REG NASA NPR 7120-2011 NASA Health and Medical Technical Authority (HMTA) Implementation.pdf

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1、NPR 7120Effective Date: November 1, 2011Expiration Date: November 1, 2016NASA Procedural Requirements_COMPLIANCE IS MANDATORYSubject: NASA Health and Medical Technical Authority(HMTA) ImplementationResponsible Office: Office of the Chief Health and Medical OfficerProvided by IHSNot for ResaleNo repr

2、oduction or networking permitted without license from IHS-,-,-Table of ContentsPrefaceP.1 PurposeP.2 ApplicabilityP.3 AuthorityP.4 Applicable DocumentsP.5 Measurement and VerificationP.6 CancellationChapter 1. Introduction1.1 Health and Medical Technical Authority Overview1.2 Health and Medical Tech

3、nical Authority Background1.3 Health and Medical Technical Authority Scope1.4 NASA Health and Medical Policy, Procedural Requirements, and Technical StandardsChapter 2. Health and Medical Technical Authority (HMTA) Roles and ResponsibilitiesChapter 3. Health and Medical Technical Authority (HMTA) Im

4、plementation3.1 Chief Medical Officer3.2 HMTA Implementation/Awareness PlanChapter 4. Dissenting OpinionsAppendix A. DefinitionsAppendix B. AcronymsAppendix C. Letter of Agreement Between Office of the Chief Health and Medical Officer,Office of the Chief Engineer, and Office of Safety and Mission As

5、surance on Health andMedical Technical Authority ImplementationAppendix D. Health and Medical Technical Authority Implementation Process DescriptionAppendix E. ReferencesLIST OF FIGURESFigure D-1. Human Space Flight Health and Medical Technical Authority Awareness FlowPathsFigure D-2. Other Health a

6、nd Medical Technical Authority Awareness Flow Paths (includingR&T)Figure D-3. Health and Medical Technical Authority Process Flow ChartLIST OF TABLESTable 1. Health and Medical Technical Authority DocumentationProvided by IHSNot for ResaleNo reproduction or networking permitted without license from

7、IHS-,-,-PREFACEP.1 PURPOSEa. This document provides the procedural requirements and processes for implementing Healthand Medical Technical Authority (HMTA) throughout the Agency.P.2 APPLICABILITYa. The requirements of this NASA Procedural Requirements (NPR) shall be applied to protectthe health and

8、safety and safeguard the performance of crewmembers involved in human spaceflight activities and to enable successful human space flight and other Research and Technology(R&T) programs/projects, as appropriate.b. This NPR shall be applicable to NASA Headquarters and NASA Centers, includingComponent

9、Facilities and Technical and Service Support Centers. This NPR applies to the JetPropulsion Laboratory (JPL), other contractors, grant recipients, or parties to agreements only tothe extent specified or referenced in the appropriate contracts, grants, or agreements.c. The requirements in this NPR sh

10、all apply to all human space exploration activities including,but not limited to, space systems, space suits, planetary habitats, planetary rovers, and surfacevehicles.d. The requirements in this NPR shall apply to internationally-provided space systems asdocumented in distinct separate agreements,

11、such as joint or multilateral agreements.e. The requirements in this NPR shall apply to R&T programs/projects, as appropriate.f. The requirements in this NPR shall apply to specific elements of the NASA OccupationalHealth Program, as described herein.P.3 AUTHORITYa. 51 U.S.C. 20113(a) of the Nationa

12、l Aeronautics and Space Act, as amended.b. NPD 1000.0, NASA Governance and Strategic Management Handbook.c. NPD 1000.3, The NASA Organization.P.4 APPLICABLE DOCUMENTS AND FORMSa. NPD 1800.2, NASA Occupational Health Program.b. NPD 7100.8, Protection of Human Research Subjects.c. NPD 8900.5, NASA Hea

13、lth and Medical Policy for Human Space Exploration.d. NPR 1800.1, NASA Occupational Health Program Procedures.Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-e. NPR 7120.5, NASA Space Flight Program and Project Management Requirements.f. NPR 7120.8,

14、NASA Research and Technology Program and Project ManagementRequirements.g. NPR 8900.1, Health and Medical Requirements for Human Space Exploration.h. NASA-STD-3001, NASA Space Flight Human System Standard, Volume 1 Crew Health.i. NASA-STD-3001, NASA Space Flight Human System Standard, Volume 2 Human

15、 Factors,Habitability and Environmental Health.j. Letter of Agreement between the Office of the Chief Health and Medical Officer (OCHMO),the Office of the Chief Engineer (OCE), and the Office of Safety and Mission Assurance(OSMA), Collaboration for Health and Medical Technical Authority (HMTA) Imple

16、mentation,signed June 14, 2010.P.5 MEASUREMENT AND VERIFICATIONa. The Chief Health and Medical Officer (CHMO) will monitor compliance with therequirements of this NPR through participation in the OCE Requirements Compliance Surveys.P.6 CANCELLATIONNone./S/Dr. Richard S. WilliamsChief Health and Medi

17、cal OfficerProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Chapter 1. Introduction1.1 Health and Medical Technical Authority Overview1.1.1 NASA has established the technical authority process as part of its system of checks andbalances to provide ind

18、ependent oversight of programs and projects in support of safety andmission success through the selection of specific individuals at delegated levels of authority.HMTA originates with the Administrator and is formally delegated to the AssociateAdministrator (AA) and then to the CHMO.1.1.2 HMTA imple

19、ments the responsibilities of the OCHMO to assure that Agency health andmedical policy, procedural requirements, and standards are addressed in program/projectmanagement when applicable and appropriate. HMTA provides independent oversight of allhealth, medical, and space crew/personnel performance m

20、atters that either arise in associationwith the execution of NASA programs or projects, or are embedded in NASA programs orprojects.1.1.3 In this NPR, a requirement is identified by “shall,” a good practice by “should,”permission by “may” or “can,” expected outcome or action by “will,” and descripti

21、ve material by“is” or “are” (or another form of the verb “to be”).1.2 Health and Medical Technical Authority Background1.2.1 The CHMO is responsible for implementing HMTA at the NASA Centers. Due toresource (e.g., lack of personnel) and infrastructure (e.g., lack of medical expertise) differences,HM

22、TA implementation varies among Centers, thus differing significantly from the OCE andOSMA Technical Authority (TA). These differences increase risk that HMTA issues will eitherbe missed or identified too late in the program/project life cycle to allow for designmodifications without significant impa

23、ct to cost and schedule.1.2.2 To assist the CHMO with HMTA implementation, the Chief Engineer and the Chief,Safety and Mission Assurance (SMA) agreed to support HMTA implementation through theutilization of Engineering and SMA personnel as HMTA awareness and communication links ateach Center (not in

24、cluding Johnson Space Center (JSC) due to its existing HMTA infrastructure),as described in this NPR (Appendix D). This support arrangement for HMTA implementationwas documented in a Letter of Agreement between OCHMO, OCE, and OSMA, “Collaborationfor Health and Medical Technical Authority (HMTA) Imp

25、lementation,“ signed June 14, 2010(Appendix C).1.3 Health and Medical Technical Authority Scope1.3.1 For NASA program/project management, the scope of HMTA shall encompass thefollowing:a. Health, medical, and human performance, policy, requirements, and standards for all humanspace flight programs a

26、nd projects.b. Health, medical, and human performance policy, procedural requirements, and technicalstandards levied on or supported by all R&T programs and projects.Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-c. NASA-unique occupational and envi

27、ronmental health requirements addressed in paragraph1.4.3 of this NPR that are not mandated by external Federal entities (e.g., Occupational Safetyand Health Administration and Environmental Protection Agency).d. Health, medical, and human performance issues that arise where there is no NASA-unique

28、orFederally mandated health/medical requirement or standard. In such cases, program/projectmanagement shall consult with the appropriate level of HMTA to resolve the issue.1.3.2 HMTA is not related to non-program/project management health and medical issues (e.g.,Center operations). Except as descri

29、bed in paragraph 1.3.1.c of this NPR, HMTA is not relatedto program/project health and medical issues which are governed by laws, regulations, andrequirements external to NASA (e.g., Occupational Safety and Health Administration,Environmental Protection Agency, and research subject protection regula

30、tions). NASA policyfor occupational health is provided in NPD 1800.2, NASA Occupational Health Program.NASA policy for protection of human research subjects is provided in NPD 7100.8, Protection ofHuman Research Subjects.1.4 NASA Health and Medical Policy, Procedural Requirements, and Technical Stan

31、dards1.4.1 The OCHMO establishes Agency-level health and medical policy, proceduralrequirements, and technical standards for use by programs and projects when applicable andappropriate. NPD 1000.0, NASA Governance and Strategic Management Handbook, identifiesthe CHMO as the Agency HMTA. NPD 8900.5,

32、NASA Health and Medical Policy for HumanSpace Exploration, establishes NASA health and medical policy for human space exploration.NPR 8900.1, Health and Medical Requirements for Human Space Exploration, establishesrequirements and processes for implementing NASA health and medical policy for human s

33、paceexploration.1.4.2 The OCHMO establishes and maintains NASA health, medical, and human performancetechnical standards for human space exploration as follows:a. NASA-STD-3001, NASA Space Flight Human System Standard, Volume 1 Crew Health,establishes standards for providing a healthy and safe envir

34、onment for crewmembers and forproviding health and medical programs for crewmembers during all phases of space flight.b. NASA-STD-3001, NASA Space Flight Human System Standard, Volume 2 HumanFactors, Habitability and Environmental Health, addresses habitability and environmental health,focuses on hu

35、man physical and cognitive capabilities and limitations and defines standards forspacecraft (including orbiters, habitats, and suits), internal environments, facilities, payloads, andrelated equipment, hardware, and software systems with which the crew interfaces during spaceoperations.1.4.3 Additio

36、nally, the OCHMO has developed several NASA-unique occupational healthrequirements that are included in the scope of HMTA. These requirements are addressed in thefollowing specific sections of NPR 1800.1, NASA Occupational Health Program Procedures:a. Section 2.15, Shift Work and Balancing Work-Rest

37、 Cycles.b. Sections 4.2.3.2 and 4.2.3.3, Occupational Exposure Limits (OELs).Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-c. Section 4.5, Reproductive and Developmental Health.d. Section 4.6, Nanotoxicology.e. Section 4.8, Hearing Conservation.1.4

38、.4 Table 1 provides a list of relevant Agency and HMTA policy and requirements documents.HMTA Document Number TitleNPD 1000.0 NASA Governance and Strategic ManagementHandbookNPD 1000.3 The NASA OrganizationNPD 8900.5 NASA Health and Medical Policy for HumanSpace ExplorationNPR 8900.1 Health and Medi

39、cal Requirements for HumanSpace ExplorationNPR 1800.1NASA Occupational Health ProgramProcedures (Sections 2.15, 4.2.3.2, 4.2.3.3,4.5, 4.6 and 4.8 apply to HMTA)NASA-STD-3001 NASA Space Flight Human System Standard,Volume 1: Crew HealthNASA-STD-3001NASA Space Flight Human System Standard,Volume 2: Hu

40、man Factors, Habitability andEnvironmental HealthTable 1 HMTA DocumentationProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Chapter 2. Health and Medical Technical Authority (HMTA) Roles andResponsibilities2.1 The CHMO is the HMTA as authorized by NPD

41、 1000.0, NASA Governance and StrategicManagement and NPD 8900.5, NASA Health and Medical Policy for Human Space Exploration.The CHMO shall be responsible for:a. Providing overall leadership of the HMTA process for human space flight programs/projects,R&T programs/projects (as appropriate), and NASA-

42、unique occupational health requirementsdescribed in paragraph 1.4.3 of this NPR.b. Establishing and maintaining unique NASA health, medical, and human performance policy,procedural requirements, and technical standards.c. Ensuring effective implementation of the HMTA process (including documentation

43、, HMTApoints of contact, compliance verification, and resolution of HMTA dissenting opinions)throughout the Agency.d. Appointing a Chief Medical Officer (CMO) at designated Centers, who shall be a NASA civilservice physician.e. Developing, with Center Directors, Center HMTA Implementation/Awareness

44、Plans for eachCenter.f. Developing HMTA awareness training modules for use by engineering and SMA personnel atNASA Centers.g. Certifying, through established Agency processes, that programs and projects comply withAgency health and medical requirements prior to human space flight missions.h. Designa

45、ting an OCHMO HMTA point of contact (POC) for resolution of non-human spaceflight issues.i. Hearing dissenting opinions resulting from HMTA decisions when they cannot be resolved atlower levels.2.2 The Chief Engineer, through agreement with the CHMO (Appendices C and D), isresponsible for supporting

46、 HMTA implementation through the utilization of engineeringpersonnel as HMTA awareness and communication links at each Center, as described in thisNPR. The OCE will assist the OCHMO in implementing HMTA awareness training at NASACenters. Compliance verification of HMTA implementation across the Agen

47、cy will be assessedthrough OCHMO participation in the OCE Requirements Compliance Survey process.2.3 The Chief, SMA, through agreement with the CHMO (Appendices C and D), is responsiblefor supporting HMTA implementation through the utilization of SMA personnel as HMTAawareness and communication link

48、s at each Center, as described in this NPR. The OSMA willassist the OCHMO in implementing HMTA awareness training at NASA Centers.2.4 NASA Center Directors shall be responsible for:Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-a. Concurring with the CHMO appointment of a Center CMO, where assigned, to exerciseHMTA for specified activities conducted at that Center.b. Developing with the CMO (if applicable) and the OCHMO a Center HMTAImplementation/Awareness Plan.c. Ensuring that necessary resources are provided to effectiv