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B
Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report
At the request of the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services, the Institute of Medicine convened the Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations to develop guidance that state and local public health officials can use to establish and implement standards of care that should apply in disaster situations—both naturally occurring and manmade—under scarce resource conditions. Specifically, the committee was asked to identify and describe the key elements that should be included in crisis standards of care protocols, to identify potential indicators and triggers, and to develop a template matrix that can be used by state and local public health officials as a framework for developing specific guidance for healthcare provider communities to develop and implement crisis standards of care. This appendix provides a summary of the committee’s recommendations, findings, and practical guidance. A complete copy of the report is available through www.iom.edu/disasterstandards.
Based on a review of the currently available state standards of care protocols, published literature, and testimony provided at its workshop, the committee concluded that there is an urgent and clear need for a single national set of guidance for states with crisis standards of care that can be generalized to all crisis events and is not specific to a certain event. However, the committee recognizes that within such a single general framework, individual disaster scenarios may require specific considerations, such as differences between no-notice events and slow-onset events, while the key elements and components remain the same.
For the purpose of developing recommendations for situations in which healthcare resources are overwhelmed, the committee defined the
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level of health and medical care capable of being delivered during a catastrophic event as “crisis standards of care.”
“Crisis standards of care” is defined as 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. The formal declaration that crisis standards of care are in operation enables specific legal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations.
The committee emphasized 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—that is, not to adopt crisis standards of care—is very likely to result in greater death, injury, or illness.
THE VISION
In order to ensure that patients receive the best possible care in a catastrophic event, the nation needs a robust system to guide the public, healthcare professionals 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, recognized 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 compassion and care, a duty to steward resources, and a goal of maintaining the trust of patients and the community
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Equitable processes—processes and procedures for ensuring that decisions and implementation of standards are made equitably
Transparency—in design and decision making
Consistency—in application across populations and among individuals regardless of their human condition (e.g., race, age, disability, ethnicity, ability to pay, socioeconomic status, preexisting health conditions, social worth, perceived obstacles to treatment, past use of resources)
Proportionality—public and individual requirements must be commensurate with the scale of the emergency and degree of scarce resources
Accountability—of individuals deciding and implementing standards, and of governments for ensuring appropriate protections and just allocation of available resources
Community and provider engagement, education, and communication—active collaboration with the public and stakeholders for their input is essential through formalized processes
The rule of law
Authority—to empower necessary and appropriate actions and interventions in response to emergencies
Environment—to facilitate implementation through laws that support standards and create appropriate incentives
DEVELOPING CRISIS STANDARDS OF CARE PROTOCOLS
Throughout the report, the committee emphasized the need for states to develop and implement consistent crisis standards of care protocols both within the state and through work with neighboring states, in collaboration with their partners in the public and private sectors. The committee’s intent was to provide a framework that allows consistency in establishing the key components required of any effort focused on crisis standards of care in a disaster situation. It also hoped that by suggesting a uniform approach, consistency will develop across geographic and political boundaries so that the guidance will be useful in contributing to a single, national framework for responding to crises in a fair, equitable, and transparent manner.
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Recommendation 1: Develop Consistent State Crisis Standards of Care Protocols with Five Key Elements
State departments of health, and other relevant state agencies, in partnership with localities should develop crisis standards of care protocols that include the key elements—and associated components—detailed in this report:
A strong ethical grounding;
Integrated and ongoing community and provider engagement, education, and communication;
Assurances regarding legal authority and environment;
Clear indicators, triggers, and lines of responsibility; and
Evidence-based clinical processes and operations.
The report also contains 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 B-1.
TABLE B-1 Five Key Elements of Crisis Standards of Care Protocols and Associated Components
Key Elements of Crisis Standards of Care Protocols
Components
Ethical considerations
Fairness
Duty to care
Duty to steward resources
Transparency
Consistency
Proportionality
Accountability
Community and provider engagement, education, and communication
Community stakeholder identification with delineation of roles and involvement with attention to vulnerable populations
Community trust and assurance of fairness and transparency in processes developed
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Key Elements of Crisis Standards of Care Protocols
Components
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
Legal authority and environment
Medical and legal standards of care
Scope of practice for healthcare professionals
Mutual aid agreements to facilitate resource allocation
Federal, state, and local declarations of:
Emergency
Disaster
Public health emergency
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 severity
Disruption of social and community functioning
Resource availability
Triggers for action
Critical infrastructure disruption
Failure of “contingency” surge capacity (resource-sparing strategies overwhelmed)
Human resource/staffing availability
Material resource availability
Patient care space availability
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Key Elements of Crisis Standards of Care Protocols
Components
Clinical process and operations
Local/regional and state government processes 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 consistencies in the application of crisis standards of care
Coordination of resource management
Specific attention to vulnerable populations 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
The letter report states that “state authorities have the political and constitutional mandate to prepare for and coordinate the response to disaster situations throughout their state jurisdictions” and outlines a process by which states should begin to develop crisis standards of care protocols. These steps include the following:
Outline Ethical Considerations: Convene a “Guideline Development Working Group” of appropriate stakeholders to establish ethical principles that will serve as the basis for the crisis standards of care.
Review Legal Authority for Implementation of Crisis Standards of Care: Review existing legal authority for the implementation of crisis standards of care and address legal issues related to the successful implementation of these standards, such as liability
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protections or temporary changes in licensure or certification status or scope of practice.
Develop Guidance for Provision of Medical Care Under State Crisis Standards of Care: Establish an “Advisory Committee” that will find a comprehensive set of materials to inform its deliberations in the “Indicators and Triggers” and “Clinical Process and Operations” sections of the report.
Conduct a Public Stakeholder Engagement Process: Although representatives of various healthcare and other interested professional groups and the public have been involved in drafting the ethical principles and crisis standards of care, a robust engagement process is also necessary to provide an opportunity for review and comment by the provider and public community at large. Particular attention should be paid to conduct outreach to and gather input from vulnerable populations, including those with medical special needs.
Establish a Medical Disaster Advisory Committee: During a disaster, this committee will provide ongoing advice to the state authority regarding changes to the situation and potential corresponding changes in the implementation of crisis standards of care.
ETHICAL FRAMEWORK
An ethical framework serves as the bedrock for public policy and cannot be added as an afterthought. Hence, ethical principles underlie the committee’s vision for crisis planning, outlined above. In addition, ethically and clinically sound planning will aim to secure fair and equitable resources and protections for vulnerable groups. The committee concluded that core ethical precepts in medicine permit some actions during crisis situations that would not be acceptable under ordinary circumstances, such as implementing resource allocation protocols that could preclude the use of certain resources on some patients when others would derive greater benefit from them. But even here, it is the situation that changes during disasters, not ethical standards per se. The context of a disaster may make certain resources unavailable for some or even all patients, but it does not provide license to act without regard to professional or legal standards. Healthcare professionals are obligated always to provide the best care they reasonably can to each patient in their care,
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including during crises. When resource scarcity reaches catastrophic levels, clinicians are ethically justified—and indeed are ethically obligated—to use the available resources to sustain life and well-being to the greatest extent possible. As a result, the committee concluded that ethics permits clinicians to allocate scarce resources so as to provide necessary and available treatments preferentially to those patients most likely to benefit when operating under crisis standards of care. However, operating under crisis standards of care does not permit clinicians to ignore professional norms nor to act without ethical standards or accountability.
Recommendation: Adhere to Ethical Norms During Crisis Standards of Care
When crisis standards of care prevail, as when ordinary standards are in effect, healthcare practitioners must adhere to ethical norms. Conditions of overwhelming scarcity limit autonomous choices for both patients and practitioners regarding the allocation of scarce healthcare resources, but do not permit actions that violate ethical norms.
COMMUNITY AND PROVIDER ENGAGEMENT, EDUCATION, AND COMMUNICATION
The committee strongly recommended extensive engagement with community and provider stakeholders. Such public engagement is necessary not only to ensure the legitimacy of the process and standards, but more importantly to achieve the best possible result. The letter report discusses considerations for engaging with community and provider stakeholders prior to the event, during the event, and after the event. The report also notes that although there are likely to be substantive population-level mental health risks from a mass casualty public health emergency that requires crisis standards of care, there is also an opportunity to promote resilience at the individual and population levels to mitigate these risks. Thus it is important to develop a national platform to support resilience that can customized by communities at the local level. The report also emphasizes that building trust is particularly important in more vulnerable populations, including those with preexisting health inequities and those with unique needs related to race, ethnicity, culture,
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immigration, limited English proficiency, and lower socioeconomic status.
Recommendation: Seek Community and Provider Engagement
State, local, and tribal governments should partner with and work to ensure strong public engagement of community and provider stakeholders, with particular attention given to the needs of vulnerable populations and those with medical special needs, in:
Developing and refining crisis standards of care protocols and implementation guidance;
Creating and disseminating educational tools and messages to both the public and health professionals;
Developing and implementing crisis communication strategies;
Developing and implementing community resilience strategies; and
Learning from and improving crisis standards of care response situations.
LEGAL ISSUES IN EMERGENCIES
The letter report also addressed issues related to the implementation of crisis standards of care, including legal considerations. Questions of legal empowerment of various actions to protect individual and communal health are pervasive and complicated by interjurisdictional inconsistencies. The law should clarify prevailing standards of care and create incentives for actors to respond to protect the public’s health and respect individual rights.
Recommendation: Provide Necessary Legal Protections for Healthcare Practitioners and Institutions Implementing Crisis Standards of Care
In disaster situations, tribal or state governments should authorize appropriate agencies to institute crisis standards of care in affected areas, adjust scopes of
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practice for licensed or certified healthcare practitioners, and alter licensure and credentialing practices as needed in declared emergencies to create incentives to provide care needed for the health of individuals and the public.
OPERATIONAL IMPLEMENTATION OF CRISIS STANDARDS OF CARE
Clinical Care in Disasters
An important consideration regarding the framework for the implementation of crisis standards of care in a disaster includes the recognition that it will never be an “all or none” situation. Disasters will have varying impacts on communities, based on many different variables that might affect the delivery of health care during such events. Response to a surge in demand for healthcare services will likely fall along a continuum ranging from “conventional” to “contingency” and “crisis” surge responses (Figure B-1; Hick et al., 2009). Conventional patient care uses usual resources to deliver health and medical care that conforms to the expected standards of care of the community. The delivery of care in the setting of contingency surge response seeks to provide patient care that remains functionally equivalent to conventional care. Contingency care adapts available patient care spaces, staff, and supplies as part of the response to a surge in demand for services. Although this may introduce minor risk to the patient compared to usual care (e.g., substituting less familiar medications for those in short supply, thereby potentially leading to medication dosage error), the overall delivery of care remains mostly consistent with community standards. Crisis care, however, occurs under conditions in which usual safeguards are no longer possible. Crisis care is provided when available resources are insufficient to meet usual care standards, thus providing a transition point to implementing crisis standards of care.
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FIGURE B-1 Continuum of incident care and implications for standards of care.
NOTE: Post-anesthesia care unit (PACU); intensive care unit (ICU).
aUnless 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.
bInstitutions 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.
cInstitutions (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: Adapted from Hick et al. (2009); Wynia (2009).
The goal for the health system is to increase the ability to stay in conventional and contingency categories through preparedness and anticipation of resource needs prior to serious shortages, and to return as quickly as possible from crisis back across the continuum to conventional care (Tables B-2 and B-3).
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Indicators
Institution/Agency
Region
State
Contingency care being provided and unable to rapidly address shortfall
Any hospital reporting
Any hospital reporting
Any hospital reporting
Resource-specific shortage (e.g., antibiotic, immunoglobulin, oxygen, vaccine)
Notification by supplier
Notification by hospitals
Notification by hospitals/suppliers
Outpatient care
Marked increase in appointment demand or unable to reach clinic due to call volume
Staff illness rate
> 10%
> 10%
> 10%
School Absenteeism
Not applicable
> 20%
> 20%
Disruption of facility or community infrastructure and function
Utility or system failure
> 1 hospital affected
> 5 hospitals affected or critical access hospital affected
aThe indicators in this table should be developed in relation to usual resources in the area and usage patterns—numbers are examples only.
TABLE B-5 Possible Triggers for Adjusting Standards of Care
Category
Trigger
Space/structure
Non-patient care locations used for patient care (e.g., cot-based care, care in lobby areas) or specific space resources overwhelmed (operating rooms) and delay presents a significant risk of morbidity or mortality; or disrupted or unsafe facility infrastructure (damage, systems failure)
Staff
Specialty staff unavailable in timely manner to provide or adequately supervise care (pediatric, burn, surgery, critical care) even after callback procedures have been implemented
Supply
Supplies absent or unable to substitute, leading to risk to patient of morbidity (including untreated pain) or mortality (e.g., absence of available ventilators, lack of specific antibiotics)
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Crisis Standards of Care Implementation Criteria
Prior to implementation of formal resource triage, the following conditions must be met or in process (Devereaux et al., 2008):
Identification of critically limited resources and infrastructure
Surge capacity fully employed within healthcare facility
Maximal attempts at conservation, reuse, adaptation, and substitution performed
Regional, state, and federal resource allocation insufficient to meet demand
Patient transfer or resource importation not possible or will occur too late to consider bridging therapies
Request for necessary resources made to local and regional health officials
Declared state of emergency (or in process)
Crisis Standards of Care Triage
Triage occurs routinely in medicine, when resources are not evenly distributed or temporarily overwhelmed. These decisions are generally ad hoc, based on provider expertise, and have minimal effects on patient outcome. Thus standards of care are routinely adjusted to resources available to the provider without requiring a formal process or declarations. However, the situation in disasters is more complex, as services may not be available due to demand, with severe consequences to the patient who does not receive these resources. Reactive triage involves the ad hoc decisions made by clinical or administrative personnel to an exigent circumstance to allocate available resources in the face of an unanticipated shortfall. These decisions must be accountable to general principles of ethical resource allocation, but do not follow a structured, systematic process. Situational awareness is not available. Proactive triage involves systematic decisions made by clinical or administrative personnel to a situation requiring resource triage where situational awareness is available and the decision making is accountable to the incident management process. Additional details about reactive and proactive triage are available in the letter report.
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Prerequisite Command, Control, and Coordination Elements
The implementation of crisis standards of care and fair and equitable resource allocation requires attention to the core elements of incident management, including situational awareness, incident command, and adequate communication and coordination infrastructure and policies. Without this foundation, medical care will be inconsistent, and resources will not be optimally used (Hick et al., 2009). All healthcare systems must also understand how their incident management system interacts with that of jurisdictional emergency management and any coalition hospital response partners, including the process for obtaining assistance during an emergency (Figure B-2).
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FIGURE B-2 Overview of relationships among agencies, committees, and groups.
NOTE: Depending on the organization of the state, the functional layout, details, and relationships among the units might vary.
Crisis Standards of Care Operations
When crisis care becomes necessary, a threshold has been crossed requiring that the affected institution(s) either quickly address the situation internally, or, more likely, appeal to partner facilities and agencies for assistance in either transferring patients to facilities with resources or bringing needed resources to the facility. If these strategies cannot be
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carried out, or if partner facilities are in the same situation (e.g., a pandemic influenza scenario), then systematic implementation of crisis standards of care at the state level may become necessary in order to codify and provide guidance for triage of life-sustaining interventions as well as to authorize care provided in non-traditional locations (alternate care facilities).
The state has an obligation to ensure consistency of medical care to the highest degree possible when crisis care is being provided. Usual coordination and resource requests outlined above are used to minimize healthcare service disruption and/or to provide the most consistent level of care across the affected area and the state as a whole. When prolonged or widespread crisis care is necessary, the state should issue a declaration or invoke emergency powers empowering and protecting providers and agencies to take necessary actions to provide medical care and should accompany these declarations with clinical guidance, developed by the State Disaster Medical Advisory Committee, to provide a consistent basis for life-sustaining resource allocation decisions. The state, through its emergency powers, resource allocation, and provision of clinical guidance, attempts to “level the playing field” at the state level, as well as provide legal protections for providers making difficult triage decisions and provide relief from usual regulations that might impede coping strategies such as alternate care facilities.
Some hospital coalitions cover large metropolitan areas and thus the Regional Medical Coordination Center (RMCC) acts as liaison between the state and its constituents. The RMCC may be an agency, such as public health, or a hospital or other facility designated by the system. The RMCC attempts to ensure regional medical care consistency and may do so by acting as a resource “clearinghouse” between the healthcare facilities and emergency management and coordinating policy and information to meet regional needs. This may involve a Regional Disaster Medical Advisory Committee or at least a medical advisor or coordinator with access to technical experts in the area, particularly in large metropolitan areas because the specific needs of the area may not be well addressed by state guidance. However, the regional guidance cannot be inconsistent with that of the state.
Individual hospitals and healthcare facilities should work through tactical mutual aid agreements with other local facilities and at the regional level to ameliorate conditions that might force crisis standards of care. When these strategies have been exhausted, healthcare facilities, working through local public health authorities, should request a state
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emergency declaration recognizing that crisis conditions are at hand, that a change in acceptable standards of care are required, and that crisis standards of care must be initiated.
The individual healthcare institution surge capacity plan should incorporate the use of a “clinical care committee” that is composed of clinical and administrative leaders who can focus a hospital or hospital system approach to the allocation of scarce, life-saving resources (Phillips and Knebel, 2007; Hick and O’Laughlin, 2006; O’Laughlin and Hick, 2008). A clinical care committee is activated by the facility incident commander when the facility is practicing contingency or crisis care due to factors that are not readily reversible. This committee is responsible for making prioritization decisions about the use of resources at the relevant healthcare institution (e.g., hospital, primary care, emergency medical services agency, and others). A sample institutional process is included in the letter report.
Decision Tools and Resource Use Guidance
Although the most examined decision tools revolve around mechanical ventilation, guidance is also available for other core medical care components (medications, oxygen, etc.) and limited guidance is available for specific other resources, including blood products, elective surgery triage, trauma care, radiation, burn care, and cancer (Box B-2, Figure B-3). See the letter report for additional details.
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BOX B-2
Exclusion Criteria Prompting Possible Reallocation of Life-Saving Interventions
Sequential Organ Failure Assessment (SOFA) score criteria: patients excluded from critical care if risk of hospital mortality > 80%
SOFA > 15
SOFA > 5 for >5 d, and with flat or rising trend
> 6 organ failures
Severe, chronic disease with a short life expectancy
Severe trauma
Severe burns on patient with any two of the following:
Age > 60 yr
> 40% of total body surface area affected
Inhalational injury
Cardiac arrest
Unwitnessed cardiac arrest
Witnessed cardiac arrest, not responsive to electrical therapy (defibrillation or pacing)
Recurrent cardiac arrest
Severe baseline cognitive impairment
Advanced untreatable neuromuscular disease
Metastatic malignant disease
Advanced and irreversible neurologic event or condition
End-stage organ failure (for details see Devereaux et al., 2008)
Age > 85 yr (see Lieberman et al., 2009)
Elective palliative surgery
SOURCE: Adapted from Devereaux et al. (2008).
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FIGURE B-3 Triage algorithm process.
aExample exclusion criteria include severe, irreversible organ failure (congestive heart failure, liver, etc.), severe neurologic compromise, extremely high or not improving SOFA scores, etc.
SOURCE: Adapted from Devereaux et al. (2008).
Finally, throughout the letter report, the committee emphasized the importance of consistent implementation of crisis standards of care in a disaster situation within and among states.
Recommendation: Ensure Consistency in Crisis Standards of Care Implementation
State departments of health, and other relevant state agencies, in partnership with localities should ensure consistent implementation of crisis standards of care
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in response to a disaster event. These efforts should include:
Using “clinical care committees,” “triage teams,” and a state-level “disaster medical advisory committee” that will evaluate evidence-based, peer-reviewed critical care and other decision tools and recommend and implement decision-making algorithms to be used when specific life-sustaining resources become scarce;
Providing palliative care services for all patients, including the provision of comfort, compassion, and maintenance of dignity;
Mobilizing mental health resources to help communities—and providers themselves—to manage the effects of crisis standards of care by following a concept of operations developed for disasters;
Developing specific response measures for vulnerable populations and those with medical special needs, including pediatrics, geriatrics, and persons with disabilities; and
Implementing robust situational awareness capabilities to allow for real-time information sharing across affected communities and with the “disaster medical advisory committee.”
Recommendation: Ensure Intrastate and Interstate Consistency Among Neighboring Jurisdictions
States, in partnership with the federal government, tribes, and localities, should initiate communications and develop processes to ensure intrastate and interstate consistency in the implementation of crisis standards of care. Specific efforts are needed to ensure that the Department of Defense, Veterans Health Administration, and Indian Health Service medical facilities are integrated into planning and response efforts.
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CONCLUSION
Crisis standards of care, as described in the report, will be required when the intent and ability to provide usual care is simply no longer possible due to the circumstances. As acknowledged by the committee, some governments have made great strides in determining how to approach resource scarcity, but much work remains to be done.
Indeed, the committee highlighted a number of areas worthy of further discussion, evaluation, and study. Some of these issues constitute real or perceived barriers that will make the implementation and operationalization of crisis standards of care difficult to achieve. Some simply reflect the fact that the study of this area of disaster medicine remains an evolving pursuit requiring multidisciplinary participation. Nonetheless, the discussion around this topic has matured tremendously in the past few years. Despite the gaps that remain, the committee was greatly encouraged by the search for solutions taking place.
In studying this issue, the committee’s intent was to provide a framework that allows consistency in describing the key components required by any effort focused on standards of care in a disaster. It also intended that, by suggesting such uniformity, consistency will develop across jurisdictions, regions, and states so that this guidance will be useful in contributing to a uniform national framework for responding to crisis in a fair, equitable, and transparent manner.
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