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Exploration Laboratory Analysis

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the downselection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institute's rHEALTH X and Intelligent Optical System's lateral flow assays combined with Holomic's smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements. The technology demonstrations and metrics for success will be finalized in FY16. Also, the downselected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

In-Flight laboratory↗

Medical System Requirements Development for Lunar Operations

The major health hazards of spaceflight include higher levels of damaging radiation, altered gravity, extended periods of isolation and confinement, a closed and potentially hostile living environment, and the stress associated with being a long distance from Earth. As we increase the duration of lunar stays with foreseeable communication latencies and disruptions, there will be a progressive need for crew to maintain their own health and independently respond to critical medical events. The Exploration Medical Capability element of the NASA Human Research Program is developing a set of Medical System requirements for lunar transit and surface operations. These requirements specify the capabilities, processes and procedures of a habitat Medical System needed for a range of conditions known to occur during spaceflight. Requirement text is written so as not to constrain innovative design solutions necessary for a resilient system. The requirement set includes attributes and functions the Medical System imposes on eight additional habitat systems. A key property of the Medical System is the provision of medical knowledge that will be stored, updated, analyzed, and secured within a Habitat Data System. A Task Performance Support System will aid in medical data acquisition and interpretation, crew training, medical condition prevention, diagnosis and treatment, provide interactive procedures, and track medical inventory. A Wellness System will focus on the provision of countermeasures to prevent, mitigate or treat adverse physical and behavioral health effects while the Medical System recommends adjustments to these countermeasures to maintain crew health. An Environmental Monitoring System will share out-of-bounds readings of air and water quality, acoustics, and radiation exposure levels with the Medical System to help identify issues before they affect crew health and performance. A Communications System will provide secured and private consultations between crew and the ground medical team and their loved ones on Earth. The Medical System also imposes requirements on a Research & Testbed System, fostering advanced medical science such as human research. A Waste Management System provides biohazard waste containment and waste disposal options (recycle and reuse). An Extravehicular Activity System supports crew health during lunar surface activities. And finally, a Maintenance Support System ensures that medical equipment is performing as expected. These requirements are being specifically developed for lunar surface operations but could help to identify Medical System requirements for any space habitat (e.g., I-Hab, commercial endeavors, etc.).

technology↗

The Pathway to a Safe and Effective Spaceflight Medication Formulary: Expert Review Panel Recommendations

Exploration spaceflight poses several challenges to the provision of a comprehensive medication formulary. This formulary must accommodate the size and space limitations of the spacecraft, while addressing individual medication needs and preferences of the crew, consequences of a degrading inventory over time, the inability to resupply used or expired medications, and the need to forecast the best possible medication candidates to treat conditions that may occur. The Exploration Medical Capability (ExMC) Element's Pharmacy Project Team has developed a research plan (RP) that is focused on evidence-based models and theories as well as new diagnostic tools, treatments, or preventive measures aimed to ensure an available, safe, and effective pharmacy sufficient to manage potential medical threats during exploration spaceflight. Here, we will discuss the ways in which the ExMC Pharmacy Project Team pursued expert evaluation and guidance, and incorporated acquired insight into an achievable research pathway, reflected in the revised RP.

Daniels, V. R.↗

Post-Flight Back Pain Following International Space Station Missions: Evaluation of Spaceflight Risk Factors

INTRODUCTION Back pain during spaceflight has often been attributed to the lengthening of the spinal column due to the absence of gravity during both short and long-duration missions. Upon landing and re-adaptation to gravity, the spinal column reverts back to its original length thereby causing some individuals to experience pain and muscular spasms, while others experience no ill effects. With International Space Station (ISS) missions, cases of back pain and injury are more common post-flight, but little is known about the potential risk factors. Thus, the purpose of this project was to perform an initial evaluation of reported post-flight back pain and injury cases to relevant spaceflight risk factors in United States astronauts that have completed an ISS mission. METHODS All US astronauts who completed an ISS mission between Expeditions (EXP) 1 and 41 (2000-2015) were included in this evaluation. Forty-five astronauts (36 males and 9 females) completed 50 ISS missions during the study time period, as 5 astronauts completed 2 ISS missions. Researchers queried medical records of the 45 astronauts for occurrences of back pain and injury. A case was defined as any reported event of back pain or injury to the cervical, thoracic, lumbar, sacral, or coccyx spine regions. Data sources for the cases included the Flight Medicine Clinic's electronic medical record; Astronaut Strength, Conditioning and Rehabilitation electronic documentation; the Private Medical Conference tool; and the Space Medicine Operations Team records. Post-flight cases were classified as an early case if reported within 45 days of landing (R + 45) or a late case if reported from R + 46 to R + 365 days after landing (R + 1y). Risk factors in the astronaut population for back pain include age, sex, prior military service, and prior history of back pain. Additionally, spaceflight specific risk factors such as type of landing vehicle and onboard exercise countermeasures were included to evaluate their contribution to post-flight cases. Prior history of back pain included back pain recorded in the medical record within 3 years prior to launch. Landing vehicle was included in the model to discern if more astronauts experienced back pain or injury following a Shuttle or Soyuz landing. Onboard exercise countermeasures were noted for those astronauts who had a mission following 2009 deployment of the Advanced Resistive Exercise Device (aRED) (EXP 19 to 41). T-test and chi-squared tests were performed to evaluate the association between each individual risk factor and post-flight case. Logistic regression was used to evaluate the combined contribution of all the risk factors on post-flight cases. Separate models were calculated for cases reported by R + 45 and R + 1y. RESULTS During the study time period, there were 13 post-flight cases reported by R + 45 and an additional 5 reported by R + 1y. Most of these cases have been reported since EXP 19 with 10 cases by R + 45 and 4 by R + 1y. Individual risk factors of age, sex, landing vehicle, and prior military service were not significantly associated with post-flight cases identified at R + 45 or R + 1y (p greater than 0.05). Having back pain or injury within 3 years prior to launch significantly increased the likelihood of becoming a case by R + 1y (p = 0.041), but not at R+45 (p=0.204). Additionally, astronauts who experienced onboard exercise countermeasures that included aRED had a significantly increased risk of becoming a case at R + 45 (p = 0.024) and R + 1y (p=0.003). Multiple logistic regression evaluating all the risk factors for cases identified no significant risk factors at either the R + 45 or R + 1y time period (p greater than 0.05). Overall model fit was poor for both the R + 45 (R(exp 2) = 0.132) and R + 1y (R(exp 2) = 0.186) cases showing that there are risk factors not represented in our model. CONCLUSIONS Regardless of cause, post-flight cases are reported more often since aRED was deployed in 2009. This may reflect improved documentation or unidentified risk factors. No spaceflight risk factor explains the data fully. Post-flight cases are probably due to multi-faceted factors that are not easily elucidated in the medical data.

Laughlin, M. S.↗

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗

Assessment of Medical Risks and Optimization of their Management using Integrated Medical Model

The Integrated Medical Model (IMM) Project is a software-based technique that will identify and quantify the medical needs and health risks of exploration crew members during space flight and evaluate the effectiveness of potential mitigation strategies. The IMM Project employs an evidence-based approach that will quantify probability and consequences of defined in-flight medical risks, mitigation strategies, and tactics to optimize crew member health. Using stochastic techniques, the IMM will ultimately inform decision makers at both programmatic and institutional levels and will enable objective assessment of crew health and optimization of mission success using data from relevant cohort populations and from the astronaut population. The objectives of the project include: 1) identification and documentation of conditions that may occur during exploration missions (Baseline Medical Conditions List [BMCL), 2) assessment of the likelihood of conditions in the BMCL occurring during exploration missions (incidence rate), 3) determination of the risk associated with these conditions and quantify in terms of end states (Loss of Crew, Loss of Mission, Evacuation), 4) optimization of in-flight hardware mass, volume, power, bandwidth and cost for a given level of risk or uncertainty, and .. validation of the methodologies used.

Fitts, Mary A.↗

CPAP Ventilators Needed for Rapid Response to COVID-19 by Modification of CPAP Equipment

Early on in the COVID-19 pandemic, potential ventilator shortages were a critical issue identified by national health care providers. Capacity modeling at the time suggested patient demand may exceed ventilator supply. Thus, the challenge became finding an urgent interim solution to meet health care needs. Our initial hypothesis was that CPAP technology could be modified to provide similar functionality to a ventilator, relieving demand and allowing physicians to decide which patients need high end machines, ultimately saving lives. In conjunction with medical experts and pulmonologists, we were able to identify three key thrusts associated with this research problem: (1) modification of CPAP technology to allow for 02 input that would be capable of providing ventilation; (2) development of an alarming function that would provide real-time audible alarms to alert medical personnel to critical conditions, which would be used inline with CPAP technology; and (3) a method of sterilizing expiratory air from such a system in order to protect medical personnel from biohazard, since CPAPs vent to the atmosphere. We were unable to realize results for thrust 1 (CPAP modification for 02); we identified potential safety issues associated with utilizing medical grade oxygen with a common CPAP device. In order to characterize and mitigate these issues, we would need to partner closely with a device manufacturer; such a partnership could not be achieved in the timeframe needed for this rapid response work. However, we determined that some medical grade BiPAP devices do not need this modification and that the significant progress on thrusts 2 and 3 would be sufficient to buy down risk of a massive ventilator shortage. Our team built a prototype alarm system that can be utilized with any assistive respiratory device to alert on all key conditions identified by medical personnel (high pressure, low pressure, apnea, loss of power, low battery). Finally, our team made significant progress in the rapid prototyping and demonstration of an inline UV air purifier device. The device is cost efficient and can be manufactured at scale with both commercially available and additively manufactured parts. Initial tests with SARS-CoV-2 analog bacteriophage MS2 show 99% efficacy at reducing bioburden. Following a successful demonstration of the prototype device with medical personnel, we were able to obtain follow-on (non-LDRD) funding to provide additional device characterization, validation, and production in order to respond to an immediate regional need.

42 ENGINEERING↗

Assessment of Model Outcomes Between the Integrated Medical Model (IMM) and the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT)

The Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) is a computational model that provides human health and medical risk predictions for crewed spaceflight missions. MEDPRAT utilizes discrete event modeling and dynamic probabilistic simulation to predict critical mission outcomes (total medical events, crew health index, quality time lost, loss of crew life, removal to definitive care), condition occurrences, and resource consumption. Input parameters for MEDPRAT include crew attributes (e.g., sex), types of mission activities (e.g., whether and where crew members perform an extravehicular activity (EVA)), available resources, treatment information, and probability distributions for medical conditions. As an evolution of the Integrated Medical Model (IMM), MEDPRAT provides enhanced capabilities and higher fidelity, and incorporates more appropriate assumptions for long-duration spaceflight. IMM is the currently accepted standard for quantifying spaceflight mission medical risk in NASA operations that uses a probabilistic risk assessment (PRA) approach. MEDPRAT builds on the same logical foundation as IMM but implements the model architecture through highly optimized Monte Carlo sampling methods. An analysis is performed comparing the outputs from IMM with those from MEDPRAT V1.0 and V2.0 for the same reference missions in order to quantify similarities and differences in the model outcomes. The juxtaposition between IMM and MEDPRAT V1.0 and 2.0 shown in this report demonstrates that these two models generate very similar results; where differences in outcomes are shown, these are in accordance with the underlying assumptions and differences in the model architectures. This validation effort further establishes the credibility and reliability of the MEDPRAT software.

Matthew T Prelich↗

Recommendations from NASA's Operational and Research Musculoskeletal Summit

Introduction: Continuously evolving medical standards of care, limited crew training time, and the inherent constraints of space flight necessitate regular revisions of the mission medical support infrastructure and methodology. A three-day Operational and Research Musculoskeletal Summit was held to review NASA s current strategy for preflight health maintenance and injury screening, risk mitigation for musculoskeletal injuries or syndromes, treatment methods during flight, and research topics to mitigate risks to astronaut health. The Summit also undertook consideration of the best evidence-based terrestrial musculoskeletal practices to recommend their adaptation for use in space. Methods: The types and frequencies of musculoskeletal injuries sustained by short- and long-duration astronauts were obtained from the Longitudinal Study of Astronaut Health. The Summit panel was comprised of experts from the clinical and research communities, as well as representatives from NASA Headquarters, the Astronaut corps, and the offices of JSC Medical Operations, JSC Human Adaptation and Countermeasures, Glenn Research Center Human Research, and Astronaut Strength Conditioning and Rehabilitation. Before the summit, panelists participated in a Web-based review of NASA s Space Medical Conditions List (SMCL). Results: The Summit generated seventy-five operational and research recommendations to the NASA Office of Space Medicine, including changes to the SMCL and to the musculoskeletal section of the ISS debrief questionnaire. From these recommendations, seven were assigned highest value and priority, and could be immediately adopted for the exploration architecture. Discussion: Optimized exercise and conditioning to improve performance and forestall musculoskeletal damage on orbit were the primary area of focus. Special attention was paid to exercise timing and muscle group specificity. The panel s recommendations are currently in various stages of consideration or integration into the ISS and Exploration programs. This effort serves to enhance the on-orbit system so comprehensive treatment can be delivered in a more effective and standardized manner.

Jones, J. A.↗

Post Flight Reconditioning for US Astronauts Returning from the International Space Station

Prior to spaceflight, each astronaut undergoes medical requirement testing to establish a preflight baseline for physiologic functions. Astronauts returning from the International Space Station can experience deficits in all or some of the following areas: aerobic capacity, muscular strength, power, endurance, stamina, bone, balance, agility, coordination, orthostatic tolerances, proprioception, neurovestibular function and flexibility. These losses occur from living in microgravity and are consistent with deficits seen in terrestrial, de-conditioning individuals. Since 2001, the Astronaut Strength, Conditioning and Rehabilitation (ASCR) specialists have administered a reconditioning program, focusing on all deficits, which improves the physical condition of all returning astronauts. In most cases, astronauts have reached or surpassed their preflight physical condition. Purpose: This presentation will describe and explain the postflight reconditioning program for returning astronauts. Methods: The postflight reconditioning program is designed to stress the body systems that affect the following: aerobic capacity, muscular strength, power, endurance, stamina, bone, balance, agility, coordination, orthostatic tolerances, proprioception, neurovestibular function and flexibility. Postflight reconditioning begins on landing day, is scheduled for two hours per day, 7 days a week for 45 days and is tailored to the specific needs of the astronaut. Initially the program focuses on basic ambulation, cardiovascular endurance, strength, balance, flexibility and proprioception. The program advances through 45 days and specific attention is given to each astronaut s overall condition, testing results, medical status, and assigned duties after their mission. Conclusion: Astronauts will experience noticeable deficits in their physical condition after living in microgravity for an extended length of time. After completing postflight reconditioning, it is shown that astronauts have regained, and in most cases improved upon, their preflight baseline condition.

Nieschwitz, Bruce↗

Apparatus for detecting at least one predetermined condition and providing an informational signal in response thereto in a medication infusion system

A medication infusion system provides redundant safety and includes condition detecting and informational alarm signal generating apparatus for indicating if (1) a fluid leak occurs in different portions of the system; (2) a programmable input from a patient or physician would result in exceeding a safe dosage limit; (3) the reservoir containing medication has been filled; (4) the intended medication pumping does not correlate with the pumping actually effected; (5) battery voltage is low; (6) the medication reserve is low; and (7) the system has been switched off. The apparatus may provide subcutaneous electrical, thermal, or audible stimulation to the patient and also provides a signal which a physician may monitor. The stimulation may be coded to separately identify each above-listed deviation in nominal system performance. In addition, the number of medication requests are correlated with actual medication dispensing to assure proper operation. An identification scheme is provided which matches the patient with his or her corresponding medication.

Fischell, Robert E.↗

Microminiaturized, biopotential conditioning system (MBCS)

Multichannel, medical monitoring system allows almost complete freedom of movement for subject during monitoring periods. System comprises monitoring unit (biobelt), transmission line, and data acquisition unit. Belt, made of polybenzimidizole fabric, is wrapped around individual's waist and held in place by overlapping sections of Velcro closure material.

Belasco, N.↗

Implementation of a SysML Model-Based Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

One goal of the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element Systems Engineering (SE) team is to define the technical system needed to support crew medical system capabilities for future exploration missions, including orbital and surface operations for long duration lunar missions. This is accomplished through the development of a Medical System Foundation, which communicates medical system requirements, capabilities, conditions, and resources that define a starting point for a medical system that meets the specification for design reference missions and associated Levels of Care (as defined by NASA-STD-3001). The starting point for creating this Medical System Foundation Model is the development of a Concept of Operations (ConOps) that describes the operation of the system from the point of view of the users. It includes a comprehensive and thoroughly vetted list of the users, their specific needs, the goals of the system, key assumptions about the system, and definitions of the system’s operational environments. The use case scenarios included in the ConOps illustrate required medical system capabilities for Level of Care IV and enable the ExMC SE team to develop integrated medical system requirements and identify capabilities required to meet those requirements. For this “Long Duration” Medical System Foundation development effort, ExMC replaced the traditional document-based ConOps with a model-based ConOps using model-based systems engineering. This approach has several advantages, including the facilitation of more efficient understanding of the material through information-dense images with less opportunity for misinterpretation than text alone, the roll-out of changes to the ConOps to stakeholders in real-time as they are approved, and the consolidation of all salient information into one centralized location. This discussion will focus on both how the model represents the ConOps content and how the SE team utilized lessons learned in an agile environment to improve the way this information was created and presented to stakeholders.

M Kaetzer↗

Implementation of a SysML Model-Based Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

One goal of the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element Systems Engineering (SE) team is to define the technical system needed to support crew medical system capabilities for future exploration missions, including orbital and surface operations for long duration lunar missions. This is accomplished through the development of a Medical System Foundation, which communicates medical system requirements, capabilities, conditions, and resources that define a starting point for a medical system that meets the specification for design reference missions and associated Levels of Care (as defined by NASA-STD-3001). The starting point for creating this Medical System Foundation Model is the development of a Concept of Operations (ConOps) that describes the operation of the system from the point of view of the users. It includes a comprehensive and thoroughly vetted list of the users, their specific needs, the goals of the system, key assumptions about the system, and definitions of the system’s operational environments. The use case scenarios included in the ConOps illustrate required medical system capabilities for Level of Care IV and enable the ExMC SE team to develop integrated medical system requirements and identify capabilities required to meet those requirements. For this “Long Duration” Medical System Foundation development effort, ExMC replaced the traditional document-based ConOps with a model-based ConOps using model-based systems engineering. This approach has several advantages, including the facilitation of more efficient understanding of the material through information-dense images with less opportunity for misinterpretation than text alone, the roll-out of changes to the ConOps to stakeholders in real-time as they are approved, and the consolidation of all salient information into one centralized location. This discussion will focus on both how the model represents the ConOps content and how the SE team utilized lessons learned in an agile environment to improve the way this information was created and presented to stakeholders.

Mary Susan Kaetzer↗

Control of iodine and tellurium for use in domestic molybdenum-99 production efforts

Three initial proof-of-concept experiments were performed to test the removal of I and Te from solutions containing Mo for potential abatement during chemical processing to purify 99 Mo. All three proof-of-concept experiments produced results indicating that further optimization could provide methods for I and/or Te abatement from multiple matrices. Decamp and Happel (2013) describe the use of CL resin from Eichrom Technologies loaded with Ag + combined with Amberlite XAD-4 in the chromatographic separation of irradiated fission products in 1 M HNO 3 to separate iodine species where iodide and iodate react with Ag + and I2 adheres to the Amberlite resin. The method worked well under processing conditions in a medical isotope facility although many separation methods use higher concentrations of HNO 3 which could adversely impact the Ag + loading. The experiment performed here used a roughly 2 mL column of CL resin loaded with Ag + and Amberlite XAD-4 to separate µg quantities of I, Te, and Mo in 3 M HNO 3 .

38 RADIATION CHEMISTRY, RADIOCHEMISTRY, AND NUCLEA↗

Personalized, disease-stage specific, rapid identification of immunosuppression in sepsis

Introduction Data overlapping of different biological conditions prevents personalized medical decision-making. For example, when the neutrophil percentages of surviving septic patients overlap with those of non-survivors, no individualized assessment is possible. To ameliorate this problem, an immunological method was explored in the context of sepsis. Methods Blood leukocyte counts and relative percentages as well as the serum concentration of several proteins were investigated with 4072 longitudinal samples collected from 331 hospitalized patients classified as septic (n=286), non-septic (n=43), or not assigned (n=2). Two methodological approaches were evaluated: (i) a reductionist alternative, which analyzed variables in isolation; and (ii) a non-reductionist version, which examined interactions among six (leukocyte-, bacterial-, temporal-, personalized-, population-, and outcome-related) dimensions. Results The reductionist approach did not distinguish outcomes: the leukocyte and serum protein data of survivors and non-survivors overlapped. In contrast, the non-reductionist alternative differentiated several data groups, of which at least one was only composed of survivors (a finding observable since hospitalization day 1). Hence, the non-reductionist approach promoted personalized medical practices: every patient classified within a subset associated with 100% survival subset was likely to survive. The non-reductionist method also revealed five inflammatory or disease-related stages (provisionally named ‘early inflammation, early immunocompetence, intermediary immuno-suppression, late immuno-suppression, or other’). Mortality data validated these labels: both ‘suppression’ subsets revealed 100% mortality, the ‘immunocompetence’ group exhibited 100% survival, while the remaining sets reported two-digit mortality percentages. While the ‘intermediary’ suppression expressed an impaired monocyte-related function, the ‘late’ suppression displayed renal-related dysfunctions, as indicated by high concentrations of urea and creatinine. Discussion The data-driven differentiation of five data groups may foster early and non-overlapping biomedical decision-making, both upon admission and throughout their hospitalization. This approach could evaluate therapies, at personalized level, earlier. To ascertain repeatability and investigate the dynamics of the ‘other’ group, additional studies are recommended.

Immunology↗

G-induced vestibular dysfunction ('the wobblies') among aerobatic pilots: a case report and review

G-induced vestibular dysfunction (GIVD) is a condition well known to aircraft pilots who experience high positive and negative G loads during unlimited-aerobatic competitions and air-show demonstrations. After landing and walking from their aircraft, pilots with GIVD manifest an extremely unstable gait, which they call the wobblies. This article includes a report of one such case of GIVD, which to the author's knowledge is the first published case report of this condition in the medical literature. The author also discusses what is known and theorized about the pathogenesis of GIVD, and he reviews its diagnosis, treatment, and prevention.

Case Reports↗