20-10-COVID-19_NETCCN RPP.pdf

Request for Project Proposals

Solicitation Number: MTEC-20-10-COVID-19_NETCCN_TATRC “National Emergency Telecritical Care Network (NETCCN)”

Issued by:

Advanced Technology International (ATI), MTEC Consortium Manager (CM) 315 Sigma Drive

Summerville, SC 29486 for the

Medical Technology Enterprise Consortium (MTEC)

Request Issue Date: April 16, 2020

Enhanced White Paper Due Date: April 27, 2020 Noon Eastern Time Zone

Request for Project Proposals MTEC-20-10-COVID-19_NETCCN_TATRC Number W81XWH-15-9-0001

Table of Contents 1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

1.2. Purpose

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

2.2. Proposer’s Conference

2.3. Funding Availability and Type of Funding Instrument Issued

2.4. Acquisition Approach

2.5. MTEC Member Teaming

2.6. Proprietary Information

2.7. Offeror Eligibility

2.8. Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions

2.9. Nontraditional Defense Contractor Definition

2.10. Cost Sharing Definition

2.11. MTEC Assessment Fee

2.12. Intellectual Property and Data Rights

2.13. Expected Award Date

2.14. Anticipated Enhanced White Paper Selection Notification

3 Enhanced White Paper

3.1. Enhanced White Paper Rationale

3.2. Enhanced White Paper Submission

3.3. Submission Format

4 Enhanced White Paper Preparation Instructions

4.1. General Instructions

5 Technical Requirements

5.1. Introduction

5.2. Scope of Work

5.3. Potential Follow-On Tasks [Beyond Task 5 described in Section 5.2]

5.4. Restrictions on Animal and Human Subjects

6 Enhanced White Paper Preparation

6.1. Preparation of the Enhanced White Paper

6.2. Enhanced White Paper Evaluation:

6.3. Step 2: Cost Proposal (for Only Those Offerors Recommended for Funding)

6.4. Freedom of Information Act (FOIA)

6.5. Enhanced White Paper and Cost Proposal Preparation Costs

7 Selection

7.1 Best Value

8 Points-of-Contact

9 Acronyms/Abbreviations

10 Enhanced White Paper Template

11 BIDS Instructions

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the U.S. Army Medical Research and Development Command (USAMRDC) and other DoD agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:

(a) biomedical research and prototyping;

(b) exploration of private sector technology opportunities;

(c) technology transfer; and

(d) deployment of intellectual property (IP) and follow-on production.

MTEC is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from large businesses, small businesses, contract research organizations, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations; for more information on the MTEC mission, see the MTEC website.

MTEC operates under an Other Transaction Agreement (OTA) for prototypes with USAMRDC. As defined in the OTA Guide dated November 2018, a prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing.

A process, including a business process, may be the subject of a prototype project. Although assistance terms are generally not appropriate in OT agreements, ancillary work efforts that are necessary for completion of the prototype project, such as test site training or limited logistics support, may be included in prototype projects. A prototype may be physical, virtual, or conceptual in nature. A prototype project may be fully funded by DoD, jointly funded by multiple federal agencies, cost-shared, funded in whole or part by third parties, or involve a mutual commitment of resources other than an exchange of funds.

1.2. Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC support of the U.S.

Army’s Telemedicine and Advanced Technology Research Center (TATRC). Military relevance is a critical component of the Enhanced White Paper submission. Strategic and tactical oversight for the award(s) supported by this RPP will be provided by the TATRC.

In support of COVID-19 response, the goal of this RPP is to support the rapid development, deployment and testing of the National Emergency Telecritical Care Network (NETCCN) - a cloud-based, low-resource, stand-alone health information management system for the creation and coordination of flexible and extendable “virtual critical care wards.” These high acuity, virtual wards would bring high-quality critical care capability to nearly every bedside, be it healthcare facility, field hospital, or gymnasium.

Based on cellular communication networks, mobile technologies and cloud computing, the RPP will support the extension of high-quality intensive care to traditional (e.g. critical access hospitals and clinics) and non-traditional and temporary healthcare facilities (e.g. field hospitals and gymnasiums) which lack adequate critical care expertise and resources necessary for care of COVID-19-related illnesses.

Through a step-wise approach, this RPP will fund multiple teams consisting of healthcare organizations and technology vendors to rapidly, iteratively and collaboratively prototype, test and refine tele-critical care and data visualization solutions to support local, regional and ultimately national COVID-19 care and situational awareness.

*Note: Pending successful completion of this effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

Each MTEC Enhanced White Paper submitted must be in accordance with the mandatory format provided in Section 10 of the RPP.

Note that the terms Enhanced White Paper and Proposal are used interchangeably throughout this RPP.

2.2. Proposer’s Conference

The MTEC is pleased to announce that a Proposers Conference will be conducted specific to this RPP, MTEC-20-10-COVID-19_NETCCN_TATRC. 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 the solicitation.

Second, the Military Sponsor provides an overview of the technical requirements of the solicitation. 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.

The Proposers Conference is scheduled to take place Monday, April 20 at 3:00 PM ET. Register via the following link: https://attendee.gotowebinar.com/register/811606013843567631

2.3. Funding Availability and Type of Funding Instrument Issued

The U.S. Government (USG) Department of Defense (DoD) currently has available up to $7Million

(M) FY20 funds for Tasks 1, 2, and 3 of this program. Any potential follow-on funding is subject to availability and is expected to be awarded non-competitively and negotiated based on outcomes, cost sharing, partner matching and estimates for additional study completion.

The anticipated Period of Performance (PoP) for Tasks 1, 2, and 3 is up to 45 days. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks [e.g., up to 18 months for Tasks 1 – 5].

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. Award funding will be structured incrementally and based upon completion of Milestones and Deliverables.

2.4. Acquisition Approach

It is expected that MTEC will make up to 6 awards to qualified teams to accomplish the statement of work. If a single Enhanced White Paper is unable to sufficiently address the entire scope of this RPP’s technical requirements (outlined in Section 5), multiple 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.

The Government-selected Awards will be funded under the Other Transaction Agreement (OTA) Number W81XWH-15-9-0001 with MTEC administered by the CM, ATI. The CM will negotiate and execute a Base Agreement with MTEC members (if not yet executed). This Base Agreement will be governed by the same provisions as the OTA between the USG and MTEC. Subsequently, any Enhanced White Paper that is selected for award is expected to be funded through a Research Project Award issued under the Base Agreement. A sample of the MTEC Base Agreement can be found on the MTEC website at www.mtec-sc.org.

https://attendee.gotowebinar.com/register/811606013843567631 http://www.mtec-sc.org/

At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their Enhanced White Paper that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Enhanced White Paper that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement. Please note that Base Agreements are only issued if an Offeror has been selected for an award; therefore, only those organizations that already have a MTEC award will have a Base Agreement Number.

Offerors are advised to check the MTEC website periodically during the Enhanced White Paper preparation period for any changes to the MTEC Base Agreement terms and conditions as well as clarifications found in Frequently Asked Questions (FAQ) responses.

2.5. MTEC Member Teaming

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to submission of Enhanced White Papers) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. 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, 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.

There are two sections as part of the profile relevant to teaming:

“Collaboration Interests” - Select the type of teaming opportunities your organization would be interested in. This information is crucial when organizations need to search the membership for specific capabilities/expertise that other members are willing to offer.

“Solicitation Collaboration Interests” - Input specific active solicitations that you are interested in teaming on. This information will help organizations interested in a specific funding opportunities identify others that are interested to partner in regards to the same funding opportunity. 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 can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website.

2.6. Proprietary Information

The MTEC CM will oversee submission of Enhanced White Papers submitted in response to this RPP. The MTEC CM shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than the evaluation of an Offeror’s Enhanced White Paper and the subsequent agreement administration if the Proposal is selected for award. Please mark all Confidential or Proprietary Information as such. An Offeror’s submission of an Enhanced White Paper under this RPP indicates concurrence with the aforementioned CM responsibilities.

Also, as part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private entities (e.g., foundations, investor groups, organizations, individuals) that award grants or otherwise co-fund research, and/or operates in research areas that are aligned with those of MTEC. These private entities may be interested in reviewing certain Proposals within their program areas, allowing opportunities to attract supplemental funding sources. On your Proposal Cover Page, please indicate your willingness to allow MTEC Officers and Directors access to your Proposal for the purposes of engaging in outreach activities with these private organizations. MTEC Officers and Directors granted Proposal access have signed Non-disclosure Agreements (NDAs) and Organizational Conflict of Interest (OCI) statements. Additionally, these MTEC Officers and Staff represent organizations that currently are not MTEC members, and therefore their parent organizations are not eligible to submit Proposals or receive any research project funding through MTEC. Additionally, all Technical Evaluation Panel participants will agree to, and sign a nonproprietary information and conflict of interest document.

2.7. Offeror Eligibility

MTEC membership is not required for the submission of an Enhanced White Paper in response to this upcoming MTEC RPP. However, membership will be required for Offerors recommended for award. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

2.8. Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions

Enhanced White Papers that fail to meet the mandatory statutory conditions with regard to the appropriate use of Other Transaction authority, as listed below, will not be evaluated and will determined ineligible for award. Please see Appendix 4.3 of the Enhanced White Paper template for additional details.

Mandatory statutory conditions (the Offeror shall assert that at least one of the following conditions is met):

(1) There is at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent in the prototype project.

(2) All significant participants in the transaction other than the Federal Government are small businesses (including small businesses participating in a program described under section 9 of the Small Business Act (15 U.S.C. 638)) or nontraditional defense contractors.

(3) At least one third of the total cost of the prototype project is to be paid out of funds provided by sources other than the Federal Government.

The Offeror shall submit Warranties and Representations (see Section 10, Appendix 4.3) specifying the critical technologies being offered and/or the significant extent of participation of the nontraditional defense contractor, small business or nonprofit research institution. The nontraditional defense contractor can be an individual so long as he/she has a DUNS Number and meets the requirements in the Warranties and Representations. The significance of the nontraditional defense contractor’s, small business’ or nonprofit research institution’s participation shall be explained in detail in the signed Warranties and Representations.

Inadequate detail can cause delay in award.

Per the DoD OT Guide, rationale to justify a significant extent includes:

1. Supplying a new key technology, product or process

2. Supplying a novel application or approach to an existing technology, product or process

3. Providing a material increase in the performance, efficiency, quality or versatility of a key technology, product or process

4. Accomplishing a significant amount of the prototype project

5. Causing a material reduction in the cost or schedule of the prototype project

6. Provide for a material increase in performance of the prototype project

2.9. Nontraditional Defense Contractor Definition

A nontraditional defense contractor is a business unit that has not, for a period of at least one year prior to the issue date of the Request for Project Proposals, entered into or performed on any contract or subcontract that is subject to full coverage under the cost accounting standards (CAS) prescribed pursuant to section 26 of the Office of Federal Procurement Policy Act (41 U.S.C.

422) and the regulations implementing such section.

2.10. Cost Sharing Definition

Cost sharing is defined as the resources expended by the award recipients on the proposed statement of work (SOW). If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or in-kind contribution (see below for a definition of each); provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.). Cost sharing above the statutory minimum is encouraged if possible, as it leads to stronger leveraging of Government-contractor collaboration.

Cash Contribution

Cash Contribution means the Consortium and/or the Research Project Awardee (or Awardees' lower tier subawards) financial resources expended to perform a Research Project. The cash contribution may be derived from the Consortium's or Research Project Awardee (or Awardees' subawards) funds or outside sources or from nonfederal contract or grant revenues or from profit or fee on a federal procurement contract.

An Offeror’s own source of funds may include corporate retained earnings, current or prospective Independent Research and Development (IR&D) funds or any other indirect cost pool allocation. New or concurrent IR&D funds may be utilized as a cash contribution provided those funds identified by the Offeror will be spent on performance of the Statement of Work (SOW) of a Research Project or specific tasks identified within the SOW of a Research Project. Prior IR&D funds will not be considered as part of the Offeror's cash.

Cash contributions include the funds the Offeror will spend for labor (including benefits and direct overhead), materials, new equipment (prorated if appropriate), awardees' subaward efforts expended on the SOW of a Research Project, and restocking the parts and material consumed.

In-Kind Contribution

In Kind Contribution means the Offeror’s non-financial resources expended by the Consortium Members to perform a Research Project such as wear-and-tear on in-place capital assets like machinery or the prorated value of space used for performance of the Research Project, and the reasonable fair market value (appropriately prorated) of equipment, materials, IP, and other property used in the performance of the SOW of the Research Project.

Prior IR&D funds will not be considered as part of the Consortium Member's cash or In-Kind contributions, except when using the same procedures as those that authorize Pre-Award Costs, nor will fees be considered on a Consortium Member's cost sharing portion.

If the offer contains multiple team members, this information shall be provided for each team member providing cost share.

2.11. MTEC Assessment Fee

Per Section 3.4 of the Consortium Member Agreement (CMA), each recipient of a Research Project Award under the MTEC OTA shall pay MTEC an amount equal to 1% of the total funded value of each research project award. Such deposits shall be due no later than 90 days after the research project award is executed. Awardees are not allowed to use MTEC funding to pay for their assessment fees.

Additionally, MTEC has established two methods of payment to be made to MTEC surrounding the licensing/commercialization of Intellectual Property developed with funding received from MTEC Research Project Awards:

Royalty Payment Agreements

Government-funded research projects awarded through MTEC will be subject to a 10% royalty on all Net Revenues received by the Research Project Award recipient resulting from the licensing/commercialization of the technology, capped at 200% of the Government funding provided.

Additional Research Project Award Assessment

In lieu of providing the royalty payment agreement described above, members receiving Research Project Awards may elect to pay an additional assessment of 2% above the standard assessment percentage described in Section 3.4 of the CMA. This additional assessment applies to all research project awards, whether the award is Government funded or privately funded.

2.12. Intellectual Property and Data Rights

Intellectual Property (IP) rights for MTEC Research Project Awards will be defined in the terms of an awardee’s Base Agreement and resultant Task Orders. MTEC reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the government and the individual performers during the entire award period.

The Offeror shall comply with the terms and conditions defined in the Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort will be delivered to the Government with Government purpose data rights or unlimited data rights unless otherwise asserted in the proposal and agreed to by the Government. Rights in technical data in each Research Project Award shall be determined in accordance with the provisions of MTEC Base Agreement.

The Offeror is required to complete Appendix 4.2. Data Rights of the Enhanced White Paper template to identify any items to be furnished to the Government with restrictions.

2.13. Expected Award Date

Offeror should plan on the period of performance beginning May 27, 2020 (subject to change).

The Government reserves the right to change the proposed period of performance start date through negotiations via the CM and prior to issuing a Research Project Award.

2.14. Anticipated Enhanced White Paper Selection Notification As the basis of selections is completed, the Government will forward their selections to the MTEC CM to notify Offerors. Proposers will receive a notification letter, delivered by email, from the

MTEC CM of the results of the evaluation. Those successful will move forward to the next phase of the process while those not selected will gain evaluation rationale for non-selection.

3 Enhanced White Paper

3.1. Enhanced White Paper Rationale

The MTEC will use an accelerated approach to award for this RPP. Because of the nature and urgency of the requirements set forth in this RPP, this streamlined approach is anticipated to be a better means to highlight company methodologies and skills required to address the technical requirements described herein. The Enhanced White Paper process requires extremely quick turnaround times by Offerors. The following sections describe the formats and requirements of the Enhanced White Paper.

Offerors who submit Enhanced White Papers in response to this RPP must submit by the date on the cover page of this RPP. Enhanced White Papers received after the time and date specified will not be evaluated.

3.2. Enhanced White Paper Submission

Enhanced White Papers shall be submitted by the date and time specified on the cover page using BIDS: https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm. Include the MTEC Solicitation Number (MTEC-20-10-COVID-19_NETCCN_TATRC) on each Enhanced White Paper submitted. See RPP Section 11 for further information regarding BIDS registration and submission.

Do not submit any classified information in the Enhanced White Paper submission.

3.3. Submission Format

Offerors shall submit files in Microsoft Office formats or Adobe Acrobat (PDF – portable document format) as indicated below. ZIP files and other application formats are not acceptable.

All files must be print-capable and without a password required. Filenames must contain the appropriate filename extension (.docx, .doc, .pptx, .ppt .xlsx, .xls or .pdf). Filenames should not contain special characters. Apple users must ensure the entire filename and path are free of spaces and special characters.

An automated BIDS receipt confirmation will be provided by email. Offerors may submit in advance of the deadline and update (or replace any of the files) up until the submission deadline.

Neither MTEC nor ATI will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror receives errors and fails to https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm upload the full submission prior to the submission deadline, the submission will not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

4 Enhanced White Paper Preparation Instructions

4.1. General Instructions

The Enhanced White Paper and Cost Proposal format provided in this MTEC RPP are mandatory and shall reference this RPP number (MTEC-20-10-COVID-19_NETCCN_TATRC). Offerors are encouraged to contact the Point-of-Contact (POC) identified herein up until the Enhanced White Paper submission date/time to clarify requirements.

Offerors shall submit Enhanced White Papers for evaluation according to the criteria set forth herein. Offerors are advised that only ATI as the MTEC’s CM, with the approval of the Government Agreements Officer, is legally authorized to contractually bind or otherwise commit funding for selected Awards as result of this RPP.

5 Technical Requirements

5.1. Introduction

Situation: Preparation for COVID-19 Related Critical Care Capability Shortages

Although the United States has more critical care beds per capita than other developed nations, emerging national and international experience with COVID-19-related critical illness suggests a high level of oncoming system stress on critical care resources and a likely potential for intensive care unit (ICU) beds and care teams to be overwhelmed. Tele-critical care can be a powerful force-multiplier in the extension of limited critical care resources in both high-census urban centers and rural communities in which access to critical care – facilities, equipment and trained clinicians - is limited even under normal conditions. Many local and regional health systems have invested extensively in telemedicine capabilities, but many of these systems lack sufficient scalability, and are limited both in interoperability with other telehealth systems and scope and reach of partner provider-networks and supported tele-clinical services. The vision for this effort is to extend local tele-critical care capability sets to a broader, flexible network – first locally, then step-wise regionally and nationally – that can be leveraged wherever there is need.

Overall Goal of Program

With respect to the COVID-19 challenge, the overall goal of this program is to support the rapid development, deployment and testing of the National Emergency Telecritical Care Network (NETCCN) – a cloud-based, low-resource, stand-alone health information management system for the creation and coordination of flexible and extendable “virtual critical care wards.” These high acuity, virtual wards would bring high-quality critical care capability to nearly every bedside, be it healthcare facility, field hospital, or gymnasium.

Based on cellular communication networks, mobile technologies and cloud computing, the RPP will support the extension of high-quality intensive care to traditional (e.g., critical access hospitals and clinics) and non-traditional and temporary healthcare facilities (e.g., field hospitals and gymnasiums) which lack adequate critical care expertise and resources necessary for care of COVID-19-related illnesses.

Through a step-wise approach, this RPP will fund multiple teams consisting of healthcare organizations and technology vendors to rapidly, iteratively and collaboratively prototype, test and refine tele-critical care and data visualization solutions to support local, regional and ultimately, national COVID-19 care and situational awareness.

Goal of RPP MTEC-20-10-COVID-19_NETCCN_TATRC

This RPP specifically targets care contexts where critical care expertise – particularly important for managing hypoxic respiratory failure and organ dysfunction associated with COVID-19 – is not resident [such as at general medical facilities and/or intermediate “new facilities” established to augment hospital wards (e.g., gymnasiums)], where in these cases, tele-critical care could be used to provide access to expert consultation and improve patient outcomes.

Technical Considerations

Much of the technology required for this program is available now for other use-cases, but needs to be rapidly adapted for COVID-19 use-cases. These technologies include:

1) Secure, mobile communications capabilities, including synchronous audio/video, asynchronous messaging, and in some cases, access to continuous physiological monitoring

2) Clinician-facing web portal and/or mobile-based application (goal is availability on every device) to support clinical and operational situational awareness and visualization of individual patients, groups of patients and their data, and care team groups

3) Capability for real-time, essential clinical encounter documentation (SOAP note or similar concept) as well as asynchronous/synchronous data collection and reporting

4) Cloud-based information storage

5) Capability to export clinical data through PDF reports

6) Additional capability for real-time and/or asynchronous exchange with electronic health records (EHRs), Health Information Exchanges (HIEs) and/or other applicable computerized physical order entry (CPOE) systems via HL7, FHIR and/or other applicable standards

Virtual Hospital Wards/ICUs Creation of rapidly deployable, scalable virtual hospital wards/ICUs will allow the application of high-quality intensive care to community hospitals, critical access hospitals, field hospitals, acute-care wards, and other existing or temporary health care facilities. This will allow geographic extension of limited critical care resources, including expertise in management of COVID-19 related critical illness, be a force multiplier in the construction of new critical care support teams, and reduce transfers of patients between regions and facilities, thereby limiting transmission, conserving personal protective equipment (PPE), and reducing exposure of transport teams and vehicles.

Illustrative examples of a virtual ward:

1) A small rural hospital has 4 beds in their PACU that function as ICU beds when needed. The hospital has several nurses who are certified as critical care nurses but rarely practice critical care. There is a pharmacist available during the day. Respiratory therapy is available 24/7 but does not have capability to assign more than one therapist at a time. The hospital has a small Emergency Room. One emergency physician is on at a time and is the backup provider for emergency procedures and resuscitation for the hospital. The hospital also has one general surgeon and one specialist in hospital medicine who are not critical care trained but are comfortable with stabilizing critically ill patients until they can be transported to the larger regional hospital.

2) A gymnasium has been set up as a temporary field hospital to handle the surge of COVID-19 admissions. While many of these patients have mild illness, a significant number have deteriorated and now require critical care. Although it has relatively complete capabilities in terms of equipment and supplies, the field hospital does not have an electronic health record and has limited capabilities for telemetry or other centralized monitoring. Additionally, the medical staff to cover this hospital is a skeleton crew pulling from local hospitals that are also overwhelmed as well as first responders with various levels of medical training. Family members of patients have been recruited to provide basic bedside care.

3) An elderly man is sick with COVID-19. He cannot be admitted to the local hospital or any of the surrounding hospitals because they are at capacity. The patient’s son does not feel that it is safe to drive him elsewhere and is uncertain about what, if anything can be done. He’s heard about this NETCCN application and that he can ask for help and stay connected to critical care experts virtually. He downloads the application. The application opens and guides him through a simple registration process which connects him to a triage professional.

The triage professional determines that the patient should be “admitted” to a virtual ward where the TCC team can monitor progress using local sensors (possibly the mobile device or a wearable) and rounds on him every few hours. Ultimately, they coach the patient’s son through palliative care. The patient’s son is immensely grateful for the team’s professionalism and support in this difficult time.

Requirements for successful virtual wards:

1) Self-contained health information management system (or system of systems) using elastic cloud computing at a minimum, Internet of Things (IoT) connections, and anticipated incorporation of future artificial intelligence (AI) to enable:

a) Patient flow management: virtual triage, admission and discharge, including the ability to rapidly divert patients to lower acuity care when indicated

b) Patient level information management: basic electronic health record management including patient charting, order and treatment recording, and clinical result reporting

c) Continuity of care through shift change, provider turnover, and patient transfer using lightweight patient hand-off tools

d) Integrated audio-visual communications capability including tools for communication with bedside providers, monitor/device viewing, and image sharing (for example videoconferencing or .jpg upload) as well as tools for electronic communication with patients and family members

e) Use of a HITRUST, FEDRAMP Cloud Security platform

2) Information sharing and reporting capabilities:

a) A governance structure or “network of networks” must be implemented to coordinate this response

b) Reporting and data visualization tools of both patient and system level data are crucial for information sharing, dissemination of consensus best-practice recommendations, measures of system stress, and rapid reallocation of resources

c) Patient-level data should be aggregated and stored for later analysis, can eventually be batch loaded into existing electronic medical records (EMRs) when resources allow in accordance with HL7, FHIR and/or other applicable standards.

d) System should allow for alerts, bulletins, and other timely communications to be pushed out to users

e) Integrated information sharing should include the ability to push training and educational materials to frontline clinicians, especially those who will be asked to provide care outside of their pre-emergency scope of practice

f) Each Offeror/team must address the standards, technology, data and workflow processes that will be included in their specific solution set for this RPP.

Coverage model for virtual hospital wards:

1. Use tele-critical care clinicians as a force multiplier—published ratios suggest that one virtual intensivist can monitor and respond to emergencies for 75-125 patients and one remote ICU nurse can provide virtual monitoring for 30-60 patients

2. Recognize that these numbers, however, represent experienced tele-critical care teams supporting established systems, not ad hoc solutions. Expect at least a 50% drop in efficiency when starting a new telemedicine/tele-critical care system (so, 30-60 patients for physicians, and 15-30 patients for nurse monitoring and problem triage)

3. With experience, or if the situation demands, this care model could be expanded until the remote team can manage up to twice the initial number of patients.

4. Because these patients will be at high risk of acute life-threatening deterioration, bedside procedural capabilities will also be of paramount importance. Each ward will need access to proceduralists:

a) aides/trained lay persons to help turn/position patients and suction airways

b) nurses or paramedics to place intravenous (IV) lines, Foley catheters and administer medications

c) respiratory therapists to adjust and troubleshoot mechanical ventilators

d) physicians to place central lines, perform thoracentesis, or intubate patients and when necessary, facilitate transfer (e.g., extracorporeal membrane oxygenation

(ECMO))

5. Virtual plus local staffing model for at least 100-150 patients should be developed and well described by Offerors as a deliverable. For example:

a) 1 telemedicine intensivist

b) 2-4 telemedicine registered nurses (RNs)/Respiratory Therapists

c) Shared access to telemedicine pharmacist (and other specialty providers as needed) across multiple virtual wards

d) Possible Minimum Bedside Clinicians ratios of: 1 Physician/APP:60 patients, 1

Nurse:20-30 patients, 1 aide:5-10 patients, 1 family member/friend:patient

e) One bedside procedure team per site [1-3 members per site: MDs (emergency medicine, hospitalist, anesthesiologist, etc.)]

5.2. Scope of Work

*Optimal Applicant Teams: It is preferred that Enhanced White Papers propose projects that address the entire scope of work (Tasks 1-5). An optimal team responding to this RPP would consist of clinical experts, technology experts and entities with experience in change management and rapid cycle innovation. However, enhanced white paper submissions that only partially address the requirement are also encouraged, with the understanding that these Offerors may be teamed with other Offerors with complementary expertise to construct a complete team that can address the full scope of work.

The goals of this RPP are to provide a first system for deployment within 45 days of award (end of Task 3), a refined system for deployment within 6 months of award (end of Task 4), and a final system for deployment within 18 months of award (end of Task 5).

The intent of this RPP 20-10-COVID-19_NETCCN_TATRC is to initially award Tasks 1, 2, and 3.

Information regarding Tasks 4 and 5 is intended to provide context so the Offeror is aware of potential work that could follow-on after the completion of Tasks 1, 2, and 3. The Offeror does need to price and provide details on how they would complete this follow-on work in Tasks 4 and 5.

Task 1: Initial system configuration and testing (15 days) (Completion of Task 1 is anticipated to be within 15 days of project start date)

Offerors are expected to bring forth systems which they have currently developed that would facilitate the capture, exchange and archive of medical clinical information as described above.

This task is largely based on the validation and initial outfitting of systems that would support generic consultation services from the virtual hospital wards to a central hub of specialists.

Actions within this task would include:

Offerors are strongly recommended to bring forth teams that include clinical care experts (preferably critical care subject matter experts [SMEs]) to assist in the production of a solution composed of software, hardware, and workflow (+/- data analytics). Note: Upon award, the Awardee will be connected to government clinical SMEs, but are also expected to have their own, specific clinical experts for this effort.

Alpha testing to determine capabilities of proposed systems.

Early user feedback and direct observation will be collected to determine performance in providing a deliverable with Task 1.

It is recommended that high fidelity simulation and/or real-world use guides agile development in this phase.

Go/No-go Decision Point: As determined necessary by the government, at the conclusion of Task 1, the Government may conduct a review of the work completed and down-select Awardees based on an evaluation of the approach’s viability and system capabilities to meet the program’s technical requirements.

Task 2: Rapid Development (30 days) (Completion of Task 2 is anticipated to be within 15 days of completion of Task 1)

Task 2 focuses on the second phase of development and testing. The actions expected in this task include:

Potential rapid prototyping of software to support operations based upon user feedback.

Beta testing by selected national tele-critical care (TCC) partners using real patients and experienced providers.

Scalability, reliability, interface, and user environment testing to assess ability to field the system at scale (multiple state coverage) in support of less austere and trained personnel.

This should be cloud based, ideally hosted on a HITRUST, FEDRAMP compliant server.

Just-in-time training plan for clinical, technical and administrative end-users tested and ready.

Go/No-go Decision Point: If appropriate, at the conclusion of Task 2, the Government may conduct a review of the work completed and down-select Awardees again to a smaller set of systems for deployment based on the evaluation of a combination of the system performance metrics and the availability of funds to test multiple systems.

Task 3: Deployment and Enhancement (45 days) (Completion of Task 3 is anticipated to be within 15 days of completion of Task 2)

During this task, the systems will be fielded to actual users and experience real world use at scale.

Simultaneously, new adaptations can be made to fit the specifics of the COVID-19 pandemic, so movement from generic data transmission to more specific formats and clinical practices that represent COVID-19 support.

Deploy system to multiple sites (dozens of sites are anticipated) with full implementation support services.

Training should be self-contained within the application and not require in-person training for both consumers and TCC service teams; customer support (for consumers and service experts) may be offered through the application (e.g., chat function) or by phone call. The application should offer a simple method to collect user feedback/feature requests.

Institute sustainment operations to maintain a high level of reliability, security and availability of the system.

Work with user teams to develop COVID-19 specific formats and practices that can be used to improve data capture and clinical flow.

Go/No-go Decision Point: If appropriate, at the conclusion of Task 3, the Government may conduct a review of the work completed and down-select Awardees again to a smaller set of systems for deployment based on the evaluation of a combination of the system performance metrics and the availability of funds to test multiple systems.

Optional Follow-on Task 4: Automated Improvements (3-6 months) (Completion of Task 4 is anticipated to be within 4.5 months of completion of Task 3)

This task aims to incorporate automated improvements that can enhance the care as well as reduce time with consultation personnel so that they can extend their care to a larger patient population. Examples of possible actions include:

Incorporation of continuous monitoring devices and associated data beyond medical devices (e.g., wearables), access to ventilator settings and waveforms and access to IV pump settings.

Remote control of medical equipment including IV pumps, ventilators, hospital beds and other priority devices/equipment most associated with the mission.

Incorporation of autonomous systems (e.g. ventilators, sedation) into the workflow.

Application of AI and machine learning to clinical deterioration prediction, resource allocation, and outbreak forecasting.

Note: During Task 4 the Government will be able to make a U.S. Food and Drug Administration (FDA) SME available to the Awardees to advise on any FDA clearance concerns, if required.

Go/No-go Decision Point: If appropriate, at the conclusion of Task 4, the Government may conduct a review of the work completed and down-select Awardees again to a smaller set of systems for deployment based on the evaluation of a combination of the system performance metrics and the availability of funds to test multiple systems.

Optional Follow-on Task 5: Full Scale Development and Integration (6-18 months) (Completion of Task 5 is anticipated to be within 12 months of completion of Task 4)

This task expands the system to incorporate the greater network and systems of the DoD and civilian workplaces.

Drop-in mobile network capabilities in the event of loss of critical communications infrastructure.

Interoperability with most/all medical devices.

Interoperability and communication with major existing electronic medical record systems.

Increased ability to perform procedures remotely including ultrasound, vascular access and intubation.

Additional Points of Consideration for Implementation:

1. Extremely compressed timeline: This is an ambitious timeline but represents a high priority for the tele-critical care community and the nation.

2. Device interoperability concerns: The ideal solution will be operating-system and device-agnostic to ensure the broadest possible interoperability. Necessary in the future is a “plug-and-play” concept for medical devices into the NETCCN system (e.g., any heart rate monitoring device – wearable, ECG, telemetry, etc. – should populate the HR data of the monitoring software. In the short term, this will need to be achieved through the use of APIs.

3. Task Summary/Lessons Learned: the Government intends to share valuable lessons learned among Awardees at the conclusion of each task to ensure the most rapid progress of the NETCCN development and avoid duplication or redundancies. Awardees will prepare evaluation reports and presentations at the conclusion of each task to summarize activities, highlight successes, identify barriers and anticipated issues, emphasize lessons learned, and highlight any other key items from the project. The ability to use the prototype in real-time for these evaluations will be expected. An emphasis on simplicity for the end-user is expected given the context that these tools will be expected to be used in (i.e., crisis and disasters).

4. Network access and reliability: social distancing, working from home, self-quarantine and shelter-in-place requirements have the potential to place significant stress on existing wireless networks and other internet service providers. One solution to this problem would be for prioritization of NETCCN traffic (identified by application use) over other resource intensive but less crucial communications.

5. A plan for provider licensing/credentialing for local, regional and national responses using the NETCCN is being developed by the Government.

6. All Awardees will be expected to collaborate and work together to identify and resolve key issues that could prevent or slow local, regional and national implementation of NETCCN capabilities. Such areas of collaboration across teams might include agreement on standards, data models workflows, measures and evaluation criteria and clinical models.

5.3. Potential Follow-On Tasks [Beyond Task 5 described in Section 5.2] There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Awards (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 awardees:

Scale and sustain the NETCCN from state and/or regional to national/international needs Cross-team activities including but not limited to evaluation reports, publications, presentations, hack-a-thons and standards development activities

Adaption and testing of NETCCN’s use in follow-on COVID-19 or other potential pandemics, emergencies, and disasters.

5.4. Restrictions on Animal and Human Subjects

Enhanced White Papers must comply with restrictions and reporting requirements for the use of animal and human subjects, to include research involving the secondary use of human biospecimens and/or human data. The Awardee shall ensure local Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) approvals, continuing review (in the intervals specified by the local IACUC and IRB, but at a minimum, annually), and approval by the U.S. Army Animal Use and Review Office (ACURO) and U.S. Army Human Research Protections Office (HRPO). Offerors shall include IACUC, ACURO, IRB and HRPO review and approval in the SOW/Milestones Table.

These restrictions include mandatory government review and reporting processes that will impact the Offeror’s schedule.

For example, the clinical studies under this RPP shall not begin until the USAMRDC Office of Research Protections (ORP) provides authorization that the research may proceed. The USAMRDC ORP will issue written approval to begin research under separate notification. Written approval to proceed from the USAMRMC ORP is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects.