6835--Blanket Purchase Agreement (BPA) for Bulk Oxygen Delivery and Services in support of Veterans Health Administration, Veterans Integrated Service Network (VISN) 20, Northwest Network.
Page 2 THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regar... Page 2 THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method. The intended contract is a firm-fixed price supply purchase. There is an SBA Non-Manufacturer Rule Class waiver for this requirement. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, is conducting market research to identify potential sources which can provide the following in support of the Veterans Health Administration, Veterans Integrated Service Network (VISN) 20, Northwest Network. VISN 20 has a need for a five-year Blanket Purchase Agreement (BPA) for medical grade liquid bulk oxygen, bulk oxygen storage devices and associated services to the locations listed on the price/cost schedule below. In order to be considered for this requirement, prospective vendors shall have the capability to supply the entire area listed. Deliveries shall be made according to the contractor s standard delivery timeframe or seven (7) calendar days after delivery request, whichever is shorter. The emergency delivery of ordered items shall be delivered within 24-hours. Acronyms This section lists acronyms that are used in this solicitation: CFR Code of Federal Regulations CGA Compressed Gas Association CGMP Current Good Manufacturing Practices C-O Contractor-owned CO Contracting Officer COR Contracting Officer Representative FDA U.S. Food & Drug Administration G-O Government-owned NFPA National Fire Protection Association OSHA U.S. Department of Labor, Occupational Safety and Health Administration USP United States Pharmacopeia Basic Informational Requirements Upon award of a Task Order, the contractor shall provide to the ordering CO: 1. Contractor s regular work hours. 2. Contractor s telephone number for call-in orders during regular work hours. 3. Contractor s telephone number and instructions for placing Emergency service calls. 4. Contractor s telephone number for expert advice concerning awarded products. Basic Performance Requirements Upon award of a Task Order, these basic performance requirements shall take place: 1. Items will be delivered in accordance with individual TOs. 2. Delivery and service scheduling will be provided in the TO or by the CO. 3. The Contractor shall notify the ordering CO, their COR (if any), and administering CO immediately in the event of a product recall. Liability Insurance Requirements The contractor shall maintain liability insurance in the amount of $1 million per occurrence and shall provide an annual Certificate of Liability to the administering CO and to each ordering CO. Licensing, Authorization, and Selling Permissions If the Contractor is the manufacturer of the bulk liquid oxygen being supplied, the Contractor shall annually provide verification to the administering CO and any ordering COs that it holds current licensing, permits, certifications, and/or registrations required by the relevant regulatory authorities in the service area covered by the contract. If the Contractor is not the manufacturer of the bulk liquid oxygen being supplied, the Contractor shall annually provide verification that the manufacturer from which it obtains the bulk liquid oxygen provided under this contract has current licensing, permits, certifications or registrations required by the relevant regulatory authorities in the service area covered by the contract. If the Contractor is not the manufacturer of the bulk liquid oxygen being supplied, the Contractor shall also provide annual proof of authorization from the manufacturer to resell the bulk liquid oxygen the Contractor is providing. In the event of a change in manufacturer, the Contractor shall provide advance notice to the administering CO and any ordering COs prior to the change taking place and shall provide copies of the new manufacturer s licenses, permits, certifications or registrations required by the relevant regulatory authorities in the service area covered by the contract. The Contractor shall also provide proof of authorization from the new manufacturer to resell the bulk liquid oxygen the Contractor is providing. Throughout the term of this contract, Contractor shall maintain all federal, state, and local licenses applicable to the Contractor as well as any required FDA certifications. Applicable Regulations & Standards The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor is responsible for ensuring that all products, equipment, and services provided under the contract comply 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. 21 CFR Parts 210 & 211 - CGMP supplying medical grade oxygen. 29 CFR 1910.104 OSHA Standards for the installation of bulk oxygen systems on industrial and institutional consumer premises. 49 CFR Transportation Federal Food, Drug, and Cosmetic Act, Chapter V ANSI/CGA M-1 2018 Standard for Medical Gas Supply Systems at Health Care Facilities NFPA 55: Standard for Compressed Gases and Cryogenic Fluid Code, 2013 Edition NFPA 99: Standard for Health Care Facilities, 2015 Edition U.S.P. 23: US Pharmacopoeia & National Formulary current edition Density data and volume measurement equivalents published in CGA 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 1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas All medical gases shall conform to specifications prescribed in the USP and the National Formulary. All medical gas manufacturers and fillers of medical gases shall be registered with the FDA. All medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA s CGMP regulations and Title 21 CFR Parts 210, 211 and 201 for labeling. The following specifications also apply: a. Federal Specification BB-C-101D, Carbon Dioxide (CO2) Technical and USP, dated 3/17/2011. b. CGA Publications G-7-Compressed Air for Human Respiration, dated May 2008, and ANSI / CGA G 7.1-Commodity Specification for Air, dated October 2011. 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 USP) c) An Air Liquefaction Statement (where appropriate) d) Lot number or other unique identification number e) Actual analytical results for full USP 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 USP 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 h) Material Safety Data Sheets shall be provided to the facility COR upon request i) A copy of all inspection reports shall be provided to the facility COR upon the completion of any C-O or G-O bulk oxygen system inspections that are required by regulation Bulk Liquid Oxygen Storage Devices Storage Device Ownership G-O bulk liquid oxygen storage devices and appurtenances shall be maintained by and at the expense of the Government in a manner ensuring compliance with applicable regulations, standards, and industry practices. If the Government facility does not own their bulk liquid oxygen storage devices, the Contractor may be requested to provide a C-O device with an appropriate back-up system on a TO. Each Government facility that requires installation of C-O equipment shall provide a suitable location and foundation for the installation of the C-O bulk liquid oxygen storage devices in accordance with NFPA Standard 55 2010 Edition Chapter 9. Additionally, each facility shall provide access to an electrical power source and hook-up to a facility-maintained alarm system. The Contractor shall assist VA electricians with hooking up the facility-maintained alarm system, consistent with NFPA 55 & 99 code requirements. The Contractor must have the required conduits on site. G-O devices and C-O devices shall not be exchanged or intermingled with one another. The Contractor shall not remove G-O devices from the facility without written approval and a record of such from the ordering CO or their designee. Should the facility cause the loss of a C-O device, or should the Contractor cause the loss of a G-O device, it is between the facility and the Contractor to resolve the issue. Installation of Contractor-Owned Equipment All C-O equipment shall be installed in accordance with NFPA 55: Standard for Bulk Oxygen Systems at Consumer Sites, 2010, NFPA 99 Standard for Health Care Facilities, 2005 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. Prior to installation of a rented storage device, the Contractor and ordering CO should schedule a site visit to verify location conditions. Contractor-Owned Equipment The Contractor shall be liable for the integrity, suitability, and safety of C-O devices that will ensure compliance with applicable regulations, standards, and normal good practices. 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 additional cost to the Government with all relevant costs included in the monthly rental fee. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each bulk liquid oxygen storage device shall have an outlet that allows access for testing the purity of the oxygen. C-O equipment shall be installed, inspected, and maintained by the Contractor without additional cost to the Government with all relevant costs included in the monthly rental fee. C-O 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 liquid oxygen systems for this purpose. C-O equipment shall be maintained or repaired in accordance with NFPA 55: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA s Current Good Manufacturing Practices (CGMP) Regulations. 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 to avoid interruption of oxygen supply. Should a future TO or contract be awarded to a vendor other than the incumbent Contractor, the incumbent Contractor shall not remove the relevant rented storage device(s) until the transition of storage devices can be coordinated and completed. The incumbent Contractor shall continue to provide and maintain its storage devices during this transition period. If additional transition time is required beyond TO or contract expiration, separate contract arrangements shall be made by the ordering facility. Bulk Fills Storage devices will be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility s TO requirements or as agreed upon in a written document signed and dated by the COR. At the time of each delivery, Contractor must provide a legible signed and dated physical 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 facility representative supervising the delivery. Storage Device Sizes Storage devise sizes shown in the Price/Cost Schedule are the sizes required by the VISN 20 facilities covered by this contract. All capacities are approximate, and the Government shall be billed only for actual amounts used. In accordance with the Federal Food, Drug and Cosmetic Act, the actual contents of the storage device must appear on the label. The Government is responsible for providing a pad sufficiently rated by a Certified Project Engineer to support main and reserve tanks filled to full capacity. This includes security fencing, NFPA 55 & 99 code compliance, and safe access for resupply operations. Laws and Regulations Storage devices for gases and liquid forms of gases shall comply with the Department of Transportation specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current DOT regulations (Title 49-Transportation, Code of Federal Regulations). Filling, packaging, labeling, etc., for liquid oxygen shall comply with the Federal Food, Drug, and Cosmetic Act. Marking In addition to marking required by the aforementioned laws and regulations, marking shall comply with: American National Standards Z48.1-1954 (R 1971), Method of Marking Portable Compressed Gas Containers to Identify the Material Contained. CGA Publication C-7-Guide to Preparation of Precautionary Labeling and Marking of Compressed Gas Containers, dated 10/21/2011. Cylinders shall be color-coded in accordance with CGA Publication C-9-Standard Color Marking of Compressed Gas Containers Intended for Medical Use, dated September 2013. Handbook of Compressed Gases, Chapter 10. All unauthorized or inapplicable markings, tags, and labels shall be removed. When shipment is by commercial carrier, shipping tags complying with Federal Standard 123G dated 6/6/1997 shall be attached to each storage device to be protected by the valve protection cap. The contract data markings required by the applicable standard shall be applied to one side of the tag and the identification markings on the reverse side. Consignee markings may be omitted when shipment is by Contractor's truck. Valves Valves shall comply with CGA Safety Bulletin SB-26 dated August 2014 and CGA Publication V-1--Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections, dated May 2013. Valve protection caps for storage device designed to receive such caps shall be securely attached to the storage device in a manner to protect the valves from injury during transit and delivery to the purchaser's receiving area. For liquid storage devices, all fittings must be permanently brazed to prevent their removal. In addition, each storage device should contain a 360-degree cryoband applied at the top of the storage device with the drug product name repeated around the entire storage device. Services The Contractor shall provide the following services: Training Prior to first filling, Contractor must perform in-service training to include the following facets for C-O and G-O systems: the refill procedure, any preventive maintenance support requirements that may be needed from the facility, and an explanation of the volume alarm and low pressure set-points. 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). Delivery The Contractor shall deliver ordered bulk liquid oxygen to the locations indicated on individual TOs. The Contractor and the CO (or their designee) shall coordinate the delivery time, location, and other details. The ordering facility may choose to use telemetry monitoring services from the Contractor to time their deliveries. If an ordering facility uses telemetry monitoring to automate the placing of delivery orders, the ordering facility shall define the fill point to be used and properly account for order automation risk regarding funding. Deliveries shall be considered timely if made within the Contractor s standard delivery timeframe or 7 calendar days after delivery request (whichever is shorter), or within 24 hours of the order being placed if it is an Emergency order. Failure of the Contractor to remain current with agreed upon delivery schedule and requirements does not constitute an emergency for purposes of charging an Emergency Delivery Fee. The Contractor s delivery vehicles and delivery personnel shall meet the relevant federal, state, and local standards. Emergency Supply Support The ordering facilities may be designated Federal Emergency Medical Facilities with significant contingency and emergency response roles. Accordingly, the Contractor shall provide to ordering facilities a contingency plan offering strategies to provide emergency supply support during major catastrophic events. The contingency plan will clearly detail and identify the number of storage devices used and document the process and timeline for initiating and furnishing supplies for the system. These strategies shall include 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.) at no additional costs. Should the deliveries be needed, the Contractor must perform full delivery to the ordering facility of the required quantities of 90% or more of the order within 24 hours of ordering by the facility, with 99% or more of remaining quantities delivered within the next 24-hour period. These deliveries may use the Emergency Delivery Fee. Alarm Set-Point Testing Prior to first filling and annually thereafter, alarm set-point testing and written verification must be presented using a qualified third-party expert per NFPA 99, 2015 Edition for C-O and G-O systems. Any code deficiencies in the facility s existing system, as defined by NFPA 55, Chapter 9 Bulk Oxygen System must be identified by the Contractor. A detailed explanation of these deficiencies must be presented in writing to the ordering CO (or their designee), who must also sign for the explanation. Gauge Testing Prior to first filling and annually thereafter, the Contractor must verify, in writing, the accuracy of all gauges on C-O tanks. If the gauge(s) are G-O and it is requested after TO award, Contractor will provide a written proposal with price to verify accuracy of the gauge(s). The individual facility may choose whether or not to accept this proposal. Services For Government-Owned and Contractor-Owned Storage Devices The Contractor s price for bulk liquid oxygen fills shall include the furnishing (at no additional cost) of all services which are required at each and every filling of a storage device to comply with applicable regulations, specifications, and normal good practices. Such services shall include but not be limited to: tags indicating cylinder is Full , In Use , or Empty , routine inspection, testing, evaluation, spot de-icing, and cleaning services required, pin-indexing (when required), attachment of Government-furnished warning tags (when required). The Contractor is responsible for all maintenance and testing of C-O storage devices. Measurement And Conversion Computation Density data and volume measurement equivalents printed in CGA Publication P-6--Standard Density Data, Atmospheric Gases and Hydrogen, dated October 2012 shall be used when necessary to convert measurement of the oxygen from one form to another (for example, from cubic feet to gallons). Hydrostatic Testing The Contractor shall perform hydrostatic testing as ordered and in accordance with the following terms. Method: G-O storage devices which are eligible for extended hydrostatic retest period, testing by modified hydrostatic method, or visual inspection in lieu of hydrostatic testing, shall be serviced by the most economical means which will comply with Department of Transportation regulations (49 CFR 173.34), unless otherwise specified by the ordering facility. When modified or reduced DOT test requirements are contingent upon past usage of the storage devices, a written statement from the ordering facility indicating that the storage devices have been used exclusively for a specific gas may be considered acceptable evidence of the storage devices eligibility for modified testing or inspection. Hydrostatic testing shall be performed in accordance with CGA s Publication--C-1, Methods for Hydrostatic Testing of Compressed Gas Cylinders, dated January 2016. The ordering facility shall pay for the hydrostatic testing of G-O storage devices. The Contractor shall be responsible for all testing of C-O storage devices at no additional cost to the Government. Retest Date: If applicable DOT regulations would require retesting of a storage device within three (3) months after scheduled date of shipment to Continental U.S. destination, or within six (6) months after scheduled date of shipment to overseas destination, the storage device shall be retested. The Contractor will be required to retest any G-O storage device when requested by the ordering facility, regardless of scheduled retest data. Visual Inspections: Visual inspections shall be performed in accordance with the applicable CGA Publications C-6--Standards for Visual Inspection of Steel Compressed Gas Cylinders, dated May 2013 or C-6.1--Standards for Visual Inspection of High-Pressure Aluminum Compressed Gas Cylinders, dated May 2013. Storage Device De-icing In the event of major ice build-up on the storage system, vaporization tubes, or any connecting valves, tubing or pipes not covered by the normal services performed by the Contractor, an ordering facility may request the Contractor to perform work to de-ice the affected component. Upon acceptance of the request, the Contractor shall perform the service on an agreed-upon timeline to maintain the equipment and not cause damage and ensure the proper operation of the components. De-icing services shall use the De-icing Service line-item pricing. Workplace Conditions Contractor s personnel provided under this contract are employees of the Contractor and shall not be considered VA employees. Contractors working on VA property shall be subject to the same rules and regulations as all contracted employees. Parking is allowed only in areas not designated for patient use. All traffic laws and parking rules on the grounds are strictly enforced. Failure to follow these laws and regulations may result in a citation being issued that will have to be resolved through the Federal Court system. Prior to reporting to work, the Contractor will need to contact the ordering facility s designated point of contact to arrange an escort to the on-site badging department. VA staff will issue a temporary ID badge to the Contractor employee, who will then properly display the badge while working onsite. Upon completion of the assignment, the Contractor employee will return the badge. The VA reserves the right to refuse any Contractor access to VA property, for any or no reason. Contractors shall comply with all security requirements imposed by the ordering facility. Contractors shall not receive personal telephone calls or texts on their cell phone while rendering services. A VA employee must accompany Contractors who are providing services. The Contractor shall remove and dispose of any waste related to providing the ordered services. VA Facility Hours of Operation: Standard operating hours for CBOCs and larger VA facilities are normally 8:00 AM to 4:30 PM Monday through Friday in the time zone of the facility, excluding federal holidays. VA Emergency Departments normally operate with 24-hour coverage. TOs may require services to be available 24/7, 365 days a week to include Federal Holidays. Federal holidays are: New Year s Day Martin Luther King Jr Birthday President s Day Memorial Day Independence Day Juneteenth Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day No gray market or remanufactured items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. Nonmanufacturers. In order to qualify as a small business concern for a small business set-aside, service-disabled veteran-owned small business set-aside or sole source contract, HUBZone set-aside or sole source contract, WOSB or EDWOSB set-aside or sole source contract, 8(a) set-aside or sole source contract, partial set-aside, or set aside of an order against a multiple award contract to provide manufactured products or other supply items, you must be the manufacturer or producer of the end item being procured (and the end item must be manufactured or produced in the United States); or provide an agreement with a manufacturer and certify that you: Do not exceed 500 employees; Are primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; and Take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice. Note: Dependent on the results of the market research, should a set-aside be determined as the most appropriate acquisition method, FAR clause 52.219-14 or VAAR clause 852.219-75 may apply to the formal solicitation should a solicitation be issued (see Disclaimer and Important Notes). Potential candidates having the capabilities necessary to provide the above stated supplies at a fair and reasonable price are invited to respond to this Sources Sought Notice via e-mail to Jennifer Robles at jennifer.robles1@va.gov no later than February 19, 2024, 5PM EST. No telephone inquiries will be accepted. RESPONSES SHOULD INCLUDE THE FOLLOWING INFORMATION: Company name, address, SAM UEI and business size; point of contact name, phone number, and e-mail address; whether services are presently offered on a current GSA Federal Supply Schedule contract. NAICS Code 325120, Size Standard: 1,000 employees, is applicable to determine business size standard. Nonmanufacturers shall provide an agreement with a manufacturer and certify as to the requirements listed above. Any questions or concerns may also be directed via email to Jennifer Robles at jennifer.robles1@va.gov. Disclaimer and Important Notes: This Sources Sought Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought Notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time.
Data sourced from SAM.gov.
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