Isolation Gown Combined Synopsis Solicitation 6.28.2022.st.pdf

COMBINED SYNOPSIS SOLICITATION

I. 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.

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

III. The solicitation document and incorporated provisions and clauses are currently in effect through

Federal Acquisition Circular 2022-06, effective May 26, 2022.

This acquisition is being posted as a full and open competition and is not set aside for small business.

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

IV. a. The Division of Strategic National Stockpile (DSNS), of the U.S. Department of Health and Human

Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), has a requirement for up to 75,200,000 ANSI/AAMI PB70 Level 2 Isolation Gowns, plus an optional quantity of up to 150,400,000 Level 2 Isolation Gowns that are domestically manufactured with 100% domestic components as is required by the Infrastructure and Investment Jobs Act (IIJA)/Make PPE in America. See Section B- SUPPLIES OR SERVICES AND PRICES/COSTS. This requirement and the quantity that will ultimately be procured is subject to availability of funds. The Government reserves the right to include any unordered base quantity into the quantity for the optional ordering period.

b. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

V. See Sections B and C below for description of requirements.

VI. The period of performance is anticipated to total 36 months, 5 August 2022 through 4 August 2025:

a. Base Period: 12 months

Level 2 Isolation Gowns quantity – 75.2 million, anticipated Delivery Period: 5

August 2022 - 4 August 2023.

b. Optional ordering quantity has an ordering period of 36 months, anticipated to be 5 August 2022 - 4 August 2025:

Level 2 Isolation Gowns optional quantity – 150.4 million

VII. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and

Commercial Services, applies to this acquisition.

VIII. The provision 52.212-2, Evaluation-Commercial Products and Commercial Services, applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services, with its offer. (Note, if offerors are registered within the

System for Award Management (SAM) and certs and reps are up to date, make a statement to that effect in accordance with this clause).

IX. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and

Commercial Services, applies to this acquisition.

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

Executive Orders Commercial Products and Commercial Services, 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.

See Sections D through I.

XI. 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 agree to sign a non-disclosure agreement (applicable and enforceable to all employees of the contractor) to not disclose any details relating to the contract and to 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 used in performance of the contract 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 of the contract during the time 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.

XII. 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.

XIII. Offers are due no later than 22 July 2022 on or before 3:00 p.m. Eastern Time, with the Subject Line RFP 75A50322R00008, by email to dsnssolicitations@cdc.gov.

The offeror’s complete proposal (including all information required to be submitted as part of the offeror’s Volume A -Technical Proposal, and Volume B - Price/Business Proposal) must be received by the date and time specified for receipt of offers.

Electronic submissions only will be accepted and shall be submitted via email to dsnssolicitations@cdc.gov. All submissions must include the solicitation number and the word

“SUBMISSION”. Email submissions are limited to 2MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) mailto:dsnssolicitations@cdc.gov

All questions regarding this RFP of contractual or technical nature, must be submitted electronically by email to dsnssolicitations@cdc.gov no later than 1:00 p.m., Eastern Time, 11 July 2022. For proper submission of questions, include the solicitation number and the word “QUESTION” in the subject of the email. The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective offerors.

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

Sherica Teshome, Contracting Officer Office of Resource Management (ORM)

Assistant Secretary for Preparedness and Response (ASPR)

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

Email: dnssolicitations@cdc.gov

Offers are due no later than 22 July 2022 on or before 3:00 p.m. Eastern Time, with the

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

mailto:dnssolicitations@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 Unit Price line item.

Anticipated Delivery Period: 5 August

2022 through 4 August 2023

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 Unit Price line item.

Anticipated Delivery Period: 5 August

2022 through 4 August 2023

37,600,000 Each $

Optional Quantity:

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE

2001 Optional Ordering Quantity

Isolation Gowns Level 2

Size: Large

The required Isolation Gowns are to be provided in accordance with the

75,200,000 Each $

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 Unit Price line item.

Anticipated Ordering Period: 5 August

2022 through 4 August 2025

2002 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 Unit Price line item.

Anticipated Ordering Period: 5 August

2022 through 4 August 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

The Government may require the delivery of the numbered line items, identified in the schedule in Section B.1 as option items, in incremental quantities at the price stated in the award, up to the maximum quantity identified for each numbered line item, in accordance with FAR 52.217-7 Option for Increased Quantity– Separately Priced

Line Items found in Section I.2. Each option line item may be exercised more than once, until the cumulative number of units to be delivered under each optional line item is delivered. Orders may only be placed during the Period of Performance however delivery of those items may be required up to six (6) months after the conclusion of the period of performance. The total units shall not exceed the respective line-item unit maximums over the 3-year ordering period, unless changed by formal modification to the contract; however, items that may be ordered in accordance with B.3 in reference to FAR 52.217-6 Option for Increased Quantity found in Section

I.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)

5 August 2022 through __date__

(Date range) __date__ through

__date__

(Date range) __date__ through 4

August 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 & 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 2001 & 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 August 2022- 4 August 2023 (Base)

CLIN

Product

Type Aug

Sept

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

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 5: August 2022 – 4 August 2023 (Optional CLIN, Year 1)

CLIN Product

Type

Au g

Sept

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Total

2001 Isolation

Gown – L

2002 Isolation

Gown – XL

Delivery Period: 5 August 2023 – 4 August 2024 (Optional CLIN, Year 2)

Aug

Sept

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Total

Aug

Sept

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Total

Delivery Period: 5 August 2024 – 4 August 2025 (Optional CLIN, Year 3)

Aug

Sept

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Total

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)

Example Language: Offeror requires a 30-day period, from time of option execution, to ramp production and delivery to XX isolation gowns per month. At 60 days, production can increase to XX isolation gowns per month.

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 U.S. Department of Health and Human Services’ Assistant Secretary for 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 disposable medical isolation gowns (ANSI/AAMI PB70 Level 2) 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 final finished 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 final finished isolation gowns must be non-cytotoxic, non-sensitizing and non-irritating in accordance with ISO/ANSI/AAMI 10993- 5 and 10993-10.

d. Flammability

1. The final finished 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. Design

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. 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. Over the head gowns will not be considered

G. 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.

H. Labeling

1. The Isolation Gown and package labeling must comply with 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801

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 back arm seams unequal distance from shoulder

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

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.5 Shelf Life

At time of delivery, product shall be within 3 months of date of manufacture.

D.1 PACKIN G

SECTION D-PACKAGING, MARKING AND SHIPPING

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.

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 for any product delivered under this contract, regardless of whether delivery is prior to the September 24, 2022, FDA formal implementation date. 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 packing lists.

(7) Lot Numbers (on the case and gown packaging label)

(8) Quantity

(9) Expiration dating or manufacturer dating (on the case and gown package label)

(10) Shelf life or expiry dating data

(11) Part number (on the case and gown packaging label)

(12) For products with an issued NSN, product cases shall have applicable NSN annotated on case and inner packages' 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. The last 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 – 3:30 PM).

h. All pallets are to have the identical TI-HI stack pattern except for the final pallet.

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

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://www.acquisition.gov

(End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services

(NOV 2021)

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://www.acquisition.gov (End of Clause)

The start date of period of performance will be determined at time of award. The base period is anticipated to be 12 months. There will be an optional ordering period of 36 months that will begin at time of award.

FAR

SOURCE

TITLE AND DATE

52.247-34 F.O.B. Destination (Nov 1991) http://www.acquisition.gov/

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) David Kelley Division of Strategic National Stockpile (DSNS) Assistant

U.S. Department of Health and Human Services (HHS) Email: dsnssolicitations@cdc.gov | 770-488- 2662 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.

• 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 invoices for payment as authorized by HHSAR 332.7002, a written request must be mailto:dsnssolicitations@cdc.gov mailto:dsnssolicitations@cdc.gov https://www.ipp.gov/ 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 item 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 invoiced for each labor category, and (2) substantiate material 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

Indirects)- 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 non-public and procurement-sensitive information

(photos, drawings, specifications, statements of work requirements, location data, etc.) or access to non-public ASPR facilities must sign a Non-Disclosure Agreement (NDA). The NDA will be made part of the contract file. The NDA requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with ASPR employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with ASPR/SNS), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states

“All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are

Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

1) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

2) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting

Officer prior to commencement of their work with ASPR/SNS.

3) Contractor employees in designated positions or functions that have not signed the appropriate

NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

4) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

H.5 – DOMESTIC MANUFACTURING

Contractor must provide items compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. “Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

The U.S. and its territories include;

(1 ) The fifty States;

(2 ) The District of Columbia;

(3 ) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4 ) The territories of American Samoa, Guam, and the United States Virgin Islands; and

(5 ) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman

Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll

SECTION I – CONTRACT CLAUSES

I.1 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):

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-7 System for Award Management (Oct 2018)

52.204-13 System for Award Management Maintenance (Oct 2018)

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020)

52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)

52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

52.209-7 Information Regarding Responsibility Matters (Oct 2018)

52.209-12 Certification Regarding Tax Matters (Oct 2020)

52.211-17 Delivery of Excess of Quantities (Sep 1989)

52.212-4 Contract Terms and Conditions-Commercial Commercial Products and Commercial Services (Nov 2021)

52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021)

52.242-15 Stop-Work Order (Aug 1989)

HHSAR SOURCE

352.203-70 Anti-Lobbying (Dec 2015)

352.222-70 Contractor Cooperation in Equal Employment Opportunity 2.212-Investigations (Dec 2015)

352.223-70 Safety and Health (Dec 2015)

352.227-70 Publications and Publicity (Dec 2015)

352.224-70 Privacy Act (Dec 2015)

352.233-71 Litigation and Claims (Dec 2015) https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

I.2 Clauses Incorporated in Full Text

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-

Commercial Products and Commercial Services (May 2022)

The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing

Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts

(and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or

Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance

Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and

108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or

Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN

2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

_x_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV

2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American

Recovery and Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN

2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15…