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NASA Human System Risk Assessment Process

NASA utilizes an evidence based system to perform risk assessments for the human system for spaceflight missions. The center of this process is the multi-disciplinary Human System Risk Board (HSRB). The HSRB is chartered from the Chief Health and Medical Officer (OCHMO) at NASA Headquarters. The HSRB reviews all human system risks via an established comprehensive risk and configuration management plan based on a project management approach. The HSRB facilitates the integration of human research (terrestrial and spaceflight), medical operations, occupational surveillance, systems engineering and many other disciplines in a comprehensive review of human system risks. The HSRB considers all factors that influence human risk. These factors include pre-mission considerations such as screening criteria, training, age, sex, and physiological condition. In mission factors such as available countermeasures, mission duration and location and post mission factors such as time to return to baseline (reconditioning), post mission health screening, and available treatments. All of the factors influence the total risk assessment for each human risk. The HSRB performed a comprehensive review of all potential inflight medical conditions and events and over the course of several reviews consolidated the number of human system risks to 30, where the greatest emphasis is placed for investing program dollars for risk mitigation. The HSRB considers all available evidence from human research and, medical operations and occupational surveillance in assessing the risks for appropriate mitigation and future work. All applicable DRMs (low earth orbit for 6 and 12 months, deep space for 30 days and 1 year, a lunar mission for 1 year, and a planetary mission for 3 years) are considered as human system risks are modified by the hazards associated with space flight such as microgravity, exposure to radiation, distance from the earth, isolation and a closed environment. Each risk has a summary two-page assessment representing the state of knowledge/evidence of that risk, available risk mitigations, traceability to the Space Flight Human System Standards (SFHSS) and program requirements, and future work required. These data then can drive coordinated budgets across the Human Research Program, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets to provide the most economical and timely mitigations. The risk assessments were completed for the 6 DRMs and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB reviews each risk at least annually or when new evidence/information is available that adds to the body of evidence. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

Francisco, D.↗

Human Factors Engineering as a System in the Vision for Exploration

In order to accomplish NASA's Vision for Exploration, while assuring crew safety and productivity, human performance issues must be well integrated into system design from mission conception. To that end, a two-year Technology Development Project (TDP) was funded by NASA Headquarters to develop a systematic method for including the human as a system in NASA's Vision for Exploration. The specific goals of this project are to review current Human Systems Integration (HSI) standards (i.e., industry, military, NASA) and tailor them to selected NASA Exploration activities. Once the methods are proven in the selected domains, a plan will be developed to expand the effort to a wider scope of Exploration activities. The methods will be documented for inclusion in NASA-specific documents (such as the Human Systems Integration Standards, NASA-STD-3000) to be used in future space systems. The current project builds on a previous TDP dealing with Human Factors Engineering processes. That project identified the key phases of the current NASA design lifecycle, and outlined the recommended HFE activities that should be incorporated at each phase. The project also resulted in a prototype of a webbased HFE process tool that could be used to support an ideal HFE development process at NASA. This will help to augment the limited human factors resources available by providing a web-based tool that explains the importance of human factors, teaches a recommended process, and then provides the instructions, templates and examples to carry out the process steps. The HFE activities identified by the previous TDP are being tested in situ for the current effort through support to a specific NASA Exploration activity. Currently, HFE personnel are working with systems engineering personnel to identify HSI impacts for lunar exploration by facilitating the generation of system-level Concepts of Operations (ConOps). For example, medical operations scenarios have been generated for lunar habitation in order to identify HSI requirements for the lunar communications architecture. Throughout these ConOps exercises, HFE personnel are testing various tools and methodologies that have been identified in the literature. A key part of the effort is the identification of optimal processes, methods, and tools for these early development phase activities, such as ConOps, requirements development, and early conceptual design. An overview of the activities completed thus far, as well as the tools and methods investigated will be presented.

Mihriban Whitmore↗

Research to Operations: The Critical Transition

Space Life Sciences Directorate (SLSD) specializes in transitioning technology and knowledge to medical operations. This activity encompasses funding a spectrum of research and technology efforts, such as understanding fundamental biological mechanisms altered by microgravity and executing technology watches for state of the art diagnostic imaging equipment. This broad spectrum approach to fulfilling the need to protect crewmember health and performance during long and short duration missions to the International Space Station, moon and Mars is made possible by having a line of site between research and operations. Currently, SLSD's line of site is articulated in a transition to medical practice (TMP) process. This process is designed to shepherd information and knowledge gained through fundamental and mechanistic research toward the development of an operational solution such as a pre-flight selection criteria; an in-flight countermeasure, monitoring capability or treatment; or a post-flight reconditioning program. The TMP process is also designed to assist with the customization of mature hardware or technology for NASA specific use. The benefits of this process are that the concept of operational usability is interjected early in the research, design, or acquisition phase, and stakeholders are involved early to identify requirements and also periodically asked to assess requirements compliance of research or technology development project. Currently a device known as the actiwatch is being assessed for the final transition to operational use. Specific examples of research to operations transition success help to illustrate the process and bolster communication between the research and medical operations communities.

Fogarty, Jennifer A.↗

Medical Scenarios Relevant to Spaceflight

The Medical Operational Support Team (MOST) was tasked by the JSC Space Medicine and Life Sciences Directorate (SLSD) to incorporate medical simulation into 1) medical training for astronaut-crew medical officers (CMO) and medical flight control teams and 2) evaluations of procedures and resources required for medical care aboard the International Space Station (ISS). Development of evidence-based medical scenarios that mimic the physiology observed during spaceflight will be needed for the MOST to complete these two tasks. The MOST used a human patient simulator, the ISS-like resources in the Medical Simulation Laboratory (MSL), and evidence from space operations, military operations and medical literature to develop space relevant medical scenarios. These scenarios include conditions concerning airway management, Advanced Cardiac Life Support (ACLS) and mitigating anaphylactic symptoms. The MOST has used these space relevant medical scenarios to develop a preliminary space medical training regimen for NASA flight surgeons, Biomedical Flight Controllers (Biomedical Engineers; BME) and CMO-analogs. This regimen is conducted by the MOST in the MSL. The MOST has the capability to develop evidence-based space-relevant medical scenarios that can help SLSD I) demonstrate the proficiency of medical flight control teams to mitigate space-relevant medical events and 2) validate nextgeneration medical equipment and procedures for space medicine applications.

Bacal, Kira↗

Musculoskeletal Changes, Injuries and Rehabilitation Associated with Spaceflight

The in-flight musculoskeletal database provides the foundation for directing operationally-relevant research in space medicine. This effort will enable medical operations to develop medical kits, training programs, and preventive medicine strategies for future CxP missions: a) Quantify medications and medical supplies for next-generation spacecraft. b) Objective data for engineers to determine weight requirements. Flight surgeons can make specific recommendations to astronauts based on injury data, such as emphasizing hand protection while in-flight. EVA and spacecraft engineers can examine evidence-based data on injuries and design countermeasures to help prevent them.

Scheuring, Richard A.↗

NASA Johnson Space Center Biomedical Research Resources

Johnson Space Center (JSC) medical sciences laboratories constitute a national resource for support of medical operations and life sciences research enabling a human presence in space. They play a critical role in evaluating, defining, and mitigation the untoward effect of human adaption to space flight. Over the years they have developed the unique facilities and expertise required to perform: biomedical sample analysis and physiological performance tests supporting medical evaluations of space flight crew members and scientific investigations of the operationally relevant medical, physiological, cellular, and biochemical issues associated with human space flight. A general overview of these laboratories is presented in viewgraph form.

Paloski, W. H.↗

Medics: Medical Decision Support System for Long-Duration Space Exploration

The Autonomous Medical Operations (AMO) group at NASA Ames is developing a “medical decision support system” to enable astronauts on long-duration exploration missions to operate autonomously. The system will support clinical actions by providing medical interpretation advice and procedural recommendations during emergent care and clinical work performed by crew. The current state of development of the system, called MedICS (Medical Interpretation Classification and Segmentation) includes two separate aspects: a set of machine learning diagnostic models trained to analyze organ images and patient health records, and an interface to ultrasound diagnostic hardware and to medical repositories. Three sets of images of different organs and medical records were utilized for training machine learning models for various analyses, as follows: 1. Pneumothorax condition (collapsed lung). The trained model provides a positive or negative diagnosis of the condition. 2. Carotid artery occlusion. The trained model produces a diagnosis of 5 different occlusion levels (including “normal”). 3. Ocular retinal images. The model extracts optic disc pixels (image segmentation). This is a precursor step for advanced autonomous fundus clinical evaluation algorithms to be implemented in FY20. 4. Medical health records. The model produces a differential diagnosis for any particular individual, based on symptoms and other health and demographic information. A probability is calculated for each of 25 most common conditions. The same model provides the likelihood of survival. All results are provided with a confidence level. Item 1 images were provided by the US Army and were part of a data set for the clinical treatment of injured battlefield soldiers. This condition is relevant to possible space mishaps, due to pressure management issues. Item 2 images were provided by Houston Methodist Hospital, and item 3 health records were acquired from the MIT laboratory of computational physiology. The machine learning technology utilized is deep multilayer networks (Deep Learning), and new models will continue to be produced, as relevant data is made available and specific health needs of astronaut crews are identified. The interfacing aspects of the system include a GUI for running the different models, and retrieving and storing data, as well as support for integration with an augmented reality (AR) system deployed at JSC by Tietronix Software Inc. (HoloLens). The AR system provides guidance for the placement of an ultrasound transducer that captures images to be sent to the MedICS system for diagnosis. The image captured and the associated diagnosis appear in the technician’s AR visual display.

Colombano, Silvano↗

Overview and Results of ISS Space Medicine Operations Team (SMOT) Activities

The Space Medicine Operations Team (SMOT) was created to integrate International Space Station (ISS) Medical Operations, promote awareness of all Partners, provide emergency response capability and management, provide operational input from all Partners for medically relevant concerns, and provide a source of medical input to ISS Mission Management. The viewgraph presentation provides an overview of educational objectives, purpose, operations, products, statistics, and its use in off-nominal situations.

Johnson, H. Magee↗

Medical evaluations on the KC-135 1991 flight report summary

The medical investigations completed on the KC-135 during FY 1991 in support of the development of the Health Maintenance Facility and Medical Operations are presented. The experiments consisted of medical and engineering evaluations of medical hardware and procedures and were conducted by medical and engineering personnel. The hardware evaluated included prototypes of a crew medical restraint system and advanced life support pack, a shuttle orbiter medical system, an airway medical accessory kit, a supplementary extended duration orbiter medical kit, and a surgical overhead canopy. The evaluations will be used to design flight hardware and identify hardware-specific training requirements. The following procedures were evaluated: transport of an ill or injured crewmember at man-tended capability, surgical technique in microgravity, transfer of liquids in microgravity, advanced cardiac life support using man-tended capability Health Maintenance Facility hardware, medical transport using a model of the assured crew return vehicle, and evaluation of delivery mechanisms for aerosolized medications in microgravity. The results of these evaluation flights allow for a better understanding of the types of procedures that can be performed in a microgravity environment.

Lloyd, Charles W.↗

Exploration Medical System Demonstration (EMSD) Project

The Exploration Medical System Demonstration (EMSD) is a project under the Exploration Medical Capability (ExMC) element managed by the Human Research Program (HRP). The vision for the EMSD is to utilize ISS as a test bed to show that several medical technologies needed for an exploration mission and medical informatics tools for managing evidence and decision making can be integrated into a single system and used by the on-orbit crew in an efficient and meaningful manner. Objectives: a) Reduce and even possibly eliminate the time required for on-orbit crew and ground personnel (which include Surgeon, Biomedical Engineer (BME) Flight Controller, and Medical Operations Data Specialist) to access and move medical data from one application to another. b) Demonstrate that the on-orbit crew has the ability to access medical data/information using an intuitive and crew-friendly software solution to assist/aid in the treatment of a medical condition. c) Develop a common data management framework and architecture that can be ubiquitously used to automate repetitive data collection, management, and communications tasks for all crew health and life sciences activities.

Chin, Duane↗

Clinical Core Competency Training for NASA Flight Surgeons

Introduction: The cohort of NASA flight surgeons (FS) is a very accomplished group with varied clinical backgrounds; however, the NASA Flight Surgeon Office has identified that the extremely demanding schedule of this cohort prevents many of these physicians from practicing clinical medicine on a regular basis. In an effort to improve clinical competency, the NASA FS Office has dedicated one day a week for the FS to receive clinical training. Each week, an FS is assigned to one of five clinical settings, one being medical patient simulation. The Medical Operations Support Team (MOST) was tasked to develop curricula using medical patient simulation that would meet the clinical and operational needs of the NASA FS Office. Methods: The MOST met with the Lead FS and Training Lead FS to identify those core competencies most important to the FS cohort. The MOST presented core competency standards from the American Colleges of Emergency Medicine and Internal Medicine as a basis for developing the training. Results: The MOST identified those clinical areas that could be best demonstrated and taught using medical patient simulation, in particular, using high fidelity human patient simulators. Curricula are currently being developed and additional classes will be implemented to instruct the FS cohort. The curricula will incorporate several environments for instruction, including lab-based and simulated microgravity-based environments. Discussion: The response from the NASA FS cohort to the initial introductory class has been positive. As a result of this effort, the MOST has identified three types of training to meet the clinical needs of the FS Office; clinical core competency training, individual clinical refresher training, and just-in-time training (specific for post-ISS Expedition landings). The MOST is continuing to work with the FS Office to augment the clinical training for the FS cohort, including the integration of Web-based learning.

Polk, J. D.↗

Harnessing Artificial Intelligence for Medical Diagnosis and Treatment During Space Exploration Missions

BACKGROUND The medical capabilities necessary for long-duration exploration missions (LDEMs) will differ tremendously from those currently available to crew medical officers (CMOs) on the International Space Station (ISS). Ground support will be more challenging due to distance-related communication delays and data transmission, and resource utilization must be optimized given limited ability for resupply. Clinical decision support systems (CDSSs) can help mitigate these limitations. The recent launch of generative artificial intelligence (AI) tools based upon large language models (LLM) support the creation of a smart assistant for onboard triage, diagnosis, and guided treatment of medical conditions during these missions. The Informing Mission Planning via Analysis of Complex Tradespaces (IMPACT) tool can help predict which clinical problems and outcomes are likely to occur for a design reference mission (DRM) and assist Medical Operations and systems engineering teams in creating a medical system that may optimally mitigate the predicted risks. The purpose of this study was to identify AI tools currently available or in development for the assistive diagnosis and care of medical conditions predicted for an extended duration Lunar mission. METHODS The 119 medical conditions currently built into the IMPACT suite were categorized into systems, and these diagnoses were used as keywords for our literature search. Using PubMed and Google Scholar, we performed a literature survey of AI tools applicable to these conditions. Article inclusion criteria included publication between the years 2017-2023, as the sentinel paper discussing the “selective attention” driving ChatGPT and other generative transformer models was published in June 2017. Where applicable, we reviewed only the top 1000 research articles (based on relevance) for each of the keywords/phrases. AI tools whose training sets were exclusive to a pediatric patient population were excluded. We also excluded any medical diagnostic tools (such as CT, MRI, mass spectrometry) or procedures (such as endoscopy, surgery) that are unlikely to be available during LDEMs due to mass and volume constraints, CMO knowledge, skills, and abilities, and/or inherent procedural risks. RESULTS Our survey highlighted several AI-driven tools for the triage, diagnosis, and management of those medical conditions highlighted by IMPACT. Selected publications for each medical condition were then screened for inclusion within ten systems-based categories including: general diagnostic tools (25), tools to diagnose and manage respiratory (40), dermatologic (34), neurologic (28), auditory and vestibular (30), ophthalmic (34), musculoskeletal (104), infection-associated (92), and gynecologic (19) conditions, as well as tools that could be deployed in the setting of trauma and emergency (34). CONCLUSIONS Numerous AI-driven tools were highlighted within this literature survey, ranging from chatbot assistants that triage knee pain to vision transformer models for diagnosis of ophthalmic conditions using ocular surface images captured with a mobile phone. Remaining challenges include optimizing connectivity and integration of existing and developing systems into the vehicles or habitats. Notably, findings from this survey could help guide the initial design of an all-encompassing, onboard medical AI assistant for use during future LDEMs.

R A Lacinski↗

Chronic Medication and or Monitoring for Long Duration Space Flight: What Should The Policy Be?

While a private individual with a chronic medical condition could perhaps justifiably claim the right to become a "space tourist" through informed consent, NASA and other International crew members are national assets, trained at government expense to fulfill a mission considered essential to national goals. The medical requirements/policy for selection and certification of crewmembers for long duration missions to the International Space Station (ISS) should address: (1) Crewmembers with chronic conditions that require regular dosing of life-sustaining medication for the purposes of secondary or tertiary prevention (i.e. tumor suppression therapy or anticoagulation). (2) Crew members with conditions that will be worsened by spaceflight exposure, placing them at additional personal health risk though not necessarily increasing mission risk (i.e. previous radiation exposure or preflight osteopenia/osteoporosis) The following policies are recommended. A crewmember should not be assigned to an International Space Station mission who: (3) Requires medications to sustain life or who has a disease, which requires medical procedures or diagnostics to monitor and treat same. (4) Has medical condition, which would prevent participation as a candidate in many scientific and medical operational research studies, as their underlying condition would confound the collected data. (5) Requires specialized medical devices for monitoring or treatment of a medical condition, including conditions that require special provisions to conduct routine required countermeasure activities. (6) Who has a disease or requires treatment for same, and for which the effects of space travel may be deleterious to the short or long term health of the individual, An evidence-based approach will be used to provide rationale for policy recommendations under these scenarios. Operational impacts of allowing these medical conditions to fly on the ISS will also be presented.

Hamilton, Douglas R.↗

Conceptual Drivers for an Exploration Medical System

Interplanetary spaceflight provides unique challenges that have not been encountered in prior spaceflight experience. Extended distance and timeframes introduce new challenges such as an inability to resupply medications and consumables, inability to evacuate injured or ill crew, and communication delays that introduce a requirement for some level of autonomous medical capability. Because of these challenges the approaches used in prior programs have limited application to a proposed three year Mars mission. This paper proposes a paradigm shift in the approach to medical risk mitigation for crew health and mission objectives threatened by inadequate medical capabilities in the setting of severely limited resources. A conceptual approach is outlined to derive medical system and vehicle needs from an integrated vision of how medical care will be provided within this new paradigm. Using NASA Design Reference Missions this process assesses each mission phase to deconstruct medical needs at any point during a mission. Two operational categories are proposed, nominal operations (pre-planned activities) and contingency operations (medical conditions requiring evaluation) that meld clinical needs and research needs into a single system. These definitions are used to derive a task level analysis to support quantifiable studies into a medical capabilities trade. This trade allows system design to proceed from both a mission centric and ethics-based approach to medical limitations in an exploration class mission.

Antonsen, E.↗

Crew Medical Training to Progressively Enable EIMO

Background. Onboard medical capabilities have greatly expanded over the history of the US space program. Newly identified space-related medical conditions, technological advances, and longer mission durations have led to an increasing need for on-demand medical expertise. Lengthy communications delays, lack of resupply and evacuation opportunities on exploration-class missions place an ever-increasing burden on the crew to provide medical care. Having adequate knowledge, skills, and abilities (KSA) available is an essential component of successful Earth Independent Medical Operations (EIMO). Without appropriate crew training and KSA, cutting-edge medical equipment has little value. Presumably, the crew will include a qualified physician; however, if the physician is incapacitated, a non-physician crew medical officer (CMO) will be needed. While more crew time is needed for medical training, there will be concomitant increases in preflight training demands for vehicle system management, operations, science, and contingencies. In truly independent operations, onboard resources such as just-in-time training, mixed reality, decision support tools, and AI-enabled chatbot “consultants” will be needed to augment KSA. Overview. Because of crew time constraints, topical priorities must be determined for preflight training. Curricula should be developed that emphasize management of conditions with relatively high incidence and morbidity/mortality. Defining the required KSA levels to treat each condition is essential, but all crewmembers should have basic lifesaving skills. Procedural and diagnostic training on live patients and simulators should be prioritized over classroom lectures. Crews must be trained with onboard equipment, resources, mixed reality, and AI-based decision support tools. Mission simulations should include medical problems with/without ground support and with appropriate communication delays. Certification guidelines for each level of KSA must be established. Skills rapidly decay for non-physician CMO’s; both pre-flight and in-flight refresher training will be needed. During spaceflight just-in-time training, simulations, and onboard CME with crew physician can help retain skills. Discussion. Medical technology, simulation design, mixed reality, and AI are advancing at a dizzying rate. Recognizing the severe constraints on crew time, it is critical that astronaut training is highly efficient and adapted to keep pace with new innovations both pre-flight and during exploration missions. These challenges will be discussed during this panel session.

Jay Lemery↗

User and Task Analysis of the Flight Surgeon Console at the Mission Control Center of the NASA Johnson Space Center

Astronauts in a space station are to some extent like patients in an intensive care unit (ICU). Medical support of a mission crew will require acquisition, transmission, distribution, integration, and archiving of significant amounts of data. These data are acquired by disparate systems and will require timely, reliable, and secure distribution to different communities for the execution of various tasks of space missions. The goal of the Comprehensive Medical Information System (CMIS) Project at Johnson Space Center Flight Medical Clinic is to integrate data from all Medical Operations sources, including the reference information sources and the electronic medical records of astronauts. A first step toward the full CMIS implementation is to integrate and organize the reference information sources and the electronic medical record with the Flight Surgeons console. In order to investigate this integration, we need to understand the usability problems of the Flight Surgeon's console in particular and medical information systems in general. One way to achieve this understanding is through the use of user and task analyses whose general purpose is to ensure that only the necessary and sufficient task features that match users capacities will be included in system implementations. The goal of this summer project was to conduct user and task analyses employing cognitive engineering techniques to analyze the task of the Flight Surgeons and Biomedical Engineers (BMEs) while they worked on Console. The techniques employed were user interviews, observations and a questionnaire to collect data for which a hierarchical task analysis and an information resource assessment were performed. They are described in more detail below. Finally, based on our analyses, we make recommendations for improvements to the support structure.

Johnson, Kathy A.↗