36C25723Q1126 Amendment 0002.docx

5. PROJECT NUMBER (if applicable)

CODE

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2. AMENDMENT/MODIFICATION NUMBER

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6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

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9A. AMENDMENT OF SOLICITATION NUMBER

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10B. DATED

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

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15B. CONTRACTOR/OFFEROR

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Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

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13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

36C671 Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

36C671 Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240 To all Offerors/Bidders

36C25723Q1126 10-12-2023

X

See CONTINUATION Page

The purpose of this amendment is to extend the solicitation close date to post questions and answers.

1. Extend solicitation 36C25723Q1126 due date from 10/24/2023 at 4PM CDT to 10/31/2023 at 4PM CDT.

2. Disseminate the Questions and Answers. Please see the continuation sheet.

3. To provide a revised SOW with delivery addresses. Please see the continuation sheet.

4. To change LIN 0001, 0002, 0003, 1001, 1002, 1003, 2001, 2002, 2003, 3001, 3002, 3003, 4001, 4002Z, 4003 Unit from "UN" to "CCF."

5. Added line-item 0005. Please see the price/cost schedule.

Shannon Hodgson Contracting Officer

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

CLIIN 0001 BULK LIQUID FOR BULK TANK

Contract Period: Base POP Begin: 11-12-2023 POP End: 11-11-2024 PRINCIPAL NAICS CODE: 325120 - Industrial Gas Manufacturing PRODUCT/SERVICE CODE: 6835 - Medical Gases Temple VAMC Bldg. 163 see SOW for address details

CLIIN 2002 MEDICAL GRADE, ADD 20,000 UNITS FOR CLC TANK

PRINCIPAL NAICS CODE: 325120 - Industrial Gas Manufacturing

Temple VAMC Bldg. 204 and WACO VAMC see SOW for address details

CLIIN 3003 BULK LIQUID FOR BULK TANK LIQUID CONVERTER PER 100/CU FT.

Temple (both Bldgs.) and WACO VAMC see SOW for address details

Telemetry Monitoring for Temple, CLC and Waco 4004-4005-4006

EMERGENCY DELIVERY FEE

Contract Period: Base POP Begin: 11-12-2023 POP End: 11-11-2024 PRINCIPAL NAICS CODE: 325120 - Industrial Gas Manufacturing PRODUCT/SERVICE CODE: 6830 - Gases: Compressed and Liquefied

LOCAL STOCK NUMBER: SEC EXPEDITE

PRINCIPAL NAICS CODE: 325120 - Industrial Gas Manufacturing

LOCAL STOCK NUMBER: SECEXPEDITE

OXYGEN BULK LIQUID FOR BULK TANK

Contract Period: Option 1 POP Begin: 11-12-2024 POP End: 09-11-2025

OXYGEN MEDICAL GRADE, ADD 2000 UNITS FOR CLC

POP Begin: 11-12-2024 POP End: 11-11-2025

OXYGEN BULK LIQUID FOR BULK TANK LIQUID

POP Begin: 11-12-2024 POP End: 11-11-2025

Telemetry Monitoring for Temple, CLC and Waco

POP Begin: 11-12-2024 POP End: 11-12-2025

OXYGEN BULK LIQUID FOR BULK TANK

Contract Period: Option 2 POP Begin: 11-12-2025 POP End: 11-11-2026

OXYGEN MEDICAL GRADE, ADD 2000 UNITS FOR CLC

POP Begin: 11-12-2025

OXYGEN BULK LIQUID FOR BULK TANK LIQUID CONVERTER

POP Begin: 11-12-2025

Telemetry Monitoring for Temple, CLC and Waco

POP Begin: 11-12-2025

OXYGEN BULK LIQUID FOR BULK TANK

Contract Period: Option 3 POP Begin: 11-12-2026 POP End: 11-11-2027

OXYGEN MEDICAL GRADE, ADD 2000 UNITS FOR CLC

POP Begin: 11-12-2026

OXYGEN BULK LIQUID FOR BULK TANK LIQUID CONVERTER

POP Begin: 11-12-2026

Telemetry Monitoring for Temple, CLC and Waco

POP Begin: 11-12-2026

OXYGEN BULK LIQUID FOR BULK TANK

Contract Period: Option 4 POP Begin: 11-12-2027 POP End: 11-11-2028

OXYGEN MEDICAL GRADE, ADD 2000 UNITS FOR CLC

POP Begin: 11-12-2027

OXYGEN BULK LIQUID FOR BULK TANK LIQUID CONVERTER

POP Begin: 11-12-2027

Telemetry Monitoring for Temple, CLC and Waco

POP Begin: 11-12-2027

Questions and Answers

Q1. Please confirm this is for both VAMCs Waco & Temple (includes VAMC & CLC)? PG 6 of 79 in the RFQ only lists the VAMC Temple as a delivery location (no mention of CLC) yet CLIN 0004 mentions all (3) locations. Additionally, please confirm which CLINs apply to which locations as they are not specific?

A1. This will be corrected in the Statement of Work.

CENTRAL TEXAS VETERANS HEALTH CARE SYSTEM

1901 VETERANS MEMORIAL DR.

TEMPLE, TX 76504

DORIS MILLER VA MEDICAL CENTER

4800 MEMORIAL DR

WACO, TX 76711

Q2. What is the purpose of utilizing “UN” for the Unit of Measure in the CLINs for Bulk Liquid Oxygen in the Price/Cost Schedule? The industry standard billable unit for Bulk Liquid Oxygen is per 100/Compressed Cubic Feet (CCF) and PG 6 of 79 states that the “the estimated quantities are 145,150.00 CCF for the facility annual requirement.”

0. Based on this, the VA needs to specify what the CLIN quantities represent as the quantities are consistent with the CCF annual requirement, yet the VA is directing offerors to price via CF.

0. PG 14 of 79, para 12.1, states that the submitted invoice must be invoice in Cubic Feet (CF) however the Quantities in the Price/Cost Schedule are more consistent with Annual CCF Quantities provided on PG 6 of 79 and not CF Quantities.

0. Example: is the VA stating that CLIN 0001 is for 51,000 CF? This would mean that the usage is only 510 Compressed Cubic Feet Annually.

A2. Line items have been revised from UN to CCF.

Q3. Emergency Delivery – How does the VA plan to account for costs of any Emergency Delivery requests that are not due to the fault of the Contractor? Will the GOV please add an Emergency Delivery CLIN, only billable for instances where delivery is requested.

A3. Line-item 0005 was added for Emergency Delivery.

Q4. PG 8 of 79, para 3.4, “the contractor is responsible for performing minor maintenance on the GO bulk tank systems.” This is highly irregular to require a supplier to perform any repair on a GO system at no cost. There is a cost for deploying a tech to site in order to identify the maintenance issue, which may or may not require further repair after assessment. RECOMMEND the VA add a minor maintenance CLIN for deploying a technician to site to evaluate any maintenance issue (typically involves a tech on site for up to 8 hours) as it is not fair to offerors to require them to eat the potential unknown costs from deploying a tech to site for a GO installation. An alternative is adding language that the contractor will provide a quote at the time of a VA request to deploy a tech to site to observe any minor maintenance issues.

A4. A separate CLIIN not necessary, the VA handles the maintenance.

Q5. PG 9 of 79, Para 6.1 “VA facilities may accept the standard fill point established by the Contractor. However, VA Safety and/or Engineering personnel reserve the right to establish different fill point settings for the bulk liquid oxygen tank systems.” Please confirm what qualifies VA safety to adjust the tank fill points? It is highly irregular for a facility to adjust their own fill points, and it is near impossible for offerors to plan for the costs associated with it in their bid. Distribution is by far the greatest cost in Oxygen Supply/Distribution and if the VA alters the fill points this could mean more frequent deliveries which the offeror is not able to account for during the bid period. Will the VA please add a delivery fee CLIN only billable in the event the VA alters their fill points or at least language that this can be discussed in the event the VA wants to adjust the fill points?

A5. The Fill point is an estimated quantity depending on usage. A CLIIN for the fill point will not be added.

Q6. PG 8 of 79, Para 4.3, “Throughout the term of the contract, Contractor shall maintain all federal, state, and local licenses applicable to the Contractor as well as any required FDA certifications.” The RFQ clearly states the requirement in the State of Texas to distribute Medical Grade Oxygen.

The State of TX Department of Health Services requires the Contractor (in this case the PRIME SDVOB Contractor) to be licensed/registered as a Prescription Drug Wholesale Distributor with the State (Medical Grade Oxygen is a prescription drug), -- because the PRIME SDVOB meets the state of Texas definition of a (being) a Prescription Drug Wholesale Distributor (in the state) AND -- as the SDVOB is the Contract holder and, the accountable entity to the GOV – requires licensing. How is the GOV ensuring compliance with this? Please confirm that the Prime Contractor must be licensed (in the name of the Prime Contractor Wholesale Distributor) -- to distribute Medical Gases for Human Consumption by state of TX.

Based on Texas Statute -- this requirement cannot be delegated to a SUB CONTRACTOR – regardless of an NMR for NAICS 325120.

The awardee is the accountable entity to the GOV, not the sub, hence, if for instance there was any contamination of Gas, it is the Prime SDVOB contractor’s responsibility. Medical Gas is classified by the FDA as a Prescription Drug (Pharmaceutical), and given the RFQ, the only unlicensed entity in the Pharmaceutical Chain of Custody, could be the Awardee/Contract holder (the accountable entity to the GOV).

Additionally, the Licensing requirement is directly linked to the GOV’s required affirmations found in VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING--CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS requiring Offerors to certify in writing that they take ownership or possession of the item (on PGs 33-35 of 75 in the RFQ – restated, which requires licensing in the State of Texas). Being Evaluation is LPTA, if an SDVOB Offeror/Prime Contractor is not licensed in the state of TX then they are not Technically Acceptable.

0. Licensing within the VA Procurement System, is an unusually contentious issue? The State Statutes are clear, and in the State of Texas specifically in the Federal VA Contracting arena when it comes to Prime Contractors resale/wholesale/distribution of medical grade compressed gas. The argument against the state’s firm licensing requirement on other Medical Gas RFQs has been (2) case law citations from 1997 (The Ensign-Bickford Co; Case B-274904.4) & 2008 (Advant-EDGE Solutions, Inc. Case B-400367.2), which both address licensing in regard to disposal of Medical Waste. In those cases, it was ruled the Prime Contractor could use their subcontractor’s license however Medical Waste and Medical Gas are by no means the same product or function. Medical Gas (Oxygen) is prescribed by a physician and ingested by the patient while Medical Waste is neither, so this case law is really not applicable or relevant. Additionally, in those cases the contractors did not certify that they took ownership or possession of the biomedical waste at issue in those cases.

0. Per Texas Administrative Code Title 25 Part 1 Chapter 229 Subchapter W Rule 229.424 Licensure Requirements (a) (b):

0.

0. Please see the Attached “”LAWS TO REGS – VA IMPLEMENTS LEGISLATION TARGETING VOSB PASS THROUGHS… the Certificate of Compliance VAAR 852.219-76 is a result of this legislation – “targeting” firms that DO NOT meet Limitations on Subcontracting (showing the capability and capacity to the Contracting Authority that they can perform in excess of 50% of the Contract Costs billed AND taking ownership/possession of the product (delivered on the Prime’s behalf) – affirming both in the Certificate of Compliance – and restated, “taking ownership” directly relates to being licensed to legally distribute a prescription drug.

0. Lastly, if required to be licensed to distribute a prescription drug, delivered on the Offerors behalf, surely the Offeror must be insured to do this on a GOV installation.

A6. Licensing requirements may be met through a offerors subcontractor as supported by case law. This ability for the Government to consider the license of a subcontractor is consistent with GAO decisions on this topic.

Q7. What is the GOV’s rationale for evaluating Solely on Lowest Priced Technically Acceptable for the critical function of Medical Grade Oxygen (a prescription drug) for a Veterans Medical Healthcare System? Recommend Evaluating via “Best Value” to ensure the VA receives the best possible offer/service and not just to the offeror with the lowest price who meets the minimum technical requirement.

A7. In accordance with FAR 15.101-2, the Government has a high degree of confidence that reviewing the technical proposals of all offerors would not result in the identification of characteristics that would provide value or benefit to the agency. Therefore, LPTA is appropriate.

Q8. How is the GOV going to discern that the offeror is properly insured for NAICS 325120 – the actual requirement for this work to comply with the RFQ and not just by a $1M dollar threshold notated in Para 5.1 on PG 9 of 79? This is important because there are very few underwriters that will insure small businesses for compressed gases – hence the GOV’s can assure the offeror is be adequately covered if the Insurance Certificate lists the applicable NAICS. Often Small Business carry General Liability Insurance but if those firms are not insured specific to 325120 then there is a great level o risk of hiring a firm that is not adequately covered if something occurs during the life of the contract.

A8. All products, equipment, and services provided under this solicitation and contract award shall be in compliance with all applicable Federal, state, and local regulations per the SOW.

Q.9 Please confirm this is for both VAMCs Waco & Temple (includes VAMC & CLC)? PG 6 of 79 in the RFQ only lists the VAMC Temple as a delivery location (no mention of CLC) yet CLIN 0004 mentions all (3) locations. Additionally, please confirm which CLINs apply to which locations as they are not specific?

A.9 This question was address in question number 1, please see above VA response.

Q.10 Who is the current supplier?

A10. The incumbent is Air Gas.

Q11. What size bulk tank and reserve are installed currently and does the hospital lease the equipment from the current supplier?

A11. MAWP 250 PSI and TL 3000. The current equipment is Government owned.

Q12. For this requirement are we able to use the subcontractor’s insurance?

A12. No, please reference FAR 28.3.

Q13. What size bulk tank and reserve are installed currently and does the hospital lease the equipment from the current supplier?

A13. MAWP 250 PSI and TL 3000. The current equipment is Government owned.

Q14. When does the current supplier’s contract term end to supply bulk medical oxygen?

A14. 11/11/2023

STATEMENT OF WORK

Medical Grade Bulk Liquid Oxygen

1. General

1.1. The VA Central Texas Health Care System has established an ongoing requirement that requires a contractor to provide Medical Grade Bulk Liquid Oxygen. If the Government facility does not own its own bulk oxygen tank system, the Contractor shall provide a contractor-furnished tank system with an appropriate backup system (i.e., reserve tank or cylinder bank). The Contractor shall provide all needed components to support a Food and Drug Administration (FDA) medical grade bulk liquid oxygen tank system in compliance with the National Fire Protection Agency (NFPA) 99: Health Care Facilities Code. Additionally, the Contractor must utilize an off-site, automatic monitoring system (telemetry system) that independently monitors the system and notifies the Contractor when refills are required.

1.2. Location/Facility Requirements: The bulk oxygen tanks are government owned. All supplies of medical-grade liquid bulk oxygen shall be delivered to the Central Texas VA Medical Centers: Delivery Location: 1901 S. Veterans Memorial Dr., Temple TX 76502.

Tanks are located Bldg. 163 Off Veterans Drive and Bldg. 204 call operator to unlock tank, 254-413-2957. Doris Miller VA Medical Center 4800 Memorial Drive, Waco, Texas 76711.

1.2.1. The Contractor shall be required to make deliveries of medical-grade liquid bulk oxygen throughout the life of the contract. The estimated quantities are 145,150.00 CCF for the facility annual requirement.

1.3. A Point of Contact (POC) will be designated for ordering facility. The POC is responsible for local contract administration issues such as requesting deliveries and providing specific delivery instructions. The Contractor will be provided with names and contact information of the primary and alternate POC within 20 days after award of the contract for the ordering facility.

1.4. The Contractor shall provide written procedures and initial in-service training for VA staff on protocols to ensure safety on and around the tank systems at the time of initial filling of any new or upgraded bulk oxygen tank system. The Contractor shall provide additional safety training as needed by the facility to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor shall provide 24/7 emergency contact name(s), telephone number(s), fax number(s) and email addresses during training.

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 COR - Contracting Officer Representative FDA – US Food & Drug Administration GO – Government-owned NFPA – National Fire Protection Association USP – United States Pharmacopeia VA – Department of Veterans Affairs OSHA – US Department of Labor, Occupational Safety and Health Administration

3. Government-Furnished Property

3.1. The schedule of items will identify any Government owned (GO) bulk tank system(s) at each facility. GO bulk oxygen storage tank systems and appurtenances will be maintained by the Government at the Government's expense in a manner that ensures compliance with applicable federal and state regulations, standards, and commercial practices. 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.

3.2. Upon award of the contract, all GO bulk tank systems and materials must be inspected by the Contractor at the Contractor's expense. Upon inspection, the Contractor shall immediately notify the Contracting Officer if the Contractor will not be able to fill the bulk oxygen tank system because of issues related to the tank system, pad, or access to the tank system. Each facility will provide the Contractor reasonable access to the areas where work is required to be performed. Additional issues associated with Government-furnished equipment are the responsibility of the Government. Contractor shall determine the pressure and rate of flow needed at the facility based on VA provided information.

3.3. The Government will be responsible for annual maintenance and testing of GO property to ensure safety, in accordance with applicable regulations and standards.

3.4. The Contractor is responsible for performing minor maintenance on the GO bulk tank systems. Minor maintenance required of the Contractor includes validating that the fittings are securely fastened to the system, testing, minor de-icing, and adjusting alarms as required. Also, the Contractor shall provide documentation and training on how to de-ice the tank system in order to prevent damage (which could void the warranty between the VA and the tank manufacturer). In the event ice build-up occurs that cannot be remedied by the contractor during regular minor maintenance, the Contractor shall furnish the VA with a quote to remove the ice buildup from the liquid bulk oxygen tank system. After the VA reviews and approves the quote, it may place a stand-alone order to authorize the work.

4. Licensing, Authorization, and Selling Permissions

4.1. 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.

4.2. 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.

4.3. 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.

5. Liability Insurance Requirements

5.1. The contractor shall maintain liability insurance in the amount of $1 million per occurrence and shall provide an annual Certificate of Liability to the VA.

6. Ordering

6.1. The medical grade bulk liquid oxygen is ordered through telemetry systems based on automatic monitoring of the bulk liquid oxygen tank system’s established fill point, orders with the contractor are considered to be placed when the telemetry system alerts the contractor that the fill point has been reached. VA facilities may accept the standard fill point established by the Contractor. However, VA Safety and/or Engineering personnel reserve the right to establish different fill point settings for the bulk liquid oxygen tank systems. Any amended fill point settings will be communicated to the Contractor by each facility’s POC.

6.2. In the event telemetry is not used to signal the contractor to initiate a delivery request, orders shall be placed with the Contractor only by the POC through fax or e-mail at the address/fax number and contact listed below:

FAX Number:

Email Address: Jacob.sampson@va.gov Department: Supply Chain Name of Contact Person: Jacob Sampson Address: 1901 S. Veterans Memorial Dr. Temple, Tx 76504

6.3. The POC will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of POCs upon issuing the contract. When a POC is added after award, the CO will furnish the Contractor with the names of individuals as POCs. POCs are responsible for issuing and administering orders placed under this contract. POCs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized POC. Fulfilling orders from persons other than the CO or POC may result in loss or delay in payment for supplies/services provided under such orders.

6.4. If for any reason the Contractor is unable to deliver at the agreed upon day or time, the Contractor shall provide 24-hour notice to the POC 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 shall be designated by each facility. Contractor shall be provided with names and contact information of primary and backup facility representatives. This applies to all deliveries regardless of time or day of execution.

6.5. Tank systems(s) shall be filled to maximum functional capacity each time the tank is refilled.

6.6. At the time of each delivery, the Contractor shall provide to the VA a legible signed and dated document and/or electronic delivery slip that identifies the tank level prior to the fill, after the fill, and the quantity delivered at the time of delivery. This document must be countersigned by the facility representative supervising the delivery. Delivery audits shall be performed by the facility and matched for accuracy. The driver shall convert gallons to ft³ (CF) and CCF quantity and shall list these numbers on the delivery slip to be consistent with the detail on the invoice so to provide accuracy for invoice certification.

7.5 Emergency delivery shall be provided within 24 hours after receipt of Government notification. Contractor shall respond to the facility POC by either telephone or email within one hour to confirm receipt of emergency notification. Emergency status is determined by the Government when conditions warrant, such as a main bulk tank system damaged by the VA or a system imminent alarm condition, or a system leak that requires a refill in 24 hours. Failure of the Contractor to remain current with the agreed delivery schedule and requirements does not constitute an "emergency" for purposes of charging an emergency fee.

7.6 Once validated, the facility shall 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.

7.7 The Contractor shall not be required to make non-emergency deliveries on federally observed holidays. When the normal delivery day falls on a federal holiday, the Contractor shall deliver on the workday preceding that holiday. The following holidays are observed by the Federal Government (as well as any other day that is declared a national Holiday per an Executive Order issued by the President):

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) Juneteenth (June 19) Columbus Day (2nd Monday in October) Veterans Day (November 11th) Thanksgiving Day Christmas Day

7.8 Note: If the holiday falls on a Saturday, it is officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it is officially observed on the Monday following the holiday.

7. Quality Assurance Specifications and Requirements

7.1. 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).

7.2. 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 (USP).

7.3. A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include, at a minimum:

· Supplier's name and complete address

· Name of the Product (i.e., Oxygen USP.)

· An Air Liquefaction Statement

· Lot number or other unique identification numbers

· Actual analytical results for full USP monograph testing is an FDA regulation under 21 CRF 211 Subpart E. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

· Test method used to perform the analysis must be based on approved methods from current good manufacturing practice for medical gases guidance. (A statement such as "Meets USP specifications" shall not be acceptable, nor shall "Tested via Servomex" be acceptable since the specific model number is not provided.)

· Signature of authorized supplier representative and date.

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

A copy of all inspection reports and training certificates shall be provided to each facility COR upon completing any Contractor-furnished or GO bulk oxygen system inspections that are required and at a minimum done annually and consistent with NFPA 55 and NFPA 99 code requirements.

7.4. All Contractor-furnished bulk tank systems shall be maintained or repaired in accordance with NFPA 55 Code requirements (Current Edition) and FDA's Current Good Manufacturing Practices (CGMP) Regulations.

8. Applicable Regulations & Standards

8.1. 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 systems, 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 Code

NFPA 99: Health Care Facilities Code

USP 23

ANSI/CGA M-1 2018 Standard for Medical Gas Supply Systems at Health Care Facilities

8.2. 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 the measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to cubic feet to 100 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 EXAMPLE:

995-gal (1 ft³) liquid O2 multiplied by the conversion factor of 1115.1 ft³ gas

Total: 114,524.5 ft³ gas divide by 100, and that is what is to be billed.

Gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas multiplied by 100 to get the CCF.

9. Conduct of Personnel:

9.1. Contractor/Sub-Contractor employees shall conduct themselves in a professional and/or a socially acceptable manner. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor/Sub-Contractor shall be grounds for denying the employee further access to the VA premises.

9.2. The Contractor/Sub-Contractor employee(s) shall always wear visible identification on uniform shirt and badge while on the premises. The delivery truck must be clearly and appropriately labeled with Contractor/Sub-Contractor signage when on VA medical facility, Warehouse, and CBOCs.

10. Emergency Supply Support

The contractor shall, upon contract award, provide a written action plan and protocols in place that shall ensure compliance with the VA’s requirements under the contract in the event of a declared National or State Emergency which affects the Contractor’s ability to perform. The contractor shall provide annual updates to this plan over the life of the contract. In the event the plan is implemented the Contractor shall provide notification of implementation of the action plan and protocols within 48 hours of any declared National or State Emergency to the Contracting Officer and POC. In the event that a declared National or State Emergency has been declared at the time of award the Contractor shall submit the written action plan and protocols to the Contracting Officer and POC within 48 hours of award notification.

11. INVOICE AND PAYMENT

11.1. At the time of delivery, a legibly signed and dated proof of delivery (POD) document must be provided by the Contractor that identifies the tank system level prior to filling, the level after fill, and the quantity delivered in gallons, CFs and CCFs. The driver shall insure that the conversion between gallons, ft³ (CF), and CCF quantity is accurate so that these numbers listed on the delivery slip will be consistent with the details on the resulting invoice in order to facilitate invoice certification. The invoice that is submitted must match the delivery quantity on the POD document and must be invoiced in CFs.

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