FY_2018_NEI_PPE_SOW_11019.docx

Statement of Work Emergency/Disaster Event Preparation: Personnel Protective Equipment (PPE) Building 49 Central Animal Facility National Eye Institute

1. SCOPE

This Statement of Work (SOW) presents the need for laboratory animal personnel protective equipment (PPE) resource to ensure the accessibility and availability of essential supplies throughout an emergency/disaster and Government shutdowns. The supplies are required to support irreplaceable multidisciplinary animal research which is critical to the on-going mission of seven institutes at the NIH.

2. BACKGROUND

The Government’s requirement for supplies of a specific quality and quantity, which meet the specific specifications as outlined below, coupled with the potential for prolonged manufacturing times and a definitive product shelf life, underscores the critical need for this contract. It is the goal of this contract to establish a stable, cost effective, mechanism to ensure the immediate accessibility of up to a 365 days’ supply of material, as well as provide for the availability of material for rotation and replacement throughout the twelve (12) month contract period. The initial emergency/disaster reserve volume of all PPE will be determined at the time of award. The reserve volume for each category and product will be subsequently adjusted monthly in accordance with available resources and program requirements.

The Building 49 Central Animal Facility (CAF) located on the Bethesda campus of the National Institutes of Health contributes to the advancement of biomedical research by providing professional and technical support services related to laboratory animal care and use, and housing laboratory animals in support of eight institute’s intramural research program. To support our animals and the critical research programs they represent, we must ensure consistent supply of PPE materials, even during emergency and disaster situations. Due to the critical nature of these supplies, our program requirements have been incorporated into both our Facility and Institute disaster preparedness plans.

The value of disaster preparedness to laboratory animal facilities has been highlighted in recent years, because of several large-scale disasters that have impacted the U.S. research investment. The past several years have been marked by many humanitarian crises-including the unprecedented spread of Ebola in West Africa, outbreaks of Zika, chorea, yellow fever and others serve as a reminder of the importance of preparedness and a well-coordinated emergency response plan. Disaster preparedness in the laboratory animal industry seeks to reduce direct and indirect losses resulting from disasters. Losses are smallest when the disruptions to animal care and research are minimized. During emergency/disaster events, the normal supply and distribution channels will most likely be unavailable/or protracted due to the impact of the emergency and the rush of immediate orders. Our program’s disaster plan takes these factors into account; it is therefore our intention is to establish an offsite source of critical supplies with an established, laboratory animal PPE vendor with a proven track record of providing quality products and services. As outlined in our emergency plan it is the intention of our program to be able to house up to a one year’s supply of PPE products with a local vendor within a 60-mile radius of NIH in Bethesda, Maryland. The ideal vendor will need a strong disaster plan and have arrangements made with the state and federal agencies in the event of an emergency and or disaster to be able to arrange deliveries to the NIH. As a secondary backup, if the vendor is not able to transport the required supplies we will work with the local vendor to directly pick up the required items.

The Guide for the Care and Use of Laboratory Animals (8th Edition) defines animal biosecurity as “all measures taken to identify, contain, prevent and eradicate known or unknown infections that may cause clinical disease or alter physiologic and behavioral responses or otherwise make the animals unsuitable for research”. See the following for the website link: 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 (https://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth#toc). The National Animal Health Emergency Management System Guidelines define biosecurity for animal production facilities similarly as “a series of management practices designed to prevent the introduction of and the spread of disease agents.” As part of our program’s “Biosecurity Program” we must ensure the provision of an uninterrupted supply of essential PPE supplies. This plan is a shared responsibility between our program and the selected vendor to ensure the consistent availability of high quality PPE products and services.

The vendor must meet and or exceed the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance (Attachment A) as applicable. This document covers the established sanitation, pest management, and quality assurance requirements applicable to the commercial storage and transport of laboratory feed and bedding. We understand the document was published for animal feed and bedding distribution, however, since the vendor’s warehouse will store supplies which will come into contact with our 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. The Vendor shall provide the name of the firm that provides vermin and pest control services as well as a description of their pest control program. They shall also provide 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. Provide the regularly scheduled and documented program of control and monitoring that exist.

The Vendor also must provide documentation about their quality assurance practices for all PPE products. All products supplied should be free of chemical or pathologic contaminants and the presence of natural toxicants. Areas used for storage should not be subject to elevated temperatures or elevated relative humidity for prolonged periods of time as outlined below. The Vendor must provide information on manufacturing, monitoring, and storage of PPE products, as well as quality assurance results as requested. As part of our programs’ responsibility, we will inspect the site(s) at least annually to ensure that they are meeting the above requirements.

It is our intent to incorporate within the contract the ability to secure space within the suppliers’ warehouse(s) that meets the biosecurity requirements listed above to store the emergency supply of PPE. As part of the agreement, we would meet with the vendor after to award and once a year thereafter for a site visit of the warehouse to ensure that the stated requirements outlined in this statement of work are met or exceeded. This will ensure that the facility is able to maintain up to a year’s reserve of PPE products at the respective location, as well as the vendor’s ability to meet or exceed the requirement of the SOW. The vendor would be required to provide a deliverable report on a quarterly basis of the current inventory, or more often if needed. In addition, provide documentation and or statement that the reserve stock is being rotated to ensure the integrity of all products.

All PPE clothing and equipment should be of safe design and manufacture and shall be maintained in a clean and reliable fashion. The Government has taken the usability and fit of the proposed PPE into consideration with the specifications outlined. The specifications are based on the requirements that the PPE fits well and is comfortable to wear. This encourages both our staff and researchers to use the PPE. The PPE specifications are available in multiple sizes and care should be taken to ensure that they meet the specifications so that the proper size for each employee is met. It is not uncommon for several different types of PPE to be worn together; the specifications found within this document, help ensure the compatibility of the different PPE. If PPE does not fit properly, it can make the difference between being safely covered or dangerously exposed. Ill-fitting PPE will fail to provide the required level of protection for the staff and the animals, as well as discouraging appropriate use.

The distinction between exam gloves and general-purpose gloves for this procurement has been clarified by the following. Exam grade gloves are different from general purpose gloves in that they must meet a series of Food and Drug Administration (FDA) regulations requiring a specific barrier to blood or infectious agents. Exam gloves are regulated by stringent FDA requirements requiring specific production and quality control standards. Our personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting more limited interactions with animals and equipment as well as when conducting surgery. Whereas, general purpose gloves are for use in food service, industrial or any other application that does not require a specific barrier to blood or infectious agents. General purpose gloves are the most common gloves found in the marketplace and popular uses include food service, packaging, automotive, painting and health & beauty.

FDA’s regulations require that medical gloves be correctly labeled and cleared for marketing through a premarket notification submission [510(k)] prior to being distributed in the U.S. FDA’s regulations at Title 21 Code of Federal Regulations Part 820 also require manufacturers to produce gloves according to the Quality System (QS) regulation (formerly Good Manufacturing Practices regulation) to assure that gloves are produced at an acceptable quality level, thus helping to assure their safety and effectiveness. The safety and effectiveness of medical gloves can be compromised by many kinds of defects. These defects can be controlled or eliminated through proper quality control procedures. The Agency has determined that glove defects, such as pinholes, which are not readily detectable by the users of gloves, can significantly compromise the effectiveness of the barrier and result in patients or health care workers being unnecessarily exposed to infectious agents.

3. REQUIREMENTS/SPECIFICATIONS

OSHA requires PPE to meet the following ANSI standards. All proposed PPE must meet the cited ANSI standards:

· Eye and Face Protection: ANSI Z87.1-1989 (USA Standard for Occupational and Educational Eye and Face Protection).

· Head Protection: ANSI Z89.1-1986.

· Foot Protection: ANSI Z41.1-1991.

· For hand protection, there is no ANSI standard for gloves, but OSHA recommends that selection be based upon the tasks to be performed and the performance and construction characteristics of the glove material. For protection against chemicals, glove selection must be based on the chemicals encountered, the chemical resistance and the physical properties of the glove material.

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

SMS Coveralls are made of a spun bound Melt-Blown Synthetic, a unique trilaminate material. SMS coveralls offer breathability, fluid resistance, and good hold-out for dry particulates. SMS Coveralls are autoclavable and offer good tear and puncture resistance. The micro-porous layer affords protection from splashed and particle contamination. The minimum acceptable standard shall be: The lab coats are sized for maximum comfort; the weight of 1.5 ounces per square yard with five Velcro closures front; the lab coats shall have a knit cuff and collar, three pockets, blue, and shall be available in Small to Six (6) XL. The Lab Coat size specifications is listed below.

Salient Characteristics for Polypropylene Coverall:

Polypropylene Coveralls are a lightweight, economical coverall that offers protection against non-hazardous, dirty environments. Polypropylene coveralls are ideally suited for use in minimal protection applications. The minimum acceptable standard shall be: Polypropylene coverall is sized for maximum comfort and fit per ANSI/ISEA Spec 101-1996 standard with weight of 1.4 ounces per square yard, and zipper fronts. Polypropylene Coveralls with elastic wrists, elastic thumb loops and elastic ankles are available from small to six (6) XL. These polypropylene coveralls are blue and have a snap front pocket. The coverall size specifications are listed below.

Salient Physical Property of the SMS Coverall:

SMS Coveralls are made of spun bound Melt-Blown Synthetic, a unique trilaminate material. SMS coveralls offer breathability, fluid resistance, and good hold-out for dry particulates. SMS Coveralls are autoclavable and offer good tear and puncture resistance. The micro-porous layer affords protection from splashed and particle contamination. The minimum acceptable standard shall be: SMS coverall is sized for maximum comfort and with elastic wrists, elastic ankles, 2 pockets with zipper front and weight 1.8 oz. are available from small to six (6) XL. These SMS coveralls are white. The coverall size specifications is listed above.

Salient Physical Property of the Suntech Microporous Film Coveralls:

Microporous Film Coveralls are made of a laminated microporous film that is spunbound Polypropylene reinforced with a nylon scrim core. As such, Microporous Film Coveralls are strong and flexible. Microporous Film Coveralls offer excellent fluid resistance and holdout. Microporous film coveralls pass blood borne pathogen and viral penetration tests for use in containment areas. The minimum acceptable standard shall be Microporous Film coverall is sized for maximum comfort and weight is 2.11 ounces, with elastic wrists, elastic thumb loops and elastic ankles are available from small to six (6) XL offer excellent fluid resistance and holdout. These Suntech Microporous Film coveralls are white. The coverall size specifications is listed above.

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

The fabric is polyethylene with a thickness of 2.25 mil. The sole is skid resistant, blue and is packed 200 pair per case rolled in pairs and available in sizes large and XL.

Salient Physical Property of the Guardian Nitrile Gloves:

Guardian Nitrile medical grade gloves are blue, powder-free, textured, and are five (5) mil thick. Guardian nitrile medical grade gloves are available with a 12-inch cuff. These 510K certified medical grade nitrile gloves are supplied 100 per box, 10 boxes per case and available in sizes small to two (2) XL.

Salient Physical Property of the Rhino Shield Latex Medical Grade Gloves:

Rhino Shield latex medical grade gloves are blue, powder-free, textured, 14 mil thick and have a beaded 12 inch cuff. These latex gloves are 510K certified medical grade gloves. Rhino gloves are supplied 50 per box and 10 boxes per case and are available in sizes from small to two (2) XL.

Salient Physical Property of the Rhino Shield Latex Medical Grade Gloves:

Rhino Shield latex medical grade gloves are blue, powder-free, textured, 14 mil thick and have a beaded 12 inch cuff. These latex gloves are 510K certified medical grade gloves. Rhino gloves are supplied 50 per box and 10 boxes per case and are available in sizes from small to two (2) XL.

Salient Physical Property of the PE Coated Polypropylene Protective Sleeves 18”:

PE Coated Polypropylene Protective Sleeves provide excellent fluid resistance and good hold-out protection for dry particulates. The protective sleeves have elastic band at both ends. These are 1670/171 certified.

Salient Physical Property of the Polypropylene Bouffant Caps 24”:

White Polypropylene Bouffant Caps are a lightweight, economical choice in non-hazardous, dirty environments. Polypropylene bouffant caps are disposable caps that are well suited for minimal protection applications.

Salient Physical Property of the Ear Loop Mask, Blue:

Procedure Mask blue pleated with elastic latex free ear loops

Salient Physical Property of the N-95 Respiratory Mask:

3M Respirator Dust/Mist N95 mask 8210 with elastic ear loops

In addition to establishing and maintaining PPE as an emergency and disaster resource, the vendor must provide high quality laboratory PPE that meet the salient specifications as outlined above. Since PPE products have a definitive shelf life, to maintain the integrity of the stocked items the vendor shall deliver requested items from the reserve to the facility on a routine basis or upon request as outlined below. In addition, the vendor shall reestablish the reserve as directed by the Government on a as needed basis. It shall be the vendor’s responsibility to manage the reserve to ensure the continued rotation of product to protect the integrity of the resource.

The proposed vendor must be able to supply the following goods or services:

1. Ensure that the lab coats and coveralls meet the minimum sizing specifications, salient characteristics and physical properties as outline above;

2. Ensure that the gloves meet the minimum salient characteristic as outline below;

3. The vendor must meet and or exceed the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance, post award, within 30 days, See Attachment A;

4. Provide routine (weekly) deliveries to our research facility. Deliveries will be made Monday through Friday from 7:30 AM to 3:00 PM (excluding Federal Holidays);

5. Provide emergency deliveries and services in the event of an emergency or disaster within a 24-hour response time;

6. Ensure that the integrity of the products is maintained throughout storage and delivery. This includes, but is not limited to, protection from moisture and dust which may carry unwanted pathogens;

7. Ensure that less than five percent (<5%) of boxes/items are torn, ripped, or damaged upon delivery; to include faulty zippers within the coveralls.

8. Provide a credit/replacement, at the contractor’s expense, for all broken, torn, ripped, or damaged PPE items;

9. Provide return trips to correct an incorrect product delivery/order or replace damaged items within 24 hours of the original required delivery date and time;

10. Unload pallets from the delivery truck and place them on the designated animal facility loading dock;

11. Maintain current and accurate product inventory details and controls to ensure the rotation of stock, timely dating, and delivery;

12. PPE items may be added, subtracted, or otherwise modified at the discretion of the Government to meet evolving program requirements;

13. Supply a copy of the current inventory, including inventory numbers of each product by manufacturer and production dates, to the COTR on a quarterly basis, by the 10th of day of each quarter, or upon request;

14. Provide an Operations Statement which includes the vendors program for maintaining the integrity of the stored and delivered products, as well as product rotation and inventory programs, post award, within 30 calendar days; and

15. Provide a Disaster Plan to include how the contractor shall ensure the provision of services and transportation of required supplies in the event of an emergency or disaster, post-award, within 30 calendar days.

The level of stock for the emergency supply will be dependent upon the available resources and funding levels at the base, and option years, of the contract. However, a minimum one (1) month supply will always be maintained. At a minimum the emergency/disaster reserve for each PPE product will be a 30-day supply; at a maximum a 365-day supply for each PPE product. All quantities stated, unless indicated otherwise are estimates and the Government reserves the right to increase or decrease the quantities at the unit price as best fits it needs.

Anticipated period of performance: The government intent is to award a base year plus 4 option years.

4. STANDARDS

The Guide for the Care and Use of Laboratory Animals (8th Edition) defines a basis 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). Seven sources serve as the basis for selecting appropriate protective measures:

1) Protection of personnel from such hazards as allergens, infectious/zoonotic disease, and physical hazards (e.g., bites, noise, burns, chemical hazards, etc.).

2) Protection of animals from the introduction of disease. It is essential to recognize that a variety of factors (e.g., personnel/animal disease status, immunocompetence, procedure/activity, use of hazardous agents, chemicals/radiation, physical factors such as facility design and function, etc.) influence the selection of appropriate PPE. For that reason, definitive guidelines are not provided and this guideline outlines basic best practices to which exceptions may be warranted.

3) 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

4) National Institute of Health, Animal Research Advisory Committee Guidelines for Personnel Protection in Animal Facilities

5) OSHA requires that many categories of PPE meet or be equivalent to standards developed by the American National Standards Institute (ANSI).

5. OTHER CONDITIONS:

In its order fulfillment process or procedure, the Vendor must accept orders via phone or by email.

The Vendor must notify the Government immediately if a PPE product is out of stock to allow for alternate replacement if available.

No substitutions are allowed by the Vendor without explicit written permission from the Government at the time of ordering.

The Vendor must transport and store PPE materials off the floor on pallets, racks, or carts in a manner consistent with maintenance of quality and minimization of contamination, including dust, in strict accordance with the Guide for the Care and Use of Laboratory Animals and the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance.

During the life of the contract, the Vendor shall notify the Contracting Officer Representative of any change in the address of the production facility and/or distributors warehouse. This notification shall also apply in the event the PPE production is performed by a subcontractor.

The Government reserves the right to perform inspections at the distributor’s and manufacturer’s production and/or warehouse facilities prior to contract award and during the contract to assure compliance as listed above.

All deliveries will be on a clean, commercially standard 48” x 40” (121.92cm x 101.6cm) pallet. Pallets will be inspected upon delivery and shall be clean and free of contaminants and damage. The total height of the pallet and goods shall not exceed 55” (139.7cm). In addition, each pallet shall be shrink-wrapped to assure safe and proper handling.

Unless otherwise specified, deliveries shall be made to the Building 49 Loading dock. Deliveries will be made Monday through Friday from 7:30 AM to 3:00 PM (excluding Federal Holidays); if necessary alternative arrangements can be made with the Contracting Officer Representative only. Trucks arriving after the specified time may not be allowed to unload the PPE. Supplies or services scheduled for delivery on a Federal Holiday shall be made the following workday. Satisfactory performance of this contract shall be deemed to occur upon delivery and acceptance by the Government or the duly authorized representative of the items described herein.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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