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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on establishing an array of venues where medics, other ca... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on establishing an array of venues where medics, other caregivers and simulated patients agree to participate in tactical combat casualty care (TCCC) training while wearing suites of sensing technologies. This effort is aimed at providing a controlled venue to conduct these training events that is hyper realistic with respect to battlefield conditions. __________________________________________________________________________ BACKGROUND: The Military Health System (MHS) lacks a robust, accurate, and reliable methodology to collect, store, and track TCCC data. Establishing a prehospital environment data set [e.g., TCCC, prolonged casualty care (PCC), and/or en route casualty care (ERCC)] is an essential, foundational step to modernizing Military TCCC medical care. Without a means to collect data reliably and passively from the point of injury through higher echelons of care, the MHS will continue to lack the essential data to develop a trustworthy artificial intelligence (AI) to support future concepts that will sustain medical operations in the various environments of Multi-Domain Operations (MDO). Military medics and combat lifesavers often find that pausing care delivery to generate medical documentation is challenging, if not impossible, in many instances. Being able to capture the medical care being delivered in these venues may be secondary to saving lives in that moment; however, the need for timely, accurate medical documentation remains. To enhance TCCC and improve medical documentation in the MHS, a passive (e.g., with minimal human effort) documentation solution of medical care in operational environments is an essential requirement to establishing these critical TCCC data sets. Furthermore, it is vital that the processes in collecting this data does not distract the medic/caregiver’s capability and capacity to deliver care. To address this need, the US Army Medical Research and Development Command’s Telemedicine and Advanced Technology Research Center (TATRC) has recently initiated the Autonomous Casualty Care (AC2) Research Portfolio. This research portfolio seeks to develop systems of sensor suites that passively collect accurate and reliable data about casualty status, caregiver (e.g., medic and/or combat lifesaver) actions, and real time resource usage. TATRC will collect data during TCCC to develop a data set that describes casualty care. One use of this data (and associated algorithms) is to automate documentation of TCCC (e.g., DD Form 1380). Please note that this RPP is one piece that contributes to TATRC’s AC2 Research Portfolio, in this instance, to collect data from prolonged casualty care simulation events that will be leveraged to drive algorithms for autonomous documentation in a future phase of the overarching effort. TECHNICAL OBJECTIVE: A key aim of the AC2 research portfolio is to build a repository of data collected through combat medics/care givers wearing multimodal passive sensing technologies while performing TCCC tasks in laboratory, training, and hyper-realistic battlefield settings. To accomplish this will require access to an array of venues where medics, other caregivers and simulated patients agree to participate in TCCC training while wearing suites of sensing technologies. This prototype is specifically for providing a controlled venue to conduct these training events that is hyper realistic with respect to battlefield conditions. The overarching AC2 research portfolio objective is to complete 100,000 TCCC encounters/scenarios (e.g., TCCC tasks in prioritized care contexts) that generate data elements (DD Form 1380 et al.) which are aggregated and stored by 31 March 2025. The use of a collaborator/partner data collection site/training facility will allow the Government to achieve this overarching research data collection goal. DESIRE SOLUTION CHARACTERISTICS: The Government requires the following specific tasks from a qualified Offeror: • Task 1. Development of novel, realistic prehospital (e.g., TCCC, PCC, PFC, ERCC, et al) simulation scenarios scripts that meet the objectives of the AC2 Research Portfolio. • Task 2. Participate in a TATRC (Government)-led orientation about the human subject research protocol/data collection process. • Task 3. Provide training or recertification of performer team members to serve as research associates on a human subject research (HSR) protocol(s) (Go/No-Go Assessment Point) • Task 4. Conduct novel prehospital simulation events at the performer venue/location(s) with human subject participants in accordance with approved HSR protocol(s) for the AC2 research portfolio. This includes collecting data outcomes and specific measures and providing that data to the Government team. Discrete data collection events occurring monthly for a minimum of 21 months throughout the period of performance. (Go/No-Go Assessment Point) See Attachment for Figure 1 To accomplish these aforementioned critical tasks, the Government must work directly with an experienced performer capable of: (1) Developing novel, realistic prehospital (TCCC/PCC/ERCC) simulation/scenario scripts to include measures of effectiveness and clinical outcome measures. (2) Integration of the novel prehospital simulation scenario/scripts into data collection events at the performer location. (3) Participate in a Government led orientation session on human subject research protocol requirements and research data collection requirements. (4) Serve as qualified, trained research associates for data collection in accordance with Government approved human subject research (HSR) protocol(s). (5) Provide a performer venue/location(s) with high fidelity, hyper realistic battlefield environments where the novel prehospital simulation/scripts can be integrated and executed to provide data collection opportunities in accordance with approved HSR protocol(s). This includes, but is not limited to video recordings, audio recordings and collection of physiological data elements. (6) Provide for a total of 21 months of data collection opportunities at the performer venue/location(s) in accordance with TATRC HSR inclusion and exclusion criteria. This data collection will include participants, specifically, military operations (special forces operations personnel). A minimum of 50 eligible human subjects per month is required. As care team members, human subjects must be: a. Between the ages of 18 and 65; b. Have no preexisting conditions that would negatively impact their ability to provide care in a simulated trauma care scenario or work outside for prolonged periods of time (e.g., extreme allergies, extreme reactions to sun exposure, etc.); c. Be willing to have video and audio recordings and physiological monitors used to record their actions during the simulated data collection events; d. Have one or more of the following credentials: i. An active TCCC certification (e.g., All Service Members [ASM] Tier 1 course); ii. A working knowledge of combat casualty care skills and curriculum through medical-related curriculum (i.e., combat medic or equivalent training); or iii. Deployment with medical experience in the last 36 months. (7) Collect, compile, and return data collection from human subject research simulation events to a Government data repository in accordance with existing TATRC authored, OHARO approved human subjects’ protocol. It is anticipated that the existing protocol will be amended to include the selected performer. Offerors are expected to have the appropriate hardware, software, and all other relevant resources to conduct the required data collection activities. (8) Provide a point of contact to serve as a hand receipt holder for Government equipment, as required. POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The U.S. Government (USG) currently has up to $442,000 available for this upcoming program. At this time any follow-on tasks are subject to the availability of funding. MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. The PoP should not exceed 24 months. POTENTIAL FOLLOW-ON TASKS: There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Award (subject to change depending on Government review of work completed and successful progression of milestones). Note that any potential follow-on work is expected to be awarded non-competitively to the resultant project awardee(s), such as the year 2 efforts outlined in Figure 1. ACQUISITION APPROACH: This upcoming RPP will be conducted using the Enhanced White Paper approach. In Stage 1, Offerors are invited to submit Enhanced White Papers using the mandatory format contained in this upcoming RPP. The Government will evaluate Enhanced White Papers submitted and select those that best meet their current priorities using the evaluation criteria described in the upcoming RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a proposal preparation period of approximately 30 days. MTEC membership is required for the submission of an Enhanced White Paper in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple Government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations. POINT OF CONTACT: For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Research Associate, chuck.hutti@ati.org.