RITCA Pilot Statement of Objectives (SOO) 030221.pdf

Statement of Objectives (SOO) For Development of a

Resource Information Tracking and Medical-Communications Application (RITCA)

1. Background and Purpose

Trauma and burn injuries often require immediate life-saving care. In a no-notice mass casualty incident (MCI) involving emergency medicine (ED), trauma and burn care communities, these challenges are exacerbated and further compounded by resource and communication constraints.

To mitigate and provide solutions to these unaddressed challenges, BARDA has conducted extensive outreach with Burn, ED and Trauma treatment communities, identifying specific solutions which address unique treatment needs within the care continuum. For example, in burn care, BARDA’s investment in medical countermeasures (MCMs) addresses treatment capacity and throughput efficiency. In trauma, BARDA MCMs focus on devices for faster detection, triage and delivery of precise and effective care.

From our outreach, BARDA also discovered there are other common factors underpinning the efficiency of delivering appropriate care for trauma and burn injuries. Specifically, the need for effective, timely peer communication and resource tracking is particularly crucial during routine care.

Consequently, there is consensus that in an MCI this will pose a serious limitation in the efficiency to deliver care. Furthermore, this area remains the Nation’s largest unmet and unidentified need due to a lack of a clear jurisdictional responsibility to provide an effective solution. Until now, there have been no targeted investments to establish or develop tools and mechanisms which standardize methodology to address and integrate these critical requirements. Additionally, it may become necessary for trained care providers to remotely provide or guide specialized care at any facility during an MCI. From the federal perspective, there is always a need for reliable, actionable intelligence and to have clear lines of communication. The purpose of this effort is to build one such pilot in a regional disaster health response system and demonstrate its full functionality. This system has been termed Resource Information Tracking and Medical Communications Application (RITCA).

To address these needs, the Government (“USG”) plans to develop RITCA as an online and mobile phone-based application. RITCA will serve as a disaster response tool for a regional area within the broad range of the medical responder community. This application will allow for synchronous and asynchronous communication for peer-to-peer consultation between clinical providers, serve as a repository for clinical capacity and capability data and present this data in a dashboard, and allow for communication of Essential Elements of Information (EEI) across health care and federal, state, and local response personnel. [See Figure 1] Other functionalities would be evaluated, including just-in-time training for specific clinical presentations, compatibility with telemedicine capabilities, the ability to interface with various USG systems, develop capability and integrate support for ESF-8, develop models and perform analysis to support operational decision making related to allocation, distribution, and long-term planning of health system resources, and provide operations analysis, operational modeling, forecasting support and capabilities development as needed.

Figure 1 Information will be shared across various medical communities, as well as flowing upward to the state, regional and federal organizations.

2. Scope:

The USG will support advanced development of an online and mobile phone-based application with the following functions:

a) Performs synchronous and asynchronous communication for peer-to-peer consultation between clinical providers using various modalities to connect (e.g.: chat functionality, video teleconferencing, etc.)

b) Establishes a dashboard for clinical capacity and capability data and serve as a repository

c) Provide access to just-in-time training for specific clinical presentations

d) Ensure compatibility and potential to integrate with telemedicine capabilities

e) Facilitate communication of EEIs across health care & federal, state, and local response personnel

f) Operate in a low-tech, low-power environment

g) Ensure compatibility with most computers/smart phones,

h) Provide tiered access for different users

i) Enable key users to share situational awareness

j) Ensure a compatible easy-to-use interface, which is intuitive and meets the needs of the end-user community

Development of such an application will improve the ability of the USG to respond effectively during an MCI by establishing a capability for vital information exchange and provide optimal informational flow between different health care communities. This program will facilitate triage and management of casualties during an MCI that results in traumatic and burn injuries. Thus, this platform will effectively address the communication and informational challenges currently faced in frontline care.

In order to meet this scope, the objectives are outlined in the following six sections:

Section 3: Overall Program Management Objectives and Product Development Objectives Section 4: Tasks To Be Performed Section 5: Product Deployment Plan Objective Section 6: Communication Management Objectives Section 7: Risk Management Objectives

3. Overall Program Management and Product Development Objectives

3.1. Independently, and not as an agent of the USG, the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG as required to fulfill the programmatic objectives.

3.2. Minimum Specifications: The USG is seeking a technical solution that meets the following minimum specifications and outcomes:

3.2.1. Easy-to-use interface; intuitive and meets the needs of the community with no or minimal training

3.2.2. Operable in a low-tech, low-power environment, loading within a reasonable timeframe for people with limited connection speeds

3.2.3. Compatible with most computers/smart phones and telemedicine capable;

common browser and operating systems to be supported include: Google Chrome (Windows and Mac platform); Apple Safari (Mac and IOS platform);

Firefox (Windows and Mac platform); Edge (Windows platform); IOS browser;

Android browser

3.2.4. Tiered access for different users, based on factors such as role and location, with key users to share situational awareness. Administrators should have the ability to set users to the appropriate level

3.2.5. Compliance with Health Insurance Portability and Accountability Act (HIPAA), where applicable

3.2.6. Modular functionality to address the different and unique needs of each community, incorporating community feedback into further design and development efforts

3.2.7. Multichannel capability to conduct real-time video interface with multiple participants

3.2.8. Interoperable with other large-scale medical and emergency platforms (e.g.:

ASPR GeoHEALTH)

3.2.9. Capability of turning phone calls into telemedicine visits (visual voicemail)

3.3. Overarching Deliverables

3.3.1. USG and User Base Deliverables

3.3.1.1. Link clinical providers in burn, trauma, and emergency care and establish capability for vital information exchange. These linkages shall include clinical care providers, resource management between health care facilities (Burn & Trauma), State EOC, Medical EOC, ASPR (Geographic Information System (GIS) platform). [See Figure 1]

3.3.1.2. Collect, consolidate, and share real-time clinical data and information with local, state, and federal Emergency Support Function #8 (ESF-8) partners.

Provide situational awareness in a rapidly changing environment of healthcare facility capacity (e.g. licensed and staffed beds, bed occupancy) and specialized clinical assets (e.g. specialized equipment, supplies, and trained personnel) related to burn, trauma, and emergency care. [See Figure1]

3.3.1.3. Allow for E-visits and remote monitoring via asynchronous messaging and photos.

3.3.1.4. Perform operations analysis related to health system resources, particularly staffing and capacity, by working closely with the Government to understand operational questions and requests, maintaining an awareness of available data and its limitations, and leveraging available data to create analytics and visualizations to support decision-making.

3.3.1.5. Develop models and perform analysis to support operational decision making related to allocation, distribution, and long-term planning of health system resources. These models will primarily focus on resources, such as PPE, medications, hospital beds and their use, healthcare technology such as ventilators, and/or medical personnel and staffing. Mathematical models of these resources will be developed to describe the expected demand of each resource per patient and will incorporate both available data and healthcare system subject matter expertise. Resource models will be calibrated to operational data, where possible, and then deployed to end users to support operational decision-making regarding the allocation of available resources based on known and projected caseloads.

3.3.1.6. Provide operations analysis, operational modeling, forecasting support and capabilities development as needed. Analyses and capabilities development will include assessment of information requirements to support national and regional response and engagement efforts, as well as prototype enhancements of associated information management processes and capabilities necessary to improve the response to the current pandemic as well as future events. Complete ad-hoc requests for capabilities, products and analysis in support of the current response and for other emergency data management requirements.

3.3.2. Deliverables Significant to the End User Communities

3.3.2.1. Provide access during initial care for Just-In-Time educational tools to assist with the treatment of patients with burn injuries, to include videos showing types of burns, how to calculate the total body surface area (TBSA), fluid resuscitation calculator, decision support tools, austere guideline support, and videos on dressings, debridement, and escharotomy.

3.3.2.2. Provide the ability to communicate the need for United States Government to enable “smart” deployment of necessary supplies and deployment of critical care transport needs for secondary triage of patients.

3.3.2.3. Communicate updates on changes to crisis standards of care, including triage and referral guidelines.

3.3.2.4. Obtain data from individual patient encounters and photographic documentation, with storage of photographic documentation.

3.3.2.5. Ensure continuity of patient data, including tracking information and vital signs, between the point of injury and the hospital.

3.3.2.6. Facilitate an emergency telemedicine program that provides patients with timely treatment close-to-home, reduced travel time, access to board-certified emergency physicians and improved quality of care.

3.3.2.7. Facilitate an emergency telemedicine program that provides physicians with consults to help make decisions about patient care, input from board-certified emergency physicians without having to send patients to other medical care facility, educational opportunities and mentoring, increased efficiency and improved patient outcomes.

3.3.2.8. Create a defined hierarchy of users with data access and permissions.

3.3.2.9. Create triggers to automatically grant higher-level access to front-line clinicians during a no-notice event.

3.3.2.10. Alert all local and relevant users when a disaster incident has been declared.

3.3.2.11. Implement flags to differentiate patients related to both no-notice and on-going events.

3.3.2.12. Update select occupancy data automatically across the spectrum of care, with trended data for longitudinal events.

3.3.2.13. Support modules to enable patient transfer activities and healthcare system capacity management, assisting with mass patient movement and with transfer to specialty facilities.

3.3.2.14. Support access to disaster telemedicine services when appropriate, to include vetted specialists.

3.3.2.15. Possess a mechanism to share data with a common public health secure database to be used to provide immediate situational awareness and guide decision making in no-notice events.

4. Tasks To Be Performed

The tasks below are required to meet all specifications and deliverables as laid out in “Section 3. Overall Program Management and Product Development Objectives”.

4.1. Requirements

Based on the needs identified by BARDA’s outreach with the end-user partner organizations and ASPR offices, the Contractor shall document a target set of use-cases for development phases and pilot deployment. The use-cases should capture sufficient detail surrounding scenarios that best exemplify the limitations caused by the lack of information sharing between organizations/institutions/facilities.

The Contractor shall develop a set of primary requirements based on the use-case development phase. These primary requirements will be reviewed and approved by BARDA and other partner organizations to validate the Contractor’s understanding of the use-cases.

Review of the primary requirements will also focus on the development of any secondary requirements that may be required prior to release (e.g., regulatory requirements).

4.2. Phase 1- Base Application for Initial Data Elements

Create a Base Application that allows authorized users to access an initial set of data elements to be collected to from a variety of systems. This may include real-time situational awareness, patient encounters, logistical and alert data. This Base Application must be deployed, monitored and supported during a field test period.

4.3. Phase 2- Base Application for Secondary Data Elements

Update the Base Application, incorporating user feedback and expanding the set of accessible data elements. This must be deployed, monitored, support, and maintained during a field test period.

4.4. Phase 3- Base Application Final Update and Training Module

Make final updates to the Base Application, incorporating user feedback and integrate existing just-in-time training software to the Base Application as a Training Module. This must be deployed, monitored, supported, and maintained during a field test period.

4.5. Phase 4- Multi-Regional Expansion

Expand pilot to additional regions for scalability, functionality, and stress testing.

4.6. Phase 5- Expand Interfaces to United States Government Systems

Design and develop approaches to provide real-time or near-real-time information to United States Government systems.

4.7. Telemedicine Module

Design and develop the interface to an existing telemedicine suite to facilitate telemedicine encounters that incorporate real-time access to patient and logistical data. This must be deployed, monitored, supported, and maintained during a field test period.

4.8. External Partner Engagement

Research commercial partnerships with strategic organizations capable of supporting large-scale, real-time data dissemination with robust security frameworks.

4.9. Operationalize Services

Operationalize information sharing services in conjunction with BARDA and commercial partners.

4.10. Support for Emergency Support Function 8 (ESF-8) Council

Develop capability and integrate support for ESF-8 with current analytics and modeling being conducted for the Data Strategy and Execution Workgroup (DSEW) and other components of the national response.

4.11. Support for Supply Chain Logistics Operations Cell (SC-LOC)

Develop models and perform analysis to support operational decision making related to allocation, distribution, and long-term planning of health system resources. These models will primarily focus on resources, such as PPE, medications, hospital beds and their use, healthcare technology such as ventilators, and/or medical personnel and staffing.

4.12. Operations Analysis and Capabilities Development

Provide operations analysis, operational modeling, forecasting support and capabilities development as needed.

5. Product Deployment Plan Objective

5.1. The Contractor shall develop a plan to see the project through phases of the Enterprise Performance Life Cycle. Deployment planning should address:

a) Pre-release considerations

b) Timing of release

c) Training

d) Accountability

e) Documentation

f) Transition to support

g) Notification of deployment

h) Operations and maintenance planning

i) Release planning

5.2. The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to clearly indicate the critical path to support product development. Project Plan shall outline key, critical path milestones, with "Go/No Go" decision criteria and a Work Breakdown Structure.

5.3. The Contractor shall submit an updated Integrated Master Schedule in an approved format.

5.4. The Contractor shall prepare progress meeting agenda, briefing materials, action item listing, and risk register updates.

5.5. The Contractor shall submit a final report to summarize all activities, salient findings, methodologies, conclusions, and products.

5.6. The Contract shall submit a status report to include, but not limited to, risks to schedule, cost, and performance; technical and management issues, lessons learned and forecast the next steps for the next monthly performance period.

6. Communication Management Objectives

6.1 The Contractor shall provide periodic reporting throughout the duration of the contract.

Performance of the contract will be monitored by the Contracting Officer (CO)/Contracting Officer’s Representative (COR) on a regular basis. The Contracting Officer shall be responsible for inspection and acceptance of deliverables and services.

6.2 The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the CO/COR.

6.2.1 Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meeting or teleconferences, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program.

6.2.2 The Contractor shall expect bi-weekly or monthly status update meetings/teleconferences. The CO and COR will establish the schedule for these meetings.

6.3 The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

7 Risk Management Objectives

7.1 The goal of risk management is to identify potential problems before they occur and have a plan for addressing them. Risk management looks at internal and external risks that could negatively affect the project success. Risk management teams break the risk management plan (RMP) into four sections:

a) Defining a risk management strategy

b) Identifying and analyzing risks

c) Managing risks through implementing a strategy

d) Forming a contingency plan

7.2 The Contractor shall develop and maintain an RMP that will outline what risk management activities will be conducted and how they will be performed, recorded, and monitored throughout the life of the project.

7.3 The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.