Q999--657-20-2-3755-0798; Bulk Tank Oxygen Rental | PB

2 | Page Medical Grade Bulk Oxygen Statement of Work 1. General The purpose of this contract is to establish a source of supply of medical-grade liquid bulk oxygen for John J Pershing VAMC, Poplar Bluff, MO., 63901. If the Government facility does not own its own bulk oxygen tank system, the facility will identify the current vendor and if there is a need for a new Contractor-owned tank system with an appropriate back-up system (i.e., reserve tank system or cylinder bank). Specifications for the facility are listed in the solicitation schedule. Through a bilateral modification, the Government may add new method of receiving bulk oxygen based on advancement in technology that will benefit the product and/or service during the specified period of performance. All contract terms and conditions shall remain the same and agreed upon rates to share costs of new industry standards are to be documented, signed and dated by the Contracting Officer (CO) and Contractor. 1.2 Location/Facility Requirements: All supplies of medical-grade liquid bulk oxygen shall be delivered to John J Pershing VAMC, Poplar Bluff, MO., 63901. The Contractor shall have a facility and/or resources physically located in the geographic areas, in which they will supply of medical-grade liquid bulk oxygen. Through a bilateral modification, the Government may add additional delivery locations or remove any delivery locations any time during the specified period of performance. All rates, contract terms and conditions shall remain the same and the Contractor shall accept any additional locations within a sixty (80) mile radius from the John J Pershing VAMC, in Poplar Bluff, MO., 63901. 1.3 The Contractor will be required to make deliveries of medical grade liquid bulk oxygen over the life of the contract. The quantities shown in the solicitation schedule are estimates of the facility annual requirements. There is no express or implied guarantee that these quantities will be purchased. The Government is anticipating awarding an Indefinite Delivery Indefinite Quantity (IDIQ) contract for one year with four option years. Contracts awarded under the solicitation will include a +/- 10% increase or decrease of usage; which may be exercised by the Government. 1.4 The Contractor will be provided with names and contact information of the primary Contracting Officer Representative (COR) within 20 days after award of the Contract for this ordering facility. The following information applies to all deliveries, regardless of the time or day of execution: Cylinders shall be filled to the maximum functional capacity during each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the Contracting Officer (CO); 1.5 Request for delivery slips will be placed via telemetry, the setting will be approved by VA designated personnel to guarantee the VA is not without product for a maximum of 3 calendar days. Participating ordering facilities will process orders through the Contractor s web portal or ordering system. There shall be no limit on the number of orders placed by facilities in a day. The request for delivery slips will otherwise be submitted electronically or a called order by the COR or designated representative. All confirmation responses will be processed in the same day as the orders are submitted. Requests for delivery shall be placed with Contractor through the following: (Offeror to complete) FAX Number: ______________________________ Phone Number: Department: ________________________________ Name of Contact Person: ______________________ Address: ___________________________________ ___________________________________ Email: _____________________________________ Website: ___________________________________ 1.6 The Contractor shall provide written procedures, annual in-service training for VA staff on protocols to ensure safety on and around the tank systems. The Contractor will provide additional safety training as needed by the facility to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. The Contractor shall have the technical capability to work and train at the VA requests at no additional cost to the VA. Contractor shall provide 24/7 emergency contact name(s), telephone number(s), fax number(s) and email addresses during training. The VA must be trained by Contractor to be proficient to adapt to any new electronic system specifications required to accept electronic orders from the VA. 2. Acronyms 2.1 This section lists acronyms that are used in this Statement of Work and other parts of the solicitation. CCF 100 cubic feet CF Cubic feet CGA Compressed Gas Association CGMP Current Good Manufacturing Practices CO Contractor owned COR - Contracting Officer Representative VA Department of Veterans Affairs OSHA U.S. Department of Labor, Occupational Safety and Health Administration 3. Contractor-Furnished Bulk Tank System 3.1 For those facilities listed in the schedule as having Contractor owned tank systems, the facility has the right to determine if the current tank system remains in use. Complete site visit will assess slab, foundation and electronic moves of schematics of current tank systems are to be mutually evaluated by the individual facility. Contractor and Contracting Officer to determine if a new tank system is authorized and approved. The Contractor shall provide, install and maintain bulk oxygen tank system(s) with appropriate back-up system(s). Through the duration of the Contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor-owned bulk oxygen tank system(s) that will insure compliance with applicable regulations, and standards. Government facility that requires installation of Contractor owned Bulk Tank System, shall provide a suitable location and foundation for the installation of the Contractor owned bulk oxygen tank system(s). Additionally, each facility shall provide 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 Bulk Tank System to the facility-maintained alarm system. The Contractor shall work with the VA electricians and the Contractor will have the required conduits on site. Through the duration of the contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor owned tank system(s) that will insure compliance with applicable regulations, standards and commercial practices. The tank system capacity and reserve system shown in the schedule are minimum capacities required by the using facilities. The option for a facility to expand their capacity to ensure facility is meeting minimum needs for growth throughout the life of the contract will be assessed by the individual facility. Facility will identify additional Bulk Oxygen Tank System as needed on campuses. The Contractor shall work with the VA facility engineers and plumbers to locate the correct pipes for temporary tank system hook up. Each facility will have full H cylinders on hand to cover every inpatient bed that is currently hooked up to receive bulk oxygen from internal pipes A complete VA approved contingency plan must be tested prior to swap out. The manifold, cylinders for the reserve supply and portable supply of tank system, including refills if necessary during the swap out, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility s medical-grade liquid bulk oxygen system shall be furnished by the Contractor, without cost to the Government during the swap out. All contingency items, H cylinders and portable tank systems will be removed within a week after the swap out. The manifold or liquid converter shall deliver of medical-grade liquid bulk oxygen 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. 3.2 All Bulk Tank System and materials required to cover all components and separators of the tank system 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 Bulk Tank System shall be 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 Bulk Tank System rental fee for the applicable facility). Contractor owned Bulk Tank System shall be kept in standard commercial operating condition and appearance, in accordance with applicable federal and state laws, regulations, and standards of commercial practices. The Contractor shall be afforded reasonable access to the bulk oxygen systems for this purpose. 3.3 For this facility, having Contractor-owned tank systems, the Contractor shall scan and track each fill invoice with a unique item tracking number for automated process available for COR to view electronic inventory online. 4. Installation and Service of Contractor-Owned Bulk Tank System 4.1 To permit orderly transition from one Contractor to another, the Contractor shall continue to honor the contract s monthly Bulk Tank System rental fee and of medical-grade liquid bulk oxygen contract price for a maximum of ninety (90) days beyond the scheduled expiration of the contract period, unless transition from one Contractor to another is completed prior to the ninetieth day transition period. For any partial month, the Contractor shall prorate the monthly Bulk Tank System rental fee accordingly. The Contractor shall continue to provide and maintain its Bulk Tank System during this transition period. The Contractor shall provide an implementation plan that must meet the installation period. 4.1.1. Phase In: The billing period shall begin on the noted transition date. Payments shall be assessed based on the providers established rate and prorated from setup date. Prorated monthly rates are based on a 30-day month. 4.1.2. Phase Out: The Contractor realizes that the supplies being provided under this contract are vital and must be continued uninterrupted. The outgoing Contractor shall not remove any Bulk Tank System from the facility until replacement Bulk Tank System has been installed. The outgoing Contractor shall coordinate transition of Bulk Tank System / services with the incoming Contractor as soon as possible, but not to exceed ninety (90) days from date of contract expiration. If additional transition time is required beyond contract expiration, a separate Purchase Order shall be issued to the Contractor for payment of services on a pro-rated basis. Prorated monthly rates are based on a 30-day month. 4.1.3. During transition both Phase In and Phase Out, from one Contractor to another, the awarded Contractor must reconcile in conjunction with the Government and the outgoing Contractor an implementation plan, in writing. The plan is to include the timeline of events associated with a tank system swap, document the agreed upon responsibilities of each party at each participating facility. 4.2 Unless otherwise directed by the using facility, Contractor owned Bulk Tank System shall be installed by ninety (90) days from the effective date of the contract and shall be connected to the of medical-grade liquid bulk oxygen system on that date; provided. If the Contractor s Bulk Tank System replaces Bulk Tank System already in use, the exchange of Bulk Tank System shall be accomplished without interruption of medical-grade liquid bulk oxygen supply to the using facility. Contractor installed Bulk Tank System 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 to avoid interruption of medical-grade liquid bulk oxygen supply. 4.3 All Contractor owned Bulk Tank System shall be installed in accordance with NFPA 55: Compressed Gases and Cryogenic Fluids Code, Current Edition, NFPA 99 Standard for Health Care Facilities, Current 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 Bulk Tank System. 4.4 A copy of the state s pharmaceutical license shall be provided at time of solicitation submission. 4.5 If indicated by the using facility that the ownership of the installed Bulk Tank System belongs to another Contractor, the facility has the right to determine if the current tank system remains in use due to remaining years of lifecycle, cost associated with swap, such as meeting new code requirements the swap. If the facility chooses not to swap out the tank system that will require the succeeding Contractor to fill the current Bulk Tank System, and not reinstall new. The Contractor shall provide a copy of the agreement to either purchase or distribute service to fill and maintain the Bulk Tank System. 5. Delivery of Medical Liquid Bulk Oxygen 5.1 Bulk oxygen orders will be placed via telemetry and delivered to the individual ordering facility, if available. If available will be no charge to John J. Pershing VA. 5.2 The Contractor shall deliver medical-grade liquid oxygen within the time frame specified in the schedule of items for each facility. 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 based on telemetry, or other specified ordering and delivery method, mutually agreed upon with the facility COR. If the time frame for Contractor delivery is not identified in the facility requirements, the Contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility COR and Contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank system level readings, installing a telemetry unit, etc. may be arranged. The process of all orders will be agreed upon by the COR and Contractor. If for any reason the Contractor is unable to delivery at the agreed upon day or time, the Contractor shall provide 24-hour notice to the COR and must 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 each facility and identified during site inspection. 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. 5.3 Tank systems(s) will 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. 5.4 At the time of each delivery, Contractor shall provide a legible signed and dated available in electronic form. Minimum invoice includes the tank system level prior to fill, the level after fill, and the quantity delivered. This document must be countersigned by the facility representative supervising the delivery. Delivery audits will be performed and matched for accuracy. Any missing data will be identified and documented to be on the electronic delivery slip, therefore a hand-written document will be required additionally for invoicing purposes. 5.5 Emergency delivery will be provided within 24 hours after receipt of Government notification. Contractor shall respond to the facility by either fax 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 system imminent alarm condition, or system leak that requires a refill in 24 hours. Failure of the Contractor to remain current with agreed delivery schedule, or failure on telemetry notification does not constitute an emergency for purposes of charging an emergency delivery fee. Once validated, the facility will post the facility and Contractor contact names and numbers on the oxygen tank system and at each monitoring point at the facility so that 24/7 supplier staff coverage is assured. 5.6 A Contractor s fill rate is defined by the maximum fill capacity of each tank system delivered on the delivery date. The Contractor shall have a fill rate of 95% or greater for each recurring medical liquid bulk oxygen request for delivery slip. This will be measured monthly against the invoice and used as a performance measurement. The following incidents listed below can negatively impact the Contractor s fill rate: 5.7 The Contractor will not be required to make delivery on federally observed holidays. When the normal delivery day falls on a federal holiday, the Contractor shall make delivery on the next work day following that holiday. The following holidays are observed by the Federal Government: New Year s Day Martin Luther King s Birthday (3rd Monday in January) Presidents Day (3rd Monday in February) Memorial Day (last Monday in May) Independence Day (July 4th) Labor Day (1st Monday in September) Columbus Day (2nd Monday in October) Veterans Day (November 11th) Thanksgiving Day Christmas Day Or any day that is declared a national Holiday per Executive Order by the President Note: If the holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday. 6. Quality Assurance Specifications and Requirements 6.1 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). 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.). 6.3 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. 6.4 Material Safety Data Sheets shall be provided to each facility COR upon request. 6.5 A copy of all inspection reports shall be provided to each facility COR upon the completion of any Contractor owned or government owned bulk oxygen system inspections that are required by regulation at a minimum done annually. 6.6 All Contractor owned Bulk Tank System shall be maintained or repaired in accordance with NFPA 55 (Current Edition) and FDA s Current Good Manufacturing Practices (CGMP) Regulations. 7. 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, Bulk Tank System 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 55: Compressed Gases and Cryogenic Fluids NFPA 99: Standard for Health Care Facilities 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. For example, the following conversion factor shall apply for conversion from gallons to cubic feet. Calculation based on data in CGA P-6 1 ft³ liquid O2 = 860.6 ft³ gas (Table 1) 1 ft³ liquid O2 = 7.48052 gal (Table 2) Therefore: 7.48052 gal (1 ft³) liquid O2 = 860.6 ft³ gas 1 gal liquid O2 = 860.6 ft³ gas 7.48052 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas 8. CONDUCT OF PERSONNEL: 8.1. Contractor employees shall conduct their selves in a manner socially acceptable, act responsibly and with respect. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor will be grounds for denying the employee further access to the VA premises. 8.2. The Contractors employee(s) shall wear visible identification on uniform shirt and badge at all times while on the premises and the delivery truck must be clearly and appropriately labeled with Contractor signage when on VA medical facility, Warehouse, CBOC, etc. 8.3 The Contractor must be familiar with the location of the facility tanks prior to delivery and must, comply with rules associated to entering the VA medical facility provided on Attachment A. 9.Emergency Supply Support The Veterans Administration Medical Center listed in Attachment A are designated as Federal Emergency Medical Facilities with significant contingency and emergency response roles. Accordingly, the Contractor shall provide contingency plan to offer strategies to provide emergency supply support during major catastrophic events. These strategies shall include additional methods of contacting for ordering medical gas and offering Federal Emergency Medical Facilities, at no cost, the option to pre-prepare order lists tailored to potential catastrophic events likely to occur in their area (fire, mass contamination, epidemic, earthquake, tornados, typhoons, etc.). Because of the emergency nature of these orders Contractor must performance with full delivery to the facility of the required quantities of 90% or more of the order within 24 hours of callout by the facility or their geographical area(s) as designated by the CLIN(s), with 99% or more of all remaining order delivered within the next 24 hour period (the fee for calling out these pre-prepared orders shall be fixed in accordance with emergency fee). This performance requirement applies whether a single facility or multiple facilities are impacted by the catastrophe. 10. REVIEWS: 10.1. The COR or Facility POC will conduct at a minimum monthly review of invoices to reconcile the difference of filled CCF per tank system as indicated on the delivery ticket with the Contractor. 11. ORDERING, INVOICE AND PAYMENT After deliveries are made an invoice must match and include the legible signed and dated electronic document that identifies the tank system level prior to fill, the level after fill, and the quantity delivered. Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities will place orders: Company Name: Address: Phone No.: Fax No.: Contact Name: Email: Company Name: Address: Phone No.: Fax No.: Contact Name: Email: The CORs shall provide a list of authorized orders. All orders are to include the signature of the COR before orders are placed. Orders placed without the CORs authorization is not allowed and will not be paid by the purchase order. The COR may request a spreadsheet to review prior to Contractor submission of invoice or certification of invoice. The spreadsheet is to reflect all the orders delivered, emergency fees and monthly Bulk Tank System rental fees. Contractor must provide sample copy for approval at time of award submission. No advance payments shall be authorized, and no purchase card orders will be allowed/authorized. Payment shall be made on a monthly basis for product provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i) upon submission of a properly prepared invoice for prices stipulated in this contract for products delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract. Education to facility staff Education will be provided to John J. Pershing VA staff once a year on the bulk tank system and safety of it at no charge.