INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

September 24, 2009

Nicole Lurie, M.D., M.S.P.H.

Assistant Secretary for Preparedness and Response

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

200 Independence Ave., S.W. Washington, DC 20201

Dear Dr. Lurie:

On behalf of the Institute of Medicine (IOM) Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations, we are pleased to report our conclusions and recommendations. At the request of the Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, the IOM convened this committee to develop guidance that state and local public health officials and health-sector agencies and institutions 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 standards of care protocols, to identify potential 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 crisis standards of care. The committee was asked to consider the roles and responsibilities of various stakeholders in the implementation of the guidance, and to consider mechanisms for integrating the views of the general public and healthcare providers in the development and implementation of the guidance. The committee was also specifically charged with incorporating ethical principles into the guidance. To accomplish its charge within the accelerated time frame, the

committee held a 4-day meeting that included a 1-day workshop. Panel discussions at the workshop focused on federal and state efforts associ-



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September 24, 2009 Nicole Lurie, M.D., M.S.P.H. Assistant Secretary for Preparedness and Response Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services 200 Independence Ave., S.W. Washington, DC 20201 Dear Dr. Lurie: On behalf of the Institute of Medicine (IOM) Committee on Guid- ance for Establishing Standards of Care for Use in Disaster Situations, we are pleased to report our conclusions and recommendations. At the request of the Office of the Assistant Secretary for Preparedness and Re- sponse, Department of Health and Human Services, the IOM convened this committee to develop guidance that state and local public health of- ficials and health-sector agencies and institutions can use to establish and implement standards of care that should apply in disaster situations— both naturally occurring and manmade—under scarce resource condi- tions. Specifically, the committee was asked to identify and describe the key elements that should be included in standards of care protocols, to identify potential triggers, and to develop a template matrix that can be used by state and local public health officials as a framework for devel- oping specific guidance for healthcare provider communities to develop crisis standards of care. The committee was asked to consider the roles and responsibilities of various stakeholders in the implementation of the guidance, and to consider mechanisms for integrating the views of the general public and healthcare providers in the development and imple- mentation of the guidance. The committee was also specifically charged with incorporating ethical principles into the guidance. To accomplish its charge within the accelerated time frame, the committee held a 4-day meeting that included a 1-day workshop. Panel discussions at the workshop focused on federal and state efforts associ- 1

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2 CRISIS STANDARDS OF CARE GUIDANCE ated with establishing standards of care; guidance on standards of care in medical triage events; changing roles and responsibilities of healthcare workers under contingency and crisis standards of care; guidance on le- gal, ethical, and practical issues in setting standards of care in declared emergencies; and identifying triggers. The committee does seek to make clear that the extraordinary time constraints significantly limited the op- portunity to consider more evidence and enlist other stakeholders in the deliberations process. This is particularly true given the complexity and importance of the issues being considered. This letter serves as a sum- mary of the committee’s conclusions and recommendations. Greater de- tail can be found in the relevant report text that follows this letter. Through a careful review of available protocols, the committee rec- ognizes that although some federal, state, municipality, territorial, and health-sector agencies and institutions have made considerable progress in developing protocols, many states have only just begun to address this urgent need. Furthermore, there is a need to develop all protocols around the same key elements and components to ensure coordination, consis- tency, and fair allocation of scarce resources during a disaster. In the development of its national guidance on standards of care, the committee was asked to consider if there should be a single national guidance or scenario-specific guidance. Based on a review of the cur- rently 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 guidance for states for 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 the single general framework, individual disaster scenarios may require specific considerations, such as differences between no-notice events versus slow-onset events, but that the key elements and compo- nents remain the same. The committee was tasked to develop national framework guidance on the key elements that should be included in standards of care proto- cols for disaster situations. Ethical norms in medical care do not change during disasters – health care professionals are always obligated to pro- vide the best care they reasonably can under given circumstances. For purposes of developing recommendations for situations when healthcare resources are overwhelmed, the committee defines the level of health and medical care capable of being delivered during a catastrophic event as crisis standards of care.

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3 LETTER REPORT “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 circum- stances 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 stan- dards of care are in operation enables specific le- gal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations. To ensure that the utmost care possible is provided to patients 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 sets 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 o Transparency—in design and decision making o 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) o Proportionality—public and individual requirements must be commensurate with the scale of the emergency and degree of scarce resources

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4 CRISIS STANDARDS OF CARE GUIDANCE o Accountability—of individuals deciding and implementing standards, and of governments for ensuring appropriate pro- tections and just allocation of available resources • Community and provider engagement, education, and communi- cation—active collaboration with the public and stakeholders for their input is essential through formalized processes • The rule of law o Authority—to empower necessary and appropriate actions and interventions in response to emergencies o Environment—to facilitate implementation through laws that support standards and create appropriate incentives Throughout the report the committee emphasizes 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 col- laboration with their partners in the public and private sectors. This re- port 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 pro- tocols, and criteria for determining when these standards of care should be implemented. With the intent of assisting the many states that are still in the early stages of developing crisis standards of care, the committee lays out a broad process for developing crisis standards of care protocols that en- compasses the full spectrum of the health system, including emergency medical services and dispatch, public health, hospital-based care, home care, primary care, palliative care, mental health, and public health. Fur- thermore, although the compressed time frame limited the scope of the work presented here and the opportunity for a robust community- engagement process, the committee strongly recommends extensive en- gagement with community and provider stakeholders. Such public en- gagement is necessary not only to ensure the legitimacy of the process and standards, but more importantly to achieve the best possible result. Recommendation: 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 de- velop crisis standards of care protocols that include

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5 LETTER REPORT the key elements—and associated components— detailed in this report: • A strong ethical grounding; • Integrated and ongoing community and pro- vider engagement, education, and communi- cation; • Assurances regarding legal authority and en- vironment; • Clear indicators, triggers, and lines of re- sponsibility; and • Evidence-based clinical processes and opera- tions. 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 particu- lar attention given to the needs of vulnerable popula- tions 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 commu- nication strategies; • Developing and implementing community re- silience strategies; and • Learning from and improving crisis stan- dards of care response situations. 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, ethi- cally and clinically sound planning will aim to secure fair and equitable resources and protections for vulnerable groups. The committee con- cluded that core ethical precepts in medicine permit some actions during

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6 CRISIS STANDARDS OF CARE GUIDANCE crisis situations that would not be acceptable under ordinary circum- stances, 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 pa- tients, but it does not provide license to act without regard to professional or legal standards. Healthcare professionals are obligated always to pro- vide the best care they reasonably can to each patient in their care, in- cluding 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 ordi- nary standards are in effect, healthcare practitioners must adhere to ethical norms. Conditions of over- whelming scarcity limit autonomous choices for both patients and practitioners regarding the allocation of scarce healthcare resources, but do not permit ac- tions that violate ethical norms. The committee also addressed issues related to the implementation of standards of care, including legal considerations. Questions of legal em- powerment 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.

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7 LETTER REPORT Recommendation: Provide Necessary Legal Protec- tions 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 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. Finally, and continuing the theme of consistency, the committee highlighted operational issues to ensure the consistent implementation of the 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 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 evi- dence-based, peer-reviewed critical care and other decision tools and recommend and im- plement decision-making algorithms to be used when specific life-sustaining resources become scarce; • Providing palliative care services for all pa- tients, 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

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8 CRISIS STANDARDS OF CARE GUIDANCE by following a concept of operations devel- oped for disasters; • Developing specific response measures for vulnerable populations and those with medi- cal special needs, including pediatrics, geriat- rics, 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 inter- state consistency in the implementation of crisis stan- dards of care. Specific efforts are needed to ensure that the Department of Defense, Veterans Health Administration, and Indian Health Services medical facilities are integrated into planning and response efforts. The guidance outlined here is intended to assist federal, tribal, state, and local officials in the development of more uniform crisis standards of care policies and protocols that are applicable in any disaster impacting the public’s health. Applying the guidance and principles laid out in the report, the committee developed two brief case studies that may serve to illustrate the implementation crisis standards of care. Recognizing the current attention and concern surrounding the 2009 H1N1 pandemic, one scenario focuses on a gradual-onset influenza pandemic modeled around potential issues that may arise this fall during the current pandemic. The second scenario focuses on an earthquake as a model for discussion of the issues that would arise due to a no-notice sudden onset event. The committee’s intent is to provide a framework that allows consis- tency in establishing the key components required of any effort focused on crisis standards of care in a disaster situation. It also intends that by suggesting a uniform approach, consistency will develop across geo- graphic and political boundaries so that this guidance will be useful in

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9 LETTER REPORT contributing to a single, national framework for responding to crisis in a fair, equitable, and transparent manner. The committee appreciates the opportunity to begin to lay the foun- dation for this important two-phase project as well as the opportunity to help the nation prepare not only for the upcoming pandemic, but for all disaster scenarios where the health system may be stressed to its limits. We look forward to undertaking the second phase of this project, in which the committee will expand stakeholder and public engagement efforts, as well as update and expand the guidance based on input and feedback from individuals and groups involved in the development and implementation of crisis standards of care. Lawrence O. Gostin, J.D., Chair Dan Hanfling, M.D., Vice Chair Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations

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10 CRISIS STANDARDS OF CARE GUIDANCE BACKGROUND The current influenza pandemic caused by the 2009 H1N1 virus un- derscores 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 communi- ties across the United States. Although this may occur over hours, days, or weeks, this overwhelming surge on the healthcare system will dra- matically 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). 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 re- sponse, 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 develop- ment of systematic and comprehensive policies and protocols for stan- dards 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 nation- ally/regionally consistent crisis standards of care policies and protocols that are applicable to all disaster situations. The committee developed

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11 LETTER REPORT BOX 1 Statement of Task In response to a request from the Department of Health and Human Ser- vices’ Office of the Assistant Secretary for Preparedness and Response (ASPR), the Institute of Medicine (IOM) will convene an ad hoc committee to conduct a two-phase activity on standards of care for use in disaster situations. The committee will focus attention on developing guidance to establish stan- dards of care that should apply to disaster situations—both naturally occurring and manmade—where resources are scarce. Ethical principles will be incorpo- rated into the standards. Phase 1 An ad hoc committee of the IOM will conduct a study and issue a letter re- port to the ASPR by October 1, 2009. The letter report will provide guidance on standards of care for use in disaster situations. Specifically, the committee will: • Develop preliminary framework guidance that identifies and describes the key elements that should be included in disaster standards of care protocols; • Identify potential triggers that can be used by state and local public health officials to develop standards of care protocols that will assist healthcare providers; • Develop a template matrix that can be used by state and local public health officials as a framework for developing specific guidance for healthcare providers to develop disaster standards of care; • Consider roles and responsibilities of various stakeholders in the im- plementation of the guidance; and • Consider mechanisms for integrating the views of the general public and healthcare providers in the development and implementation of the guidance. The letter report will identify triggers that indicate a need to change from nor- mal standards to disaster standards. Disaster standards will consider ap- proaches to conserving, substituting, adapting. and doing without resources. The committee will not be responsible for establishing, creating, or defining standards of care. The committee will also commission a paper to be delivered by Septem- ber 1, 2009. This commissioned paper will provide background to the commit- tee deliberations and will examine the key elements in existing state and local standards of care protocols and the impact of allocation schemes on disaster standards, and propose framework guidance for national disaster standards that can be applied to nH1N1 response for the coming fall flu season. In addi- tion, the commissioned paper will explore issues related to the implementation of standards of care protocols, including legal considerations. The committee will base its recommendations on currently available policies, protocols, pub- lished literature, and other available guidance documents and evidence, as well as its expert judgment.

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82 CRISIS STANDARDS OF CARE GUIDANCE available information that was the best available to the committee at the time of writing. Although the most examined decision tools revolve around mechani- cal ventilation, guidance is also available for other core medical care components (medications, oxygen, etc.) and limited guidance is available for specific other resources (see Box 6) (Minnesota Department of Health, 2008). Little guidance is available for the dispatch, EMS, home care, long-term care, and ambulatory care environments as part of the overall health system within a community. Though much of the core component guidance does apply, agencies and entities should examine potential scarce resources and outline coping strategies using base prin- ciples similar to those for hospital environments (Rubinson et al., 2008; ANA, 2008). None of the current systems or guidance was designed for pediatrics or other medical special needs patients, and this gap should be addressed by appropriate specialty expert groups. Finally, the needs of other vulnerable populations should also be kept in mind to ensure fair- ness in the system that is developed. BOX 6 Select Specific Resource Issues Note: synopsis and examples are not comprehensive, but suggest areas for state guidance and expert working group efforts. Blood products—The American Association of Blood Banks can facilitate blood delivery rapidly to areas affected by disasters. However, in the immediate af- termath of a catastrophe, local shortages may occur. Hospital blood banks and their suppliers should determine triage plans ahead of time, altering in- dications for transfusion and capping use of products where necessary (Schmidt, 2002; Ontario Ministry of Health and Long-term Care, 2008). Elective surgery triage—Assessment of surgical schedules during an event may require a cancellation of the procedures that are most likely to require post- operative critical care and may assist in opening/maintaining capacity. De- termining which procedures may be safely deferred and for how long is important. Ontario’s and Utah’s plans both include assessments of elective surgeries (Ontario Ministry of Health and Long-term Care, 2008; The Utah Hospitals and Health Systems Association, January 2009). Trauma carea—Catastrophic disasters may produce overwhelming numbers of trauma patients. Most disasters do not overwhelm surgical services, but con- tingency (conducting temporizing surgical procedures, performing bedside procedures, limiting interventions to patients with good outcome and single- system trauma) and crisis (providing no interventions in the operating room in favor of controlling hemorrhage in multiple patients and performing chest decompression and other limited life and limb-saving interventions) plans

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83 LETTER REPORT should be understood by the surgical and support staff (Eastridge et al., 2006; Propper et al., 2009). Radiationa—Guidelines for triage of radiation incident victims are widely available, though literature and predictive instruments are scant for victims of combined trauma and radiation injury (Waselenko et al., 2004; Fliedner et al., 2001; REMM, 2009; IAEA, 2009). Guidance for response to an improvised nuclear device detonation with more detailed guidance for health and medical re- sponse is to be published in 2010 (DHS, January 2009). Burn carea—Care of multiple burn victims requires exceptional amounts of anal- gesia, intravenous fluids, and burn dressings. However, these may be inex- pensively and easily stockpiled. In mass casualty events, an age/percentage burn table has been published as an adjunct for triage decisions (Saffle et al., 2005). Providing care to many victims with limited staff and burn unit space must be addressed in planning (Posner et al., 2003). Cancer—During a disaster, continued comfort and care appropriate to the re- sources available should be ensured. Particular emphasis for palliative care needs should be considered in this population. Ontario has published basic guidance to assist with determining priorities for this special population (On- tario Ministry of Health and Long-term Care, 2008). Renal replacement—Availability of renal replacement therapy may be extremely limited after a disaster due to competing demands for dialysis from incident- related patients or unsafe water supply. Deferral of usual dialysis schedules and indicators may have to occur, and other measures instituted. Ontario has published basic guidance to assist with determining priorities for this special population (Ontario Ministry of Health and Long-term Care, 2008). Vaccines—Pandemic and other vaccines may initially be in short supply, and pri- orities may need to be established. Liability and mass vaccination logistic is- sues may have to be addressed. Guidance for administration will come from the Centers for Disease Control and Prevention, or CDC (e.g., Advisory Committee on Immunization Practice’s recommendations for 2009 H1N1 vaccine priority groups). However, further splitting of priority groups may have to occur at the state and even institutional level depending on supply (CDC, 2009c). Antiviral medications—By example, some medications in relative shortage may be targeted to those at highest risk, those most likely to benefit, or use reduced to prevent evolution of resistance. Limited treatment of 2009 H1N1 with anti- viral medication recommendations from the CDC are an example of this form of triage of resources and must be adopted and circulated by the state and voluntarily implemented by providers (CDC, 2009d). a Regional (may be interstate or intrastate) planning should provide for hospitalization of the most critical patients at appropriate centers, with diffusion of less critical victims to commu- nity hospitals and transfers used when possible.

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84 CRISIS STANDARDS OF CARE GUIDANCE Some literature is available to predict in-hospital requirements for critical care and to make general mortality predictions, and these may be useful when determining whether to hospitalize patients, send them home, or transfer them to an alternate care setting. However, these scores are not as useful in comparative prediction of mortality and are not pre- cise, thus, the committee cannot recommend specific prognostic tools based on clinical assessment at this time (Talmor et al., 2007; Challen et al., 2007). A concept originating in military triage which, though not a tool per se, may be used to weigh resource commitment is “minimum qualifica- tions for survival” (MQS), which is the idea that one critically ill patient may consume the resources that could save several other patients, and may have their resource allocation reduced or withdrawn by establishing a ceiling on resources expended on a single patient (Christian et al., 2006). As an example, in military mass casualty experience described by Propper, 8 percent of patients consumed 43 percent of blood products used. In situations of resource shortages where the resource is titrated or dosed (medications, IV fluids, blood products, but not ventilators), the clinical care committee may wish to establish a ceiling on the amount of resources required in addition to changes to indications for treatment (Propper et al., 2009; Beekley et al., 2007; Eastridge et al., 2006; AMA, 2007). Triage of limited mechanical ventilators may have to occur in perva- sive events when no alternatives are available and temporizing therapies (e.g., bag-valve ventilation) cannot be implemented. Using the CDC’s Flu Surge 2.0 models for a severe pandemic (and assuming an 8-week pandemic wave, which is likely more compressed than what will be ob- served) suggests that at a busy, urban Level 1 trauma center, approxi- mately 0.62 patients per hour may present during the peak weeks of the first wave with respiratory failure, necessitating ongoing monitoring and triage of resources to those with the best possible chance of survival (CDC, 2006). Those triaged to receive mechanical ventilation thus re- ceive a therapeutic trial of ventilation. Predictions are applied to all ICU patients, not just incident-related patients. If the patient does not respond to an adequate trial, worsens, or another patient with a significantly bet- ter chance of benefit presents, the trial may be ended and the resource reallocated (Devereaux et al., 2008b; Hick and O’Laughlin, 2006; Chris- tian et al., 2006; Hick et al., 2007; VHA, 2008). Notably, the “therapeu- tic trial” may require days, as young, healthy individuals with severe pneumonia or respiratory distress syndrome may take many days to re-

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85 LETTER REPORT spond to treatment. All patients should be reassessed at least every 24 hours, however. As triage continues over days to weeks, the trend toward healthier patients on the available ventilators will likely reduce the de- gree of ventilator turnover compared to early in the triage process. The impact of such decisions on providers and family, not to men- tion patients, cannot be understated and requires careful management of expectations on hospital admission as well as support and thoughtful transition plans as care is withdrawn to assure patient comfort and con- tinued supportive care to the extent possible. Due to the unique characteristics of ventilators (limited, expensive, technically complex resources that provides life-saving intervention and cannot be shared or titrated), much of the current decision tool efforts have centered around ventilator triage and critical care triage (Devereaux et al., 2008b; Christian et al., 2006; Hick et al., 2007; Hick and O’Laughlin, 2006). The decision tools generally are based on prognosis of the acute illness and any severe, underlying diseases that drastically limit life expectancy. Guidelines for ventilator triage have already been adopted by several states and are in consideration by many others (Minnesota Department of Health, August 2008; The Utah Hospitals and Health Systems Associa- tion, January 2009; Colorado Department of Public Health and Environ- ment, July 2009). These guidelines are generally based on several articles published in the past few years. Thus far, the Sequential Organ Failure Assessment (SOFA) score is used by all proposed systems as a core component (Vincent et al., 1996; Moreno et al., 1999; Vincent et al., 1998; Peres Bota et al., 2002; Pettila et al., 2002). SOFA uses clinical and some simple laboratory variables (PaO2, bilirubin, creatinine) to pre- dict outcome by assessing degree of organ system dysfunction and is one of the least complex and most predictive available metrics for prognosis prediction in critical care. Some systems consider other factors such as expected duration of ventilation, underlying diseases, or duration of benefit (Minnesota De- partment of Health, August 2008; Devereaux et al., 2008b). Others in- corporate exclusion criteria to varying degrees (VHA, 2008, 2009; The Utah Hospitals and Health Systems Association, January 2009; Devereaux et al., 2008b; White et al., 2009; Christian et al., 2006; Hick and O’Laughlin, 2006). Incorporation of age as a specific variable has been proposed by one author (White et al., 2009). Though the “fair innings” argument to allow ventilator allocation to younger patients is attractive at face value, age is not a medically useful

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86 CRISIS STANDARDS OF CARE GUIDANCE predictor of outcome; use of age as a criterion in and of itself also raises ethical and legal concerns. Until society determines through public en- gagement that age-based triage (or other non-medical criteria such as functional capacity) is appropriate and defines an appropriate range, the committee recommends avoiding age-based criteria. Furthermore, the committee cautions against the prima facie use of DNR status as a deci- sion tool, as underlying, life-limiting medical conditions should primarily be used as triage criteria rather than the fact that the patient has provided an advance directive. The committee also notes that, although SOFA is useful to assign retrospective survival prediction, it was not designed as a prospective predictor of survival, and thus, differences in a single point on the SOFA scale are of unknown clinical significance for prediction of outcome. This should be considered, particularly when attempting any modifica- tion or extension of the SOFA scale beyond its initial construct that may further compromise its predictive value and when using systems that would assign or discontinue a resource based on a single-point change in the SOFA score. SOFA has not been validated on a pediatric population. Although the principles of increasing mortality with increasing multi-organ dysfunc- tion do apply, caution must be exercised when using SOFA to make any- thing but broad comparisons. Currently, predictive scoring systems for pediatrics (e.g. PRISM, P-MODS) are being considered for use in per- forming pediatric triage for ventilator allocation (Pollack et al., 1988; Graciano et al., 2005). However, at least one of these tools, PRISM, in- volves the evaluation of additional laboratory variables than those re- quired for SOFA, and therefore might be more difficult to apply under conditions of crisis care. The other tool, P-MODS, evaluates parameters different than those used in SOFA scoring. The committee concludes that urgent recommendations from pediatric disaster groups and research are needed to address this gap. Adopters of decision tools should understand their limitations and scope and communicate issues of uncertainty to the triage team members. The only process and triage system that is the output of an expert, specialty society working group with broad stakeholder input at this time is that of the American College of Chest Physicians (ACCP) (Devereaux et al., 2008b). The advantage of the ACCP process, though less specific than some systems, is that it considers duration of need and underlying disease in addition to the SOFA score acuity assessment. The basic triage process is outlined in Figure 4 and the exclusion criteria are described in

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87 LETTER REPORT Box 7, with additional supportive materials available in the original arti- cle. This process has informed most state guidance and other system guidance, including the VHA and other guidelines (Minnesota Depart- ment of Health, August 2008; VHA, 2008, 2009; The Utah Hospitals and Health Systems Association, January 2009; Colorado Department of Public Health and Environment, July 2009). If triage of mechanical ventilation/critical care becomes necessary assess existing critical care patients according to: • SOFA score • Expected duration of mechanical ventilation • Any severe, life-limiting underlying disease states • Other disease-specific factors Order patients from most sick to least sick and reassess daily or as conditions warrant New patient requires mechanical ventilation - Assess patient SOFA score, expected duration (rough) of mechanical ventilation, and underlying disease states or other contributing data/prognosticators (as above) Patient has exclusion criteria?a YES NO Triage out of critical care area YES Existing patients that no longer require critical care with appropriate transition (improved) or meet exclusion criteria (worsening)? a care for condition and reassess resource availability NO NO Treatment trial of ventilation if available for new patient, if no ventilator available contrast needs of new patient against existing “most sick” patient(s) - Compelling reason to reallocate from currently ventilated patients? YES Reallocate ventilator/resources to new patient, transition care for prior ventilated patient to available support given circumstances including appropriate palliative care FIGURE 4 Triage algorithm process. a Example exclusion criteria include severe, irreversible organ failure (CHF, liver, etc), severe neurologic compromise, extremely high or not improving SOFA scores, etc. SOURCE: Adapted from Devereaux et al. (2008b).

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88 CRISIS STANDARDS OF CARE GUIDANCE BOX 7 Exclusion Criteria Prompting Possible Reallocation of Life Saving Interventions Severe, chronic disease with a short life Sequential Organ Failure As- expectancy sessment (SOFA) score criteria: A. Severe trauma patients excluded from critical B. Severe burns on patient with any two of care if risk of hospital mortality the following: > 80% i. Age > 60 yr A. SOFA > 15 ii. > 40% of total body surface area af- B. SOFA > 5 for >5 d, and with fected flat or rising trend iii. Inhalational injury C. > 6 organ failures C. Cardiac arrest i. Unwitnessed cardiac arrest ii. Witnessed cardiac arrest, not re- sponsive to electrical therapy (defi- brillation or pacing) iii. Recurrent cardiac arrest D. Severe baseline cognitive impairment E. Advanced untreatable neuromuscular disease F. Metastatic malignant disease G. Advanced and irreversible neurologic event or condition H. End-stage organ failure (for details see Devereaux et al., 2008b) I. Age > 85 yr (see Lieberman et al., 2009) J. Elective palliative surgery SOURCE: Adapted from Devereaux et al. (2008b) Critical care and ventilator allocation decision tools should be consistent with currently available evi- dence-based expert panel and national critical care guidelines, although modifications may be made to meet the specific needs of the state. Of note, ventilators may not be the only relevant limitation to me- chanical ventilation, as available staff, oxygen, and medication supply may not be able to support significantly more ventilators than the hospi- tal normally uses due to design and supply limitations, thus, wholesale purchase of ventilators may not obviate the issue. Finally, decision tools may be supplemented by event-specific information (e.g., mortality data

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89 LETTER REPORT during a pandemic for particular underlying disease states or age ranges) or by supplemental prognostic information (e.g., as discussed in pallia- tive care section). During an event such as a pandemic, federal guidance may be issued or epidemiologic information may be available that may affect state guidelines. As evidence improves in triage science, modifications to these rec- ommendations are likely. The state department of health or other appro- priate office must maintain an advisory panel that can consider and incorporate necessary updates to this information prior to and during events and provide feedback on or assist with crisis clinical guidance development to ensure that the best available evidence is used should this type of triage be required. These state entities are encouraged to work with localities to ensure that local/regional coordination is occurring in real-time. Recommendation 6: 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 in response to a disaster event. These efforts should include: • Using “clinical care committees,” “triage teams,” and a state-level “disaster medical advisory committee(s)” that will evaluate evi- dence-based, peer-reviewed critical care and other decision tools and recommend and im- plement decision- making algorithms to be used when specific life-sustaining resources become scarce. • Providing palliative care services for all pa- tients, including provision of comfort, com- passion, 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 devel- oped for disasters;

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90 CRISIS STANDARDS OF CARE GUIDANCE • Developing specific response measures for vulnerable populations and those with special medical needs, including pediatrics, geriat- rics, and persons with disabilities. • Implementing robust situational awareness capabilities to allow for real-time information sharing across affected communities and with the “disaster medical advisory committee.” CONCLUSION The potential tragedy wrought by catastrophic disaster, whether natu- rally occurring or due to intentional acts, should serve as a clarion call to political leadership, policy makers, disaster planners, and the community at large to carefully plan for the allocation of scarce resources efficiently and fairly. Under circumstances in which demand for care exceeds sup- ply, access to a broad continuum of healthcare resources—including those required for life-sustaining intervention—may be curtailed. Disas- ter events may challenge the depth of human, materiel, and intellectual resources required to respond to them. A highly pathogenic pandemic, detonation of a nuclear weapon, destructive earthquake, or severe hurri- cane could each pose challenges to the delivery of health care beyond the “imaginable.” For this reason, it is imperative that as a nation, we con- sider our response to such events, ensuring that the processes we use to triage the delivery of care meet the highest ethical standards, and are based on the humanitarian imperative that “all possible steps should be taken to prevent or alleviate human suffering arising out of…calamity, and that civilians so affected have a right to protection and assistance” (The Sphere Project, 2004). In addition, while all populations remain vulnerable to catastrophic events particular populations remain more vulnerable than others. These populations—as described in the commit- tee’s report—should be given particular attention to make sure their unique needs are considered in disaster planning and response efforts. As such, the Committee supports the efforts of the World Health Organiza- tion and similar agencies in affirming the importance of addressing health inequities and the social determinants of health because those most vulnerable in communities prior to a disaster are those most likely to be impacted adversely by the disaster itself (WHO, 2008).

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91 LETTER REPORT A number of overarching, guiding principles that were first eluci- dated in 2004 (AHRQ, 2005b) remain relevant in the discussion of this complex topic and were considered by the committee: • Allocation of scarce resources is ultimately intended to preserve the functioning of the healthcare system, and to deliver the best care possible under emergency circumstances. • Planning for the health and medical response to a catastrophic, mass casualty event must take a regional, systems approach, and involve a broad array of public and private community stake- holders. • Adequate ethical and legal frameworks must be in place that pro- tect both the rights of patients and the rights of those providing care to patients, despite the austere conditions under which such care is being delivered. • Active engagement of the public is essential; transparent com- munication of the complexities and challenges related to disaster responses must occur before, during, and after any catastrophic event to mitigate the potential for social disorganization and to promote community resilience. Crisis standards of care, as described in this report, will be required when the intent and ability to provide usual care is simply no longer pos- sible 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 fur- ther discussion, evaluation, and study. Some of these issues constitute real or perceived barriers that will make the implementation and opera- tionalization 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 (see Table 8), the committee is greatly encouraged by the search for solutions that are taking place. In studying this issue, the committee’s intent is to provide a frame- work that allows consistency in describing the key components required by any effort focused on standards of care in a disaster. It also intends that, by suggesting such uniformity, consistency will develop across ju- risdictions, regions, and states so that this guidance will be useful in con-

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92 CRISIS STANDARDS OF CARE GUIDANCE tributing to a uniform national framework for responding to crisis in a fair, equitable, and transparent manner. TABLE 8 Impediments to Crisis Standards of Care Implementation Key Elements Gaps to Crisis Standards Implementation Ethical elements o Articulation of community values and preferences regarding allocation of scarce resources o Consultation and education for practitioners and com- munity about which actions are ethically justifiable during crisis standards, and which are not Community and provider Absence of public and stakeholder discussion frame- o engagement work Absence of “clearinghouse” repository for collected o works Financial impact of resource-sparing strategies o Financial commitments for community engage- o ment/education processes Incomplete, inconsistent regional partnership devel- o opment Legal authority and Inconsistent liability protections o environment Inconsistent application of scope of practice o Uncertainty about existing liability protections o Uncertain role of community “informed consent” o Indicators and triggers o Limited situational awareness and real-time informa- tion exchange Clinical process and Limited evidence base for select population groups o operations (pediatrics, geriatrics) Uncertain expectations for completion of diminished o documentation Uncertain process for deescalation from crisis care to o conventional care (return to “normalcy”) Uncertain processes for developing constructive after- o action reports documenting crisis care responses Uncertain strategy for using community-based assets o of the health system (i.e., private practices, ambulatory care clinics) in managing a crisis surge response Lack of meaningful/realistic exercise opportunity to o evaluate scarce resource planning