Reusable Healthcare Elastomeric Respirator (RHER) – Prototypes

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued. The solicitation number for this requirement is 2021-Q-57250 and is hereby issued as a Request for Quote (RFQ) using FAR Subpart 13.1 Simplified Acquisition Procedures. The NAICS Code for this synopsis/solicitation is 541330, Size Standard 500 employees. Solicitation/ Purchase Request issued as a Request for Quotes (RFQ) number 2021-Q-57250. This document incorporates provisions and clauses that are in effect through Federal Acquisition Circular 2021-04, Effective 19 Jan 2021. A Firm-Fixed Price purchase order will be issued in writing to the sole source identified vendor. The Government contemplates award of a firm-fixed price contract resulting from this solicitation for the following Contract Line Item Number (CLIN): The requirement is for Reusable Healthcare Elastomeric Respirator (RHER) –Prototypes The equipment is to be delivered to NIOSH Pittsburgh, 626 Cochrans Mill Rd., Bldg 166, Pittsburgh, Pennsylvania CLIN 0001 : Reusable Healthcare Elastomeric Respirator (RHER) – Conceptual Prototypes: Qty: 1 EA STATEMENT of WORK Background Healthcare providers are considering the use of reusable filtering ori-nasal masks instead of disposable N95 filter half-masks to mitigate the effect of depleting stocks of disposable masks during times of high demand such as during a pandemic. Although respirator manufactures have products drawn from their industrial line and modified for healthcare use, these products are not fully optimized for the required purpose. The RHER is ergonomically designed to be donned quickly, be low profile and to allow for improved downward vision. It is designed to be non-threatening to benefit the patient experience, have splash guards, deflect the exhaled breath rearward, easy to dismantle for cleaning/disinfecting, and packable for storing in a small space. With input from NIOSH-NPPTL healthcare and respiratory experts, conceptual prototypes of the Reusable Healthcare Elastomeric Respirators (RHER) were produced for bench testing and evaluation by researchers at NPPTL. This conceptual design need to be refined and elevated into a prototype that can be used in hospital demonstration studies. For this purpose, final features to be incorporated into a prototype need to be determined by examining and testing the conceptual prototype that was developed. Project Objectives The objective of this project is to design and produce functional prototypes of reusable healthcare elastomeric respirators using the existing conceptual prototypes as the initial design basis. Through this approach, a custom design that meets the specific requirements of the healthcare worker and will be available for further development and refinement. The refined prototype could then be used in hospital demonstration studies to assess its application in the working environment. Eight hundred (800) functional RHER prototypes would be produced through an iterative development process for hospital demonstration studies. A technical data package and a final report will be generated for record of the work completed. Configuration and Design The RHER will consist of an ori-nasal mask body incorporating an exhalation valve with a feature to filter the exhaled breath, inhalation filter attachment ports, and possibly a speech diaphragm. It will be equipped with a head harness assembly to be donned quickly and worn comfortably. The RHER would be low profile and ergonomically designed to allow the user a wide field of vision. The ori-nasal mask, attachments and harness would be cleanable and reusable. It would incorporate N95 or P100 particulate inhalation filter element(s) and exhaled breath filter element(s) that would be disposable after use. Other important features would be: Non-threatening appearance and color for the benefit of the patient Silicone face contact surfaces contoured to get the best fit to NIOSH headforms appropriate for the healthcare community Exhaled breath directed away from patient and filtered Splash guards to protect against fluid ingress through service ports Packable for storing in small spaces and contained in a case with two spare filter elements Easy to dismantle (and assemble) without tools for cleaning and disinfecting Project Tasks and Deliverables The project will commence with research and re-evaluation of the conceptual RHER prototype features to establish the best design direction for the prototype. Feature re-evaluation will be aided by examining the feedback from NIOSH-NPPTL and external healthcare experts, and researchers. Test data from the conceptual prototypes and computational fluid dynamics analysis will be applied in finalizing the prototype RHER design. Then, detailed drawings with materials and performance / design requirements will be created for constructing prototypes. Information from the Configuration and Design Criteria section above will be used as a guideline in producing the outputs and deliverables for the RHER prototypes. RHER prototypes must be capable of being bench tested to evaluate their performance on NIOSH breathing machines. Tooling, molds, and other parts as required must be produced for this purpose, with Some parts being machined. Tooling and molds must be capable of enduring limited production runs of up to 1,000 parts. The complete assembly must be resilient enough for bench and human subject testing. The assemblies should be able to be dismantled with tools and repeated cleaning and disinfecting. Tasks: Research performance needs with input from NPPTL and re-evaluate the required features from NPPTL researchers and healthcare experts. Improve upon the conceptual RHER design from this input and then produce solid models, production drawings and tooling drawings to produce the RHER prototype and its carrying case. Gain approval on the prototype design and tooling from the NPPTL program office. Finalize the design and produce tooling and fixtures, machined parts, and procure stock parts as necessary to produce prototypes. Produce prototypes and storage cases to house one RHER prototype and two filter elements to the required quantities. Notes: Preliminary prototypes may need to be constructed for analysis purposes. This would be an iterative process where multiple prototypes will need to be made and checked to improve the design incrementally and arrive at the final design as state in task 4 above. Filter element design is not within the scope of this work, however, the filter housing, cover and interface to the RHER prototype is included within this scope. The deliverables from this project will be a design package, final report and prototype items, namely the RHER prototype, carrying case and associated documentation as follows: One (1) package (on readable CD) Solid model/ drawings of RHER prototypes, its constituent parts, molds and tooling to produce the parts. Eight hundred (800) RHER prototypes with carrying cases for one prototype and two filter elements. One (1) Final Report of the RHER prototype design. Draft reports must be sent to the program office for review and comment before the finalizing the report. Project Reviews Design review – A design review meeting will be held at the contractor’s site or NIOSH facilities or virtually to review and discuss the RHER design, and input for improving upon the conceptual prototype design. Subsequent meetings will be held as necessary at NIOSH Pittsburgh, or contractor site or virtually. Project Support NIOSH-NPPTL respirator experts will be consulted to draw on their expertise on mask designs “The agency conducts research and development continually to gain knowledge and improve personal protective equipment such as respirators. Although there are a number of respirator products available for use by the US workforce, particular features are sought by a workforce segment; in this case healthcare workers. The RHER is developed for healthcare workers with input from healthcare experts and researchers on its required features. Exhaled breath filtering (or source control) is a recent feature requirement due to the current pandemic and the RHER will also incorporate this feature.” Special Considerations: Electronic and Information Technology Accessibility (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. (b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm. (c) The Section 508 accessibility standards applicable to this contract are: 1194. 205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues. (d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. (e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. Your quote shall include the following: • Total Price for CLIN 0001 The quote format is at the discretion of the offeror. It is the offeror's responsibility to be familiar with the applicable clauses and provisions. Clauses and provisions may be accessed via the Internet at website http://farsite.hill.af.mil. To be eligible to receive an award resulting from this solicitation, contractor must be registered in the System for Award Management. To register apply via the Internet at http://www.sam.gov. For questions on registration contact Federal Service Desk at 866-606-8220. **Include FAR 52.212-3, Offeror Representations and Certifications with Offer or indicate if it is available online at SAM.gov. In accordance with the FAR 13.106-1(a)(2), offerors are notified that award will be made on the basis of lowest price technically acceptable. Technical acceptability is determined by conformance to all details described for each CLIN. Offerors will be evaluated in accordance with FAR 13.106-2. A Firm-Fixed Price purchase order will be issued in writing to the successful offeror. No telephonic quotes will be processed. All responses must be received no later than 12:00 P.M., Eastern Standard Time on June 28, 2021. Please send any questions and quotes to Dwight Favors at [email protected].