Portable Patient Transport System (PPTS)

STATEMENT OF OBJECTIVE (SOO) DISTRIBUTION A. Authorized for public release; distribution unlimited. Project Title: Portable Patient Transport System (PPTS) Background The Capability Program Executive Chemical, Biological, Radiological, and Nuclear Defense (CPE-CBRND) and Joint Project Manager for CBRN Protection are seeking readily available systems for a single, non-ambulatory patient system to support the Biocontainment, Isolation, and Quarantine (BIQ) PPTS program. This man-portable system will control and prevent the spread of biological threats (biothreats) while transporting a single, non-ambulatory infectious patient by air, rail, ground, or sea. The desired solution is a complete system consisting of a patient containment enclosure with an integrated, battery-powered air filtration system. This system must generate negative pressure, provide sufficient air changes per hour (ACH), and filter all exhaust air. Essential features include glove ports, pass-through interfaces, and windows to allow for continuous patient care. ACQUISITION STRATEGY & PROGRAM OVERVIEW This Statement of Objectives (SOO) defines the goals for a multi-phased prototype project awarded under the authority of 10 U.S.C. § 4022 Phased Acquisition and Success Criteria The program consists of two Segments. Segment I contains one phase, and Segment II contains two phases (Phase II and III). The Government intends to make up to five (5) Other Transaction Agreements for Segment I (Phase I). Down selections will occur, at a minimum, at the conclusion of each segment; however, the Government reserves the right to execute an earlier down selection should circumstances, such as a critical failure, necessitate it. Following the completion of Segment I, the Government will evaluate performers and down-select up to two solutions to proceed to the Segment II option (Phase II and III). Evaluation criteria for potential selection for the Segment II option will be based on the affordability of the prototype, availability of funds and the prototypes ability to meet the threshold requirements and user feedback in Segment I testing as described in Attachment 1, Table 2 and 5. To be considered successful and eligible for a non-competitive follow-on production award, a prototype must meet the following criteria. Table 1: Minimum criteria for a successful prototype. Requirement Threshold Leak Containment The PPTS shall hold at least 3 liters of liquid contamination inside the containment enclosure without leaking. Force Protection Negative pressure differential of 0.01 In.w.g Head to foot airflow 12 Air Changes per Hour (ACH) 99.97% at 0.3-micron particle diameter Power 12 hours continuous operation System shall provide a low battery warning During battery hot swap, power interruption shall be less than or equal to 1 minute Regulatory Compliance System shall be authorized for marketing by the US FDA for an indication that aligns with CPE-CBRND objective intended use. Patient/Crew Interface System must provide visibility of the patient from head-to-waist System will have pass-through interfaces from the system exterior to the system interior System will include glove ports located near patient head, torso, and feet to enable proper patient care Air Filtration System The system must be able to indicate system interruption via alarms Weight System will comply with the person-portable lifting limits (excluding patient) specified in MIL-STD-1472 Interoperability System shall accommodate 90% of adult male and females (5th to 95th percentile) Airworthiness Collection of test data including favorable results for EMS, altitude, rapid decompression, crash hazard acceleration, explosive atmosphere, and NVD testing. The System must meet all military, federal, and international airworthiness and transport requirements for airlift in accordance with: MIL-HDBK-516 for C-17, C-130, KC-135 and HH-60. Patient Restraint •The PPTS restraint straps shall be capable of being released without breaking containment regardless of the state of attachment to a conveyance and/or transport platform. •The PPTS shall have restraint straps for safe physical patient restraint inside the containment enclosure appropriate to the manner of movement regardless of state of attachment to a vehicle. •The PPTS restraint straps shall accommodate 90% of personnel for all key sizing dimensions (5th to 95th percentile, male and female body dimensions). •The PPTS restraint straps shall be in the vicinity of the patient’s chest, waist, and legs. Transfer Pouch The PPTS shall provide at least one transfer pouch to allow items to be passed into the containment area while maintaining a negative pressure differential of 0.01 inches of water gauge or more inside the containment enclosure during the transfer. Exterior Disinfection The PPTS exterior surfaces shall be compatible with one or more Environmental Protection Agency (EPA)-registered disinfectants for a contact time of 15 minutes. Litter Compatibility System shall be compatible with NATO litter Ambulance Integration System shall meet SAE J3027 crash-compliance for Department of Transportation vehicle transport requirements and be compatible with ground vehicles UFM 82/83 ambulance and AMBUS. 1. The PPTS shall not detach from the NATO litter per SAE J3027. 2. The NATO litter assembly shall not detach from the ambulance gurney per SAE J3027. Follow-on Production Authority In accordance with 10 U.S.C. 4022, and upon a determination that the project for this transaction has been successfully completed, any competitively awarded system Other Transaction Authority (OTA) because of this Call for Solutions may result in the award of a follow-on production agreement or transaction without the use of competitive procedures for up to 476 units over four years. PROPOSAL SUBMISSION REQUIREMENTS: This Statement of Objectives (SOO) outlines the overall goals of the…