previousQuestions and answers.docx

1. TYPE OF CONTRACT: As the NAICS for this RFQ is 325210 Industrial Gas Manufacturing, please confirm whether this is a Service Contract or a Supply Contract.

This is a supply requirement as it has a supply NAICS and FSC Code and SBA Class Waiver

1. CLIN 0001 – LIQUID NITROGEN 250L:

· PG 2 OF 8 in the SOW (Section 2.5.1.1) states that liquid nitrogen will be required in “various types and purity including but not limited to refrigerated, NF, High Purity, and high pressure (standard pressure expectation is 22 PSI).” The SOW requires a pressure expectation of 22PSI, but CLIN 0001 in the Pricing Sheet (and Table 4.2 in the SOW) require liquid nitrogen delivered in a 350 PSI dewar. Will the GOV please confirm the correct PSI requirement?

This has been adjusted in Section 2.5.1.1 of the SOW to 350 PSI.

· Will the GOV allow offerors to propose a different size Liquid Nitrogen VGL such as a 230 Liter which is much more common? 250L is an abnormal size, and we have seen suppliers begin to phase these sizes out in favor of more common sizes such as a 230L.

This has been adjusted in Section 4.2 and the CLINs to 230 L.

1. RENTAL CLINS: The Pricing Sheet (and Table 4.2 in the SOW) calculates the daily rental charges for (12) cylinders per month in CLIN 0004, (12) cylinders per month for CLIN 0005, and (4) cylinders per month for CLIN 0006. Will the GOV please confirm if the provided monthly totals in CLINs 0004-0006 represent the estimated on-hand cylinder totals to be maintained for the Research Department?

Please note this is an Indefinite Delivery Indefinite Quantity (IDIQ) requirement. With the exception of Liquid Nitrogen, which will always be kept at 4 on-hand cylinders, all other cylinder counts represent estimates.

1. OXYGEN MANIFOLD CYLINDER SIZE: PG 8 of 8 in the SOW (Section 4.5.1.2) states that “Attaching oxygen cylinders to manifold systems, when required, shall also be performed by the lab staff and/or Biosafety to be on side to hook up the tanks as needed.” Will the GOV please confirm if oxygen cylinders for the oxygen manifold system will be required on the contract that results from this solicitation? Manifold systems most commonly require oxygen cylinders in size H/K/200, but the only oxygen cylinders included in the Pricing Sheet are size E. Please confirm.

Confirming that, with regard to this requirement, the small manifold system in question will use size E oxygen cylinders.

1. DELIVERY REQUIREMENTS:

1. DELIVERY LOCATIONS: PG 3 of 8 in the SOW (Section 3.2) states that “The contract items will be ordered and delivered to the AVAHCS, Research Department located on the 5th floor clinical addition. The supply systems will be located at the existing Research 5th floor 1670 Clairmont Road, Decatur, GA 30033.” However, PG 4 gives a list of (4) delivery points, including rooms 12C188, 4A125, 4A150, and 5A138. The delivery point room numbers seem to be spread across (3) floors (the 4th, 5th, and 12th floors). Will the GOV please confirm if all delivery points are on the 5th floor as stated in Section 3.2 or if that was an error and delivery points are on the previously referenced (3) floors?

This has been adjusted in Section 3.2 to indicate that supply systems are on the 4th, 5th, and 12th floors. POC offices for Research Department are located on the 5th floor clinical addition.

1. DELIVERY TIMES: PG 2 of 8 in the SOW (Section 2.5.2.1) says that deliveries will be made between the working hours of 8AM and 4:30PM, but PG 3 (Section 3.7.5.2) says that deliveries will be made between 8AM and 12PM. Section 2.5.2.1 does specify that delivery times in Section 3.0 will take precedence, but will the GOV please confirm the expected delivery window? An 8-hour delivery window such as 8AM-4PM or 7AM-3PM is the industry standard, and a restricted, 4-hour delivery window would result in higher delivery fees. Would the GOV be amenable to honoring the 8AM-4:30PM delivery window presented in Section 2.5.2.1 and allow offerors to price a standard delivery fee?

This has been adjusted in Section 3.7.5.2 to 8 AM – 4:30 PM.

1. DELIVERY DAYS: PG 4 of 8 in the SOW (Section 3.7.5.2) lists the delivery days as Monday-Friday (for twice-per-month deliveries as detailed in Section 3.7.2). Is the Research department currently receiving deliveries every day of the business week? Or does the facility have established delivery days (e.g., MON/FRI or TUE/THUR) for a more efficient logistical flow when deliveries are made twice per month?

Established delivery days for more efficient logistical flow are preferred and are at the discretion of the vendor, so long as deliveries are made in accordance with the SOW.

1. DELIVERY FREQUENCY: Will the GOV confirm how many deliveries are expected per month? As detailed in question 3c above, the SOW states that deliveries will be made twice per month (24 deliveries annually), but CLIN 0007 in the Pricing Sheet states that there will be (4) deliveries per month, for a total of (48) deliveries per year. Please confirm the expected delivery frequency.

This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Estimates were provided. SOW paragraph 3.7.2 was updated.

1. EMERGENCY DELIVERY PROCEDURES: How does the GOV project to account for costs incurred for any emergency deliveries required within (24) hours that are not the fault of the contractor (either via an added CLIN or P-Card)? Please note that any off-cycle deliveries, including weekends and holidays, would be considered an emergency delivery and incur an emergency delivery fee.

Emergency deliveries are not within the scope of this contract.

1. TRANSITION: PG 3 of 8 in the SOW (Section 2.5.2.6) states that “There will be 30 days between award of contract and award effective/start date.” The industry standard is to allow 30-60 days for a formal, event-based transition between contractors (often depends on if the awardee is hiring the incumbent supplier or not). Will the GOV please revise the solicitation to specify that event-based transitions for medical gas contracts may take up to 60 days? Additionally, does the GOV have a anticipated date in which to have this awarded being the Base Year POP begins 9/1/2026?

No change will be made. The Government’s requirement is 30 days as stated in the SOW. Exceptions to the Government’s requirement may result in a determination that the vendor cannot comply with the delivery requirements outlined in the SOW.

1. TECHNICAL SUBMISSION REQUIREMENTS:

0. REDACTED TECHNICAL: PGs 26-27 of 45 in Attachment 2 (Instructions to Offerors) requires the submission of redacted Technical files for Volume 2, including a redacted base document for the Technical submission, redacted evidence of licensure for manufacturers, and redacted manufacturer agreements/authorization. Please confirm the utility of providing these redacted technical documents. Is there a blind evaluation committee that will be reviewing proposals? Will the GOV remove this requirement if there is not a blind evaluation committee that will be reviewing submissions? Please note that due to the file size of the multiple redacted PDFs, a separate email (or emails) will be required to send the redacted documents during the submission process.

The solicitation addresses your question:

Note A, 1 below found on page 26 of Attachment #2

0. MANUFACTURER CERTIFICATIONS: PGs 1-2 of 8 in the SOW (Section 2.4.1) states that “If the Contractor is not the manufacturer…the Contractor must provide evidence of the medical gas manufacturer’s current licenses, permits, certifications, or registrations required by the FDA in the states in which this contract is performed, as well as an executed copy of the resellers agreement within ten (10) calendar days of contract award…” However, the Instructions to Offerors on PGs 26-27 of Attachment 2 (Section A) requires offerors to provide “evidence” to support Sections 2.4.1.1 or 2.4.1.2 with their bid submissions, where both of the referenced sections in the SOW refer to evidence of manufacturer licenses as well as authorized agreements.

The (2) sections above contradict one another. Please confirm if nonmanufacturer offerors must provide the manufacturer’s/supplier’s licenses/certifications as well as authorization agreements at the time of bid submission or within (10) calendar days of contract award.

The Government does not see a contradiction:

Contract performance requirements are listed in the SOW. If awarded, the contractor has the timeline listed in the SOW to comply with the SOW requirements. If they fail to comply, that is a question of contract administration and shall be handled as such.

The Quote submission requirements are listed in Attachment #2 and use future tense since there is no active contract. The Government is asking HOW the offeror will meet the requirement and submission requirements are outlined in detail.

1. INSURANCE REQUIREMENTS: There is no mention of required liability insurance in the solicitation. 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? 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.

FAR 52.228-5 was not included in the RFQ because it is not applicable IAW RFO 28.310 (a).

However, vendors can address insurance they deem relevant under Quote submission Instructions C, 2), a).

1. CONTROLLED UNCLASSIFIED INFORMATION (CUI): Will the contract resulting from this solicitation include any CUI (or any other term/acronym that refers to sensitive contract material within in the VA) – as it pertains to a CMMC certification for federal contractors?

No.

1. LOSS OF USE FOR CONTRACTOR-OWNED CYLINDERS: PG 7 of 8 in the SOW (Section 4.4.7) provides language specifying that the GOV will pay its LOU invoice via a “bilateral contract modification with appropriate release of claims language.” Since procedures are in place to fund LOU via a modification, will the GOV please consider adding an unfunded LOU CLIN up front so that we can ensure the LOU is adequately addressed and funded at the end of an ordering period when LOU is observed? Please note, the only way to determine Loss of Use is by conducting a joint audit between the VA and the Prime Contractor to compare what is physically on hand at the facility.

0. To protect Contractors who must front these charges with their suppliers in order to continue delivering medical gases, to ensure compliance with the Prompt Payment Act, and to establish accountability procedures for the VA, we recommend including the current LOU verbiage from the VISNs 9/10 Medical Cylinders Contract that does address payment procedures (36C77623D0910):

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

No change will be made. The SOW includes 4.4.7.3 and already addresses how this will be handled.

1. AWARD ELIGIBILITY:

10. To ensure uninterrupted delivery of medical-grade gases to the Research Department and to avoid post-award delays that could impact patient care, will the GOV revise the solicitation to require offerors to submit, with their proposal submission, evidence that they currently hold all applicable federal, state, and local licenses required for the distribution and delivery of medical-grade gases, including gases classified as prescription drugs, as a definitive responsibility criterion? We ask for confirmation due to the contradiction in the RFQ as detailed in Question 5b.

This was already answered above in 7b. The requirement will not change.

10. Given that medical oxygen and other medical-grade gases are life-sustaining products regulated as prescription drugs, does the GOV intend to limit competition to offerors that are already legally authorized to distribute and deliver such products at the time proposals are submitted, in order to avoid delays in commencement of performance following award?

Delays in performance are a contract administration concern. The requirement already addresses the Government’s requirements for quote submission and clarified that in 7b.

10. Will the status of an offerors’ license (in this case, a registered wholesaler of drugs and/or devices in the state of Georgia) be evaluated as a definitive responsibility criterion during the consideration of offers?

A responsibility determination will be made in accordance with RFO 9.103 and 9.104-1.

Any technical concerns will be evaluated as described in the RFQ.

10. How will the GOV evaluate a proposal submitted by an offeror that does not possess an active and applicable medical gas distribution license at the time of proposal submission but proposes to obtain or rely upon such licensure after award?

Matters of contract administration will be handled as such.

The RFQ addresses submission requirements, and this question has already been addressed in 7b above.

1. FAR/VAAR COMPLIANCE ENFORCEMENT: Please confirm the GOV POC who enforces and ensures post-award compliance with FAR 52.212-4 (Contract Terms and Conditions—Commercial Products and Commercial Services) as well as VAAR 852.219-76 (Limitations on Subcontracting for Supplies and Products/Certificate of Compliance)?

A warranted Contracting Officer is responsible for post award compliance.

1. LICENSING COMPLIANCE OF THE OFFEROR: Will the GOV please confirm that the required federal and state of Georgia licenses and certifications applicable to the offeror must be provided in the name of the Prime Contractor at the time of bid submission (and cannot be delegated to a subcontractor), which is required of an offeror in order to comply with the applicable federal, state, and local regulations in order to meet the requirements of the Statement of Work in this RFQ (wholesale distribution of medical-grade oxygen/compressed gases where medical-grade oxygen is defined by the FDA as a prescription drug)? Please see the below reference information regarding compliance with the FDA, CFR, and the state of Georgia:

This is the same question that was asked previously. The RFQ states the requirement. Contract administration concerns will remain contract administration concerns.

1. PG 1 of 8 (Section 2.4):

0. “All products, equipment and services provided under the contracts awarded under this contract shall be in compliance with all applicable Federal, state, and local regulations.”

1. PG 2 of 8 (Section 2.4.1.3):

0. “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.”

0. INFO ONLY - REFERENCE INFORMATION REGARDING FEDERAL WHOLESALE DISTRIBUTION LICENSING REGULATIONS BY THE CFR, FDA & STATE OF GEORGIA:

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

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

· Per the Food and Drug Administration, Code of Federal Regulations Title 21, definition of a Wholesale Distributor. Based on the SOW and, the offeror qualifies as being a Wholesale Distributor (restated, medical grade/US Pharmacopoeia Oxygen is defined as a prescription drug).

· LINK: 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:

· Per the Georgia Board of Pharmacy Facility License application:

· LINK: https://gbp.georgia.gov/applications-and-forms

· Per the Georgia Pharmacy Law, Title 26, Chapter 4

0. LINK: https://gbp.georgia.gov/documents/georgia-law (If you are not directed to the Lexis Nexis site from this link, please click on the Georgia General Assembly link to be taken to the applicable Georgia Code):

· Article 1 General Provisions 26-4-5 Definitions:

· Article 6 Sections 113 & 115:

· Per Georgia Board Rule 480-7-.03:

· LINK: https://rules.sos.ga.gov/gac/480-7 image4.png image5.png image6.png image7.png image8.png image9.png image10.png image11.png image1.png image2.png image3.png