Revision 2 - Reusable Isolation Gown Submission Form.pdf

Source Selection Information See FAR 2.101 & 3.104

REVISION #2

PROPOSAL SUBMISSION FORM FOR REUSABLE ISOLATION GOWN UNDER

SOLICITATION SPE1C1-20-R-0139

COMPANY: _______________________________________ GOWN LEVEL: __________________

LOT SUBMITTED UNDER: _______________________________________

SOURCE OF SUPPLY: _______________________________________

The following document is provided to assist you in preparing your proposal for solicitation SPE1C1-20- R-0139. Please review the addendum to 52.212-1 Instructions to Offeror – Commercial Items for instructions on how many forms are required if you plan on submitting multiple places of performance, fabric suppliers, and/or sources of supply. If you are submitting your proposal under the Berry Compliant lot (Lot 1), you shall complete #1. If you are submitting your proposal under the Buy American Act Compliant End Items from Domestic or Qualifying Countries or Provide an End Item Whose Primary End Item Fabric is Manufactured in the United States lot (Lot 2), you shall complete #2.

1. Offerors are cautioned that there is a strong preference for an item in which all components are of domestic origin in compliance with clause 252.225-7012, Preference for Certain Domestic Commodities (DEC 2017), often referred to as the Berry Amendment. Please note that the gown being acquired under this lot of this solicitation is considered to be an item of clothing for purposes of the Berry Amendment.

I, (name) do hereby confirm by signature below that all articles or items of “clothing,” including the materials and components thereof, being offered for sale to the Department of Defense have been grown, reprocessed, reused, or produced in the United States, other than sensor, electronics, or other items added to, and not normally associated with, clothing (and the materials and components thereof).

Signature: ____________________________________________________

2. By completing this section, you are certifying that your product does not comply with the Berry

Amendment and certify that the item being provided that is:

[ ] Buy American Act Compliant End Item from a Domestic and/or Qualifying Country

Country of End Item Manufacture: _____________________________________

[ ] An item whose primary end item fabric is manufactured in the United States

I, (name) do hereby certify by signature below that the item being proposed under this lot meets the requirements indicated by the option checked above.

Signature:

Please provide the following information in the boxes provided. Once complete, you are to attach the documents listed herein to this form via the paperclip icon in Adobe. If the information required herein is not completed directly in this form, your proposal will be considered nonresponsive and will be rejected as it does not meet the terms and conditions of the solicitation making the proposal ineligible for award.

1. Minimum Quantity Acceptable for Award: The offeror will not accept a contract for less than

_______________________________________________ each.

2. Delivery Capabilities: The offeror shall enter the quantity of gowns it can provide within the time periods listed below. Please note that this is not a running total and the quantities you enter below are what you will be required to deliver on that date if you should receive a contract based on your proposal. If the quantity capability for a specific time period (i.e. September 30, 2020) is zero (0) then include such in the chart below. If an offeror is unable to make at least 3 incremental deliveries under this solicitation with a cumulative total of 75,000 gowns by January 15, 2021, the offer may be considered non-compliant and ineligible for award. As listed in the solicitation, offerors may submit offers under multiple lots; however, individual proposal submission forms and PDMs shall be submitted per place of performance. If an offeror is planning to use multiple fabric suppliers, it shall include the test data/CoCs outlined in the proposal submission form for each fabric supplier; however, only one (1) PDM is required.

Furthermore, offerors are cautioned that this solicitation, and SPE1C1-20-R-0137 (for the disposable surgical gown) and SPE1C1-20-R-0138 (for the disposable isolation gown) are independent of each other. Therefore, any awards resulting from these solicitations are independent of each other. If an offeror plans on submitting a proposal under multiple solicitations, they shall factor in their capacity and allocate it accordingly. If an offeror receives multiple awards under any of these solicitations, including awards for multiple lots and/or gown types, delivery dates will not be revised/extended from the proposed schedule the offeror provides below. All three (3) solicitations require incremental deliveries, preferably starting within 30 days after award so that government’s estimated buy quantity under each solicitation can be received by 15 January 2021. Multiple awards are anticipated under each solicitation/lot which may include overlapping deliveries.

September 30, 2020 October 31, 2020 November 30, 2020 December 31, 2020 January 15, 2021

February 28, 2021 March 31, 2021 April 30, 2021 May 31, 2021 June 30, 2021

July 31, 2021 August 31, 2021 September 29, 2021

3. Monthly Maximum Capacity: ______________________ per month. Note, if an award is made based on this proposal, the Government will not place delivery orders that exceed this quantity within any 30 day period.

4. Unit Price: $ each NOTE: Offerors shall provide one (1) unit price that is applicable to both sizes. This price will be used for price evaluation purposes; however, all contract awards will be issued with a unit of issue being a full pallet quantity (which you shall list on page seven (7) of this form). The award price will therefore be the unit price listed here multiplied by the quantity per pallet you list on page seven (7) of this form.

5. Sizes. Offerors shall submit proposals that contain all of the sizes listed below. The below size tariff represents the percentage of each size the Government estimates it will order of the awarded quantity; however, the Government reserves the right to order any combination of sizes. Offerors shall check the below box to certify that the proposal and unit price include the below listed sizes.

[ ] This proposal includes both sizes.

Large Extra-Large 50% 50%

6. Authorized Negotiators: The offeror represents that the following person is authorized to negotiate on its behalf with the Government in connection with this request for proposal. Please list names, titles, e-mail addresses, and telephone numbers for each authorized negotiator. As noted in the solicitation, awarding contract(s) based on initial proposals is planned.

Name: ________________________________________________

Title: ________________________________________________

Email Address: ________________________________________________

Telephone Number: ________________________________________________

7. If you are a large business (NAICS code 339113 / 750 employees) a small business subcontracting plan is required in accordance with FAR 52.219-9 Small Business Subcontracting Plan (MAR 2020). You shall title the PDF of this document as “Small Business Subcontracting Plan” and attach it to this form.

8. FAR 52.215-6 -- Place of Performance applies.

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation, [ ] intends, [ ] does not intend [check the applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

(b) If the offeror or respondent checks “intends” in paragraph (a) of this provision, it shall insert in the following spaces the required information:

Place of Performance (Street Address, City, State, County, Zip Code):

Name and Address of Owner and Operator of the Plant or Facility if Other Than Offeror or Respondent:

9. Procurement Note Identification of Sources of Supply. Contractors shall list the sources of supply for all materials/components used in the manufacture of this item. This includes base fabric/material, thread, rubber/elastics, etc. that will be used in the manufacture of this gown. This information will be redacted from any resultant award made from your offer.

(a) Offeror shall complete the following for the materials used in the manufacture of its proposed items

Material #1: ________________________________________________ Manufacturer (including address) of the material:

Material #2: ________________________________________________

Material #3: ________________________________________________

Material #4: ________________________________________________

Material #5: ________________________________________________

REVISION #2

PROPOSAL SUBMISSION FORM – TEST DATA SUB-FACTOR OF PDM EVALUATION

FACTOR

1. As part the product demonstration model evaluation factor, you shall complete the below page(s) in this document. A complete proposal submission form will require offerors to include TWO attachments to this form as outlined below. You shall label the attachments exactly as listed below in bold font and attach them to this form via the Adobe attachment function (paperclip icon). The attachments are as follows:

• ATTACHMENT #1: Photographs & Technical Drawings. Photograph(s) and/or technical drawing(s) for EACH size and fabric or basic material for the reusable isolation gown manufactured at the facility listed in your response to FAR 52.215-6 Place of Performance under the proposal submission form. Color and basic material shall be identified. Photos and/or technical drawings shall align the product with information listed herein and in the solicitation and show that the gown provides 360 degree coverage of the user.

• ATTACHMENT #2: Test Reports and CoCs. Copies of all test reports and CoCs referenced below. All test reports shall be from testing facilities that are equipped and capable of performing the required tests as prescribed in the referenced test methods. All test reports shall be from testing facilities possess either:

o ISO 17025 accreditation OR o ISO 9001 or equivalent management systems

• TEST REPORTS ARE REQUIRED for the following:

o Barrier Performance (AATCC 42 and 127) o Tensile Strength (ASTM D5034) o Tear Strength (ASTM D5587 or D5733) o Seam Strength (ASTM D1683/D1683M) o Biocompatibility - Offerors can submit one of the following options:

Complete test report in accordance with ISO 10993-10 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.)

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 o Flammability - Offerors can submit one of the following options:

(CPSC standard 16 CFR Part 1610) Documentation indicating the exact exception under 16 CFR Part 1610.1 that is applicable to the proposed item. Offerors claiming an exemption to the Flammability testing requirement in accordance with 16 CFR 1610 shall certify, for each item offered, that the item fully meets the exemption criteria listed in subsection 1610.1(d) of 16 CFR 1610. The certification shall include a detailed description of ALL materials contained in the offered item.

The offeror shall certify that the offered item does not pose a flammability risk to the user under normal use. The Government reserves the right to conduct laboratory testing or other means of product verification, and/or require test reports from the Contractor to verify that the offered item does not pose a flammability risk to the user under normal use.

Offerors shall follow the directions in the solicitation for submission of PDMs. Offerors shall follow the directions in the solicitation for submission of PDMs. The timeliness of PDM submission will be based on the tracking information provided by the offeror. The offeror shall provide the carrier name (must ONLY be either UPS/Federal Express) and tracking number below:

Carrier Name: ______________________________________

Tracking Number: ___________________________________

2. Product dimensions, in inches, for EACH size of reusable isolation gown manufactured at the facility listed in your response to FAR 52.215-6 Place of Performance (all dimensions measured with the Gown laying flat, with the back closed.) Product dimensions shall include the following at minimum:

a. Chest Finished Width, measured from folded edge to folded edge, one inch below the armholes.

b. Finished Length, measured from the highest point of neck opening straight down to the bottom edge of the Gown.

c. Sleeve Length, measured from the shoulder seam to the bottom edge of the cuff. If the Gown utilizes raglan sleeves or other designs lacking a traditional shoulder seam, the Sleeve Length may be measured from neck opening or other suitable reference point as long as the reference point is identified along with the measured length.

[ ] Please affirm that the proposed gown does not contain latex by checking this box as gowns containing latex are not acceptable.

Manufacturing Information (Place applicable information in this column) Manufacturer Manufacturer's CAGE Manufacturer's Part Number Product's Country of Origin

Product Data / Information (Place applicable information in this column) Number of Gowns per Case/Pack (QUP) Number of Cases per Pallet Number of Gowns per Pallet Gown Material Color(s) Offered

Chest Measurement (in inches) – LARGE Back Length (in inches) – LARGE Sleeve Length (in inches) – LARGE Chest Measurment (in inches) – EXTRA- LARGE Back Length (in inches) – EXTRA-LARGE Sleeve Length (in inches) –EXTRA- LARGE

Requirements - Offerors shall provide the documentation listed under the “ATTACHMENT #1:

Photographs & Technical Drawings” paragraph in the above section as one (1) PDF document. Offerors shall provide the documentation listed under the “ATTACHMENT #2: Test Reports and CoCs” paragraph in the above section as one (1) PDF document. Offerors shall label these documents as outlined in the above section and shall then attach these documents to this form via the paperclip attachment icon.

Offerors are then to provide the page(s) the specific test reports/COCs are found on in the below table.

Offerors are further reminded that proposal submission forms and PDMs will be independently evaluated.

If an offeror is submitting more than one form and PDM, it shall attach the "Photographs & Technical Drawing" and “Test Reports and CoCs” to each form even if they are the same photo/drawing and/or reports/CoCs. The Government will not take documents attached to one form and apply them to another form. It is the offerors responsibility to ensure they are submitting a complete and accurate proposal which includes but is not limited to all attachments outlined herein and a PDM.

# Requirement Page Number Information is Located On

Documentation that gown is able to be laundered and machine dried without damage at a minimum of 25 laundering cycles

Barrier Performance - AATCC 127 and AATCC 42 Lab Reports for Barrier Performance for the Corresponding Protection Level of Gown

Tensile Strength - ASTM D5034 Lab Reports for the Corresponding Protection Level of Gown

Tear Strength - ASTM D5587 (woven textiles), or ASTM D5733 (nonwoven textiles) Lab Reports for the Corresponding Protection Level of Gown

Seam Strength - ASTM D1683/D1683M Lab Reports for the Corresponding Protection Level of Gown

Biocompatibility – If using a complete test report, list the page(s) this report can be found on in your attachment as your response. If using one of the other options, put “N/A” as your response and ensure either number 7 or 8 are completed.

Biocompatibility – If using a CoC as outlined in the above section, list the page(s) this CoC can be found on in your attachment as your response. If using one of the other options, put “N/A” as your response here and ensure either number 6 or 8 are completed.

Biocompatibility – If using the FDA website/guidance, list the page(s) this documentation can be found on in your attachment as your response. If using one of the other options, put “N/A” as your response here and ensure either number 6 or 7 are completed.

Flammability – If using lab reports for Class 1 or Class 2 Flammability in accordance with 16 CFR Part 1610, list the page(s) this report can be found on in your attachment as your response. If you are claiming an exception to this requirement, put “N/A” as your response here and ensure number 10 is completed.

Flammability – If using an exception, list the page(s) this documentation can be found on in your attachment as your response. If you are including lab reports, put “N/A” as your response here and ensure number 9 is completed.

NOTE: Under no circumstances will the Government accept blanketed statements of an items ability to meet the Government needs. Offerors shall provide the above which fully demonstrate the proposed items ability to meet the Government’s need. Any proposal received that provides a blanket statement without supporting documentation shall be considered non-responsive and will be rejected.

NOTE: DLA Troop Support will not be performing laboratory testing as part of the PDM evaluation process and will instead rely upon the test reports and COCs submitted by the Offeror to verify these requirements. The Government reserves the right to utilize laboratory testing or other means of product verification during any resultant contract(s).

REVISION #2

PROPOSAL SUBMISSION FORM – PAST PERFORMANCE DATA

As listed in the solicitation, you shall provide past performance information on three (3) of your most recent awards for the same and/or similar items. Enter the information in the below table ONLY. If there is no available past performance for the same/ or similar items, provide your most recent performance on any government or commercial contract(s) that best demonstrate your capabilities. If you are using a different facility to manufacture these items as listed in your response to FAR 52.215-6 Place of Performance, provide two (2) records of your own past performance experiences and one (1) record for the company listed in your response to this clause.

Past Performance Record #1 Description of the Item(s) Provided:

Contract Number/Other Identification:

Contract Holder Name and Address:

Points of Contact Contract Holder:

Contract Award Date and Ending Date:

Total Contract Length:

Contract Type:

Number of Customers:

Number of Delivery Points:

Maximum Contract Dollar Value:

Annual Dollar Value (if an LTC):

Maximum Monthly Production Quantity:

Quality Issues if Experienced:

For substandard quality, the offeror shall specifically address any warranty actions taken, quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

Total Number of Deliveries That Were Made Ahead of Schedule/Were Early

Total Number of Deliveries That Were Made on Time

Total Number of Deliveries That Were Late Mitigating Circumstances Regarding Late Deliveries:

Steps Taken to Correct Delivery Problems if Experienced:

Problems or Discrepancies if Experienced:

Please include a description of how these problems were handled, the timeliness of your response/action, the corrective action taken, and if there was any urgency to the problem(s).

Past Performance Record #2 specifically address any warranty actions taken, quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

problems were handled, the timeliness of your

Past Performance Record #3 specifically address any warranty actions taken, quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

problems were handled, the timeliness of your