7.30 Beta.SAM Questions and Answers SPE1C1-20-R-0139.docx

Below is the current cumulative list of Questions & Responses to solicitation SPE1C1-20-R-0139 as of July 30, 2020 at 1:00PM, providing clarification for this solicitation. Answers may be revised so all offerors are cautioned to review the questions and answers frequently as there may be some additional changes or clarifications to previously provided answers. Previously posted versions of this Q&A are still visible on Beta.Sam by clicking on previous postings in solicitation’s History section.

Please note that Revision #2 Proposal Submission Form was attached to Amendment 2 to the Solicitation. All references to any version of the proposal submission form below is taken to mean the Revision #2 Proposal Submission Form.

1. Questions regarding lot applicability, Berry Amendment, and Buy American Act, the following is applicable:

All offerors shall review the language at FAR 25.003 and DFARS 225.003 for definitions and what it means to be considered a domestic or qualifying country end product. To determine if a proposed item meets the requirements of each specific lot, offerors should review the following regulations which include lists of compliant countries:

a. Berry Compliant Lots: DFARS clause 252.225-7012 Preference for Certain Domestic Commodities

b. Buy American Act Compliant Lots: DFARS 225-872-1 provides a list of Buy American Act qualifying countries

Waivers and/or changes to the lot structure will not be made at this time.

2. Question: Can DLA Troop Support accept non-qualifying end item products under the Buy American Act/US fabric production lot?

Answer: Per page 5 of the solicitation:

This lot applies when offers under lot 1 do not provide for sufficient quantities available within the time required. A domestic non-availability determination has been approved and the Berry Amendment is not applicable to this lot. Additionally an exception to the application of the TAA has been granted to the extent that BAA compliant offers can meet the government's needs. For this acquisition, the provisions of DFARS 252.225-7000 and DFARS 252.225-7001 are applicable only to the extent that offers are received from domestic or qualifying countries. The subject item is considered a commercial-off-the-shelf (COTS) item. Offerors must either meet the requirements of the BUY AMERICAN ACT by providing a domestic end product or a qualifying country end product OR provide an end item whose primary end item fabric is manufactured in the United States. Under this lot, awards will be made in accordance with the following order of precedence:

1) Buy American Act compliant offers of domestic or qualifying country end items;

2) Offers of end items whose primary end item fabric is manufactured in the United States, regardless of country of end item manufacture. Offers of end items whose primary end item fabric is manufactured in the United States will ONLY be considered if quantity requirements cannot be met in the required timeframe with Buy American Act compliant offers of domestic or qualifying country end items.”

3. Question: We do not see any specifics regarding material which you want the gowns to be made of.

Answer: The solicitation is requiring commercial-off-the-shelf gowns and is not defining a required material. The only requirement is that the material does not include latex, meets the requirements listed in the product description, and there are test reports and/or COC as required in the solicitation and/or proposal submission form for the proposed item’s material.

4. Question: For Past Performance, could you please confirm that DLA is willing to accept commercial contract information in addition to any SPRS performance data?

Answer: Past performance will be rated as outlined in the addendum to 52.212-2 Evaluations – Commercial Items. Commercial contracts provided by the offeror on the Proposal Submission Form will be used to determine the offeror’s responsibility if they are in line for an award.

5. Question: As to Berry Amendment, if all Level 2 and 3 gown are manufactured to the same specifications and standards in ISO rated facilities, do we need to provide specific information as to each factory, or simply identify separate locations? Are samples required from each factory location or only the manufacturer itself?

Answer: The solicitation outlines requirements for submitting proposals for multiple factories (AKA places of performance). Please review pages 21-22 specifically which address this question.

6. Question: If I respond with multiple places of performance and raw material solutions, would the entire proposal be disqualified if one gown PDM does not meet the label requirements, delivery time or technical requirements?

Answer: The offeror needs to submit its proposal as outlined in the addendum to 52.212-1 Instruction to Offerors – Commercial Items, specifically the guidance provided on pages 22-23 of the solicitation. If this guidance is followed and the offeror’s proposal is in line for an award, awards would be made for the PDMs/proposal submission forms that are determined to be technically acceptable. Awards would not be made to PDM/proposal submission forms that are determined not to be technically acceptable.

7. Question: We understand that you are accepting one PDF file only. If we respond on behalf of multiple entities, we would expect our PDF file to be quite large and are concerned that the email system would block the proposal. Are there other options for submitting the proposal?

Answer: Email is the only authorized method for submitting proposals. As listed throughout the solicitation, you shall electronically submit: 1) the signed solicitation and any subsequent amendments and 2) one proposal submission form for each place of performance, lot, and/or level of gown with all required documents attached in the corresponding proposal submission form. Therefore, you can submit the required documents in multiple emails; however, you need to clearly state the proposal is being sent in batches (i.e. email 1 out of 5) and use the same subject line for each email.

8. Question: Is there a tolerance on the Gown Size Chest Measurements provided?

Answer: Please review the measurements listed on page 14 of the solicitation. These are minimum measurements. As long as the proposed item for that size meets that minimum measurement but does not exceed the minimum requirement of the next size, it is acceptable.

9. Multiple questions were received regarding using multiple places of performance, cut and sew facilities, and fabric suppliers. Offerors shall review the guidance listed in the solicitation, specifically pages 21-22, for guidance on how proposals need to be submitted if these situations apply. For solicitation submission purposes, a place of performance has been defined on page 22 of the solicitation.

10. Question: Can we switch to using another material that is already on our supplier list if it looks different than what we start with initially?

Answer: If an award is made based on an offeror’s proposal, only the fabrics included in the proposal submission form would be authorized for production. If an offeror wishes to add something after the award is made, pre-production samples and/or test reports/COCs may be required in order to receive approval to use in production.

11. Multiple questions were received regarding the requirements of ISO 17025 and seam strength testing listed in the solicitation. If any changes are made to these requirements it will be done so via an amendment. The amendment will be posted to the DIBBS website (if required) and offerors should continue to monitor this website for any amendments.

12. Multiple questions were received requesting specifications and/or drawings. This acquisition is for commercial items. It is the offeror’s responsibility to determine which specific materials, designs, and methods of construction are appropriate to meet the specified requirements in the solicitation.

13. Multiple questions were received about the length of the gown. Minimum length is not spelled out explicitly. It is the Offeror's/Contractor's responsibility to ensure that the offered item(s) will provide adequate protection and coverage to the user. ASTM F3352 states, in part, that the gown must provide coverage "from the knees up to but not including the neck". Suggest potential Offerors review Section 5 "Design Requirements" in ASTM F3352-19 for more information.

14. Multiple questions were received about the quantity unit pack. Multiple Gowns shall be packed in each case. The number of Gowns per case shall be determined by the Contractor. Gowns shall be packed in cases in a quantity and manner that ensures that the Gowns will arrive to the end user undamaged and in good condition.

15. Multiple questions were received about registering in SAMs. To register in SAM, please go to www.sam.gov, Getting Started – Register Entity.

16. To further clarify questions received regarding submitting proposals, proposal submission forms, and PDMs under this acquisition when using different places of performance, materials, or for different levels of gowns, the following information is provided:

a. Only ONE (1) copy of the solicitation (and all subsequent amendment(s)) needs to be returned regardless of how many sources of supply, gown levels, fabric suppliers, lots, etc. an offeror is planning to offer under this acquisition. Delivery schedules, pricing, and technical information is be submitted only in the attached submission form. This information is not on the Standard Form 1449.

b. Offerors shall submit ONE (1) completed copy of the submission form attachment for each place of performance (per facility). Offerors would provide information concerning the minimum quantity acceptable for award, delivery capabilities, monthly maximum capacity, unit price, place of performance, identification of sources of supply, test data information for the PDM, and past performance information in the proposal submission form for that place of performance ONLY. If an offeror is proposing more than one place of performance, a PDM and submission form is required for each place of performance (facility).

c. If an offeror is submitting under different lots, different proposal submission forms and PDMs are required.

d. Offerors are allowed to use multiple fabric suppliers. Test reports/CoCs/and any other documentation required for the fabric as outlined in the solicitation and/or proposal submission form must be submitted for each fabric supplier.

e. Below are examples of how proposals would be submitted if submitting different gown levels, multiple lots, and multiple places of performance (listed below as manufacturing sites):

Proposals Submission with One Place of Performance and One Fabric Supplier

Proposals Submission One Place of Performance and Two Fabric Suppliers

Proposals Submission with Two Place of Performances and One Fabric Supplier

Proposals Submission with Two Place of Performances and Two Fabric Suppliers

To further assist offerors in finding the proposal submission form, a copy is attached to the combined synopsis/solicitation. Additionally, the following screenshots are provided to show offerors how to obtain this, and all other attachments to the solicitation and/or subsequent amendments via the DIBBS website.

1. If searching for the request for proposal, click on the solicitation number as shown below:

2. Once in the solicitation, you will see a column entitled “Attachments.” This is where all attachments to the solicitation and any subsequent amendments will be:

To further assist offerors in finding the proposal submission form, a copy is attached to the combined synopsis/solicitation. Additionally, the following screenshots are provided to show offerors how to obtain this, and all other attachments to the solicitation and/or subsequent amendments via the Beta.Sam website.

1. Click arrow (left side) to open tool bar, if not already opened.

3. Click on paperclip icon to view attachments.

Preference to US end item manufacturing and qualifying end up manufacturing and those using US fabrics.

As noted in lot w us and qualifying end products. And those vendors using US Domestic fabrics.

3. Attachments will appear. Double click to open and view the attachments.

17. Question: We would like to source the same quality fabric from multiple suppliers. Is it necessary to submit PDM’s for each supplier?

ANSWER: Separate PDMs are required for each place of performance. Test reports/CoCs/and any other documentation required for the fabric as outlined in the solicitation and/or proposal submission form must be submitted for each source.

18. Question: If one PDM fails, then only that particular “place of performance” fails, not the whole bid?

Answer: Correct. The failing PDM for that specific place of performance would not be considered for award. This is why offerors must separate their proposal through a submission form so each PDM can be evaluated as a separate offer.

19. Question: Can PDMs be submitting in a color different than what will be provided if awarded a contract?

Answer: PDM(s) may be presented in an alternate color if accompanied by a letter describing the color that will be delivered under contract. PDM fabric type (woven, knit, non-woven) must be equivalent to the type that will be delivered under any resultant contract. If you are awarded a contract, only the PDMs and/or fabrics included in your proposal submission form would be authorized for production. If you wish to add something after award, pre-production samples and/or test reports/COCs may be required.

20. Question: I’d like to confirm the correct delivery date for this proposal. On page 6 of the solicitation, it states, “Within each lot, the Government intends to award multiple contracts to fulfill these quantities in the most advantageous manner to ensure all available quantity is received by January 15, 2021.” However, on page 2 of the Reusable Gown Submission Form, it requests a delivery schedule until September 2021. Can you confirm the correct due date to deliver the full quantity of gowns?

Answer: The sentence on page six (6) of the solicitation is indicating to offerors that the Government is attempting to purchase as many gowns as possible, from as many lowest priced technically acceptable offerors as possible, so that the estimated quantity of 10,000,000 gowns are received by January 15, 2021. Any contract awards issued from this solicitation will be indefinite delivery, indefinite quantity contracts and will contain a 12-month ordering period. Requesting a delivery schedule until September 2021 allows the Government to place individual delivery orders for a 12-month period for the quantities outlined in the individual contract awards up to the individual contract maximum.

21. Question: I did not see DFARS 252.211-7006 - PASSIVE RADIO FREQUENCY IDENTIFICATION (RFID) called out in the bid. Please advise if RFID tags are required?

Answer: RFID is not required.

22. Question: If we are submitting a Reusable Level 2 Isolation Gown, not referencing the word surgical, please confirm that FDA clearance 510K is NOT required.

Answer: Confirming that a premarket document number (FDA 510K clearance) is NOT required for Isolation Gowns. This acquisition is for Isolation Gowns only. Isolation Gowns offered under this solicitation or furnished under any resultant contract shall not be labeled as “Surgical Gowns” or “Surgical Isolation Gowns”, nor shall they be marketed or recommended for use in any surgical setting.

23. Question: What would be the impact if a variation in quantity would be more than the permissible ZERO (0) PERCENT DECREASE (e.g. 1.5% decrease)?

Answer: Zero Percent Decrease is the requirement. A response that alters this requirement will be considered non-compliant.

24. Question: On page 1 of SF1449, should we fill out blocks 19-24?

Answer: No, completing Revision #2 Proposal Submission Form, attached to Amendment 2, will provide the necessary information discussed in blocks 19-24.

25. Question: On the Proposal Submission Form, it asks that materials are listed. Is this section intended to be BOM with fabric and trims listed or just list each material submitted in the case of multiple materials?

Answer: Using Revision #2 Proposal Submission Form, attached to Amendment 2, list each material/component used in manufacturing the gown.

26. Question: Please provide additional details for wash tag required on reusable gowns.

Answer: Per ASTM F3352, Section 5.4: Isolation gowns which are intended for reuse shall have either a means for recording or marking the number of processing cycles, or have an area (or multiple areas) on the gown that a processor could use to employ their own means for recording or marking the number of processing cycles. The recording area shall be visible/readable by the wearer.

27. Question: Do offerors need to complete the FAR BAA representation/certification in FAR 52.212-3 or just the DFARS BAA rep/cert?

Answer: 52.212-3 is in the solicitation For Lot 2, the provisions of DFARS 252.225-7000 and DFARS 252.225-7001 are applicable only to the extent that offers are received from domestic or qualifying countries (Page 5 of the Soliciation).

28. Question: Please confirm that offerors do not need to submit their code of business ethics and conduct with their offers.

Answer: The Code does not need to be submitted with their offer. Please review 52.212-13 and the solicitation for more information.

29. Do offerors have to sign every single page of the solicitation? Or just sign on page 1 and provide all pages?

Answer: Offerors do not need to sign every single page. Offerors are required to sign the solicitation, amendments, submission form, and any attachments as directed in those documents, including any potential required signature throughout those documents.

30. On Page 1 of the Proposal Submission Form, please clarify the term “Source of Supply”. For example, does this refer to the bidder, the country of supply, the manufacturer?

Answer: For the text box on page 1 of Revision #2 Proposal Submission Form, attached to Amendment 2, please write in the name of the end item manufacturer.

31. Please clarify if a bidder can offer different price points if they are using different sources of supply for fabric or manufacturers. For example, if there are two different sources of supply or two different manufacturers, can a bidder submit two different prices that reflect the differences in cost or must there be a blended price? If multiple price points are acceptable should this proposal use one Proposal Submission Form and note the different pricing options?

Answer: Page 3 of the Revision #2 Proposal Submission Form, attached to Amendment 2, states: “Offerors shall provide one (1) unit price that is applicable to both sizes”.

32. For the PDMs, does the sample have to be produced at that particular place of manufacture? We have multiple manufacturing sites but the gowns are otherwise identical in design, construction, and materials. We understand that test results and CoCs must be submitted with a Proposal Submission Form specific to each Place of Performance. However, after reading all Q&A released through 7/24, we are still unclear on whether the lab tests must be performed on a product fabricated at that particular Place of Performance. Or, provided that we are using the same materials, design, construction methods, and quality controls at multiple factories, can the test results from samples produced at one factory be used with the Proposal Submission Form for the other factories?

Answer: Please review pages 6 through 9 of the Revision #2 Proposal Submission form attached to Amendment 2. You are required to submit a PDM and a Revision #2 Proposal Submission Form for every place of performance. Each proposal form requires Attachments #1 (“Photographs and Technical Drawings”) and #2 (“Test Reports and CoCs”). If the test reports are identical as you’re using the same materials, you would attach them accordingly. You need to submit separate forms and PDMs so that they can be independently evaluated. Each form stands alone. The Government will not apply test reports/COCs from one form to another. If you fail to attach the test report/COCs (even if they are exactly the same from form #1 to form #2, your proposal will be considered non-compliant and may not be eligible for award).

33. At page 14, the RFP states that “each reusable gown shall include detailed laundering instructions”. On the other hand, page 15 says that one set of laundering instructions should be provided in each unit pack. Are detailed laundering instructions required to be included on a sew-in label for each gown? Please note that a sew-in label reflecting detailed laundering instructions is neither possible not consistent with industry practice. Please confirm that detailed laundering instructions are only required to be included in the case pack and not on the sew-in label.

Answer: Per ASTM F3352-19 the laundering instructions are to be included at the case level. Isolation Gowns are intended to be issued to the customer in full case increments, therefore including one set of laundering instructions per case is sufficient. Laundering instructions are not required for each sew-in label. Refer to Section 11 of ASTM F3352-19 for general labeling requirements.

34. With regard to the detailed laundering instructions that must be included in the case pack, do these need to be submitted with the PDM?

Answer: Per Page 23 of the solicitation “One (1) complete Reusable Isolation Gown, folded and packaged in accordance with Solicitation requirements. Labels shall clearly identify the type, protection level, and size of the Gown.” Placement of label(s) in the PDM shall be identical to placement of label(s) in any subsequent production. Refer to Section 11 of ASTM F3352-19 for general labeling requirements.

35. Please clarify the language “Lot Numbering Required” at section 6 on page 7. Does this mean that lot numbers are required or that a Unique Device Identification (UDI) number is required in each gown? UDI numbers are currently not required for Class I medical devices. “Lot Number Required” means manufactured lots shall be numbered.

Answer: UDI/serial numbering of each Gown is not required by the Government, but may be included at the manufacturer’s discretion. Lot numbering for traceability IS required. Refer to Section 11, note 5 of ASTM F3352 for additional guidance.

36. Can you please confirm if ALL TESTING is required at time of PDM submission?

Answer: Yes, all Test Reports that are required shall be submitted with the offeror’s proposal at submission. Please note additional options for Biocompatibility and the new flammability exemption Amendment 2.

37. Will a manufacturer Certificate of Compliance be acceptable in lieu of a test report on all required tests?

Answer: No, Per Page 23, test reports are required for Barrier Performance, Tensile Strength, Tear Strength, Seam Strength, and Flammability (unless the offeror claims exemption, then the offeror shall certify that the offered item does not pose a flammability risk to the user under normal intended use.). See Amendment 2 for more on biocompatibility requirements.

38. In TABLE 1 - Requirements and test methods from Solicitation SPE1C1-20-R-0139 ---- For Barrier Performance and the associated AQL and RQL (which is directly from ASTM F3352-19) noted by A. at the bottom of the TABLE 1 Question.......is data proof for AQL and RQL required for submission to the RFP or is it noted (not required for the RFP) for ongoing supply quality if awarded a contract from SPE1C1-20-R-0139?

Answer: Passing test results must be submitted with each offer. The AQL and RQL pertain to testing of production lots of any resultant contract(s).

39. For the Level 2 reusable isolation gowns - do the seams need to be seam sealed?

Are the seams required to be tested to AATC 42 and AATCC 127?

Answer: The design & construction of the seams is the responsibility of the manufacturer. Seams must meet barrier performance requirements as specified in ASTM F3352.

40. The Revised Response Form cites “Documentation that gown is able to be laundered and machine dried without damage at a minimum of 25 laundering cycles”, but we cannot find reference in the solicitation or response form on what specific documentation is acceptable. Question: What is acceptable documentation that the gown is able to be laundered and machine dried without damage at a minimum of 25 laundering cycles?

Answer: A Certificate of Compliance is acceptable for this requirement. Per the solicitation “All Reusable Isolation Gowns shall meet the requirements of ANSI/AAMI PB70 before and after a minimum of 25 laundering cycles (wash and dry) when laundered in accordance with the manufacturer's instructions.” The Government reserves the right to request test reports or use other means to verify any Certificates of Compliance.

41. ASTM D 5034 Tensile Strength - The scope of this test method is wovens, non-wovens, and felted fabrics and is not recommended for knit fabrics. Request the use of ASTM D3787 for knit fabrics.

Answer: In the case of knits, ASTM D3787 is acceptable in lieu of ASTM D5034. The offeror shall clearly indicate that the reason for using the alternate test method is due to the material being knitted fabric.

42. ASTM D 5587 Tear Strength – Refer to Section 5. Significance and Use, 5.5. 100 % polyester textured filament knit fabrics will not rupture or tear, but rather show a single high peak due to yarn distortion and therefore will not provide meaningful results. Request to exclude this test requirement for knitted fabrics.

Answer: Tear Strength is not required for knits. The offeror shall clearly indicate that the reason for not including Tear Strength test data is due to the material being knitted fabric.

43. ASTM D 1683 Seam Strength – The scope of this test method is woven fabrics only. Request to exclude this test requirement for knit fabrics, or allow for a modification to ASTM D 3786 to test seam strength for knits.

Answer: In the case of knits, ASTM D751 is to be used in lieu of ASTM D1683/1683M. Refer to paragraph 10.4 in ASTM F3352-19.

44. Which test method is required for evaluating “damage” after 25 launderings? Will evaluation criteria be provided?

Answer: Damage would include degradation of performance such that the Gown no longer meets the stated requirements. Offers must contain test data or a Certificate of Conformance indicating that the offered item meets Barrier Performance requirements before and after 25 laundering cycles.

45. What performance is expected of the seams in Level 2 and Level 3 isolation gowns? They may be different, level dependent. ASTM F3352-19, Table 1 specifies specific seam strength for both levels. Furthermore, section 5.2 discusses design and considers the critical zone as “the entire gown, including seams….” It goes on to say that these critical areas need to have a performance of Level 1. If I interpret all of this correctly, the gown can be Level 2 or 3, yet the seam performance (a weak spot), needs to only be Level 1.

Answer: Yes, seams must meet Level 1 barrier performance.

46. On Page 23 of the solicitation, Part 12 #6, states that the label shall clearly identify the type, protection level, and size of the gown. Did this label need to be affixed to every gown for production, or was this label just for the PDM?

Answer: All Isolation Gowns delivered under and future contract(s) must be labeled. Refer to section 11 of ASTM F3352.

47. The following clarification is provided to assist offerors in completing the proposal submission form REVISION 2:

1. On page 1, please enter the name of the company submitting the proposal as your response to “COMPANY.” This would be identical to the company name provided in block 17a of SF1449.

1. On page 1, please enter the name of the end item manufacturer as your response to “SOURCE OF SUPPLY.”

1. If your company is submitting the proposal AND manufacturing the end item, your response to “COMPANY” and “SOURCE OF SUPPLY” would be identical.

1. On page 4, under 52.215-6 Place of Performance, if you check “intends” (which indicates you are using a facility located at an address that differs from your response to block 17a of SF1449), please complete the two text boxes provided included with the provision. The name provided here would be identical to your response to “SOURCE OF SUPPLY” on page 1.

1. On page 4, under 52.215-6 Place of Performance, if you check “does not intend” (which indicates that you are using the address listed in your response to block 17a of SF1499 to manufacture the end item), then you are not required to complete the two boxes immediately below this paragraph and your responses to “COMPANY” and “SOURCE OF SUPPLY” would be identical.

1. On page 7, please enter the name, CAGE code, part number, and country of origin for the company manufacturing the end item. This should be identical to your response to “SOURCE OF SUPPLY” on page 1 and your response to 52.215-6 Place of Performance on page 4 if you check “intends.” If the offeror is also manufacturing the end item, the responses to “COMPANY” and “SOURCE OF SUPPY” would be identical to the response here.

NOTE: As stated in the solicitation, amendments and the proposal submission form REVISION #2, if you are using multiple places of performance you shall submit separate proposal submission forms and a PDM for each place of performance. You can only enter one (1) place of performance under the first box under 52.215-6 Place of Performance (and the name and address of the owner and operation of that facility if other than offeror/respondent).

48. Question: What documentation or label should go with the gown to be tied to our proposal and solicitation?

Answer: The offer should provide relevant information with their PDM in order to clearly identify which PDM is associated to an offeror’s submission form. Such information should be included in a cover letter referencing the solicitation number, lot number, offeror’s name, end item manufacturer name, and gown level.

Solicitation and Any Subsequent Amendments

Proposal Submission Form

PDM

Attach Test Reports, CoCs, and other required documentation from fabric supplier #1

Attach Test Reports, CoCs, and other required documentation from fabric supplier #2

Proposal Submission Form for Gown Made by Company #2

PDM for Gown Made by Company #1

Attach Test Reports, CoCs, and other required documentation

PDM for Gown Made by Company #2

Proposal Submission Form for Gown Made by Company #1

Proposal Submission Form for Gown Made by Company #2

PDM for Gown Made by Company #1

PDM for Gown Made by Company #2

Proposal Submission Form for Gown Made by Company #1

Proposal Submission Form

PDM

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