Effective Date: December 16, 2016
Expiration Date: December 16, 2022
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E.1.1 An operational exception defined in this appendix shall only be considered when it is known that a health, human performance, or medical standard cannot be met and the risk to the crew reaches a level which requires a more thorough review, including the consideration of ethical and policy factors. This determination shall be made by the Health and Medical Technical Authority.
E.1.2 Exception to a health, human performance and medical standard shall be considered an operational exception under the authority of the NASA Administrator (Appendix G).
E.1.3 The evaluation of the operational exception to a health, human performance, and medical standard is based on a three-level decision framework that examines:
a. Level 1: Decisions about allowing risk to astronaut health and safety in excess of that permitted by health/medical standards (Appendix G);
b. Level 2: Decisions about undertaking specific missions (see E.2); and
c. Level 3: Decisions concerning individual astronaut participation and crew composition (see E.3).
E.2.1 Determining the need for an operational exception to a health, human performance, and medical standard which cannot be met for all crew members during a proposed human space flight mission should originate early in the Program/Project development.
E.2.2 The AA of the Human Exploration and Operations Mission Directorate (HEOMD) will:
a. Include the CHMO in Design Reference Mission (DRM) discussions and Program/Project Pre-Formulation activities to assess the need for an operational exception to a health, human performance, and medical standard.
b. In consultation with the CHMO, determine the Program/Project Key Decision Point (KDP) by which evaluation of the operational exception (including, approval by the NASA Administrator) must be finalized before the AA requests the operational exception.
c. Document the identification and evaluation of the operational exception in appropriate Risk Management processes.
E.2.3 When it is known that a health, human performance, and medical standard cannot be met for all crew members during a proposed human space flight mission, evaluation of an operational exception to that standard for the mission can be considered per the following process:
a. The Health and Medical Technical Authority (i.e., CHMO and JSC HMTA) will conduct a health/medical risk assessment for the proposed mission and will provide the impact to the mission LOC/LOM by not meeting the health, human performance and medical standard, along with the impact to crew member's long-term health (post-mission health).
b. The CHMO risk assessment will be reviewed through the established risk management process of the Human System Risk Board and the HMTA and provided to HEOMD.
c. The CHMO will provide recommendations to mitigate the human health and performance impacts of the operational exception.
d. HEOMD will combine the CHMO assessment with the operational, engineering, and safety analyses conducted by the Mission Directorate and the Office of the Chief Engineer (OCE) and the Office of Safety and Mission Assurance (OSMA) technical authorities to develop the overall mission risk assessment.
e. Prior to the Program/Project KDP identified in D.2.3, presentation of the mission's risk posture, including the operational exception, will be made to NASA senior management through the established reporting mechanisms (i.e., Agency Program Management Council).
f. The NASA Administrator, in consultation with senior management, will make the final determination to accept the operational exception to the health, human performance, and medical standard for the mission (Appendix G). In making this decision, factors that will be considered include:
(1) the overall risk assessment for the mission;
(2) a balancing of the overall risk with the ethical principles and responsibilities identified in Appendix F; and
(3) other characteristics of the mission (e.g., national priorities, time urgency, expected benefit, mission design to meet objectives compared to other alternatives).
g. If the operational exception to a health, human performance, and medical standard is approved, the relevant ethical responsibilities and principles identified in Appendix F must be met (e.g., informed decision, provision of appropriate medical monitoring, and health care), the actions to meet them will be identified, and implemented by the appropriate Agency organizations.
E.3.1 When, because of operational or programmatic necessity, the operational community wants to offer a flight assignment to an individual crewmember under circumstances where a crew health, human performance, and medical standard cannot be met for the crewmember, an operational exception to that standard for the individual can be evaluated per the following process:
a. The Crew Selection Authority will develop a rationale and justification for the request to except the health, human performance and medical standard, which may include:
(1) operational factors;
(2) programmatic factors; and
(3) consideration and possible balancing of competing ethical principles and responsibilities as identified in Appendix F (e.g., avoid harm vs. fairness and equality of opportunity).
b. The Aerospace Medicine Board will assess the risk of the health, human performance, and medical standard being exceeded for the individual and provide the assessment to the HMTA, who will then provide a risk analysis on exceeding the standard to the Crew Selection Authority and the individual.
c. Based on the original proposal and the HMTA assessment, the Crew Selection Authority, in consultation with Agency senior management and other relevant stakeholders (e.g., astronaut office) will make a determination regarding crew assignments. The final decision as to whether an operational exception to a health/medical standard will be granted for an individual crew member will be made by the NASA Administrator. (Appendix G).
d. An individual assigned to a mission in this situation will fly under an operational exception under the authority of the NASA Administrator.
e. Flight assignments under these conditions should only be made with full assurance by the Agency that the appropriate ethical responsibilities identified in Appendix F will be met; including, the understanding and acceptance by the crewmember of the risks involved, assurance that all feasible means of exposure control will be implemented, and assurance that all feasible attempts to monitor long-term health effects will be made.
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