LOX_Tank_SOW_final_2_Nov_17.docx

LIQUID OXYGEN (LOX) TANK AND RESERVE

STATEMENT OF WORK (SOW)

02 Nov 2017

1. General Information.

1.1 Description of Services (Requirements). The Contractor shall provide a committed source of supply of medical-grade liquid bulk oxygen for Wilford Hall Ambulatory Surgical Center (WHASC), JBSA Lackland, Texas. The Contractor shall provide a 6,000 gallon contractor-owned tank with a 500 gallon secondary supply and a reserve system.

1.2. The Contractor shall ensure all bulk storage sites are installed, repaired and maintained in accordance with all applicable codes, standards and regulations, including but not limited to NFPA 99: Health Care Facilities Code, 2015 Edition, NFPA 55: Compressed Gases and Cryogenic Fluids Code, 2016 Edition, and their referenced documents as of the date of publications. Additional Air Force Guidance is found in AFI 91-203, Air Force Consolidated Occupational Safety Instruction, 15 Jun 2012, and AFI 41-209, Medical Logistics Support, 6 Oct 2014.

1.3 The quantities are estimates of the facility’s monthly requirements for WHASC. There is no express or implied guarantee that these quantities will be purchased. Contracts that include the installation of contractor-owned equipment will include a 30 day transition period at the beginning and end of the contract period.

1.4. Functional Requirements Evaluator Designees (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. 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.

1.5. Prior to the first fill and thereafter, the Contractor must perform in-service training to include refill procedures, any preventive maintenance support requirements that may be needed from the WHASC systems, explanation of all volume alarms and low pressure set-points. The Contractor will provide written procedures and training for the Logistics staff at WHASC to accomplish in case of an emergency shutdown or other sudden, unplanned termination of the refilling process. The Contractor shall provide 24/7 emergency contact name(s) and telephone number(s) upon contract award.

1.5.1. Prior to the first filling and thereafter, alarm set-point testing and written verification must be presented through the use of a qualified third party expert per National Fire Protection Association (NFPA) 99, Standard for Health Care Facilities (current edition) for contractor owned and Government owned systems. Any code deficiencies in WHASC’s existing system, as defined by NFPA 55, Standard for Bulk Oxygen Systems at Consumer Sites (current edition) must be identified by the Contractor.

1.5.2. Prior to the first filling, and thereafter, the Contractor must verify, in writing, the accuracy of all gauges on contractor owned tanks. The contractor shall provide and maintain all gauges. The gauges shall remain accurate at all times. The Government may choose to exercise this option at its desire.

2. Applicability

2.1. 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.

2.2. Where nationally recognized good practices or standards have been established for the process employed, such practices and standards shall be followed (See Appendix A for all applicable standards).

2.3. Systems shall be installed in compliance with Food and Drug Administration Current Good Manufacturing Practices as found in 21 CFR 210 and 21 CFR 211.

2.4. Tank construction shall be in accordance with NFPA 55 for above ground tanks. Nonstandard containers shall not be permitted.

2.5. Bulk cryogenic fluid systems shall be anchored with foundations in accordance with the provisions of CGA M-1, Guide for Medical Gas Installations at Consumer Sites.

2.6. 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 EOSC into the facility has been certified. Required tests need to be performed and verified when the connection is made. All required certification will be required from the new bulk supply point to the EOCS. Certification reports will be required within 3 work days of the completed test.

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

2.8. 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 fittings shall be permitted to be cleaned by a supplier or agency other than the manufacturer.

2.9. 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.

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

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

2.11.1. 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.

2.11.2. 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.

2.12. 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.

2.12.1. 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 Piping Purge Test, Piping Particulate Test, Verifier Piping Purity Test, Final Tie-In Test, and Operational Pressure Test. 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.

2.12.2. Inspection. Container systems equipped with cathodic protection shall be inspected for the intended operation by a cathodic protection tester. The cathodic protection tester shall be certified as being qualified by the National Association of Corrosion Engineers, International (NACE).

2.12.3. 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.

2.12.4. 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.

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

2.14. The central oxygen system design shall facilitate oxygen system purity monitoring. This outlet shall be upstream (on the source side) of other oxygen outlets.

2.15. 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.

3. Contractor-Furnished Equipment.

3.1. For Contractor owned tanks, the contractor personnel shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Through the duration of the contract, the contractor personnel shall be liable for the integrity, suitability, and safety of contractor owned tank(s) to insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are maximum capacities required by the using facility. 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 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. Failure of contractor owned-furnished equipment shall be repaired within 24 hours of notification. If repair cannot be completed within this time period the contactor shall provide service at the EOSC at no additional cost to the government. See Appendix A for all tank maintenance standards.

3.2. 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). 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.

4. Installation of Contractor-Owned Equipment.

4.1. 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 notice of award to complete non-affixed owned equipment connection. 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.

4.2. Upon expiration or termination of the contract and if the Contractor is not awarded a follow-on contract, the Contractor shall remove contractor owned equipment at no additional cost to the Government. 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. . The Contractor shall continue to provide and maintain its equipment during this transition period.

4.3. 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. 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.

4.4. Manufactured assemblies shall be pretested by the manufacturer prior to arrival at the installation site in accordance with NFPA 99.

5. Delivery of Medical Liquid Bulk Oxygen.

5.1. Bulk oxygen fills will be coordinated with the FRED or authorized representative.

5.2. The Contractor shall deliver medical-grade liquid oxygen within 3 calendar days after tank installation is complete, between the hours of 0630-1600 hours. The time-frame identified may be either 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. If the time frame for contractor delivery is not identified, 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. All deliveries must be monitored by a qualified and trained technical representative that will be designated by the facility. This applies to all deliveries regardless of the time or day of execution.

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 and maintain 99% purity or as agreed upon in a written document signed and dated.

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.

5.5. At the time of each delivery, the Contractor must 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 or a facility representative supervising the delivery.

5.6. Emergency delivery will be provided within 24 hours after receipt of Government notification. The Contractor must respond to the facility by either telephone or email within one hour to confirm receipt of the emergency request and to ascertain the nature of the emergency. Emergency status is determined by the Government. The FRED or a facility representative shall notify the Contractor 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 the agreed upon delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.

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

6. Quality Assurance Specifications and Requirements

6.1. All medical gas manufacturers and fillers of medical gases must be registered with the FDA as "drug manufacturers". 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).

6.2. 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.) 23.

6.3. A valid certificate of analysis shall be provided with each delivery of medical-grade liquid bulk oxygen. The certificate of analysis shall include, at a minimum:

A. Supplier’s name and complete address.

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

C. 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).

H. Signature of authorized supplier representative and date.

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

6.5. A copy of all inspection reports shall be provided to the FRED or facility representative upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation (See Appendix A). The inspection reports are to be provided within 30 days after the completion of the inspection.

6.6. 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.

6.7. The Contractor shall specify United States Pharmacopoeia (USP) Oxygen. “USP” indicates that the oxygen conforms to the requirements of the USP. The USP standard provides the basic measures required for medical gas concentration, quality and purity. 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. A copy of all inspection reports shall be provided to the FRED or facility representative upon the completion of any contractor owned or Government owned bulk oxygen system inspection required by regulation.

7. Conduct Requirements.

7.1. 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.

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

7.3. The Government, through the Contracting Officer (CO), 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 CO only.

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

7.5. 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.

8. Insurance Requirements

8.1. Workers’ compensation and employer’s liability.

8.1.1. Contractors are required to comply with applicable Federal and State workers’ compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer’s liability section of the insurance policy, except when contract operations are so commingled with a contractor’s commercial operations that it would not be practical to require this coverage.

8.1.2. Employer’s liability coverage of at least $100,000 shall be required, except in States with exclusive or monopolistic funds that do not permit workers’ compensation to be written by private carriers. (See 28.305(c) for treatment of contracts subject to the Defense Base Act.)??

8.2. General Liability.

8.2.1. The CO shall require bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

8.2.2. Property damage liability insurance shall be required only in special circumstances as determined by the agency.

8.2.3. Automobile liability. The CO shall require automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operated in the United States shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

9. Applicable Regulations and Standards

9.1. The regulations and standards applicable to this contract are listed in Appendix A. The list is not comprehensive and the Contractor is responsible for ensuring that all products, equipment and services provided under this contract are in compliance 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.

Appendix A

Applicable Regulations & Standards

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 59th Medical Wing Instruction 41-203, Cylinder-Gases, 25 August 2016

AFI 41-209, Medical Logistics Support, 6 Oct 2014

AFI 91-203, Air Force Consolidated Occupational Safety Instruction, 15 Jun 2012

ASME B31.3, Process Piping

CGA G-4.1, Cleaning Equipment for Oxygen Service

CGA M-1, Guide for Medical Gas Installations at Consumer Sites.

National Fire Protection Association (NFPA) 99: Standard for Health Care Facilities, 2015 Edition

National Fire Protection Association (NFPA) 55: Compressed Gases and Cryogenic Fluids Code 2016 Edition

Title 21, Code of Federal Regulations, Parts 210 & 211 - CGMP regulations for supplying medical grade oxygen.

UFC 4-510-01, Design: Military Medical Facilities, 1 May 16

Appendix C

CYLINDERS OWNED BY CONTRACTOR (RENTALS ONLY)

Refill requirement will be called in by the 59th MLRS/SGSKS or designated representative on an as required basis and a No lower than 120 on meter.

MEDICAL GAS DELIVERY LOCATIONS:

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