Combined Synopsis-Solicitation.docx

Combined Synopsis-Solicitation Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through the most current Federal Acquisition Circular. The most current Federal Acquisition Circular can be found at Acquisition.gov.

This solicitation is set-aside for Service-Disabled Veteran Owned Small Businesses (SDVOSB).

The associated North American Industrial Classification System (NAICS) code for this procurement is 325120, Industrial Gas Manufacturing, with a small business size standard of 1,200 Employees.

The FSC/PSC is 6835 Medical Gasses.

The Manchester Veteran Affairs Medical Center (VAMC) is seeking to a contractor to provide a bulk oxygen.

All interested companies shall provide quotations for the following:

Supplies/Services

DEPARTMENT OF VETERANS AFFAIRS

STATEMENT OF WORK

BPA Contract – MEDICAL GRADE LIQUID BULK OXYGEN

1.0 INTRODUCTION

The VA Medical Center in Manchester is seeking a qualified contractor for the distribution and supply of medical-grade liquid bulk oxygen at our campus. Service performance will be for the VAMC- Manchester at 718 Smyth Road, Manchester, NH 03104.

2.0 BACKGROUND

VA Manchester’s requires periodic supplies of Medical-Grade Bulk Oxygen. The Facility Service, Maintenance Department, currently rents the bulk oxygen tanks through an existing BPA that will no longer be effective once this contract is awarded. This Medical Grade Liquid Bulk Oxygen BPA will replace the existing contract and includes all items listed in this document.

3.0 SCOPE

· Period of performance: Blank Purchase Agreement (BPA) for a period of five (5) years. Estimated period of performance 09/30/2024-09/30/2029.

· The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid bulk oxygen for this facility. This Government facility does not own its own bulk oxygen tanks. The Government facility currently has an existing contractor supplied 6000-gallon vertical tank with a 500-gallon reserve tank back-up system. The Government facility shall require the contract to provide a contractor a contractor supplied vertical 1500-gallon tank with an appropriate 150-gallon reserve tank back-up system for Manchester, all meeting NFPA 99 code standards. Each tank shall be placed where the existing was. Removal of existing tanks/associated equipment and replacement with new tanks/associated equipment shall be required by the contractor. The contract shall also provide for digital readouts at each separate facility. If existing equipment is antiquated and out-of-date that requires an upgrade to suffice code standards, these shall be inclusive as install requirements. Specifications for this facility are listed in the solicitation schedule; O2 Tank Pad As-Builts, Med Gas EOSC Final Report & Commissioning Report.

· The Contractor is responsible for the system up to the connection point at the bulk pad. The Government is responsible for the system from the tie-in point and throughout the distribution system.

· If the Contractor requires interruption of services for the tank/equipment replacement, coordination with the hospital is required. The Contractor shall provide a temporary liquid Oxygen supply while exchange of tanks/equipment takes place. The Contractor shall provide a separate line-item price for such work to include services and supply costs for a temporary liquid Oxygen service. The line item shall include temporary equipment and services, duration, and anticipated costs of medical gas supplies for the duration. This cost shall be a line item that affects only the base year final cost and does not affect the permanent tank system price option years. The Contractor is responsible for ensuring that the supply tanks are tied into the existing building distribution system without any interruption to service. The contractor shall coordinate the tie-in of the new system during the weekend hours so as not to impact clinical operations.

· If the hospital is relocating the tank system from an old location to a new location, the Government may require the Contractor to provide a temporary liquid Oxygen supply while the Government ties in their distribution system to the new tank system. The Contractor shall provide a temporary liquid Oxygen price for this temporary service that is separate from the permanent tank system price. The contractor shall coordinate the tie-in of the new system during the weekend hours so as not to impact clinical operations.

· The contractor shall provide the total cost as well as the unit cost per Cubic Foot (CF) to supply 11,000 CF of medical-grade, liquid oxygen which is the estimated approximate total annual requirement for the Manchester VA Medical Center. There is no express or implied guarantee that these quantities will be purchased. The base contract period for all contracts awarded under this solicitation will be effective upon the date of award and extend through a one-year period. Please note that the contracts that include the installation of contractor-owned equipment will include a 90-day transition period at the beginning and end of the contract period. (See paragraph 6.1) The contract awarded under the solicitation will include a five-year BPA Blank Purchase Agreement.

· Prior to first filling, contractor must perform in service training to include the following facets for contractor owned and government owned systems: the refill procedure, any preventative maintenance support requirements that may be needed from the Medical Center systems, and an explanation of all the volume alarms and low pressure set points. The contractor will provide written procedures and training for VA staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor will provide 24/7 emergency contact name(s) and telephone number(s).

· 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, latest Edition for contractor owned and government owned systems. Any code deficiencies in the Medical Center’s existing system, as defined by NFPA 50, 1.3.3, “Standard for Bulk Oxygen System”, NFPA 55 “Compressed Gases and Cryogenic Fluids Code and ANGI/CGA M-102018 “Standard for Medical Gas Supply Systems and health Care Facilities” must be identified by the contractor. A detailed explanation of these deficiencies must be present in writing to the COR. Receipt of this written explanation must be signed by the COR.

· Prior to the first filling, and annually thereafter, the contractor must verify in writing the accuracy of all gauges on contractor owned tasks. If the gauge(s) are government owned, contractor will provide, if requested after award, a written proposal with price to verify accuracy of the gauges(s). This facility may choose to exercise this option at its desire.

4.0 GOVERNMENT-FURNISHED PROPERTY

· The solicitation schedule will identify the bulk oxygen storage tank(s) at this facility as being CO (Contractor Owned).

· This government facility currently has CO owned bulk storage. This facility will provide access to an electrical power source and hook-up of additional contractor owned equipment to the facility-maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system.

5.0 CONTRACTOR-FURNISHED EQUIPMENT

· The contractor shall provide, install, and maintain contractor owned bulk oxygen tank(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 supplied tanks that will ensure compliance with applicable regulations, standards, and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by this 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 this facility. 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.

· All equipment and materials required to perform on the contract (other than what is specifically listed in section 4, Government-Furnished Property) shall be provided by the contractor must be in brand new condition. Contractor furnished 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 contracts monthly equipment rental fee for this facility.) Contractor furnished equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The exterior appearance of the tanks shall be kept free of all rust, peeling, or flaking paint and any other exterior surface blemishes and or discoloration. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

· The contractor shall provide, install a telemetry monitoring satellite system to automatically read the meter for deliveries. The installation, inspection and maintenance costs shall be included in the contract’s monthly equipment rental fee for this facility.

6.0 INSTALLATION OF CONTRACTOR-OWNED EQUIPMENT

· Unless otherwise directed by this facility, contractor supplied equipment shall be installed by the effective date of the contract and shall be connected to the medical gas system on that date provided: that the contractor shall be allowed a maximum of ninety days after receipt of notice of award to complete installation. If the contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to this facility. Ownership of the contractor installed equipment shall not transfer to the government and equipment 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 gas supply.

· 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 a maximum of ninety days beyond the scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to the ninety-day transition period. For any partial month, the contractor shall prorate the monthly equipment rental fee accordingly. The contractor shall continue to provide and maintain its equipment during this transition period.

· No guarantee is given or implied that the data included in the schedule regarding contractor owned equipment currently located at this facility is complete and accurate as to the factors affecting the cost of furnishing and installing the required contractor supplied tanks and appurtenances. Offerors are strongly encouraged to visit this facility site prior to submitting a bid and take other steps as may be reasonably necessary to ascertain the nature of location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting the COR designated in the solicitation schedule.

· All contractor supplied equipment shall be installed in accordance with the NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001, NFPA 99 Standard for Healthcare Facilities, latest Edition, and FDA’s Current Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

· In addition to digital readout of tank parameters, the contractor will provide the Manchester VA Medical Center personnel with access to their website which shows these parameter values in real time.

7.0 LICENSING, AUTHORIZATION AND SELLING PERMISSIONS

· If the Contractor is the manufacturer of the medical grade bulk oxygen being supplied under this contract, it shall annually provide verification that it holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed.

· If the Contractor is not the manufacturer of the medical grade oxygen being supplied under this contract, the Contractor shall annually provide verification that the manufacturer from which it obtains the medical grade bulk oxygen provided to VA under this contract holds current licensing, permits, certifications or registrations required by the FDA and the states in which this contract is performed. In addition, the Contractor shall provide annual updates to any agreements it has with the medical-grade oxygen manufacturer affirmatively demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor is providing under this contract. In the event of a change in manufacturer, the Contractor shall provide advance notice to the VA prior to the change taking place and shall provide copies of the new medical-grade oxygen manufacturer’s current licenses, permits, certifications or registrations required by the FDA and the states in which this contract is performed. The Contractor shall also provide a copy of its agreement with the new manufacturer demonstrating that the Contractor has authorization by the manufacturer to resell the oxygen the Contractor intends to provide under this contract.

· 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.

8.0 DELIVERY OF MEDICAL LIQUID BULK OXYGEN

· Bulk Oxygen is ordered by and delivered to this individual ordering facility. Delivery hours are before 8:00am or after 4:00pm, Monday through Friday.

· The contractor shall deliver medical-grade liquid oxygen every 21 days on Mondays, or when the reorder point for either tank is reached. If for any reason the contractor is unable to deliver at the agreed upon day or time, the contractor will provide 24-hour notice to the COR, so that the facility can initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 6, 2004, all deliveries must be monitored by a qualified and trained technical representative that will be designated by this facility. In addition, VAPD will need to be notified to provide escort during delivery. Contractor will be provided with the names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution.

· All deliveries must be signed for by a designated POC at the VA Medical Center. A delivery slip must be left for each delivery to verify against each invoice submitted.

· Tank(s) will be filled to a maximum functional capacity at each refilling procedure unless otherwise specified in this facility 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 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 this facility representative supervising the delivery.

· Emergency delivery will be provided within 24 hours after receipt of Government notification. Contractor must respond to this facility by either telephone or e-mail within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition or system leak. Failure of the contractor to remain current with agreed delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.

· Contractor shall provide the Manchester VA Medical Center COR a quarterly report of delivery dates and amounts to be tallied on a spreadsheet for the calendar year. Amounts shall be shown in cubic feet.

9.0 QUALITY ASSURANCE SPECIFICATIONS AND REQUIREMENTS

· All medical gas manufactures 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 (CGMO) Regulations, and all labeling shall comply with FDA’s labeling regulations (21 CFR Part 201).

· 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).

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 from 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

· Material Safety Data Sheets shall be provided to this facility COR upon request.

· A copy of all inspection reports shall be provided to this facility COR upon the completion of any contractor owned or government owned bulk oxygen system inspectors that are required by regulation.

· All contractor owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA’s Current Good Manufacturing Practices (CGMP) Regulations.

10.0 APPLICABLE RULES AND REGULATIONS

The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor is responsible for ensuring that all products, equipment, and services provided under the contract are in compliance with applicable Federal state and local regulations. If applicable, the editions in effect as of the date of this solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

· Title 21, Code of Federal Regulations, Parts 210 & 211 0 CGMP regulations for supplying medical grade oxygen.

· 29 CFR 1910.104 Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises.

· 49 CFR – Transportation

· Federal Food, Drug, and Cosmetic Act

· NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 Edition

· NFPA 99: Standard for Health Care Facilities, Latest Edition

The contract period of performance will be determined at time of award.

Place of Performance/Place of Delivery

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services”

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· 52.203-16, 52.204-4, 852.203-70, 852.219-75

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services”

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services”

The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020), 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023), 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021), 52.219-28, Post Award Small Business Program Rerepresentation (FEB 2024), 52.219-33, Nonmanufacturer Rule (SEP 2021), 52.222-3, Convict Labor (JUN 2003), 52.222-26, Equal Opportunity (SEP 2016), 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020), 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020), 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021), 52.222-41, Service Contract Labor Standards (AUG 2018), All quoters shall submit the following:

1. Questions: Any questions must be submitted in writing no later than Friday 21 June 2024 at 3:00 PM EST. Answers to the questions will be posted the following week.

2. Quote: Offeror shall provide a quote using the table above. Offerors must also provide all applicable labor rates for the solicited services so they can be compared to the applicable wage determination for compliance with the Service Contract Labor Standards.

All quotes shall be sent to the Contracting Officer, David Valenzuela at david.valenzuela2@va.gov.

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The following are the decision factors:

1. Price: Quotes will be compared by price.

1. Technical: The offeror’s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services IAW the Statement of Work in a timely efficient manner.

1. Contractor shall provide specification sheets for proposed equipment and include within the solicitation response.

1. Vendors shall be certified as a SDVOSB in VetBiz or VetCert, failure to be certified will remove vendors from consideration.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

Submission of your response shall be received not later than 8 July 2024 at 3:00 PM EST. All quotes shall be emailed to David Valenzuela at david.valenzuela2@va.gov.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact: David Valenzuela, david.valenzuela2@va.gov.

Effective Date: 03/15/2023 Revision: 01