VENDOR QUESTIONS - SOUTHERN NEVADA VA HCS - MED CYLS - 36C26125Q0577_Redacted.pdf

Hello, See response in Blue.

Mohammed Hussain Contracting Officer Network Contracting Office 21 U.S. Department of Veterans Affairs Office: (916) 923-4534

“INTEGRITY, COMMITMENT, ADVOCACY, RESPECT, AND EXCELLENCE – these are VA Core Values.” As our client, please take a few moments and let us know how we did by completing the attached Survey”

PRE-DECISIONAL - For Internal VA Use Only

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.

Service contract for the delivery of specialty medical gas cylinders

2. PERIOD OF PERFORMANCE: What is the GOV’s rationale for a one-year POP for this opportunity, rather than a Base Year plus options? Is there any plan within the VA to merge requirements into to VISN-level or region-level contracts?

In previous years we were advised to do one year option. In the next FY contract are looking to move to a base plus four or a national contract if available

3. CLINS / PRICE SCHEDULE:

a. CLIN 0001: CLIN 0001 is for GFE dewar fills with the annual quantity listed at 252 liters, but there is no size or quantity of dewars provided. Please confirm how many liquid nitrogen dewars the GOV owns (by facility) and what the sizes are for each

GOV owns13 (10 Liter) but 10 are serviceable.

b. CLIN 0018: CLIN 0018 is for the part number “OX USPEAWBDSM MF” and the description specifies that this is the MRI oxygen E cylinder. The provided part number is unrecognizable; will the GOV please confirm if CLIN 0018 is for the “OX USPEAWBDSMRI” part number (which is the correct identifier for the Walk-O2-Bout that is an MRI conditional oxygen E cylinder)?

OX USPEAWBDSM MF is “E Tanks MRI O2” , USPEAWBDSMRI is the old product number

c. CLIN 0021: CLIN 0021 is for a Normal Delivery Fee, but PG 8 of 75 (Section 10.2) in the RFQ states that “The Contractor shall include all delivery charges of the oxygen in their unit price.” Will the GOV please confirm if offerors are to price CLIN 0021 or to include normal delivery charges in the unit price for each line item?

d. LUNG DIFFUSION GAS: There are no lung diffusion gases included in the list of CLINs on PGs 18-24 of 75 in the RFQ, but VA.gov shows that the VAMC North Las Vegas has a pulmonary department. Will the GOV please confirm that the VAMC does not require any lung diffusion gases?

The facility does not use this gas often. Supply Chain will procure this item on an as needed basis.

4. VA Owned Cylinders/GFE: Given CLIN 0024 is for Hydrostatic Testing, what cylinders (by CLIN) are VA Owned/GFE (other than the Dewar in CLIN 0001) and how many of each does the VA own on its property books? Are GFE’s utilized only at the VAMC or also at the CBOCs?

This facility does not own tank aside from DEWAR in CLIN 0001

5. “Excel RFQ Price List”: Can the GOV please provide clarification regarding the following language for price submission as there is no excel RFQ price list provided?

a.

There was no excel sheet attached. This was done in error.

6. FACILITIES: PG 5 of 75 (Section 2.1) states that this RFQ’s objective is “To acquire regular delivery/refill of medical grade gases at one (1) VA Medical Facility, Primary Care Clinics (NE/NW/SE/SW), Community Based Outpatient Clinics (Laughlin/Pahrump) and any new/other locations established,” but only the VAMC North Las Vegas is listed under Ordering Procedures on PG 6 and it’s also the only facility listed on the Delivery Schedule on PG 24. Will the GOV please confirm that the following (6) additional facilities will require service under the contract resulting from this solicitation:

Confirm the locations listed below are complete

a. Master Chief Petty Officer Jesse Dean VA Clinic (Laughlin CBOC): 3650 South Pointe Circle, BLDG D, Suite 200, Laughlin, NV 89029

b. Northeast Las Vegas VA Clinic: 4461 East Charleston Blvd, Las Vegas, NV 89104

c. Northwest Las Vegas VA Clinic: 3968 North Rancho Dr, Las Vegas, NV 89130 https://dvagov.sharepoint.com/sites/VHAProcurement/CORSURVEY_/Lists/FY23%20VHA%20Procurement%20Customer%20Satisfaction%20Survey/NewForm.aspx?Source=https%3a%2f%2fdvagov.sharepoint.com%2fsites%2fVHAProcurement%2fCORSURVEY_%2fLists%2fFY23%2520VHA%2520Procurement%2520Customer%2520Satisfaction%2520Survey%2foverview.aspx&OR=Teams-HL&CT=1666788752616&xsdata=MDV8MDJ8fGZjY2RmYzQzNmI1MTQyOTA2ZTc0MDhkY2MxM2FiOWRmfGU5NWYxYjIzYWJhZjQ1ZWU4MjFkYjdhYjI1MWFiM2JmfDB8MHw2Mzg1OTc3MDUyMTE0MDY3MTd8VW5rbm93bnxUV0ZwYkdac2IzZDhleUpXSWpvaU1DNHdMakF3TURBaUxDSlFJam9pVjJsdU16SWlMQ0pCVGlJNklrMWhhV3dpTENKWFZDSTZNbjA9fDB8fHw%3d&sdata=bXRsendMUTRCb3poUm1OaGxGNjJiTnloejB2MXdCOC9kNVFiYU9zei9uYz0%3d

d. Pahrump VA Clinic: 220 South Lola Lane, Pahrump, NV 89048

e. Southeast Las Vegas VA Clinic: 1020 South Boulder Hwy, Henderson, NV 89015

f. Southwest Las Vegas VA Clinic: 7235 South Buffalo Dr, Las Vegas, NV 89113

g. If the above locations are confirmed to require service, will the GOV please identify what gases are used by location and how the VA Clinics are currently receiving those gases (e.g., internal VA transport or direct delivery)? Will the GOV also provide the estimated annual quantities per cylinder type that offerors should expect to deliver to each VA Clinic?

All locations require service. Each location only uses OX USPEAWDBS Plus (Oxygen Medical Grade Size E Wak-O2- Bout Aluminum Plus). The tanks are delivered by contractor direct delivery. Estimated quantity is

h. The West Cheyenne VA Clinic (3525 West Cheyenne Ave, Suite 106, North Las Vegas, NV 89032) is not included in the GOV’s Section 2.1 objective on PG 5 of the RFQ. Please confirm that the West Cheyenne VA Clinic does not require service.

Confirm the Cheyenne location does not need support

7. INVOICING PROCEDURES: PG 8 of 75 (Section 10.2) states that “The delivery receipt(s) shall be included with all invoices submitted.” Please confirm if the Proofs of Delivery (PODs/delivery receipts) are to be submitted as attachments in Tungsten or provided via email?

It would be requested to have the ability to submit both ways

8. DELIVERY PROCEDURES: PG 9 of 75 shows a sample delivery document that includes the contract number, the ordering official, and a safety data sheet for each delivery. Will the GOV please confirm if these items (highlighted below) are currently being provided on all Proofs of Delivery (PODs)? Is the current supplier providing a Safety Data Sheet with each delivery?

Contract number is not needed, Ordering Official is not required and Safety Data Sheet is not required

If an SDVOSB Prime Contractor were to be awarded this opportunity and subcontract for the delivery of the gases, the PODs would not include contract-specific information like the contract number or the authorized ordering official’s name. Is the GOV amenable to altering the delivery document requirements to allow Safety Data Sheets to be provided as requested (more common) and to remove contract-specific information if an award is made to an SDVOSB?

Sample delivery document from PG 9:

9. BULK LANGUAGE: Is there any relevance to the Bulk Oxygen language in the RFQ as it is not applicable to the contract that will result from this solicitation?

Bulk oxygen will be ordered in a separate contract

The RFQ is only soliciting for Medical Gas Cylinders, but the following Bulk Oxygen language/requirements are included:

a. PG 6 of 75 (Section 4.2): “The Contractor shall not connect to the VA facility liquid oxygen system until approved by VA personnel.”

b. PG 7 of 75 (Section 6.3): “The VA has determined that emergencies include but are not limited to: low level alarms, imminent alarm condition, or system leak.”

c. PG 7 of 75 (Section 8.2) includes the following bulk language referring to a required Certificate of Analysis:

0. SUBMISSION REQUIREMENTS:

a. PG 51 of 75 (General Instructions) states that “Quoters shall submit their proposal to Derek Brown via GSA eBuy,” but the SF1449 says that “Quotes shall be submitted to Mohammed Hussain at mohammed.hussain2@va.gov.” Please confirm the correct POC for quote submissions.

Submit quote via email. Mohammed.Hussain2@va.gov Please also confirm if offerors are required to submit via GSA eBuy or via email. If required to submit via GSA eBuy, please provide additional information on the procedures for submitting through this site.

No GSA eBuy submission required. Submit via email to Mohammed Hussain.

b. PG 51 of 75 (Instructions for Preparation and Submission of Offers) specifies that offerors’ Technical submissions should include “…manuals related to the deliverables along with warranty information and instructions. Additionally, the contractor shall submit technical information that clearly demonstrate the features and how the system works…” Please clarify what “manuals” and “warranty information and instructions” are required by the VA as these specific submission requirements are unclear. Additionally, please clarify what “technical information that clearly demonstrates the features and how the system works” is referring to in relation to medical gas cylinders. What “system” features is the VA asking offerors to demonstrate?

This is the generic language I put in all solicitations. If there are no manuals related to the deliverables or system features applicable, then do not submit.

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) mailto:mohammed.hussain2@va.gov mailto:Mohammed.Hussain2@va.gov of FAR 52.228-5 – Insurance Work on a Government Installation.

Insurance requirements will be added in the award document.

2. EVALUATION: PGs 57-58 of 75 in the RFQ (52.212-2) states that the awarded offer will be most advantageous to the Government, with the factors of technical, price, delivery, and socioeconomic status being considered. Will the GOV please confirm if all (4) considered factors will be weighted the same or if price, for example, will be weighted as equal or greater than technical and/or delivery during the evaluation process?

All factors will be weighed equally. Price will not the lone factor for award. Price must be fair and reasonable.

3. 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 a CLIN provided for Lost Tanks in the Price Schedule (CLIN 0020) specifying that the GOV will pay its LOU invoice following a joint cylinder audit between the Prime Contractor and the VA, but there is no provided language detailing HOW the GOV will ensure payment is provided (e.g., paid for via separate purchase order?). Restated, how will the vendor 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.

It will be paid via the same PO number that will be issued at time of award.

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):

Thank you. I will add the language as stated below.

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

4. CONTRACTOR QUALIFICATIONS: PG 5 of 75 (Section 3.1) states that “The Contractor shall be a medical gas manufacturer/deliverer of medical grade gases that is registered with the Federal Drug

Administration (FDA) and is in good standing.” Will the GOV please confirm that the term “deliverer” is referring to the wholesale distributor requirements that an SDVOSB Prime Contractor is held to when a subcontractor is delivering on their behalf? While the SDVOSB Prime Contractor is not required to register with the FDA, the FDA does require wholesale distributors to register with the state for licensing to include secretary of state (for tax purposes) in which the work is being performed. Yes confirm

5. LICENSING REQUIREMENT:

a. Please confirm that the SDVOSB offeror must comply with the FDA/Code of Federal 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 oxygen/compressed gases where medical-grade oxygen is 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 (see INFO ONLY reference below): SDVOSB has to comply

PG 9 of 75 under Regulations and Standards (Section 9.1):

· “…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.”

Ø PG 30 of 75 under FAR 52.212-4:

· “(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.”

b. Additionally, please confirm if licensing of the offeror for wholesale distribution (in compliance with the FDA, CFR, and the state of Nevada) is a precondition for award? If not, how long will the GOV allow the offeror to become licensed as they cannot deliver a prescription drug (e.g., medical-grade oxygen) until they are adequately licensed for wholesale distribution in Nevada? Please keep in mind that being licensed in the offeror’s home state is a precondition for applying for an out-of-state license (i.e., two states cannot be applied for simultaneously).

Yes confirm

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

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

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

· 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 SDVOSB offeror qualifies as being a Wholesale Distributor (restated, medical-grade/US Pharmacopoeia Oxygen is defined as a prescription drug).

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

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

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-21%2Fchapter-I%2Fsubchapter-C%2Fpart-205&data=05%7C02%7C%7C329f64eca3d44d338c5308ddaa9707f8%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638854287850523356%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=61jNhig64RwgJk9p8FIL0p%2Fk0M33Q8L2IdXsBp1Mk14%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2Fcfcfr%2FCFRSearch.cfm%3Ffr%3D203.3&data=05%7C02%7C%7C329f64eca3d44d338c5308ddaa9707f8%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638854287850538192%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=W2z1OFHH8gs%2BTZahza8NZKBjb3X1mx8mYZK4H%2B%2BKz6Y%3D&reserved=0

· State of Nevada Board of Pharmacy Wholesaler Requirements (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

· Per NRS 639.233 of the Nevada Board of Pharmacy’s Chapter 639 (Pharmacists and Pharmacy General Provisions):

LINK: https://www.leg.state.nv.us/nrs/nrs-639.html

· Per NRS 639.0155 of the Nevada Board of Pharmacy’s Chapter 639 (Pharmacists and Pharmacy General Provisions):

o LINK: https://www.leg.state.nv.us/nrs/nrs-639.html o

· Per NRS 639.016 of the Nevada Board of Pharmacy’s Chapter 639 (Pharmacists and Pharmacy General Provisions):

o LINK: https://www.leg.state.nv.us/nrs/nrs-639.html https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.leg.state.nv.us%2Fnrs%2Fnrs-639.html&data=05%7C02%7C%7C329f64eca3d44d338c5308ddaa9707f8%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638854287850551476%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=91SO3SL8XmJwPjlL4TcWUTJuX4B0JbA6sa9Ucg5%2FTbE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.leg.state.nv.us%2Fnrs%2Fnrs-639.html&data=05%7C02%7C%7C329f64eca3d44d338c5308ddaa9707f8%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638854287850564603%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=pVaEBfzesyZIaAMKw79zqf7SFuXSSsMOCRmNeZdSUlM%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.leg.state.nv.us%2Fnrs%2Fnrs-639.html&data=05%7C02%7C%7C329f64eca3d44d338c5308ddaa9707f8%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638854287850577614%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Ej0jzereFN9gYjkjTp7aVePrsRtG%2FbFof3xJtuknXYE%3D&reserved=0