Military-Civilian National Disaster Medical System (NDMS) Interoperability Study (MCNIS) Pilot Program

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for an Other Transaction Agreement (OTA) for Prototype Project Request for Project Proposals (RPP) focused on the development and implementation of the National Disaster Medical System (NDMS) Pilot Program (Pilot). The Pilot is a congressionally required prototype, which will serve as a proof of concept to inform nationwide changes to the existing NDMS. The purpose of the Pilot is to strengthen interoperable partnerships of the NDMS to care for our Nation's combat casualties by increasing medical surge capabilities and capacities at five regional sites. This will be achieved through a collaborative network of federal and civilian NDMS partners. The current Pilot Phase I activities (currently underway during Year 0) will be transitioning (as of September 30, 2021) to Phase II (Pilot Implementation). This RPP is specifically focused on the activities associated with Phase II, which include conducting further NDMS studies, systematically implementing recommended changes, measuring intervention outcomes, and iteratively making improvements to optimize Pilot performance at the five sites. The information generated in Phase II (which will include, but is not limited to, tasks awarded under this MTEC RPP) will inform system-wide changes for nationwide implementation in Phase III. BACKGROUND: The FY20 National Defense Authorization Act (NDAA) states the Pilot will be conducted over five years at no less than five locations. The FY20 NDAA was reauthorized in FY21 (Section 741), and it directs the Pilot to establish partnerships with public, private, and nonprofit healthcare organizations in these locations. It also directs the Pilot to establish requirements for staffing, specialized training, medical logistics, telemedicine, patient regulating, movement, situational status reporting, tracking, and surveillance. The Pilot will be conducted in collaboration with the Secretaries of Veteran Affairs, Health and Human Services, Homeland Security, and Transportation. These agencies selected the following five (5) sites representing regional NDMS networks at which the Pilot will be conducted: Washington, DC; San Antonio, TX; Sacramento, CA; Omaha, NE; and Denver, CO. The NDMS definitive care partners in these metropolitan regions will be comprised of military and veterans administration healthcare facilities, Federal Coordinating Centers (FCCs), NDMS partner hospitals, and local health departments within a larger metropolitan area. The Pilot will be carried out at these sites over five (5) years in three (3) Phases. Phase I is a study called the Military-Civilian NDMS Interoperability Study (MCNIS) and is already underway. MCNIS is designed to identify the NDMS medical surge issues, gaps, and best practices for each location. MCNIS is being conducted by the Operational Research and Integration Office-National Center for Disaster Medicine and Public Health (ORION). During Phase II, study findings will be incorporated into site specific implementation plans, which will be written and operationalized at each of the Pilot sites over five (5) years, per the NDAA. Information, procedures, activities and requirements from each of the sites will be used to develop a model prototype regional system for implementation nationally. Phase III of the Pilot will consist of reporting the results of the Pilot and planning for Pilot expansion in other NDMS locations. Pilot implementation (Phase II), components of which are the focus of this RPP, will start on September 30, 2021 (note that this is the NDAA-mandated date for the broader Phase II activities but may not align with the actual award date for the resulting MTEC award). During Phase II, ORION will continue to strategically lead and integrate the Pilot effort and continue conducting mixed methods research to assess and guide Pilot operationalization. To complement ORION's research and strategic integration role, a Field Implementation Team (FIT) will be created through this RPP as the Phase II operational arm of the Pilot. The FIT will execute Pilot implementation through operational lines of effort and Site Operational Coordinators in full coordination with ORION. Of note, this RPP only applies to tasks assigned to FIT during the first year of the five year Pilot implementation. It does not apply to ORION tasks. The Pilot is functionally and organizationally comprised of ORION and FIT collaboratively working together as one Pilot team to conceive, carry out, and study Pilot implementation at the five sites. TECHNICAL REQUIREMENTS: The intent of this RPP is to initially award requirements 1-12 in addition to sub-study (A) as described below with a 12-month Period of Performance (PoP). Therefore, all Enhanced White Paper submissions shall propose projects that address the specific requirements 1-12 and sub-study (A) by detailing how the Offeror will accomplish/achieve all aspects of these Year 1 requirements to include a clear approach to execute all tasks based upon the Offeror's unique methodology. Therefore, the Offeror shall also clearly identify the major milestones in the Statement of Work/Milestone Payment Schedule associated with accomplishing these Year 1 requirements. Although Offerors are not required to detail how they will accomplish/achieve all aspects of sub-studies B-E, the Enhanced White Paper shall briefly outline the proposed methodology to the extent possible to demonstrate the Offeror's capability and its understanding of the resources (to include subject matter experts and subcontractors) required to address the technical requirements. Offerors are invited to provide further details to address a more specific technical approach to support these sub-studies; however, this is not mandatory to meet the minimum requirements of this RPP as the focus should be on the work that can be achieved within the detailed funding limits (see paragraph entitled - POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE below for more information). As such, sub-studies B-E represent the additional work contemplated by the Government that may be added in a post-award stage. Should these additional sub-studies be added to the scope of work in the post award stage, the period of performance may also be extended beyond the initial 12-month PoP. Of note, implementation at the five (5) Pilot sites will need to be sustained and studied over the following 48 months (five years total) beyond the initial 12- month PoP [funding for these additional 48 months is unknown at this time]. It is expected that MTEC will make a single award to a qualified team to accomplish all tasks. The NDMS shall be led by a centralized point of contact at the prime performer. It is possible that several subcontractors will be required to accomplish the full scope of the project throughout Phase II (remaining 48 months of Phase II). Furthermore, the Government recognizes that the composition of the team may change as the project requirements evolve over time. Therefore, the Offeror shall include the overall project management plan as part of the Enhanced White Paper submission (refer to the full RPP available on MTEC's website for the detailed instruction and mandatory template). The Offeror shall also describe its strategy to adjust (i.e. expand) the team, as needed, throughout the period of performance (to include potential follow on tasks) to ensure the proper level of effort, access to the necessary subject matter experts, etc. Therefore, while Offerors are not required to propose against sub-studies B-E in great detail, the Enhanced White Paper shall discuss how the current team would be qualified to accomplish these sub-studies and a plan to evolve the team, if applicable, to fully address the demands of those sub- study requirements. The requirements for this prototype project against which Offerors shall propose to execute Phase II (Year one of the PoP) of the NDMS program are below (and represent - Requirements 1-12 as referenced above). Note that Offerors are encouraged to propose the use of commercial off-the-shelf products as much as possible rather than proposing the development of new, unique systems/software to avoid extra cost to the Government related to maintenance and updates in the future. Attend a Phase II Kick-off meeting in September 2021 for a debrief on the Phase I Pilot Study (MCNIS) which is currently ongoing in Year 0 (subject to change depending on the actual award date for this requirement). During this meeting, the MCNIS findings will be presented and validated by the convened Pilot stakeholders. The transition to Phase II, Pilot Implementation, will occur at that time. Provide comprehensive coordination between the ORION staff and each of the five sites, working by/with/through NDMS Pilot partners at each site. Provide five (5) Site Operational Coordinators (SOCs) and support teams/staff to conduct this coordination function. SOCs must have expertise in hospital emergency preparedness and experience in NDMS definitive care roles and responsibilities. Additional support staff are expected to be assigned to complete the below tasks, as directed by the FIT-Integration lead and coordinated with the SOCs at the five sites). The Offeror is expected to staff and organize against each requirement appropriately. SOCs and their support teams/staff are expected to be embedded on-site at the National Center for Disaster Medicine and Public Health (NCDMPH) with ORION staff with frequent calls, meetings, and visits to their respective regions throughout the year. Relocation vs. long-distance support/coordination Pilot sites will be assessed for out-years (balance of Phase II time). Additionally, the FIT Integration Lead and requisite support staff are also expected to be on-site embedded with ORION for this PoP. Operational Lines of Effort staff may be on-site, but are not required; the Operational Lines of Effort structure is notional and simply intended to convey functional tasks and not staffing level or organization. (Months 1-12) In conjunction with and under the direction of ORION staff and leadership, assess MCNIS Phase I research findings; develop, refine, and translate these findings into Pilot implementation plans for the five pilot sites. (Months 1-6) In conjunction with and under the direction of ORION staff and leadership, establish interoperable Pilot requirements for the following medical surge domains: staffing, specialized training, medical logistics, telemedicine, patient regulating, movement, situational status reporting, tracking, and surveillance. (~Months 1-3) In conjunction with and under the direction of ORION staff and leadership, establish site-agnostic process and outcome metrics to evaluate the effectiveness of the pilot program at all five sites to include baseline medical surge capacity, capability, and interoperability of the nine medical surge domains. (~Months 1-3) In conjunction with and under the direction of ORION staff and leadership, create medical surge interoperability benchmarks for Pilot sites with associated metrics to measure performance. (~Months 1-3) In conjunction with and under the direction of ORION staff and leadership, work with local federal and civilian NDMS partners at each of the five sites to refine and validate site-specific implementation plans, while also synchronizing core implementation elements across all five sites to ensure consistency, where appropriate. (Months 1-6) In conjunction with and under the direction of ORION staff and leadership, write a master implementation plan and sub-implementation plans for each of the five sites based on MCNIS Phase I findings and site-specific refinement and validation efforts. Implementation plans must establish and strengthen partnerships with - public, private, and nonprofit health care organizations, health care institutions, health care entities, academic medical centers or institutions of higher education and hospitals to increase the local NDMS interoperability and medical surge capacity to support the definitive care requirements of a large scale overseas conflict. (Months 3-6) In conjunction with and under the direction of ORION staff and leadership, begin to operationalize implementation plans at the five sites in collaboration with NDMS partners (It is expected that implementation will continue beyond this PoP for the remaining four years of Phase II, pending funding) (Months 6-12) In conjunction with and under the direction of ORION staff and leadership, conduct a federal level Pilot tabletop exercise, to include representation from the five sites, to validate MCNIS findings, refine the master implementation plan, and assess interagency and baseline public/private partnership metrics. (Months 9-12) Provide initial draft Report to Congress to the Sponsor's Office which will be reviewed and finalized by the Government to inform Congress on the NDMS pilot program in accordance with the NDAA required elements. (Months 1-4) Augment the implementation plans for each Pilot site, based on the direction of ORION staff and leadership and recommendations generated by the Pilot sub-studies (listed below). (Months 6- 12) Sub-Study Requirements: Enhanced White Papers shall include Sub-study A in the proposed work. However, information below related to Sub-studies B-E is for informational purposes so that Offerors can provide more complete Enhanced White Papers. This work may be added, non-competitively, at any time after the PoP has been initiated [i.e., during the initial 12-month PoP dependent on funding availability and successful completion of milestones]. The Enhanced White Paper shall briefly outline the proposed methodology for each sub-study (B-E) to the extent possible to demonstrate a course of action that addresses the technical requirements described in this RPP. A. Conduct Sub-study (A): Assess COVID-19 lessons-learned at each Pilot site, specifically translating these lessons-learned into actionable NDMS recommendations to augment Pilot implementation plan interventions. B. Conduct Sub-study (B): Perform medical surge modeling of national NDMS healthcare capacity, demonstrating the quantity, quality, and duration of available definitive care within the NDMS definitive care hospital partner network over time. Modeling must include three separate cohorts: (1) Military Treatment Facilities, (2) Veterans Affairs Medical Centers, and (3) civilian NDMS definitive care partners. C. Conduct Sub-study (C): Conduct a comprehensive review and analysis of the Federal NDMS legislative landscape, specifically describing: (1) the applicable Federal agency policies, plans, and procedures; and (2) the current Federal laws and regulations governing NDMS and recommending options for new or updated laws and regulations to enable the NDMS to meet the definitive care requirements of a persistent and large scale overseas conflict. Special attention should be given to the gaps/weaknesses in authorities, responsibilities, funding (direct and indirect) and organizational structure of NDMS. D. Conduct Sub-study (D): Conduct a review of the State/Regional NDMS legislative landscape, specifically focused on changes needed to strengthen regional participation in NDMS to support the definitive care requirements of a large-scale overseas conflict. E. Conduct Sub-study (E): Conduct a study of the direct and indirect incentives which may be created, augmented, and/or aligned to ensure non-federal civilian healthcare organizations will support the NDMS definitive care mission when activated. At the end of the 1-year PoP, the following deliverables shall be provided to the Government (or successful completion of milestone(s) shall be demonstrated): Interoperable Pilot requirements for the following medical surge domains: staffing, specialized training, medical logistics, telemedicine, patient regulating, movement, situational status reporting, tracking, and surveillance [deliverable is due no later than January 15, 2022]; Site-agnostic process and outcome metrics to evaluate the effectiveness of the pilot program at all five sites to include baseline medical surge capacity, capability, and interoperability of the nine medical surge domains [deliverable is due no later than January 15, 2022]; Medical surge interoperability benchmarks for Pilot sites with associated metrics to measure performance; A master implementation plan and sub-implementation plans for each of the five sites based on MCNIS phase I findings and site-specific refinement and validation efforts; A federal level Pilot tabletop exercise, to include representation from the five sites, to validate MCNIS findings, refine the master implementation plan, and assess interagency and baseline public/private partnership metrics; Draft report on the NDMS pilot program in accordance with the NDAA required elements for the Sponsor to provide to Congress; Operationalized implementation plans at the five sites in collaboration with NDMS partners; and Sub-study (A) report which will assess COVID-19 lessons-learned at each Pilot site, specifically translating these lessons-learned into actionable NDMS recommendations to augment Pilot implementation plan interventions. 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 2 - 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: The U.S. Government (USG) Department of Defense (DoD) Uniformed Services University of the Health Sciences (USUHS) currently has available a total of approximately $9.47 million (M) to support technical requirements and sub-studies for Phase II Pilot Implementation. The Rough Order of Magnitude (ROM) pricing required as part of Offerors Enhanced White Paper shall follow the template in the RPP. Award and funding from the Government is expected to be limited to the funding specified above and is contingent upon the availability of federal funds for this program. Awards resulting from this RPP are expected to be made in Fiscal Year 2021 under the authority of 10 U.S.C. - 2371b. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). It is expected that MTEC will make a single award to a qualified team to accomplish all tasks. The award shall be led by a centralized point of contact at the prime performer organization. If a single Enhanced White Paper is unable to sufficiently address the entire scope of this RPP's technical requirements, several Offerors may be asked to work together in a collaborative manner. However, if an optimal team is not identified, then MTEC may make multiple, individual awards to Offeror(s) to accomplish subset(s) of the key tasks. Therefore, it is highly recommended that only Offerors interested in the potential to collaborate with other Offerors submit proposals in response to this RPP. Award funding will be structured incrementally and based upon completion of Milestones and Deliverables to include formal In Process Review meetings and Critical Decision points incorporated as milestones within the Milestone Payment Schedule (MPS). The Period of Performance (PoP) is not to exceed 12 months for the initial scope of work, which is limited to requirements 1-12 and sub-study A. However, as the Pilot Implementation will be conducted over five years, 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. As of the release date of this RPP, future year Defense Appropriations Bills have not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this RPP is approximate and subject to realignment. Funding of Enhanced White Papers received in response to this RPP is contingent upon the availability of federal funds for this program. ACQUISITION APPROACH: This 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 RPP. The Government will evaluate Enhanced White Papers submitted and will select the proposal(s) that represents the best value using the evaluation criteria listed in this RPP. The Offeror(s) 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 as well as a detailed summary of the Enhanced White Paper technical evaluation. MTEC membership is required for the submission of an Enhanced White Paper in response to this MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/ PROPOSERS CONFERENCE: MTEC will host a Proposers Conference that will be conducted via webinar within two (2) weeks after the release of this RPP. The Proposers Conference is a virtual webinar format that provides potential Offerors the opportunity to interact directly with both MTEC and the Military Sponsor related to this specific funding opportunity. The flow of the Proposers Conference is as follows. First, MTEC provides an administrative overview of this solicitation. Second, the Military Sponsor provides an overview of the technical requirements. Finally, all attendees are invited to anonymously type in questions into the webinar's chat function, which are answered verbally and live by the appropriate presenter from MTEC or the Military. We highly encourage anyone interested in this funding opportunity to listen in and/or ask questions. The Proposers Conference typically lasts between 1 and 2 hours. A transcript of the questions and answers period of the Proposers Conference will be posted to the MTEC members only website. Further instructions for registration will be forthcoming via email. If you are unable to attend the Proposers Conference, please submit questions via email to contact@example.gov prior to the date of the Proposers Conference (TBD) so that MTEC can incorporate answers into the published questions and answers transcript. Offerors are advised to check the MTEC website periodically during the proposal preparation period for any clarifications found in Frequently Asked Questions (FAQ) responses. 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 this RPP or otherwise believe a team may be beneficial to the Government. The following mechanisms are in place to help facilitate teaming in relation to this 21-11- NDMS RPP. Collaboration Database Tool: MTEC members are encouraged to use the MTEC Database Collaboration Tool. The purpose of the tool is to help MTEC member organizations identify potential teaming partners by providing a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, Research and Development (R&D) highlights/projects, and technical expertise. The Primary Point of Contact for each member organization is provided access to the collaboration database tool to make edits and populate their organization's profile. The Collaboration Database can be accessed via the - MTEC Profiles Site tab on the MTEC members-only website. MTEC Public-facing Webpage: MTEC has also launched a webpage on the MTEC public website specific to this RPP to help MTEC member organizations team with others in preparation for submission of Enhanced White Papers. Please visit for more details: https://www.mtec-sc.org/21- 11-ndms-desire-to-team-partner/. MTEC Member Connect: MTEC will host a virtual - connect session via webinar to help the membership collaborate and partner in relation to 21-11-NDMS RPP. Each organization will be allotted 1-2 mins to pitch using a standard 1-slide format. Your pitch can be focused on whatever you think would most benefit 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. ADMINISTRATIVE INFORMATION: Enhanced White Papers are due no later than May 28, 2021 at 12:00pm Eastern Time. The full version of the RPP is available on the MTEC website (mtec-sc.org); this summary announcement is solely intended to notify interested parties. MTEC membership is required for the submission of an Enhanced White Paper in response to this MTEC RPP. An Offeror submitting an Enhanced White Paper as the prime contractor must be an MTEC member of good standing by May 24, 2021. To join MTEC, please visit http://mtec-sc.org/how-to-join/ POINTS OF CONTACT: Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at contact@example.gov Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Administrative questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov To view this solicitation, visit https://www.mtec-sc.org/solicitations/