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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP) which w... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP) which will be focused on strengthening the capabilities of the National Disaster Medical System (NDMS) to care for our Nation’s combat casualties by increasing medical surge capabilities and capacities at five regional sites (as further detailed below). The Government intends to solicit proposals from local healthcare facilities, academic institutions, and professional entities with experience working in or supporting the healthcare industry to propose and execute Pilot Site Projects. These projects will leverage a collaborative network of federal and civilian NDMS partners who support the execution and implementation of the individual projects. Under this new RPP, Pilot resources will be aimed at developing and fielding civilian NDMS partner-led projects, which include conducting further NDMS related studies, systematically implementing recommended changes, measuring intervention outcomes, and iteratively making improvements to optimize Pilot performance at the five sites. Through these partner-led projects, the Pilot aims to strengthen NDMS capacity, capability, and interoperability at each site. As a result, the Pilot will move closer to accomplishing its partner-based, outcome-focused mission. ____________________________________________________________________________________ Background: In accordance with the Fiscal Year (FY) 2020 and FY21 National Defense Authorization Acts (NDAA), the National Disaster Medical System (NDMS) Pilot Program commenced on 30 September 2021. The Pilot’s intent is to increase medical surge capabilities and capacities to care for our Nation’s combat casualties by strengthening interoperable NDMS partnerships at five Pilot sites. As directed by the FY21 NDAA, the Pilot is a collaboration between the Secretary of Defense and the Secretaries of Veteran Affairs, Health and Human Services, Homeland Security, and Transportation. These agencies are supporting the Pilot in its five sites: Washington, DC/National Capital Region; San Antonio, TX; Sacramento, CA; Omaha, NE; and Denver, CO. The Pilot was preceded by the Military-Civilian NDMS Interoperability Study (MCNIS). This study was the Pilot’s first phase. It created the partnerships and data-driven foundation for Pilot implementation (Phase II). Over the first year of the Pilot implementation (Phase II), the collaborative Pilot team (consisting of two complementary components: the Operational Research and Integration Office-National Center for Disaster Medicine and Public Health (ORION) and the Field Implementation Team (FIT)) built on the MCNIS accomplishments and established the Pilot’s initial plans, metrics, and operational framework. This work was accomplished in collaboration with Federal agency partners at the strategic level and with both government and private sector partners at the local Pilot-site level. During Year 2 of Phase II, in addition to Field Implementation Teams (FIT) supported efforts, Pilot resources will be aimed at developing and fielding civilian NDMS partner-led projects at the Pilot sites. This is a significant change from Year 1. In Year 1, through the prototype project previously awarded through MTEC resulting from Request for Project Proposals (RPP) MTEC-21-11-NDMS RPP (issued on April 23, 2021), the Pilot established relationships with site partners and used those partnerships to guide understanding, planning, and operational efforts. In Year 2, the Pilot seeks to develop partner-“owned” and led projects as described in the below technical requirements of this new RPP. Solution Requirements: It is anticipated that one or more opportunities will be funded and implemented as partner-led projects at each of the identified five sites (Washington, DC/National Capital Region; San Antonio, TX; Sacramento, CA; Omaha, NE; and Denver, CO). The Operational Research and Integration Office-National Center for Disaster Medicine and Public Health (ORION) will provide strategic direction and oversight to these partner-led projects to ensure the work is appropriately coordinated with Federal partners and integrated across the Pilot’s lines of effort. These partner-led projects will test their proposed solutions regionally and, in turn, the Pilot staff will evaluate the applicability of the projects to strengthen NDMS capacity, capability, and interoperability across the larger NDMS network. The National Center for Disaster Medicine and Public Health (NCDMPH) has identified seven (7) Focus Areas for funding site-specific improvement projects under the NDMS Pilot Program. Additional details are provided below for each Focus Area. The upcoming RPP is expected to include example tasks for each Focus Area; however, Offerors may also propose novel projects which will address a Focus Area need. FOCUS AREA #1: MEDICAL SURGE STAFFING There is a national shortage of healthcare workers in the U.S. and the COVID-19 pandemic has increased the number of healthcare workers leaving their professions. Several states identified innovative ways to help share staff during the pandemic and their experience may serve as a best practices model for other states. During a national or regional medical surge to support combat casualties from an overseas contingency, the Department of Defense (DoD) and their NDMS definitive care partners will need to utilize innovative solutions to increase the number of staffed beds across the country. FOCUS AREA #2: POST-ACUTE CARE COORDINATION The NDMS definitive care network does not formally include post-acute providers such as skilled nursing, rehabilitation, behavioral health, long-term care and home health services. These providers do not routinely participate in regional NDMS exercises or planning events. However, a majority of NDMS stakeholders believe these providers can and should play an important role in supporting the expanded distribution of patients across the continuum of care during a regional or national NDMS activation for an overseas wartime contingency. The role of post-acute care facilities may include caring for patients as a result of bed-decompression at acute care facilities OR directly receiving and caring for lower acuity military patients returning from the combat area. FOCUS AREA #3: REGIONAL PATIENT REGULATING & PATIENT TRANSFER MANAGEMENT Nationally, many regions use a single healthcare or public health entity to manage patient transfers between different healthcare facilities. One of the benefits is the Federal Coordinating Center (FCC) Coordinators have a single point of contact to regulate patients across their Patient Reception Area (PRA). FOCUS AREA #4: STATE MEDICAL SURGE & NDMS INTEGRATION During the first year of Pilot implementation, several Pilot sites identified the need to improve the integration of local and state level patient movement related operations and processes with their corresponding federal partners and operations during an NDMS activation. This focus area promotes improved collaboration and integration of state entities with their local health jurisdictions and the relevant Federal agency partners during an NDMS activation. FOCUS AREA #5: NDMS MEDICAL SURGE TRAINING AND EDUCATION FOR DEFINITIVE CARE PARTNERS Based on MCNIS and the Pilot’s first year, we consistently found NDMS partners had unclear and at times conflicting understanding of associated NDMS roles, responsibilities, plans, and operations. There are multiple ways to educate and train partners on local medical surge plans. Enhanced educational materials and training platforms may improve the response to medical surge events. FOCUS AREA #6: NATIONAL EMERGENCY MEDICAL SYSTEM (EMS) CAPABILITY AND CAPACITY Movement of patients within the United States after transportation from an overseas conflict has been identified as a critical issue to improve the NDMS definitive care component. Concerns have been raised about local capabilities to transport large numbers of patients from FCC PRAs to an appropriate level of definitive healthcare, as well as the capability to move patients across a region, state, or the nation in a ‘hub and spoke’ model to equitably and efficiently distribute a large number of patients. FOCUS AREA #7: ECONOMIC MODELING The ability of private and academic healthcare systems to treat a large number of critically ill and injured patients during a large-scale crisis is complicated by their need to remain financially solvent and their dependency on high-value/high-margin care. During the COVID-19 pandemic, civilian healthcare systems required federal bailout funding to offset the large financial shortfalls incurred by canceling elective care and surgery and treating high volumes of COVID-19 patients. As further detailed the upcoming RPP, any resultant awards may require the collaboration, support, and/or sharing of information with other MTEC members (and their lower tier awardees) currently performing under NDMS Research Project Awards. Furthermore, coordination (e.g., via attendance and participation in coordination meetings) among the Offerors selected for award and/or various stakeholders may also be required. NOTE: Submission Guidance To meet the intent of this upcoming RPP, each “Enhanced White Paper” proposal shall specifically address at least one of the seven (7) Focus Areas. Offerors are not limited to a single submission but rather are encouraged to propose all possible solutions for Government evaluation. While projects may focus on a specific region’s situation and needs, they should ideally be useful for other NDMS regions nationally. Note: Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. 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(s) (subject to change depending upon Government review of work completed). Note that any potential follow on work is expected to be awarded non-competitively to resultant project awardee(s), potentially as an addition of a new subcontractor(s). Such follow-on work may include (but is not limited to) the following: Continuation of Phase II into Years 3 – 5, potentially with additional sub-studies; Expansion of the program into a Phase III, which will increase the number of sites participating in the Pilot and provide comprehensive recommendations for the entire NDMS. Potential Funding Availability and Period of Performance: A proposed budget and Period of Performance (PoP) should be commensurate with the nature, scope and complexity of the proposed research. For information purposes, the U.S. Government (USG) Department of Defense (DoD) Uniformed Services University of the Health Sciences (USUHS) anticipates that the size of resulting awards will value approximately $1 million (M) per regional site in Fiscal Year 2023 (FY23) for this program, although variability in the number and scope of proposed research projects per site may result in some sites being allocated greater funding than others. Offerors are encouraged to scope out their budgets in alignment with major deliverables of the proposed work so that large budgets are easier to evaluate and the Sponsor can more easily allocate available funding. The funding estimated for this RPP is approximate and subject to realignment. Award and funding from the Government is contingent upon the availability of federal funds for this program. Additionally, if funding is available after evaluation of all proposals received under this RPP, the Government may issue a subsequent RPP including all aspects or only a portion of those contained within this RPP to solicit for additional site projects. MTEC expects to make multiple awards to qualified Offerors in FY23 to accomplish the scope of work. The PoP is not to exceed 12 months, as this solicitation is focused on proposals that offer near-term solutions to immediately improve the NDMS, which can be completed within the specified PoP. However, as the Pilot Implementation will be conducted through Fiscal Year 2026, as directed by the NDAA, any resulting award(s) may be modified to extend the PoP and add additional work to further support the overall Phase II activities. Such modifications are expected to be awarded non-competitively. 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 and select those that best meet their current priorities using the evaluation criteria that will be detailed 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 short proposal preparation period (30 days or less). 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 Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. The following two resources may help Offerors form a more complete team for this requested scope of work. The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: Business Expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction Advisory], and Technical Expertise [i.e., chemistry, manufacturing and controls (CMC), clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps. MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website. MTEC will host a virtual “connect” session via webinar to help the membership collaborate and partner for this effort. Each organization will be allotted 1-2 minutes to pitch using a standard 1-slide format. Your pitch can be focused on whatever you think would be most beneficial to you in relation to the NDMS RPP, for example, seeking a partner or offering a capability. There will be contact info on each slide so that you can follow-up directly with whomever you would like. Both MTEC members and non-members will be invited to listen in to the presenters. 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. Lauren Palestrini, MTEC Director of Research Programs, lauren.palestrini@mtec-sc.org.