36C24422Q0510 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

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)

(X)

CHECK

ONE

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)

1 93

00244

Department of Veterans Affairs Network Contracting Office 4

1601 Kirkwood Hwy Wilmington DE 19805

To all Offerors/Bidders 36C24422Q0510

X

X X

See CONTINUATION Page

The purpose of this amendment is to:

1. Provide the Questions & Answers in response to the RFQ.

2. Updated SOW reflecting clarifications from Questions & Answers.

3. Add IDIQ Minimum and Maximum amounts.

4. Correct the Butler VAMC address in the delivery schedule.

5. Provide a revised Attachment 1 SCHEDULE OF ITEMS with a corrected address for Butler VAMC.

No additional changes have been made and all other terms and conditions remain unchanged.

Andrea Aultman-Smith Contracting Officer

CONTINUATION PAGE

VISN 4 MEDICAL GRADE BULK LIQUID OXYGEN

Solicitation: 36C24422Q0510

Questions & Answers

Question #1: Please Confirm that CLINs 0001, 0002 and so on, are ADMIN CLINs not to price and that pricing is done in the Sub CLINS AA – AF.

Government Response:

CLINS 0001, 0002, 0003, etc. are Informational CLINS and the SubCLINS 0001AA, 0001AB, 0001AC, etc. are mostly priced SubCLINS, but some are not separately priced. The Attachment 1 SCHEDULE OF ITEMS has a column that denotes whether CLINS/SubCLINS are priced or not separately priced.

Question #2: Please clarify the purpose of CLIN AE & AF – which are listed on Page 5 of 192 – yet are put as non-priced CLINs in the ATTACHMENT 1 Schedule of items? What is the purpose of these CLINS? Please note, RPO Central did the same thing and said it was “a reminder that the suppliers had to have these – which are TECH/ADMINISTRATIVE in nature (not price related). What is the goes rationale for these? Recommend they be removed from the ATTACHMENT 1 Schedule of Items, which is an odd place to put non pricing information?

This is for (10) VAMCs so this is a bit confusing.

SubCLINS 000XAE and 000XAF are included to identify specific deliverables the Government requires from the contractor, and they will remain in the contract.

Question #3: Page 129 of 192 – will the GOV consider (7) Ordering periods (what was bid on all RPOC Bulk Oxygen requirements) vice the Base Plus 4 Options.

The Government anticipates awarding a base year ordering period plus 4 one-year ordering periods.

Question #4: Please confirm that there are no tanks at the VAMC Butler (they were removed), yet CLIN 003 page 7 of 192 lists Tanks at Butler?

Currently Butler VA Medical Center does not have any Bulk Oxygen tanks. The Tanks listed under CLIN 003 would be the size needed in the event they decide to participate in this requirement when their individual facility contract ends.

Question #5: ATTACHMENT 1 lists Tanks at “Abie Abraham” which is a different address than the VAMC Butler, can the GOV Please reconcile the addresses and the requirement at “Abie Abraham” as the RFQ does not list Abie Abraham? Can the GOV clarify what is the actual requirement and where “Abie Abraham” is?

The Government will correct the facilities and addresses in an amendment to the solicitation.

Question #6: P 140 of 192 Para 19 Facility Requirements - Identifies the Butler VAMC address as 325 New Castle Rd but then references in the Attachment 1 Schedule of Items CLIN 0003 (and subsequent years) the Facility as Abie Abraham VAMC 353 North Duffy Road. Please confirm which is the correct Butler facility and location address?

The Government will correct the facilities and addresses in an amendment to the solicitation.

Question #7: Page 132 of 192 states:

6.2. If the Contractor is not the manufacturer of the medical grade bulk liquid oxygen being supplied under this contract, the Contractor shall annually provide verification that the manufacturer from which it obtains the medical grade bulk liquid 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 bulk liquid 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 bulk liquid 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

Yet further states, on Page 132 of 192 Para 6.3 “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. There are states that require listening in this bid, which includes the offeror being licensed in their home state?

Succinctly, how is the GOV ensuring compliance with this? Please Note there are States (for example Tennessee has changed State law to require licensing about 2 years ago) There are states in VISN 4 where that state board(s) of pharmacy specifically require the Prime Contractor (SDVOB) to be licensed, as the SDVOB is the Contract holder and, the accountable entity to the GOV. Please note that in those states that require licensing - all parties in the pharmaceutical supply chain are required to be licensed in those States where the Board of Pharmacy requires as Medical Grade Oxygen and Specialty Gases for Human Consumption are classified by the FDA as a drug that requires a physician’s prescription. For uniformity, please see the current RFQ for the VAMC Miami, FL MED CYLs (Bulk & CYLs are the same), that clearly depicts that offers must be “fully licensed in the State of Florida:” We understand VISN 4 “is not Florida – but it is still the Veterans Administration – hence uniformly applicable, where required by individual states (see State of DE Example above see hyperlink below).

https://sam.gov/opp/4a495f18469a4fd7ab1b2996b6d1192c/view

6830--Medical Gases for Miami VA Health system - 36C24822Q0322

P. 8 Para 10. QUALIFICATIONS, CERTIFICATION AND TRAINING

Contractor shall be fully licensed and accredited to provide medical gas services in the states of Florida for the duration of the resulting contract. * Provide current licensing with Technical Quote.

Please note, where applicable these licensing requirements are applicable to the Prime Contractor, not the subcontractor. Lastly (unbelievably) some Cities require a Franchise Tax for operating in their City (Tucson, AZ).

The prime contractor is required to hold all licenses that are applicable to the contractor to deliver Bulk Oxygen to Delaware and Pennsylvania. See addendum to FAR 52.212-1 Instructions to Quoters for document submission requirements.

Question #8: INSURANCE – Page 123 of 192 Statement of Work Para 7.1 states: “Liability Insurance Requirements 7.1. 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.”

Shouldn’t the GOV be asking that the Liability Insurance insures performance of NAICS 325120 in the remarks section? This is important because there are very few underwriters that will insure small businesses for compressed gases – hence the GOV would be covered if the Insurance Certificate lists the applicable NAICs?

The requirement is for general liability insurance, it is not specific liability coverage for a particular NAICS code. Paragraph 7.1 requires the contractor to provide an annual Certificate of Liability to the VA.

Question #9: Page 132 of 193 Statement of Work Para 8.1 states:

“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 shall be communicated to the Contractor by each facility’s POC or COR.”

Relative Comment: This is a very contentious item in that if the Facility representative changes the Set Points – this increases the delivery frequency, in that a facility could change the reorder points seen on the site visit, etc. Can the GOV inform offerors what facility choose to modify their set points, so their delivery fees are adjusted? The reason being is an awardee would be initiating resupply when the tank is half full or more, with no predicated calculations when bidding? Can the GOV provide what facilities intend to set their own reorder point, and if so, allow the offer to annotate their delivery fee as such? In practical terms, the highest cost of Bulk Oxygen is distribution, distribution costs are already driven higher by the increased COVID-19 response, as well as the work situation driving the price of gasoline significantly higher.

Any fill points that have been established by Facility Safety/Engineering personnel have been annotated in Paragraph 9 Facility Requirements, under Delivery Instructions.

Question #10: Can the GOV confirm what this is being solicited under? (FAR 13)? This is important int that the evaluation for this requirement (10) VAMCs, is “lowest price technically acceptable (LPTA)” and given the dollar threshold for FAR 13, $250K, yet if the requirement exceeds that threshold, the contract file must contain the rationale for using LPTA – and be approved by the Head of Agency. Respectfully, can the GOV confirm that this has been done (often a FOIA is submitted to validate this). The reason we ask is (10) VAMCs, supplying Bulk Liquid Oxygen during pandemic conditions is a critical hospital function – linking

Please note, page 165 of 192 states “Past Performance is not a separate evaluation factor for this procurement.” Past Performance will be reviewed as part of the Contracting Officers Responsibility determination prior to Contract Award in accordance with FAR part 9.104-1” Additionally, the same requirements are applicable for NOT using Recent and Relevant Past Performance as an evaluation factor – relegating Responsibility matters, an administrative (not operational) determination? In sum, the Contracting file must also contain the GOV’s rational for NOT using Past Performance as an evaluation metric? This is a very contentious item.

The solicitation states in Addendum to 52.212-2 (page 173) that, “This is a commercial item acquisition that will be conducted under the authority of FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. FAR Parts 14 and 15 are not being used.”

Reference: FAR 13.5 - Simplified Procedures for Certain Commercial Products and Commercial Services

Question #11: REPAIRS OF GFE: Recommend adding a CLIN for Approved Maintenance / Annual Inspection of GFE Tanks (VAMC Erie is the only GFE Tank). How does the vendor response to a maintenance request from the facility with no CLIN, not established threshold to bill for? Please note, on call Maintenance TECHs are generally regional in nature, and Union Labor. The NFPA requires the “owner of the tanks” to have them inspected annually by a 3PP, which include certifying the alarms. In other contracts, this was one CLIN for “GFE Maintenance and/or Annual Inspection.” How does VISN 4 plan to do this for GFE Maintenance?

The Government will revise the SOW in an amendment to the solicitation to show in paragraph 3.3. The government is responsible for providing annual maintenance and testing on GFE, and paragraph 3.4, minor maintenance required of the Contractor includes validating that the fittings are securely fastened to the system, testing, and adjusting alarms as required.

https://www.acquisition.gov/far/part-13#FAR_Subpart_13_5 https://www.acquisition.gov/far/part-13#FAR_Subpart_13_5

If the Government determines that repairs are necessary on GFE, it will obtain a quote for the repairs and procure them separately.

Question #12: CYLINDER REQUIREMENTS? Page 137 of 192. Shouldn’t any cylinders be supplied on the Medical Cylinder Contract? This is Bulk Liquid Oxygen and not all suppliers are in the Cylinder business, nor certified to transport Cylinders? This function is normally under the Cylinder Contract, and installed by VA Personnel just like they do internal to the Hospital as COVID 19 protocols and liability insurance requirements apply?

The H Cylinder banks are back-up capacity for the Primary Bulk Tanks at 2 facilities and will remain as such.

Question #13: PG 130 of 192, Statement of Work Para 3.2 – “The Contractor shall perform the hook-up of Contractor owned equipment to the facility-maintained alarm system. The Contractor shall be liable for, and shall indemnify a hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, resulting from the fault, negligence, or wrongful act or omission of the Contractor, its agents, or employees.” Request amending this language to “Contractor will assist the VA Electrician with hook up of Contractor Owned Equipment to facility-maintained alarm system (called a “home run” connection in electrical terms. Contractor cannot perform the electrical hook up due to liability as stated in the RFQ.

What is the GOV’s rationale for “The Contractor shall be liable for, and shall indemnify a hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, resulting from the fault, negligence, or wrongful act or omission of the Contractor, its agents, or employees.” What is the rationale for this? It does not “hold up legally” in that the RFQ, as solicited, is asking a vendor to take considerable risk when they don’t even know what may occur, especially if the GOV is negligent?” No credible contractor would do this, and this was stricken from the RPOC language.

The Government will revise the SOW in an amendment to the solicitation to amend the questionable language used to reflect “The Contractor shall assist VA electricians with hooking up the facility-maintained alarm system, consistent with NFPA 55 & 99 code requirements, which require an uninterrupted electrical connection between the alarm panel(s) inside the facility and the gauges on the tanks” and omit the liability statement.

Question #14: PG 137 of 192, Statement of Work Para 14.8 – “Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the Contractor at no additional cost.” Request removing this language as contractor cannot perform this service due to liability.

2 facilities use H Cylinder banks for back-up capacity to their Primary Bulk Tanks, so this language must stay.

Question #15: PG 129 of 192 Para 1.1 - "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." Request to add a CLIN for monthly telemetry monitoring as there is cost associated with this service. Additionally, is there a telemetric requirement for the VAMC Erie GFE Tank? This unit would have to be installed/monitored, and maintained, hence a Monthly Telemetry CLIN is quite common in Federal GOV RFQs.

There will be no separate CLIN for this item as the cost associated with the telemetry system shall be included with the tank rental.

Erie VAMC will not have a telemetry system installed on their GFE Tank.

Question #16: Can you provide the incumbent vendor and last contract dollar amount awarded for each location?

The current vendor is RAS Enterprises, 2512 25th Ave Ste 3, Gulfport, MS 39501.

Approximate FY21 delivery orders total: $416,082.26

Approximate FY20 delivery orders total: $410,682.67

Disclaimer: This is provided for informational purposes only. It reflects the Government’s requirement under the current contract and may not necessarily be indicative of the

Government’s requirement under the new contract. Please refer to the solicitation’s Statement of Work for the new Government requirement.

Question #17: Would the VA give consideration to extending the effective date out, at least 8 months from the 5/1/22 effective date, in order to allow for non-incumbents to compete, given the unprecedented long lead times to obtain new medical oxygen tanks and associated equipment?

The Government is not able to extend the effective date of the contract for 8 months. The Government realizes that there may be delays during start-up, however the effective date of the contract will remain 5/1/22.

STATEMENT OF WORK

Medical Grade Bulk Liquid Oxygen

Department of Veterans Affairs (VA)

Veterans Integrated Service Network (VISN) 4

1. General

1.1. The Veterans Health Administration (VHA), Veteran Integrated System Network (VISN) 4, has established an ongoing requirement that requires a Contractor to provide medical grade bulk liquid oxygen for the facilities included in this Statement of Work. If the Government facility does not own its own bulk oxygen tank, the Contractor shall provide a Contractor-owned tank with an appropriate back-up system approved by the Contracting Officer Representative (COR) (i.e., reserve tank or cylinder bank).

Specifications for each facility are listed in Paragraph 19 Facility Requirements of this Statement of Work. 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. The telemetry units must be solar powered, cellular unit that transmits the signal via a telephone call to the Scheduling Center.

1.2. All supplies of medical grade bulk liquid oxygen shall be delivered to the VA Medical Centers/Health Care System Networks identified in Paragraph 19 Facility Requirements of this Statement of Work. The quantities shown are estimates of each facility’s annual requirements. There is no express or implied guarantee that these quantities shall be purchased. The contract shall have a base one-year period and four

(4) one-year option periods which may be exercised by the Government. Please note that this contract includes the installation of Contractor-owned equipment and shall include a 90-day transition period at the beginning and end of the contract period. (See SOW Paragraph 5.1).

1.3. A Contracting Officer Representative (COR) shall be designated for this contract. A letter of delegation that outlines the COR’s specific responsibilities shall be provided to the Contractor and COR at the time of contract award. A Point of Contact (POC) shall be designated for each ordering facility. The POCs are responsible for local contract issues such as requesting and accepting deliveries, providing specific delivery instructions, and issue payments to the Contractor.

1.4. Prior to first filling and annually thereafter, Contractor must perform in-service training to VA staff at each site and shall include the following facets for Contractor owned and Government owned medical grade bulk liquid oxygen systems: the refill procedure, any preventive maintenance support requirements that may be needed from the medical center systems, and an explanation of all the volume alarm and low pressure set points. The 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).

1.5. The Contractor prior to first filling, and annually thereafter, must conduct alarm set-point testing and written verification must be presented using a qualified third-party expert per NFPA 99, 2021 Edition for Contractor owned and Government owned systems. Any Code deficiencies in the Medical Center’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 COR.

Receipt of this written explanation must be signed for by the COR.

2. Acronyms

2.1. This section lists acronyms that are used in this Statement of Work.

ARO – After Receipt of Order

B/U – Back Up

CCF – 100 cubic feet

CF – Cubic feet

CGA – Compressed Gas Association

CGMP – Current Good Manufacturing Practices

CO – Contractor owned

COR – Contracting Officer Representative

DOT – Department of Transportation

FDA – U.S. Food & Drug Administration

GO – Government owned

NFPA – National Fire Protection Association

OSHA – U.S. Department of Labor, Occupational Safety and Health Administration

RST – Reserve Tank

USP – United States Pharmacopeia

VA – Department of Veterans Affairs

3. Government-Furnished Property

3.1. Paragraph 19 Facility Requirements of this Statement of Work shall identify the bulk oxygen storage tank(s) at each facility as being either GO (Government Owned) or CO (Contractor Owned). Government owned bulk oxygen storage tanks and appurtenances shall be maintained by and at the expense of the Government in a manner that shall ensure compliance with applicable regulations, standards, and normal good practices.

3.2. Each Government facility that requires installation of Contractor owned equipment shall provide a suitable location and foundation for the installation of the Contractor owned bulk oxygen tank(s) in accordance with NFPA Standard 55 2020 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, which require an uninterrupted electrical connection between the alarm panel(s) inside the facility and the gauges on the tanks.

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, and adjusting alarms as required.

4. Contractor-Furnished Equipment

4.1. For those facilities listed in Paragraph 19 Facility Requirements of this Statement of Work as having Contractor owned tanks, the Contractor shall provide, install, and maintain 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 owned tank(s) that shall 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 cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

4.2. All equipment and materials required 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 equipment shall be installed, inspected, and maintained by the Contractor at the Contractor’s expense (i.e., all installation, inspection and maintenance costs shall be included in the contract’s monthly equipment rental fee for the applicable facility.) Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The Contractor shall be provided by each requiring facility reasonable access to the bulk oxygen systems for this purpose.

4.3. The tank capacity and reserve system shown in the in Paragraph 19 Facility Requirements of this Statement of Work are minimum capacities required by the using facilities. The option for a facility to expand its capacity to ensure the facility is meeting minimum needs for growth throughout the life of the contract will be assessed by the individual facility. Each facility will identify any additional medical grade bulk liquid oxygen tank systems it may need on its campus. The Contractor shall work with the VA facility engineers and plumbers to locate the correct pipes for temporary tank system hook up.

4.4. Prior to first filling, and annually thereafter, the Contractor must verify, in writing, the accuracy of all gauges on Contractor owned tanks.

5. Installation of Contractor-Owned Equipment

5.1. Unless otherwise directed by the using facility, Contractor owned 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 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 medical-grade liquid bulk oxygen supply.

5.2. 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.

5.3. No guarantee is given or implied that data included in Paragraph 19 Facility Requirements regarding Contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required Contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility sites prior to submitting a quote and take other steps as may be reasonably necessary to ascertain the nature and 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 POC designated in the Paragraph 19 Facility Requirements.

5.4. All Contractor owned equipment shall be installed in accordance with NFPA 55:

Standard for Bulk Oxygen Systems at Consumer Sites, 2020, NFPA 99 Standard for Health Care Facilities, 2021 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.

6. Licensing, Authorization, and Selling Permissions

6.1. 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.

6.2. 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.

6.3. 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.

7. Liability Insurance Requirements

7.1. 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.

8. Ordering

8.1. In the event that 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 shall be communicated to the Contractor by each facility’s POC or the COR.

8.2. In the event that the facility chooses not to allow telemetry to be used to signal the Contractor to initiate a delivery request, orders shall be placed with the Contractor by the respective facility POC listed in Paragraph 19 Facility Requirements through fax or e-mail at the address/fax number and contact listed below:

FAX Number:

Email Address:

Department:

Name of Contact Person:

Address:

8.3. POCs shall be authorized to request deliveries against 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.

Fulfilling delivery requests from persons other than the CO or POC may result in loss or delay in payment for supplies/services provided under such requests.

9. Delivery of Medical Liquid Bulk Oxygen

9.1. Bulk oxygen is ordered by and delivered to the individual ordering facilities. The list of facilities and information regarding their unique delivery requirements is included in Paragraph 19 Facility Requirements.

9.2. The Contractor shall deliver medical-grade liquid oxygen within the timeframe specified in Paragraph 19 Facility Requirements for each facility. The timeframe identified is the number of calendar days after the Government places the order. 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 and Contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. 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 COR and POC, so that the facility can 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 COR and facility POCs immediately after award of this contract. This applies to all deliveries regardless of time or day of execution.

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

9.4. 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 counter-signed by the facility POC supervising the delivery. The driver shall convert gallons to 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.

9.5. Emergency delivery shall be provided within 24 hours after receipt of Government notification. Contractor must respond to the facility by either telephone 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 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.

9.6. 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.

9.7. 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 (January 1)

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 (4th Thursday of November)

Christmas Day (December 25)

9.8. 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.

10. Quality Assurance Specifications and Requirements

10.1. 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).

10.2. 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.).

10.3. A valid certificate of analysis shall be provided with each delivery of liquid oxygen.

The certificate shall include, at a minimum:

10.3.1. Supplier’s name and complete address

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

10.3.3. An Air Liquefaction Statement where appropriate

10.3.4. Lot number or other unique identification number

10.3.5. 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.)

10.3.6. 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.)

10.3.7. Signature of authorized supplier representative and date.

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

10.5. A copy of all inspection reports shall be provided to the facility COR upon the completion of any Contractor owned or Government owned bulk oxygen system inspections that are required by regulation and at a minimum done annually and consistent with NFPA 55 and NFPA 99 code requirements.

10.6. All Contractor owned 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.

11. Applicable Regulations & Standards

11.1. 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, 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.

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

11.1.2. 29 CFR 1910.104 Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises

11.1.3. 49 CFR – Transportation

11.1.4. Federal Food, Drug, and Cosmetic Act

11.1.5. NFPA 55: Standard for Bulk Oxygen Systems at Consumer Sites, 2021 Edition

11.1.6. NFPA 99: Standard for Health Care Facilities, 2020 Edition

11.1.7. USP 23

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

11.2. 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 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

1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas

12. Conduct of Personnel

12.1. 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.

12.2. The Contractor/Sub-Contractor employee(s) shall wear visible identification on uniform shirt and badge at all times 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.

13. Emergency Supply Support

13.1. 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 COR. 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 COR within 48 hours of award notification.

14. Contractor Owned Cylinders

14.1. This section applies to all Contractor owned cylinders that are provided under this contract as a back-up system to a primary bulk oxygen system.

14.2. Laws and Regulations: Cylinders and other containers for gaseous 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 and subsequent updates to DOT regulations (Title 49-Transportation, Code of Federal Regulations). Packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act.

14.3. 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."

14.4. All unauthorized or inapplicable markings, tags, and labels shall be removed.

When shipment is by commercial carrier, shipping tags complying with Federal Standard 123F dated 5/15/91 shall be attached to each cylinder 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.

14.5. Valves: Valves shall comply with Compressed Gas Associates Standard CGA-V- 1 (11th Edition, 2003), "Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections." Valve protection caps for cylinders designed to receive such caps shall be securely attached to the cylinders in a manner to protect the valves from injury during transit and delivery to the purchaser's receiving area. Refer to 49 CFR 173.301(g)).

14.6. Color Coding: All cylinders shall be color coded in accordance with the Compressed Gas Association Pamphlet CGA C-9-1988, “Standard Color Marking of Compressed Gas Containers Intended for Medical Use.”

14.7. The Contractor shall be responsible for all testing required by regulation of Contractor owned cylinders at no additional cost to the Government.

14.8. The Contractor’s price for the oxygen shall include the furnishing of, at no additional cost, all services which are required at each and every filling of a cylinder to comply with applicable regulations, specifications, and normal good practices. Such services are of the type normally provided in the supply of medical cylinder gases, and shall include, but not be limited to: tags indicating cylinder is "Full," In Use," or "Empty";

inspection, testing, evaluation, and cleaning services required at each and every filling;

pin-indexing, when required, and attachment of Government-furnished warning tags, when required. Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the Contractor at no additional cost. In addition to services listed in this paragraph, the Contractor is responsible for all maintenance and testing of Contractor-owned cylinders.

15. Government Owned Cylinders

15.1. Individual Agency Ownership of Cylinders: Government owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either Government-owned or Contractor-owned, without authorization of the Contracting Officer Representative (COR) at the ordering agency.

16. De-Installation of Contractor Furnished Tank System

16.1. 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 a replacement bulk tank system or a temporary liquid bulk oxygen supply has been successfully installed guaranteeing supply to the VA facility. In the case where the incoming Contractor is not the incumbent, the outgoing Contractor shall coordinate bulk tank system/services transition with the incoming Contractor beginning at 120 days prior to the end of the contract, assuming a new Contractor has been identified at that time. The Contractor shall continue to provide and maintain its bulk tank system during this transition period. If additional transition time is required beyond contract expiration, a separate Purchase Order shall be issued to the Contractor for the payment of services on a pro-rated basis.

Pro-rated monthly rates are based on a 30-day month. Contractor agrees that the rates in effect at the time its contract expires shall remain in effect under this separate purchase order.

17. Invoice And Payment

17.1. 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 CCFs. The driver shall insure that any conversion between gallons, ft³ (CF), and CCF quantity is accurate so that these numbers listed on the delivery slip shall 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 CCFs.

17.2. Invoices shall be submitted monthly in arrears. The Contracting Officer Representative (COR) or Facility Point of Contact (POC) is responsible for acceptance of services and/or the processing of any reports for the services provided to the government.

17.3. Payments to the Contractor will be issued monthly following receipt of invoice and acceptance of services.

18. VHA Supplemental Contract Requirements for Combatting COVID-19

18.1. Contractor employees who work in or travel to VHA locations must comply with the following:

18.1.1. Documentation requirements:

18.1.1.1. If fully vaccinated, Contractors shall show proof of vaccination.

18.1.1.1.1. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

18.1.1.2. If unvaccinated, Contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval.