Attachment 1 - Technical Questions - FINAL - 07.01.2020.pdf

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6515--PPE - GOWN - COVID-19 - 36E776-20-AP-0267 (VA-20-00053277)
Solicitation number
36A77620R0002
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This document provides questions and answers related to a solicitation for surgical and isolation gowns issued by the Department of Veterans Affairs. The solicitation seeks proposals for approximately 8 million gowns total, including 2 million Level 4 surgical gowns, 3 million Level 3 surgical gowns, and 3 million Level 2 isolation gowns. Offerors are permitted to submit proposals for one, two, or all three product categories. Delivery requirements include 25% of awarded quantities within 14 days of award, 50% within 30 days, and 100% within 60 days. The solicitation will remain open until September 30, 2020 or until all quantities are awarded, and proposals will be evaluated according to the trade agreements and domestic preference criteria specified in FAR Clause 52.225-5.

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36A77620R0002 0002.docx DOCX document
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Attachment 2 - SOW - Gowns Surgical-Isolation - REVISED - 07.01.2020.pdf PDF
36A77620R0002.docx DOCX document
Attachment A SOW - Gowns Surgical-Isolation Final 06.17.2020.doc DOC document
Attachment B Proposal Submission Cycles 6-24-2020.xlsx XLSX spreadsheet

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1. Is it acceptable to submit multiple options for each CLIN?

A: No. The price schedule in section B of the solicitation does not ask for multiple options for each

CLIN.

2. Does the associated documentation (FDA certificate, test results etc.) count as part of the 30 pages?

Test reports often run 8‐15 pages which would prevent us including them and it being allowed under the page count.

A: Testing reports will not be included in the page count.

3. With regard to SOW Surgical Gown Level 4 MTR 8 A. Please confirm if the gown will be used in surgery / procedural areas A: YES, Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed, or infectious diseases are suspected (non‐ airborne) All surgical gowns must be labeled as a surgical gown.

B. If not all of them will, please confirm the number that will be used in surgery / procedural areas.

A: N/A ‐ See response above C. Please confirm the number of each size that the VA requires A:

M‐100,000 L‐ 600,000

XL – 600,000

XXL‐ 600,000

XXXL – 100,000

4. With regard to SOW Surgical Gown Level 3 MTR 8 A. Please confirm if the gown will be used in surgery / procedural areas A: YES, Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases. All surgical gowns must be labeled as a surgical gown.

B. If not all of them will, please confirm the number that will be used in surgery / procedural areas A: N/A ‐ See response above C. Please confirm the number of each size that the VA requires A:

M‐150,000 L‐ 900,000

XL – 900,000

XXL‐ 900,000

XXXL – 150,000

5. With regard to SOW Surgical ISOLATION Gown Level 2 MTR 8 A. Please confirm if the gown will be used in surgery / procedural areas A: Our requirement is for a non‐sterile Level 2 isolation gown.

B. If not all of them will, please confirm the number that will be used in surgery / procedural areas A: N/A ‐ See response above C. Please confirm the number of each size that the VA requires A: Level 2 Isolation Gowns requirement is for One Size Fits All

6. DELIVERY ‐ Please confirm that you require 1.75 million gowns to be delivered within 14 days of contract award.

A: The price schedule indicates the quantities required. Solicitation Attachment A SOW provides the schedule for deliverables. See below for schedule for deliverables.

Deliverable Item Delivery Date

1 25% of PPE awarded to be delivered NLT 14 days of award

2 50% of PPE awarded to be delivered NLT 30 days of award

3 100% of PPE awarded to be delivered NLT 60 days of award

Note, we are not requiring a vendor to be able to fill all quantities listed to be considered. The only requirement is to provide a minimum of 200,000 gowns for the product you are proposing to be considered.

7. This is an exceptionally high number and can only be achieved by having this stock on hand. Is it possible to extend the initial delivery dates?

A: Not at this time.

8. Is that accurate that only the Level 2 isolation gown is ok to be non‐sterile?

A: Yes.

9. Can you bid on only delivering one style of gown or do you have to be able to do all 3?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only. Offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

10. Since this is for disposable gowns, so we cannot bid any reusable?

A: Our requirement is for disposable gowns.

11. In regard to the bid for the Level 2, 3, & 4 Gowns, when will the bid be awarded so we make sure we can deliver the required amount "(25%) 14 days of award”?

A: Once proposals are submitted, evaluations will be conducted in accordance with the solicitation.

Upon completion of evaluations, the VA will make an award determination.

12. Would there be any possibility that the Level 2 gowns would be separated out of this solicitation to be sourced alone?

A: No. You can provide a proposal for Level 2 gowns only if you choose. See Note in Section B.2 of the Solicitation.

13. Is this a requirement limited to TAA compliant countries only or Berry Amendment compliant (USA produced and manufactured)? If not, is sourcing from Turkey permitted under this solicitation?

Please advise.

A: In the interest compliance with FAR Clause 52.225‐5 Trade Agreements, the Government will first determine where the product is manufactured. All products manufactured in the United States (domestic products) and Countries designated under the FAR Clause 52.225‐5 (non‐domestic products in compliance with FAR Clause 52.225‐5) will be evaluated a head of product not manufactured in the United States or not designated under FAR Clause 52.225‐5. If quantities cannot be filled with domestic or non‐domestic products in compliance with FAR Clause 52.225‐5, the Government will evaluate all other products offered. Section E8 (D) in the solicitation provides a detailed summary of how evaluations will be conducted.

14. In addition, please clarify the deadline. Is the deadline July 7th for the entire 8 million gowns requirement?

A: July 7, 2020 is the deadline for the first proposal submission cycle. Note, the solicitation will remain open until September 30, 2020 4:00 PM EDT or until all quantities listed in the price schedule, located in section B, are filled. Proposal submissions will be in two‐week cycles. Cycle one starts with the issuance of this solicitation. Attachment B, Proposal submission cycles, provides information specific to Proposal submission cycles. Offers/Quotations received after the due dates outlined in attachment B will be pushed to the following Proposal submission cycle.

15. Can I propose any of the three Levels of protection being 2, 3 or 4?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

16. This contract opportunity will be open for offers until September 30th? This means that a source will not be selected until after that.

A: The solicitation will remain open until September 30, 2020 4:00 PM EDT or until all quantities listed in the price schedule, located in section B, are filled. Proposal submissions will be in two‐week cycles. Cycle one starts with the issuance of this solicitation. Attachment B, Proposal submission cycles, provides information specific to Proposal submission cycles. Offers/Quotations received after the due dates outlined in attachment B will be pushed to the following Proposal submission cycle.

17. When it says Buy American, does that mean 100% of the Gowns Must be manufactured and acquired in the USA?

A: FAR Clause 52.225–5, Trade Agreements applies to this procurement. Please review FAR Clause 52.225–5, Trade Agreements for requirements of that clause.

18. Schedule for Deliverables and quantities ‐ The government states the delivery schedule below in the SOW and quantities in the solicitation. Please clarify the delivery schedule. For example, If we are awarded the Level 2 gown, 3,000,000 units we will deliver 25% of the gowns 750,000 units within 14 days of award (25% of 3,000,000 = 750,000 units). Question ‐ For the second deliver 50% within 30 days of award, is the government wanting delivery of 50% of the base awarded units (3,000,000 gowns) which is 1,500,000 units delivered on the second delivery or is the government wanting 50% of the outstanding units after the first delivery? If the second deliver is based on base award units (3,000,000) the second delivery will consist of 1,500,000 units and if the second delivery is based on outstanding units after first delivery (2,250,000) the second delivery will consist of 1,125,000 units. This question also applies to the third delivery.

A: Solicitation Attachment A SOW provides the schedule for deliverables. See below for schedule for deliverables.

Deliverable Item Delivery Date

1 25% of PPE awarded to be delivered NLT 14 days of award

2 50% of PPE awarded to be delivered NLT 30 days of award

3 100% of PPE awarded to be delivered NLT 60 days of award

19. In the SOW the government requests Sizes Regular/Large, Medium, XL, XXL and XXXL. Can the government please break down the number of units per size for Item Number 1, 2 and 3?

A:

Level 2 Isolation gowns – One Size Fits All.

Level 3:

M‐150,000 L‐ 900,000

XL – 900,000

XXL‐ 900,000

XXXL – 150,000

Level 4:

M‐100,000 L‐ 600,000

XL – 600,000

XXL‐ 600,000

XXXL – 100,000

20. Item 1 Surgical Gown Level 4. In the Minimum Technical Requirements (MTRs) # 3 the government states “Raglan Sleeves”. Can the government please provide an example of what you are looking for. Pictures or similar product model number would be greatly appreciated.

A:

21. Item 2 Surgical Gown Level 3. In the Minimum Technical Requirements (MTRs) # 3 the government states “Raglan Sleeves, Elastic Wrist”. Can the government please provide an example of what you are looking for. Pictures or similar product model number would be greatly appreciated.

22. Item 3 Isolation Gown Level 2. In the Minimum Technical Requirements (MTRs) # 3 the government states “Raglan Sleeves, Elastic Wrist”. Can the government please provide an example of what you are looking for. Pictures or similar product model number would be greatly appreciated.

23. We wanted to confirm all 8,000,000 gowns are to be delivered to HHS/PSC/SCMS, 4 Center Drive, North East, MD 21901. Attn: VHA – COVID 19. Can you also provide the days and hours this facility accepts deliveries? We do not see any other delivery locations.

A: Address is confirmed. Receiving hours are 7am to 3pm.

24. Do we need to go through a process to register in SAMS before we can bid on this RFQ?

A: Federal Acquisition Regulations require that federal contractors register in the System for Award Management (SAM) database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their Proposal.

25. I need to know if 50% down and 50% when product ships is acceptable.

A: No. Advance payments are not an option for this procurement. See Note in Section E2 (A) of the solicitation.

26. Will a decision be made for this solicitation in September?

A: The solicitation will remain open until September 30, 2020 4:00 PM EDT or until all quantities listed in the price schedule, located in section B, are filled. Proposal submissions will be in two‐week cycles. Cycle one starts with the issuance of this solicitation. Attachment B, Proposal submission cycles, provides information specific to Proposal submission cycles. Offers/Quotations received after the due dates outlined in attachment B will be pushed to the following Proposal submission cycle.

27. Can a company submit information for 2 out of 3 of the products, or do they have to submit it for the entire thing?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only. Offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

28. "Provide a completed copy of the representations and certifications at FAR 52.212‐3 (see FAR 52.212‐3(b) for those representations and certifications that the Offeror shall complete electronically." Is it sufficient to include a copy of our current Reps and Certs from SAM.gov?

A: Yes, it if it is up to date.

29. General questions‐ What literature do you require for MTR 1‐15?

A: The manufacturers product specification sheet detailing all MTR’s as well as the test reports that are in compliance with CDC and FDA guidelines.

30. A. Surgical Gown Level 4 MTR 2‐ Do you want even distribution of sizing for Sizes: Regular/Large, Medium, XL, XXL, XXXL?

A: NO. See 3C above.

MTR 8‐ Assumption is sterile are required for Level 4 Gowns. Please advise.

A: Yes, Level 4 surgical gown must be sterile and must be double packaged. See MTR # 8.

B. Surgical/Isolation Gown Level 3 MTR 2‐ Do you want even distribution of sizing for Sizes: Regular/Large, Medium, XL, XXL, XXXL?

A: NO. See 4C above.

MTR 8‐ Assumption is nonsterile are required for Level 3 Isolation Gowns. Please advise if sterile or non‐sterile is preferred.

A: Level 2 Isolation gowns are non‐sterile. Level 3 surgical gowns are sterile. Our requirement does not include Level 3 isolation gowns.

C. Surgical/Isolation Gown Level 2 MTR 2‐ Do you want even distribution of sizing for Sizes: Regular/Large, Medium, XL, XXL, XXXL?

A: NO. See 5C above.

MTR 8‐ Assumption is nonsterile are required for Level 2 Isolation Gowns. Please advise.

A: Level 2 Isolation gowns are non‐sterile.

31. Surgical Gown – Level 3 “The contractor shall provide 3,000,000 Level 3 Isolation Gowns. The Isolation gown shall meet the following MTRs: Isolation Gown Level 3”. Additionally, language used in MTR 8 and MTR 14, refers to sterile and non‐sterile gowns. As medical professionals, we understand that the difference between surgical and isolation gowns is significant. If these gowns are not being used in the operating room theatre but will be used by healthcare professionals caring for Covid patients, then Isolation Level 3 gowns are appropriate.

A. Please confirm Level 3 “Surgical” Gowns will be used outside of the operating room environment.

A: Level 3 “Surgical” Gowns may be used in the operating room & sterile procedure environment. Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases.

B. Please confirm if Level 3 Isolation will be acceptable to fill the requested order for Level 3 gowns.

A: No, our requirement is for Level 3 Surgical gowns.

32. We can provide both Level 2 and Level 3 Isolation gowns listed per the timeline of Schedule of Deliverables (para E), however, to provide a greater savings to the Veterans Administration, it would be advantageous to allow for delivery of all items within 60 days as opposed to the listed schedule. Is this an acceptable alternative?

A: No. Follow guidance issued in solicitation Attachment A schedule for deliverables.

33. Are the quantities listed are the final or subject to change?

A: Quantities required are listed in the solicitation. If a change to quantities is required, an amendment to the solicitation will be issued.

34. Do we get favorability as a small business?

A: Proposals will be evaluated in accordance with the solicitation.

35. In the Solicitation form block no.17 (a) I am not sure of what information is required in the area that reads' CODE' and the other one that reads 'FACILITY CODE'.

A: Those blocks may remain blank.

36. Also, in Block 19‐ Can I include all the items we are bidding for?

A: Refer to E2 of the Solicitation for submission requirements.

37. Can a vendor submit offer for Isolation Gowns Levels 2 & 3 only without an offer for Level 4 Surgical?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

38. The solicitation does not specifically mention whether or not if it would be permissible for us to submit a proposal for just one of the Gown orders, a combination of them (e.g. Level 2 & 3 Gowns ) or if we must submit a proposal for all of them as listed (e.g. Levels 2, 3 & 4 ). We appreciate any clarification you can provide on this issue. I thank you in advance your assistance on this matter.

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

39. Do we need to be registered with GSA to bid on this?

A: No.

40. Will we get a code for box 17?

A: The “CODE” block may remain blank. Name, Address, Telephone Number, and DUNS are required.

41. Do we have the permission to submit two different bids? I ask because I noticed the precedence of a domestically made product vs a non‐domestic product.

A: No. You can only submit one proposal for each proposal submission cycle.

42. Regarding the solicitation for the Level 2,3 & 4 gowns the due date for submission on the beta.sam.gov portal indicates a June 30 deadline however the excel Attachment B (issued June

24) Submission Cycle indicates a June 29 technical questions deadline and July 7 actual due date.

Kindly confirm that the proposal submission due date is July 7.

A: JUL 7 is the due date for the first proposal submission cycle. See Section E.8 (D) of the Solicitation.

43. I'm able to get all the Levels of gowns, but do they have to all come from 1 supplier or is it possible for me to submit with multiple suppliers under the same contract? Would you need me to send in multiple submissions (1 for each supplier)?

A: YES, one (1) supplier per CLIN per cycle.

44. Would we still be able to bid, and would it be on the same scale as VBE?

A: This Acquisition is Unrestricted.

45. We only have one size which can fit all from S ‐ XL. So, we are missing XXL and XXXL. Do you think you will consider it?

A: See sizes above, 3C, 4C & 5C.

46. How many gowns of each Level do you need?

A: See price schedule in solicitation.

47. Can the VA provide a breakdown of quantity for each size for each Clin?

A: See sizes above, 3C, 4C & 5C.

48. Are these all to be sterile gowns? SOW States only if for surgery, can we clarify as this will significantly change the price.

A: Level 3 & Level 4 are for sterile surgical gown.

49. If they are sterile gowns, any specific requirements on the packaging?

A: Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), product labeling should describe an intended use with the desired Level of protection.

Sterile surgical gowns must be wrapped in a barrier wrap, sterilized and packaged in a second, exterior package. All surgical gowns must be labeled as a surgical gown in compliance to FDA guidelines.

50. What is the turnaround timeline once the bid is awarded? i.e. how soon will the award take place after the bid has closed and the distribution of supplies is initiated?

A: Once proposals are submitted, evaluations will be conducted in accordance with the solicitation. Upon completion of evaluations, the VA will make an award determination.

51. Material for Level 2 & 3: We can provide you with Polypropylene +Polyethylene (PP+PE) to meet Level 2 and Level 3 requirements of the bid. We can provide you with sample for testing.

A: No, this does not meet our salient characteristics

52. Our qlty is one size fits most. Will you consider this size, or you need size breakdown based on solicitation?

A: See sizing above 3C, 4C & 5C.

53. If you need your sizes, do you have dimensions required so we can do pricing based on each size?

A: See sizing above 3C, 4C & 5C.

54. Can you please clarify what exactly is being asked for when it says, “FDA Approved”? I do also see where it states, “if applicable”. Obviously, the manufacturer would have an FDA registration.

For surgical, I am assuming FDA 510 K clearance would be required. For the Level 2 “isolation” gown, it is not, correct?

A: We do not know what you mean by “if applicable” and cannot answer that. All gowns must meet FDA standards, please see link below: https://www.fda.gov/medical‐devices/general‐ hospital‐devices‐and‐supplies/personal‐protective‐equipment‐infection‐control

55. Our products country of origin is India. Can we supply for this solicitation?

A: In the interest compliance with FAR Clause 52.225‐5 Trade Agreements, the Government will first determine where the product is manufactured. All products manufactured in the United States (domestic products) and Countries designated under the FAR Clause 52.225‐5 (non‐ domestic products in compliance with FAR Clause 52.225‐5) will be evaluated a head of product not manufactured in the United States or not designated under FAR Clause 52.225‐5. If quantities cannot be filled with domestic or non‐domestic products in compliance with FAR Clause 52.225‐5, the Government will evaluate all other products offered. Section E8 (D) in the solicitation provides a detailed summary of how evaluations will be conducted.

56. Can VA accept PP+PE quality if it passes Level 2 and Level 3?

A: Not at this time.

57. Can we offer one product to cover Level 2 and Level 3?

A: No, Level 2 is for non‐sterile Isolation, Level 3 is a sterile Surgical.

58. As for size, can we offer one size fit most, and if not, can we get requested VA dimensions to quote based on correct data?

A: See sizing above 3C, 4C & 5C.

59. For Level 2 gowns do you accept Polyethylene / Polybond (plastic) isolation gown?

A: Not at this time.

60. Confirm that invoices shall be submitted after the delivery of the gowns. What are the payment terms you anticipate (i.e. 30 days?)

A: Invoices will be handled in accordance with the Prompt Payment Act.

61. Do we have to submit the bid for all of the three lined items, or can we do one or two lined items?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

62. Are there any plans to alter this delivery schedule?

A: Not at this time.

63. For Level 3 & 4 gowns – do these gowns need to be sterile and individually packaged? Or are you requesting bids for both sterile and non‐sterile?

A: Gowns need to be sterile and individually packaged. See 49 above

64. For Level 4 gowns, would you be willing to accept this shipping:

25% at 3.5 weeks 50% at 5 weeks 100% at 8 weeks A: No. Follow guidance issued in solicitation Attachment A schedule for deliverables.

65. Do we just sign the SF 1449 for and leave all other fields blank?

A: No. Refer to E2 of the Solicitation for submission requirements.

66. I saw that there are different quantities for the different Level gowns, are you guys looking for one vendor to provide all quantities or could we provide a full quantity for one of the gowns?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

67. I saw that it said that the opportunity will be open for 113 days, is that until a proposal is chosen or will a proposal be chosen in 113 days?

A: The solicitation will remain open until September 30, 2020 4:00 PM EDT or until all quantities listed in the price schedule, located in section B, are filled. Proposal submissions will be in two‐ week cycles. Cycle one starts with the issuance of this solicitation. Attachment B, Proposal submission cycles, provides information specific to Proposal submission cycles.

Offers/Quotations received after the due dates outlined in attachment B will be pushed to the following Proposal submission cycle.

68. Will Chinese made products be considered for this solicitation or only TAA items?

A: In the interest compliance with FAR Clause 52.225‐5 Trade Agreements, the Government will first determine where the product is manufactured. All products manufactured in the United

States (domestic products) and Countries designated under the FAR Clause 52.225‐5 (non‐ domestic products in compliance with FAR Clause 52.225‐5) will be evaluated a head of product not manufactured in the United States or not designated under FAR Clause 52.225‐5. If quantities cannot be filled with domestic or non‐domestic products in compliance with FAR Clause 52.225‐5, the Government will evaluate all other products offered. Section E8 (D) in the solicitation provides a detailed summary of how evaluations will be conducted.

69. Is there a specific color or is white acceptable?

A: No specific color requirement.

70. Would the VA allow an elasticated fabric cuff for the end of the raglan sleeve? The specification is not clear on this point.

A: All gowns must have Elastic Wrist.

71. The timeline for delivery will be between 45 to 60 days after award. Will the Govt consider our bid if we submit with the following timeline?

A: No. Follow guidance issued in solicitation Attachment A schedule for deliverables.

72. We currently supply gowns for Cleveland Clinic and some other major hospitals. As you may know, SMS material is scarce ‐ will you accept "PE material" for the gowns? That is what hospitals are currently purchasing.

A: Not at this time.

73. Is there a preference for Domestic or North American manufacturing?

A: In the interest compliance with FAR Clause 52.225‐5 Trade Agreements, the Government will first determine where the product is manufactured. All products manufactured in the United States (domestic products) and Countries designated under the FAR Clause 52.225‐5 (non‐ domestic products in compliance with FAR Clause 52.225‐5) will be evaluated a head of product not manufactured in the United States or not designated under FAR Clause 52.225‐5. If quantities cannot be filled with domestic or non‐domestic products in compliance with FAR Clause 52.225‐5, the Government will evaluate all other products offered. Section E8 (D) in the solicitation provides a detailed summary of how evaluations will be conducted.

74. Can we respond with just Level 3 isolation gowns to fulfill the Level 2 isolation gowns requirement and be responsive to the solicitation if we do not bid on the Level 3 and Level 4 surgical gowns requirement, or would that be considered a non‐responsive bid?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

75. We do not have access to the other Level gowns. Can we submit a quote for just the Level2?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

76. We are a Dubai UAE based import export company with business partners in the Far East. Would these types of tenders be open to companies in other countries or are they exclusive to USA companies?

A: In the interest compliance with FAR Clause 52.225‐5 Trade Agreements, the Government will first determine where the product is manufactured. All products manufactured in the United States (domestic products) and Countries designated under the FAR Clause 52.225‐5 (non‐ domestic products in compliance with FAR Clause 52.225‐5) will be evaluated a head of product not manufactured in the United States or not designated under FAR Clause 52.225‐5. If quantities cannot be filled with domestic or non‐domestic products in compliance with FAR Clause 52.225‐5, the Government will evaluate all other products offered. Section E8 (D) in the solicitation provides a detailed summary of how evaluations will be conducted.

77. Can we just bid Level 2 isolation gown and Level 3 surgical gowns?

A: Offerors are not required to propose on all CLINs to be considered. Offerors can propose Level 4 gowns only. Offeror can propose Level 3 gowns only, offerors can propose Level 2 gowns only. See Note in Section B.2 of the Solicitation.

78. Does Level 3 surgical gowns have be from 510K certified manufacturer?

A: YES, A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.

79. Any recommended size chart to follow?

A: See 3C, 4C, 5C above

80. Do the Level 2 and 3 isolation gowns have to be sterile or non‐sterile?

A: The requirement for Level 2 gowns is: NON‐STERILE, ISOLATION. The requirement for Level 3 gowns is: SURGICAL, STERILE.

81. Are partial quantity proposals accepted for each CLIN?

A: Yes, partial quantities of each or all CLINS will be accepted. We are not requiring a vendor to be able to fill all quantities listed to be considered. The only requirement is to provide a minimum of 200,000 gowns for the product you are proposing to be considered. See note in Solicitation Attachment A SOW provides the schedule for deliverables.

82. I was wondering if this solicitation is for reusable isolation gowns as well. Or only disposable?

A: Our requirement is for disposable gowns.

83. I am inquiring if the VA would accept all gowns awarded to a vendor would be accepted in 25 days post award with none being delivered prior to that?

A: No. Follow guidance issued in solicitation Attachment A schedule for deliverables.

84. On page 4 of the Attachment A‐Statement of Work, it states Surgical Gown – Level 3 and Isolation Gown Level 3. Which is correct?

A: The requirement is for Level 3, Sterile, Surgical Gowns. Surgical Gown – Level 3 is correct.

File details come from the government source that posted it. Updated .