Questions and AnswersII_IsolationGowns_Redacted.pdf

will our delivery schedule be adjusted accordingly?

5 Page 12, Section “g. Design”, Subpart 1b:

RFP States “All Isolation Gowns shall close in the back, with overlap of the back portions to ensure complete coverage and means of securing the gown in the closed position with ties.”

a. In reference to the Overlap, is the gown expected to maintain overlap coverage up to and including the point where it is secured at the neck?

Isolation gowns are expected to maintain complete coverage in the front and back including the point where it is secured at the neck.

6 Are we expected to submit our Quality Control Plan? If so, where in our Technical Proposal are, we supposed to include?

Offerors are expected to submit the quality control plan within five business days from the date of award, in accordance with C.5 Deliverables.

7 Page 42, Subfactor 5, please define “Specifications”.

Specifications is defined as the description of the isolation gowns offered such as, product description, AAMI level, part/model number, gown dimensions, shelf life, design, description, color and front and back gown images.

8 Page 7, B.5.A, please confirm Delivery period as it currently states November 5 2022 – November 5 2024?

B.5.A Delivery Period for CLINs 1001 & 1002- should be December 31, 2022 through December 30, 2024.

9 What is the difference between “Factor 3:

Past Performance” of the past amendments and “Factor 3: Similar Experience” of this amendment?

The GAO noted that evaluation under an experience factor is distinct from its evaluation of an offeror’s past performance. Experience focuses on the degree to which an offeror has actually performed work while past performance focuses on the quality of that work. A prospective contractor must always be determined to be responsible or nonresponsible, and past performance must be considered for that purpose. See FAR 9.103(b) and 9.104-1(c).

10 Specifically, why was the wording changed from "Past Performance" to "Similar Experience"?

See Question 9.

11 FAR 52.219.7 was added in I.2(b)(15);

however, there is no additional explanation of this throughout the amendment. How is this being implemented? What percentage, if any, of this contract is being set aside for small businesses?

FAR 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644). This item is unchecked under 52.212-5 and will be updated with amended 0007.

12 In order for design and quality to be verified, are you requiring/accepting samples of each CLIN?

The SNS is not requiring or accepting samples of each CLIN, and is relying on the manufacturer to provide isolation gowns that meet the requirements in the Amendment 0005 of the and aligns with the gowns and information provided in their proposal. After contract award, the USG finds the proposed isolation gowns no longer meet the design or quality the USG has the right to terminate the contract. The USG has the right to perform quality checks as needed.

13 Does the total submission email need to be less than 2MB, or is that the maximum file size for each attachment? If additional size is needed, should a second email be sent?

Amendment 0007 increases the maximum file size to 10MB for email attachments.

Also, vendors may send multiple emails.

14 Are detailed test results allowed to be submitted as separate attachments outside of the master Volume A - Technical Proposal file?

Offerors shall submit test results in the Volume A-Technical Proposal file. See Section M- Evaluation Factors For Award- Factor 2- Technical Capabilities- Subfactor 7- Test Reports.

15 If additional files are allowed, do you prefer them as separate attachments to the same email or as hyperlinks to a cloud file?

If hyperlinks are allowed, can they be embedded in Volume A - Technical Proposal under each Subfactor?

Offerors shall not submit hyperlinks to a cloud file or embed in Volume A- Technical Proposal under each subfactor.

16 For clarity's sake, and to avoid any similar issues to the last submission, if more than 2MB is needed how would you like that to be submitted from the offeror's end?

See response to question 13

17 Will the contracting officer make available exactly the contract representations, certifications and clauses required for submission as part of the business proposal? There are multiple references to representations, certifications and/or clauses in Amendment 0005 that are unclear on exactly what offerors should be including in the business proposal to address a full and complete submission.

Offerors shall see instruction in Section K- Representations, Certifications, and Other Statement of Offerors- K.1. 52.252-1.

18 Will the contracting officer clarify the 2MB email submission limit? Does this apply only to the technical and business proposals? Individually or collectively?

Should we submit our proposal in more than one email if any single attachment exceeds 2MB? The amendment requires that any included instruction/information documents shall be clear and readable if the image is enlarged. Our labeling/packaging submission alone is

4MB.

See responses on Question 13.

19 In the RFP section C.3.1 f.1.F on page 12, it states offerors shall provide the full test report for Biocompatibility. Page 17 states the Biocompatibility reports shall be provided to the COR/POC for review and approval within 45 days from the start of the contract and on pages 42-43 it states offerors shall provide a plan to obtain and deliver biocompatibility test reports to COR/POC within 30 days of award.

Question: Shall the full biocompatibility test report be provided in the proposal on the date of submission?

If biocompatibility test reports have already been completed for the proposed isolation gowns the Offerors shall indicate the date the report was completed and the accredited laboratory’s information (name, address, etc.) with the initial proposal. The actual test reports, laboratory accreditation and testing scope documentation for biocompatibility will be provided separately and within 45 days of award. Refer to Subfactor 8: Biocompatibility Report/Plan on page 43 of the RFP.

20 Will any weight be attached to bids from companies that have invested in new technologies to ensure America has a viable isolation gown manufacturing base for the future?

Offerors will be evaluated in accordance with Section M- Evaluation-Commercial Products and Commercial Services.

21 What is the government’s plan to enforce the 100% made-in-America requirement

Offerors proposal must be in accordance with Section H.5 Domestic Manufacturing- Contractor must certify that the Isolation Gowns provided are compliant with the IIJA/Make over the life of the contract to ensure a level playing field?

PPE in America. The goods must be manufactured in the U.S. or its territories, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States. Offerors shall provide documentation supporting their claim that the offered product is a domestic end product. The Offeror shall demonstrate that they can meet Domestic End Product Requirement identified in Section C.4 Product Technical Requirements. This is a mandator requirement.

22 In the last Q&A, HHS stated “If available, accelerated aging and real-time testing reports could be provided to validate shelf-life claims.” Does this mean shelf life test results are not essential to a successful bid?

Test results and validating documentation are not needed if there are no shelf-life claims being made on the proposed isolation gown. If the isolation gown does not have a shelf-life claim, the product, when delivered to the SNS, shall have no more than 3 months expended since the date of manufacturer.

And, yes, if the Offeror is making a shelf-life claim (a statement in the proposal, on the technical specification sheets, and or an expiration date listed on the isolation gown packaging, etc) on the proposed Isolation Gown then the Offeror must provide supporting data and documentation, such as accelerated aging and or real-time testing reports and other validating documentation, to support these shelf-life claims. Isolation gowns that have a shelf life, shall be delivered to the SNS with no more than 20% of total shelf life expended.

23 Since HHS has allowed successful bidders an extension to demonstrate compliance with cytotoxicity standards, will a grace period also be granted for shelf life test completion?

Offeror must provide the test to support shelf life claims made in their proposal.

Shelf-life validation is required for any Offeror making a shelf-life claim (such as with a statement in the proposal, on the technical specification sheets, and or with an expiration date listed on the isolation gown packaging, etc) for the proposed isolation gown(s). If shelf life has not been previously determined from industry practices like accelerated and real-time testing, or other, then shelf-life claims shall not be made on a product. If shelf-life claims cannot be validated then claims (such as with a statement in the proposal, on the technical specification sheets, and or with an expiration date listed on the isolation gown packaging, etc) shall not be made on the proposed isolation gown.

24 Will lab results from facilities outside of the US but in North America be accepted?

Yes, test reports on the offered isolation gown from outside the U.S. are allowable. Offerors shall provide test reports on the offered isolation gown, that have been conducted at an independent ISO 17025 accredited laboratory, with each test being within the scope of the laboratory’s accreditation. Test reports must be in English and include a description of the test device and components tested. Offerors shall provide documentation supporting the laboratory’s ISO 17025 accreditation and illustrating that each test performed at the laboratory is within their scope of accreditation. Refer to Section C and Subfactor 7: Test Reports in Sections L and M.

25 What steps will the government take to ensure compliance with raw materials being sourced from the United States?

See response to Question 21.

26 A common tactic in the PPE space is to buy cheap products from overseas (mostly Asia or Mexico) and simply re-box them in the United States. What steps will the government take to ensure that reboxing is not occurring?

See Section M- Evaluation Factors- Technical Capability- Subfactor 3- Labeling and Packaging

27 The period of performance changed from 12 months to 24 months. Does this mean that HHS now has 24 months of funding for 150 million gowns?

HHS Requirement is for 24 months and quantity of 150,400,000.

The period of performance is anticipated to total 24 months from the date of award. The new anticipated period of performance is December 31, 2022 through December 30, 2025. Base Period: 24 months- Domestic Isolation Gowns Level 2 Quantity totals 150,400,000.

28 The period of performance changed from 12 months to 24 months. Does this mean that funding is only obligated/secured for Year 1 PoP of 75 million gowns, but now the delivery timeframe is 24 months?

Funding will be obligated for the 24 months.

29 Was the terminology and evaluation criteria surrounding shelf life

The Agency previously received two bid protests, which resulted in voluntary corrective action. One was a GAO protest and the other was a protest filed with the Agency. The changed because of a protest? Was the protest at the agency level, or in

GAO/COFC?

protests resulted in voluntary corrective action, in which the Agency intended to review its requirements in light of the protest grounds, amend the solicitation, extend the due date for receipt of proposals; and take other actions, as deemed necessary and appropriate by the Agency.

The terminology and evaluation criteria surrounding shelf life changed based on the Agency’s assessment of its needs.

30 Why was the terminology changed surrounding evaluation criteria for Shelf Life?

The terminology changed for evaluation of shelf life based on the Agency’s assessment of its needs.

31 Will HHS give additional consideration and more points during Source Selection to vendors who can show that their product has tested at Level 3 standards?

The requirement is for an AAMI Level 2 isolation gown. An AAMI Level 3 isolation gown that meets the AAMI Level 2 isolation gown criteria and is labeled as an AAMI Level 2 gown, will be considered and weighed equivalent to an AAMI Level 2 isolation gown. An isolation gown labeled AAMI Level 3 will not be considered.

32 Will HHS/SNS give additional consideration and more points during Source Selection to vendors who can demonstrate scalability and quality assurance through technological innovations that can be rapidly applied throughout the industrial base?

The Government intends to evaluate and make award(s) in accordance with the terms of the Solicitation and all applicable statutes and regulations.

33 Will the government prioritize and give additional consideration to small businesses with a strong record of past performance to the federal government in manufacturing of PPE?

34 What is the current SDVOSB subcontracting goal for HHS on this contract?

This acquisition is subject to the requirements of FAR Subpart 19.7 (The Small Business Subcontracting Program). A Subcontracting Plan shall be submitted by offerors who are large business concerns only. Offerors must comply with FAR 52.219-9 Small Business Subcontracting Plan (Nov 2021).

The HHS current subcontracting goal is 22.85% for Small Business (hereafter referred to as SB), 4.49% for Small Disadvantaged Business, including 8(a) Program Participants, Alaska Native Corporations (ANC) and Indian Tribes (hereafter referred to as SDB), 1.77% for Women-Owned Small Business, 1.29% HUBZone, 2.64% Serviced-disabled Veteran-owned Small Business (SDVOSB) and Economically Disadvantaged. Offerors shall provide past experience in meeting proposed subcontracting goals along with processes that have been implemented to correct inabilities to meet subcontracting goals. Past performance in meeting or exceeding SB subcontracting goals shall be demonstrated utilizing copies of Electronic Subcontracting Reporting System(eSRS) reports. Offerors shall include most recent eSRS reports covering the last three (3) years.

The eSRS reports shall include contracts of similar size and scope to this requirement. In order to be considered for award the “successful offeror” SHALL have a subcontracting plan that complies with HHS Agency subcontracting goals for each socioeconomic category in order to receive award. If the apparent successful offeror fails to negotiate a subcontracting plan acceptable to the contracting officer within 30 days or the time limit prescribed by the contracting officer, the offeror will be ineligible for award.

35 Given that temperature, humidity, and other storage conditions greatly impact Shelf Life, how will the government ensure those conditions are being met in the delivery locations to ensure proper shelf life?

See response to Question 22

36 Given that this is a full and open competition and Best Value, is the HUBZone price differential applicable to this solicitation? (10% price evaluation in accordance with FAR 19.1307)

37 Will the government please confirm that only testing from US-based labs is acceptable for this submission?

Test reports on the offered isolation gown from laboratories within the U.S.-and outside the U.S are allowable. Offerors shall provide test reports, on the offered isolation gown, that have been conducted at an independent ISO 17025 accredited laboratory, with each test being within the scope of the laboratory’s accreditation. Test reports must be in English and include a description of the test device and components tested. Offerors shall provide documentation supporting the laboratory’s ISO 17025 accreditation and illustrating that each test performed at the laboratory is within their scope of accreditation. Refer to Section C and Subfactor 7:

Test Reports in Sections L and M

38 Does the government anticipate making many awards to small business with the intent of Industrial Base Expansion?

The government anticipates making award in accordance with IIJA/Make PPE in America

39 Does the government anticipate prioritizing small business over large business?

All offerors will be evaluated based on the offerors compliance with the terms and conditions of the solicitation.

40 How much funding is currently obligated for this requirement?

Funding will be obligated based on the negotiated awardee price.

41 Will the government please confirm that those vendors who have already spent significant time, energy, resources and money to complete 10993-5 and 10993-10 biocompatibility studies (with US materials) *before* submission of this RFP will be given extra consideration during source selection?

Biocompatibility testing shall be completed on all U.S. made and sourced isolation gowns offered in these proposals. Biocompatibility testing will not be reviewed in the initial proposal to allow Offerors’ time to complete the testing and meet the requirement. Therefore, all biocompatibility test submissions will be weighed the same.

If biocompatibility test reports have already been completed for the proposed isolation gowns the Offerors shall indicate the date the report was completed and the accredited laboratory’s information (name, address, etc.) with the initial proposal. The actual test reports, laboratory accreditation and testing scope documentation for biocompatibility will be provided separately and within 45 days of award. Refer to Subfactor 8: Biocompatibility Report/Plan on page 43 of the RFP.

42 If vendors are allowed to submit biocompatibility studies *after* award, will the government also allow shelf life studies (whether accelerated aging or normal shelf life aging) to be conducted *after* award?

See response to question 23.

43 Will vendors be deemed non-compliant and eliminated from competition if they do not submit shelf life data for their gowns?

See response to question 22.

44 Will the government allow shelf-life studies to be performed concurrently during the course of the period of performance as opposed to submitting shelf-life studies now with the RFP’s proposal?

45 Given the extraordinary cost associated with a US-based shelf life study (some estimates range from $20k to $60k), will the government require shelf life studies to be performed *before* RFP proposal submission? Or can it be performed after submission like the biocompatibility studies?

46 The CDC states “ The majority of isolation gowns do not have a

See response to question 22.