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Custom Integration of Multiple Medical Functionalities

INTRODUCTION: Previous spaceflight experience and results from probabilistic risk assessment of spaceflight medical risk have highlighted the need for vital sign measurements, medical scopes, and clinical imaging tools for managing medical conditions during spaceflight. The Human Research Program’s Exploration Medical Capability (ExMC) Element and the Mars Campaign Office’s Exploration Medical Integrated Product Team (XMIPT) have performed ground-based evaluations of two Commercial-off-the-Shelf (COTS) Multi-functional Integrated Medical (MIM) devices, which integrate various medical capabilities together in one device. The key findings from these evaluations are presented in a complementary presentation, leaving this presentation to focus on forward recommendations for customized integration of multiple medical functionalities. KEY COMPONENTS: The key features of a custom integration of multiple medical functionalities includes devices and capabilities that optimally reduce medical risk. The COTS MIM devices incorporated functionality for best supporting Earth-based, emergency, pre-hospital care. Our custom integration will use probabilistic risk assessment tools, such as the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT), to determine the optimal functionality to include based on medical risk minimization. An additional feature of custom integration includes the ability to adapt to different requirements within different vehicles and/or missions. The COTS MIM devices store data in patient specific records, however, the format of the records is not modifiable, and data are not easily transferred from the MIM device to a central data architecture outside of the manufacturer’s established system. Our concept for custom integration will use devices that have an open application programming interface, which can easily connect to independent data architectures and third-party visualization software. The ultrasound capabilities included within the COTS MIM devices did not satisfy many of the Artemis Research and Operations Working Group’s ultrasound functional needs, and therefore, incorporation of higher quality ultrasound capabilities within a customized integration will be beneficial. The COTS MIM devices included minimal procedural guidance and clinical decision support tools. Supplemental tools of this type would need to be supplied along with the COTS MIM devices if they were to be used operationally, so another advantage of customization is the ability to integrate these support tools along with the medical functionality, for a more streamlined user experience. CONCLUSION: Investigation of a customized integration of medical functionality provides a method for further understanding the needs of a long-term exploration spaceflight medical system. The crew members of these exploration missions will need to operate more and more independently from Earth-based ground support. Therefore, having an optimized, streamlined medical system, which contains the functionality and supporting information needed, while remaining within mission and vehicle constraints, will help to maintain crew health and performance, which is necessary for achieving high levels of mission success.

B E Lewandowski↗

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

Guarro, Sergio B.↗

Simulation Assisted Risk Assessment: Blast Overpressure Modeling

A probabilistic risk assessment (PRA) approach has been developed and applied to the risk analysis of capsule abort during ascent. The PRA is used to assist in the identification of modeling and simulation applications that can significantly impact the understanding of crew risk during this potentially dangerous maneuver. The PRA approach is also being used to identify the appropriate level of fidelity for the modeling of those critical failure modes. The Apollo launch escape system (LES) was chosen as a test problem for application of this approach. Failure modes that have been modeled and/or simulated to date include explosive overpressure-based failure, explosive fragment-based failure, land landing failures (range limits exceeded either near launch or Mode III trajectories ending on the African continent), capsule-booster re-contact during separation, and failure due to plume-induced instability. These failure modes have been investigated using analysis tools in a variety of technical disciplines at various levels of fidelity. The current paper focuses on the development and application of a blast overpressure model for the prediction of structural failure due to overpressure, including the application of high-fidelity analysis to predict near-field and headwinds effects.

Lawrence, Scott L.↗

It Depends - An Overview of Probabilistic Risk Analysis Concepts

How do you understand the data and assumptions in your probabilistic analysis? The PRA analyst needs to understand the data and input assumptions to effectively communicate the system/mission's risks. The decision maker also needs to understand conservatisms and how to interpret uncertainty in the PRA results. Properties such as assumptions on the distributions, uncertainty, use of test data, and common cause modeling can be the subject of much discussion, but often are the leading drivers of a risk profile.

risk assessment↗

Predictive Modeling to Assess and Address Challenges and Limitations Associated with Clinical Care and Decision Support in Deep Space

Probabilistic risk assessment (PRA) is a method for assessing and integrating the risk of failure in a multivariate system. While it is often applied by engineers designing complex machines, it could also be applied to humans to assess the probability of a health “failure” treating diseases as the multiple “variables” and the human as the “complex machine.” The Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) was developed to apply PRA to assess medical risk for exploration spaceflight and inform the design of medical systems for space flight. The NASA engineering community utilizes event-driven and fault tree probabilistic techniques to classify risk in the space flight environment by leveraging the inherent knowledge of complex space flight system design and testing to quantify risk. However, in harmonizing the risk of human space flight, answering the question of “How do we balance astronaut health, performance and resource risks with other engineering risks on exploration space missions?” remains a profoundly challenging and largely qualitative practice. The Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) is one aspect of the Human Research Program’s efforts to represent space fight human health and performance risks quantitatively.

L Mcintyre↗

Reliability Analysis of Complex NASA Systems with Model-Based Engineering

The emergence of model-based engineering, with Model- Based Systems Engineering (MBSE) leading the way, is transforming design and analysis methodologies. The recognized benefits to systems development include moving from document-centric information systems and document-centric project communication to a model-centric environment in which control of design changes in the life cycles is facilitated. In addition, a “single source of truth” about the system, that is up-to-date in all respects of the design, becomes the authoritative source of data and information about the system. This promotes consistency and efficiency in regard to integration of the system elements as the design emerges and thereby may further optimize the design. Therefore Reliability Engineers (REs) supporting NASA missions must be integrated into model-based engineering to ensure the outputs of their analyses are relevant and value-needed to the design, development, and operational processes for failure risks assessment and communication.

FMEA/FMECA↗

Risk Assessment: Evidence Base

Human systems PRA (Probabilistic Risk Assessment: a) Provides quantitative measures of probability, consequence, and uncertainty; and b) Communicates risk and informs decision-making. Human health risks rated highest in ISS PRA are based on 1997 assessment of clinical events in analog operational settings. Much work remains to analyze remaining human health risks identified in Bioastronautics Roadmap.

Johnson-Throop, Kathy A.↗

Risk Management at NASA and Its Applicability to the Oil and Gas Industry

NASA has a world-class capability for quantitatively assessing the risk of highly-complex, isolated engineering structures operated in extremely hostile environments. In particular, the International Space Station (ISS) represents a reasonable risk analog for High Pressure, High Temperature drilling and production operations on deepwater rigs. Through a long-term U.S. Government Interagency Agreement, BSEE has partnered with NASA to modify NASA's Probabilistic Risk Assessment (PRA) capabilities for application to deepwater drilling and production operations. The immediate focus of the activity will be to modify NASA PRA Procedure Guides and Methodology Documents to make them applicable to the Oil &Gas Industry. The next step will be for NASA to produce a PRA for a critical drilling system component, such as a Blowout Preventer (BOP). Subsequent activities will be for NASA and industry partners to jointly develop increasingly complex PRA's that analyze other critical drilling and production system components, including both hardware and human reliability. In the presentation, NASA will provide the objectives, schedule, and current status of its PRA activities for BSEE. Additionally, NASA has a Space Act Agreement with Anadarko Petroleum Corporation to develop a PRA for a generic 20K BOP. NASA will summarize some of the preliminary insights gained to date from that 20K BOP PRA as an example of the distinction between quantitative versus qualitative risk assessment.

PRA↗

Science Goals in Radiation Protection for Exploration

Space radiation presents major challenges to future missions to the Earth s moon or Mars. Health risks of concern include cancer, degenerative and performance risks to the central nervous system, heart and lens, and the acute radiation syndromes. The galactic cosmic rays (GCR) contain high energy and charge (HZE) nuclei, which have been shown to cause qualitatively distinct biological damage compared to terresterial radiation, such as X-rays or gamma-rays, causing risk estimates to be highly uncertain. The biological effects of solar particle events (SPE) are similar to terresterial radiation except for their biological dose-rate modifiers; however the onset and size of SPEs are difficult to predict. The high energies of GCR reduce the effectiveness of shielding, while SPE s can be shielded however the current gap in radiobiological knowledge hinders optimization. Methods used to project risks on Earth must be modified because of the large uncertainties in projecting health risks from space radiation, and thus impact mission requirements and costs. We describe NASA s unique approach to radiation safety that applies probabilistic risk assessments and uncertainty based criteria within the occupational health program for astronauts and to mission design. The two terrestrial criteria of a point estimate of maximum acceptable level of risk and application of the principle of As Low As Reasonably Achievable (ALARA) are supplemented by a third requirement that protects against risk projection uncertainties using the upper 95% confidence level (CL) in radiation risk projection models. Exploration science goals in radiation protection are centered on ground-based research to achieve the necessary biological knowledge, and in the development of new technologies to improve SPE monitoring and optimize shielding. Radiobiology research is centered on a ground based program investigating the radiobiology of high-energy protons and HZE nuclei at the NASA Space Radiation Laboratory (NSRL) located at DoE s Brookhaven National Laboratory in Upton, NY. We describe recent NSRL results that are closing the knowledge gap in HZE radiobiology and improving exploration risk estimates. Linking probabilistic risk assessment to research goals makes it possible to express risk management objectives in terms of quantitative metrics, which include the number of days in space without exceeding a given risk level within well defined confidence limits, and probabilistic assessments of the effectiveness of design trade spaces such as material type, mass, solar cycle, crew selection criteria, and biological countermeasures. New research in SPE alert and risk assessment, individual radiation sensitivity, and biological countermeasure development are described.

Cucinotta, Francs A.↗

Proof-of-Concept for a Long-Term Health Metric to Quantify End of Mission Health Status in Astronauts

NASA has long used Probabilistic Risk Assessment (PRA) when high-stakes decisions need to be made about complex systems. For spaceflight medical risk, the Human Research Program’s Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) is a significant step towards robustly quantifying the risk to crew health during exploration missions. However, there remains a significant gap in the ability to comprehensively characterize and assess risk across the disparate functionalities and capabilities which comprise the entire Crew Health and Performance (CHP) system. To fill this gap, the Crew Health and Performance – Probabilistic Risk Assessment (CHP-PRA) project aims to perform risk characterization for the CHP system by assessing performance risk in addition to medical risk. This effort also includes quantifying Long-Term Health (LTH) risk in addition to in-mission risk outcomes within the CHP-PRA results. LTH risk encompasses the timeframe from immediately post-flight, through the rest of an astronaut’s career, through retirement, and until death. A proof-of-concept LTH risk metric is based on medical condition end-state, as defined by the Evidence Library, capturing the spaceflight specific medical impacts persisting into post-flight[1]. Condition outcomes in the Evidence Library progress through three Clinical Phases (CP): the diagnostic phase (CP1), the treatment/convalescent phase (CP2), and the end-state phase (CP3) which represents the detrimental effects of the condition after the crew member has recovered to the maximal extent. Each CP has an associated Task Impairment (TI), defined as the degree of crew incapacity due to experiencing the condition, and is quantified with a 0-1 range. Conditions with an associated CP3 (e.g. Sepsis, Traumatic Hypovolemic Shock, Sudden Cardiac Arrest, etc.) typically have serious consequences that can cause an astronaut to be fully or partially debilitated throughout the remainder of the mission. Consequently, the Cumulative CP3 TI End-of-Mission Health Status Metric is developed by CHP-PRA to quantify the cumulative effects of all conditions which progressed to the CP3 state throughout the entirety of the mission. Hence, this End-of-Mission Health Status Metric attempts to serve as an indicator of an astronaut’s health state at the time of landing. The severity of the lingering effects of in-mission medical events are dependent on mission activities and the level of available in-mission medical care. This allows the associated cumulative TI metric to be used in comparison with the crew’s end of mission health status for different levels of in-mission resources. This presentation provides the strategy for using CP3 as an LTH metric component, as well as a proof-of-concept demonstration of LTH risk characterization using this component.

long term health↗

Probabilistic Assessment of Cancer Risk from Solar Particle Events

For long duration missions outside of the protection of the Earth s magnetic field, space radiation presents significant health risks including cancer mortality. Space radiation consists of solar particle events (SPEs), comprised largely of medium energy protons (less than several hundred MeV); and galactic cosmic ray (GCR), which include high energy protons and heavy ions. While the frequency distribution of SPEs depends strongly upon the phase within the solar activity cycle, the individual SPE occurrences themselves are random in nature. We estimated the probability of SPE occurrence using a non-homogeneous Poisson model to fit the historical database of proton measurements. Distributions of particle fluences of SPEs for a specified mission period were simulated ranging from its 5 th to 95th percentile to assess the cancer risk distribution. Spectral variability of SPEs was also examined, because the detailed energy spectra of protons are important especially at high energy levels for assessing the cancer risk associated with energetic particles for large events. We estimated the overall cumulative probability of GCR environment for a specified mission period using a solar modulation model for the temporal characterization of the GCR environment represented by the deceleration potential (^). Probabilistic assessment of cancer fatal risk was calculated for various periods of lunar and Mars missions. This probabilistic approach to risk assessment from space radiation is in support of mission design and operational planning for future manned space exploration missions. In future work, this probabilistic approach to the space radiation will be combined with a probabilistic approach to the radiobiological factors that contribute to the uncertainties in projecting cancer risks.

Kim, Myung-Hee Y.↗

IMPACT, a Tool Suite for Crew Health and Performance System Trade Analyses and Decision Support - Status of Development

Mission planners, systems engineers, and clinicians that support crew health and performance face very difficult choices on upcoming exploration missions. Given that there will be a heavily constrained mass and volume allocation for a medical system on these missions, what medical capability should be manifested to minimize both medical risk and mission risk? Given that not all promising research and technology proposals can be funded, how can proposals be prioritized so that those funded research investments produce the maximum benefit in reducing overall medical risk? The Informing Mission Planning via Analysis of Complex Tradespaces (IMPACT) project seeks to answer these kinds of questions and others to support upcoming exploration missions. IMPACT enables risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This presentation will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include an updated medical database, consisting of an Evidence Library for medical conditions and a medical item database (MedID) for medical resources, dynamic Probabilistic Risk Assessment (PRA) capabilities, System Modeling Language (SysML) models, and contextual data visualizations of output data. IMPACT is the result of a multi-center collaborative effort. The trade space analyses performed by IMPACT can directly inform mission, vehicle, and habitat development by quantifying medical risk, given a design reference mission, crew attributes and a set of medical capabilities. This presentation will update the audience on the development status of the tool suite as it nears its System Acceptance Review (SAR). It will review IMPACT’s constituent parts, briefly discuss typical outputs and outline the plans for transitioning to operations, currently scheduled for later in FY23. Recent development successes on the IMPACT project include the integration of the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) v2.0 to accommodate segmented missions with multiple carriers and medical systems, full onboarding of the IMPACT Medical Database (IMPACT-MD), clustering medical resources and skills into medical capabilities and mutually-dependent bundles, and the ability to perform trade analyses on different medical sets, different design reference missions (DRM), with different crew complements and extra-vehicular activity (EVA) schedule.

IMPACT↗

IMPACT 1.0—Task Impairment: A Novel Approach for Assessing Impairment during Exploration-Class Missions

Exploration-class and International Space Station (ISS) missions have significantly different levels of associated medical risk for crewmembers. The Integrated Medical Model (IMM), the probabilistic risk assessment tool used for ISS medical trade-space analyses, uses a Functional Impairment (FI) metric to determine quality time lost should a crewmember be afflicted with a medical condition. While IMM-based FI has been successful for ISS operations, it has limitations when applied to exploration-class missions. As the National Aeronautics and Space Administration (NASA) looks ahead to Gateway, Artemis, and Martian missions, a novel, dynamic, and mission-appropriate impairment paradigm is necessary for accurate contingency planning. This paradigm, Task Impairment (TI), fulfills that need by utilizing mission-specific tasks. TI will allow future capability for a loss of mission metric, previously not available with IMM. TI serves as a replacement metric for FI within IMPACT, the next-generation trade-space analysis tool suite created to replace the IMM. IMPACT significantly increases the fidelity of probabilistic risk assessment for exploration-class missions. The Human Exploration of Mars Preliminary List of Crew Tasks (MTL, a source of 1100+ exploration-class mission-specific tasks for crewmembers) was used to calculate TI. Using the Task List, 18 individual Human System Categories were identified as being required to perform each task (e.g., Cardiopulmonary, Cognitive, etc.). Each of the 1200+ tasks were mapped to the Human System categories listed in the Task List. The total number of tasks in each category were tallied to determine how many tasks required each Human System. Lastly, each of the 120 medical conditions from the IMPACT condition list were mapped to the Human System categories to complete the TI calculation. NASA subject matter experts across five medical specialties established consensus for the mapping of each condition. The resulting total tasks impaired by each condition were used to calculate discrete TI values. This process was repeated for each of the four severity/resource utilization variants of each condition, and for each of the three phases of clinical care. Through this process, discrete TI values were calculated for each of the 120 IMPACT medical conditions and their variants. The Task Impairment metric provides higher fidelity, dynamic utility, and quicker analysis of medical impairment compared to the previous Functional Impairment metric used for the Integrated Medical Model. TI will be used for higher fidelity medical impairment analysis and contingency planning during Lunar, Martian, and other long-term exploration-class missions.

William L Fernandez↗

Impact Real World System Validation

Introduction NASA has developed a new evidence-based data-driven probabilistic risk assessment and tradespace analysis tool as a successor to the Integrated Medical Model. This updated decision support tool is known as IMPACT (Informing Mission Planning via Analysis of Complex Tradespaces). IMPACT estimates the frequency and consequences of medical conditions that might arise during exploration missions. A validation analysis of IMPACT was performed with respect to a set of International Space Station (ISS) and Shuttle Transportation System (STS) real world system (RWS) referent data due to the limited referent data available from exploration missions. Methods Observed mission and crew characteristics from STS and ISS missions were used as model inputs within MEDPRAT (Medical Extensible Dynamic Probabilistic Risk Assessment Tool). For each mission, two hundred thousand simulations were generated. For each mission, model outputs included occurrence counts for each condition, total medical events (TME), and the probability of loss of crew life (LOCL). These simulated model outputs were compared to the RWS referent data. Results The predicted number of total medical events exceeded the total RWS medical events for ISS missions and combined ISS and STS missions and fell within the 90% confidence interval for STS missions. For the 32 ISS missions simulated by IMPACT, the number of total medical events was overpredicted for 19 missions and fell within the 90% confidence interval for 13 missions. For the 21 STS missions, the total number of medical events was overpredicted for 3 missions, fell within the 90% confidence interval for 16 missions, and was underpredicted for 2 missions. Combined, 29 missions were in range, 22 were overpredicted, and 2 were underpredicted. The predicted LOCL probability for the 32 ISS missions, the 21 STS missions, and the combined ISS and STS missions was consistent with the zero LOCL events observed in the RWS referent data. The validation analysis included a comparison of the number of medical events predicted by IMPACT and the number of medical events observed in the RWS data on a condition-by-condition basis. For ISS missions, 50 conditions were in range, 52 conditions were statistically underpowered (not enough observed sample to draw any conclusions on precision), 8 conditions were overpredicted, and 9 conditions were underpredicted. Overall, only 14% (17/119) of conditions were out of range for STS missions, 40 conditions were in range, 59 conditions were statistically underpowered, 10 conditions were overpredicted, and 10 conditions were underpredicted. Overall, only 17% (20/119) of conditions were out of range. For combined ISS and STS missions, 11 conditions were overpredicted, and 11 conditions were underpredicted. Overall, only 18% (22/119) of conditions were out of range. For combined ISS and STS missions, 49 conditions were in range, 46 conditions were statistically underpowered, 18 conditions were overpredicted, and 8 conditions were underpredicted. Overall, 21% (26/121) of conditions were out of range. Conclusion The results of this validation analysis should not be interpreted as a pass/fail test of the validity of IMPACT. Instead, this validation analysis should be used to assess some of the IMPACT outcomes in terms of consistencies and inconsistencies with the ISS and STS RWS referent data.

L. Boley↗

A Reliable Earth Return System for Safe Recovery of Mars Samples

The objective of a Mars sample return mission is to bring selected Mars surface materials to Earth. Numerous approaches for the Earth-return segment have been analyzed including propulsive or aerocapture return to low-Earth orbit followed by Space Shuttle rendezvous and direct entry. Of these approaches, ballistic entry of a small capsule terminating in a ground landing has been shown to be the lowest risk strategy. Over the past two years, significant work has been performed towards development of a robust direct entry vehicle for Mars sample return. In June 1999, the NASA Planetary Protection Officer provided initial guidance to the former Mars Sample Return Project. The sample return phase of the mission was assigned a restricted Earth return planetary protection classification. The draft mission requirement states that the total mean probability of release of unsterilized Mars material into the Earth;s biosphere must be less than 1.0E-06 (1 in a million). This strict requirement drives the approach and design of the Earth return system. To meet this requirement, selection of the Earth return strategy and development of the Earth return system must be guided by risk, not performance, based decisions. An initial Probabilistic Risk Assessment (PRA) was performed to address the direct entry Earth return system containment assurance reliability and to identify high-risk elements of this system. The results of this PRA identified risk elements that include thermal protection system performance during entry, spin-eject orientation and aerodynamic stability during entry, structural integrity under atmospheric deceleration and impact loads, and tracking/recovery of this system. This initial probabilistic risk quantification demonstrates that, with the proper development program, a prototypical direct entry design can satisfy the containment assurance reliability requirement. Through the current Mars Sample Return Advanced Technology Development effort, an extensive design, analysis, and test program is presently proceeding with the aim of reducing the containment assurance risk of this system. This technology development effort, guided by a continuing PRA, focuses on key risk areas of a direct entry Earth return system including: the thermal protection system, impact dynamics, structural performance, aerodynamic stability, and ground recovery. This development program will culminate in a system validation flight test, 1-2 years prior to launch of the flight system. This flight test would include the launch, entry, and recovery of a full-scale Earth return system, as a scientific validation of the key risk elements to verify nominal design performance. The results of the initial PRA suggested several dominant failure sequences that can be validated in a flight test. These include: demonstrating the thermal protection system reliability and performance during entry, demonstrating the spin-eject orientation and aero-dynamic stability during entry, demonstrating the structural integrity under atmospheric deceleration and impact loads, and demonstrating tracking and recovery of the Earth return system. This single test will directly address over 50% of the total containment assurance risk elements. This presentation will begin by presenting the relative risk of various Earth return strategies. The results of the initial probabilistic risk assessment will be presented followed by a discussion of the development accomplishments and plans for demonstration of a highly reliable direct entry Earth return system.

Braun, R.↗

Probabilistic Assessment of Risks from Solar Energetic Particle Events

Solar energetic particle events pose a radiation hazard for space crews and a risk of harmful radiation effects in spacecraft electronics. To assess these risks, engineers need to know the worst-case environment that they must plan for or design to withstand. Depending on the application, engineers may need to know the instantaneous worst-case environment, the radiation environment that accumulates during one solar particle event or the cumulative worst-case environment for their entire mission. Also, depending on their application, they will need to know this environment at a confidence level which they will specify. We will present a probabilistic model for the peak fluxes, event-integrated fluences and mission-integrated fluences for solar protons and heavy ions. The model will provide these worst-case environments at user-specified confidence levels. Examples of the use of this model will also be shown.

Adams, James H., Jr.↗

Gateway Program Safety and Mission Assurance Integration - the Future of Safe Deep Space Human Exploration

As a foundational element of the National Aeronautics and Space Administration (NASA) Artemis Campaign, the Gateway is an incrementally built cislunar spacecraft that will serve as a platform for deep space human exploration, science, and technology demonstration. The Gateway will be a unifying catalyst for international partners around the world to establish sustained deep space scientific investigations, lunar surface access, and missions to Mars. As human exploration moves farther away from Earth, spacecraft designs must prioritize and optimize mass and volume allocations, while minimizing human and spacecraft risk. To accomplish this objective, the Gateway Program Safety and Mission Assurance functions develop, implement, and ensure compliance with requirements, in concert with the accurate characterization and transparent communication of residual hazard risks, for integrated safety, reliability and maintainability and quality assurance. Safety and Mission Assurance was a key contributor during Gateway program pre-formulation and formulation activities where safety and reliability analysis was embedded in the Gateway Systems Engineering and Integration team. During these early program stages, a preliminary Gateway Integrated Hazard Analysis and Preliminary Gateway Probabilistic Risk Assessment assisted in Gateway architectural and operational definition as part of a risk-informed design process. As the deep space architecture has matured, the integrated Safety and Mission Assurance analyses have matured, new safety review processes have been developed, and requirements have been refined to ensure compliance with integrated safety and mission assurance objectives. The Gateway Program is currently concluding the preliminary design review informed milestone, where the primary objectives included: - Ensured completeness and consistency of the preliminary design, including the meeting of all requirements within appropriate margins and acceptable risk posture. - Identification of any major issues moving forward to the Critical Design phase. At this milestone, Safety and Mission Assurance provided numerous products, including Gateway Top Risks and Risk Mitigation Plans, updated integrated hazard analyses, updated probabilistic risk assessment, Crew Survival Analysis Report, and updated Safety and Mission Assurance Requirements and Plans. These products provide a many-faceted perspective on the inherent risk and available mitigations involved in flying the current proposed vehicle design and anticipated stack configurations. In addition, Safety and Mission Assurance identified top technical, process and workforce concerns to be addressed as the program progresses toward the critical design phase. This paper will detail the evolution of the Gateway Program Safety and Mission Assurance integration functions, provide its current status and lessons learned for future human spaceflight programs. Throughout this paper the key tenets of the Gateway Program Safety and Mission Assurance will be discussed: - Application of a risk-informed approach to identify and mitigate areas of highest risk. - Leverage of valuable processes and lessons learned from earlier spaceflight programs. - Development of Safety and Mission Assurance products to inform design risk trades. - Utilization of common Safety and Mission Assurance practices to identify safety risks for multiple perspectives: top-down, bottom-up, and across lines of integration. - Approval of safety hazards at the appropriate level of authority, keeping most deliberation closest to design expertise and elevating risks of greatest concern for program-level consideration. - Championing of Safety and Mission Assurance processes and forums to foster a pervasive safety culture that is transparent, inclusive, and collaborative between all partners. These tenets have allowed the Gateway Safety and Mission Assurance function to play a key role in optimized vehicle design evolution, and early identification and mitigation of Gateway program and Artemis mission risk.

Helen Vaccaro↗

Impact, A Tool Suite for Crew Health and Performance System Trade Analyses and Decision to Support - Transition to Operations

Mission planners, systems engineers, and clinicians that support crew health and performance face very difficult choices on upcoming exploration missions. Given that there will be a heavily constrained mass and volume allocation for a medical system on these missions, what medical capability should be manifested to minimize both medical risk and mission risk? Given that not all promising research and technology proposals can be funded, how can proposals be prioritized so that those funded research investments produce the maximum benefit in reducing overall medical risk? The Informing Mission Planning via Analysis of Complex Tradespaces (IMPACT) project seeks to answer these kinds of questions and others to support upcoming exploration missions. IMPACT enables risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This presentation will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include an updated medical database, consisting of an Evidence Library for medical conditions and a medical item database (MedID) for medical resources, dynamic Probabilistic Risk Assessment (PRA) capabilities, System Modeling Language (SysML) models, and contextual data visualizations of output data. IMPACT is the result of a multi-center collaborative effort. The trade space analyses performed by IMPACT can directly inform mission, vehicle, and habitat development by quantifying medical risk, given a design reference mission, crew attributes and a set of medical capabilities. This presentation will update the audience on the development status of the IMPACT tool suite as it comes out of its System Acceptance Review (SAR) and nears Transition to Operations (TTO). It will review IMPACT’s constituent parts, briefly discuss typical outputs, and outline the plans for transitioning to operations, currently scheduled for later in FY24. Recent development successes on the IMPACT project include the integration of the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) v2.0 to accommodate segmented missions with multiple carriers and medical systems, full onboarding of the IMPACT Medical Database (IMPACT-MD), clustering medical resources and skills into medical capabilities and mutually-dependent bundles, verification of IMPACT-MD, and the ability to perform trade analyses on different medical sets, different design reference missions (DRM), with different crew complements and extra-vehicular activity (EVA) schedules.

IMPACT↗