Attachment 2 - IIJA Compliant PPE Specifications -FINAL - Amendment 11.docx

RFP 75N98023R00014 Attachment #2 Amendment #11

IIJA Compliant PPE Specifications, Certification Levels, and Attributes

NIH Supply Center, Division of Logistics Services (DLS) August 31, 2023

Table of Contents

List of Tables

Overview The purpose of this document is to identify specifications, certification levels, and attributes of Infrastructure Investment and Jobs Act (IIJA) compliant PPE. The authors of this document recognize that the PPE needs across NIH are broad and may change. This document aims to provide an overview of some of the standards and certifications that may be present on different types of PPE. The lists provided are not comprehensive and the intended use of the products should inform the certifications and standards that should be associated with a product. Some categories of PPE list several standards. These standards and certifications may or may not exist simultaneously for the same product as the requirements change based on the intended use scenarios for many types of PPE. The list does include only some examples and do not include all of the interested standards, certifications, or PPE types. The information below should not be considered complete or absolute. The intended use scenario must be carefully considered before purchasing is initiated.

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

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

II. When a Contractors' 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 prior to production and/or delivery and incorporated into the contract as a contract modification.

III. 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 Contracting Officer. Under no circumstances shall NIH incur additional costs for product upgrades, unless the cost variance is approved by the government COR and government Contracting Officer 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 Contractors' new product to meet the requirements of the existing Order, at no additional cost to the Government.

IV. It is preferred that ISO 17025 certified labs are used for testing the PPE (if not a certified product).

V. The Contractor shall have:

i. Capability for nationwide delivery (validated through previous commercial or government contracts)

ii. Ability to deliver to NIH Supply Center up to twice weekly on designated day and to designated dock.

iii. Surge capability to meet the disaster relief or increased customer demands (ex. Force majeure events, evolving customer needs, etc.)

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

Table 1. Utilization of gloves and associated certifications

*As applicable, please identify the certification levels, standards, and the corresponding requisite AQLs of the American made PPE product(s) you are offering to the Government.

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

Table 2. Expected utilization of gloves and sizes

Table 3. Specific Attributes of IIJA Compliant Nitrile Gloves

· 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

· 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

· 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 % of pinhole defects in disposable gloves. The lower the AQL, the lower the risk of exposure.

PPE Masks The below table lists the expected utilization of masks and respirators, and associated certifications.

Table 4. Expected utilizations of masks and associated certifications

42 CFR 84 (required) in addition to ASTM F1862, CPSC CS-191-53 (16 CFR Part 1610), ISO-10993-1,

42 CFR 84 (required) In addition, there may be certification to one or more other standards, such as NFPA 1981, NFPA 1984, NFPA 1986, NFPA 1987

Surgical Tie-On

Procedure Earloop

Clear Masks

Note: NIOSH has approved clear respirators. If a clear respirator is desired, the requirements for respirators should be referenced.

NIOSH approved Respirators The U.S. National Institute for Occupational Safety and Health (NIOSH) approves respirators for use in occupational settings in the United States. The certification and approval process for respiratory protective devices is governed by Part 84 of Title 42 of the Code of Federal Regulations (42 CFR 84). Respiratory protective devices so classified include air-purifying respirators APR) such as filtering facepiece respirators and elastomeric respirators that utilize filters or chemical protective cartridges that have incorporated particulate filter elements. Enforcement agencies such as OSHA and MSHA have requirements for proper selection, use, care and maintenance of NIOSH approved respirators required to be used in occupational settings.

NIOSH approved respirators are provided with an approval label that describes the protections to which they are certified. A respirator should be selected based on the expected exposures and hazards. NIOSH approved respirators should verify that their respirator is approved by accessing the NIOSH Certified Equipment List. Respirators must be NIOSH approved and available in a range of sizes that will fit multiple face shapes and sizes. The protections listed on the NIOSH approval label assume that the respirator is properly fitted to the wearer.

Face Coverings that are not Respirators Procedural masks are breathable disposable masks designed for one-time use in medical environments, including patient procedures, isolation, or dental practices. Procedural masks are traditionally characterized by an ear loop attachment and a colored outer layer. They are used to protect both patients and staff from the transfer of respiratory droplets by coughing, sneezing, or talking.

Conversely, surgical masks are loose-fitting disposable masks designed for one-time use in medical environments. Intended for operating rooms, surgical masks are characterized by surgical ties behind the head and closeness of fit. They are designed to protect the clinician from contaminated fluid or debris generated during procedures.

Non-Medical Face Coverings – All masks proposed under this heading must be, at a minimum, Disposable 3-ply masks OR reusable, washable fabric masks.

Other PPE: Coveralls, Lab Coats, Jackets, Gowns, Shoe Covering, and Headwear Table 5. Utilization of other PPE and associated certifications

Lab Coats & Jackets

Coveralls

Surgical gowns

Faceshields

ANSI Z89. 1 -ADD IN TITLE.]

Safety Glasses/Goggles

Caps

Shoe Covers

ALL PPE RESPONSES SHOULD INDICATE WHICH LEVEL OF PROTECTION IS PROVIDED BY THE RESPONSIVE OFFEROR:

Table 6. Civilian PPE OSHA/EPA Classification [footnoteRef:39][footnoteRef:40] [39: OSHA PPE information] [40: EPA PPE information]

Adequate for radiation event response where other hazards have been determined not to be present Lowest level of respiratory and skin protection.

Working in confined areas where hazards have not been fully characterized.

Identified or suspected hazards requiring maximal respiratory protection.

Working in atmospheres containing less than 19.5% oxygen.

Lower-level skin hazard may be present.

Hazard have been identified.

Hazards will not be absorbed by or adversely affect exposed skin.

All criteria for using an air purifying respirator are met (i.e., concentrations of all airborne contaminants are known, appropriate filters are available, oxygen levels are sufficient).

Atmosphere contains no known hazards.

No or very low potential for unexpected respiratory or skin contact with environmental hazards.

When identified or potential risk of biological, liquid vapor chemical hazard exposure exists First responders

When entering the most heavily contaminated radiation zones to rescue victims or protect valuable property necessary for public welfare.

First responders and first receivers

When caring for patients/victims likely to be contaminated with radiological material.

First receivers

When working in post-decontamination areas should wear Standard Precautions PPE (per protocol) for infection control purposes[footnoteRef:41] [41: Standard precautions PPE and procedures used to prevent transmission of infections within healthcare settings provides adequate protection against low levels of radiological contamination that may be found in post-decontamination areas of the hospital (e.g., emergency department and surgical suites). No formal PPE is required to be worn when delivering care to persons with high dose radiation exposure although reverse isolation procedures will need to be observed as neutropenia becomes prominent.]

ADDITIONAL COMPOSITION STANDARDS - Animal Lab Facilities

Suppliers should ensure the PPE meets the specifications above and below and are available in multiple sizes to meet the capability for several different types of PPE to be worn together. If PPE does not fit properly, it will not meet the required safe level of protection for the staff and the animals.

Suppliers must meet the standards for personal protective equipment (PPE) found here:

1. The National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance: NIH STD No. 1F March 6, 2008: NIH STD12008b. This document covers the established sanitation, pest management, and quality assurance requirements applicable to the commercial storage and transport of laboratory feed and bedding. Since the supplier’s warehouse will store supplies which will come into contact with the NIH animals or their environment, the area must also be protected from the risk of contamination from animal pathogens, toxic and or hazardous substances. Ideally, the product(s) shall also be protected from dust which may carry or harbor potential pathogens, toxins or hazardous agents. Awarded Contractor(s) will be required to provide (upon award) the name of the firm that provides vermin and pest control services as well as a description of their pest control program. Awarded Contractor(s) shall also provide, upon award, a copy of the pesticides used, program for maintaining the stored product(s) free of pesticide residues, facility map, and the latest quality assurance report and service report and provide the regularly scheduled and documented program of manufacturing, storage, control and monitoring that exist.

2. The National Research Council (2011). Guide for the Care and Use of Laboratory Animals, 8th Edition. Pages 21, 22, 141. Institute of Laboratory Animal Resources, Commission on Life Sciences. This document provides the framework for understanding the potential hazards when working in an animal facility and the specific protective measures to reduce the risk, with an emphasis on personnel protective equipment (PPE).

3. National Institute of Health, Animal Research Advisory Committee Guidelines for Personnel Protection in Animal Facilities

In addition to the standards and certifications set forth above for fluid resistance, tear and puncture resistance and protection from splash and particulate contamination, the minimum acceptable standards for animal lab specific PPE is as follows:

Salient Characteristics for Spun Bound Melt-Blown Synthetic (SMS) Lab Coats:

· Weight of 1.5 ounces per square yard

· Velcro closures front;

· Knit cuff and collar

· Minimum of 3 pockets

· Available in Small to Six (6) XL as set forth here:

Salient Characteristics: Polypropylene Coverall (protection against non-hazardous dirty environments):

· ANSI/ISEA Spec 101-1996 standard

· Weight of 1.4 ounces per square yard

· Zipper fronts

· Snap front pocket

· Elastic wrists, elastic thumb loops, elastic ankles

· Available in sizes small to six (6) XL

Salient Physical Property of the SMS Coverall:

· Elastic wrists, elastic ankles,

· 2 pockets with zipper front

· Weight is 1.8 oz.

· Available from small to six (6) XL.

Salient Physical Property Microporous Film Coveralls:

· Laminated microporous film/spun bound Polypropylene reinforced with a nylon scrim core for strength, flexibility, fluid resistance and durability.

· Must pass blood borne pathogen and viral penetration tests for use in containment areas.

· Weight is 2.11 oz.

· Elastic wrists, elastic thumb loops and elastic ankles

· Available from small to six (6) XL

Salient Physical Property of the Non-Skid/Water Resistant Shoe Cover:

· Polyethylene fabric

· 2.25 mil thickness

· Skid-resistant sole

· Available in sizes large and XL.

Salient Physical Property of Medical Grade Nitrile Gloves:

· Powder-free

· 5 mil thickness

· Available with 12“cuff

· Available in sizes small to 2XL

Salient Physical Property for medical grade latex gloves:

· Powder-free

· Textured

· 14 mil thickness

· Beaded 12“ cuff

· Must be 510K certified medical grade

· Available in sizes small to 2XL

Salient Physical Property of the PE Coated Polypropylene Protective Sleeves:

· PE Coated Polypropylene

· 18-inch sleeves

· Elastic band at both ends of sleeves

· 1670/171 certified

Salient Physical Property of the Polypropylene Bouffant Caps

· 24 inches

· Disposable image1.jpeg image2.jpeg image3.png image4.jpeg image5.jpeg image6.png image7.jpeg image8.png image9.jpeg image10.jpeg image11.emf image12.png