Questions and Answers to Disposable Isolation Gown RFP 7.28.docx

Below is the current cumulative list of Questions & Responses to solicitation SPE1C1-20-R-0138 as of July 28, 2020, 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.

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.

Solicitation clarifications are directly below and Questions and Answers start of page 7 of this document.

CLARIFICATIONS:

Clarification #1: 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 to 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

Clarification #2: 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:

Clarification #3: 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.

2. Click on paperclip icon to view attachments.

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

QUESTION AND ANSWERS:

Based on questions received in response to the solicitation as of July 27, 2020, the following clarifications are also provided for this solicitation:

1. Question: Seam Strength (ASTM D1683/D1683M) testing is required per the solicitation. However, the test is not included in ‘Requirements’ table on Page 7 of the Revised Response Form. How would DLA like us to submit the required test in the proposal?

Answer: Seam strength has always been a requirement per ASTM F3352 (for Isolation Gowns) and ASTM F2407 (for Surgical Gowns). The updated forms correctly identify this test as being required for proposal submission.

2. Question: Can you specify the seams that you would like tested for ASTM D1683?

Answer: All seam types and material combinations that will be used in the end item must be tested. If identical materials and seam types are used in various locations (ex. Side seam, sleeve seam) then only one set of test results will be required for those locations.

3. Question: Regarding gowns that are Low Density Polyethylene (LDPE), and LDPE and derived from Olefins, Laboratory Test for Flammability 16 CFR Part 1610.1 (D) (2) specifies exemptions from testing. Please confirm that no flammability test is required for this material.

Answer: Changes to Flammability testing requirements are addressed in Amendment 0002. Note that the exemptions referenced in this question apply only to fabrics. In any case, products offered in response to this solicitation must not pose flammability risks to the user under normal use.

4. Question: The solicitation states that “test reports shall be from an ISO 17025 accredited testing facility.” Is an ISO 9001 accredited facility not sufficient?

Answer: This requirement has been addressed in Amendment 0002. ISO 9001 or equivalent quality management systems may be found to be acceptable in lieu of ISO 17025.

5. Question: The inclusion of the Seam Strength (ASTM D1683/D1683M) test requires that PDMs will need to completed and then sent for testing before submission to DLA Troop Support. We’ve found that even expedited testing requires at least two days. This will make submission of PDMs at 11 a.m. EDT on Aug 3 very challenging.

Answer: The wording of both ASTM F3352 (for Isolation Gowns) does NOT require that seam strength testing be conducted on completed end items. Representative seams may be created for testing purposes. All seam types and material combinations that will be used in the end item must be tested.

6. Question: Is Barrier Performance (AATCC 42 AND AATCC 127) required for Garment and/or Seam?

Answer: The Barrier Performance requirement applies to the entire gown, including seams but excluding cuffs, hems, and bindings. Therefore the fabric or basic material must be tested, as well as the seams that are not part of cuffs, hems, or bindings.

7. Question: Are surgical gown proposals accepted under the isolation gown solicitation if all requirements are met?

Answer: 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.

Based on questions received in response to the solicitation as of July 24, 2020 at 11:30 AM, the following clarifications are also provided for this solicitation:

1. 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.”

2. Question: How the gowns are to be folded (including the PDM)

Answer: The only requirement is in ASTM F3352 section 11 which states that the “gown shall be folded and packaged in such a way that the size and level of barrier performance is visible.”

3. Question: If any information is needed on the gown label besides "...the type, protection level, and size of the Gown." E.g., no manufacturer or contract number?

Answer: Please refer to ASTM F3352 section 11 with ASTM D3951 Commercial Packaging section 5.1.6. The manufacturer and contract number will be on the box/case and not the gown level label.

4. Question: How is the PDM to be packaged?

Answer: It is preferred that you package it the same way you would in production.

5. Question: Page 7 of the Revised Proposal Submission Form asks for 5 test reports to be attached but that section does not match the required reports of Page 6 sec. 1 Test Reports and CoC's which lists 6 reports.

Answer: Page five (5) of the revised proposal submission form is provided for offerors to list their sources of supply as required under procurement note Identification of Sources of Supply. This is where you will list the manufacturers of the individual components used to make the gown (i.e. end fabric is manufactured by Company ABC, thread is manufactured by Company DEF, etc.) Page six (6) of the revised proposal submission form lists the test reports/COCs you must submit to the form to show that the proposed item meets all requirements.

6. Question: Does each factory location need to meet any minimum standard, ie ISO Certification, FDA approved, or other certifications?

Answer: No, there are no specific ISO Certifications or FDA requirements for the facilities.

Based on questions received in response to the solicitation as of July 22, 2020 at 3:00 PM, the following clarifications are also provided for this solicitation:

1. Question: Our understanding is FDA product-specific assertion as to Level 2 and Level 3 is required, is this a correct assumption?

Answer: No FDA registration is needed on level 2 or 3 isolation gowns per ASTM F3352.

2. Question: In Table 1: Requirements and Test Methods, D1683/D1683M are specified for Seam Strength. These are only applicable to woven materials, and our submission is made from a non-woven material. Can we use ASTM D751 instead?

Answer: Yes, as per section 10.4 of ASTM F3352. Section 10.4 of ASTM F3352 clearly spells out which test method to use for materials that are not woven fabric.

3. Question: We are a distributor of PPE including disposable and reusable isolation gowns. We subcontract with a manufacturer to make the gowns, however in the proposal submission form it says to enter the manufacturer cage code. Do we enter our cage code or the manufacturer we subcontract with cage code?

ANSWER: The manufacturer’s CAGE code would be the company manufacturing the item. In this case, you would list the subcontractor used. The offeror’s CAGE code (if other than manufacturer) should be listed on page 3 of the solicitation standard form 1449.

4. Question: Does the label need to be attached to the gown.

Answer: Yes, Isolation gown ASTM F3352 – 19 section 11

5. Question: If attached to the gown in what location.

Answer: Placement must meet ASTM F3352 – 19 section 11 The gown shall be folded and packaged in such a way that the size and level of barrier performance is visible.

6. Question: What material should be used to make the label

Answer: Label materials are not specified. Labels must meet the requirements specified in the solicitation including, but not limited to, the requirements of ASTM F3352-19.

7. 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 Disposable Isolation 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 technically acceptable offerors as possible, so that at the estimated quantity of 189,750,000 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.

8. 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.

9. Question: Can you provide additional information on the hem requirements?

Answer: The design of any hems, if included, is at the manufacturer’s discretion provided the end item meets all specified requirements and does not ravel or otherwise degrade under normal use. Hems or raw edges that ravel or shed material under normal use are considered unacceptable.

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

ANSWER: See above flow charts for proposal submission forms and PDMs when using multiple fabric suppliers.

11. 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.

12. Question: Please verify the level of RFID required, if any – pallet, case, item, etc… Since the unit of issue will be the pallet, the pallet/case are one in the same. We see no mention of RFID in the solicitation.

Answer: RFID is not required under this acquisition.

13. Question: Please confirm with the Unit of Issue being a pallet, the standard MIL-STD-129 label is only needed on the pallet.

Answer: A label is required for the case/exterior case and the pallet.

14. Question: Our supplier has multiple manufacturing facilities across the country. Is a PDM required for each facility?

Answer: A PDM is required per place of performance (manufacturing location) including facilities owned and operated by the same company.

15. Multiple questions were received about how many Gowns should be placed in each box/case. This is also known as “Quantity Unit Pack” or QUP. 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.

Based on questions received in response to the solicitation as of July 22, 2020 at 10:30 AM, the following clarification is provided for this solicitation:

1. Questions regarding lot applicability, Berry Amendment, Buy American Act, and/or Trade Agreements, 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, qualifying or designated 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 OR provide an end item whose primary end item fabric is manufactured in the United States.

c. Trade Agreement Act Compliant Lots (if applicable): FAR Subpart 25.4 provides a list of applicable Trade Agreements.

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

2. Question: Can we supply you Gowns that are manufactured in China?

Answer: Offers of end products from other countries not defined under the above regulations, including China, can be submitted under Lot 3, but the provisions of the TAA apply and offers of TAA compliant end products have a preference over non-TAA compliant offers. It is recommended that offerors review the language at FAR 25.003 and DFARS 225.003 for definitions and what it means to be considered a domestic, qualifying or designated country end product. To determine if a proposed item meets the requirements of each specific lot, offerors should review the answer to the above listed question.

3. Question: The proposal submission form attached to the solicitation is for a reusable isolation gown and refers to SPE1C1-20-R-0139. Is this correct?

Answer: Amendment 0002 is issued to include the correct form (attached to the amendment). The amendment can be found on the DIBBS website or Beta.Sam.

4. 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.

5. 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: The incorrect form was attached to this solicitation (the form was for the reusable gown while this acquisition is for disposable isolation gowns). Amendment 0002 is issued to delete this form and replace it with the correct form. Past performance will be rated as outlined in the addendum to 52.212-2 Evaluations – Commercial Items. Commercial contract provided will be used to determine the offeror’s responsibility if they are in line for an award.

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

7. 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 determination not to be technically acceptable.

8. 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.

9. Question: Will you consider open back and/or overhead gowns?

Answer: No.

10. 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.

11. 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.

12. Question: How do I register in SAM.Gov?

Answer: To register in SAM, please go to www.sam.gov, Getting Started – Register Entity.

13. Question: Do we need to 'finish' the neck on the disposable gown?

Answer: It was a note in the tech data of each item “hem” or “hems” are applicable only to fabrics or other materials that may ravel or degrade if edges are not hemmed. Films, laminates, and non-woven fabrics are not required to be hemmed unless there is risk of raveling or degradation of the edges through normal use.

14. Multiple questions were received regarding the requirements of ISO 17025 and seam strength testing listed in the solicitation. Changes to ISO 17025 are made via an amendment 0002. The amendment is posted to the DIBBS and Beta.Sam website. Offerors should continue to monitor this website for any amendments.

15. Multiple questions were received regarding the biocompatibility requirements listed in the solicitation. Amendment 0001 is issued to change these requirements as follows:

Reference is made to the biocompatibility requirements listed in the solicitation and proposal submission form. The following changes are hereby made:

Offerors can include the following as an attachment to its proposal submission form to demonstrate the proposed items ability to meet the biocompatibilities listed in the solicitation:

a. Complete test report in accordance with ISO 10993-10, OR

b. In lieu of a test report, a Certificate of Compliance, stating that the product(s) offered conform to the requirements of ISO 10993-10, may be accepted. (Note: the Government reserves the right to request test reports to validate all COCs.), OR

c. Documentation, in accordance with current FDA guidance, that demonstrates that the product(s) offered are safe for the intended use and do not require testing in accordance with ISO 10993-10. The FDA guidance is listed in this website: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and

16. Multiple questions were received requesting specifications and/or drawings. This acquisition is 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.

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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