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OCR for page 1
Workshop Summary
INTRODUCTION
When a nation or region prepares for public health emergencies such
as a pandemic influenza, a large-scale earthquake, or any major disaster
scenario in which the health system may be destroyed or stressed to its
limits, it is important to describe how standards of care would change
due to shortages of critical resources. Such “crisis standards of care” are
the level of health and medical care capable of being delivered during a
catastrophic event (whether naturally occurring or manmade). To ensure
that fair and equitable care is provided to patients in a catastrophic event,
nations and regions need a robust system to guide the public, health care
professionals and institutions, and governmental entities at all levels.
Crisis standards of care has been the focus of several recent and
ongoing Institute of Medicine (IOM) activities, including a series of
workshops (IOM, 2010) and a letter report, Guidance for Establishing
Crisis Standards of Care for Use in Disaster Situations (IOM, 2009). An
IOM consensus committee is currently updating the preliminary guidance
issued in the 2009 letter report, and is expected to issue a full report in
2012.1
Building on these activities, the IOM Forum on Medical and Public
Health Preparedness for Catastrophic Events sponsored a session at the
17th World Congress on Disaster and Emergency Medicine (WCDEM),
held May 31 to June 3, 2011, in Beijing, China.2 The session, moderated
1
See http://iom.edu/Activities/PublicHealth/DisasterCareStandards.aspx for further in-
formation.
2
The role of the ad hoc planning committee of the IOM Forum on Medical and Public
Health Preparedness for Catastrophic Events was limited to developing this session for
1
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2 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
by Mark Keim, senior science advisor for the Office of the Director in
the National Center for Environmental Health at the Centers for Disease
Control and Prevention, focused on opportunities and challenges to integrate
crisis standards of care principles into international disaster response plans.
The workshop used the IOM’s Crisis Standards of Care as a means to
stimulate a discussion among international stakeholders. Expert panelists
discussed:
The challenges of providing fair and equitable care in mass
casualty incidents
A potential framework for the equitable delivery of care in
situations of scarce resources, and strategies for operationalizing
crisis standards of care in austere environments
Strategies for integrating crisis standards of care principles into
disaster response plans
The impact of international disaster response on changing the
standard of care in the “host” country
This report summarizes the presentations and commentary by the
invited panelists.
SURGE CAPACITY PLANNING AND
CRISIS STANDARDS OF CARE
In the United States, catastrophic disasters have been relatively
infrequent events. For the purposes of this discussion, such events have been
historically considered as those in which there are around 1,000 or more
human casualties, explained Dan Hanfling, special advisor for Emergency
Preparedness and Response at Inova Health System. Catastrophic disasters in
the late 1800s and early 1900s were generally natural disasters (e.g., flash
floods, forest fires) or transportation-related incidents (e.g., sinking
steamships). Excluding the 1918 influenza pandemic and casualties of
war, the U.S. health care system was not faced with catastrophic disasters
for most for the 20th century. However, the terrorist attacks of 2001 and
the devastation from Hurricane Katrina in the Gulf Coast in 2005 have
the WCDEM. This summary has been prepared by the rapporteurs as a factual overview
of the presentations at the session. Statements, recommendations, and opinions expressed
are those of individual presenters and participants, and are not necessarily endorsed or
verified by the IOM or the Forum.
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3
WORKSHOP SUMMARY
focused new attention on standards of care in the context of mass
casualty events and associated shortages of critical resources.
The 2009 H1N1 influenza pandemic, Hanfling noted, also brought to
light several specific questions to consider as part of overall surge
capacity planning: Which patients and health care providers should
receive limited resources, and who decides? Should professional
standards of care change? What are the triggers for implementation of a
potential shift in the standards under which such care is delivered?
Should there be legal mechanisms to protect health care workers acting
in good faith under crisis circumstances? These questions would apply to
both a slow onset incident, like a pandemic, or a no-notice incident like
an earthquake.
Responses to recent large-scale disasters have demonstrated
problems with efficacy and optimizing the international and national
relief of the medical and health teams (Benjamin et al., 2011; Burnweit
and Stylianos, 2011; Morton and Levy, 2011; Tappero and Tauxe, 2011).
In addition, international disaster response brings a number of additional
challenges given the large and varied number of organizations involved in
providing immediate and long-term care. Each organization has different
responsibilities, missions, systems, and authorities. However, there often
are not a set of different clearly defined responsibilities between the
different organizations, which lead to challenges in response and recovery
where this division is unclear or non-existent. There are numerous open
and unclear aspects to these issues, and they all influence the capacity
and effective response in large scale disasters, especially those related to
the provision of international relief (Peleg et al., 2011).
Defining Crisis Standards of Care
To begin to address issues regarding standards of care in national
planning for response to mass casualties, the U.S. Department of Health
and Human Services (HHS) Agency for Healthcare Research and Quality
(AHRQ) released two reports, Altered Standards of Care in Mass
Casualty Events (2005) and Providing Mass Medical Care with Scarce
Resources: A Community Planning Guide (2007).3 AHRQ emphasized
that there will be a “spectrum of patient care delivery options” available,
and there needs to be stewarding of scarce resources to deliver a standard
3
Available in the AHRQ online archive at http://archive.ahrq.gov/research/altstand/
and http://archive.ahrq.gov/research/mce/ (accessed December 1, 2011).
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4 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
of care appropriate and sufficient for the situation. Incident planning and
response must recognize that standards will change, and protocols for
triage will need to be adaptable. The reports note that along the spectrum
of care, there will be some patients who are “too well” to receive care,
and some who are too sick to survive, but all will need to receive some
level of health care consideration.
Building on the AHRQ reports, Hanfling highlighted several
publications describing the augmentation of scarce resources in a hospital
critical care setting (Rubinson et al., 2005, 2008) and, recognizing that
access to ventilators may be a limiting step in the delivery of care, the
triage of ventilator resources during a public health emergency (Christian
et al., 2006; Hick and O’Laughlin, 2006; Powell et al., 2008). Highlighted
among these efforts, Hanfling said, was the use of a scoring tool—for
example, the sequential organ failure assessment (SOFA)—as a means to
help discern who would be most likely to benefit from access to a
ventilator.
IOM Guidance for Establishing Standards of Care for Use in
Disaster Situations
In the fall of 2009, at the request of the HHS Office of the Assistant
Secretary for Preparedness and Response, the IOM established the
Committee on Guidance for Establishing Standards of Care for Use in
Disaster Situations. As its first task, the committee issued a letter report
describing a framework for establishing crisis standards of care (IOM,
2009).4
The IOM committee defined crisis standards of care as follows:
[A] substantial change in usual healthcare operations and the level of
care it is possible to deliver, which is made necessary by a pervasive
(e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane)
disaster. This change in the level of care delivered is justified by
specific circumstances and is formally declared by a state government,
in recognition that crisis operations will be in effect for a sustained
period. (IOM, 2009, p. 3)
4
As noted earlier, this committee is now engaged in a second phase of deliberations to
update the preliminary guidance in the letter report. A full report is expected in the spring
of 2012.
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5
WORKSHOP SUMMARY
Crisis standards of care would be implemented when standard
contingency plans for a surge in demand for care are insufficient (Figure
1). As discussed in the 2009 IOM report, the surge capacity following a
mass casualty incident falls into three basic categories, depending on the
magnitude of the event: conventional, contingency, and crisis surge
capacity (Hick et al., 2009). The categories will also represent a
corresponding spectrum of patient care delivered during a disaster event.
As the imbalance increases between resource availability and demand,
health care—emblematic of the entire health care system—maximizes
conventional capacity, then moves into contingency, and, once maximized,
moves finally into crisis capacity. A crisis situation may lead to an
overwhelming demand for services, and result in shortages of equipment,
supplies, pharmaceuticals, personnel, and other critical resources, necessitating
operational adjustments (Figure 2). Hanfling noted that under conventional
and contingency responses, the focus of care is the patient; however,
when the response shifts to crisis mode, the focus of care becomes more
“Conven onal” Surge Capacity
“Conven onal” Standard of Care
“Con ngency” Surge Capacity
“Con ngency” Standard of Care
“Crisis” Surge Capacity
“Crisis” Standard of Care
FIGURE 1 The operational flow of surge capacity planning and standards of care.
SOURCES: Hanfling presentation at WCDEM (based on Hick et al., 2009, and
regional workshop presentations summarized in IOM, 2010).
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6 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
of a population-based approach. As the continuum shifts to the right
toward crisis care, continual efforts are made toward recovery and
resupply to reestablish conventional care.
Summarizing the letter report, Hanfling noted that the committee
stressed the need for fairness and equitable processes (transparency,
consistency, proportionality, accountability) in decisions regarding altered
standards of care. He also noted the need for stakeholder engagement and
appropriate legal and regulatory authority.
Incident demand/resource imbalance increases
Risk of morbidity/mortality to patient increases
Recovery
Conventional Contingency Crisis
Usual patient Patient care areas repurposed (PACU, Facility damaged/unsafe or
Space
care space fully monitored units for ICU-level care) non-patient care areas
utilized (classrooms, etc.) used for
patient care
Usual staff Staff extension (brief deferrals of Trained staff unavailable or
Staff
called in and non-emergent service, supervision of unable to adequately care for
utilized broader group of patients, change in volume of patients even with
responsibilities, documentation, etc.) extension techniques
Cached and Conservation, adaptation, and substitution Critical supplies lacking,
Supplies
usual supplies of supplies with occasional reuse of possible reallocation of
select supplies
used life-sustaining resources
a
Usual care Functionally equivalent care Crisis standards of care
Standard
of care
Usual operating Austere operating
conditions conditions
Indicator: potential Trigger: crisis
for crisis standardsb standards of carec
FIGURE 2 Continuum of incident care and implications for standards of care.
a
Unless temporary, requires state empowerment, clinical guidance, and
protection for triage decisions and authorization for alternate care
sites/techniques. Once situational awareness achieved, triage decisions should be
as systematic and integrated into institutional process, review, and
documentation as possible.
b
Institutions consider impact on the community of resource use (consider
“greatest good” versus individual patient needs—e.g., conserve resources when
possible), but patient-centered decision making is still the focus.
c
Institutions (and providers) must make triage decisions balancing the
availability of resources to others and the individual patient’s needs—shift to
community-centered decision making.
SOURCES: Reprinted with permission from IOM (2009, p. 53). Originally
adapted from Hick et al. (2009); Wynia (2009).
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7
WORKSHOP SUMMARY
Principles to Guide Crisis Standards of Care
In order to ensure that patients receive the best possible care in a
catastrophic event, the 2009 IOM report laid out a vision to guide the
development of crisis standards of care. The report stated that the United
States needs a robust system to guide the public, health care profession-
als and institutions, and governmental entities at all levels. To achieve
such a system of just care, the committee set forth the following vision
for crisis standards of care:
Fairness—standards that are, to the highest degree possible, rec-
ognized as fair by all those affected by them (including the
members of affected communities, practitioners, and provider
organizations); evidence based; and responsive to specific needs
of individuals and the population focused on a duty of compas-
sion and care, a duty to steward resources, and a goal of main-
taining the trust of patients and the community
Equitable processes—processes and procedures for ensuring that
decisions and implementation of standards are made equitably
Transparency—in design and decision making
o
Consistency—in application across populations and among
o
individuals regardless of their human condition (e.g., race,
age, disability, ethnicity, ability to pay, socioeconomic sta-
tus, preexisting health conditions, social worth, perceived
obstacles to treatment, past use of resources)
Proportionality—public and individual requirements must be
o
commensurate with the scale of the emergency and degree of
scarce resources
Accountability—of individuals deciding and implementing
o
standards, and of governments for ensuring appropriate pro-
tections and just allocation of available resources
Community and provider engagement, education, and
communication—active collaboration with the public and stake-
holders for their input is essential through formalized processes
The rule of law
Authority—to empower necessary and appropriate actions
o
and interventions in response to emergencies
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8 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
Environment—to facilitate implementation through laws that
o
support standards and create appropriate incentives
The report also included guidance to assist state public health
authorities in developing these crisis standards of care. This guidance
includes criteria for determining when crisis standards of care should be
implemented, key elements that should be included in the crisis standards
of care protocols, and criteria for determining when these standards of
care should be implemented. The five key elements that should be
included in crisis standards of care protocols, along with associated
components, are summarized in Table 1.
TABLE 1 Five Key Elements of Crisis Standards of Care Protocols and
Associated Components
Key Elements of Crisis
Standards of Care
Protocols Components
Fairness
Ethical considerations
Duty to care
Duty to steward resources
Transparency
Consistency
Proportionality
Accountability
Community and provider Community stakeholder identification
engagement, education, with delineation of roles and involvement
and communication with attention to vulnerable populations
Community trust and assurance of
fairness and transparency in processes
developed
Community cultural values and
boundaries
Continuum of community education and
trust building
Crisis risk communication strategies and
situational awareness
Continuum of resilience building and
mental health triage
Palliative care education for stakeholders
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9
WORKSHOP SUMMARY
Key Elements of Crisis
Standards of Care
Protocols Components
Medical and legal standards of care
Legal authority and
Environment Scope of practice for health care
professionals
Mutual aid agreements to facilitate
resource allocation
Federal, state, and local declarations of:
Emergency
o
Disaster
o
Public health emergency
o
Special emergency protections (e.g.,
PREP Act, Section 1135 waivers of
sanctions under EMTALA and HIPAA
Privacy Rule)
Licensing and credentialing
Medical malpractice
Liability risks (civil, criminal,
constitutional)
Statutory, regulatory, and common-law
liability protections
Indicators and triggers Indicators for assessment and potential
management
Situational awareness (local/regional,
state, national)
Event specific
Illness and injury—incidence and
o
severity
Disruption of social and community
o
functioning
Resource availability
o
Triggers for action
Critical infrastructure disruption
Failure of “contingency” surge capacity
(resource-sparing strategies over-
whelmed)
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10 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
Key Elements of Crisis
Standards of Care
Protocols Components
o Human resource/staffing availability
o Material resource availability
o Patient care space availability
Clinical process and Local/regional and state government process-
operations es to include
State-level “disaster medical advisory
committee” and local “clinical care
committees” and “triage teams”
Resource-sparing strategies
Incident management (NIMS/HICS)
principles
Intrastate and interstate regional consist-
encies in the application of crisis
standards of care
Coordination of resource management
Specific attention to vulnerable popula-
tions and those with medical special
needs
Communications strategies
Coordination extends through all
elements of the health system, including
public health, emergency medical
services, long-term care, primary care,
and home care
Clinical operations based on crisis surge
response plan:
Decision support tool to triage life-
sustaining interventions
Palliative care principles
Mental health needs and promotion of
resilience
While the crisis standards of care principles discussed at the
workshop and this summary are derived from a national (U.S.)
perspective, it was the view of some of the participants that these
principles could be at least partially extrapolated to an international
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11
WORKSHOP SUMMARY
perspective. The crisis standards of care definition established by each
country or response agency, while reliant on the same set of foundational
principles, will need to consider the cultural values and priorities when
establishing its own definition.
Crisis Standards of Care as Part of the Overall Surge Capacity
Planning Framework
Hanfling reiterated that standard of care is a continuum that ranges
from conventional and contingency to crisis care. He suggested that
standard of care is part of an overall framework for response,
incorporating planning, substituting, adapting, reusing, and reallocating
resources. There must be situational awareness that a response is shifting
away from a conventional response to a contingency or crisis response
because of the changing availability of resources. A participant correctly
noted that one variable that is changing as a crisis evolves is the
provider’s scope of practice; the provider is still providing the highest
level of standard of care within that evolving scope of practice or set of
emerging circumstances.
Developing National/Regional Crisis Standards of Care:
The Duty to Plan
Hanfling stressed that there is a moral responsibility to plan for
catastrophic events. The IOM committee stated that
in an important ethical sense, entering a crisis standard of care
mode is not optional—it is a forced choice, based on the
emerging situation. Under such circumstances, failing to make
substantive adjustments to care operations—i.e., not to adopt
crisis standards of care—is very likely to result in greater death,
injury, or illness. (IOM, 2009, p. 15)
Along these same lines, Yoshikura Haraguchi, formerly of the
Division of Pathophysiology at National Hospital, Tokyo Disaster
Medical Center, Tachikawa City, Tokyo, Japan (retired), said the aim of
disaster medicine is to foster the development of a resilient society and to
facilitate recovery. He noted that the prime minister of Japan has referred
to a concept of working toward a “society of minimal misfortune.”
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12 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
Haraguchi defined the key elements of a systematic disaster medicine
approach as ethics; transparency, communication, and legal support;
reliability and trust; responsibility and accountability; and public education
to achieve “disaster literacy.” Comfort, compassion, dignity, fairness,
equitability, and consistency are critical, especially for vulnerable populations
(e.g., children, women, the elderly, the impoverished).
It must also be recognized that catastrophic response to disasters are
actually long-term events, which may last weeks and months. When
considering standards of care, we must consider the long-term recovery
phase and capacity building, not just the acute phase response, Hanfling
said, citing the work of Subbarrao and colleagues (2010). Countries have
very different levels of health care and different governance structures,
yet there is a need for balanced and consistent international response.
Hanfling highlighted several key components that may serve to help
develop uniform crisis standards of care:
Incorporate a crisis response framework at the very outset of the
acute phase of response efforts
Monitor use of resources to attain achievable and desirable
outcomes
Establish consistency of health care delivery strategies:
Respect the sovereignty of the “host nation”
o
Develop consistent use of foreign medical teams (based on
o
an opt-in classification approach)
Set goals for long-term recovery early in the response;
o
emphasize transition of services
Understand role of palliative care in planned clinical
o
response
Jean Luc Poncelet, area manager in Emergency Preparedness and
Disaster Relief for Latin America and the Caribbean, Pan American
Health Organization/World Health Organization (WHO), noted that a
challenge to developing standards and criteria is the variety of mass
casualty incidents that are scattered broadly across a large geographic
region and attended to by different actors at different times. The
standards applicable to a plane crash, for example, may be different from
those relevant to a hospital fire, which may be different again from a
volcanic eruption.
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13
WORKSHOP SUMMARY
Operationalizing Crisis Standards of Care
in Diverse International Settings
The Japanese Experience
Haraguchi described the Japanese experience with the 2011
earthquake and subsequent nuclear crisis as a “mega-disaster,” or
catastrophic health event. Such a catastrophic event can trigger a
“malignant cycle” of increasing distress. For example, an earthquake
may directly cause other natural disasters (e.g., landslide, tsunami, fire,
flood) and building destruction, leading to general trauma and specific
diseases, as well as secondary artificial and complex disasters (e.g.,
traffic system failure; chemical hazard from factories or traffic incidents;
biological hazard; nuclear hazard). Shortages of care and supplies result,
apathy sets in, and public health and mental health issues emerge, both in
victims and caregivers. Downstream, there is rumor and/or demagogy,
societal unrest, gradual spread of economic crisis, national crisis, and a
broken medical system, all of which can have global impact far beyond
the borders of the original event. Interruption at each step in the
malignant cycle, through appropriate planning and implementation of
plans, is essential, Haraguchi said.
Experiences from Latin America and the Caribbean
Poncelet explained that following a succession of major disasters in
Peru in 1970, Nicaragua in 1972, and Guatemala in 1976, the Minister of
Health for the region called for a common approach to disaster response,
and thus began casualty management in Latin America and the
Caribbean. The main goal was to optimize available resources to save
lives, while respecting national health practice and criteria.
Poncelet highlighted some special issues of casualty management for
the small islands in the Caribbean, which usually have only one health
facility. Therefore, a special program has been in place now for more
than 15 years to train first responders. In remote areas, the first
responders are the community members who are on scene in the first
minutes or hours of the response. Thus far more than 1,000 health, police,
fire, defense force, and airport staff have been trained in the English-
speaking Caribbean, Poncelet said, and mass casualty management plans
and teams have been established in many islands. Triage, he noted,
remains the responsibility of senior health professionals.
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14 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
Before the January 2010 earthquake in Haiti, enough hospital beds
were available for victims in most of the mass casualty incidents in Latin
America and the Caribbean. The conditions and experience in Haiti,
however, were completely different, Poncelet said. Under normal
circumstances, the local capacity in Haiti is quickly saturated, even
during a small event, and victims are generally evacuated to other
countries (e.g., Guadeloupe or Martinique). There is emergency training
in Haiti, but it is of limited impact as no real ambulance or emergency
services exist. Following the earthquake, triage services were limited to
the few very experienced non-governmental organizations (NGOs)
already in the country, and to some well-prepared field hospitals and
medical teams. The triage criteria were very different from one institution
to another, all justifiable, Poncelet said, but with different perspectives.
Poncelet also noted the tendency to forget about mass fatalities. The
fatality rate in Haiti was extreme and it became impossible, he said, to
fully adhere to guidelines that had been established before the earthquake
for the management of dead bodies.
Barriers and Challenges to Operationalizing Crisis Standards of Care
The health community has been working on mass casualty
management for many years, Poncelet said, so what is stopping us from
making progress? An obvious barrier to progress is funding; this is
challenging in wealthy countries, and even more so in lower-income
countries. Government leadership is looking for a return on their
investment, a demonstration of positive impact. But, Poncelet explained,
there is no real way to demonstrate the economic return on investment in
casualty management, in part because events are so rare. What is
measurable, he suggested, is progress in capacity building, especially
when measured against preestablished criteria and through simulation
exercises.
Frederick “Skip” Burkle, senior fellow at the Harvard University
Humanitarian Initiative, added that rapid urbanization compounds the
challenge. Urbanization is the stronghold of the economy in most countries,
but during periods of rapid urbanization, the population exceeds the existing
public health infrastructure.
Participants also discussed some of the legal concerns, including the
case of Anna Pou, a physician who found herself facing criminal charges
for decisions she made while working in a hospital with no electricity
and a large number of very ill patients in New Orleans immediately after
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15
WORKSHOP SUMMARY
Hurricane Katrina. Although the criminal cases were dismissed, she is
still facing civil charges. It was noted that legal mechanisms under
discussion could provide some protections for health care providers
operating under the most challenging conditions. This also emphasizes
the importance of having a well-planned, well-articulated, proactive
response plan, Hanfling said, so the need for reactive decision making is
reduced. This can best be achieved through improved assessment and
coordination prior to and during the initial response.
A concern was raised that in the setting of an event resulting from
terrorism, the flow of information will likely not be as forthcoming as it
would be in a natural disaster.
A disconnect was also noted between the international humanitarian
community and national authorities. The international community makes
rules, regulations, and standards for itself that are not necessarily
comparable to or compatible with what is being done by the national
authorities (if anything is being done at the national level).
Ethical Framework
Haraguchi stressed that ethics is the foundation of crisis standards of
care. He applied classical philosophy to the question of ethics in disaster
medicine, citing the concepts of utilitarianism, or “the greatest good for
the greatest number of people,” proposed by Bentham and Mill, and the
Maximin Principle of Rawls, which seeks justice or fairness by providing
the greatest benefit to those who are the worst off.
Hanfling added that respect for the host nation or region is
paramount. Response planning needs to be done in the context of the
existing capabilities, with an understanding of the local strengths,
weaknesses, gaps, culture, etc. The goal is to develop an ethical
framework for thinking about the delivery of care in crisis. Burkle noted
that the basic disaster cycle is “prevention, response, and recovery,” but
Australia has added “anticipation” and “assessment” to the front end of
the cycle (Rogers, 2011). Specifically, information on communities is
collected at the national level to better understand the different
characteristics and risks of different communities. The time for such
assessment, Burkle stressed, is before a crisis so that when something
happens, needs are already known.
Poncelet said that ethical standards of care can be more readily
agreed to among neighboring and similar countries whose income,
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16 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
technical capacity, and approach to care are similar. It is easier to be fair,
Poncelet said, when everyone is operating in an environment that is
limited by the same conditions and functionality. Crisis standards of care
should be at least as fair as conventional standards in day-to-day
operations.
The international response to the 2010 earthquake in Haiti provides
several examples of the ethical dilemmas faced in trying to provide the
highest level of care to the greatest number of victims in a disaster
response. Hanfling cited an article on the Israeli field hospital in Haiti
(Merin et al., 2010), which described their basic triage approach: how
urgent is the patient’s condition, are there adequate resources to meet the
patient’s needs, and can the patient’s life be saved with the interventions
offered? The U.S. government (Bureau for Medicine and Surgery of the
U.S. Navy and the U.S. Navy Ship Comfort), working with the Ministry
of Public Health in Haiti (Ministere de la Santé Publique et de la
Population), recognized the dilemma of implementing short-term
solutions (i.e., amputation) and the effect these had on long-term
impacts, and discouraged practitioners from offering complex medical
treatments or surgical interventions that could not be sustained in Haiti
after the end of the international disaster relief effort (Etienne et al.,
2010). Poncelet noted that as each country assesses its mass casualty
management plan or response using their own criteria, it can be very
difficult to address questions of ethics. In the case of Haiti, for example,
serious ethical questions persist regarding standards of care and the
resulting amputee crisis.
Many difficult ethical questions need to be considered, Poncelet said.
For example, should a foreign medical team work below its capacity to
be fair and provide care comparable with another country’s capabilities?
In other words, is the “lowest common denominator” of care an ethical
solution? Should a trauma technique be implemented when the foreign
team knows that they will leave before the follow-up process ends? Or,
correspondingly, can a team refuse to provide some type of treatment
because follow-up will not or cannot be provided by the host country?
Community and Stakeholder Engagement and Education
All participants discussed the importance of community and provider
engagement and education. Any process is of little value without
community support and education of professionals regarding how to
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17
WORKSHOP SUMMARY
implement the process. Only through the training of nationals, and
relevant national authorities, as they are the first responders and final
authority, will we be able to find a long-term sustainable solution to
crisis care, Poncelet said. Disaster medicine needs to solve community-
level issues, Burkle agreed, and added that we have to find ways to make
it more attractive to work at the community level.
Hanfling and Burkle stressed the importance vetting crisis triage
processes at the community level during the planning stages, and
Hanfling noted that the IOM committee is exploring the issue of
community engagement in some detail as part of its current task. Keim
added that a community often feels empowered by engagement in
planning activities before the disaster, but is then disempowered by the
multitude of national and international responders that often take over
decision making.
Panelists discussed the need for, and impact of, financial and social
incentives to encourage stakeholder participation. Poncelet stressed the
importance of showing the community the benefit of disaster preparedness.
He noted that the World Bank has decided that it is economically
beneficial to be involved in disaster preparedness, and this drives their
involvement.
Many participants also noted that a positive messaging approach is
more effective than negative messaging. Haraguchi explained the
Japanese philosophy as one that encourages learning about and preparing
for disaster, so that people can work together positively to overcome
disaster and continue to enjoy life.
The benefits of including diverse stakeholders at the table were also
discussed. A participant pointed out that employers, unions, farm
collectives, and other similar organizations should be included in planning
discussions as they have vested interests in disaster preparedness, facing
financial risk in the case of epidemic diseases or terrorism. In most
developed countries, these entities also pay a large portion of insurance
premiums for their workers. It was also noted that involving
transnational corporations may help to foster a more level playing field
among nations that may not cooperate naturally. If these stakeholders are
not actively engaged, then they are likely not to adopt the new standards
in their plans.
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18 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
THE INTERNATIONAL HEALTH
REGULATIONS TREATY
Burkle from Harvard described the International Health Regulations
(IHR) Treaty.5 The 2003 SARS pandemic shook up the global health
community, Burkle said. Up until that point, WHO had maintained a
passive relationship with countries, offering expertise, but respecting the
sovereignty of countries (i.e., countries can refuse WHO assistance).
However, the World Health Assembly of Ministers of Health, realizing
the severity of the outbreak, held an emergency session and granted
WHO the authority to intervene. Thus, WHO evolved from its short-term,
geographically focused capacity to having global authority with sustained
long-term prevention, preparedness, and response responsibilities. This was
instrumental in controlling SARS, Burkle said. The new WHO authority
was formalized as the IHR Treaty, which entered into force in 2007.
A key to success of the treaty is striking the right balance between
the sovereignty of individual nation-states and the common good of the
international community. The treaty obligates WHO to obtain expert
advice on any declared public health emergency of international concern,
and provide that advice to nation-states. The treaty also encourages
countries to provide each other with technical and logistical support for
capacity building.
IHR will influence the establishment of crisis standards of care by
emphasizing the importance of information sharing and exchange in
disaster situations. The importance of situational awareness in helping to
support proactive decision making cannot be overstated. With regard to
standards of care capacities, the IHR treaty:
Establishes systematic approaches to surveillance early warning
systems and response (countries must establish core capacities
for surveillance and response by 2012)
Requires National Focal Points to ensure a two-way channel of
communications between WHO and member states
Requires countries to share information relevant to public health
risks
Introduced a decision instrument algorithm, Annex 2, for public
health action (see Figure 3)
5
See http://www.who.int/ihr/en/index.html (accessed on December 19, 2011).
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WORKSHOP SUMMARY
A recent survey mentioned by Burkle suggests that many nation-
states still lack core capacities to detect, assess, and report risks, and may
not meet the 2012 deadline. Sixty percent of the 194 nation-states
responded to the survey; only 58 percent had national plans, and less
than 10 percent indicated they had fully established the IHR capacities
required under the Treaty.
Burkle noted that a primary barrier to achieving the goals of the
Treaty is the lack of any enforceable sanctions. In the absence of legal
consequences, there has instead been a system of “shame and blame” to
push countries along. (Burkle noted that one of the reasons cited for not
completing the survey discussed above is that countries were embarrassed
that they did not yet have the required capacity.) However, the nation-
states signed the Treaty, and there is an awareness that this is something
larger than any individual country.
Events detected by national surveillance system
A case of the following Any event of A case of the following diseases:
diseases: potential • Cholera
• Smallpox international public • Pneumonic plague
• Poliomyelitis due to health concern, • Yellow fever
wild-type poliovirus including those of • Viral hemorrhagic fevers (Ebola, Lassa,
• Human influenza unknown causes Marburg)
caused by a new or sources • West Nile fever
subtype • Other diseases of special national or regional
• Severe acute concern, e.g., dengue fever, Rift Valley fever,
respiratory syndrome meningococcal disease
Apply criteria in decision algorithm
1. Is the public health impact of the event serious?
2. Is the event unusual or unexpected?
3. Is there a significant risk for international spread?
4. Is there a significant risk for international trade or travel restrictions?
Yes to any two of the above criteria
Event shall be notified to the World Health Organization under IHR 2005
FIGURE 3 IHR Annex 2 Decision Algorithm.
SOURCE: Burkle presentation at WCDEM, adapted by Burkle from Annex 2 of
the IHR.
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20 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
The IHR in Practice:
The 2009 H1N1 Influenza Pandemic
The new Treaty was put to the test during the 2009 H1N1 influenza
pandemic. An external review of the global response to the pandemic
(WHO, 2011) found that pandemic responders were in place in 72
percent of the countries when H1N1 appeared; there was timely detection
of the outbreak through the Global Influenza Surveillance network; and
there was effective partnering, interagency coordination, and rapid field
deployment of teams of experts that had been trained by WHO prior to
the pandemic.
Nations provided samples of live influenza virus to laboratories in
the developed world. A vaccine candidate was developed within 32 days,
and vaccine seed strains and control reagents were available within a few
weeks. To allay concerns that the vaccine would be too costly for
developing countries, WHO now has a mandate to provide pandemic
influenza vaccine for all those countries that cannot afford it. There is
also now a provision to ensure equitable distribution of available
vaccine. Early recommendations were made regarding the initial target
groups for vaccination (including children, Indians in Mexico, Indians in
Canada, Maori in New Zealand, Aboriginal tribes in Australia), many of
whom had no prior immunizations or natural immunity to the influenza
virus. Weekly analysis and reporting of the surveillance data was done,
and ultimately, proper treatment courses were distributed in 72 countries.
Burkle highlighted some of the key lessons learned from
implementing the Treaty in response to the 2009 pandemic H1N1
influenza. First, determining the severity of a pandemic in the early stages
is difficult. A participant noted that there is some confusion regarding
severity. The speed at which the outbreak spreads is the severity of the
outbreak, and the phase is declared based on how many regions are
affected. Another aspect, however, is the number of casualties or fatalities
as a result of the outbreak. The 2009 H1N1 was widespread, but not as
dangerous as expected. Another point noted by Burkle was that although
the first candidate vaccine was available rapidly, the realities of vaccine
development meant that no approved vaccine was available for 6 months.
The initial IHR pandemic phase structure was rather complex, and the new
Annex 2 consists of a simplified phase structure: baseline, alert plan,
pandemic. The need for more global health experts was also identified. In
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WORKSHOP SUMMARY
the end, however, despite some bureaucratic “hiccups” (e.g., vaccine
manufacturing issues), Burkle said this is exactly the approach needed
from a global health authority.
The IHR as a Potential Framework for International
Surge Planning and Crisis Standards of Care
Certain aspects of the IHR Treaty can now be considered existing
standards of care (e.g., time to first candidate vaccine) governing
response to a disaster (Burkle et al., 2011). The Treaty provides a
historically unprecedented level of global cooperation for pandemics.
This leads to the question of whether such a model for global standards
of care could be applied to other large-scale disasters. (Burkle noted that
the IHR covers nuclear and chemical health incidents, but have only been
tested thus far in pandemics.) To accomplish this, Burkle commented, an
authority must be in place to guarantee universal standards of care to
prevent the type of public health emergencies that arise due to the lack of
infrastructure, and/or destroy any infrastructure that did exist. A key
question is who that authority might be.
Burkle recalled that the former United Nations (UN) Department of
Humanitarian Affairs (DHA) had the responsibility of coordinating the
humanitarian community and the UN agencies, but was stripped of all
operational responsibilities in 1997 and redesignated the Office for the
Coordination of Humanitarian Affairs (OCHA) to avoid being seen as a
competitor with UN Field agencies. Currently, OCHA ensures coordination
among UN actors and key NGO communities at the country level, and
mobilizes resources on behalf of the entire UN system. Burkle opined that
OCHA has the best disaster managers, but it is chronically underresourced,
underfunded, and lacks needed authority. A participant countered that he
did not see OCHA as being the organization that would have the capacity
or the inclination to take on such a role. Burkle clarified that this was one
example of the type of organization that could evolve to this role.
(Furthermore, he wondered what the organization might look like today,
had the original DHA operational authority not been abolished.) Some
kind of global authority is needed, Burkle said, and there may be some
potential for formation of an OCHA-like organization.
Burkle also noted that a framework to facilitate proactive planning is
discussed in the work of Walker et al. (2010) on a “blueprint for
professionalizing humanitarian assistance.”
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22 CRISIS STANDARDS OF CARE: INTERNATIONAL DISASTER PLANS
CLOSING COMMENTS
Mass casualty preparedness pays off (e.g., prepositioned medical
kits, aid agreements among countries, responders with knowledge of the
local language, etc.), Poncelet said, and more preparedness is clearly
needed. For large disasters, global standards should be established for
mass casualty and fatality management. Hanfling cited two existing
frameworks, which may serve as additional resources: the UN International
Search and Rescue Guidelines classification system for international search
and rescue teams and the Virtual Onsite Operational Command Center for
team response registration and selection. Furthermore, models such as the
IHR could serve as a potential blueprint for developing a crisis standards
of care framework. There will be no global solution, however, before there
are local solutions. Through this workshop, and subsequent workshop
summary, the hope was expressed that a broader dialog would be initiated
to stimulate additional efforts and Crisis Standards of Care concept
development within the individual nation and larger international
community. For example, while these issues were not discussed in detail
at the workshop, it is important to address these moving forward: Is there
a need for classification, criteria and standards for medical teams who
arrive at the scene? What standards can be put in place for standard
operating procedures, education, training, drills, equipment, response
systems, international relief, and assessment?
