THIS IS A REQUEST FOR INFORMATION (RFI), NOT A SOLICITATION Comprehensive Ventilator & PAPR Maintenance management Contract Request for Information (RFI) DISCLAIMER This Market Survey Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. This is not to be construed as commitment to the Government to procure any item/services, or for the Government to pay for the information received. The purpose of this Market Survey is to identify companies that are capable of providing the above-mentioned services. This is not a solicitation. This will not bind the contractor or the Government in any way or at any time into a contract with any of the specified terms below. The solicitation number for the MARKET SURVEY is ASPR75A506112021SNS this number is assigned to this action for references only, there is not a solicitation at this time. Background The mission of 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), 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 and pandemic events. When state, local, tribal, and territorial public health and healthcare systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event. Public health emergencies or pandemic events present multiple challenges to the health care environment and the ability of the respiratory therapist to provide mechanical ventilation to all persons in need. The Strategic National Stockpile (SNS) maintains a repository of ventilators and powered air purifying respirator (PAPR) systems that would be used to supplement the supply currently in use by the nation’s acute care facilities. Instructions The sole purpose of this RFI is to assist ASPR in understanding the service provider landscape, identify good ideas and strategies, and avoid solicitation or contracting parameters which would be detrimental to ASPR's mission or industry's ability to provide innovative and cost-effective solutions. ASPR does not plan to respond back to companies that submit responses to this RFI except perhaps to ask a clarifying question regarding a response provided by a company. Scope U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Division of Strategic National Stockpile has a need for a comprehensive storage and maintenance contractor to oversee the service requirements, storage, deployment, replenishment of ancillary supplies, and recovery of ventilators that may be requested and allocated to areas of need. This is a requirement for the preventive maintenance (PM) services of all SNS ventilators and PAPR (Powered air purifying respirator) systems. This service shall include forecasting calibrations, normal wear replacement of parts, and accurate recording of maintenance activities performed. The contractor shall be responsible for, storage, transportation, deployment, recovery, inventory, quality control, and reporting equipment at the contractor's facility to maintain optimal material conditions in preparation to a response. The criticality for the SNS ventilators and PAPR (Powered air purifying respirator) systems to have preventive maintenance service contract impacts readiness. Should the SNS ventilators not be serviced and available for deployment it would result in serious reduction in capability to respond to an event due to a natural or man-made disaster, terrorist event, or pandemic emergency. There is a need for cost-effective methodologies that would allow the Strategic National Stockpile increased preparedness of various ventilator assets into rapid deployment condition. Contractors must support the following requirements: The Contractor shall be responsible to provide all capabilities, (such as but not limited to expertise, record management, labor, material, equipment, and properly licensed and secure facilities) and meet all of the current Federal, State, and Local regulatory requirements to include but not limited to the Occupational Safety and Health Administration (OSHA), National Institute for Occupational Safety and Health (NIOSH), and Department of Transportation (DOT) requirements to perform the services involved under this requirement. Should the Government require deployment of the government-owned property while maintenance activities are being performed, the Contractor shall complete the maintenance activity to be fully operational and transport the government-owned property onto contractor managed transportation upon request. Shipping reports shall be provided to the DSNS representative prior to shipment and shall include truck number, air tracking information, location shipping to, item nomenclature, serial/lot numbers, and any special handling notes. Contractor shall maintain inventory records on the government-owned property and provide the Government with reports that capture all maintenance activities pertaining to government-owned property. This reporting requirement includes making reports available monthly or as requested by the government. If government-owned property shipping is needed, the contractor shall provide shipping reports to the DSNS representative prior to shipment. The shipping report shall include truck number, air tracking information, location shipping to, item nomenclature, serial/lot numbers, and any special handling notes in spreadsheet format. The contract shall allow for flexibility to accommodate for slight changes to the equipment such as serial numbers, kit components, ancillaries, and containerization. Industry Questions 1. SCOPE: There is not a need for the contractor to have access inside a Federally controlled facility and it will not be necessary to incorporate identity verification security considerations for the requirement. All storage, inventory management, charging, and maintenance activities has typically been performed at the contractor’s facility which adheres to medical equipment maintenance operations in compliance of Code of Federal Regulations (CFR) Title 10 Part 20, CFR Title 21 Parts 800-1299, moreover, the Contractor will have an established facility that conforms to the following criteria: The facility space should be separated and secured from other tenants to include external points of egress. Internal roof access is preferred. If external is utilized, the access must be secured. Ambient warehouse storage with the ability to maintain temperature ranges from 59 to 86 degrees Fahrenheit. Space for storage, staging, receiving, and shipping product. The facility must have dock doors to adequately support receiving and shipping simultaneously. Glass frontages and skylights are not preferred. If present, the Contractor shall install tinted security film or other physical barriers. Comply with local zoning requirements and cGMP requirements as applicable. Provide the following redundant systems: Uninterrupted Power Source (UPS) for all data capture and security systems. Data back-up of electronic data capture. All communications, water, fire, natural gas, power, and sewer service connections are all located within 5 feet of building. Facilities constructed after 2000 shall have been constructed utilizing International Building Code (IBC). Facilities constructed prior to 2000 shall have been constructed utilizing Uniform Building Code (UBC). The Government reserves the right to verify compliance with these building codes. An established medical equipment management facility and logistics footprint across the Continental United States (CONUS) within 30 miles of International Airports and capable of supporting a minimum of 4,000 pallet positions (each) to include additional areas dedicated to supporting Reprocessing/Cleaning, Interfacility Logistics, Clinical Engineering, Kitting, and Transportation Services. In addition to the primary facilities the Contractor will have no less than 50 additional medical equipment management facilities (and supporting logistics & clinical engineering capabilities) in cities throughout the CONUS to support last mile Reprocessing/Cleaning, Interfacility Logistics, Clinical Engineering, and Transportation requirements. The government reserves the right to do a pre-award site inspection to validate contractor’s ability to meet all facility and logistics requirements on day 1 of contract initiation. 2. SCOPE: Are there other functions beyond those already noted that should be added to the scope either because they are related services or they are directions that the industry predicts will become more germane to this domain area in the future? 3. SCOPE: Contractor will be evaluated to monitor and ensure quality standards are adhered to via site visits and providing monthly production, inventory and status reports, adherence to schedules, accurate reporting of activities, and ability to maintain SNS assets. The combination of telephonic communications, E-mails, and reports will be the primary means to track activities. Please describe major advantages or disadvantages. SOURCING: Market Research is being conducted to determine small business industry capabilities to service ventilators and other respiratory devices on a national scale, and if subcontracting relationships exist for preventive maintenance, management, storage, and transportation services of SNS ventilators located throughout the nation. 4. SOURCING: ASPR has a history of making a single rather than multiple source contract awards for these services; should ASPR consider a different approach for this solicitation given its size, breadth, heterogeneity of services, and the federal landscape of multiple award contracts? 5. SOURCING: How should ASPR best incorporate small businesses into the sourcing strategy including special categories such as women-owned, veteran-owned, small disadvantaged, HUBZone, etc.? 6. SOURCING: What strategies should ASPR employ in the solicitation to assist in a Best Value award determination? What techniques have worked well in other solicitations? 7. OTHER: Any other suggestions or ideas for ASPR to consider in this solicitation? Please include them with your RFI response. ASPR appreciates industry feedback on any or all of the following questions. Responses should be sent to the following email address
[email protected] no later than June 21, 2021. Please limit responses to any question to no more than 2 pages. Responses should be in Microsoft Office product format (e.g. Word, Excel, PowerPoint, etc.). Responses will be kept confidential. Response or non-response to this RFI will have no bearing on the standing of any proposer in subsequent solicitations. Contracting Office Address: Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, SNS Contracts Branch Office (Atlanta), 2945 Flowers Rd. South, Atlanta, GA, 30341-4146, UNITED STATES