S06-RFQ amendment 36C26225Q0173 0001.docx

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)

644-25-1-021-1328

36C262

NCO 22

Department of Veterans Affairs NCO 22 - Gilbert Network Contracting 335 East Germann Road Gilbert AZ 85297

36C262

NCO 22

Department of Veterans Affairs NCO 22 - Gilbert Network Contracting 335 East Germann Road Gilbert AZ 85297 To all Offerors/Bidders

36C26225Q0173

X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 12-09-2024 15:00 PST See CONTINUATION Page 644-3650160-021-828100-2631 0100441S9

The purpose of amendment 0001 is:

1. Extend the Proposal Submission date

2. Answer Contractor questions.

3. LIMIT response to no more than thirty-five (35) typewritten pages with a 12pt font-size.

There are no other changes to the terms and conditions of this Solicitation.

All other terms and conditions remain in full force and effect.

Anthony C. Dela Cruz Contracting Officer

VA-VHA-RPOW-2024-0101

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

MEDICAL GAS DELIVERY FOR PHOENIX MAIN CAMPUS, ALL OUTLYING CBOCS AND THE NEW OPC @ 32ND STREET

A.2 DELIVERY SCHEDULE

1.00

1. EXTENSION REQUEST: The RFQ for the Phoenix VA HCS was released on 11/21/24 (THURS) with questions being due 11/26 (TUES) and the bid due 11/29 (FRI) – right before and immediately after the Thanksgiving holiday. Due to the restrictive turnaround of this solicitation surrounding a Federal Holiday, we request a submission deadline extension to ensure that offerors can receive the Q&A responses back from the VA and have enough time to review and respond appropriately in our bid submission.

Answer: Extended 12/9/2024 15:00 PT

1. SOLE SOURCE LANGUAGE: PG 5 OF 72 states that “We will continue our ongoing services as a Sole Source requirement due to the needs of the Hospital and the Outlying CBOCs…” As this is an open SDVOSB solicitation, please clarify why Sole Source language is included in the RFQ.

Answer: This is SDVOSB Set-Aside Solicitation.

1. CLINs / CYLINDERS:

· CLIN 0001: PG 12 of 72 in the RFQ includes a lump sum CLIN of (1) YR for the “Medical Gases for Main Hospital and CBOCs.” How does the awardee invoice on a monthly basis when the provided CLIN is structured on an annual invoicing basis? Based on this structure, the offeror can only invoice once per year even though industry standard for invoicing is monthly (which is also listed as a requirement in the RFQ on PG 9); The costs for delivering medical gas cylinders to all required locations within the Healthcare System will result in fluctuating monthly costs, not a flat annual rate. With the function of the SOW’s requirements, offerors cannot price a flat annual rate.

· Please note that the VA included an itemized list of CLINs on PGs 71-72 of the RFQ but did not provide any reference to or instructions on pricing that list, nor were any unit price fields provided per line item.

· We request that the required gases/cylinders be provided in itemized CLINs that reflect the RFQ’s individual gas requirements as depicted on PGs 71-72 of the RFQ.

· RENTAL CLINs: PG 9 of 72 in the RFQ (Section 8.0) details monthly rental requirements for contractor-owned cylinders and liquid containers in (4) rental groupings, but there is no reference to or groupings provided for offerors to price the rentals of Walk-O2-Bout cylinders, Walk-O2-Bout MRI compatible cylinders, or high pressure (6K) cylinders – all of which are included on the itemized list of CLINs on PGs 71-72 in the RFQ. Please confirm that the VA will provide rental CLINs in an itemized list that will allow offerors to price the actual requirements for the facility.

· RENTAL PERIOD: Section 8.0 also explicitly requires “monthly rental of contractor-owned cylinders” in the section heading and in the first bullet; however, the line items for the (4) rental groupings provided include “per day” for the cost requirement. Contradicting information is included within the same section with the VA instructing Contractors to assess “monthly” and “daily” rental charges. Please confirm that rental charges will be assessed on a monthly basis.

· Additionally, in reference to rental charges, Section 8.0 also states that the “Contractor shall not bill at a rate higher than their standard commercial rate.” A Contractor’s offeror is the price based on the unique conditions of the RFQ, so there is no “standard commercial rate.” Please clarify what this statement means.

· GFE / CONTRACTOR-OWNED CYLINDER REQUIREMENTS: Please also confirm how many of each GFE cylinder type the GOV has on its property books by item number as well as the estimated/average on-hand balances at any given time.

· GFE HYDROSTATIC TESTING CLIN: The third bullet in Section 2.4 states that the “Contractor shall be responsible for all testing of cylinders at no extra charge to the facility.” Please confirm that the GOV is not stating that Contractors are responsible for all GFE maintenance items – other than for the line items provided (e.g., hydrostatic testing). If the facility requires additional maintenance on GFE (e.g., testing, valve replacement, painting/stenciling, etc.), respective CLINs need to be added for such services. Without the provision of specific service CLINs, Contractors are not responsible for the general maintenance of GFE cylinders.

Answer: GFE/Contractor cylinders are to be inventoried by Contractor within 30 days of award. Using Service provided usage and requirement based on current contractor information.

Provide pricing based on pg. 71-72 information. Contractor’s format varies and is acceptable.

1. DELIVERY SCHEDULE/NEGOTIATE: Is the GOV amenable to negotiating the delivery schedule for each facility with the awardee (e.g., delivery days and times)?

Answer: Delivery times were provided by using service and can be negotiated once awarded.

1.

CYLINDER MANIFOLD SYSTEMS: PG 9 of 72 in the RFQ (Section 6) lists included services that the Contractor is required to provide at no additional cost to the GOV, including the “…attaching of oxygen cylinders to manifold systems (when required)…” Will the GOV please remove this language as this is highly nonstandard and vendors cannot perform this function due to liability reasons (damaging manifold or entering facility and possibly interacting with patients)? Standard industry practice is delivering to centralized delivery point (e.g., loading dock), and distribution/hookup of cylinders within the facilities is the responsibility of GOV personnel. Vendors cannot be liable for the hook-up of cylinders to any GFE manifolds/appurtenances due to liability, risk of damaging GFE equipment, and because drivers are not certified for this type of service. This function should only be performed by VA personnel who are more familiar with and properly trained on the systems unique to the Phoenix VA HCS.

Answer: VA personnel are not trained. Contractor must be able to provide service or they are not eligible to compete.

1. TECHNICAL REQUIREMENTS: PG 46 of 72 requires that offerors submit (2) versions of their Technical Submission – a redacted copy and an unredacted copy. As this can be a time-consuming process, please confirm that the VA is only asking offerors to redact their VOL II Technical Base Document and not ALL accompanying attachments included in the Technical Submission. Please note that due to the file size of a redacted PDF, a separate email will be required to send the redacted document during the submission process.

Answer: A redacted copy.

1. INSURANCE REQUIREMENTS: How is the GOV going to validate that offerors are properly insured for NAICS 325120/221210 – the actual requirement for this work to comply with the RFQ and not just the dollar value threshold listed on PG 12 of 72 in the RFQ? How do offerors confirm to the GOV that they have the correct type of Liability Insurance, and does this need to be affirmed at the time of bid submission (if not, an awarded firm could be turned down or not be able to afford this coverage in the amounts the GOV requires, respective to NAICS 325120)? This is important because there are very few underwriters that will insure small businesses for the distribution of compressed gases and why confirmation of the applicable NAICS is being requested, in accordance with paragraph (a) of FAR 52.228-5 – Insurance Work on a Government Installation – which is included on PG 29 of 72 in the RFQ.

Answer. Contractor signature is acknowledgement of compliance with all clauses and upon request of Contracting Officer contractor must provide validation.

Per FAR 52.228-5 Insurance Work on a Government Installation, The Contractor shall, at its own expense, provide and maintain during the entire performance of this contract, at least the kinds and minimum amounts of insurance required in the Schedule or elsewhere in the contract.

1. EVALUATION: The SF1449 states that bids will be evaluated on a lowest-price, technically acceptable basis, but PG 22 of 72 in the RFQ includes an incomplete Solicitation Provision for the Evaluation. While it does state that the “contract resulting from this solicitation ... will be most advantageous to the Government, price and other factors considered” and goes on to list “Technical and Price” as the factors, but the following sentence states that “The following factors shall be used to evaluate offers: Technical and past performance, when combined, are .” Please confirm that the evaluation basis is LPTA or what factors will be considered in evaluating offers as “most advantageous” and how those factors will be weighted. If LPTA, what is the GOV’s rationale for awarding to the lowest priced offeror that meets the bare minimum instead of what offer brings the most value for such a critical hospital function such as medical-grade oxygen (classified by the FDA as a prescription drug) for Veteran consumption?

Answer. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Price Only Technical and past performance, when combined, are equal to price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

1. LICENSING: PG 11 of 72 in the RFQ (Section 12) states that “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.”. Additionally, the RFQ includes the “852.219.76 CERTIFICATE OF COMPLIANCE,” which requires the offeror to affirm in writing “that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice” which in this case is a prescription drug (the FDA classifies Medical Grade Gas, such as Oxygen, as a prescription drug for human consumption). Based on the requirements and conditions of the Statement of Work, the SDVOSB Prime meets the definitional requirements of both the FDA and the State of Arizona as a Wholesale Distributor of Medical Gas (which the State of Arizona Board of Pharmacy requires Distribution licensure of the SDVOSB, and this, like General Liability Insurance, cannot be delegated to a subcontractor licensing, nor construed as being synonymous with a Medical Gas Manufacturing License – as identified in the first two bullets on PG 11 of 72 under LICENSING, AUTHORIZATION, AND SELLING PERMISSIONS).

· With the inclusion of requirements on PGs 11 of 72 as well as the inclusion of FAR 52.212-4, please confirm that the GOV is requiring that the Offeror must comply with all State of Arizona licensing regulations (e.g., State of AZ Board of Pharmacy) in regards to Wholesale/Distribution of Prescription Drugs/Cryogenic Gases for Human Consumption applicable to the Prime Contractor and that any state-regulated compliance for distribution cannot be delegated to the subcontractor (further exemplified in the 852.219-76 Certificate of Compliance, where the offeror states in writing that they take ownership/possession of the product, which in this case Medical Grade Oxygen is classified by the FDA as a prescription drug)?

· Is all applicable proof of licensure required at the time of bid submission? If not, when would proof of licensure be required to ensure compliance with PG 11 of 72 & FAR 52.212-4?

· If so, is the GOV affirming that a non-licensed offeror is in noncompliance with the solicitation, and would a noncompliant offeror be considered not technically acceptable?

0. INFO ONLY - REFERENCE INFORMATION REGARDING WHOLESALE DISTRIBUTION LICENSING REGULATIONS BY THE FDA & IN THE STATE OF ARIZONA:

· Per the Food and Drug Administration, Code of Federal Regulations Title 21, definition of a Wholesale Distributor

· https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=203.3

· Per Section 201(g) of the FD&C Act (21 USC 321(g)) provides that the term "drug" means

· CFR Code of Regulations, Title 21, Chapter 1, Subchapter C, Part 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTOR

· https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-205

· Per the Arizona Administrative Code, Title 4 Professions and Occupations, Chapter 23 Board of Pharmacy – 4 A.A.C. 23 (PDF attached):

· Section R4-23-601 (A) General Provisions (Page 40; Notated as Page 38 on the PDF itself):

· Section R4-23-607 (Page 50; Notated as Page 48 on the PDF itself):

· Section R4-23-692 (Page 73; Notated as Page 71 on the PDF itself):

· Per the Arizona Revised Statutes (https://www.azleg.gov/ars/32/01929.htm):

· Section 32-1929:

Answer: Specific state requirements do not apply to the Federal Government. State’s does not have jurisdiction over the Veterans Affairs (VA). VA is not a reseller.

Truman Leong, Compliance Officer for the Arizona State Board of Pharmacy. Stated, on 8/1/2024 via email, “that the State does not have jurisdiction over the Veterans Affairs (VA).”

The State of Arizona permits two different types of operations to allow them to do business in Arizona (including virtual/prime/sub-entities). Depending on the business operations the entity might choose to have both permits.

1. FAR COMPLIANCE: Please confirm that the offeror must comply with all federal, state, and local regulations required of the offeror in order to meet the requirements of the statement of work as stated in FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023) on PGs 14-19 of 72 in the RFQ. More specifically:

0. FAR 52.212-4, para. (q): “Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.”

0. Is it the GOV’s position that the SDVOSB offeror must be in compliance with the State Arizona’s Board of Pharmacy Regulations at the time of bid submission based on the language provided in FAR 52.212-4?

Answer. Contractor signature is acknowledgement of compliance with all clauses and upon request of Contracting Officer contractor must provide validation.

Per FAR 52.228-5 Insurance Work on a Government Installation, The Contractor shall, at its own expense, provide and maintain during the entire performance of this contract, at least the kinds and minimum amounts of insurance required in the Schedule or elsewhere in the contract.

1. FAR COMPLIANCE ENFORCEMENT: Please confirm who the GOV entity is that enforces and ensures compliance with FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services?

Answer: The contracting officer is a designated individual responsible for executing, managing, providing, and overseeing contract is being executed in accordance with agreed upon contract on behalf of the government agency.

1. LOSS OF USE FOR CONTRACTOR-OWNED CYLINDERS: What are the procedures to account for Loss of Use (LOU) costs for Contractor-Owned cylinders lost while in the VA’s possession? There is no provided language specifying that the GOV will pay its LOU invoice following a joint cylinder audit between the Prime Contractor and the VA, which was included in the recently released New Mexico VA HCS solicitation (also in VISN 22). There is also no language detailing HOW the GOV will ensure payment is provided (e.g., paid for via separate purchase order?). Restated, how the vendor will arrive at payment procedurally and be reimbursed in a timely manner for any lost cylinders? Please note, the only way to determine Loss of Use is per a VA/Prime Contractor joint-audit and compare what is physically on hand at the facility.

· We recommend including the current LOU verbiage from the VISNs 9/10 Medical Cylinders Contract that does address payment procedures (36C77623D0910 – awarded in SEPT 2023):

· NOTE: Just-in-Time invoicing is not included in this RFQ for the Phoenix VA HCS; the above image is simply an example of the LOU PO language previously recommended to the VA.

Answer. For each contractor-owned cylinder lost or damaged beyond repair while in the Government's possession, the Government shall pay to the Contractor the replacement value, less the allocable rental paid for that cylinder. These cylinders shall become Government property. If any lost cylinder is located within 30 calendar days after payment by the Government, it may be returned to the Contractor by the Government, and the Contractor shall pay to the Government an amount equal to the replacement value, less rental computed in accordance with SOW. This will be a demurrage charge which will be negotiated and issued on a separate Purchase Order.

Please confirm receipt and let us know if you require any clarification. RAS is actively licensed to distribute medical gas within the State of Arizona in compliance with the State’s Board of Pharmacy (See attached license).

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