Attachment 7 - SOO.pdf

Statement of Objectives

Aerospace Medicine, Clinical Research, Human Systems Integration Research, and Expeditionary Medicine

I. Background

The Air Force Research Laboratory, Aerospace Systems Directorate, 711th Human Performance Wing, Aeromedical Section AFRL/RQKHC conducts research in the following areas:

a. Force Health Protection –Focus on research to prevent injury and illness and the early recognition or detection of emerging threats.

b. EN Route Care –Continuum of care during transport of patients from point of injury to point of definitive care.

c. Operational Medicine (OM)–Air force Medical Service (AFM) sponsored OM encompasses interest in definitive diagnosis, care and treatment in-garrison, to insure the highest quality of healthcare for active duty members and their families.

d. Expeditionary Medicine - Improving expeditionary medical care during contingency operations including medical countermeasures against combat and operational stressors to maximize warrior health, performance and well-being.

e. Human Performance and Systems Integration - Maximizing operational human performance for a fit and healthy force.

The goal of this research in the aforementioned technologies is to enhance (1) support the health and performance of Airmen performing across dynamic domains of air, space, and cyber operations, (2) bring innovative techniques and technology into the operational environment to improve outcomes and,

(3) provide the Air Force with subject matter expertise in Human Systems

Integration to ensure weapons systems are designed, developed, or adapted with human capabilities and limitations in mind.

II. Description of Effort

The primary research interests are described in detail below:

1. FORCE HEALTH PROTECTION (FHP)

Research and development in Force Health Protection (FHP) is focused on research and technologies to prevent injury and illness, and the early recognition or detection of emerging threats. The intent is to pursue R&D/technology advancement integration into existing risk assessment/reduction processes to reduce manpower, time, and/or logistical impact; increase the capability to characterize exposures; and provide near real-time risk information to Commanders. The FHP focus areas are, Occupational & Environmental Health (OEH) Hazards, and Personalized Health Protection Initiatives.

1.1 Occupational and Environmental Health Hazards

Research is required to discover and develop new and innovative technologies to make USAF personnel aware of hazards in the workplace and the ambient environment and to detect such conditions in the battlespace environments.

Current research and development is desired to address enhancement of capabilities to detect, measure, and assess OEH contaminants and extreme environmental conditions (e.g., high and low temperatures, dust storms, high altitude, etc.) during deployments/operations to include base opening and disaster and humanitarian response. This research is required to provide information to support health risk assessments and risk management decisions.

In addition, relevant research into mitigating these risks is required.

1.1.1. The goal for sensor and detector technology is to be capable of sensing and conducting surveillance anywhere, anytime and to be able to instantaneously and securely transmit the data to an end user for risk assessment. Information would be securely stored for future use.

Specific interest items include, but are not limited to:

Detect and identify chemical, biological, toxins, radiological, directed energy, poisons and physical hazards on surfaces

(including soil and powder), in liquids and in the air in near real-time at the detector's point of operation and notify end user of risk.

Improve health surveillance situational awareness or increase new technology detection by integrating advanced diagnostics and other innovative technologies for rapid pathogen identification, characterization and detection with relevant information systems currently in operations.

Develop, test and evaluate real-time health threat surveillance and reporting system inclusive of all available health information/databases to identify risks/outbreaks and provide decision support to operational commanders.

1.1.2. The goal for mitigation technology is to be capable of reducing or eliminating occupational and environmental health hazard risks. The program is comprised of multiple areas of interest including, but not limited to: hearing protection, directed energy protection, and high altitude/hypoxia protection. These goals also include building partner nations' capacity regarding medical operations in denied environments to better address interoperability gaps such as longer dwell times and potentially significant increased dependence on partner nation medical assets for casualty care.

1.2. Health Risk Identification via Big Data

Humans are amassing data at an exponential rate, and smart businesses are using analytics to turn this information into useful, actionable knowledge. The medical community has begun applying similar analytic techniques to healthcare. The military medical community has the added advantage of combining operational data with medical data, increasing the capacity to generate new knowledge to identify health risks to specific subsets of individuals. Current areas of interest include but are not limited to: risks and benefits of pharmaceutical use among aviators; identification of clinically meaningful subpopulations of Air Force Medical Service (AFMS) beneficiaries;

detection of changes in medical diagnoses or healthcare utilization patterns among high-demand career fields; analysis of medical reasons for lost duty time; assessment of deployment risk factors and post-deployment medical conditions; and occupational health hazard identification.

1.3. Patient-Centered Precision Care – Personalized Medicine

1.3.1. Genomic Medicine Research: The personalized medicine modernization effort focuses on advancing the field of genome-informed personalized medicine with an emphasis on targeted prevention, diagnosis, and treatment for common, complex conditions typically treated in the primary care setting. The program is comprised of multiple focus areas including but not limited to: knowledge generation studies to include effectiveness of specific genomic testing and cost-benefit analyses; and development of an advanced genomic diagnostic system to translate genomic sequence testing into clinically actionable information for providers and patients.

1.3.2. Omics Research (metabolomics, proteomics, transcriptomics;

microbiomics, epigenetics): The modernization program for ‘omics includes knowledge generation studies to advance a rapidly expanding spectrum of ‘omics research for integration into the genomic medicine research program and the eventual implementation into routine medical care. Areas of interest include but are not limited to: identification of markers guiding targeted prevention, diagnosis, and therapies for improved health throughout the patient lifecycle and mitigation of environmental threats to military service personnel.

1.3.3. Gene Environment Interaction (GxE) Research: Research is beginning to show that environmental factors can have long reaching impacts on an individual or their offspring through epigenetic mechanisms. Research is needed that will provide a more complete understanding of the GxE to enable targeted treatment and prevention of many common diseases.

2. EN ROUTE CARE (EC)

EN route care seeks to enhance the ability to safely transport patients from point of injury to definitive care while reducing footprint and improving efficiency.

Research is needed:

(1) To address EC gaps during patient transport to include staging.

(2) To understand the impact of flight on patient care practices for various disease and injury states and equipment.

(3) To ensure patient safety through the continuum of care.

(4) To enhance medical technology development and assessment supporting EC.

The three broad areas of research include:

2.1 Impact of Transport

The AE environment exposes patients to a variety of stressors: hypoxia, decreased atmospheric pressure (hypobaria), vibration, temperature changes, decreased humidity, fatigue, and noise. Knowledge is sought on the impact of this environment on patient physiology in general, as well as, on specific disease and injury states and equipment. Specific injury and disease states of interest include but are not limited to: thrombo-embolic disease, acute lung injury/acute respiratory distress syndrome, traumatic brain injury (TBI), compartment syndrome, severe orthopedic injuries, psychological conditions, infectious disease, and bacterial growth at altitude, hemorrhage and shock.

2.2 EN Route Medical Technology

Long transport times and delays from point of injury to definitive care drive the requirement for evidence-based methods and practices in emergent and surgical care to ensure optimal outcomes through the continuum of care. Research is needed:

(1) Ensure the clinical validity of medical devices used during transport.

(2) Development of new medical technologies to enhance patient care en route.

(3) Physiological monitoring mechanisms for situational awareness including but not limited to physiological sensors, mobile electronic medical alerts and decision support during ERC.

2.3 EN Route Patient Safety

Research leading to solutions to improve patient safety and mitigate risk in all EC environments with a focus on prevention is sought. Research areas of interest include but are not limited to: research and training leading to patient safety standards, monitoring and reporting, human factors research impacting patient safety, root cause analysis, pain management techniques and methods incorporating prevention into practice guidelines, integrated system/process to track patients, treatment/medications, personal possessions, weapons and their disposition thru the continuum of care.

3. OPERATIONAL MEDICINE (OM) (IN-GARRISON CARE)

Air Force Medical Service (AFMS) sponsored Operational Medicine research encompasses interest in definitive diagnosis, care, and treatment in-garrison.

The overall aim of AFMS Operational Medicine is to ensure the provision of the highest quality health care for active duty members and their families. Current areas of interest include but are not limited to: Phased activities to develop and apply knowledge and/or enhance technical sophistication of novel medical devices, systems, pharmaceutical (drugs, biologics/vaccines), Medical

Information Management/Information Technology (IM/IT), Medical Informatics, Medical Modeling and Simulation Training, and other medical products related to diagnosis, treatment, rehabilitation, and maintenance of clinical health problems of concern to the warfighter, his/her family members and other beneficiaries of military healthcare.

3.1 Current areas of interest include but are not limited to:

a. Vascular injury management.

b. Wound Care.

c. Chronic disease treatment, prevention and surveillance (i.e., cardiovascular disease, diabetes).

d. Surveillance and management of comorbidities associated with cancer

e. Chronic pain management.

f. Home health care.

g. Patient safety.

h. Virtual environments, virtual clinics, patient avatar and medical gaming scenarios with or without haptics.

i. Joint integrated clinical database and correlate access.

j. Interventions within military populations for community-level problems, e.g. family maltreatment, binge.

k. Understanding and advocating resiliency.

l. Substance abuse inclusive of pre-determinant risks (genomics, behavioral), psychological assessment and management.

m. Interventions related to health issues specific to women in military.

n. Diet-based nutrition and supplements.

o. Interoperable human patient simulators.

p. Advanced regenerative, reconstructive, and transplantation modalities for restoration of facial form and function following trauma or burns.

q. Methods and utility of glycemic control in trauma patients.

r. Emergency Preservation and Resuscitation.

s. Functional limb salvage and restoration including transplantation modalities.

4. EXPEDITIONARY MEDICINE (EM)

EM is focused on:

4.1 Expeditionary Logistics - developing/validating novel procedures, materials, techniques, and tools to reduce size and weight, optimizing power requirements, and minimizing logistics footprint associated with expeditionary operations.

4.2 Expeditionary Casualty care -optimizing existing and developing new casualty care tools & techniques; improving methods and techniques for use of remote monitoring and triage systems;

improving capability to treat Directed Energy casualties, identifying and mitigating issues related to casualty care in an expeditionary setting, and validation of best-fit technologies in casualty care mission(s).

Broad areas of research relate to mechanisms, techniques, and tools to improve outcomes associated with care delivered in the expeditionary settings throughout the entire continuum of care from First Responder to Theater Hospitals Key areas include: Expeditionary

Trauma Care, treatment of emerging threat (DEW) injuries; irregular warfare; contingency operations; humanitarian relief operations;

EMEDS; Global Reach Lay down team support.

Combat Casualty Care material solutions research and materiel development areas of interest include but are not limited to:

4.2.1 Advanced diagnostics and epigenomics applied research.

Identify novel biomarkers for trauma triage and course of care which would support:

a. Remote monitoring and triage systems which provide decision support and or autonomous care.

b. Objective system is a single “tricorder” like device to perform multiple monitoring and diagnostic functions.

c. Effective infectious disease prevention.

4.2.2 Miniaturization of sensors - Reduce size, weight, power requirements of electronic medical equipment to reduce logistics footprint. Include monitoring systems (e.g., heart, blood pressure, respiratory) and systems to monitor for CBRN events.

4.2.3 Combat-related traumatic brain injury continues to be a significant cause of casualty mortality and morbidity.

a. Non-invasive Traumatic Brain injury (TBI) diagnostic capability.

b. Research needed for mechanisms/procedures, techniques and tools to improve outcomes.

4.2.4 Airway/Breathing Management

a. Optimal mechanical ventilation.

b. Enhanced oxygen generation capabilities (e.g., Ceramic Oxygen generator).

4.2.5 Pain management throughout the continuum care.

4.2.6 Trauma, Hemostasis and Resuscitation:

a. Hemorrhage control: Non-compressible torso hemorrhage and junctional hemorrhage remain preventable causes of casualty death.

b. Technology and techniques to reduce the impact of hypothermia, i.e.

new drug therapy, advanced vascular access, and optimize fluid resuscitation techniques.

c. Currently utilized blood products for casualty resuscitation possess limited shelf-life and require controlled storage conditions.

d. Research focused on reducing inflammatory response & cascade effects following injury. Methods to minimize and improve outcomes from sepsis and the coagulopathy of trauma.

4.2.7 Incidence and cause of chronic disease and illness in the deployed environment including but not limited to urinary incontinence.

4.2.8 Training:

a. Deployable CT Scan for EMEDS training to provide more realistic training.

b. Ultrasound training to support FAST exams.

c. Virtual training options to maintain currency, clinical or support knowledge in OCONUS locations.

d. Proficiency training in the use of deployed Electronic Health Record

(EHR).

e. Pre-deployment training for burn unit.

f. Address the lack of knowledge of the use of Extracorporeal Life Support

Systems (ELCS) in a complex clinical setting.

5. Human Performance and Systems Integration

AMS human performance research is needed in order to optimize warfighter effectiveness in all environments including, but not limited to: hot and humid, cold and dry, and high altitude. Effectiveness optimization includes, but is not limited to: maintaining orientation and awareness and detecting, preventing, and mitigating effects of adverse environments and events on operator and maintainer performance.

The human performance optimization and sustainment effort includes research in the areas of improved cognitive performance, contribution to sustained effectiveness during high operational tempo, operational human performance measurement, injury prevention during high-demand physical training, enhancement of human and machine interface, and enhanced battle space situational awareness. Additionally, the development of Air Force

Human Systems Integration (HSI) program analysis aids is essential in addressing human performance issues. The Human Systems Integration effort includes research into tools and methods for incorporating the human into capability concept refinement, technology development, system design and development, and associated specifications. This includes models of the human suitable for use by engineers to describe the human as part of the system.

Nationally, healthcare is plagued with systems problems that are experienced by both patients and medical personnel as inefficient, poorly designed processes—and the Military Health System and the AFMS are no exception.

Human performance and systems integration specialty services are needed to maximize the value generated by the AFMS in terms of both patient and population-level health and performance outcomes and the costs to obtain these outcomes. The efficiency, effectiveness, safety, accessibility, affordability, and patient-centeredness of health care can be significantly improved by application of systems methodologies successfully used in other domains. Within the AFMS, human performance and systems integration applications span the spectrum from micro-system process improvement activities to more macro-system optimization problems involving health services planning and large dataset mathematical modeling.

5.1 Current areas of interest include but are not limited to:

a. Remotely piloted aircraft crew selection, training, aeromedical qualification and ground control station interface optimization.

b. Optimal personnel selection methods for a variety of military career fields using computer based screening and other relevant tools that match skills, aptitude, and interests with appropriate career tracks.

c. Medical Standards, fatigue management, workload and cognitive assessments to avoid overload and enhance mission suitability and effectiveness.

d. Life support, cockpit, and human interface concerns within remotely piloted and manned aircraft and / or ground-based systems.

e. Cooperative efforts that apply USAFSAM’s Hypobaric Chambers and Human Centrifuge in the assessment of human performance and protective system and life support test and evaluation.

f. Application of systems engineering/human systems integration, operations research, management science, and related methods to healthcare both at the micro (clinical workflow) and macro (health system) level.

g. Develop advanced ergonomic and anthropometric tools and analytical methods for: human body measurement, workstation interface measurement, quantifying the effects of protective equipment on operator performance, and accurately modeling human physical performance in operator workstations and protective equipment.

III. Deliverables

See Contract Data Requirements List (CDRLs), Attachment 6 of the Broad

Area Announcement (BAA) for possible delivery items. The attached CDRL document is an example for planning purposes and each resulting award shall have its own tailored CDRL package.

IV. OPSEC

General OPSEC procedures, policies and awareness are required in an effort to reduce program vulnerability from successful adversary collection and exploitation of critical information. OPSEC will be applied throughout the lifecycle of the contract. The Critical Information List will be provided upon request by the AFRL/RYOY Information Protection Office. While working on the government installation OPSEC will be provided by the AFRL/RYOY Information Protection Office. The contractor shall participate with the

Government in the development of a Program Protection Plan (PPP), to include the identification of Critical Program Information (CPI), and shall also participate with the Government in determining countermeasures needed to safeguard the CPI throughout the acquisition process. The contractor shall plan for and execute program protection in accordance with the PPP and program.

The Contractor shall provide OPSEC protection for all sensitive/critical information and indicators involved in execution of this contract/Task Order, as defined by AFI 10-701 (Operations Security). 711 HPW Critical Information and

Indicators are protected under the 711 HPW Operations Security Program and the 711 HPW Critical Information and Indicators List (CIIL). Contractor employees granted access to critical information and indicators will be provided initial

OPSEC training by the 711 HPW OPSEC Coordinator upon in-processing and prior to being granted access to CIIL items related to the contract/Task

Order. The contractor will also participate in 711 HPW’s annual OPSEC training and education programs, which includes periodic updates and refresher training on CIIL items applicable to the contract/Task Order. The 711 HPW OPSEC coordinator will evaluate the OPSEC posture of AF contract activities and operations.