36C77625Q0229 0001 - Attachment 1 - Questions.pdf

RFQ 36C77625Q0029 0001 – Questions Received

1. What are the recent and relevant Past Performance requirements? We did not see the mention of Past Performance submissions/questionnaires under Factor

(2) Technical on PG 63 of 81 in RFQ 36C77625Q0229. How will the GOV deem an offeror is technically acceptable without the requirement of past performance submission requirements as an evaluation factor?

2. How is evaluation being conducted (i.e., is it an evaluation committee chaired by the MIDCON Program Manager)? The bid submission is restricted to the Contracting Officer, but will there be a summary report of recommendations by multiple committee members?

3. What is the GOV’s rationale for not providing an SDVOSB Set-Aside? This revised iteration of the VISN 16 medical gas cylinders was changed from an SDVOSB set-aside opportunity with a tiered evaluation method (RFQ 36C77625Q0028) to the current unrestricted opportunity with an LPTA evaluation method (RFQ 36C77625Q0229). The GOV confirmed in the canceled RFQ’s Q&A process that the “rule of two” was met in order to set aside the RFQ to SDVOSBs under a tiered evaluation. Please clarify why this revised RFQ for VISN 16 is now unrestricted with an LPTA evaluation method when the GOV confirmed the “rule of two” was met during the Sources Sought process. After the revisions made in the SOW for this opportunity to be more accessible to SDVOSBs, VOSBs, and other small businesses, why is the GOV soliciting on an unrestricted basis, especially considering these solicitations should be issued in accordance with the Veterans First Contracting Program? Additionally, why wouldn’t the GOV want to evaluate on a “Best Value/Most Advantageous” basis in order to ensure the VA receives the best possible offer/service instead of just awarding to the offeror with the lowest price that meets the minimum technical requirement?

4. This revised iteration of the VISN 16 RFQ (36C77625Q0229) removes VAAR 852.215-70 – Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors – which is required in all unrestricted VA solicitations. Please clarify why this VAAR clause has been removed (it was included in the canceled RFQ) and confirm whether SDVOSB and VOSB firms will receive credit during the evaluation, as required by para. (b) in VAAR 852.215-70. Please also clarify what constitutes “full credit” and “partial credit” under VAAR 852.215-70 (in comparative evaluation to a large business):

852.215-70Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

As prescribed in 815.304-71(a), insert the following clause:

Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (OCT 2019)

(a) In an effort to achieve socioeconomic small business goals, VA shall evaluate offerors based on their service-disabled veteran-owned or veteran-owned small business status and their proposed use of eligible service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) as subcontractors.

(b) Eligible service-disabled veteran-owned small businesses offerors will receive full credit, and offerors qualifying as veteran-owned small businesses will receive partial credit for the Service-Disabled Veteran-Owned and Veteran- Owned Small Business Status evaluation factor. To receive credit, an offeror must be registered and verified in the Vendor Information Pages (VIP) database.

(c) Non-Veteran offerors proposing to use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation factor.

Offerors must state in their proposals the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the VIP database.

(d) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by

VA to have willfully and intentionally misrepresented a company's SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

5. Do large businesses have a submission requirement for a Small Business

Subcontracting Plan?

6. Will the GOV please provide the VA 2268 and the 2268A required for this procurement?

7. This revised iteration of the VISN 16 RFQ (36C77625Q0229) removes the stringent requirement for the Contractor to use EDI to process orders and acknowledge orders in accordance with ANSI ASC X.12M and instead offers the ability to establish an email-based ordering system or offer an approved web application, with a secondary method of ordering being the use of EDI (PG 6 of 81, Section 6). However, PGs 4-5 (Section 4) states that “The Contractor must electronically submit an ANSI X12 810 – Invoice transaction set for each delivery of gases to FSC” and that “All invoicing for payment is to be filed electronically using EDI Transaction set 810.” Please confirm if the EDI invoicing requirements were left in the Contract Admin Data section of the revised RFQ by mistake, since the bulk of the EDI information regarding orders was removed. Please also confirm that the awarded Contractor will invoice via Tungsten if the VA is placing orders through an email-based system or an approved web application.

8. PG 14 of 81 (Section 7.5.6) requires an annual, on-site inventory, which requires the Prime Contractor to incur costs to travel to the facility and conduct with the GOV, but an Annual Audit CLIN is not provided. What is the GOV’s rationale for requiring the Contractor to conduct a total (9) annual audits for (8) VAMCs and (1) HCC at the Contractor’s expense, which estimates to about $150,000 in legitimate business expenses (travel, lodging, meals, etc.) for the duration of the 5-year contract, especially when the audits are mandatory in order to meet the SOW and be eligible for award? PG 8 of 81 (Section 1.5) states that “The quantities for each line item number in the solicitation are estimates only. There is no expressed or implied guarantee that these quantities will be purchased. The actual quantities ordered by the facilities will vary based on the medical needs of each facility.

Quantities may increase or decrease based on the volume of Veterans and their medical needs. The contract shall be for the actual quantities as ordered by each VA Health Care facility.” Respectfully, what is the GOV’s rationale for not providing an Annual audit CLIN, as there is no means to forecast/depict costs for items that are not guaranteed? We request the GOV add an Annual Audit CLIN.

9. What is the GOV’s rationale for not including facility-conducted internal audits during each contract year? Wouldn’t this be consistent with comparing a vendor’s invoice “against the facilities’ records” (as stated on PG 5 of 81, Section 5) if annual inventories are required of the Contractor? This is important for offerors to understand because it equates to the provision of empirical evidence that invoices are “incorrect” should the VA contest any Loss of Use (LOU) invoices for contractor-owned cylinders lost while in the GOV’s possession.

10. PG 22 of 81 (Section 15) is referring to a Contractor Representative and the communication procedures expected and that “the name of the person shall be designated in writing to the Contracting Officer.” Please confirm that this section is referring to multiple Contractor POCs by functionality (e.g. Customer Service, Accounting, Operations, etc.) and not a single individual. It is not reasonable for

(1) POC, referenced in Section 15.3, to perform all functions and have decisioning authority for functional areas, to include Contract Administration. All employees take PTO, take sick time, and are not available every day of a contract term. To best serve and respond to the GOV for a contract of this size, multiple POCs representing the VA’s specific needs will be the most efficient and timely manner for the Contractor to meet the GOV’s requests. Please confirm that the GOV will accept departmental POCs to ensure that a Contractor representative is readily available at all times.

11. Does the RFQ require Just-In-Time (JIT) ordering?

12. Can the GOV please clarify the applications/implications of the term POSITIVE

VARIANCE as there is no such industry term? Where does the term originate from within the medical gas industry? Please note that the list of definitions found on Acquisition.GOV does not list POSITIVE VARIANCE in reference to any contract. More info: https://www.acquisition.gov/far/part-2

13. PG 14 of 81 (Section 8.1) requires an orientation meeting for each of the main

VA facilities. Is this orientation synonymous with FAR 42.5, the Contracting Officer’s Post Award Orientation? Will the Contracting Officer be present at each of these facility meetings so as to provide clarification/implementation guidance?

Please note that there is normally a VISN-level meeting followed by facility-specific meetings on another date.

14. What is the transition time allotted between contracts/contractors?

15. PG 18 of 81 (Section 10.3) states that “All orders shall be delivered in accordance with the delivery parameters set for at each location found in Attachment D.2 – Facility Locations. It is the responsibility of the Contractor to ensure that each facility receives their orders on the specified delivery dates.”

Can we please confirm/validate the specific delivery schedule for each facility?

Are the delivery days presented in Attachment D.2 the correct delivery days?

Attachment D.2 has Tuesdays and Fridays as the scheduled delivery days for ALL facilities. Please confirm that this is the actual requirement and all vendors are bidding on (2) delivery days per week.

16. How does a vendor address off-schedule deliveries (not on TUES & FRI) that are not the fault of the Contractor when requested by a facility? Off-schedule, weekend, and holiday deliveries are normally Emergency Deliveries as they meet the Emergency Delivery parameters outlined on PG 19 of 81 (Section 10.12), which states that “Emergency deliveries shall be delivered within twenty-four (24) hours after being placed, including weekends and Holidays. Emergency status is determined by the Government. Failure of the Contractor to remain current with the agreed delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.” Please confirm off-schedule deliveries requested by the VA facilities that are not the fault of the Contractor will be considered as an Emergency Delivery and will incur an Emergency Delivery fee (i.e., days other than the identified TUES/FRI delivery days).

17. PG 20 of 81 (Section 11.1) states that “The Contractor shall provide a written action plan and have protocols in place to ensure compliance with the VA’s requirements under the contract, specifically, in the event of a declared National or State Emergency which may impact the Contractor’s ability to perform. In the event the plan is implemented, the Contractor shall provide notification of the implementation of the action plan and protocols within 48 hours of any declared National or State Emergency to the CO and COR.” Will the GOV provide any planning factors? We understand this is projective in nature, but we must provide this Emergency Support. More specifically:

https://www.acquisition.gov/far/part-2

➢ Please clarify the differences regarding response time parameters between the emergency delivery requirements detailed in Section 10.12 and the above statement in Section 11.1 (i.e., does the 24-hour turnaround requirement change in the event of a declared emergency at the national/state level?).

➢ What VISN 16 planning guidance will the VA offer to Contractors for implementing our Emergency Action Plan (even if post-award)? Will the GOV share the VISN 16 Emergency Response Plan with offerors in order to formulate their Emergency Action Plans, even if it’s only for applicable annexes to account for VA specifics when proposing implementation of our Emergency Action Plan, to include time to develop that plan?

18. PGs 22-23 of 81 (Section 18) includes the following requirements:

“17.1. If the Contractor uses a subcontractor for any services under this contract and the subcontractor tracks any information or data while conducting any services then that information or data shall be shared with the VA in its original form. This information or data includes but is not limited to cylinder delivery data, cylinder pick-up data, cylinder on hand quantities for specific VA facilities, and cylinder audit results.

17.2. This information or data shall be shared at any time upon request by the VA.

17.3. If the information or data contains any pricing information, then that information may be redacted.”

We ask the following questions/make the following requests regarding Section 18:

➢ Since any contract exists between the GOV and the awardee, which may be a large or small business, what is the GOV’s rationale to ask this? It is common for large businesses to have other large businesses/small businesses as subcontractors (for liquid nitrogen and dry ice, for example).

➢ We ask for the GOV to state the legal authority for this requirement given the GOV lacks privity with an awardee’s subcontractor. This requirement is not found in other Medical Gas contracts. Restated, since the contract is between the GOV and the awardee, and not between the GOV and the awardee’s subcontractor, please provide the GOV’s rationale for including this language.

➢ Please remove this requirement as it is nonstandard and the GOV lacks privity with a subcontractor’s contract administration data.

➢ For reference, in Bulk Oxygen contracts, it is extremely common for one large business to buy gas from a competitor (another large business) who is better situated geographically or who has better capacity (COVID-19 emergency response, for example).

19. What is the GOV’s rationale for only allowing a 45-day window after the end of the POP/option year to conduct all audits for VISN 16 – as stated on PG 20 of 81 (Section 13.2)? Will the GOV modify this requirement to 90 days, allowing for 45 days before and 45 days after the completion of a POP? In doing this, the Contractor can schedule the density of the audits prior to the end of the POP so that all Loss of Use documentation is codified prior to the end of the POP, allowing for a clear delineation between LOU for each contract period/option year (or contract transitions). The way it is structured in the RFQ mandates/facilitates the LOU of cylinders being identified well into the ensuing period or a new contract.

20. PG 12 of 81 (Section 6.10) states that the “Contractor shall determine the need for hydrostatic testing based on the date code on the GFE cylinder and shall perform said testing for the price indicated in the LIN on this contract.” There is no CLIN provided to fund hydrostatic testing; will the GOV add CLINs for the 5-and 10-year inspections of GFE cylinders?

21. 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 provided language on PG 21 of 81 (Section 13.11) in the RFQ stating that “The COR will ensure payment of the approved LOU invoice occurs in accordance with the Prompt Payment Act,” but there is no 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?

➢ 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 and rental balances being removed once a PO has been issued by the VA (36C77623D0910):

➢ Please also note that the following LOU verbiage from the current VISN 16 Medical Cylinders Contract also addresses removing rental balances once an LOU invoice has been paid (36C77620D0017):

22. : LICENSING –

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):

➢ PG 9 of 81 (Section 2.3)

• “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.”

➢ PG 28 of 81 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.”

➢ PG 37 of 81 under FAR 52.223-3:

• “(g) Nothing contained in this clause shall relieve the Contractor from complying with applicable Federal, State, and local laws, codes, ordinances, and regulations (including the obtaining of licenses and permits) in connection with hazardous material.”

b. Additionally, please confirm if licensing of the offeror for wholesale distribution (in compliance with the FDA, CFR, and the states within VISN 16) 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 the VISN 16 states? 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).

➢ INFO ONLY - REFERENCE INFORMATION REGARDING FEDERAL

WHOLESALE DISTRIBUTION LICENSING REGULATIONS BY THE FDA & IN

THE STATE OF ARIZONA:

• 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 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 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=20 3.3 o

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

o

• State of Mississippi Board of Pharmacy Wholesale Distributor Regulations (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

• Per the Mississippi Pharmacy Practice Act Regulations, Definitions:

o LINK: https://www.mbp.ms.gov/sites/default/files/2021- 09/DEFINITIONS%20as%20of%201-2012.pdf https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=203.3 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=203.3 https://www.mbp.ms.gov/sites/default/files/2021-09/DEFINITIONS%20as%20of%201-2012.pdf https://www.mbp.ms.gov/sites/default/files/2021-09/DEFINITIONS%20as%20of%201-2012.pdf

• Per the Mississippi Pharmacy Practice Act Regulations, Article XLI:

o LINK: https://www.mbp.ms.gov/sites/default/files/2021- 09/DEFINITIONS%20as%20of%201-2012.pdf o

• State of Louisiana Board of Drug and Device Distributors (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

• Per the Louisiana Administrative Code, Title 46 Professional and Occupational Standards, Part XCI. Wholesale Drug Distributors, Chapter 3 Wholesale Drug or Device Distributors, Section 301 (A):

o LINK: https://www.drugboard.la.gov/wp-content/uploads/Web- CurrentRuleText.pdf o

• Per the Louisiana Administrative Code, Title 46 Professional and Occupational Standards, Part XCI. Wholesale Drug Distributors, Chapter 3 Wholesale Drug or Device Distributors, Section 301 (G):

o LINK: https://www.drugboard.la.gov/wp-content/uploads/Web- CurrentRuleText.pdf https://www.mbp.ms.gov/sites/default/files/2021-09/DEFINITIONS%20as%20of%201-2012.pdf https://www.mbp.ms.gov/sites/default/files/2021-09/DEFINITIONS%20as%20of%201-2012.pdf https://www.drugboard.la.gov/wp-content/uploads/Web-CurrentRuleText.pdf https://www.drugboard.la.gov/wp-content/uploads/Web-CurrentRuleText.pdf https://www.drugboard.la.gov/wp-content/uploads/Web-CurrentRuleText.pdf https://www.drugboard.la.gov/wp-content/uploads/Web-CurrentRuleText.pdf

• Per Louisiana Board of Drug & Device Distributors website:

o LINK: https://www.drugboard.la.gov/ o

• State of Arkansas Board of Pharmacy’s Laws, Rules, and Regulations (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

• Per Section F, Controlled Substances and Legend Drugs, Section 20-64- 505, Wholesale Distributor – Permit Required:

o LINK: https://healthy.arkansas.gov/wp-content/uploads/Merged-Lawbook- 2025-Jan-17.pdf o

• State of Florida Statutes; Title XXXIII; Regulation of Trade, Commerce, Investments, and Solicitations (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

• Per Ch. 499, Florida Drug and Cosmetic Act, Section 499.01, Permits, Subsection (e):

https://www.drugboard.la.gov/ https://healthy.arkansas.gov/wp-content/uploads/Merged-Lawbook-2025-Jan-17.pdf https://healthy.arkansas.gov/wp-content/uploads/Merged-Lawbook-2025-Jan-17.pdf o LINK:

http://www.leg.state.fl.us/Statutes./index.cfm?App_mode=Display_Statute&UR L=0400-0499/0499/0499.html o

• State of Texas Department of State Health Services (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no “federal” license):

• Per Texas Administrative Code, Title 25, Part 1, Chapter 229, Subchapter W, Rule 229.421, Definitions (29):

https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir= F&p_rloc=149478&p_tloc=9733&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229 &rl=421 o

W, Rule 229.424, Licensure Requirements (a)(b):

https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir= &p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=229&rl=424 http://www.leg.state.fl.us/Statutes./index.cfm?App_mode=Display_Statute&URL=0400-0499/0499/0499.html http://www.leg.state.fl.us/Statutes./index.cfm?App_mode=Display_Statute&URL=0400-0499/0499/0499.html https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=149478&p_tloc=9733&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=421 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=149478&p_tloc=9733&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=421 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=149478&p_tloc=9733&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=421 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=229&rl=424 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=229&rl=424

W, Rule 229.423, Exemptions (d)(1):

https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir= P&p_rloc=149481&p_tloc=&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=

23. Please let us know if the VA can advise if there are any changes to the Pricing Schedule from the original solicitation?

https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=P&p_rloc=149481&p_tloc=&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=424 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=P&p_rloc=149481&p_tloc=&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=424 https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=P&p_rloc=149481&p_tloc=&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=229&rl=424