Questions and Answers to Disposable Isolation Gown RFP 1.docx

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

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: The solicitation will be amended and the correct form will be attached. Please monitor the DIBBS website for the amendment as it will be available on the website as soon as it released.

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). An amendment will be 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 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.

15. 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.

16. Multiple questions were received regarding the biocompatibility requirements listed in the solicitation. An amendment will be 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

17. Multiple questions were received requesting specifications and/or drawings. Please note that the gown being acquired under this acquisition is a commercial-off-the-shelf item and there are no specifications and/or drawings. 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.