Previous Questions and answers.docx

Questions and Answers. Responses in Red

1. CURRENT CONTRACT INFO: What is the current contract number, and who is the current supplier for this requirement?

Please see the SAM posting:

1. CLINS / ATTACHMENT 3 PRICING SHEET:

1. There are (7) gas items in the VA-provided Excel Pricing Sheet that are not addressed/depicted in the Statement of Work breakdown of each Lab’s requirement. Please confirm which Labs utilize these gases, tank ownership (VA Owned or Rented), and the estimated frequencies required.

0. 0008 – Argon Compressed Gas 200cf (K)

0. 0009 - Air Compressed Gas Zero Grade 200cf (K)

0. 0005 - Nitrogen Compressed High Purity 300cf (T)

0. 0006 – Compressed Nitrogen Gas, NF Grade 200cf (K)

0. 0007 - Nitrogen Ultra High Purity Grade 300cf (T)

0. 0012 - Carbon Dioxide Liquified Gas w/Syphon Tube 50 pounds (K}

0. 0015 – Liquid Nitrogen 20 Liters (predictably this is the “cryo-dewar” mentioned under Building 114, Room 301 Kaunitz Lab, at West GLA VAMC) This is an Indefinite Delivery Indefinite Quantity (IDIQ) Contract. Quantities and CLINs are estimates ONLY. Also note SOW 2.5.2, SOW 2.5.2.4 and 2.5.2.5.

1. Gas description requirement Clarifications:

1. 0001 - Nitrogen, Refrigerated Liquid 160 Liters 22psi

0. Is this industrial grade required? No, Medical Grade is required

0. Is the size 160 or 180 liters? The SOW only notates 180L yet there are Part #’s that infer 160L and there are no CLINs for 180L. 180L is more standard/common than 160L. all of our tanks are 160l, but it should be noted that 160L and 180L are interchangeable. That being said these tanks fit into brackets so the tanks diameter must be the same or smaller as the 160L 1.

1. 0002 - Nitrogen NF Grade Refrigerated Liquid 160 liters 22psi

1. Confirm Medical Grade is required based on the “NF?” Yes, medical grade is required

1. 0003 – Nitrogen Refrigerated Liquid 240 Liters 22psi

2. Is this industrial grade required? Medical grade is required

1. 0004 - Nitrogen Refrigerated Liquid High Pressure 240 Liters 22psi

3. Confirm the PSI as 22psi is considered “Low Pressure” and not “High Pressure?” Per the SOW, standard pressure for liquid nitrogen is 22 PSI

1. 0005 - Nitrogen Compressed High Purity 300cf (T)

4. Confirm that High Purity (99.998% Purity) is what is required for this? Yes

1. 0006 - Nitrogen Ultra High Purity Grade 300cf (T)

5. Confirm that Ultra High Purity (99.999% Purity) is what is required for this? Yes

1. 0011 – Carbon Dioxide Liquified Gas 50 pounds (K) 22psi

6. Is this industrial grade required? No, we require medical grade

1. 0012 - Carbon Dioxide Liquified Gas w/Syphon Tube 50 pounds (K}

7. Is this industrial grade required? Medical Grade Required

1. 0013 - Oxygen Compressed Medical Grade 23cf (E):

8. Is this a post valve (no regulator attached) or an integrated valve (regulator already attached)? We have regulators that we attach our oxygen tanks to

1. 0017 - Mix 0.05%Carbon Dioxide 99.95% Nitrogen 200cf certified standard

9. Verify the cylinder size as there is a contradiction between the Price List (states 200cf which is a size H/K) and the SOW under Building 115, Room 313 Pisegna Lab (states that it’s a Size T which is 300cf). K size

9. 180L versus 160L Liquid Nitrogen - Confirm the Size (in Liters) required for the following Labs at West GLA VAMC as there are contradictions between the Pricing Sheet and the Statement of Work (note there are no CLINs for 180L). Note, 180L is much more standard/common than 160L. all of our tanks are 160l, but it should be noted that 160L and 180L are interchangeable. That being said these tanks fit into brackets so the tanks diameter must be the same or smaller as the 160L 1.

10.

1. VA OWNED TANKS: What are the # of tanks owned by the VA on their property books as this is critical information for offeror planning/predictability purposes given several of these VA owned tanks notated have a low frequency of once every 6 months? For example, if the VA only owns (2) of a particular tank, there could be potential issue if the 6-month point comes up and the VA Owned Cylinder needing fill is out of test and can’t be filled. The following are based on the Lab Requirements breakdown in the SOW where “Tank is VA Owned” is notated.

2. Medical Carbon Dioxide, K size Cylinder

2. Oxygen Compressed Medical Grade 23cf (E)

2. Oxygen Compressed Medical Grade 200cf (K)

2. Carbon Dioxide Liquified Gas 50 pounds (K) 22psi

2. Mix 5%Carbon Dioxide 95% Oxygen K 200cf certified standard

2. Mix 0.05%Carbon Dioxide 99.95% Nitrogen 200cf certified standard

2. Nitrogen, Refrigerated Liquid 160 Liters 22psi As stated earlier, this contract is an IDIQ contract. All quantities are estimates until ordered.

We currently own:

· 18 CO2 K sizeTanks

· 12 O2 K size tanks

· 12 o2 E size tanks

· 1 T size tank (Custom Mix)

· 1 K size tank (Custom Mix) Summary

· 31 K size tanks

· 23 E size tanks

· 1 T size tank

1. HYDROSTATIC TESTING: What is the GOV’s preferred method to handle costs for Hydrostatic Testing of GOV Owned Cylinders (thru added CLIN, P-card, or separately)? There are multiple GOV Owned Cylinder types notated, but no mention for how to address compliance when these cylinders eventually reach their out of test date (typically 5-year & 10-year testing).

Hydrostatic testing is not included in this requirement.

1. EMERGENCY DELIVERY: How does the GOV project to account for costs incurred for any Emergency Deliveries required within (24) hours (either added CLIN or P-Card)? While the SOW states that “There is no expectation for same day emergency delivery under this contract,” if the VA places an order in the afternoon for a next day delivery, this is often considered emergency conditions with real costs on the contractor’s distribution operations (especially in a major metropolitan area such as Los Angeles). Typically, truck routes and space on the truck are quickly established/committed in the early afternoon for the next day so a potential VA order may require the distribution team to reroute assets from another customer in order to fulfill the VA’s order.

The timeframe for delivery is expected was written in the SOW and the business, not the Government, needs to make a determination of how to account for this pricing. Be advised, offeror created CLINS are not permissible.

1. CYLINDER LOSS OF USE: Will Loss of Use be addressed Annually or only at the end of the 5-year contract term?

Cylinder loss is handled on a case-by-case basis as loss is discovered.

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

A warranted Contracting Officer ensures post-award compliance.

1. AWARD ELIGIBILITY: Does the evaluation committee/entity consider an unlicensed wholesale distributor of medical-grade gases (for example, oxygen is an FDA defined prescription drug) to be a responsible offeror pre-award, regardless of any potential Federal Exemptions (state compliance requirements are still applicable)? Restated, is an unlicensed offeror in the State of California considered eligible for award?

Contractor responsibility is covered in FAR 9 and falls under the review of a warranted Contracting Officer. The Government does not believe this “responsibility” consideration is what you are referring to.

The Government believes you are referring to Technical Acceptability. Technically Acceptability will be evaluated IAW the criteria found in the Evaluation Section of the RFQ.

1. LICENSING/COMPLIANCE REQUIREMENT OF SDVOSB OFFEROR: Please confirm that the offeror must comply with State of California licensing regulations at the time of bid submission in order to meet the requirements of the Statement of Work in this RFQ (wholesale distribution of medical-grade/compressed gases where for example medical-grade oxygen such as CLINs 0013 & 0014 are defined by the FDA as a prescription drug) as the bid states multiple times that the offeror must be compliant with federal, state, and local regulations to include licensing, regardless of any potential federal exemptions (offeror must still be compliant with State of CA).

The Contractor must comply with the licensing requirements while performing under the contract.

0. Section 2 of the SOW, para 2.4, under PRODUCT SPECIFICATIONS: “All products, equipment, and services provided under the contracts awarded under this solicitation shall be in compliance with all applicable Federal, state, and local regulations. All applicable licenses/certifications/insurance or other required documentation shall be provided to the Government Point of Contact and the Contracting Officer within 10 days after the contract award”

0. Section 2 of the SOW, para 2.4.1.3 under LICENSING, AUTHORIZATION, AND SELLING PERMISSIONS: “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. Contractor must also provide, annually, verification that the manufacturer from which it obtains the medical gases placed into the medical gas cylinders 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.”

0. FAR 52.212-4 is notated as inclusive but does not provide full text . Para (q) of 52.212-4 states: 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. Inclusion of 852.219-76 “VA Notice of Limitations on Subcontracting - Certificate of Compliance for Supplies and Products” as a submission requirement of SDVOSB offerors: Offeror must sign in writing validating “The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.”

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

· Per the Food and Drug Administration, Code of Federal Regulations, Title 21 – Definition of a Wholesale Distributor: Based on the SOW and requirement of the offeror to sign VAR 852.219-76 (Certificate of Compliance affirming that the offeror takes ownership/possession of the product in accordance with industry standards), 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:

0. Per the California Board of Pharmacy Licensing Requirements for Wholesale Distributors & Nonresident Wholesale Distributors (Note, there is no “federal” license):

· LINK: https://www.pharmacy.ca.gov/applicants/wls.shtml

0. Per PG 209 of 856 the 2026 State of CA Lawbook, Article 11. Wholesalers, Third-Party Logistics Providers and Manufacturers:

· LINK: https://www.pharmacy.ca.gov/laws_regs/lawbook.pdf image3.png image4.gif image5.png image6.png image7.png image8.png image1.png image2.gif