SOW NITRO GLOVES PPE .pdf

STATEMENT OF WORK

Personal Protective Equipment

Infrastructure Investment and Jobs Act Compliant

Gloves Delivery Contract

1.0 BACKGROUND

On November 15, 2021, the President signed The Infrastructure Investment and Jobs Act (IIJA)

(Pub. L. 117-58). In addition to authorizing funds for federal-aid highways, highway safety programs, and transit programs, under Section, Subtitle C of the IIJA, the “Make PPE in

America”, the Department of Homeland Security (DHS), Health and Human Services (HHS) and the US Department of Veteran Affairs (VA) are required to purchase all personal protective

Equipment (PPE) from American suppliers (manufacturers and distributors) with 100 percent

American-made components.

HHS, DHS, and VA are required, under IIJA, to invest in a long-term strategy to meet the needs of its workforce, through domestic production of PPE–items critical to the US national response to a public health crisis, and sustainment of a strong and robust PPE supply chain. As part of this long-term strategy, IIJA, Section 70953 (a)(3)(b) “Requirement of Long-Term Contracts for

Domestically Manufactured Personal Protective Equipment” requires that all PPE Contracts be issued for a duration of at least two years, plus all option periods necessary, to encourage investment in the production of PPE including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States.

The National Institutes of Health (NIH), as a component organization/sub-agency of HHS (or

“The Department”) has an ongoing operational need for an array of medical grade and surgical gloves to sustain mission critical activities for health and longevity mission critical research.

The Department does not currently have an existing agency-wide IDIQ for PPE and requires one to meet multiple policy mandates as well as its own operational mission requirements. The HHS workforce is one of the largest Government consumers of gloves in its mission work for scientific research, patient care, and operational continuity.

2.0 SCOPE

The purpose of the contract is to ensure a 100% domestically sourced, American manufactured product (gloves), including 100% of all components of IIJA Compliant medical grade and surgical grade gloves to NIH and all HHS agency customers.

2.1 Contract Type

The NIH is seeking Firm Fixed Pricing for Products under a multiple award IDIQ scenario through open market solicitation that shall include capable small businesses that meet the threshold requirements of IIJA. The Government will seek volume discounts and agency prioritization for

PPE, in a cost-effective approach that supports PPE inventory management, budget development and forecasting for NIH (and Departmental) PPE consumption.

2.3 Other Direct Costs

None are included under this firm fixed price commercial product delivery contract. All labor, travel and delivery costs are the responsibility of the contractor.

3.0 General Requirements

To ensure and sustain an NIH mission-ready supply chain, the requirements below must be met.

1. The Contractor shall ensure continuity and ready availability (no lapse in delivery and order fulfillment support to NIH) to sustain delivery to the Government within one week of Task Order placement.

2. When a Contractor’s product has changed, as a result of new technology, or if the product is no longer available, (e.g., discontinued production), the Contractor shall propose a replacement product of equal or greater capabilities/value. The proposed alternative must be approved by the Government COR and Contracting Officer (CO) prior to production and/or delivery and incorporated into the contract as a contract modification.

3. The Contractor shall be allowed to replace the product(s) on the Contract twice per year.

The new technology shall be approved by the Government COR and CO. Under no circumstances shall NIH incur additional costs for product upgrades, unless the cost variance is approved by the Government COR and Government CO and incorporated via formal contract modification. Upon approval of a product upgrade, the Contractor shall retain resources necessary to address all Task Order requirements for the legacy product(s). If resources are not available to address all requirements for the legacy product(s), the legacy product(s) shall be replaced with the Contractor’s new product to meet the requirements of the existing Order, at no additional cost to the Government.

The Contractor shall have:

• Capability for nationwide delivery (validated through previous commercial or Government contracts)

• Ability to deliver to the NIH Supply Center up to twice weekly on designated days and to designated docks.

• Surge capability to meet the disaster relief or increased customer demands, (i.e., force majeure events, evolving customer needs, etc.)

4.0 PPE Gloves Specifications

The table below lists the expected utilization of latex, nitrile, vinyl, neoprene and polyisoprene gloves and associated certifications.

Table 1. Utilization of gloves and associated certifications

PPE Glove Type Proposed Utilization

(Estimates) Certification Level

Latex 20% ASTM D35771, ASTM D35782, ASTM D51513, ASTM

D61244, ASTM D69785, ASTM F28786, ASTM F16717,

FDA CFR 21 177.2600 8, ISO 111939, NFPA 199910, USP

80011, ANSI/ISEA 105-201112

Vinyl 10% ASTM D5151, ASTM D525013, ANSI/ISEA 105-2011

Neoprene

(polychloroprene), Polyisoprene

10% ASTM D3577, ASTM D6978, ASTM F1671, ASTM

D697714, ANSI/ISEA 105-2011

Nitrile 60% ASTM D5151, ASTM D6124, ASTM D63191, ASTM

D6978, ASTM F2878, ASTM F1671, NFPA 1999,

USP 800, ISO 11193, ANSI AQL of 1.5, ANSI/ISEA

105-2011

Single-use examination gloves must meet the standards of ASTM D6319 and NFPA 1999.

The table below lists the expected utilizations of latex, neoprene/ polyisoprene, vinyl, and nitrile gloves by glove sizes.

Table 2. Expected utilization of gloves and sizes

PPE Glove Size Proposed Utilization (Estimates)

X-Small 5%

Small 10%

Medium 40%

Large 25%

1 ASTM D3577 Standard Specification for Rubber Surgical Gloves 2 ASTM D3578 Standard Specification for Rubber Examination Gloves 3 ASTM D5151 Standard Test method for detection of holes in medical gloves 4 ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves 5 ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs 6 ASTM F2878 Standard Test Method For Protective Clothing Material Resistance To Hypodermic Needle Puncture 7 ASTM F1671 Standard Test Method For Resistance Of Materials Used In Protective Clothing To Penetration By Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration As A Test System 8 FDA CFR 21 177.2600 Rubber articles intended for repeated use 9 ISO 11193 Single-use medical examination gloves 10 NFPA 1999 Standard on Protective Clothing for Emergency Medical Services 11 USP 800 Hazardous Drugs – Handling in Healthcare Settings 12 ANSI/ISEA 105-2011 - Hand Protection Selection Criteria 13 ASTM D5250 Standard Specification for poly(vinyl chloride) gloves for medical application 14 ASTM D6977 Standard Specification for Polychloroprene Examination Gloves for Medical Application

PPE Glove Size Proposed Utilization (Estimates)

X-Large 15%

2XL to 6XL 5%

Table 3. Specific Attributes of IIJA Compliant Nitrile Gloves

Protective Attributes and Ratings Characteristics

• Puncture level 2-4

• Tensile Strength range 14 MPa to 21 MPa

• Chemical Resistance: acid, base, oxidizing, flammability, corrosives

• Chemo rated

• Clean room rated

• Required Protection: UV light, radiation rated

• Cold resistant

• Heat resistant

• Cut resistance 1-5

• Tear Level 1-4

• Sterility Assurance Level (SAL) of 10-6, USP

• Textured & non textured

• Thickness: Fingertips 0.05-0.10 mm and 2.8-

9.1 mil; Palm 3.9-4.7mil

• Length 8-12 inches

• Cuffed (beaded, extended) and non-cuffed

• Exam, medical grade for patient care, surgical, laboratory (bioresearch), dental, animal handling

• Latex free

• Range of colors to include: blue, purple, black, white, green

• Ambidextrous and hand specific options

• Non-Sterile & Sterile

When providing PPE commodity lists to the Government, contractors must include the American

National Standards Institute (ANSI) Acceptable Quality Levels (AQLs) for all gloves. The AQL refers to an internationally used quality standard for measuring the percentage of pinhole defects in disposable gloves. The lower the AQL, the lower the risk of exposure.

5.0 SHIPPING, PACKAGING, MARKING, AND INSPECTION ACCEPTANCE

GUIDANCE

Please see Attachment 3 of this SOW for guidance on packing, shipping, marking, inspection acceptance, and delivery guidance. Delivery times and locations are also provided in the attachment. This Attachment is hereby contained within this document.

6.0 PERIOD OF PERFORMANCE

The contract shall be established for Base Years (24-months) plus three 12-month Option

Years, as follows:

Base Year: 01 June 2025 – 31 May 2026

Option Year 1: 01 June 2027 – 31 May 2028

Option Year 2: 01 June 2028 – 31 May 2029

7.0 POST AWARD INFORMATION

7.1 Quality Control

The contractor shall develop and maintain an effective quality control program to ensure finished products are in accordance with this SOW and are 100% sourced and manufactured in the USA

(compliant with IIJA). The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective products. The contractor’s quality control program ensures the work complies with the requirement of the contract.

7.2 Facility Access to NIH

Commercial vehicle deliveries must undergo security screening at the Commercial Vehicle

Inspection Facility (CVIF), located on Rockville Pike between North Drive and Wilson Drive.

The facility is open 24 hours a day, 7 days a week (inbound traffic only).

Contractors with frequent official business at NIH can be issued special temporary IDs. You must provide an original letter on company letter head or a memo from your NIH Project Officer justifying your need for a temporary ID. The letter/memo must contain your full name and date of birth and must be presented in person with a valid photo ID at the NIH Guard Office

Operations Branch, part of the NIH Police, located in building 31/B4BE09. Phone: 301-435-

5095.

7.3 Supply Chain Risk Management

The U.S. Government reserves the right to conduct physical site visits pre- and post-award.

Potential critical partners submitting proposals to NIH will be required to provide a copy of their supply chain security plan within their proposal in response to NIH solicitations. Additionally, the

U.S. Government reserves the right to request supplier and sub-tier supplier information pre- and post-award.

8.0 REPORTS AND DELIVERABLES

8.1 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post-award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The COR and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the COR will apprise the contractor of the Government’s views of the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

8.2 In addition to 100 percent order fulfillment to the Government customer, through vendor managed inventory, the contractor shall provide to the Government COR and CO the following:

a. MONTHLY NLT the 5th of each Month, Contractor must provide a Report online items

(sizes, colors, specifications) by agency customer, to include the order #, customer name, dollar value, quantity ordered, agency, customer delivery address and phone number for the previous 30 days.

b. QUARTERLY (NLT January 15, April 15, July 15 and October 15th of each year during the PoP) Contractor shall provide a written summary report for all orders by types, sizes, dollar value, specifications, quantities, agency and customer to COR.

c. ANNUALLY (NLT October 29 during each active PoP), Contractor shall provide a written summary report for all orders by types, sizes, dollar value, specifications, quantities, agency, and customer to COR.

d. Supplier Managed Inventory.

e. If applicable, please provide updates on new technology, new sub-tier suppliers, and/or organization changes that may impact the Government.

8.3 Contractor Furnished Items and Responsibilities

The Contractor shall furnish all supplies, materials, equipment, and services required to perform work under this SOW.

Schedule of Deliverables Deliverable Frequency # of Copies Medium/Format Submit To

Quality Control Plan (QCP)

Submit with proposal package on or before

Solicitation Close Date

1 Original MS Word or

MS Excel

Spreadsheet

CONTRA

CTING

OFFICER

Monthly Report (Supplier

Managed Inventory and

Order fulfillment by

Agency, dollar value, quantity, customer, and glove type)

NLT the 5th of each

Month

1 Original and 1 Copy

MS Word or

MS Excel

Spreadsheet

COR with copy to

NIH

Supply

Chief

QUARTERLY Report

(Supplier Managed

Inventory and Order

Fulfillment by Agency, dollar value, quantity, customer, and glove type).

If applicable, please provide updates on new technology, new sub-tier suppliers, and/or organization changes that may impact the

Government.

NLT January 15, April

15, July 15 and October

15th of each year during the PoP

1 Original and 1 Copy

MS Word or

MS Excel

Spreadsheet

COR with copy to

NIH

Supply

Chief

ANNUAL Report

(Supplier Managed

Inventory and Order

Fulfillment by Agency, dollar value, quantity, customer, and glove type).

If applicable, please provide updates on new technology, new sub-tier suppliers, and/or organization changes that may impact the

Government.

NLT October 29 during each active PoP

1 Original

2 Copies

MS Word or

MS Excel

Spreadsheet

COR with copy to

CO and

NIH

Supply

Chief

8.4 Performance Requirements Summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of delivery required. These thresholds are critical to mission success.

Performance Objective Performance Threshold Method of Surveillance

1. Accurate Timely Delivery of gloves for order fulfillment

100 percent accuracy for 100 percent completion of customer order

100 percent Inspection by COR

2. Deliverable reports 100 percent on time submission

100 percent Inspection by COR

3. Corrective Deliverables 100 percent within 3 business days

100 percent Inspection by COR when completed

4. Response Time for Emergency

COR request (i.e. After Normal

Working Hours and Weekends)

95 percent Within 24 Hours of

Notification by COR

100 percent Inspection by COR

9.0 CONTRACTING OFFICER REPRESENTATIVE (COR)

The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: ensure that the Contractor performs the technical requirements of the contract;

perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of

Contractor personnel. An appointment letter issued to the COR, a copy of which is sent to the

Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

10.0 CONTRACT ADMINISTRATION ITEMS

10.1 Payment and Invoicing

HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting

Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the

Contracting Officer’s written authorization with each payment request.

The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform

(IPP) at https://www.ipp.gov with a copy to the Contracting Officer Representative (COR) and the

Contract Specialist (CS).

Invoice Requirements

An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract

Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number

(e.g., Indefinite Delivery Contract number; General Services Administration number); or BPA

Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed. *

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award. *

NOTE: If your invoice must differ from the line items on the award, please contact the

Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

10.1.1 COR Action

The COR, or Government Representative, will provide a written response VIA E-MAIL within two business days of discovery for any non-compliant product or invoice.

10.1.2 Corrective Action (CA)

CA is any action required to restore deliverables, components, or replacement end products to meet acceptance by the Government under the terms and conditions of this Contract. CA shall be completed within 3 business days of notification of non-acceptance by the Government.

10.1.3 Sales Tax Exemption

The Contractor is hereby advised that the United States Government and Agencies are exempt from State and Local Government Tax by virtue of Article 6 of the United States Constitution.

No exemption certificate is required.