Amendment 0005_Isolation Gowns103122.75A50322R00008.pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment, you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to revise the solicitation to ensure it is in compliance with the Infrastructure Investment and Jobs Act (IIJA)/Make PPE In America.

Solicitation 75A5032200008 is hereby amended in its entirety.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OFCONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

2. AMENDMENT/MODIFICATION NUMBER

00005

PAGE OF PAGES

1 50

5. PROJECT NUMBER (If applicable)

6. ISSUED BY

ASPR/SNS

2945 Flowers Road Atlanta, Georgia 30341

CODE ASPR 7. ADMINISTERED BY (If other than Item 6)

Same as Block 6

CODE ASPR

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) 9A. AMENDMENT OF SOLICITATION NUMBER

75A50322R00008

9B. DATED (SEE ITEM 11)

10/31/2022

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

(X)

4. REQUISITION/PURCHASE REQUISITION NUMBER 3. EFFECTIVE DATE

10/31/2022

1. CONTRACT ID CODE

COMBINED SYNOPSIS SOLICITATION

Amendment 0005 to Solicitation 75A50322R00008

The solicitation document for RFP 75A50322R00008 dated June 28, 2022, indicating a proposal due date of July 22,2022, is hereby superseded in its entirety by the attached RFP 75A50322R00008, Amendment 0005 dated November 1, 2022, indicating a proposal due date of November 17, 2022. See below for a list of additional changes. Offerors are directed to use the RFP attached to this amendment for their response to this solicitation. Responses to the original RFP will not be evaluated. In accordance with FAR 52.212-1(b)(9) acknowledgment of solicitation amendments is required.

The attached solicitation document for RFP 75A50322R00008 incorporate the following additional changes to the solicitation:

1. Changes the due date of the proposal from 1:00 pm ET, August 3, 2022, to 1:00 pm, November 17, 2022. The offeror’s complete proposal (including all information required to be submitted in Volume A – Technical Proposal, and Volume B – Price/Business Proposal) must be received by the date and time specified for receipt of offers. Only electronic submissions will be accepted. Complete proposals must be submitted via email to dsnssolicitations@cdc.gov with the subject line “RFP 75A50322R00008, Amendment 0005 – Domestic

Isolation Gowns Level 2.” Email submissions are limited to 2 MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

2. 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.

a. Base Period: 24 months

Domestic Isolation Gowns Level 2 Quantity- 75,200,000

Anticipated Period of Performance: December 31, 2022 through December 30, 2024.

b. Option period: 12 months Domestic Isolation Gowns Level 2 Quantity – 150,400,000

Anticipated Period of Performance: December 31, 2024 through December 30, 2025.

3. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition

Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested.

4. The solicitation number is 75A50322R00008 which is a Request for Proposal (RFP). Contract Type will be Firm Fixed Price (FFP).

5. The solicitation document and incorporated provisions and clauses are currently in effect through Federal Acquisition

Circular 2022-06, effective May 26, 2022.

I. Contract Type will be Firm Fixed Price.

II. NAICS Code: 339113 (Surgical appliance and supplies manufacturing). The size standard is 750 employees.

III Offerors shall include a completed copy of FAR 52.212-3, Offeror Representation and Certifications-Commercial Items, with their Offers. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, offerors shall make a statement to that effect in accordance with the clause).

IV. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2021), applies to this acquisition.

VI. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive

Orders-Commercial Products and Commercial Services (Oct 2022) applies to this acquisition and FAR clauses applicable include 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition

Regulation (HHSAR) clauses.

mailto:dsnssolicitations@cdc.gov

VII. a. There are no special contract requirements or terms and conditions related to contract financing arrangements.

b. Pursuant to Presidential Decision Directives 39 and 62 and Sections 311 and 319 of the Public Health Service Act, SNS storage locations are sensitive and shall not be disclosed.

The Contractor shall sign a non-disclosure agreement (applicable and enforceable to all employees of the contractor) to not disclose any details relating to the contract, and hold all employees and/or subcontractors involved in the performance of this requirement to the same. At any time, the Government may request employees and/or subcontractors related to this performance to sign a non-disclosure agreement. HHS Non-Disclosure forms shall be released to the awardees as part of their award package.

The Contractor shall adhere to the sensitivity requirements relating to the contract whenever granted access to DSNS Sensitive

But Unclassified information (SBU), and all times thereafter. The contractor shall not share the Sensitive But Unclassified information (SBU) or the HHS Non-Disclosure Agreement (NDA) without Government approval.

VIII. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this contract in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

IX. The point of contact for information regarding this combined synopsis/solicitation is

Sherica Teshome, Contract Specialist

Office of Resource Management (ORM)

Administration for Strategic Preparedness and Response (ASPR)

U.S. Department of Health and Human Services (HHS)

Email: dsnssolicitations@cdc.gov

I. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A-Health

Resources Priorities and Allocations System.

II. Offers are due no later than November 17, 2022, by 1:00 p.m. Eastern Time, with the Subject

Line RFP 75A50322R00008, by email to dsnssolicitations@cdc.gov.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Line Items

Base Quantity:

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE

1001 Isolation Gowns Level 2 Size:

Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work (SOW) below, Terms and

Conditions contained herein, and the

Contractor’s proposal dated

2022.

This is a Firm Fixed Price line item.

Anticipated Delivery Period: December 31, 2022 through December 30, 2024

37,600,000 Each $

1002 Isolation Gowns Level 2 Size:

X-Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work (SOW) below, Terms and

Conditions contained herein, and the

Contractor’s proposal dated

2022.

This is a Firm Fixed Price line item.

Anticipated Delivery Period: December 31, 2022 through December 30, 2024

37,600,000 Each $

Optional Quantity

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE

Optional Ordering Quantity

Isolation Gowns Level 2 Size:

Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work (SOW) below, Terms and

Conditions contained herein, and the

Contractor’s proposal dated

2022.

This is an option for increased quantity; see

B.2 below.

This is a Firm Fixed Price line item.

Anticipated Ordering Period: 31 December 2022 through 30 December 2025

75,200,000 Each $

Optional Ordering Quantity

Isolation Gowns Level 2 Size:

X-Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work(SOW) below, Terms and

Conditions contained herein, and the

Contractor’s proposal dated

2022.

This is an option for increased quantity; see

B.2 below.

This is a Firm Fixed Price line item.

Anticipated Ordering Period: 31 December

2022 through 30 December 2025

75,200,000 Each $

* NOTE: The Government reserves the right to make multiple awards under this solicitation, and different vendors are likely to propose on and may be awarded different quantities of isolation gowns. The exact number of isolation gowns across all awards is unlikely to equal exactly 75.2 million for the base quantity or 150.4 million for the option, and the total number (across all awards) may vary by up to 10%. Each individual vendor’s award will show only the quantity awarded to them. No one vendor is anticipated to receive the total requirement. However, the Government reserves the right to make a single award if determined to be in its best interest.

B.2 Option for Increased Quantity – Separately Priced Line Items ( Surge Support Services) Included as Separately Priced

Line Items 2001-and 2002

The contractor shall provide additional supplies (Isolation Gowns) if the Government has a requirement for it. The contractor must be capable of responding to unanticipated demands for increased capacity of the quantities within existing capabilities covered under this SOW that may require an “increase” in supplies. Increased quantity requirements are demands for accelerated or increased supplies identified in this SOW, due to ‘emergency response’ or public health related events, Presidential/Congressional inquiries/directives, or similar.

The Government reserves the right to exercise an option CLIN under this contract to meet increased requirements. The

Government reserves the right not to exercise the optional CLIN(s) for increased support, if no increased requirements are required during the entire performance of this contract.

B.2 are separate from and in addition to the items specified in the Separately Priced Line Items 2001 and 2002 Prices applicable during the ordering period:

Product Name (Date range)

31 December

2022 through date

(Date range) date through date

(Date range) date through 30

December 2025

Isolation Gowns Level 2

Size: Large Unit price is per Each.

Isolation Gowns Level 2

Size: X-Large Unit price is per Each.

NOTE: The contractor may add or delete columns from the above table, if needed.

The amount of funding for each instance of exercising an option CLIN can be calculated as follows: number of units X price per unit for the CLIN being exercised funding amount.

The Contracting Officer will notify the contractor of the Government’s intent to exercise the option by preliminary written notice to the Contractor. The Contractor will be notified in writing, by letter or email, at least fifteen (15) business days before the expiration of the contract. After that preliminary written notification, a funded, unilateral modification will be issued to formally exercise the option and order the isolation gowns.

The Government may exercise option CLINs 2001 and 2002, for only some or all of the Items or may obtain all of them over time. The Government’s unilateral right to exercise option CLINs 2001and 2002, is within its sole discretion.

B.3 Increased Quantity Limitations

In reference to FAR 52.217-6 Option for Increased Quantity found in Section I.2, the total allowable increased quantity under this clause is 20% of the total contract quantity. This option may be exercised more than once but the total number of items ordered in accordance with FAR 52.217-6 shall not exceed a cumulative total of 20% of the vendor’s total contract quantity. The amount of funding for each instance of exercising this option can be calculated as follows: (number of units) X (price per unit for the ordering period applicable at the time the option is exercised) = funding amount.

This is a surge option that is included due to the unpredictability of events for which Level 2 isolation gowns may be required (e.g., a natural disaster or public health event) however, this surge option may be exercised whether or not there is a declared disaster or public health event. The Government cannot accurately predict the scope and timing of a need for additional isolation gowns in the case of such an event.

The Contracting Officer will notify the contractor of the Government’s intent to exercise the option by preliminary written notice to the Contractor. The Contractor will be notified in writing, by letter or email, at least fifteen

(15) business days before the expiration of the contract. After that preliminary written notification, a funded, unilateral modification will be issued to formally exercise the option and order the isolation gowns.

B.4 Volume Discounts

Vendors must provide a volume-based pricing table. Example provided below; vendors may update these volume ranges:

Base CLIN 1001 & 1002 Pricing Breakout:

Volume Range Price

1-10,000,000 $

10,000,001 – 25,000,000 $

25,000,001 – 50,000,000 $

50,000,001 + $

Option CLIN 2001 & 2002 Pricing Breakout:

Volume Range Price

1-10,000,000 $

10,000,001 – 50,000,000 $

50,000,001 – 100,000,000 $

100,000,001 + $

B.5. Delivery Schedule Milestones

Offerors shall provide the following information:

B.5.A - Below is a delivery schedule template for CLINs 1001 & 1002. Offerors shall update this with their proposed delivery schedule and quantities. It is anticipated that SNS warehouses cannot receive more than

10 Million isolation gowns per month cumulative from all vendors. Accordingly, monthly quantities for the

Base Period shall not exceed 10 million per month.

Delivery Period: 5 November 2022- 4 November 2024 (Base)

CLIN

Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Se p

Oct

Nov

Annual

Total

Isolation

Gown - L 37.6M

Isolation

Gown - XL

37.6M

CLIN

Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Annual

Total

Isolation

Gown - L 37.6M

Isolation

Gown - XL

37.6M

B.5.B - Offerors shall update the below table with their maximum production/delivery capabilities. Delivery

Period 31 December 2022 – 30 December 2023 (Optional CLIN, Year 1)

CLIN

Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Annual

Total

Isolation

Gown - L

Isolation

Gown - XL

Delivery Period: 31 December 2023 – 30 December 2024 (Optional CLIN, Year 2)

CLIN Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Annual

Total

2001 Isolation

Gown – L

2002 Isolation

Gown – XL

Delivery Period: 31 December 2024 – 30 December 2025 (Optional CLIN, Year 3)

CLIN Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Total

2001 Isolation

Gown – L

2002 Isolation

Gown – XL

B.5.C – Offerors shall provide a breakout detailing the “ramp” timeframe(s) for the optional quantities, required to manufacture and deliver additional quantities. (Which table should be labeled B.5.C)

B.6. Type of Contract- This is a fixed price contract

SECTION C - STATEMENT WORK STATEMENT (SOW)

Title: ANSI/AAMI Level 2 Disposable Isolation Gowns Manufactured in the U.S. or its Outlying Areas

C.1 Background:

The Strategic National Stockpile (SNS) ─ managed by the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services ─ is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local medical supplies and equipment during public health emergencies. The supplies, medicines, and devices for lifesaving care contained in the SNS can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient.

The mission of the SNS is to prepare and support partners and provide the right materiel at the right time to secure the nation's health. When state, local, tribal, and territorial public health and medical authorities request federal assistance to support their response efforts, the SNS ensures medical countermeasures are available and can be rapidly deployed to counter the effects of chemical, biological, radiological, nuclear and explosive threats as well as pandemics, emerging infectious diseases and natural disasters.

The Strategic National Stockpile (SNS) ─ managed by the U.S. Department of Health and Human Services’

Administration for Strategic Preparedness and Response ─ is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local medical supplies and equipment during public health emergencies. The supplies, medicines, and devices for lifesaving care contained in the SNS can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient.

The mission of the SNS is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical authorities request federal assistance to support their response efforts, the SNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Medical gowns are one part of an infection control strategy and are examples of personal protective equipment (PPE), which are disposable devices intended for medical purposes that are worn over the arms and body to prevent contamination between patient and health care personnel. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

C.2 Purpose: The U.S. Government is interested in establishing multiple awards for the purchase of domestically manufactured ANSI/AAMI PB70 Level 2 disposable medical Isolation Gowns used in healthcare settings. In establishing multiple awards for such medical isolation gowns, the Government is attempting to increase the availability of domestically produced compliant PPE. This will enable the United States to ensure sufficient domestic availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus, offerors are advised to pay special attention to the requirement regarding location of manufacturing.

Medical gowns promote infection control practices and help protect patients and healthcare workers against microorganisms and body fluids during routine care, examinations, and medical procedures. The choice of medical gown(s) is dependent on the level of risk of contamination. The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) PB70 establishes a system of classification for surgical and isolation gowns used in healthcare facilities, based on their liquid barrier performance. The

ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection and Level 4 being the highest level of protection.

C.3 Scope of Work: The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver

ANSI/AAMI PB70 Level 2 disposable medical Isolation Gowns that comply with the technical requirements of this SOW. Medical gowns that are Level 1 disposable isolation gowns, reusable isolation gowns, reusable surgical gowns, disposable surgical isolation gowns, disposable surgical gowns, gowns made of film (e.g., polyethylene), over the head gowns, open back gowns, gowns that contain antimicrobial or antiviral agents, and gowns containing nano materials do not meet the technical requirements for this SOW.

Product Technical Requirements

The quantities to be procured shall be proposed in the following size ratios:

Isolation Gowns ANSI/AAMI Level 2, Disposable Size Ratio:

o 50% Large o 50% X-Large

1. Isolation Gowns ANSI/AAMI PB70 Level 2, Disposable

Required isolation gowns are non-sterile, disposable gowns, used to protect health care personnel and patients from the transfer of microorganisms and body fluids in patient isolation situations and are typically used for routine patient care in healthcare settings.

a. Salient Characteristics

1. ANSI/AAMI PB70 Level 2

2. Material made of woven fabric, non-woven fabric, and composites. Film gown composition, such as polyethylene, will not be considered

3. Disposable, single use, non-sterile

4. Is not made with natural rubber latex

5. Meets ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in

Healthcare Facilities

6. Is listed in the Food and Drug Administration (FDA) Establishment Registration &

Device Listing for isolation gowns, Product Code OEA

7. All gowns must be free from defects (see below: End Item Visual Defects)

8. Isolation gowns color shall be Yellow or Blue

9. Elastic wrist or knitted cuffs

b. Barrier Protection

1. Meets ANSI/AAMI PB70 Level 2 requirements; all areas of the Isolation Gown except bindings, cuffs, and hems are considered critical zones of protection that must pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 20 cm H20

a. ANSI/AAMI PB70 standard states that barrier performance testing of critical zone areas of a gowns should be conducted using an adequate sample size that is determined based on the production lot size and general inspection level II to meet an acceptable quality level (AQL) of 4%. For examples of suitable sampling plans specific to barrier performance properties, see

ANSI/AAMI PB70 Annex C. For an original classification of a product, the sampling plan shall be applied independently to each material or component, or both, and the finished product across multiple lots (three or more with a minimum sample size of 32 per lot).

b. AATCC 42 – At minimum, testing 3 non-consecutive lots, 32 gowns per lot, with 3 critical zone samples (front/chest area, sleeve seam, and point of attachments/ties) from each gown per lot is required to support the barrier protection level claim; total of 288 tested samples. All critical zone areas that are made with different materials or processing must be tested as well.

c. AATCC 127 – At minimum, testing 3 non-consecutive lots, 32 gowns per lot, with 3 critical zone samples (front/chest area, sleeve seam, and point of attachments/ties) from each gown per lot is required to support the barrier protection level claim; total of 288 tested samples. All critical zone areas that are made with different materials or processing must be tested as well.

c. Biocompatibility

1. The Isolation Gowns must be non-cytotoxic, non-sensitizing and non-irritating in accordance with ISO/ANSI/AAMI 10993- 5,10993-10, and 10993-1.

d. Flammability

1. The Isolation Gowns must meet Consumer Product Safety Commission (CPSC) standard 16 CFR Part 1610, Class I or Class II for flammability.

e. Gown Strength

Material specimens for testing shall be removed from manufactured isolation gowns and conditioned in accordance with Section 9 of ASTM F3352 and shall be representative of the actual finished gowns. Average tensile strength for each material direction shall be reported. Sample size for the physical property requirements shall be determined according to the specified standard test method. Examples of acceptable sampling plans for the physical properties are found in references such as ANSI/ASQ Z1.4 and Z1.9, ISO 2859-1, and ISO 3951.

1. Seam strength

a. Meets ASTM D1683/D1683M requirements; at a minimum >30 N [>7 lbf].

b. An average seam strength shall be calculated and reported for each type of seam used in the isolation gown.

f. Test Reports

2. Tear strength

a. Meets ASTM D5587 (woven textiles) or ASTM D5733 (non-woven textiles) requirements; at a minimum >10 N [>2.3 lbf].

b. An average tear strength shall be calculated and reported for both machine and cross-machine directions.

3. Tensile strength

a. Meets ASTM D5034 requirements; at a minimum >30 N [>7 lbf].

b. An average tensile strength shall be calculated and reported for both machine and cross-machine directions.

1. Offerors shall provide full tests reports (e.g., AATC 42) that must be conducted at an independent ISO 17025 accredited laboratory, with each test being within the scope of the accreditation laboratory. Test reports, data, and documentation shall be in English. Test reports must include a description of the test device and components tested (including the manufacturer part/model and lot numbers), sample preparation, test procedure and/or the standard followed result values, averages, and appropriate sampling size to meet the specific standard

Test Reports shall include:

A. Barrier Protection (AATCC 42 and AATCC 127)

B. Flammability (CPSC Standard 16 CFR Part 1610)

C. Seam Strength (ASTM D1683M)

D. Tensile Strength (ASTM D5034)

E. Tear Strength (ASTM D5587 or D5733)

F. Biocompatibility (ISO 10993-5 and ISO 10993-10)

g. Design

1. Full Coverage, no open back.

a. All Isolation Gowns shall provide 360-degree protection to the healthcare worker in a manner that, at a minimum, ensures that both arms and the front, back, and sides from the knees up to but not including the neck are fully covered during movement and use when the correct gown size is worn.

b. 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.

2. Overhead gowns will not be considered.

h. Size and Dimensions

1. Sizes: large and extra-large; universal sizes will not be considered

a. Size Ratio:

50% Large

50% X-Large

2. Dimensions: The Isolation Gown dimensions must meet gown length, chest width, and sleeve lengths commonly used in the commercial industry, per the specific size.

Dimensions that do not meet the minimum or that significantly exceed the minimum length, chest, width, and sleeve length will not be considered.

a. Large and extra-large gown sizes should reflect dimensions currently available in the commercial market. Examples of approximate gown dimensions include chest width:

large 27 inches and extra-large 30-31 inches; sleeve length: large 22-23 inches and extra-large 24 inches; and gown length 46 inches.

i. Labeling

1. The Isolation Gown and package labeling must comply with SNS requirements, ASTM F3352- 19 Section

11.1 and 11.2 Labeling Requirements and meet FDA’s general device labeling requirements per 21 CFR

Part 801. See also FAR 52.212- 4(q).

a. Under 21 CFR Part 801 and 21 CFR 830.300,Unique Device Identifiers (UDI are required for isolation gowns starting September 24, 2022; UDI shall be appropriately included on the inner gown packaging and outer case packaging labeling and published in FDA’s Global Unique

Device Identification Database (GUDID).

2. The Isolation Gown must be folded and packaged in such a way that the size and level of barrier performance is visible.

3. European and CE markings shall not be present on the labeling.

End item visual defects:

Isolation gowns must not have defects, which include, but are not limited to, visible tears, cuts, holes, excessive stains, or excessive patches and must contain no foreign matter such as dirt, grease, extraneous fabric, thread or other visual or olfactory defects on the surface of the gown or folded into the gown.

(NOTE: In the below list of example defects, all references to “hem” or “hems” are applicable only to fabrics or other materials that may ravel or degrade if edges are not hemmed. 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.)

Examples of defects (not inclusive of all types of defects): Appearance

Sleeve

a. Gown not symmetrical, bottom hem twisted, affecting appearance or function

a. Sleeve puckered or pleated at joining to armhole

b. Sleeve tight at armhole, causing puckers, or pleats on fronts or back at armhole seam

c. Sleeve lengths vary by more than 3/4 inch

d. Sleeve back arm seams unequal distance from shoulder

Material defects

a. Hole, cut, tear, smash, burn, exposed drill hole, thin place, needle chew, visible mends, knots, Slubs

Cleanliness

Odor

a. Any spot or stain

b. Excessive thread ends no more than 1/4-inch (more than 3) not trimmed or removed

a. Any noxious, foul, or strong smell

Component and assembly

a. Any component part misplaced or required operation omitted, not as specified, distorted, full, tight, or twisted

b. Any part of gown caught in unrelated stitching

c. Any defective components

d. Any component not as specified

e. Any component part twisted, distorted, pleated, misshaped, tight, or full

f. Fullness creating unwanted permanent fold, pleat, or crease in fabric or garment

g. Missing or detached closure ties or other fasteners

Stitching and Seams, if applicable

a. Seam twisted, puckered

b. Ends of stitching not secured as specified

c. Thread break (all stitch types) stitched less than 1/2- inch beyond end of break

d. Skipped stitches or open seams with puckering, waviness, or raw fabric edges showing through stitch lines

e. Seams that have uneven tensions that restrict stretch or cause cracking or breaking of threads

f. Edges not hemmed or with raw fabric edges

Gauge of stitching and seam allowances

a. Irregular, unevenly gauged, or corresponding stitching not uniformly gauged

b. Edge or raised stitching sewn too close to edge resulting in damage to cloth

Open seams

a. Any seam open on outside of gown

b. NOTE: For stitched seams, an “open seam” is defined as one (1) or more broken or two

(2) or more consecutive skipped or runoff stitches. For non-stitched seams (such as heat- sealed, RF or ultrasonic welded, or bonded by adhesive), an “open seam” is defined as any lengthwise break in the continuous attachment of two or more panels of material

Stitch tension

a. Loose tension resulting in a loose seam, or tight tension (stitches break when strain is applied to the direction of seam)

Stitches per inch

a. Less than minimum specified

b. More than maximum specified

c. NOTE: This defect is to be scored only when the condition exists on one half or more of the stitching or seam

Shaded parts

a. Badly shaded parts

b. Shade variation within part or between parts

Packaging

a. Any gown not packaged in accordance with this scope of work

Sizing

Label

a. Any measurement on the gown that is out of tolerance

a. Missing, incorrect, illegible, or not attached where specified

C.4 Shelf Life

At time of delivery, product shall have no more than 20% of total shelf-life expended. Offerors shall provide data and documentation to support any shelf claim.

C.5 Deliverables

Deliverable Format/Deliver to Date

Delivery Documents Scan and email to COR/POC 2 Business days prior to delivery.

Packing Slips Scan and email to COR/POC 48 hours after delivery

Monthly Report E-mail to COR/POC Within 2 business days from the beginning of each month

Delivery Schedules E-mail to COR/POC 5 Business days prior to the beginning of each month

Biocompatibility

Reports

E-mail to COR/POC Within 45 days of award or prior to first delivery, whichever comes first

Final Report E-mail to COR/POC Within 5 business days from end of contract.

Quality Control

Plan(QCP)

E-mail to COR/POC Within 5 business days from the end of the contract

Monthly Report – The monthly report shall be in excel format and contain at a minimum, the following information for each delivery that occurred in the previous month:

1. Date of Delivery

2. Location of Delivery

3. Freight Carrier

4. Quantity of pallets, cases, and each

5. Manufacturer

6. Part number

7. Lot #

Delivery Schedules – The delivery schedules for the upcoming month shall be provided to the COR/POC 5 business days prior to the beginning of each month and include the anticipated dates, quantities, location, and truck loads for delivery of the upcoming month.

Biocompatibility Reports –Biocompatibility reports (ISO 10993-5 and ISO 10993-10) shall be provided to the

COR/POC for review and approval within 45 days from the start of the contract. The reports shall be 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 (including the manufacturer part/model and lot numbers), sample preparation, test procedure and/or the standard followed result values, averages, and appropriate sampling size to meet the specific standard. The ISO 17025 accreditation and testing scope supporting documentation for the testing facility shall also be provided. The testing shall be conducted on the

Isolation Gown that is the same as what will be delivered under this award.

The biocompatibility test reports must support and illustrate that the Isolation Gowns are non-cytotoxic, non-sensitizing and non-irritating. Should the biocompatibility test reports not be provided within 45 days, or the test reports not meet the specifications required within Section C, the Government reserves the right to Terminate the contract for non-performance.

Quality Control Plan Report- Offerors will be qualitatively evaluated based on their Quality Control Plan and whether it addresses the appropriate controls (e.g., process controls, lot release testing) implemented within the Quality

System as, for example, seam strength and integrity may vary across different lots and lot measure release testing may help ensure product quality and consistency to meet specifications.

Final Report – The final report shall be a detailed summary of all deliveries under the performance of this contract.

SECTION D-PACKAGING, MARKING AND SHIPPING

D.1 PACKING

All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting

Officer or Contracting Officer’s Representative (COR) or other persons designated to receive shall be paid by the Contractor.

The Isolation Gown must be folded and packaged in such a way that the size and level of barrier performance is visible.

Gowns shall be individually wrapped or packaged with up to 10 gowns per bag. Outer cartons/Cases shall have no more than 100 individual gowns in total.

D.2 MARKINGS

All product delivered under this contract shall be packaged, marked and shipped in accordance with

Government specifications and FDA regulations. This requirement intends to require vendors to adhere to the

FDA’s Unique Device Identification (UDI) Policy requirements, effective as of September 24, 2022, for any product delivered under this contract. At a minimum, each deliverable shall include the following information at time of delivery:

1. Ordering Agency

2. Packing Slip with Contract number

3. Description of product

4. Contract Number

5. Contract Name and Address

6. Storage Requirements shall be on all packings lists

7. Product name, lot number, part number, UDI, quantity, gown size, AAMI level, date of manufacture, and expiration dating/use by date (if applicable) included on both the outer case and the inner gowns packaging label

8. FDA’s general device labeling requirement per 21 CFR Part 801 and ASTM F3352-19 Section 11.1 and 11.2

Labeling Requirement

9. Shelf life or expiry dating data

10. For products with an issued National Stock Number (NSN), product cases shall have applicable NSN annotated on case and inner package labels.

D.3 DELIVERY LOCATION & SHIPPING REQUIREMENTS

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States (CONUS), The contractor shall adhere to the following shipping requirements:

a. No partial case or package quantities will be accepted unless approved by SNS in advance.

b. No mixed lot numbers per case or per packages will be accepted.

c. No mixed sizes (e.g., larges or extra larges mixed in on one pallet) will be accepted.

d. One lot number will be used per pallet. Only one pallet may contain multiple lot numbers per order.

e. Lots must be clearly identified.

f. Duplicate lots must only have one expiration date (i.e., the same two lot numbers must not have different expiry dates).

g. Contractor shall contact designated POC (for the respective address items are being delivered to) to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:30PM).

h. All pallets are to have the identical TI-HI stack pattern for all deliveries throughout this contract except for the final pallet.

i. The product/case packaging configuration shall be identical for all deliveries throughout this contract.

j. All product to be delivered on Heat Treated 48" by 40" pallet, not to exceed 60” in height, stretch wrapped, and secured to pallet for safe transport.

k. Product is to be stacked in such a way that no portion of the cased materials may exceed the dimensions of pallet.

l. All cases must be positioned on the pallet in a way that allows for labels to be viewable.

m. The exact delivery locations shall be provided by the COR; Delivery will be within the CONUS

SECTION E- INSPECTION AND ACCEPTANCE

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):http://farsite.hill.af.mil/

(End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions-Commercial Services

(Nov 2021)

52.246-2 Inspection of Supplies-Fixed Prices (Aug 1996)

“Notwithstanding the clause at FAR 52.212-4(a), inspection and acceptance shall be governed in accordance with

FAR 52.246-2”.

SECTION F- DELIVERIES AND PERFORMANCE

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hil.af.mil/(End of Clause)

FAR TITLE AND DATE

52.246-16 Responsibility for Supplies (Apr 1984)

52.247-34 F.O.B. Destination (Nov 1991)

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR/DSNS personnel:

Contract Specialist

Sherica Teshome

Office of Resource Management (ORM)

Assistant Secretary for Preparedness and Response (ASPR)

U.S. Department of Health and Human Services (HHS) Email: dsnssolicitations@cdc.gov 202-205- 5919 office

Contracting Officer

Annette Wright, Team Lead

Office of Resource Management (ORM)

Assistant Secretary for Preparedness and Response (ASPR)

U.S. Department of Health and Human Services (HHS) Email: dsnssolicitations@cdc.gov| 404-273- 3127 office

Contracting Officer’s Representative (COR)/Technical Point of Contact (POC)

Charlene Booth

Division of Strategic National Stockpile (DSNS) Assistant

U.S. Department of Health and Human Services (HHS) Email: dsnssolicitations@cdc.gov | 470-806-3776 office

G.2 ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS - INVOICE

PROCESSING PLATFORM (IPP)

All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform

System (IPP):

• Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial

Services included in commercial items contracts. The IPP website address is:

https://www.ipp.gov.

• The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in

SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

• Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

• The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

mailto:dsnssolicitations@cdc.gov mailto:dsnssolicitations@cdc.gov mailto:dsnssolicitations@cdc.gov https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

If your company is already registered to use IPP, you will not be required to re-register. If the Contractor is unable to comply with the requirement to use IPP for submitting I invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

Additional Office of the Assistant Secretary for Preparedness and Response (ASPR) requirements:

I. The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order

II. Invoices must break-out price/cost by contract line number (CLIN) as specified in the pricing section of the contract

III. Invoices must include the Dun & Bradstreet Number (DUNS) of the Contractor

IV. Invoices that include time and materials or labor hours CLINS must include supporting documentation to (1) substantiate the number of labor hours invoices for each labor category, and (2) substantiate materials costs incurred (when applicable).

V. Invoices that include cost-reimbursement CLINs must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirect)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

(End)

SECTION H—SPECIAL CONTRACT REQUIREMENTS

H.1 – CONTRACTING OFFICER

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States

Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

H.2 – CONTRACTING OFFICER’S REPRESENTATIVE

Performance of work under this contract is subject to the technical direction of the COR identified in Section

G.1 Administration or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that:

i. Constitutes additional work outside the contract specification(s)/work statement;

ii. Constitutes a change as defined in the “Changes” clause of this contract;

iii. Causes an increase or decrease in the contract price, or the time required for contract performance

iv. Interferes with the contractor’s right to perform under the terms and conditions of the contract;

or

v. Directs, supervises or otherwise controls the actions of the contractor’s employees.

Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the contracting officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR, if the opinion of the contractor, any direction of the

COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract. The COR is responsible for confirming the inspection/acceptance of product delivered prior to payment of invoices.

H.3 – CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under the contract and applicable law.

H.4 – NON-DISCLOSURE AGREEMENT

All Contractor’s employees that will have access to…