Medical Policy in NASA
Rich Williams
NASA Chief Health and Medical Officer
July 27, 2015
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Practical Policy Implications
• If your organization has a policy, and you are not practicing in
compliance with the policy, you are in jeopardy
• If you are doing a particular practice that should be covered by a policy,
and you don’t have one, you are in jeopardy
• Usually you realize the full extent of the jeopardy in the aftermath of
untoward events
• Ignorance is not a viable excuse
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Politics and Policy
• Politics
– activities that relate to influencing the actions and policies of a
government or getting and keeping power in a government.
• Policy
– a course or principle of action adopted or proposed by a government,
party, business, or individual.
– Government policies
• Legislative Activities
– Statutes
» Authorizations
» Appropriations
• Code of Federal Regulations
• Executive Orders
• Administration Decisions (OMB, OSTP)
• Agency level Policy
• Level 2 Policy (Center policy in NASA)
Federal Regulatory Agencies
• Federal Regulatory Agencies
– Occupational Safety and Health Administration (OSHA)
– Environmental Protection Agency (EPA)
– Federal Aviation Administration (FAA)
– Nuclear Regulatory Commission (NRC)
– Food and Drug Administration (FDA)
• These agencies promulgate regulations for public safety and well being
• Regulations enforce landmark legislation passed by Congress
– Occupational Safety and Health Act – 1970
– Clean Air Act – 1970
– Clean Water Act – 1972
– Federal Aviation Act - 1958
Other Federal Agencies
• Science and Technology Research and Development Agencies
– National Aeronautics and Space Administration (NASA)
– Department of Energy (DOE)
– National Institutes of Health (NIH)
– Centers for Disease Control and Prevention (CDC)
– National Institute for Occupational Safety and Health
– National Science Foundation (NSF)
– National Oceanic and Atmospheric Administration (NOAA)
• Some are organized under Departments (Commerce, Health and Human
Services, Transportation, etc.)
• Some are independent, established by statute
NASA Authority
• Established by the National Aeronautics and Space Act of 1958 “To
provide for research into problems of flight within and outside the
earth's atmosphere, and for other purposes.”
• Sec. 203. (b) In the performance of its functions the Administration is
authorized-– (1) to make, promulgate, issue, rescind, and amend rules and
regulations governing the manner of its operations and the exercise of
the powers vested in it by law;
• The NASA Administrator is authorized to promulgate internal NASA
policies governing activities within the Agency
• Health and medical policy formulation, promulgation, and oversight is
delegated to the Chief Health and Medical Officer
• Technical Authority
NASA Policy Formulation
• NASA Policy
– Guides all agency functions, including technical
programs/projects, which are further guided by technical
standards
– NASA Policy Directives
– NASA Procedural Requirements
– NASA Standards
– Center level policies
• NODIS (NASA Online Directive Information System)
– http://nodis3.gsfc.nasa.gov/
– System in which NASA policies are published
– Comprehensive process of publication
• Plans, Requirements
– Programmatic (Exploration Systems, International Space Station)
• Project (Orion, SLS, etc)
NASA Health and Medical Policies
• NASA ground workforce health and safety is regulated by OSHA
– Executive Order 12196, February 26, 1980, Occupational Safety and Health
Programs for Federal Employees
• NASA environmental health issues are regulated by EPA
• NASA public use vehicle operations (research aircraft, spacecraft) are
controlled by NASA policy directives, procedural requirements, standards
and requirements
• NASA health and medical policies and standards “regulate” aircrew and
space flight crew selection, qualification, and health related requirements in
NASA research aircraft and spacecraft
– NPD 8900.1G: MEDICAL OPERATIONS RESPONSIBILITIES IN
SUPPORT OF HUMAN SPACE FLIGHT PROGRAMS (Revalidated with
change 1 dated 8/25/12)
• NASA-STD-3001, NASA Space Flight Human System Standards Volumes 1 & 2
• NASA Crewmembers Medical Standards
– NPD 8900.3H: Astronaut Medical and Dental Observation Study and Care
Program
– NPD 8900.5B: NASA Health and Medical Policy for Human Space
Exploration
– NPR 8900.1A: NASA Health and Medical Requirements for Human Space
Exploration
NASA Technical Authority
• Technical Authority is the authority, responsibility, and
accountability to establish, approve, and maintain
technical requirements, processes, and policy
• NASA established Technical Authority as a response to
Columbia Accident Investigation Board Recommendation
Technical Authority serves as a balance to
programmatic authority, relevant to safe and
reliable operations in engineering, safety, and
health/medical related areas.
NASA Technical Authorities
• The NASA Chief Engineer - Engineering technical authority
• The Director of the Office of Safety and Mission Assurance - Safety
technical authority
• The NASA Chief Health and Medical Officer - Health & Medical technical
authority (HMTA)
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NASA
Policy Policy
Documentation
Flow
NASA
Documentation
Flow
NASA Policy
Directive
(NPD)
NPDs are NASA directives and “policy statements that describe what
is required to achieve NASA’s vision, mission, and external
mandates, and who is responsible for carrying out those
requirements.”
Procedural
Requirements
(NPR)
NPRs are NASA directives that “provide Agency mandatory
instructions and requirements to implement NASA policy as delineated
by an associated NPD.”
NASA Technical
Standards
Program/Project
Requirements
Deliverables
A NASA Technical Standard is a “document that contains common
and repeated use of rules, conditions, guidelines, or characteristics for
products or related processes…” A standard can become an Agency
requirement “when a directive specifies its use…”
Medical Boards in Support of NASA Health Care
• Medical Policy Board (HQ)
– CHMO chairs, Board is advisory
• CHMO has permanent waiver authority
– Membership: Federally employed physicians
– Medical policy development and approval
– Reviews/approves crew health and medical standards
– Review of health and medical issues with recommendations to the
Mission Directorate AA’s and other NASA leaders
– Reviews (internally and externally) health and bioethical related issues
• Aerospace Medicine Board (JSC)
– Clinical board
• Medical certification
– Temporary waiver authority
– Recommends health and medical policy
– Develops crew health and medical standards
Principles of Policy Formulation
• Policies should be needed
– Oversight and implementation authorities should
concur on need
• Policies should be driven by and based on evidence
• Policies must support and enable mission success
• Stakeholders must be consulted
– Directly affected entities
– Indirectly affected entities
• Expert opinions must be solicited
– External advice is critical
• Extended policy effects must be anticipated and
accommodated
“NASA should develop and use an
occupational health model for the
collection and analysis of astronaut health
data, giving priority to the creation and
maintenance of a safe work environment.”
“Safe Passage”
Institute of Medicine, 2001
Health and Medical Technical Requirements
• Health and Medical Standards
– Crew Medical Qualification Standards
– Exposure Control Standards
– Habitability standards
– Fitness for Duty Standards
• Standards serve as declaration of acceptable risk
• Standards serve as basis for biomedical research
requirements and health related systems
requirements
Health and Medical Standard Setting
• Health and Medical Standards
– Based on the best available scientific and clinical
evidence.
• clinical findings
• research findings
• lessons learned from previous space missions
• analogue environments
• current standards of medical practices
• terrestrial data
• risk management data
• expert opinion/recommendations
– Periodically and regularly reviewed, and updated as
new evidence emerges
Health and Medical Standard Setting
• Background
– Medical standard setting process based on regulatory agency
models
– Performance standards to set exposure/outcome limits and/or
fitness for duty criteria for hazardous exposures (microgravity,
radiation) and for the liabilities of isolation and confinement.
– Environmental and habitability standards
– Crew medical qualification standards
– The adequacy of products or deliverables to meet the standards
are assessed using an appropriate review mechanism.
• engineering design reviews
• OCHMO Transition to Medical Practice process
• independent technical evaluations.
Health and Medical Standard Setting
• Types of Standards Relevant to Space Specific Exposures
– Fitness for duty standards, and other criteria and limits as
appropriate
• Fitness for duty standards consist of a minimum measurable
capability or capacity for a given physiological or behavioral
parameter that allows successful performance of all required
duties.
– Permissible Exposure/Outcome Limits (PEL/POL)
• PEL/POLs delineate an acceptable maximum decrement or
change in a physiological or behavioral parameter, as the
result of exposure to the space environment, or a quantifiable
limit of exposure to a space flight factor over a given length of
time (e.g. life time radiation exposure).
Current Space Flight Health Standards
Area
Type
Standard
Bone
POL
Maintain bone mass at
≥-2SD
Cardiovascular
FFD
Maintain ≥75% of
baseline VO2 max
Neurosensory
FFD
General Sensory Motor,
Motion Sickness,
Perception, Gaze
Control
Behavioral
FFD
Maintain nominal
behaviors, cognitive test
scores, adequate sleep
Immunology
POL
WBC > 5000/ul; CD4 + T
> 2000/ul
Nutrition
POL
90% of spaceflightmodified/USDA nutrient
requirements
Muscle
FFD
Maintain 80% of
baseline muscle
strength
Radiation
PEL
≤ 3% REID (Risk of
Exposure Induced
Death, 95% C.I.
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Health and Medical Standard Setting
• Process (NPR 8900.1A, Appendix C: NASA Health and Medical
Requirements for Human Space Exploration
– Identify the need for a standard
• Human System Risk Board
– Operational, oversight, research communities
– Decision to formulate a medical standard (OCHMO)
– Draft the standard (internal group, augmented by external experts, with
ops community involvement)
– Review the draft standard (external group)
– Revision (internal group, augmented by experts, with ops community
involvement)
– Solicit comments from affected entities (astronaut office; Exploration and
Operations mission directorates, technical authorities, etc.)
– Analysis of policy implications (OCHMO)
– Final standard published (MPB through appropriate NASA document)
– Ongoing review (review every 5 years or sooner)
Risk Management: An Evidence Based Approach
• Regularly collect/evaluate accumulated data and evidence concerning
risks
• Evidence base identifies need for policy formulation
– Create/update health and medical human system standards and/or
requirements
• Human System Risk Board evaluates status of risk reduction and
oversees standard development/revision
– Involves input from research and operational communities
• Chief Health and Medical Officer approves all new and revised standards
– Medical Policy Board
• Health and Medical Technical Authority supports and monitors
programmatic implementation of standards and requirements
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Integrated Human System Risk Mitigation
Framework
Integrated Human System Risk Mitigation
Policy, Operations, and Research
are integrated through a Human Health Risk Framework
Framework
OCHMO
Standards/Risks
Evidence/Experience Base
– Office of the Chief Health and Medical
Officer (OCHMO) – Level I – NASA HQ
• Develops Medical Policy, Health and
Performance Standards, and Bioethics
• Risk Assessment and Mitigation Implemented via the Health and Medical
Authority (HMTA) – Level II – JSC
- Crew Health and Safety (CHS)
• Medical Operations & Occupational
Health (career health care/post career
monitoring)
- Human Research Program (HRP)
• Human health & performance research in
support of space exploration
- Perform research necessary to
understand & reduce health &
performance risks
- AES & STMD – Technology/Protocol
Development
– International Space Station (ISS), Orion,
Commercial Crew Programs
• Implementation of Medical Operations
– Medical Requirements, Tests and
hardware
• System Maturation Teams (SMTs)
Coordination
HMTA
Risk Assessment &
Mitigation
Crew Health & Safety
Human Research Program
Space Biology
CASIS
AES
STMD
Terrestrial – Government,
Private
Program Requirements/
Countermeasure
Implementation
ISS
CCP
MPCV/Orion
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Policy Development Example 1: Risk Acceptance
In Exploration
Long duration and exploration class space missions beyond low Earth orbit may
pose hazards that go beyond current risk limits, where current health/medical
standards cannot be met or the level of knowledge doesn’t permit a standard to
be developed.
• OCHMO requested the Institute of Medicine to produce a report on policy and
ethical issues and principles relevant to crew health/medical standards for longduration and exploration space missions. The Committee was asked to:
 Consider the application of existing health/medical standards and the
factors that should be considered in implementing them and the potential
development of new health standards.
 Provide a framework of ethical and policy principles that can help guide
decision-making associated with implementing health/medical standards
for long duration and exploration class space missions when existing
standards cannot be fully met, or the level of knowledge of a given
condition is sufficiently limited that an adequate standard cannot be
developed for the mission.
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Institute Report
of Medicine Report
Institute of Medicine
“Health Standards for Long Duration and Exploration
Spaceflight: Ethics Principles, Responsibilities, and
Decision Framework” (April, 2014)
The report makes 4 recommendations:
•
The first 3 recommendations are directed at how
OCHMO develops and implements health and
medical standards.
•
The fourth recommendation provides a tri-level
decision-making framework based on the ethical
principles and responsibilities that can be used
when a health/medical standard(s) cannot be
met, or when there are health/medical risks that
are not fully understood for a proposed long
duration or space exploration mission.
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IOM Report Recommendation
Adopt an Ethics-Based Decision Framework
• NASA should apply the relevant ethics principles and
fulfill the concomitant responsibilities through a threelevel, ethics-based decision framework that examines:
– Level 1: Decisions about allowing risk to astronaut health and
safety in excess of that permitted by health/medical
standards,
– Level 2: Decisions about undertaking specific missions, and
– Level 3: Decisions concerning individual astronaut
participation and crew composition.
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Ethical Principles & Responsibilities
Principles
•
•
•
•
•
•
avoid harm
beneficence
favorable balance of risk and benefit
respect for autonomy
fairness
fidelity
Responsibilities
•
•
•
•
•
•
informed decision-making process
continuous learning strategy
independent advice
communicate with all relevant stakeholders
equality of opportunity
provide preventive long-term health screening and surveillance of
astronauts
• protect privacy and confidentiality
Health/Medical
Standard
Be Met –
WhenWhen
Health/Medical
Standards
Can’tCan’t
be Met:
Committee OptionsCommittee Options
If a human spaceflight mission cannot meet NASA’s current health/medical standards, or if
inadequate information exists to revise a standard, the committee identified and examined 3
options:
•
Liberalizing existing health/medical standards
 Current standards are based on best available data
 Modifying standards outside of established process is arbitrary
•
Establishing more permissive health/medical standards for long duration and exploration
class missions
 No clear and compelling justification for why acceptable risks and levels of
uncertainty should be greater for long duration/exploration space missions
•
Only ethically acceptable option that could allow for increased risk exposures in the
context of long duration and exploration spaceflight is granting an exception to
existing health/medical standards.
 Exceptions to health/medical standards in these situations should be “used under very
limited circumstances following the ethics based framework recommended ” and that
“exceptions increase the responsibilities for NASA and society.”
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Process and Criteria for Granting Exceptions
The selection of the process and criteria to grant exceptions to existing
health standards should be evidence-based and should reflect policies
that encourage independent advice and transparency of process.
Based on the ethics principles identified, criteria for reviewing exception
requests could include requirements that the proposed mission:
•
•
•
•
•
•
be expected to have exceptionally great social value,
have great time urgency,
have expected benefits that would be widely shared,
be justified over alternate approaches to meeting the mission’s objectives,
be committed to minimizing harm and continuous learning,
have a rigorous process to assure that astronauts are fully informed about
risks and unknowns,
• their decisions meet standards of informed decision making, and that they are
making a voluntary decision, and
• provide health care and health monitoring for astronauts before, during, and
after flight and for the astronaut’s lifetime.
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Report Implementation
Granting an exception to health/medical standards (or lack of standards due to limited
knowledge) will be “used under very limited circumstances” and would only be approved
at the Agency Level after careful assessment of the risk and benefits with ethical
principles guidance.
•
Would not represent a standard medical waiver
Processes for implementing all 3 levels of decision making developed within the context of
the Agency’s overall risk assessment processes:
•
•
•
•
•
health/medical risk analysis
combined with total mission risk analysis – safety, engineering, health/medical
individual risk assessment for each astronaut involved in the mission
balancing of competing ethical principles
operational justification for granting an exception to a standard
•
Operational exception will be under the authority of the Administrator
•
Will require implementation of additional ethical responsibilities
•
Process will be documented in OCHMO NPR 8900.1, NASA Health and Medical
Requirements for Human Space Exploration
•
Implementation plan reviewed by all relevant stakeholders and approved by Agency
Program Management Council
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Policy Development Example 2:
Astronaut Health Care
• Under existing authority, NASA can:
– Provide comprehensive health care for active NASA astronauts during
all mission phases
• Pre-flight
• During flight
• Post flight
– Monitor the health using annual examinations for all astronauts,
including those who are retired or separated from NASA
• Lifetime Surveillance of Astronaut Health (Longitudinal Study of
Astronaut Health)
• What NASA cannot do:
– Provide health care for retired/separated astronauts
• Illnesses or injuries related to space flight are handled through the
Workers’ Compensation program (Federal Employees
Compensation Act)
Astronaut Health Care: Institute of Medicine
• NASA should develop a comprehensive health care
system for astronauts for the purpose of collecting
and analyzing data while providing the full continuum
of health care to ensure astronaut health. A NASAsponsored health care system for astronauts should
care for current astronauts, astronauts who are in
training, and former astronauts, as well as, where
appropriate, their families;
Federal Agencies:
Proposing Legislation
• Call for legislation
– Usually in anticipation of an Authorization Bill
• Offices propose legislation
– Legislative language (as it will appear in the amending bill)
– Sectional analysis
• Reviews by the Office of Management of the Budget (OMB)
• Reviews by other Federal Agencies, coordinated by OMB
• Briefings to congressional staff
• Language is/is not written into legislation
Astronaut Health Care
Legislative Language 2005
Health Care Program for Astronauts and their
Dependents
SEC. XXX. The National Aeronautics and Space Act of 1958, as
amended (42 U.S.C. 2451, et seq.), is amended by adding a new
section XXX as follows:
“Health Care Program for Astronauts and their
Dependents”
“Sec. XXX. (a) AUTHORITY.—Subject to the requirements set forth
in this section, the Administration is authorized to establish a
program to provide health care to all active and former United
States astronauts and their dependents as defined in subsection
(b) for the purpose of care, study, and observation of the short
and long term effects of space flight on human beings.
NASA Authorization Act of 2005
Public Law 109–155
109th Congress December 30, 2005
SEC. 708. NASA HEALTHCARE PROGRAM.
The Administrator shall develop a plan to better understand the
longitudinal health effects of space flight on humans. In the development
of the plan, the Administrator shall consider the need for the
establishment of a lifetime healthcare program for NASA astronauts and
their families or other methods to obtain needed health data from
astronauts and retired astronauts.
Astronaut Health Care
Legislative Language 2011
Long Term Study of Astronaut Health
SEC. XXX. The National Aeronautics and Space Act of 1958, as
amended (42 U.S.C. 2451, et seq.), is amended by adding a new
section XXX as follows:
“Long Term Study of Astronaut Health”
“Sec. XXX. (a) AUTHORITY.—Subject to the requirements set forth
in this section, the Administration is authorized to establish a
program to provide health care to all active and former United
States astronauts as defined in subsection (b) for the purpose of
direct support of the human space flight mission and for care,
study, and observation of the short and long term effects of space
flight on human beings. The Administration is also authorized to
provide primary care and behavioral health care to the dependents
of active, flight assignable astronauts at on site NASA clinics for
the purpose of direct support to the human space flight mission.
Astronauts may purchase health care coverage for their
dependents under this plan at their own expense.
Astronaut Health Care
Legislative Language 2015
• Title changed to “Astronaut Occupational Healthcare”
• Health monitoring and care delivery limited to
occupational illness and injury
• Dependents not mentioned
• Approved by OMB, under consideration by legislative
branch
Summary: Principles of NASA Policy Formulation
• Risk management is the driver
• Policies should be needed
– Oversight and implementation authorities should
concur on need
• Policies must support and enable mission success
• Stakeholders must be consulted
– Directly affected entities
– Indirectly affected entities
• Expert opinions must be solicited
• Extended policy effects must be anticipated and
accommodated
National Aeronautics and Space Administration
Medical Policy in NASA
Rich Williams
Chief Health and Medical Officer
July 27, 2015