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Institute of Medicine (US) Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations; Altevogt BM, Stroud C, Hanson SL, et al., editors. Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report. Washington (DC): National Academies Press (US); 2009.

Cover of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations

Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report.

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BACKGROUND

The current influenza pandemic caused by the 2009 H1N1 virus underscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communities across the United States. Although this may occur over hours, days, or weeks, this overwhelming surge on the healthcare system will dramatically strain medical resources and could compromise the ability of healthcare professionals to adhere to normal treatment procedures and conventional standards of care. The Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), charged the Institute of Medicine committee responsible for this study with the task of developing guidance to establish standards of care that should apply to disaster situations—both naturally occurring and manmade—under conditions in which resources are scarce (Box 1).

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BOX 1

Statement of Task. In response to a request from the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), the Institute of Medicine (IOM) will convene an ad hoc committee to conduct a (more...)

The Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations brings together a broad spectrum of expertise, including state and local public health, emergency medicine and response, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication (Appendix E). This letter report is not intended to obviate or substitute for extensive additional consideration and study of this complex issue, but is focused on articulating current concepts and preliminary guidance that can assist state and local public health officials, healthcare facilities, and professionals in the development of systematic and comprehensive policies and protocols for standards of care in disasters where resources are scarce. These policies and protocols must conform to rigorous standards of science, law, and ethics.

The committee focused its efforts on establishing a framework for the development and implementation of standards of care and associated triggers during disaster events. It was not responsible for establishing, creating, or defining what should be such crisis standards of care and associated triggers.

This guidance is intended to assist federal policy makers and state and local officials in the development of more extensive and nationally/regionally consistent crisis standards of care policies and protocols that are applicable to all disaster situations. The committee developed two case studies that illustrate the application of the guidance and principles laid out in the report to two different scenarios (Appendix C). Recognizing the current attention and concern around the 2009 H1N1 pandemic, one scenario focuses on a gradual-onset pandemic flu, modeled around issues that may arise this upcoming flu season. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event.

2009 H1N1 Influenza Pandemic and Other Public Health Emergencies and Disasters

Although there is still significant uncertainty about the likely severity and extent of the 2009 H1N1 influenza outbreak in the fall, there is great concern that demand for healthcare services could increase dramatically, resulting in a severe strain on medical resources across the United States. Mexico reported the first case of the novel virus nH1N1 on April 12, 2009, and by June 11 the World Health Organization (WHO) raised its pandemic alert level to a full-blown pandemic. Within 9 weeks of the first reported cases, every WHO region reported cases, and now the virus has spanned the globe, affecting more than 170 countries (WHO, 2009b). The virus spread throughout most of the southern hemisphere during that region’s winter influenza season, while continuing to circulate in the summer months in the northern hemisphere.

In the United States, 9,079 hospitalizations and 593 deaths associated with 2009 H1N1 were reported to the Centers for Disease Control and Prevention (CDC) as of August 30, 2009 (CDC, 2009a). During the peak U.S. influenza season, multiple viral strains may be circulating simultaneously—2009 H1N1 and seasonal influenza. Over the past few years, in anticipation of a severe pandemic of H5N1 (“bird flu”) and other public health emergencies (e.g., bioterrorism), many states and healthcare institutions have been developing pandemic and other emergency preparedness plans that include enhancing healthcare system surge capacity to respond to catastrophic and mass casualty events. Government agencies and the healthcare system are now heavily preparing for the possibility of needing to implement their pandemic plans (or revised versions of them to reflect the current severity of the H1N1 pandemic) during the upcoming influenza season, even though at present 2009 H1N1 has not been highly pathogenic.

Although the 2009 H1N1 pandemic is currently receiving the highest attention in the medical and public health community, the nation also faces the possibility of many other potential public health emergencies and disasters that could severely strain medical resources. For example, the detonation of an improvised nuclear device in a large city would cause massive numbers of injured and dead (IOM, 2009a). Similarly, other disasters caused by terrorism or by natural causes, such as fires, floods, earthquakes, and hurricanes, have the potential to overwhelm the medical and public health systems.

Scarce Resources, Demand for Healthcare Services, and Standards of Care

In preparation for response to any large-scale disaster or public health emergency, healthcare facilities are developing surge plans that include efforts to increase and maximize use of available resources, as well as to manage demand for healthcare services. Facilities can use resource-sharing agreements (e.g., mutual aid agreements) and other mechanisms that enable full use of the community’s resources, which should include the regional resources and capabilities of the health systems of the Veterans Administration, the Department of Defense (DoD), and Indian Health Services. Communities may also request resource support from state and federal disaster supply caches, including those of the Strategic National Stockpile. However, in the setting of an influenza pandemic, where the shortage of resources is likely to occur on a national scale, the availability of such supplementary support is much less certain. Beyond preparedness stocking, facilities can also implement a variety of strategies that permit conservation, reuse, adaptation, and substitution for certain resources, doing so in a way that minimizes the impact on clinical care (Rubinson et al., 2008b; Rubinson et al., 2008a; Minnesota Department of Health, August 2008). To manage demand, surge plans may also include the use of an alternate care system that allows for the delivery of healthcare services along a stratified spectrum which includes home health care, community-based care, and the use of alternate care facilities (Hick et al., 2004; Kaji et al., 2006; Barbisch and Koenig, 2006; Davis et al., 2005; Hanfling, 2006; California Department of Public Health, 2008; Kelen et al., 2009).

However, these measures may not always be sufficient, especially in a wide-reaching public health emergency or disaster in which resources are simultaneously strained in communities across the nation. Faced with severe shortages of equipment, supplies, and pharmaceuticals, an insufficient number of qualified healthcare providers, overwhelming demand for services, and a lack of suitable space, healthcare practitioners will have to make difficult decisions about how to allocate these limited resources if contingency plans do not accommodate incident demands. Under these circumstances, it may be impossible to provide care according to the conventional standards of care used in non-disaster situations, and, under the most extreme circumstances, it may not even be possible to provide the most basic life-sustaining interventions to all patients who need them. The impact of these circumstances will likely carry a tremendous social cost on the healthcare workforce and the nation as a whole.

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 (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. Note 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. 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.

Recognizing that such a spectrum exists may help communities identify where they are along this continuum, provide a uniform and consistent way to evaluate and report surge conditions, and illustrate the spectrum of adaptations required to address the situation.

State and Local Policies and Protocols

The issue of crisis standards of care for use in disaster situations involving scarce resources arose largely since 2004, when the Agency for Healthcare Research and Quality (AHRQ) and the ASPR within HHS convened a meeting of experts. Drawn from the fields of bioethics, emergency medicine, emergency management, health administration, law and policy, and public health, experts engaged in groundbreaking discussions and confronted these issues directly. Their deliberations led to a report, Altered Standards of Care in Mass Casualty Events (AHRQ, 2005b), which laid out major concerns and areas that require consideration and recommended next steps for future action. A subsequent report, Mass Medical Care with Scarce Resources: A Community Planning Guide, laid down the framework for much of the current planning efforts (Phillips and Knebel, 2007).

Since the release of the 2005 AHRQ report, many federal, state, and local efforts to develop protocols for the allocation of scarce resources and for standards of care have occurred. Nevertheless, a recent report on state preparedness by the U.S. Government Accountability Office (GAO) and a recent review of HHS’s Hospital Preparedness Program by the Center for Biosecurity of UPMC concluded that among the key components of medical surge planning, “standards of care during a mass casualty event” remained in need of significant additional attention and planning (GAO, June 2008; Toner et al., 2009). Areas of particular concern cited were the need for states to develop protocols for implementing standards of care in disaster situations and the need to achieve a higher level of consistency across neighboring jurisdictions.

Federal policy makers and state and local officials, in consultation with stakeholders from the private healthcare sector, could use the results of this committee’s work to inform the development of more extensive and nationally/regionally consistent standards of care policies and protocols.

Copyright 2009 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK219952

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