised 6 December 2022

1. Description of Services / General Information. The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, other items, and non-personal services necessary to provide United States Pharmacopoeia (USP) medical-grade liquid oxygen storage tank for Wilford Hall Ambulatory Surgical Center (WHASC), JBSA Lackland, Texas.

Background. The contractor shall provide, assemble, install, configure, and test a Contractor-owned USP medical-grade liquid oxygen bulk storage tank system, designed to provide for inventory replenishment system to provide 100% utilization of 6,000-gallon primary tank and 500-gallon reserve tank system, inventory monitoring, and consistent replenishment quantities. The primary storage tank content level at 120 cubic feet on meter and maintain 99% purity is acceptable, the Government prefer no lower than 120 cubic feet on meter. To minimize the impact of these deficiencies and improve services to the clinical staff; a committed source in bulk-uninterrupted supply, up-to-the minute tank-level readings, automatic re-ordering, and reliable liquid oxygen supply is planned.

Scope. To improve the inventory replenishment system in 59th Medical Operation Group (59 MDOG) by leasing a Contractor-owned storage tank; 6,000-gallon primary tank and 500-gallon reserve tank. The project consists of six (6) overall requirements: (1) set-up and installation of 6,000-gallon primary tank and 500-gallon reserve tank in accordance with this SOW, (2) tank rental, (3) deliver bulk USP medical-grade liquid oxygen, (4) telemetry, (5) annual FDA inspection, and (6) removal and site restoration IAW SOW. The contractor is not responsible for removal of the existing storage tanks and site restoration.

The storage tanks shall operate as follow:

The primary storage tank shall be replenished only when the primary tank content level reach 120 cubic feet on meter.

The reserve tank will be used as backup until the primary tank is replenished.

At the time of replenishment, the contractor shall be responsible for rotating inventory from reserve tank to primary tank.

Location:

Building 4554 1100 Wilford Hall Loop JBSA Lackland, TX 78236

1.1. Description of Services.

1.1.1. Leasing. The contractor shall provide completely functional USP medical-grade liquid oxygen bulk storage tanks, 6,000-gallons primary tank and 500-gallons reserve tank IAW National Fire Protection Association (NFPA), United States Food and Drug Administration (FDA), United States Code Federal Regulations (CFR), and Occupational Safety and Health Administration (OSHA) at Building 4554, except for any Government items supplied listed in paragraph 4.

Period of Performance for this requirement:

Base year: 19 January 2023 - 18 January 2024 Option Year 1: 19 January 2024 - 18 January 2025 Option Year 2: 19 January 2025 - 18 January 2026 Option Year 3: 19 January 2026 - 18 January 2027 Option Year 4: 19 January 2027 - 18 January 2028

1.1.1.1. Design. The contractor shall provide one (1) copy of design to the Functional Requirements Evaluator Designees (FRED) within fourteen (14) days after acceptance of set-up/installation. Design shall include floor plans, oxygen system purity monitoring layouts, pipe connections and layouts for entire storage tank system as specified by the requirements in paragraph 1 in this SOW. All designs shall be in accordance with all applicable codes, standards, and regulations. See list of applicable standards in Appendix A.

1.1.2. Setup/Installation. The contractor shall provide installation and delivery a completely functional Contractor-owned U.S.P.

medical-grade liquid oxygen bulk storage tanks, 6,000-gallons primary tank and 500-gallons reserve tank, for the 59th Medical Operation Group (59 MDOG) military healthcare facility in accordance with all applicable codes, standards, and regulations. The tank capacity and reserve system shown in the supplies or services and prices or costs are maximum capacities required by the using facility. Contractor-owned cylinders (rentals only) are acceptable.

1.1.2.1. Primary Tank. The contractor shall deliver and install primary tank size 6,000-gallon on the existing cement pad size (length x width) 25 ft. x 26 ft. The contractor shall utilize existing standard spill pad – 12 ft. x 10 ft.

1.1.2.2. Reserve Tank. The contractor shall deliver and install reserve tank size 500-gallon on the existing cement pad size (length x width) 25 ft. x 26 ft. The contractor shall utilize existing standard spill pad – 12 ft. x 10 ft. The reserve tank shall provide at least a 24-hour capacity for Wilford Hall Ambulatory Hospital patient flow.

1.1.2.3. Telemetry. The Contractor-owned U.S.P. medical-grade liquid oxygen bulk storage tanks shall provide telemetry unit. The telemetry unit shall provide for continuously monitor tank level, for uninterrupted supply. The telemetry unit may provide the feature to provide an automatically mark a place-order level for delivery; this is not a feature to automatically place order for the Government. Refill requirement will be called in by the FRED on an as required basis and a no lower than 120 on meter. The contractor shall include monthly telemetry services per month in their quote.

1.1.2.4. Applicability.

1.1.2.4.1. The WHASC, building 4554, is a Category 1 risk facility as defined by NFPA 99. Installation shall be in accordance with all applicable paragraphs of NFPA 99 and NFPA 55 for bulk cryogenic fluid systems in medical gas applications at health care facilities. See list of applicable standards in Appendix A.

1.1.2.4.2. Where nationally recognized good practices or standards have been established for the process employed, such practices and standards shall be followed. See list of applicable standards in Appendix A.

1.1.2.4.3. Systems shall be installed in compliance with FDA current good manufacturing practices (CGMP). Introducing a drug product into a system that has not been installed in accordance with CGMP is prohibited. 21 CFR 210 and 21 CFR 211 prohibits adulteration of drugs. See list of applicable standards in Appendix A.

1.1.2.4.4. Tank construction shall be in accordance with NFPA 55 for above ground tanks. Nonstandard containers shall not be permitted. See list of applicable standards in Appendix A.

1.1.2.4.5. Bulk cryogenic fluid central supply system shall be installed and maintained in compliance with CGA M-1, applicable regulations, and FDA current good manufacturing practices (CGMP). See list of applicable standards in Appendix A.

1.1.2.4.6. An Emergency Oxygen Supply Connection (EOSC) presently exists. Installation of bulk supply system shall tie into the existing piping as required. NOTE: The piping from the government-owned EOSC into the facility has been certified. The contractor shall perform a certification by conducting the required tests and verifications of completely functional connections from the new bulk supply piping system to the government-owned EOSC. The contractor shall document findings on a certification report, if any, defective connections and corrective action taken required to obtain a completely functional connections from the new bulk supply point to the government-owned EOCS. The contractor shall provide a one (1) copy of certification report to the FRED within 3 days after acceptance of set-up/installation.

1.1.2.4.7. Alarms shall tie into the existing Master Alarm Panels. The contractor shall verify the operation of all alarm circuits.

1.1.2.4.8. Piping Materials for Field-Installed Positive Pressure Medical Gas Systems to include tubes, valves, fittings, station outlets, and other piping components in medical gas systems shall have been cleaned for oxygen service by the manufacturer prior to installation in accordance with the mandatory requirements of CGA G-4.1, Cleaning Equipment for Oxygen Service, except that fitting shall be permitted to be cleaned by a supplier or agency other than the manufacturer.

1.1.2.4.9. Piping, tubing, fittings, and related components shall be designed, fabricated, and tested in accordance with the requirements of ASME B31.3, Process Piping, or other approved standards and shall be in accordance with NFPA 55. Reference NFPA 99 and NFPA 55 for additional medical gas piping/tubing requirements.

1.1.2.4.10. Joints in piping and tubing shall be in accordance with the requirements of ASME B31.3, Process Piping, or other approved standards.

1.1.2.4.11. Emergency Shutoff Valves. Accessible manual or automatic emergency shutoff valves shall be provided to shut off the cryogenic fluid supply in case of emergency.

1.1.2.4.11.1. Manual emergency shutoff valves or the device that activates an automatic emergency shutoff valve on a bulk source or piping systems serving the bulk supply shall be identified by means of a sign.

1.1.2.4.11.2. Emergency shutoff valves shall be located at the point of use, at the source of supply, and at the point where the system piping enters the building.

1.1.2.4.12. Connection/Tie-ins. The Contactor-owned storage tanks shall be furnished with manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other necessary devices or connections for proper tie-ins with the facility’s gas system.

1.1.2.4.12.1. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system.

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

1.1.2.5. Contractor-owned tank(s) maintenance. The contractor shall provide maintenance to Contractor-owned U.S.P. medical-grade liquid oxygen bulk storage tanks. The contractor shall be liable for the integrity, suitability, and safety of Contractor-owned tank(s) to ensure compliance with applicable regulations, standards and normal good practices.

1.1.2.5.1. 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.

1.1.2.5.2. The contractor shall be responsible for installation, inspection, and maintenance of all Contractor-owned equipment at no additional cost to the Government.

1.1.2.5.3. Work order. Failure of Contractor-owned-furnished equipment shall be repaired within 24 hours of notification.

1.1.2.5.3.1. If repair cannot be completed within 24 hours, the contractor shall provide service at the EOSC at no additional cost to the Government.

1.1.2.6. Installation of Contractor-owned equipment. Unless otherwise directed by the using facility, contractor owned equipment shall be connected to the medical gas system by the start of the contract Period of Performance; provided that the contractor shall be allowed a maximum of three (3) calendar days after receipt of award to complete non-affixed owned equipment connection.

1.1.2.6.1. 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 completion of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor to avoid interruption of services.

1.1.2.7. Transition period. Upon expiration or termination of the contract, the contractor shall remove Contractor owned equipment.

1.1.2.7.1. 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 scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to transition period.

1.1.2.7.2. The contractor shall continue to provide and maintain its equipment during this transition period.

1.1.2.7.3. Contracts that include the installation of Contractor-owned equipment will include a 30-day transition period at end of the contract period.

1.1.2.8. All Contractor-owned equipment shall be installed in accordance with the NFPA 55, NFPA 99, and the Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMP) Regulations.

1.1.2.8.1. The Contractor shall comply with all Occupational Safety and Health Administration (OSHA) standards and applicable safety requirements, including proper signage and use of personal protective equipment.

1.1.2.9. Manufactured assemblies shall be pretested by the manufacturer prior to arrival at the installation site in accordance with

NFPA 99.

1.1.2.10. Qualification of Installers. Installers under this solicitation shall meet the requirements outlined in NFPA 99 and NFPA 55.

1.1.2.10.1. Systems shall be installed by personnel qualified in accordance with CGA M-1, Guide for Medical Gas Installations at Consumer Sites, or ASSE 6015, Professional Qualification Standard for Bulk Medical Gas Systems Installers.

1.1.2.10.1.1. The contractor shall provide one (1) copy of certification to the FRED within 3 days after receipt of order. Certification of CGA M-1 Guide for Medical Gas Installations at Consumer Sites is acceptable. Certification of ASSE 6015 Professional Qualification Standard for Bulk Medical Gas Systems Installers is acceptable.

1.1.2.11. The central oxygen system design shall facilitate oxygen system purity monitoring.

1.1.2.11.1. This outlet shall be upstream (on the source side) of other oxygen outlets.

1.1.2.12. Cryogenic containers and systems shall be marked in accordance with nationally recognized standards and in accordance with NFPA 99 and NFPA 55. The contractor shall be responsible for all labeling and signage requirements.

1.1.3. Teardown/Demolition. At the completion of the Contractor-owned USP medical-grade storage tank lease, the contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, other items, and non-personal services necessary for the removal of Contractor-owned USP medical-grade storage tanks to include, but not limited to:

1.1.3.1. Teardown and removal of Contractor-owned USP medical-grade storage tanks.

1.1.3.2. Demolition and removal of all existing utilities, piping, and restoration of the site to its original condition – leveled and the establishment of grass.

1.1.3.3. A written 30-day notice of intent to demolish/remove leased Contractor-owned USP medical-grade storage tanks shall be provided by the Government. All removal, demolition, and site restoration shall be completed within 30 days from date of notice.

1.1.4. Testing and Inspection. The contractor shall be responsible for all Performance Criteria and Testing — Category 1 (Gases, Medical–Surgical Vacuum, and WAGD) as outlined in NFPA 99 and NFPA 55.

1.1.4.1. The contractor shall be responsible for all testing of install equipment and components as outlined in NFPA 99 and NFPA

55. This includes but not limited to:

1.1.4.1.1. Piping Purge Test.

1.1.4.1.2. Piping Particulate Test.

1.1.4.1.3. Verifier Piping Purity Test.

1.1.4.1.4. Final Tie-In Test.

1.1.4.1.5. Operational Pressure Test.

1.1.4.1.6. A Medical Gas Concentration Test shall be performed after purging each system with the gas of system designation. The allowable concentration shall be ≥99% oxygen.

1.1.4.2. Inspection. Container systems equipped with cathodic protection shall be inspected for the intended operation by a cathodic protection tester.

1.1.4.2.1. The cathodic protection tester shall be certified as being qualified by the National Association of Corrosion Engineers, International (NACE).

1.1.4.2.1.1. The contractor shall provide proof of NACE cathodic protection tester certification to the FRED within three (3) days after acceptance of set-up/installation.

1.1.4.2.2. Piping systems shall be tested and proved free of leaks after installation as required by the codes and standards to which they are designed and constructed.

1.1.4.2.3. Test pressures shall not be less than 150 percent of the maximum allowable working pressure when hydraulic testing is conducted or 110 percent when testing is conducted pneumatically.

1.1.4.3.

1.1.5. USP medical-grade bulk liquid oxygen delivery. The contractor shall provide delivery of USP medical-grade bulk liquid oxygen.

1.1.5.1. The contractor shall deliver USP medical-grade liquid oxygen in bulk to a Contractor-owned bulk storage tanks, the quantities are estimates of the facility’s monthly requirements for WHASC. See historical data in paragraph 7.

1.1.5.1.1. There is no express or implied guarantee that these quantities will be purchased.

1.1.5.2. Delivery of Medical Liquid Bulk Oxygen. Bulk oxygen fills will be coordinated with the FRED.

1.1.5.2.1. The contractor shall deliver USP medical-grade liquid oxygen within 3 calendar days after tank setup and installation is accepted.

1.1.5.2.2. Delivery timeframe. The contractor shall schedule delivery during the normal hours of operation specified in paragraph

3.2 of this SOW.

1.1.5.2.2.1. The timeframe means the number of calendar days after receipt of the Government’s order, the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point, or other specified ordering and delivery methods.

1.1.5.2.2.2. If the timeframe for contractor delivery is not identified, the contractor shall provide 24-hour notice prior to new identified delivery date and obtain approval by the FRED.

1.1.5.2.2.3. The contractor shall coordinate alternate ordering/delivery methods with the FRED to pre-scheduled deliveries, calling for tank level readings, and installing a telemetry unit.

1.1.5.2.2.4. All deliveries will be monitored by the FRED. This applies to all deliveries regardless of the time or day of execution.

1.1.5.3. Liquid Oxygen Tank(s) will be filled to maximum functional capacity at each refilling, unless otherwise specified, but will not fall below 120 cubic feet on meter and maintain 99% purity or as agreed upon in a written document signed and dated.

1.1.5.4. IAW 59 MDWI 41-203, para 2.4.1, the contract supplier is required to provide a Certificate of Purity documenting the concentration for each container along with the delivery slip.

1.1.5.4.1. The contractor shall provide one (1) copy of a Certificate of Purity document along with one (1) copy of delivery slip to the FRED per completed delivery.

1.1.5.5. At the time of each delivery, the contractor shall provide a legibly signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the FRED.

1.1.5.6. Emergency delivery. The contractor shall provide emergency delivery of USP medical-grade liquid oxygen within 24 hours after receipt of Government notification.

1.1.5.6.1. The contractor shall provide a respond to the FRED by either telephone or email within one hour to confirm receipt of the emergency request and to ascertain the nature of the emergency.

1.1.5.6.2. Emergency status is determined by the Government. The FRED shall notify the contractor when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak.

1.1.5.6.3. Failure of the contractor to remain current with the agreed upon delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.

1.1.6. Quality Assurance Specifications and Requirements

1.1.6.1. All medical gas manufacturers and fillers of medical gases must be registered with the FDA as "drug manufacturers". See list of applicable standards in Appendix A.

1.1.6.2. All oxygen shall be manufactured, processed, packed, transported, and stored according to the FDA’s Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with the Code of Federal Regulations General Labeling Provisions (CFR Title 21 Part 201). See list of applicable standards in Appendix A.

1.1.6.3. 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 (USP) 23. See list of applicable standards in Appendix A.

1.1.6.4. Certificate of Analysis. A valid certificate of analysis shall be provided with each delivery of USP medical-grade liquid oxygen in compliance with 21CFR Part 211 Subpart E. The contractor shall provide one (1) copy of a valid certificate of analysis to the FRED per completed delivery. A valid certificate of analysis shall include, at a minimum:

1.1.6.4.1. Supplier’s name and complete address.

1.1.6.4.2. Name of the Product (i.e. Oxygen U.S.P.).

1.1.6.4.3. Air Liquefaction Statement where appropriate.

1.1.6.4.4. Lot number or other unique identification number.

1.1.6.4.5. Actual analytical results for full U.S.P. monograph testing. The contractor shall provide a written document that reflects the quality attributes of medicines approved by the FDA. Some of these attributes include:

1.1.6.4.5.1. Identity. Tests to identify that a particular substance is the medicine that it claims to be.

1.1.6.4.5.2. Strength. Testing methods and acceptable ranges for the potency of a medicine, as reflected in FDA’s approvals. For example, this indicates the amount of API in a medicine.

1.1.6.4.5.3. Purity. Information on impurities that may be present in a medicine and the amounts of these that are permitted, along with testing methods to identify and measure them. An impurity is any component in the API or finished dosage form which is not the desired product or other formulation components. Levels that exceed may present patient safety concerns.

1.1.6.4.5.4. Performance. Laboratory tests to predict and demonstrate how a medicine will be released as it enters the human body.

1.1.6.4.5.5. A statement such as “the product meets the minimum purity of 99.5%” is not acceptable.

1.1.6.4.6. Test method used to perform the analysis.

1.1.6.4.6.1. A statement such as “Meets U.S.P. specifications” is not acceptable; nor

1.1.6.4.6.2. A statement such as “Tested via Servomex” is not acceptable.

1.1.6.4.7. Signature of authorized supplier representative and date.

1.1.6.5. Safety Data Sheets shall be provided to the FRED upon request.

1.1.6.6. A copy of all inspection reports shall be provided to the FRED upon the completion of any Contractor-owned or government-owned bulk oxygen system inspections that are required by regulation.

1.1.6.6.1. The contractor shall provide one (1) copy of inspection reports to the FRED within 30 days after the completion of the inspection.

1.1.6.7. All Contractor-owned equipment shall be maintained or repaired in accordance with NFPA 99, NFPA 55 and FDA’s current good manufacturing practices (CGMP) regulations.

1.1.6.8. The contractor shall specify United States Pharmacopoeia (USP) Oxygen. “USP” indicates that the oxygen conforms to the requirements of the USP.

1.1.6.8.1. The USP standard provides the basic measures required for medical gas concentration, quality and purity.

1.1.6.8.2. At every delivery, the contractor shall use an Oxygen Analyzer to check Liquid Oxygen (LOX) for 99% purity. A Certificate of Purity is required for each container when delivery of LOX is made per para 1.1.5.4 of this SOW.

2. Other Related Information.

2.1. Conduct Requirements.

2.1.1. The Government reserves the right to restrict the performance on this contract by any individual who is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the Military Treatment Facility and the installation population.

2.1.2. The contractor shall not use Government facilities or other Government property for personal or other business not related to this contract.

2.1.3. The Government, through the FRED, reserves the right to require immediate removal from contract performance on the installation or any Government facility, any individual whose actions raise reasonable suspicion that patient care or services may be compromised in any way, or that pose a threat of harm to other contractor/Government personnel or self. Removal under other circumstances will be subsequent to, and at the direction of the Contracting Officer (CO) only.

2.1.4. If a situation meriting removal occurs as outlined in the previous paragraph, the FRED will contact the CO and the contractor’s representative within 24 hours. A meeting may be required with the CO, FRED, and contractor representative to discuss further action.

2.1.5. The CO shall notify the contractor if and when permanent removal is required. In the event of a disagreement between the Government and the contractor, the decision of the CO shall be final. During the period of time between the removal and the final decision of the CO, the contractor agrees to provide backup/replacement CONTRACTOR in accordance with the terms of this contract.

2.2. Insurance requirement. The contractor is responsible for providing liability insurance for their vehicle operators. In the event of an accident, the contractor is solely responsible for all damages to the vehicle and property and/or any damage to a third party if vehicle operator found at fault. The US Government assumes no liability for damages or injuries. Contractor will be liable for loss, damage, destruction, or theft of Government property if found at fault. The contractor shall comply with FAR 52.228-5.

2.3. Applicable Regulations and Standards. The regulations and standards applicable to this contract are listed in Appendix A.

2.3.1. The list is not comprehensive, the contractor is responsible for ensuring the requirements listed in this SOW are delivered in accordance with applicable federal, state, and local regulations. The contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

2.4. Government Remedies. The CO shall follow the requirements of FAR 52.212-4, Contract Terms and Conditions-- Commercial Products and Commercial Services (Nov 2021), for contractor’s failure to correct nonconforming services.

2.5. On-Site Responsibilities.

2.5.1. The contractor shall conduct themselves in a professional, courteous manner, maintaining acceptable appearances and dress. The contractor shall report in at the beginning of each day as well as check out and provide project status at the end of the day.

2.5.2. The contractor shall be responsible for transportation to and from the jobsite as required. Building/area access will be provided to the contractor by the FRED listed in paragraph 3.1.

2.5.3. The contractor shall participate in any safety or training sessions that may be required to meet building or company regulations for contractors (not to exceed 1 hour of onsite training).

2.5.4. The contractor shall maintain a clean and safe work environment. All unused materials, containers, tools and equipment shall be removed whenever possible, and all trash and debris shall be removed at the end of each day.

2.5.5. The contractor shall take all precautions to protect all floors, walls, windows and other surfaces from stains, marring or other damage and shall be responsible for any necessary repairs.

2.5.6. The contractor shall acquire, assemble, deliver, and test all specified equipment and components to provide a fully functional system.

3.0. General Information.

3.1. Functional Requirements Evaluator Designees (FRED): (Primary) SSgt Akeela Joyner, 210-292-6423 and (Alternate) Taylor S.

Henderson, 210-292-0397.

3.1.1. The FRED will be assigned upon contract award for this ordering facility. The FRED is responsible for contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the FRED’s specific responsibilities will be provided to the contractor and FRED at the time of contract award.

3.1.2. Within 15 days after notification of contract award, the contractor shall meet with the FRED to ensure mutual understanding of facility requirements relating to the ordering method and specific details of any delivery instructions.

3.2. Hours of operation. All work shall be performed during duty hours. Work must be done within the hours of 06:30am and 4:00pm Monday through Friday. All federal holidays shall be observed. The following shall be observed as federal holidays:

New Year’s Day 01 January Martin Luther King, Jr. Third Monday in January Presidents’ Day Third Monday in February Memorial Day Last Monday in May Juneteenth 19 June Independence Day 04 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December

3.3. Project management/key personnel. The contractor shall identify a primary and an alternate point of contact (POC) for all contract matters. The primary POC shall be the project supervisor, this individual holds the responsibility of accurate contract delivery. The POC shall coordinate and direct all contractor resources for project success.

3.4. Equipment delivery. Equipment must be delivered to the contractor’s location at the time of install. No equipment shall be drop shipped to the Government. The Government will not provide any storage. See site pictures in paragraph 8.

3.5. Base entry. All base entry requirements shall be coordinated with the FRED. The contractor shall submit all access requests in accordance with AFFARS 5352.242-9000.

3.6. Locations and supplies. The contractor shall coordinate delivery to the FRED at the following address:

MEDICAL GAS DELIVERY LOCATIONS:

Wilford Hall Ambulatory Surgical Center (DX817/RGM43) 1100 Wilford Hall Loop JBSA Lackland, TX 78236

4. Government Furnished Equipment: None

5. Acronyms and Definitions.

CGMP - Current Good Manufacturing Practices EOSC - Emergency Oxygen Supply Connection FRED - Functional Requirements Evaluator Designees NACE - National Association of Corrosion Engineers, International NFPA - National Fire Protection Association OSHA - Occupational Safety and Health Administration USP - United States Pharmacopoeia FDA - United States Food and Drug Administration WHASC - Wilford Hall Ambulatory Surgical Center

6. Applicable Regulations and Standards

• 21 CFR Part 201 – Labeling https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201

• 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

• 29 CFR 1910.104 Oxygen https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.104

• 49 CFR 173.134 Class 6, Division 6.2 – Definitions and Exceptions https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173#173.134

• 59MDWI41-203, Cylinder-Gases (Compressed and Liquefied) https://static.e-publishing.af.mil/production/1/59mdw/publication/59mdwi41-203/59mdwi41-203.pdf

• 59MDWI91-203, Medical Wing Safety Program, 6 July 2020 https://static.e-publishing.af.mil/production/1/59mdw/publication/59mdwi91-203/59mdwi91-203.pdf

• AFI41-209, Medical Logistics Support, 6 Oct 2014

• AFI91-203, Air Force Consolidated Occupational Safety Instruction, 15 Jun 2012

• AFMAN41-209, Medical Logistics Support, 03 Jan 2016 https://static.e-publishing.af.mil/production/1/af_sg/publication/afman41-209/afman41-209.pdf

• AFMAN91-203, Air Force Occupational Safety, Fire, and Health Standards, 25 March 2022 https://static.e-publishing.af.mil/production/1/af_se/publication/dafman91-203/dafman91-203.pdf

• ASME B31.3, Process Piping https://www.asme.org/codes-standards/find-codes-standards/b31-3-process-piping

• CGA G-4.1, Cleaning Equipment for Oxygen Service https://www.cganet.com/revised-edition-published-cga-g-4-1-cleaning-of-equipment-for-oxygen-service/

• CGA M-1, Standards for Medical.

https://www.cganet.com/cga-m-1-publication-guides-medical-gas-supply-systems-safe-use-at-health-care-facilities/

• National Fire Protection Association (NFPA) 99: Health Care Facilities Code 2015 Edition https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=99

• National Fire Protection Association (NFPA) 55: Compressed Gases and Cryogenic Fluids Code 2016 Edition https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=55

• UFC 4-510-01, Design: Military Medical Facilities with Change 2 https://www.wbdg.org/ffc/dod/unified-facilities-criteria-ufc/ufc-4-510-01

• U.S.P. 23, the National Formulary

7. Historical Data

LOX (Gallons) 2018 2019 2020 2021 2022

Month Qty Month Qty Month Qty Month Qty Month Qty Jan-18 0.00 Jan-19 0.00 Jan-20 0.00 Jan-21 0.00 Jan-22 0.00 Feb-18 4,391.54 Feb-19 3,791.88 Feb-20 0.00 Feb-21 2,336.47 Feb-22 1,720.42 Mar-18 0.00 Mar-19 0.00 Mar-20 0.00 Mar-21 0.00 Mar-22 0.00 Apr-18 0.00 Apr-19 0.00 Apr-20 2,214.76 Apr-21 0.00 Apr-22 0.00

May-18 0.00 May-19 0.00 May-20 0.00 May-21 0.00 May-22 0.00 Jun-18 0.00 Jun-19 0.00 Jun-20 0.00 Jun-21 0.00 Jun-22 2,408.59 Jul-18 3,034.20 Jul-19 2,230.00 Jul-20 0.00 Jul-21 0.00 Jul-22 0.00

Aug-18 0.00 Aug-19 0.00 Aug-20 0.00 Aug-21 0.00 Aug-22 0.00 Sep-18 0.00 Sep-19 0.00 Sep-20 2,940.46 Sep-21 0.00 Sep-22 0.00 Oct-18 0.00 Oct-19 0.00 Oct-20 0.00 Oct-21 2,480.99 Oct-22 0.00 Nov-18 0.00 Nov-19 2,479.84 Nov-20 0.00 Nov-21 0.00 Nov-22 0.00 Dec-18 0.00 Dec-19 0.00 Dec-20 0.00 Dec-21 0.00 Dec-22 0.00

7,425.74 8,501.72 5,155.22 4,817.46 4,129.01

Estimated quantity of LOX per year: 36,000 gallons

8. Site Pictures.

8.1. USP Liquid Oxygen Tank – Site Picture 1.

8.2. USP Liquid Oxygen Tank – Site Picture 2.

8.3. USP Liquid Oxygen Tank – Site Picture 3.