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By receiving a BPA award for inclusion on the MSPV Product List, the unique manufactured item will be available for potential purchase across all VHA healthcare facilities. The Medical Supply Program Office (MSPO) in partnership with VHA Procurement will identify the “compliant” Make PPE in America Act PPE as mandatory sources on the MSPV Product List and will perform regular analysis to ensure facilities are selecting mandatory sources over other non-mandatory sources. However, obtaining a BPA award does not necessarily mean a suppliers compliant PPE item will be purchased throughout VHA healthcare facilities, as there may be other preferred compliant PPE items within the same category that are purchased. It is the goal of MSPO and VHA Procurement to make as many unique (OEM DUNS and OEM Part Number combination) manufactured compliant PPE available in all categories to offer VA healthcare providers greater options while building a more resilient supply chain.
| Q1: | Are we able to get a link to this recording? |
| A1: | No, Unfortunately VA firewalls will not allow sharing of recordings outside of the VA. |
| Q2: | I am filling in for someone. Where do we go to get a copy of the RFQ? |
| A2: | https://www.sam.gov Notice ID: 36C24124Q0125. |
| Q3: | How many awards does the VA foresee making on this requirement? |
| A3: | TBD- Depends on what is available that is compliant, unable to anticipate the number of awards. 1 award per unique item (OEM and part number/size). |
| Q4: | What is the available funding for this requirement? i.e. is this a $5m requirement or a $200m requirement? |
| A4: | Funding comes from local medical centers The funding will be available at time of order. The annual spend for the entire program is around $850M/year. A break-out of estimated annual volume by type of PPE is attached. (Attachment F). |
| Q5: | I just want to be clear that the only thing that is due is the quote sheet? |
| A5: | No, the required additional supporting documentation is shown in the RFQ within section 52.212-1. |
| Q6: | What measures are being taken to ensure only compliant Made-in-America products are contracted? |
| A6: | Per Section C7 in the SOW, all vendors must certify compliance, certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution. (SOW: Page 25-27, Section C7). |
| Q7: | Does this solicitation have no conflict with AbilityOne? |
| A7: | Not that we are aware of, if a supplier knows of an AbilityOne conflict; they should notify the listed Contracting Officer immediately. |
| Q8: | Can we submit bids for garments that we produce for the PL? |
| A8: | Per Section B in the SOW, bids should be for items that are eligible for the medical/surgical prime vendor program. Covered medical/surgical supplies eligible for order under MSPV are defined as medical, surgical, dental, and laboratory supplies excluding supplies already covered under the AbilityOne Procurement List. Public Law No: 116-155 Department of Veterans Affairs Contracting Preference Consistency Act of 2020. (SOW: Page 7, Section B (Scope). |
| Q9: | Can you confirm that a single item will NOT be awarded to more than one MSPV BPA holder? Will this be determined by the OEM (not Supplier) part number? |
| A9: | Correct, though not explicitly stated in the SOW. This is a single award RFQ. Each unique item will be awarded to one BPA holder. |
| Q10: | What are your thoughts on Berry Compliant KN95 masks? |
| A10: | We are not experts on Berry Amendment Compliance. If an item is compliant per Section C7 in the SOW, which states that all vendors must certify compliance, certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution, we encourage submission of a bid. (SOW: Page 25-27, Section C7). |
| Q11: | Revision Date for Application: We couldn't find information on the revision date for application resubmission in case of errors. Could you please provide details on the procedures and deadlines for proposal resubmission? |
| A11: | Per the cover letter, this RFQ is being issued under FAR Part 13. FAR Part 13 is not subject to revision dates. There will not be a revision date for this RFQ. (SOW: Cover Page). |
| Q12: | Did you say that all N95 masks that qualify for this program will be awarded? |
| A12: | Yes, per Section B in the SOW, quotes should be for items that are eligible for the medical/surgical prime vendor program. Covered medical/surgical supplies eligible for order under MSPV are defined as medical, surgical, dental, and laboratory supplies excluding supplies already covered under the AbilityOne Procurement List. Public Law No: 116-155 Department of Veterans Affairs Contracting Preference Consistency Act of 2020. (SOW: Page 7, Section B (Scope). |
| Q13: | How long does it take to get on a BPA if you have Authorized Letter and EDI? |
| A13: | Dependent on how many offers are received and how long it takes to conduct evaluation. Awards are tentatively anticipated to begin rolling out on a monthly basis in March 2024. |
| Q14: | Are existing TAA compliant PPE BPA’s going to be cancelled post award? |
| A14: | The specific PPE items which are not compliant with the Make PPE in America requirement will be removed from the current BPA once the full volume of demand can be met with compliant items for that need. |
| Q15: | The recording can't be shared but can the slides of this presentation be shared? |
| A15: | Yes, slides have been published with the previous amendment, on Dec 22, 2023. |
| Q16: | What safeguards will be put in place to ensure VA facilities are using the MSPV BPAs for PPE and not purchasing outside the contracts.... MSPV program leakage? We understand there may be exceptions during extraordinary events that create supply chain issues with contracted PPE items. |
| A16: | There are some smart tools coming online to help facilities in their own compliance as well as monitor at a national level. This continues to be an ongoing effort within the agency. |
| Q17: | Will the VA provide utilization volumes of existing products in advance of solicitation response dates? |
| A17: | Yes, there are volumes. This has been published by DHS, but they will be published in the overall estimated category volumes with amendment (Attachment F). |
| Q18: | My company does medical, surgical and medical equipment products that are not outlined as PPE, we are already with DAPA and we're already providing through Owens, Minor and Cardinal Health. We would like to know how do we provide the exact same services through your program? |
| A18: | If you have items that meet one of three National Requirements Thresholds ($20,000 in spend over the last 12 months, 100 Purchase Orders over the last 12 months, or purchased by at least 25 facilities over the last 12 months), then send the item details to Craig Hilliard (frederick.hilliard@va.gov), Jeremy Parker (jeremy.parker2@va.gov) and Sarah Keefer (sarah.keefer@va.gov) for inclusion in the next solicitation. |
| Q19: | I'm just wondering why the gloves are not included in this solicitation? |
| A19: | The gloves will be on a separate solicitation in the future because of the interplay of the AbilityOne and the Make PPE in America Act. More information to follow. |
| Q20: | I'm on the manufacturer side of American made PPE, is there a requirement for the for the manufacturer you refer to as the OEMs, for us to provide a list of products that we manufacture in the category? Or is it the only way you find out about them is through the submission of our vendors, or our suppliers, that are your vendors? |
| A20: | OEMs can provide that documentation to suppliers for the suppliers to submit the certification of items that are compliant with make PPE in America. Otherwise, we will ask the supplier for a good point of contact at the manufacturer, so that we can verify. |
| Q21: | Are multiple vendors encouraged to bid on our products or are you looking for one vendor for one manufactured item? |
| A21: | That is a manufacturer decision whether you want to dedicate a single supplier to cover the VA MSPV program or not. We will evaluate all quotes from suppliers with a valid authorized distribution letter for any unique item in accordance with the tiers within the RFQ. |
| Q22: | If like a small disadvantage veterans, let's say they can fulfill all you guys want, do you guys go to Tier 2 and Tier 3? |
| A22: | Tiered evaluation process is covered in pages 41-43 of SOW. |
| Q23: | When do you anticipate that solicitation going out for the next quarter, cause the next quarter would actually be in about 2 weeks? |
| A23: | No anticipated date yet. |
| Q24: | I noticed it currently in the official solicitation. There is no requirement for relevant past performance. We're interested in raising this request to see if that can be incorporated at least as a criteria for your team's consideration to add the relevant supply, track records? |
| A24: | This is addressed through a robust responsibility determination as required by FAR 9 and VAAR 809. |
| Q25: | Can there be a positive or a proven track record that they actually have supplied things like this before? Not like because there is a solicitation on the street. They just wanted to jump in and see if they can get a contract and see if it works out like a proven track record. |
| A25: | A supplier must be an authorized distributor of the OEM. Past performance is not a unique evaluation factor, it is addressed with the responsibility determination. |
| Q26: | When you hit a general category of personal protection, you listed different products, but you listed one. It's a general catchall. Would you include like disinfectant gels and wipes and cleaning solutions like that or what? What would be in that category? |
| A26: | If a vendor believes that an item fits within one of the defined categories from the law, then that vendor should quote the items. |
| Q27: | We manufacture powered air purifying respirators and filters that's listed on the on the solicitation. As long as we meet the criteria of the made in America PPE initiative, are we able to quote because the only reason I ask and I'm a little confused, you mentioned something about 7000 items and I'm not sure what the 7000 items separate RFQ? |
| A27: | There are two separate solicitations, the 7000 items were on the RFQ which closed in August 2023. That RFQ was not for PPE. |
| Q28: | We're an AbilityOne producer and we produce coveralls for the ability one program. Can we submit for bid garments that are on the PL? |
| A28: | Yes, you are able to bid on items on the PL, to certify their compliance with the law. (SOW: Section B.2 Page 7). |
| Q29: | Do you intend to solicit PPE made in America as a separate quarterly, or what do you see as the cadence moving forward after this one closes? |
| A29: | At this point, we are unsure how we will specifically address the ongoing additions of new compliant PPE items. It will be a regular interval, but we have not determined the frequency. (e.g. quarterly, semi-annual, etc). |
| Q30: | What are the other measures being taken in the evaluation to make sure that the effort made in America products to be compliant, are you only looking at their like NIOSH or FDA related or are you going to look more detail into its testing reports or other things? |
| A30: | Reference section 3.D, Page 12 in the SOW for additional information on Make PPE in America Restrictions. |
| Q31: | Are samples required? |
| A31: | Product Samples are not required for this RFQ. (SOW: Section E.1 Page 41). |
| Q32: | Do the FDA and NIOSH approvals have to be completed solicitation close? |
| A32: | Yes, technical requirements are due at the time of RFQ close. |
| Q33: | Is an authorized distributor letter required, even if you have been doing business with the manufacture for year? |
| A33: | Yes, valid ADLs are required in order to submit bids for this solicitation per section E.1 52.212-1 in the SOW and should be included in the response. Section 3.A also covers the requirements of the ADL needed to submit a bid. |
| Q34: | For your minimum requirements list for the N95 mask, it states 3M. |
| A34: | That error has now been corrected. |
| Q35: | It looks like there's no real tech eval or tech proposal, and so all your documents are going on that web link that you guys want on the pricing sheet, correct? |
| A35: | Yes, all documentation should be on the web link. If not provided on the weblink, it may be submitted via email. |
Q36: "As it relates to performance, you know, and I asked certification of part of the part of the criteria is not a performance as it relates to fit. OSHA has two fit tests standards. One of them is quantitative, the other is qualitative. The quantitative is more scientific as acting standard, and it's a little-known fact that most 95 is on the market won't pass, and OSHA quantitative fit test standard. So they're not serving the purpose of people think they are. So all of that is just kind of background for the question.
Question: Is there going to be any criteria in the proposal now or is there consideration in the future for looking into such issues so that the N95 are actually providing the level of protection that is anticipated?"
A36: Reference section 3.D, Page 12 in the SOW for additional information on Make PPE in America Restrictions.
| Q37: | After award, is there any ongoing evaluation on supplier performance? |
| A37: | Yes, BPAs are reviewed annually IAW 13.303-6 (b). |
| Q38: | Surgical gowns. Will you guys be procuring those both single sterile as well as non-sterile for custom procedure kits? |
| A38: | No custom kits are included in the VA MSPV program, due to the custom nature of those items. |
| Q39: | For the repeating items were similar items that are in the original MSPB list after in comparison, so facilities make procurement decisions right? Once this is up, they're going to have two lists that they can choose from. One is made in America List, the other is the original list, and they're going to be repeating items as the made in America PPE. Is there any procedures or measures in place to sort of enforce choosing the made in America? |
| A39: | Yes, there will be notation on facility Core and Product Lists to denote Made in America compliant PPE from non-compliant PPE. Facilities will be encouraged to use only Made in America compliant PPE. |
| Q40: | What are the requirements outlined in the Make PPE in America Act (Pub. L. 117-58) (page 43) that applicants need to comply with, and how can evidence or certifications demonstrating alignment with these requirements for materials and components, such as surgical masks, respirator masks, and other protective equipment, be gathered? |
| A40: | Section 3.D in the SOW outlines the Make PPE in America Restrictions and Section C.11 in the SOW highlights the Local clause for the Make PPE in America Act for applicants to comply with. OEMs will have the supporting documentation. |
| Q41: | Can you please provide more context regarding the individual order limitation for this RFQ? |
| A41: | Section C.11 from the SOW: Purchases for medical/surgical supplies will be placed with the PVs and not directly against BPAs. Although there are currently no plans for the government to order against this BPA, if that occurs, there is a $500,000 individual order limitation per the FAR 13.303-3. Section E.4 highlights the PPE Certification needed for PPE items quoted on this solicitation. |
| Q42: | Is the VA requiring contractors to be EDI compliant and prove EDI compliance before submission of the RFP? |
| A42: | Page 27, Section C.8, "VAAR 852.232-72 Electronic Submission of Payment Requests (Nov 2018) stipulates that EDI compliance is required. This is required prior to submission of a bid. |
| Q43: | Will contractors be ineligible for award if they do not show EDI compliance during the submission of their proposal? |
| A43: | Refer to answer on question 42. |
| Q44: | If the VA is requiring contractors to substantiate and prove EDI compliance during the submission of their proposal, what exactly does the VA want to see to prove EDI compliance? |
| A44: | Offeror must certify compliance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. All invoices must be submitted in accordance with VAAR Clause 852.232-72 (SOW: Section C.8, Page 27). Additionally, VA receives EDI compliance reports from each prime vendor in an ongoing manner for oversight. |
| Q45: | How does Industry request notes on the Interagency Working Group that is responsible for crafting acquisition regulation surrounding Nitrile Glove sourcing? |
| A45: | By reading the combined report published by the working group on SAM.gov. |
| Q46: | Given that South Korea has a Free Trade Agreement with the United States, will the VA allow raw material from South Korea to be used in the manufacturing of products for this requirement? |
| A46: | Supply Requirements, inclusive of Make PPE requirements, are outlined in the SOW, Page 12, Make PPE In America Restrictions on Foreign Acquisition Section D. |
| Q47: | Within IIJA in Section 70952 Section 6 (link here), it asks the VA to "ensure compliance with its international obligations, such as its commitments under the World Trade Organization’s Agreement on Government Procurement and its free trade agreements, including by invoking any relevant exceptions to those agreements, especially those related to national security and public health." South Korea is listed as a WTO compliant country *and* a Free Trade Agreement Compliant country in FAR 52.225-5 (Section 2, link here). Does the VA consider raw materials from South Korea to therefore be compliant with IIJA requirements for the purpose of this RFP? |
| A47: | Refer to answer on question 46. |
| Q48: | DLA has a "Domestic Non-Availability Determination" complete for NBR that is used to make Nitrile Gloves. Would the VA consider doing the same DNAD such that nitrile gloves could be procured from SDVOSBs? |
| A48: | Nitrile Gloves are not included in this RFQ. |
| Q49: | Are we allowed to submit other PPE products that aren't expressly called for in the RFP documents (Attachment B)? |
| A49: | Bids should be submitted for PPE products that match one of the identified PPE categories referenced in Attachment B-- PPE Minimum Technical Requirements. Offerors may propose supplies from their respective catalogs they wish to provide to the government which are within the scope of the defined PPE categories, excluding any supplies already covered under the AbilityOne Procurement List. This is referenced in the SOW, Section B, Page 6. |
| Q50: | Will the VA require hard copy, physical samples of the products? If so, when? |
| A50: | Per the SOW, Section E1, Page 41, Product samples are not required under this RFQ. |
| Q51: | Once the VA makes a BPA award for a specific product to a contractor, does the VA guarantee minimum purchase quantities per year? |
| A51: | BPAs, inherently, do not have minimum quantities. Per SOW Section A, Background, Page 6, Facilities will order from the MSPV Product List, which will be formed by awarding Blanket Purchase Agreements (BPAs). |
| Q52: | Does the VA see it as a "conflict of interest" if large businesses (such as Cardinal Health, McKesson, Owens & Minor) are awarded the VA MSPV Distribution contracts and then also given awards for this VA MSPV Made in America RFP? |
| A52: | Tiered evaluation process is covered in pages 41-43 of SOW. |
| Q53: | Once the VA makes an award under the MSPV Made in America, how does the contractor "push sales" on the MSPV contract vehicle? |
| A53: | Per SOW Section A, Background, Page 6, Facilities will order from the MSPV Product List, which will be formed by awarding Blanket Purchase Agreements (BPAs). Orders placed by the facilities are filled through the designated Prime Vendor (PV) for that facility. The PV stocks their distribution center (DC) with the item from the identified BPA holder on a recurring basis. Supplier sales teams would continue to push sales and identify the item as available through the VA MSPV program. |
| Q54: | In order to support industry and small business, can the VA award guaranteed minimum volumes for products that they chose to award? For example, if an SDVOSB is awarded bouffants under the VA MSPV Made in America RFP, in the award can the VA state "guarantee of 2 million bouffants per year for five years"? |
| A54: | BPAs, inherently, do not have minimum quantities. Per SOW Section A, Background, Page 6, Facilities will order from the MSPV Product List, which will be formed by awarding Blanket Purchase Agreements (BPAs). |
| Q55: | Will the VA use these VA MSPV awards to replenish and standup the VA PPE stockpile? |
| A55: | This is possible, but not definite. |
| Q56: | Does the VA see it as a conflict of interest at all to award this MSPV Made in America requirement to the same contractors who will be serving on the VA MSPV distribution contract? |
| A56: | Conflict of interest is a post quote, pre-award concern in Federal procurement and a part of the responsibility determination process. |
| Q57: | Will the VA prioritize and give higher evaluation to those offerors that have had their products lab tested in the United States? |
| A57: | Tiered evaluation process is covered in pages 41-43 of SOW. |
| Q58: | Will the VA give higher priority and points in the evaluation phase to those offerors that served the federal government in PPE manufacturing and delivery during the pandemic? |
| A58: | Tiered evaluation process is covered in pages 41-43 of SOW. |
| Q59: | If the VA makes an award for a product (for example, isolation gowns), does that mean that within the MSPV program only Made in America isolation gowns can be used and procured by the VA? Or will the VA still be buying isolation gowns on the MSPV list from other countries (like Mexico)? |
| A59: | Once any unique item (e.g. Medium Isolation gowns) have enough volume of Make PPE Compliant items to meet the annual need, only the compliant items will remain available. |
| Q60: | On the MSPV Product List there are still many items showing as Made in China. Given that China is on the non-allied list (along with North Korea, Russia, and Iran), who is the best Point of Contact at the VA to connect with to propose substitutions for those made in China products? |
| A60: | Any TAA non-compliant items are awarded in error and are already in the process of being removed. If you offer TAA compliant items, please push sales to reach the MSPV threshold for inclusion of items. If the items already meet one of the thresholds, please see the answer to question 18. |
| Q61: | Is the VA aware that forcing manufacturers/suppliers/awardees to work with Cardinal to fulfill purchase orders creates competition with Cardinal’s product suite within the VA and the federal government? Would the VA consider making volume commitments to address this, such that American manufacturers can plan production, thus ensuring a robust American manufacturing base for years to come. |
| A61: | Robust automated tools have been built to alleviate this ongoing concern from some suppliers in the MSPV program. |
| Q62: | If the VA views it as a Conflict of Interest that Cardinal, McKesson, and Medline have their own product sets and they are serving as MSPV Distributors, will the VA not allow MSPV Distributors to submit on this MSPV Made in America requirement in order to protect small business? |
| A62: | All qualified manufacturers and suppliers are encouraged to provide quotes. Conflict of interest is a post quote, pre-award concern in Federal procurement and a part of the responsibility determination process. |
| Q63: | Beyond the NIOSH minimum breathability standard, does the Government currently have any such higher performance standard requirements? If so, can you please identify these standards? If not, is there any plan for developing such standards in the future? In either case, can manufacturers submit breathability / inhalation resistance test results data as part of their submittal? If so, will there be any consideration given for N95 respirators that can demonstrate high levels of performance? |
| A63: | Please refer to VHA Directive 7701, COMPREHENSIVE OCCUPATIONAL SAFETY AND HEALTH PROGRAM. Fit testing is conducted at the individual medical center level and is required to be conducted in accordance with OSHA Standard 1910.134. |
| Q64: | N95 respirator usage compromises the lower peripheral vision of those wearing the respirator. As such, there is greater ergonomic strain and fatigue for the wearer as they overcompensate to look beyond the obstructed field of visibility. Expanded visibility also helps to facilitate a safer working environment. Is the Government seeking innovation that helps to solve these sorts of problems? In either case, can manufacturers submit data to support innovative features specific to their products? If so, will there be any consideration given for N95 respirators and other PPE products that can demonstrate higher levels of performance? |
| A64: | Yes, any additional value-added specifications should be highlighted by the quoter. |
| Q65: | Individually wrapped N95 respirators can help to further safeguard against the transmission of contagions and other forms of contaminants. Is the Government open to value-added sanitary features such as individual wrapping, as well as convenient packaging? If so, can manufacturers reference such value-added features in their proposals? |
| A65: | Yes, any additional value-added specifications should be highlighted by the quoter. |
Q66: "OSHA has two fit testing standards for N95 respirators. A fit test is a test protocol conducted to verify that a respirator is both comfortable and provides the wearer with the expected protection. Fit testing uses a test agent, either qualitatively detected by the wearer’s sense of taste, smell, or involuntary cough or quantitatively measured by an instrument, to verify the respirator’s fit.
A qualitative fit test relies on the respirator wearer’s senses to determine if there is a gap in the seal of the respirator to the wearer’s face.
A quantitative fit test uses a fit testing instrument to provide quantitative, or numerical, measurements of the amount of face seal leakage present when a user wears a respirator.
The main difference between quantitative mask fit testing and qualitative mask fit testing is that quantitative testing objectively precisely measures the amount of leakage (quantity) while qualitative testing relies subjectively on the users taste and smell to detect leakage. The qualitative fit test is very subjective. The quantitative fit test is more exact and scientifically valid.
It is a little-known fact that NIOSH certification for N95 respirators does not currently include performance requirements as it relates to OSHA fit testing standards. As such, the majority of N95 respirators will not position the user to reach the minimum passing score of 100 (out of a possible high score of 200) for quantitative fit testing. Many N95 respirators that are not specifically designed to create and maintain a good seal will score under 20 when users are quantitatively fit tested. If an individual cannot pass the OSHA quantitative fit test, such products in effect provide a false sense of protection security for the individual wearing the N95, as well as those around them. Although we are not advocating that everyone who wears an N95 should be quantitatively fit tested, in order to ensure maximum protection is actually being provided, we believe N95 respirators should have a minimum 75% quantitative fit test passing rate, based specifically upon the NIOSH bivariate panel standards.
Does the Government currently have such quantitative fit test standard performance / passing rate requirements? If so, can you please identify these standards? If not, is there any plan for developing such standards in the future to help ensure the maximum level of protection possible is being provided? In either case, can manufacturers submit quantitative fit test results data as part of their submittal? And if so, will there be any consideration given for N95 respirators that can demonstrate high levels of quantitative fit test performance?"
A66: Each VAMC site is required to hold annual fit testing for the N95 used within that VAMC for covered clinicians, this level of qualitative testing drives that facilities choice as to which N95 masks that facility will use, per clinician.
| Q67: | Medline, Concordance, and Cardinal are identified as the prime vendors for this RFQ. As such, are these three vendors required to engage with manufacturers that are going to submit for this RFQ? If so, do you have a suggestion for the best contacts and/or the recommended protocol for manufacturers to engage these vendors? |
| A67: | Upon award of a BPA, the appropriate point of contact for each Prime Vendor will be provided to new BPA holders. |
| Q68: | The previous MSPV solicitations had a pre-approved set of items that offerors had to supply. However, this time around it appears that you are asking offerors to fill the quote sheet with all items coming under the PPE definition given in the RFQ. Is this understanding correct or is the scope of items limited? Please provide some guidance on which items will go into the quote sheet. |
| A68: | Item coverage is covered in SOW Page 6 and Attachment B on the RFQ. |
| Q69: | On Pg 41 of the RFQ, the VA has identified Electronic Data Interchange as a requirement. Please advise how offerors should demonstrate proof of this system. Would a narrative suffice or does the VA require some specific documentation? |
| A69: | EDI is the computer-to-computer exchange of business documents in a standard electronic format between business partners. By moving from a paper-based exchange of business document to one that is electronic, VHA receives benefits such as reduced cost, increased processing speed, reduced errors, and improved relationships with business partners. Electronic format means an automated system transmitting information electronically according to accepted data transmissions using a system that conforms to the X12 EDI formats established by the ASC chartered by ANSI. For more information see the X12 EDI Web site (http://www.x12.org). |
| Q70: | Can you please provide more context regarding the individual order limitation for this RFQ? |
| A70: | Section C.11 of the SOW: Purchases for medical/surgical supplies will be placed with the PVs. Although there are currently no plans for the government to order against this BPA, if that occurs, there is a $500,000 individual order limitation per the FAR 13.303-3. Section E.4 highlights the PPE Certification needed for PPE items quoted on this solicitation. |
| Q71: | The surgical masks you are requesting is very specific with size and color “Surgical Masks or Procedure Mask, Medical grade, Pleat‐Style with Ear loops, Blue, 7 X 3.875 inches.” Will you allow for surgical masks that may be different than this mask but still meet all the FDA, ASTM that meet Level 1-3 classification? |
| A71: | Yes, any compliant items may be quoted and awarded. |
| Q72: | If a manufacturer has, for example, four SDVOSBs, can all four SDVOSBs bid on the contract if they each have different item numbers from each other and the same manufacturer? For example, manufacturer mask number is 1234, SDVOSB-1 is 5678, SDVOSB-2 is 9876, and so on. |
| A72: | The exact same item, meaning same manufacturer and part number, will not be awarded to more than one Offeror. Items that the IPT determines are needed to support the clinical practice of the VA, which may be similar to another item awarded, may also be awarded. |
| Q73: | In response to Q4 in the Industry Day Slide Deck, it was mentioned that "Certification of compliance of quoted items will be submitted using the soon to be added attachments D & E." Can you give a heads up as to what sort of information/documents are going to needed in attachments D & E for demonstrating domestic PPE compliance requirements? |
| A73: | FDA and NIOSH approval are required at the time of submission. Refer to quote sheet. |
| Q74: | Please confirm if the domestic requirements under this RFQ refer to both domestic sourcing of raw material & domestic manufacturing as opposed to just manufacturing domestically, while sourcing materials from other countries. |
| A74: | Please refer to SOW Page 51-53. |
| Q75: | Do the surgical gowns need to be sterile? |
| A75: | The minimum technical requirements are outlined in Attachment B. Attachment B specifies that the requirement for surgical gowns is AAMI PB70 (Level 3 or Level 4 requirements.) Conform to ASTM F2407-22a. |
| Q76: | Will you accept Covid Test Kits i..e, do they come under the scope of PPE requested in this RFQ? |
| A76: | Covid Test kits are not covered in this solicitation at this time. |
| Q77: | The question is whether this notice includes nitrile gloves made in the USA. |
| A77: | See question 19. |
| Q78: | What is the annual volume in terms of quantities or dollars that VA hospitals spend on: - Level 3 Sterile Surgical Gowns, - Level 4 Sterile Surgical Gowns,- Level 2 Isolation Gowns? |
| A78: | In FY22, the VA used 1.8m sterile surgical gowns in total. |
| Q79: | It is my understanding that we are required to source any of our PPE from one (or all) of the government’s approved prime vendors; is that correct? |
| A79: | No. PPE will not be sourced from the Prime Vendors, Prime vendors will be distributing items to facilities. See section II on Page 8 of SOW. |
| Q80: | We are an SDVOSB trying to establish ourselves as a vendor on the VA MSPV Program, but we are experiencing some barriers to entry when it comes to being able to understand (a) “who” are the other three prime vendors besides Cardinal and Medline, and (b) whether the government has any point of contact for the respective prime vendors, that may have been published by the government. Is any of this information published on SAM.GOV; or alternatively, is the government permitted to share this information more broadly? |
| A80: | The three Prime Vendors on the MSPV BPA Program are Cardinal, Concordance Health Services, and Medline. |
| Q81: | Please better define the following portion of the Make PPE in America Act – ““Domestic personal protective equipment” means personal protective equipment, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.” Specifically, we wish to understand what constitutes a component being “reprocessed” or “reused” in the USA. Does that mean a PPE item would be compliant with components sourced outside the United States but reused in the United States? What are examples of reprocessed or reused components that are compliant with the Make PPE in America Act? |
| A81: | The Government can only go by what the law says. VA is not aware of any specific examples of items which conform with this portion of the law. |
| Q82: | Does the NMR apply to Small Businesses for this solicitation? We ask because the NMR did not apply to the SB tier for the previous MSPV Q3 or MSPV Dental solicitations. |
| A82: | Per Section H, Page 14 in the SOW, the NMR applies to this RFQ. Tiered evaluation process (inclusive of NMR) is referenced on pages 41-43. |
| Q83: | Once these Make PPE in America MSPV products are awarded to supplier BPAs, do you anticipate removing TAA-compliant PPE items currently on the MSPV Product List? |
| A83: | See question 59. Non-compliant item removal will occur as needed. |
| Q84: | If TAA-compliant item removal is planned, what is the approximate timeframe to begin that process? Given the potential loss of sales for those MSPV items, we would appreciate time to plan for such removals. |
| A84: | See question 59. Non-compliant item removal will occur as needed. |
| Q85: | After the award process for this solicitation is complete, will future Make PPE in America products be allowed to be added MSPV BPAs? What will that new product addition process be and will those items require annual sales thresholds as currently identified for MSPV new item additions? It is likely that many Make PPE in America items will be newly developed and will not have previous VA sales. |
| A85: | Future solicitation/addition strategy unknown at this time pending results from this solicitation. |
| Q86: | We understand that a single OEM part number will not be awarded to more than one BPA holder. However, if the OEM has different part numbers for the same item (with the same specifications), could each item then be awarded to separate BPA holders? |
| A86: | It depends, VA clinicians would provide the final word on the value add of this scenario. |
| Q87: | What will the VA accept as 'proof' of EDI Capabilities? Will contact information for our current EDI provider suffice? |
| A87: | Offeror must certify compliance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. All invoices must be submitted in accordance with VAAR Clause 85.232-72 (SOW Page 5). |
| Q88: | If production for a product will begin in USA in the Spring of 2024, can we include the item in the bid? |
| A88: | I would recommend against quoting items which are not currently available. Due to the potential schedule slippage with domestic manufacturing and the certification documentation, requires current compliance. |
| Q89: | Is the MSPV going to remove product made in TAA countries if a significate source of USA manufactured PPE is available on the MSPV? Or will this be separate from the products on the MSPV? |
| A89: | Yes, once the total annual need is covered by compliant items, we will remove items which are not compliant with this law. |
Q90: Will there be additional solicitations for USA PPE product as more companies can manufacture in the USA?
A90: There will be additional Make PPE solicitations, the cadence has not been decided yet.
| Q91: | Will VAs be told to buy USA made PPE over TAA made PPE or will they have options? We are concerned if two products are very similar, but one is substantially cheaper, they will choose the cheaper one? |
| A91: | Yes, there will be notation on facility Core and Product Lists to denote Made in America compliant PPE from non-compliant PPE. Facilities will be required to use only Made in America compliant PPE, once the full volume of need is available. There is going to be clear policy and guidebooks for the facilities to reference. |
| Q92: | Will the VA allow for the same product to be priced differently based on the ship-to location? For example, items shipping to CONUS locations may be at one price while the same items shipping to OCONUS locations such as Alaska, Hawaii, Philippines, Guam, American Samoa, Puerto Rico and Virgin Islands may be at a different price. |
| A92: | No. Supply pricing established in BPAs between the Authorized Supplier and the government will be made available to PVs; PVs will use this exact price plus the distribution fees agreed upon between the PV and VA to invoice VA for PV distribution and supply management services. |
| Q93: | Will the VA allow responses with tiered pricing based on quantity purchased? For example: Case (80ea/cs) price would equal tier 1 pricing, Bulk Pack (220ea/bulk pack) price would equal tier 2 pricing, Pallet of 96 cases (80ea/cs) price would equal tier 3 pricing, Pallet of 220 Bulk Pack price would equal tier 4 pricing? |
| A93: | Not at this time. The government systems cannot currently support a price structure like what is described. |
| Q94: | While our preference may be to drop ship to the CONUS facilities, in the case of OCONUS shipments, could those be shipped via the PV’s CONUS Distribution Center(s) with the PV then shipping to the OCONUS VAMC as opposed to being drop shipped to the OCONUS location? |
| A94: | The Authorized Supplier shall deliver supplies in accordance with “Normal”, Expedited, “Just-In-Time (JIT)”, drop shipment, and consignment delivery methods as outlined in commercial agreements between the PV and the Authorized Supplier. Any additional terms outside of the Government's requirements, such as those described in the question, would be negotiable between the supplier and PV. |
Q95: NIOSH certification for N95 respirators does not currently include performance requirements as it relates to OSHA fit testing standards. As such, the majority of N95 respirators will not position the user to reach the minimum passing score of 100 (out of a possible high score of 200) for quantitative fit testing. Many N95 respirators that are not specifically designed to create and maintain a good seal will score under 20 when users are quantitatively fit tested. If an individual cannot pass the OSHA quantitative fit test, such products in effect provide a false sense of protection security for the individual wearing the N95, as well as those around them. Although we are not advocating that everyone who wears an N95 should be quantitatively fit tested, to ensure maximum protection is being provided, we believe N95 respirators should have a minimum 75% quantitative fit test passing rate, based specifically upon the NIOSH bivariate panel standards.
Questions:
a. Does the Government currently have such quantitative fit test standard performance / passing rate requirements?
i. If so, can you please identify these standards?
ii. If not, is there any plan for developing such standards in the future to help ensure the maximum level of protection possible is being provided?
b. Would the VA verify that vendors are able to submit quantitative fit test results data as part of their submittal?
A95: See Questions 63 & 66.
Q96: N95 Respirator Breathability. Background: Many N95 respirators are designed to meet NIOSH’s minimum standard for breathability. Studies published in the NIH National Library of Medicine “demonstrate a statistically significant correlation in the quantitative analysis between the negative side effects of blood-oxygen depletion and fatigue in mask wearers”. Greater breathability = greater comfort, including a reduction of risks associated with blood-oxygen depletion and fatigue.
Questions:
a. Beyond the NIOSH minimum breathability standard, does the Government currently have any such higher performance standard requirements?
i. If so, can you please identify these standards?"
ii. If not, is there any plan for developing such standards in the future?
b. Would the VA verify that vendors may submit breathability / inhalation resistance test results data as part of their submittal?
A96: See Questions 63 & 66.
Q97: "N95 Respirator Compromised Peripheral Vision. Background: N95 respirator usage compromises the lower peripheral vision of those wearing the respirator. As such, there is greater ergonomic strain and fatigue for the wearer as they overcompensate by looking beyond the obstructed field of visibility. Expanded visibility also helps to facilitate a safer working environment.
Question: Is the Government seeking innovation that helps to solve these sorts of problems?"
A97: See question 64.
Q98: "Individually wrapped N95 respirators. Background: Individually wrapped N95 respirators can help to further safeguard against the transmission of contagions and other forms of contaminants.
Question: Is the VA open to Value-added sanitary features such as individual wrapping, as well as convenient packaging and is there documentation supporting that position?"
A98: See question 65.
| Q99: | Block 10 of the Solicitation indicates the acquisition is set aside 100% for SDVOSB, but the tiered evaluations open it up to other entities. Was the 100% set-aside for SDVOSB checked in error? |
| A99: | No, that is the 1st tier of the RFQ and the form requires the selection. This DOES NOT MEAN that only SDVOSBs may quote. The Government seeks quotes from vendors in ALL socioeconomic categories and will evaluate in accordance with the tiered evaluation process which is covered in pages 41-43 of SOW. |
| Q100: | Both thumb-lock and elastic wrist designs are used by healthcare providers. Are both models acceptable? |
| A100: | Assuming this question is regarding gowns, yes, both are acceptable. |
| Q101: | Solicitation page 7 of 62 item C.1 states VA contemplates making purchases through the PVs, and page 8 Section II provides the MSPV Business Process, which requires an Authorized Supplier Awardee to enter into a commercial agreement with the PV (see II.A.1 on page 8). Will VA also require the PVs to enter into commercial agreements with the Authorized Suppliers? |
| A101: | Yes, this requirement is covered within the Prime Vendor IDIQ awards and not addressed in the supplier BPAs. |
| Q102: | Under the Exceptions on Solicitation page 13, section (c)(1) states the VA Senior Procurement Executive is authorized to make the certifications in paragraphs (a)(2) and (b)(3) or unreasonable cost determination in paragraph (b). Knowing that foreign producers have significantly lower labor costs than the United States, it is logical that costs of 100% domestic products will be higher. This being the case, what is the threshold for unreasonable cost determination? |
| A102: | The Government knows that wholly domestically sourced and manufactured PPE items will have different pricing than items purchased from the cheapest foreign manufacturer. Fair and reasonable determinations for this RFQ will be based upon comparison with equivalent domestically produced items and will not be directly compared to foreign manufactured item prices. |
| Q103: | On page 14 Section F states no orders are placed against the BPA. However, the language in Section C on page 7 indicates VA may place orders directly against BPAs up to a limit of $500,000 per order. Does VA intend to place any orders against BPAs? |
| A103: | No orders are placed against the BPA. The PV places orders based on their commercial agreements with BPA holders. The sole purpose of the BPA is to identify the products, prices, and sources. |
| Q104: | Page 15 Section H.1. also states “No purchases are made against this BPA” as a Term and Condition. Doesn’t this contradict the language on page 7? |
| A104: | No orders are placed against the BPA. The PV places orders based on their commercial agreements with BPA holders. The sole purpose of the BPA is to identify the products, prices, and sources. |
| Q105: | Page 29 Section C.11 paragraph c. Order of Precedence refers to the Department of Homeland Security making a determination that "...neither domestic personal protective equipment nor foreign-made domestic personal protective equipment is available due to nonavailability or unreasonable cost..." Should this be the Department of Veteran Affairs? |
| A105: | This has been corrected via amendment to the appropriate section. |
| Q106: | On page 40 under Section E.1 FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023) (Tailored), FAR clauses 52.225-5 and 52.225-6 apply only to tier 5. These tailored instructions to offerors specify 5 tiers; however, Attachment A (PPM-2018-04 Tiered Evaluation) only contains 4 tiers. Will VA be implementing 5 tiers? |
| A106: | This procurement follows VAAR 815.101.370, Tiered set-aside evaluation. (DEVIATION). Tiers are listed in E.2 52.212-2 EVALUATION (Pages 41-43) |
| Q107: | If VA is applying 5 tiers to the evaluation as stated in Section E.1, will VA consider and elevate Minority Owned Small Businesses to Tier 3? |
| A107: | This procurement follows VAAR 815.101.370, Tiered set-aside evaluation. (DEVIATION). |
INDUSTRY DAY Q & A
| IDQ1: | Can you please let me know who should I talk to regarding becoming a vendor for your Medical Group? |
| IDA1: | At the time of quote, your company must be registered as a vendor to the federal government in SAM.gov. For assistance with this process, please contact: https://www.aptac-us.org/ or https://www.apexaccelerators.us/ |
| IDQ2: | How to become a vendor on the VA MSPV program? |
| IDA2: | Win an item(s), then: |
a. Establish commercial agreements / PVON’s with Prime Vendors
b. Use your sales force to sell your items through MSPV
| IDQ3: | What items may be awarded? |
| IDA3: | Medical PPE (for the purposes of this procurement) as defined in the law: |
1. surgical masks
2. powered air purifying respirators (PAPR) (only consumable supplies)
3. head and foot coverings
4. respirator masks
5. disposable and reusable surgical and isolation gowns
6. face shields and protective eyewear
7. other gear or clothing used to protect an individual from the transmission of disease
| IDQ4: | How can we start the bidding process? |
| IDA4: | Item details and quoted prices and unit of measure / unit of issue will be submitted using the attached quote sheet excel spreadsheet. |
a. Certification of compliance of quoted items will be submitted using the added Attachments D & E
b. Any component which is exempt from domestic sourcing due to inclusion on the list at FAR 25.104 should also be noted on the attachments D & E to allow for VA tracking as that list changes.
| IDQ5: | Can you add a Women Owned Small Business (WOSB) Tier? |
| IDA5: | The tiers identified in the RFQ are the required tiers for VA to use, by policy. At this point, VA does not have authority to use a Women Owned Small Business tier, unless we have identified at least 2 WOSB interested in providing quotes, we just need to document those vendors (email the CO). Of note: this is currently in the rule-making process being addressed by a draft bill in the Senate. |
| IDQ6: | What should I enter as an index Column in this request since a specific list of items is not requested? |
| IDA6: | For the index number, please enter items in ascending numerical order: 1, 2, 3. |
IDQ7: On the quote sheet, the dropdown for product classification none of the options correspond to coveralls. Which dropdown option should I select for Tyvek coveralls?
IDA7: In the minimum technical requirements (MTR) attachment, Tyvek Coveralls are listed under garments / coveralls, however; a new quote sheet will be published to clarify the categories in the drop-down of the quote sheet as these items would fall into the ‘other gear or clothing’ category.
| IDQ8: | Do we need to submit copies of our testing results for the PPE we are providing? Attachment B states the requirements for testing, but it doesn’t say if we need to provide copies of the testing results with our submission. |
| IDA8: | Yes, we encourage you to submit any additional documentation which would assist the clinicians in properly evaluating the items. |
