BAA-11-03-HPW.doc

2-Step Broad Agency Announcement

The 2-Step Process reduces acquisition resources for both the Government and industry. It may be considered when a large number of proposals are anticipated or to determine if further Government interest is warranted. If further interest is not warranted, industry saves unnecessary bid and proposal costs and the Government saves evaluation time.

Overview Information To access hyperlinks from this electronic solicitation – hit CTRL and click on the hyperlink.

Federal Agency Name: Air Force Medical Support Agency/Modernization Directorate (AFMSA/SG9) Broad Agency Announcement Title: Air Force Medical Support Agency(AFMSA/SG9) Modernization Directorate Research/Development and Innovations

Broad Agency Announcement Type: This is the initial announcement.

Broad Agency Announcement Number: BAA-11-03-HPW Catalog of Federal Domestic Assistance (CFDA) Number(s): 12.800_AF

THIS WILL BE A TWO-STEP SOLICITATION:

First Step: WHITE PAPER DUE DATE AND TIME: 31 August 2011 5PM EST Only white papers and quad charts are due at this time.

Second Step: PROPOSAL DUE DATE AND TIME: To be provided in response to the Requests for Proposals sent to offerors that submit White Papers considered to meet the needs of the Air Force.

NOTE: White Paper/Proposal receipt after the due date and time shall be governed by the provisions of FAR 52.215-1(c)(3 Early white paper submission is encouraged.

Solicitation Request: Air Force Research Laboratory, 711th Human Performance Wing, on behalf of Air Force Medical Support Agency (AFMSA)/Modernization Directorate is soliciting white papers on the research effort described below. White Papers must be submitted to the e-mail address stated in Section VII of the Full Text Announcement. This is an unrestricted solicitation. Small businesses are encouraged to propose on all or any part of this solicitation. The North American Industry Classification System (NAICS) Code for this acquisition is 541712, and the small business size standard is 500 employees. White Papers/Proposals submitted shall be in accordance with this announcement. Offerors should be alert for any BAA amendments that may permit extensions to the white paper submission date. Following this initial request for white paper submissions, additional requests will be posted on a yearly basis, through an amendment to the BAA. Separate requests for white papers are expected for future fiscal years FY13, FY14, FY15 and FY16. Future requests will likely occur in the first quarter of each calendar year. For example, the FY13 request for white papers will likely be posted during the first quarter of calendar year 2012.

CCR Registration: Unless exempted by 2 CFR 25.110 all offerors must (1) Be registered in the Central Contractor Registration (CCR) prior to submitting an application (for an assistance award) or proposal;(2) Maintain an active CCR registration with current information at all times during which it has an active Federal award or an application or proposal under consideration by an agency; and (3) Provide its DUNS number in each application or proposal it submits to the agency. On-line registration instructions can be accessed from the DISA CCR home page at http://www.ccr.gov.

On-line Representations and Certifications (ORCA): Potential offerors are notified that effective 01 Jan 2005 to be eligible for an award, they must submit annual Electronic Representations and Certifications, otherwise known as On-line Representations and Certifications Application (ORCA) via the Business Partner Network (BPN) at http://www.bpn.gov/orca. These FAR and DFARS level representations and certifications are required in addition to the representations and certifications specific to this acquisition. Before submitting the Electronic Representations and Certifications, contractors must be registered in the Central Contractor Registration (CCR) Database.

Type of Contract/Instrument: Firm Fixed Price, Cost (no fee) or Cost Plus Fixed Fee, Cost Share contracts/Cooperative Agreements or Grants.

Estimated Program Cost: $49,500,000/5 years Anticipated Number of Awards: The Air Force anticipates awarding 10 to 20 awards per year for this announcement. The estimated value of each award is $100K to $1M annually, with total contract values of up to $3M over 3 year periods.

Brief Program Summary: AFMSA/SG9 has identified a need for medical modernization in the five following areas:

Force Health Protection – Focus is on prevention of injury and illness and the early recognition or detection of emerging threats. Key areas include: Bio-Surveillance; Bio agents of military relevance/Infectious Disease surveillance and identification; Occupational Toxicology, emerging threats (pandemic response, other environmental threats); and protective countermeasures.

Enroute Care – Focus is on continuum of care during transport of patients from point of injury to point of definitive care. Key areas include: Aeromedical Evacuation; Patient Staging; Critical Care Air Transport Team (CCATT); Medical Evacuation (MEDEVAC); and Casualty Evacuation (CASEVAC).

Operational Medicine – Focus is on definitive patient care/treatment in-garrison. Key focus areas include: clinical medicine enhancements; personalized diagnosis and treatment; traumatic brain injury; psychological health/post traumatic stress disorder; regenerative medicine; clinical patient safety; autism; and definitive care.

Expeditionary Medicine/In Garrison - Focus is on improving expeditionary medical care during contingency operations including medical countermeasures against combat and operational stressors to maximize warrior health, performance and well-being. Key focus areas include: expeditionary logistics enhancements and requirements (energy, supplies and materials) miniaturization to reduce logistics footprint; critical humanitarian/disaster relief equipment/material sets identification; deployed combat casualty care optimization and improvements in methods and techniques of remote monitoring and triage systems; Field identification, diagnosis and treatment of emerging threat Directed Energy Weapons (DEW)) injuries; infectious disease prevention, diagnosis and treatment in austere environments.

Human Performance: Focus is on operational human performance in aerospace environments - fit and healthy force; performance sustainment; occupational standards/selection; environmental and occupational health; environmental and metabolic stressors; nutrition; diagnosis of cognitive performance degradation, and applied countermeasures; assessment of cognitive demands in complex aerospace environments; fatigue management; sensory protection and sustainment (audio, tactile, visual); vision enhancement; medical team performance; medical modeling and simulation; and medical currency and competency.

Address technical questions to the following e-mail address:

det1.afrl.pkhb@wpafb.af.mil

ALL TECHNICAL QUESTIONS MUST BE SUBMITTED NO LATER THAN 15 AUGUST 2011.

Address contracting questions to:

PRIMARY: Ms. Kimberly Rhoads, 2310 8th Street, Bldg. 167, Wright-Patt AFB, OH 45433; e-mail Kimberly.Rhoads@wpafb.af.mil ; phone (937) 656-9763.

SECONDARY: Mr. Nicholas Voiles, 2310 8th Street, Bldg. 167, Wright-Patt AFB, OH 45433; e-mail Nicholas.Voiles@wpafb.af.mil ; phone (937) 656-9808.

NOTICE TO OFFERORS: The Ball Aerospace & Technologies Corporation, under contract FA8601-08-F-0105, will be participating as an advisor in evaluations of the proposals submitted under this BAA. Regulation DoDI 6000.08, paragraph 6.1.4, requires an external peer review prior to obligating or expending Defense Health Program (DHP) funding involving human subjects. Ball’s statement of work allows for this type of effort, the appropriate Organizational Conflict of Interest clause is included in their contract, and appropriate Non-Disclosure Statements have been executed. Offerors may object to the use of non-Government advisors on this acquisition however, the Contracting Officer will make the final determination regarding their use.

Full Text Announcement

I. Program Description: The primary goal for soliciting research and development (R&D) via the BAA is to ensure a balanced Medical research development technology and evaluation (RDT&E) program and enable the AFMSA to address critical material gaps. This will ensure the AFMSA identifies and develops new knowledge and technologies to fulfill critical mission requirements. AFMSA will assess the funding efforts of other government agencies to avoid redundant efforts. The intent of the solicitation presented here is to fund research targeted towards Air Force specific needs. AFMSA is soliciting white papers (and later technical/cost proposals) on the following research effort:

1. Statement of Objective/Needs:

A. ENROUTE CARE (EC)

Enroute care seeks to enhance the AFMSA’s ability to rapidly but safely transport patients from point of injury to definitive care while reducing footprint and variability and improving efficiency. We seek to maximize technological advancements and groundbreaking clinical research to match care during transport with state of the art ground medicine throughout the continuum. Research is needed to address knowledge gaps during patient transport and staging. The knowledge gained will be used to ensure that the best care is provided to our wounded/ill service members as they are moved through the system. Research/technology development is also needed on non-invasive and specific methods for assessing trauma resuscitation and timing of interventions and transport. Clinical research is needed to complement critical care and routine patient transport technology development. EC Thrust Area focus is on continuum of care during transport of patients from point of injury to point of definitive care. Key areas include: Aeromedical Evacuation (AE); Patient Staging; and Critical Care Air Transport equipment and treatment research. The three broad areas of research include:

· Physiological Effects of Aeromedical Evacuation

· Enroute Trauma and Resuscitative Care

· Enroute Patient Safety

1.1. Physiological Effects of Aeromedical Evacuation

The Air Force transports and cares for critical and routine patients in fixed-wing aircraft at about 8000 ft. cabin altitude. The AE environment exposes patients and crew to decreased atmospheric pressure (hypobaria), vibration, changes in gas volume within the body, temperature changes, decreased humidity, fatigue, vibration, and noise. Knowledge is sought on the impact of this environment on patient physiology in general, as well as, on specific disease states. Research areas 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, infectious disease and bacterial growth at altitude, hemorrhage and shock.

1.2. Enroute Trauma and Resuscitative Care

Long transport times and delays from point of injury to definitive care place unique burdens on military care providers. Delayed or inadequate resuscitation is associated with increase in infection, multiple organ dysfunction and mortality. It is crucial to identify early shock states and resuscitate patients for prolonged periods in austere environments. Aeromedical evacuation care providers face similar problems exacerbated by stricter limitations of weight, space, portability, durability, complexity of use, and complications of altitude and flight. AFMSA personnel need evidence-based methods and practices for emergent and surgical care to ensure optimal outcomes through the continuum of care. The knowledge gained will be used to ensure that the best care is provided to our wounded/ill service members as they are moved through the system. Research is also needed on non-invasive, sensitive and specific methods for assessing trauma resuscitation and timing of interventions. Clinical research is needed to complement critical care transport technology development to provide effective stabilization and resuscitation protocols for trauma patients within and between aeromedical evacuation nodes. Research and materiel development areas of interest include but are not limited to: Integrated and automated life support systems for critical care patients that reduces the footprint of existing systems and captures data with the goal of improved documentation/outcomes; devices that provides patient proning capabilities in the AE environment; technologies providing remote physiological monitoring; pain management approaches including alternative techniques; non-invasive cerebral perfusion monitoring capabilities in AE environment; non-invasive compartment syndrome detection/monitoring technology; hypo/hyperthermic treatments and technologies; early detection of hypovolemia through non-invasive means.

1.3. Enroute Patient Safety

Patient safety has the same if not increased importance and emphasis in the EC environment as in the hospital setting. The typical patient movement requires multiple hand-offs between teams of caregivers in austere environments making EC safety much more complex than in a fixed hospital setting. Human factor considerations in EC patient safety are exaggerated compared to a hospital due to the high demands, high threat, work conditions and locations such as an aircraft or casualty air staging facility. 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 leading to patient safety standards, monitoring and reporting, human factors research impacting patient safety, root cause analysis and methods incorporating prevention into practice guidelines.

B. EXPEDITIONARY MEDICINE (EM)

AFMSA sponsored Expeditionary Medicine (EM) research and technology development encompass interests in Expeditionary Logistics and Expeditionary Casualty Care. These focus areas are further defined and discussed in the subsequent sections. The overall aim is to enhance or improve expeditionary medical care during contingency operations including: improvement of expeditionary equipment capability enhancements by addressing needs related to platform capability sustainability (energy, supplies and materials); miniaturization of equipment to reduce logistics footprint, technology identification; development and/or validation of next-generation critical humanitarian/disaster relief equipment/material sets; deployed casualty care optimization and improvements; and field identification, diagnosis and treatment of emerging threat Directed Energy Weapons (DEW) injuries. This research aims to address issues related to care in the expeditionary setting and the inherent challenges in those missions. The funding available for EM R&D performed is intended to address unique AF operational needs, with the possibility of collateral benefit to other DoD entities.

2.1. Expeditionary Logistics

This focus area seeks to enhance existing or develop new expeditionary logistics procedures, materials and supplies including development and/or validation of techniques/tools to: reduce size and weight; optimize power requirements; decrease or minimize the associated logistics footprint associated with expeditionary operations; and provide in-transit visibility of medical supplies and equipment.

2.1.1. Topics of interest in expeditionary logistics related to materials and supplies include: research of new technologies suitable to application as man-portable / rugged, lightweight, renewable deployable, alternate power sources to support/augment casualty evacuation and other missions where sufficient power is not available for extended missions. Further topics in this area include: research to specify equipment and ancillary equipment needs to provide safe blood banking services including humanitarian assistance scenarios, research to analyze the strengths and weakness of various imaging technologies available for potential use in the remote deployment environment, and evaluation and determination of best-fit energy efficient equipment based on evaluation of expeditionary medicine equipment power usage employing advanced technologies that significantly reduce power, weight and cube. Additionally, research is needed to develop/validate standard equipment sets for enhanced patient management, particularly patient transfer/handoff, training, and supply/resupply.

2.1.2. Other topics of interest in EM Logistics and Supply include: Research into improved equipment to provide blood banking services in austere conditions while optimizing blood and resuscitative care product management; research into alternative methods for improving perfusion using alternative blood products and/or expanders for rapid resuscitation; determination of appropriate uses of alternative blood products in the field to restore blood volume in critically injured patients; development and/or optimization of expeditionary care management and resuscitation products to optimize outcomes in blood product resuscitation research in products to eliminate or reduce the reliance on temperature sensitive items (e.g. laboratory reagents, in the supply chain and replace with heat insensitive items/long or near-unlimited shelf-life products); and research and/or technology development in equipment and supply tracking tools.

2.2. Expeditionary Casualty Care

Expeditionary Casualty Care (ECC) funded research is focused on optimizing existing and developing new casualty care tools & techniques; improving methods and techniques for use of remote monitoring and triage systems; identifying and mitigating issues related to casualty care in a expeditionary setting, and validation of best-fit technologies in casualty care mission(s). Focus areas in ECC relate to mechanisms, techniques, and tools to improve outcomes associated with care delivered in the expeditionary settings to include pararescue first response and resuscitative care, surgery in preparation for long range transport, and treatment of directed energy injuries.

2.2.1. Air Force Pararescue personnel are responsible for the movement of a casualty to a place of safety. Initial essential stabilizing care at the point of injury minimizes loss of life and limb with emphasis on stopping bleeding, maintaining the airway, controlling pneumothorax, providing fluid resuscitation, controlling pain, monitoring patient condition, providing care in no and low-light conditions, and decontaminating open wounds. Topics of interest include:

· Research the impact of movement on combat-related injuries including motion/vibration, temperature, altitude and time in the field setting aimed at addressing how to measure, reproduce/model and study the impact of vibration on specific injury patterns as well as variations in altitude and temperature. The research should also focus on methods to mitigate harmful effects of environmental factors associated with care of combat or other casualties.

· Examine and research new methods for quickly stopping life threatening extremity bleeding used by Air Force first responders.

· Research is needed to identify rapid reliable vascular access and novel monitoring techniques for first responders.

· Research optimal oxygen delivery for battlefield injuries is needed. Need to determine the proper amount of therapeutic O2 required for critically injured patients.

· First responders need a topical infectious control wound treatment to prevent or control wound infections on traumatic limb injuries. It is important that the material is easy to use and is temperature stable.

· Research hypothermia intervention and pain management for burn patients.

· Research best practices for securing an airway on a burn patient or massive facial trauma patient moving through the AE system.

· Research therapeutic drugs given by first responders to slowed body functions providing more time to transfer of seriously wounded to definitive care.

· Non invasive device for both warming and cooling of patients to prevent hypo/hyperthermia from point of injury to Role 2/3 medical facilities.

2.2.2. Air Force support of Role III facilities in-theater has identified areas of research needed to safely prepare combat casualties for long-range transport. Emerging research programs for Enroute Care will specifically evaluate the transport piece of this complex system, but the pre-transport care to include identification of safe flying parameters and surgical practice prior to transport is covered by the EM.

· Research a negative pressure wound treatment device able to effectively remove multiple exudates on a single critically injured patient. Currently a device supports one wound site.

· Research a limb immobilization/traction system for EM use that carries through the continuum of care.

· Research is needed on pain management throughout the continuum of care to determine best practice to control and monitor pain.

· Research the use of anti-bacterial coated equipment to reduce of infectious disease.

· Research is required in injury research models for torso/junctional hemorrhage control intervention.

· Research to more effectively manage diffuse coagulopathy associated with major trauma.

2.2.3. The AF has a need to detect, quantify and assess exposures to various types of directed energy (DE). The ability to predict injury pattern(s), and both short/long-term health effects is critical. Based on the predicted energy pattern and projected health effects, there is high interest in the ability to rapidly identify and diagnose injuries expected from directed energy exposures of known threats to health, as well as the ability to treat and/or mitigate the effects of the exposure. Evaluation and validation of treatment modalities for DE injury are needed to ensure medical response, if needed, occurs in the optimal context post exposure. Further, diagnosis of an actual injury requires capturing/accurate historical information to ensure future sequelae are considered in the context of the complete hazard exposure history.

2.2.4. Focus areas of interest in ECC relate to mechanisms/procedures, techniques, and tools to improve outcomes associated with care delivered in the expeditionary setting. Areas of research may include: identification of methods to optimize human factors; evaluation of pharmacologic interventions and their neuroprotective effect against blast or acceleration injuries; research in optimizing overall expeditionary trauma care management and resuscitation at various provider skill set levels to enhance patient outcomes during pre-hospital and Expeditionary Medical Support (EMEDS) care; determination if protocols for diagnosing and treatment of TBI is valid within select AF operational communities where normal evaluation techniques may be inadequate; identification of the most effective vital signs to monitor/predict patient condition, determination/validation of need for oxygen delivery in prehospital interventions with transport time less than 3 hours; and research in identification of best treatment(s) for extremity compartment syndrome (ECS).

C. FORCE HEALTH PROTECTION (FHP)

Research and development in Force Health Protection (FHP) is focused on 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 the 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 Directed Energy (DE), Occupational & Environmental Health (OEH) Hazards, and Personalized Medicine Initiatives. Current projections demonstrate that the Directed Energy and Occupational & Environmental Health focus areas dominate research needs in the FHP thrust area.

3.1. Directed Energy

Various forms of DE are a threat that U.S. Air Force and other military operators will encounter on the modern battlefield. As DE incidents become more frequent in both domestic and foreign areas, the threat to Air Force and other military operators increases. Research is required to develop technologies that "detect to warn" and "detect to protect" to allow operators to be aware of the hazard and take appropriate actions to prevent or minimize exposure and associated adverse health effects. Exposure evaluation allows correct interventions and reduces uncertainty in treatment protocols. Also, medical decisions concerning treatment needs can be made as far forward as possible (i.e., minimizing the need for medical evacuation out of a theater of operations). Specific interest items include, but are not limited to:

· Rapid identification of hazards to operators (e .g., personal/area/mobile autonomous sensors);

· Near real-time risk assessment information to medical advisors (e.g., Combined Air Operation's Center (CAOC) notification and forwarding);

· Risk-reduction methodologies to allow implementation of appropriate interventions (e .g., to allow updated mission planning and to identify hazards to commanders); and

· Protective measures that may include personal protective equipment (PPE) to prevent injury from DE exposure.

3.2. Occupational and Environmental Health Hazards

The focus of this research area is on operational and emerging hazards (OEH). The goals are to improve capabilities of Air Force Medical Service (AFMS) Preventive Medicine personnel to identify and characterize potential hazards, increase knowledge and support policy response, identify and implement risk reduction methodologies, and provide near real-time information to medical advisors.

3.2.1. 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 on the battlefield. 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, 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.

3.2.2. The goal for sensor and detector technology is to be capable of sensing and conducting surveillance remotely. It should be direct reading, provide near real-time data, and allow the user to manipulate the data in ways to visualize temporal and geographic trends. This research need also includes the development of physiological monitors that can detect pre-clinical heat and cold stress conditions in time to prevent an injury or death. The technology must be small and portable, rugged, capable of operating in extreme temperature and humidity environments, and capable of being queried for information at any time during its deployment. Of particular interest is research and development in autonomous sensing and reporting technology that can be attached to individuals unobtrusively and a corresponding integrated network of sensors that are remote and persistent. Specific interest items include, but are not limited to:

· Detect and identify chemical, biological, toxins or radiological hazards on surfaces, in liquids and in the air in near real-time at the detector's point of operation;

· Anticipate, evaluate and recognize health threats through the fusion and analysis of medical intelligence and comprehensive health surveillance products and joint/service lessons learned;

· Monitor physiological status to anticipate casualties at the operator’s location, provide risk assessment information at a remote location, and provide near-real time information to medical advisors;

· Provide timely assessments of health risks to support Joint Forces Commands’ operational risk management decision processes; and

· Conduct heat stress mitigation research, to include development of personal devices to reduce/eliminate heat stress injury.

· Need research in the area of Nanoparticle health risk assessment and threat.Mitigate hazardous effects and restore safe use of essential contaminated resources.

3.3. Patient-Centered Precision Care – Personalized Medicine

3.3.1. 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: addressing the ethical, legal and social policy implications and policy development for the use of genomic information; education for the healthcare team to include the empowered patient; knowledge generation studies to include effectiveness of specific genomic testing and cost-benefit analyses; development of a bioinformatics/computational biology system that will support continuous learning while integrating genomic information into health informatics tools; and development of an advanced genomic diagnostic system to translate genomic sequence testing into clinically actionable information for providers and patients.

3.3.2. 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 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.

3.3.3. Functional Medicine Research: The modernization effort is interested in the science, methodologies, and comparative effectiveness research within the field of functional medicine, especially common, complex conditions, typically treated in the primary care setting. Areas of interest include:

· Identification of imbalance or dysfunction/dis-regulation/disease of normal physiology and impact on wellness

· Integration of knowledge from many different systems and methods; and the cause of the dysfunction is the diagnostic goal

· Early prediction of dysfunction

· Restoration of balance in the body which is viewed as a dynamic and complex interconnected system of mind, body, emotions and spirit

· Health measured along a wellness continuum (i.e., a spectrum moving from disease to health) is the main goal, which includes the balance of bio-energetic physiologic systems, functioning, and the body, mind, spirit triad

3.3.4. Gene Environment Interaction (GxE) Research: It has long been established that interactions between genes and environment are a critical factor for the determination of whether or not a person will develop a certain disease or condition. For certain diseases, some of these relationships are understood (e.g. diabetes, heart disease, etc.); in other cases these gene environment interactions are not well known (e.g. autism) or defined (e.g. PTSD). Furthermore, research is beginning to show that environmental factors can have long reaching impacts on an individual or their offspring through epigenetic mechanisms. A more complete understanding of the GxE will enable targeted treatment and prevention of many common diseases.

D. HUMAN PERFORMANCE (HP)

AFMS sponsored Human Performance encompasses research and technology development interests in Cognitive Performance and Fatigue Management, Physiological Performance and Targeted Conditioning, Operational and Environmental Challenges to Performance, Training for Optimal Performance of AF Medical Personnel, and Personnel Selection for Performance. These focus areas are further defined and discussed in the subsequent sections. The overall aims of AFMS Human Performance research are to enhance, optimize and maintain personnel’s performance in carrying out their assigned missions. The research performed is intended to address unique AF operational needs, with the possibility of collateral benefit to other DoD entities.

4.1 Cognitive Performance and Fatigue Management

This focus area seeks to develop diagnostic methods to determine impaired or ineffective cognitive function as well as treatments to restore/recover cognitive function depleted as a result of intense or prolonged AF operational demands on cognitive load. This area also focuses on minimization and validated treatment of fatigue in select populations including, but not limited to, Battlefield Airmen, Pararescue and other special operations/tactics personnel, Remotely Piloted Aircraft Operators, as well as AFMS personnel providing care in demanding operational environments such as deployed or enroute care settings.

4.1.1.Topics of interest in cognitive performance include: effects of movement environment on medical aircrew performance, and associated occupational hazards review, diagnosis of decreased Cognitive Performance (in Individual & Teams), treatments / techniques to recover from operations induced cognitive performance decrements, assessment or prediction of the cognitive performance effects of various challenging levels of complexity. Further topics of interest in cognitive performance include: change in operational environments, quantification of measurable cognitive effects/costs resulting from a change in complexity, information overload and mission tasking, evaluation of strategies to mitigate performance challenges associated with a change in complexity, identification of Human Systems Integration (HSI) issues as they affect cognitive performance, strategies and techniques to improve or enhanced human performance to decrease aircraft or other mishaps.

4.1.2. Topics of interest in fatigue management include: identification and treatment of fatigue in medical providers/staff secondary to workload, staffing, and training demands, identification and treatment of fatigue in select AF personnel such as Battlefield Airmen and other AF Special Operations/Tactics personnel, RPA Operators.

4.2 Physiological Performance and Targeted Conditioning

This focus area seeks to identify select AF populations with unique physiological performance requirements. These performance requirements will then drive research to optimize, enhance and maintain the physical characteristics required of these personnel. The possible expected results are validated regimens to prepare and train select AF personnel to perform their mission requirements, at least as effectively as current training approaches, while decreasing attrition rates and rates of non-mission capable personnel secondary to injury from training and operations.

4.2.1. Topics of interest include: identification of optimal selection criteria and standards for physically demanding AF occupations, validation of selection standards compared against successful training and personnel asset longevity, identification of physical performance/conditioning needs of AF populations, optimization of physical training of identified AF populations to decrease attrition secondary to training or operational demands, optimization of nutrition, physical conditioning, and overall health promotion in select AF populations. AF populations of interest may include Special Operations personnel, Remotely Piloted Aircraft (RPA) Operators and other AF career fields with potential for high attrition secondary to physical demands of their occupation.

4.2.2. A specific area of interest is the need for research on the tasks performed by Battlefield Airmen in operations and training environments to identify areas of increased risk of injury and a physical training regimen derived from that data based on scientific principles of strength and conditioning targeted on the basis of an analysis of the tasks performed. The goal to provide training that is designed to mitigate risks while optimizing battlefield performance. Research may consist of initial task analysis and physical training set up with a transition to a validated sustainable program. A physical training program based on a performed task analysis and conducted by personnel specifically trained/certified to perform high performance physical training is needed.

4.2.3. Another specific area of interest is Personnel Selection for Performance. The focus of this area is targeted to ensuring performance standards related to AF occupational requirements are validated, current and required. Selection may be concerned with establishing physical attributes, such as strength, vision, reflexes, and stamina, which predicts success in certain occupations, or that decreases attrition. The work needed includes analysis of skills/traits inherent in top performers of select AF operators to foster reproducibility of success. Topics of interest include: evaluation of screening standards for select AF occupations, establishment of criteria for certain physical attributes based on occupational requirements, and strategies to ensure optimized and sustained performance in critical AF tasks based on selection of personnel requirements of the tasks.

4.2.4. Other areas of interest include: providing science and evidence based health and fitness programs to better prepare AF personnel for deployment, research to individual’s ability to prepare, self monitor, and sustain performance during high risk operations requiring optimal physical and mental resilience, development of a comprehensive total life-cycle management process that prepares, sustains, protects, and cares for service members throughout their military service.

4.3 Operational and Environmental Challenges to Performance

This focus area is concerned with the mitigation and prevention or treatment to enhance performance in challenging environments. The environment may be operationally (motion, vibration, orientation, length of mission) challenging or environmentally (high-altitude, hot, cold, low-visibility, information overload) challenging.

4.3.1. Topics of interest include: defining operational & environmental factors that impact human performance, an adequate understanding of the acceptable levels of heat stress in training and operations, techniques and treatments to mitigate heat stress effects in training and operational settings, establishing the ability to properly monitor, prevent, and intervene in a timely fashion to heat stress. Other interests include validation of effects of high-altitude operations in AF personnel including hypoxic events, decompression sickness risks/events, monitoring and treatment of altitude related injuries or effects, techniques and treatments to improve situational awareness and mitigate motion induced sickness/disorientation in AF personnel, and identification and treatments for other AF-relevant extreme operational environments.

4.4 Training for Optimal Performance of AF Personnel

AF medical personnel have a complex, demanding mission. They receive excellent preparation through a variety of training platforms and programs prior to deployment in support of AF or DoD medical operations. However, continual advances in state-of-the-art treatment, public concerns over live-tissue training, and rigorous readiness skills requirements dictate the AF must ensure the best possible training is available to AF medics caring for our injured military. This focus area is concerned with ensuring the best platforms, right approaches, and most effective training tools & techniques are available to our medical personnel.

4.4.1. Topics of interest include: research and validation of virtual reality haptic training tools in surgical procedures, optimization of modeling & simulation for medical training, compare and contrast advancing simulation technologies with live training to validate possible replacements of live animal training, evaluation of effectiveness of synthetic tissue training & other techniques for medics in-lieu of live-tissue training, validation of effectiveness of distributed training networks and web-based systems versus live classroom training, evaluation of the effective learning management techniques in enhancing, optimizing & sustaining performance, evaluation of effectiveness of medical training virtual environments and medical games that are currently developed in industry for the military health system, and validation of various combinations of live, virtual, gaming, and constructive training approaches to evaluate optimal mixes of technologies, organizations, and learning concepts.

E. 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. Based on the Military Health Services priorities, gaps identified in the AFMS 2009 Capabilities Review and Risk Assessment (CRRA) and the needs/gaps of the MAJCOMs, the following research focus areas were identified. Operational Medicine research and technology development focus areas include clinical patient safety, psychological health/resilience, obesity, and autism. The focus areas are further defined and discussed in the subsequent sections.

5.1. Clinical Patient Safety: In 1999, the Institute of Medicine’s (IOM) report To Err is Human, Building a Safer Health System,” made patient safety a priority for many different policymakers. In this report, the National Committee on the Quality of Health Care, identified a comprehensive strategy to reduce preventable errors because of the tens of thousands of Americans that die yearly as a result of medical errors. In 2001, the IOM released a second report, Crossing the Quality Chasm: A New Health System for the 21st Century. In this report, the Committee on Quality of Health Care called for radical changes to close the gap between the type of care being delivered and high quality health care. This report identified six aims of quality care: care should be safe, effective, patient-centered, timely, efficient and equitable. The National Defense Authorization Act of 2001 mandated a DoD Patient Safety Program. As the rest of the nation struggles with improvements in the patient safety arena, so does the DoD and AFMS. Patient safety gaps were identified in the areas of human factors, medical complexity, and system failures.

5.1.1. This focus area seeks solutions dealing with human factor variations in healthcare provider education, training, modeling and simulation, fatigue, experience, depression and burnout. Additional research/technology development is required relating to the medical complexity involved in the use of complicated technologies, the multitude of available medications, and care of critically ill patients for prolonged periods of time. Lastly, additional research is needed to explore communication failures, unclear lines of authority between members of the health care team, and reliance on automated systems that lead to patient errors when the equipment malfunctions.

5.2. Psychological health/Resilience: In this time of persistently high operations tempo, in-garrison health care staff are tasked with providing quality care even in the face of staffing shortages due to deployments, budget cuts, and inability to hire personnel for temporary positions. To meet staffing shortages, members of the Air Force Reserves and Air National Guard are often activated and deployed for extended periods of time to locations in the very area in which they live and work as civilians. These prolonged deployments are sources of stress to these Airmen. Research is needed to assess these specific populations for sources of stress, as well as their resiliency and resilience enablers. In addition to Reservists and Guardsmen, active duty members that staff medical treatment facilities during periods of minimal manning need to be assessed for stressors and resilience enablers.

5.3. Obesity: This focus area seeks research and technology development to identify and treat the scope of the obesity problem in all AFMS beneficiaries. Not only does this research include identification of the scope but should also seek to assess beneficiaries’ activity levels and physical functional capabilities. Once the scope of the problem has been identified, the information will be utilized to drive research to explore and identify effective treatment programs specific to AFMS beneficiaries. As this information is being gathered, translational research is needed to support development and enhancement of currently successful patient educational programs that promote healthy lifestyles to treat obesity and prevent development of chronic diseases such as diabetes mellitus and cardiovascular disease.

5.4. Autism: This focus area seeks to continue development of an Autism Spectrum Disorder Registry of families from Wright-Patterson Air Force Base and Central Ohio with the goal of collaborating with other military Medical Treatment Facilities to provide psychological testing. The efforts will: increase the number of affected in the registry for increased statistical power for molecular studies, and will continue research to identify autism susceptibility variants in candidate genes by direct sequencing and screening for regulatory variation by measuring Allelic mRNA Expression Imbalance (AEI) and altered gene splicing.

5.4.1. In addition, this focus area will explore the use of telemedicine to deliver Autism healthcare services with the potential to: improve access to care; improve patient compliance with specialty referral; and broadening the scope of patients and families who can be effectively managed. Current AFMS staffing constraints, limited AFMS system capabilities, and a mobile patient population requires a medical infrastructure capable of meeting unique provider and patient circumstances. Using telemedicine for Autism will improve the impact of existing resources, especially in rural and underserved communities.

2. Deliverable Items:

g. Data Items: To be determined for each individual award; however, the following reports will be required at a minimum: Final Report, Funds and Man-hour Reports, Status Reports. Financial reports will be required monthly for contracts and quarterly for assistance instruments. Specific reporting requirements will be provided if a full proposal is requested.

h. Software: Each award will identify if software is to be delivered

i. Hardware: Each award will identify if hardware is to be delivered

j. Other: Interim Reports and Presentation Materials (as required)

3. Schedule:

g. Overall effort: Will be determined for each individual award

h. Data Items: Full list will be attached to request for proposal (RFP)

i. Software: Will be determined for each individual award

j. Hardware: Will be determined on each individual award

4. Other Requirements

g. Program security classification: It is anticipated that each award will be unclassified, but security classification will be addressed for each individual award.

h. Export Control: Information involved in this research effort is not expected to be subject to Export Control (International Traffic in Arms Regulation (ITAR) 22 CFR 120-131, or Export Administration Regulations (EAR) 15 CFR 710-774). If it is determined that an individual effort is subject to export control then a Certified DD Form 2345, Militarily Critical Technical Data Agreement, will be required to be submitted with proposal.

i. Export Controlled Items: As prescribed by DFARS 204.7303, DFARS 252.204-7008, Export-Controlled Item (APR 2010) is contained in this solicitation (as shown below). This clause shall be contained in ALL solicitations and resulting contracts.

EXPORT-CONTROLLED ITEMS (APR 2010)

(a) Definition. “Export-controlled items,” as used in this clause, means items subject to the Export Administration Regulations (EAR) (15 CFR Parts 730-774) or the International Traffic in Arms Regulations (ITAR) (22 CFR Parts 120-130). The term includes:

(1) “Defense items,” defined in the Arms Export Control Act, 22 U.S.C. 2778(j)(4)(A), as defense articles, defense services, and related technical data, and further defined in theITAR, 22 CFR Part 120.

(2) “Items,” defined in the EAR as “commodities”, “software”, and “technology,” terms that are also defined in the EAR, 15 CFR 772.1.

(b) The Contractor shall comply with all applicable laws and regulations regarding export-controlled items, including, but not limited to, the requirement for contractors to register with the Department of State in accordance with the ITAR. The Contractor shall consult with the Department of State regarding any questions relating to compliance with the ITAR and shall consult with the Department of Commerce regarding any questions relating to compliance with the EAR.

(c) The Contractor's responsibility to comply with all applicable laws and regulations regarding export-controlled items exists independent of, and is not established or limited by, the information provided by this clause.

(d) Nothing in the terms of this contract adds, changes, supersedes, or waives any of the requirements of applicable Federal laws, Executive orders, and regulations, including but not limited to—

(1) The Export Administration Act of 1979, as amended (50 U.S.C. App.2401, et seq.);

(2) The Arms Export Control Act (22 U.S.C. 2751, et seq.);

(3) The International Emergency Economic Powers Act (50 U.S.C. 1701, et seq.);

(4) The Export Administration Regulations (15 CFR Parts 730-774);

(5) The International Traffic in Arms Regulations (22 CFR Parts 120-130); and

(6) Executive Order 13222, as extended;

(e) The Contractor shall include the substance of this clause,…