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Crisis Standards of Care: Summary of a Workshop Series Introduction 1 The United States faces the real possibility of a catastrophic public health event that involves tens of thousands or hundreds of thousands of victims. Public health emergencies—such as the 2009 H1N1 pandemic, an intentional anthrax release, infectious disease threats such as severe acute respiratory syndrome (SARS), fires, floods, earthquakes, and hurricanes—highlight the ever-changing threats posed by acts of terrorism and other public health emergencies, while also underscoring the pressing reality of these events. A tremendous effort has been made over the past decade to prepare for public health emergencies. Many states and healthcare organizations have developed preparedness plans that include enhancing surge capacity to increase and maximize available resources and to manage demand for healthcare services in response to a mass casualty event. During a wide-reaching catastrophic public health emergency or disaster, however, these surge capacity plans may not be sufficient to enable healthcare providers to continue to adhere to normal treatment procedures and follow usual standards of care. This is a particular concern for emergencies that may severely strain resources across a large geographic area, such as a pandemic influenza or the detonation of a nuclear device. Healthcare organizations and providers may face overwhelming demand for services, severe scarcity of material resources, insufficient numbers of qualified providers, and too little patient care space. Under these circumstances, it may be impossible to provide care according to the standards of care used in non-disaster situations, and, under the most extreme 1 The planning committee’s role was limited to planning the series of regional workshops, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the regional workshops.
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Crisis Standards of Care: Summary of a Workshop Series circumstances, it may not even be possible to provide basic life-sustaining interventions to all patients who need them. In recent years, a number of federal, state, and local efforts have taken place to develop crisis standards of care protocols and policies for use in conditions of overwhelming resource scarcity. Those involved in these efforts have begun to carefully consider these difficult issues and to develop plans that are ethical, consistent with the community’s values, and implementable during a crisis. These planning efforts are essential because, absent careful planning, there is enormous potential for confusion, chaos, and flawed decision making in a catastrophic public health emergency or disaster. However, although these efforts have accomplished a tremendous amount in just a few years, a great deal remains to be done in even the most advanced plan. Furthermore, the efforts have mainly been taking place independently, leading to a lack of consistency across neighboring jurisdictions and unnecessary duplication of effort. Lastly, many states have not yet substantially begun to develop policies and protocols for crisis standards of care during a mass casualty event. These issues prompted the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events (Preparedness Forum) to organize a series of regional workshops on this topic. These workshops were held in Irvine, CA; Orlando, FL; New York, NY; and Chicago, IL, between March and May of 2009. FORUM AND WORKSHOP OBJECTIVES The IOM’s Preparedness Forum was established to foster dialogue among a broad range of stakeholders—practitioners, policy makers, community members, academics, and others—and to provide ongoing opportunities to confront issues of mutual interest and concern. The Forum provides a neutral venue for broad-ranging policy discussions that can aid in coordination and cooperation between public and private stakeholders in developing and enhancing the nation’s medical and public health preparedness. Sponsoring members include federal agencies, state and local associations, health professional associations, and private-sector business associations. The goals of the workshops on Crisis Standards of Care were to learn from the work already being done to develop state, regional, and local crisis standards of care policies and protocols; to identify areas that re-
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Crisis Standards of Care: Summary of a Workshop Series quire further development, research, and consideration; and to facilitate communication and collaboration among neighboring jurisdictions. Organized by an independent planning committee, the workshops brought together a wide range of key stakeholders, including policy makers from state and local public health departments; local and regional public health leaders; local and state government representatives; healthcare providers, including representatives of relevant medical disciplines, nursing, pediatrics, emergency medical services (EMS), palliative care, mental health, hospice, and home health; and healthcare and hospital administrators. See Appendix C for workshop agendas and Appendix E for biographical sketches of planning committee members, invited speakers, and panelists. This report is a summary of the presentations and discussions that took place during the workshop. Any opinions, conclusions, or recommendations discussed in this workshop summary are solely those of the individual participants at the workshop and are not necessarily adopted, endorsed, or verified by the Forum or the National Academies. Workshop speakers and attendees discussed the roles and responsibilities of each stakeholder community in establishing state, regional, and local crisis standards of care protocols. In addition, they were asked to discuss what resources, guidance, and expertise had been established regarding crisis standards of care, including the legal and ethical guidance used to frame those discussions in different localities across the country. Finally, meeting participants were asked to help identify and discuss what resources they needed from federal, state, and regional authorities in order to advance and accelerate the establishment of coordinated and consistent crisis standards of care protocols. This workshop summary aims to highlight the extensive work that has already been done on this topic across the nation and to raise awareness of current barriers and promising directions for future work. In particular, this document will draw attention to existing federal, state, and local policies and protocols for crisis standards of care; discuss current barriers to increased provider and community engagement; relay examples of existing interstate collaborations; and present workshop participants’ ideas, comments, concerns, and potential solutions to some of the most difficult challenges.
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Crisis Standards of Care: Summary of a Workshop Series RELATED IOM WORK ON CRISIS STANDARDS OF CARE This workshop series served as background for a subsequent Institute of Medicine letter report entitled Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations (IOM, 2009). This letter report was requested by the Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). The workshop series was organized prior to the onset of the letter report and was not technically part of those efforts. However, the committee that authored the letter report was aware of the information discussed at the regional workshops and this information was subsequently used as one of the key background sources for the committee’s work. Consequently, the letter report helped to inform and advance many of the issues that were identified by participants at the workshops. Unlike this workshop summary, the letter report offers a series of consensus committee recommendations. The report concludes that “[i]n an important ethical sense, entering a crisis standards 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 committee also concluded that there is an urgent and clear need for a single national 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 recognized 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. The report articulates current concepts and 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 crisis standards of care in disasters in which resources are scarce. The committee also identified a series of five key elements and associated components that should be included in all crisis standards of care protocols. Finally, in an extensive “operations” section, the report provides guidance to clinicians, healthcare institutions, and state and local public health officials on how those crisis standards of care should be implemented in a disaster situation. A summary of the committee’s recommendations, findings, and practical guidance is included in Appendix B.
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Crisis Standards of Care: Summary of a Workshop Series The complete letter report is available at http://www.iom.edu/disasterstandards. Definition of “Crisis Standards of Care” For purposes of developing recommendations for situations in which healthcare resources are overwhelmed, in the letter report the IOM committee defined the 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. This definition was developed by the committee that authored the letter report after the workshops took place, and no formal definition was used for the purposes of the workshop. In addition, for consistency this workshop summary uses the term “crisis standards of care” even though this term was only adopted by the IOM after the workshops took place. The remainder of this document outlines the discussions and presentations that took place during the workshops. Other Related Work The IOM letter report and these regional workshops built on a series of previous efforts, many of which were mentioned during the workshops. Workshop attendees praised the work of the Agency for Healthcare Research and Quality (AHRQ) and the Office of the Assistant Secretary for Preparedness and Response for driving the discussion for-
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Crisis Standards of Care: Summary of a Workshop Series ward. The two agencies came together in 2004 to jumpstart the discussion by convening a panel with experts in the fields of bioethics, emergency medicine, emergency management, health administration, health law and policy, and public health. The result of that meeting was a critical document, Altered Standards of Care in a Mass Casualty Event, which served as a foundational document for communities approaching the issues of critical care (AHRQ, 2005). Producing the document, however, was not easy. “When we first starting working on this subject in 2004, [hospital leaders] wouldn’t even agree to sit with us,” said Sally Phillips, director of public health emergency preparedness for AHRQ. “Their risk managers wouldn’t allow them to come.” A subsequent report, published in 2007 and entitled Mass Medical Care with Scarce Resources: A Community Planning Guide, further advanced the field by providing an initial framework for developing policies and protocols for crisis standards of care (Phillips and Knebel, 2007). Professional societies and academia also have made several recent efforts. Many workshop participants were involved with or highlighted the work undertaken through the American College of Chest Physicians, which resulted in a supplemental issue on the management of mass critical care in the journal Chest. This group brought together a multidisciplinary group of experts to provide an in-depth look at current U.S. and Canadian baseline critical care preparedness and response capabilities and limitations, and developed a framework for the development of mass critical care plans. Of particular interest to the workshop participants was the work on allocation of scarce critical care resources (Devereaux et al., 2008). The American Nurses Association (ANA) has also addressed this topic (ANA, 2008; Gebbie et al., 2009). CRISIS STANDARDS OF CARE PROTOCOLS In the past few years, several states have developed policies and protocols for allocation of scarce resources and crisis standards of care. However, these efforts have largely been taking place independently. In fact, many workshop participants expressed surprise at learning how much work had already been done on this topic in states across the nation.
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Crisis Standards of Care: Summary of a Workshop Series Many panelists and other participants at the workshops were integrally involved in developing those policies and protocols and shared their documents and experiences at the workshops. Among the states that have publicly available protocols are California, Colorado, Massachusetts, Minnesota, New York, Utah, Virginia, and Washington (California Department of Public Health, 2008; Colorado Department of Public Health and Environment, 2009; Levin et al., 2009; Minnesota Department of Health, 2008; Powell et al., 2008; The Commonwealth of Massachusetts Department of Public Health, 2007; The Utah Hospitals and Health Systems Association, 2009; Virginia Department of Health, 2008; Washington State Department of Health’s Altered Standards of Care Workgroup, 2008). In Canada, the province of Ontario has also developed crisis standards of care protocols, including particular considerations for patients with cancer or chronic renal disease/acute renal injury, and for blood services and long-term care (Ontario Ministry of Health and Long-term Care, 2008). At the federal level, the Veterans Health Administration (VHA) has developed a protocol for allocation of scarce life-saving resources in VHA during an influenza pandemic (VHA, 2008a, 2009a). Despite the ongoing work in pockets around the country, it was also clear that most state and local governments and healthcare facilities were in very early stages of developing such policies and protocols or had yet to begin. Among participants who completed the feedback survey after the workshops, just less than half responded that the organization they represented had developed or begun to develop crisis standards of care policies (see Appendix D for the complete set of responses). At the meeting in Orlando, Kenn Beeman, a senior physician in the Office of Emergency Planning and Response for the Mississippi State Department of Health, discussed significant barriers in his state that have, to date, prohibited the development of crisis standards of care protocols and the engagement of providers in this issue. Among them, “The vast number of Medicare, no-care, no-pay patients [in Mississippi, Arkansas, and West Virginia] places a burden on us from the standpoint of reimbursement,” he said. “Philosophically, [many providers] believe that they are already practicing potentially in somewhat of an altered standard of care.”
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Crisis Standards of Care: Summary of a Workshop Series Developing Crisis Standards of Care Protocols Many participants at the workshops described efforts under way in their states to begin the discussion about crisis standards of care. In many cases this involved convening a committee or panel of experts to begin to lay the groundwork. For example, in Louisiana the Department of Health and Hospitals organized a Pandemic Influenza Clinical Forum, which was designed to engage a wide variety of healthcare participants to provide guidance to the state as it develops policy and procedural guidelines for crisis standards of care (Box 1). The goal of the group is to use the clinical expertise and knowledge of its members to help develop decision-making steps or matrixes for the ethical distribution of scarce medical resources. Drawing on the experiences of states already significantly advanced in the process of developing crisis standards of care protocols, the 2009 IOM letter report laid out a five-step process that states could follow to develop such protocols (Appendix B; IOM, 2009). This process, together with the adoption of key elements and components that the committee identified, offers an opportunity to develop a consistent national framework for crisis standards of care. “The challenge is not to wait for every community in the country to have a disaster befall [its] own citizens, but to figure out how can we proactively move this conversation forward,” said Edward Gabriel, the director of global crisis management and business continuity at The Walt Disney Corporation. BOX 1 Louisiana Pandemic Influenza Clinical Forum Priorities Researching existing data/resources Planning/collaborating with other states Identifying key partners/organizations Identifying standards to be addressed Identifying the scope of clinical practice Developing “triggers” to activate Developing an algorithm for allocation of limited resources Funding to develop protocols Guidance and support from federal authorities
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Crisis Standards of Care: Summary of a Workshop Series Several workshop participants emphasized that careful advance planning to avoid or mitigate the effects of scarce resources, along with other aspects of effective surge capacity planning, would in fact decrease or delay the need to implement crisis standards of care. Who Makes the Plan? One of the topics discussed in detail at each regional meeting was who should be brought to the table to ensure that the protocols developed are fair and equitable. One of the first steps toward building consensus on fair and ethical crisis standards of care is to bring in all of the parties who have a stake in the discussion. It is not enough, clearly, for a single hospital to have an established plan for how it will handle resource shortages. Those plans must be shared and coordinated across regional lines to prevent the kind of “hospital shopping” that could cause chaos and further overwhelm the system. Participants discussed the importance of bringing political and community leaders and members of the media into the fold and encouraging them to reach out to their communities to educate, inform, and, if necessary, guide appropriate behavior. Many participants also stressed that the community must be engaged, emergency medical experts consulted, and external providers such as pharmacists and insurance providers enlisted in the cause. However, one lesson that emerged from the workshops is that the list of groups that should be involved and engaged in the planning process is much bigger even than this (Box 2). Deborah Levy, chief of health preparedness for the Centers for Disease Control and Prevention (CDC), described a program in which the CDC works with a community to develop a model for healthcare delivery during a public health crisis. Communities are selected based on a set of criteria, one of which is the level of collaboration between public health and the various components of the healthcare sector. “We want 911 and other call centers, emergency medical services, emergency departments, hospital administrators, public health, primary care providers, urgent care and other outpatient clinics, long-term care and skilled nursing facilities, hospice and palliative care, home health organizations, pharmacists, emergency management, local government such as mayors, and VA [Veterans Administration] and DoD [Department of Defense] facilities if they happen to be in your community,” said Levy. “We usually require at least three representatives from
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Crisis Standards of Care: Summary of a Workshop Series each of those sectors to be at the table and over a 2½-day time period … to think through how they’d deliver care.” Others added further to that list, including groups traditionally considered completely outside the healthcare field, such as funeral directors and morticians. The reason for including all these different participants in planning goes deeper than the simple practicality of integrating care. “If you’re doing this kind of emergency planning … every institution needs to be represented,” said Gabriel of The Walt Disney Corporation. “Otherwise they will sit back after you are done and say that they had no involvement.” Gabriel noted that the lack of participation paves the way for outsiders to criticize the difficult decisions when the time comes. That makes it particularly critical to capture the buy-in of both hospital leadership and politicians. BOX 2 Who Should Participate in Planning for Crisis Standards of Care? A Partial List Physicians Physician assistants Nurses Nurse practitioners EMTs/paramedics and dispatchers Pharmacists Hospital administrators State and local public health officials Emergency management Fire departments Police departments Ethicists Lawyers Morticians Funeral directors Citizens Elected officials Media Bloggers Teachers Large local employers Faith-based organizations Civic organizations Academia Charities and nonprofits Government Insurance companies Reinsurance companies Hospitals and hospital associations Nursing facilities Health system alliances Veterans Affairs hospitals Department of Defense facilities Community health centers Urgent care facilities Hospice and palliative care facilities Long-term care facilities Home health organizations Dialysis centers Hospital licensing agencies Regulatory agencies
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Crisis Standards of Care: Summary of a Workshop Series In order to facilitate this broad involvement in Utah, the Governor’s Public Health Emergency Preparedness Advisory Council convenes partners from government, health care, and the private sector in the governor’s executive boardroom. Members of the council are appointed by the governor. “People have a hard time saying they won’t come when they know they’re in his own executive boardroom, and that makes it very effective for us,” said Paul Patrick, director of the Bureau of EMS and Preparedness in the Utah Department of Health. Even while stressing the importance of engaging a wide range of stakeholders, several workshop participants also emphasized the importance of leadership and the use of effective procedures to ensure that the planning process does not become unwieldy. The 2009 IOM letter report outlines a five-step process that state public health authorities can use to develop crisis standards of care protocols (IOM, 2009). The process uses a series of working groups and committees to outline ethical considerations, review legal authority, and draft guidance. This is followed by a broad public stakeholder engagement process, after which the ethical elements and crisis standards of care can be finalized, incorporating changes raised during the engagement process, as appropriate. The final step of the process is the establishment of a Medical Disaster Advisory Committee that 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. In this way, the process incorporates both broad stakeholder and public engagement as well as smaller groups that can function effectively to draft, refine, and provide real-time advice about implementation. CONTINUUM OF SURGE CAPACITY AND STANDARDS OF CARE Many workshop participants stressed that making changes to usual standards of care is not an all-or-none situation. The changes required depend on the nature and extent of the disaster, the existing capabilities of the community, and the particular resources that become scarce, among many other variables. Several participants emphasized that the response to the disaster should be proportional, and changes to standards of care should be the minimum necessary given the circumstances. Efforts to define a common taxonomy and framework for discussion are a first step to ensuring a proportional response, to developing proto-
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Crisis Standards of Care: Summary of a Workshop Series civil damages as a result of medical care … unless the damages result from … circumstances demonstrating a reckless disregard for the consequences.” Medical Malpractice Act (38-79-30): “Volunteer (non-compensated) health care provider … not liable for any civil damage for any act or omission resulting from the rendering of the (medical) services unless … act or omission was the result of … gross negligence or willful misconduct.” Similar laws exist in most other states. But although these laws represent a good start, they come with one major drawback during crisis standards situations. Raymond Pepe of the Uniform Law Commission (ULC) noted that the laws “by and large immunize ordinary acts of negligence while not immunizing gross negligence or willful disregard of standards of care.” Despite the drawbacks of this limitation, several participants added, it is also necessary to discourage harmful behavior and protect patients from those who do not act in good faith during disaster responses. Crisis standards contemplated include not offering or discontinuing life-sustaining treatments such as ventilators as part of a broader triage program. “When we willfully and knowingly withdraw or withhold life support, knowing there may be a bad outcome, we tread that line of willful misconduct,” said Cheryl Starling of the California Department of Public Health. Starling and others noted that this is one of the key barriers to getting healthcare providers and facilities to come to the table to discuss crisis standards of care and disaster preparedness. These issues, she said, make “lawyers run for the hills and refuse to let people even talk about this … because [many people believe] you’re setting yourself up for negligence and willful misconduct.” This fear is especially strong with regard to the most extreme situations that involve the need to discontinue life-sustaining treatment in some patients. These issues can also make healthcare providers unwilling to act during these emergencies, even with the clearest directions in place by top-level public health administrators. If you can’t solve the legal liability issue, many noted, you can’t get anywhere. Fortunately, a great deal of work has been done on this issue at both the federal and state levels, creating a reference body of potential options for various localities to explore.
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Crisis Standards of Care: Summary of a Workshop Series Addressing the Liability Problem The first question that must be asked when approaching the problem of legal liability, Pepe said, is what legal liability is based on. “An accepted community standard of care grows out of either custom or practice, or it grows out of outcomes-based research which has led to consensus with respect to how to treat certain conditions,” said Pepe. “When you’re dealing with an alternative standard of care, you’re dealing with something fundamentally different. There’s a need to have clear legal recognition that these alternative standards exist and that practitioners are authorized to follow them.” It is important to note that there is a critical distinction between legal and medical standards of care (Box 13). Starling noted that the term “standard of care” actually comes from a legal setting, not a medical setting, defining the duty to provide a minimum acceptable standard of care. “The medical standard of care may be higher than that, but defining the legal bare-minimum of that standard of care … and analyzing how that will change during emergencies … is a critical issue that requires more work,” Starling said. Participants discussed a variety of ways in which the actual legal protections could be achieved. BOX 13 Medical and Legal Standards of Care Medical Standards of Care: The type and level of medical care required in specific circumstances by professional norms, accreditation or other requirements. Legal Standards of Care: The amount of skill that a medical practitioner should exercise in particular circumstances based on reasonable and common practice in medical care.
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Crisis Standards of Care: Summary of a Workshop Series Deputize Physicians James Geiling, chief of medical services at the White River Junction VA Medical Center, VT, noted that some states have simply “deputized” physicians during states of emergency, or the federal government can make them federal agents. These actions can be enacted rapidly, and those deputized as state agents receive the state’s “sovereign immunity-type protections” that exist in many jurisdictions. The complication of this action is that these deputized workers become the legal agents of the state or the federal government, and they must therefore be prepared to perform as the state or federal government mandates, not necessarily what their own healthcare institution or other usual employer might require. That concept can make many healthcare institutions and employers very uncertain, and they may be unwilling to cede that control. Enact Comprehensive Liability Protection Other states have taken more nuanced approaches. Virginia has enacted a comprehensive liability protection program that goes into effect if there is a declaration of emergency on behalf of the state government and it has resulted in resource shortages. Critically, the Virginia law does not require a separate act by the legislature to go into effect, but can be put into effect by the governor’s credo. Montana passed a bill earlier in 2009 “that very much touches altered standards of care in an emergent situation if declared by the governor and protects us and gives us some immunity—and it’s different from the code of practice that we have,” noted Orlando meeting participant Michael Spence of Kalispell Regional Medical Center, MT. A theme throughout the workshops was the concept of moving up the political chain of command when empowering this kind of legal liability protection, and putting the declaration of the emergency in the hands of a single powerful individual, such as a governor. Colorado, for instance, has draft executive orders that the governor can enact and that provide blanket protections for everything from license issues to who can dispense medicine. Finding ways to make the standards as consistent and evenly applied as possible will be critical to mitigating liability for providers who are trying to do the right thing. That means, for example, having liability
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Crisis Standards of Care: Summary of a Workshop Series protections that extend not just to doctors and nurses, but to triage officers, resource teams, and all other parties involved in the healthcare process. Persons involved in triage were of particular concern because triage is where many of the most difficult decisions must be made. Participants mentioned the challenge and importance of developing consistency across state lines, and this was also a theme in the 2009 IOM letter report (IOM, 2009). Credentialing and Scope of Practice In contemplating the legal ramifications of enacting crisis standards of care, one issue that was raised repeatedly at the workshops was the credentialing of out-of-state healthcare providers. Other means of augmenting the core caregiver community were seen as critical, including expanding the types of care that certain healthcare providers can provide and supporting retired healthcare workers who are interested in volunteering during times of crisis. Participants discussed the critical importance of having sufficient, qualified personnel during an emergency. Finding ways to expand the size and scope of the caregiver community, while maintaining and supporting a community-based vision for crisis standards of care, was seen as a critical task. One group that has taken the lead on this work is the Uniform Law Commission, an interstate organization that has done extensive work on the credentialing issue and has developed a draft law—the Uniform Emergency Volunteer Health Practitioners Act—that states can adopt (Box 14). It includes a robust system for the interstate recognition of healthcare licenses. “It takes the fundamental approach that there is no reason that if your state is affected by a disaster you need to review on a case-by-case basis the credentials of people who are coming in from other states,” said the ULC’s Pepe. The law limits the scope of medicine that these outside practitioners can practice, but it takes a common-sense approach of smoothing their entry into the disaster response. The idea is that multiple states can adopt the law in its written format.
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Crisis Standards of Care: Summary of a Workshop Series BOX 14 Uniform Emergency Volunteer Health Practitioners Act Helps remove some of the barriers to implementing alternative standards of care Provides a model for promoting interstate cooperation Avoids the need for federal preemption Robust system for interstate recognition of health practitioner licenses (supplements the Emergency Management Assistance Compact) Extends civil immunity and workers compensation benefits to emergency volunteers Defines permissible interstate scope of practice Permits modifications to scope of practice Enhances state emergency management authority Controls spontaneous volunteerism Creates interstate system for disciplinary enforcement At the same time, statutes across the country envision expanding scopes of practice temporarily for existing healthcare providers to let them work beyond the boundaries of their traditional expertise. Pharmacists may be asked to administer vaccinations, nurses may be asked to function in the role of nurse practitioners, and emergency medical technicians may be asked to dispense medicine. Similarly, many states have statutes that allow retired healthcare providers to provide a limited set of services, such as palliative care. These healthcare providers can be a tremendous aid during an emergency, many noted, as long as they are given tasks appropriate to their training and education. “We polled about 10,000 different perspective volunteers back in 2006,” said Johns Hopkins’ Hodge. “Seventy percent of them, or nearly 70 percent, said that their potential exposure to liability is an important or essential fact in whether or not they’ll actually participate in an emergency.” The math is simple: Better, clearer legal protections mean more personnel to confront a mass casualty event. EMTALA and HIPAA Multiple workshop participants expressed concerns about the impact of federal regulations—specifically, the Emergency Medical Treatment
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Crisis Standards of Care: Summary of a Workshop Series and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA)—on the ability to respond to a medical disaster (Box 15). EMTALA requires certain hospitals to provide emergency care to all patients, regardless of their ability to pay; patients may not simply be denied care and turned away from the hospital’s doors. HIPAA governs privacy regulations and restricts the sharing of medical information. Compliance with these regulations is a significant concern for hospitals because failure to comply can result in exclusion from the Medicare program. “How are you going to triage people to … alternate sites when you have EMTALA regulations in your face?” asked one participant, capturing the concerns of many. “How are you going to transfer people to other facilities when you have HIPAA that’s not going to let you get information back?” To some extent, these specific concerns are already accounted for in the existing legal system. An apparently less well-known fact about the HIPAA and EMTALA regulations is that, when the HHS Secretary declares a public health emergency and the President declares an emergency or a disaster pursuant to the National Emergencies Act or the Stafford Act, HHS can issue an “1135 waiver” that temporarily suspends sanctions for noncompliance with certain provisions under both HIPAA and EMTALA.2 These waivers have been enacted in the past, and can be put in place quickly (and retroactively) during a disaster setting. BOX 15 EMTALA and HIPAA EMTALA: The Emergency Medical Treatment and Labor Act was enacted by Congress in 1986 to “ensure public access to emergency services regardless of ability to pay.” The law requires hospitals participating in the Medicare system to provide medical screening examinations to patients requesting treatment for emergency medical conditions. Hospitals must also provide stabilizing treatment for these conditions, or, if such treatment is outside the hospital’s capability, provide an appropriate transfer (http://www.cms.hhs.gov/emtala/). HIPAA: Enacted by Congress in 1996, the Health Insurance Portability and Accountability Act protects the privacy of a patient’s personal health information. Medical providers are allowed to disclose that information “for patient care and other important purposes” (http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html). 2 See http://www.ssa.gov/OP_Home/ssact/title11/1135.htm.
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Crisis Standards of Care: Summary of a Workshop Series Florida’s Hood, however, cautioned about taking this comfort too far, noting that “many states have laws about medical confidentiality which are stricter than HIPAA.” Hood and others noted that the 1135 waivers do not impact these more restrictive state-level laws. The recommendation was that states should individually evaluate their laws and put in place emergency orders to remove barriers to emergency response. Legal Triage Regardless of what legal rules are in place, or what standards have been agreed to, the legal landscape will be constantly shifting during an emergency, and participants will likely have to adjust their response accordingly. Johns Hopkins’ Hodge introduced his own concept of “legal triage” to define how healthcare administrators must constantly adjust their operating procedures throughout an emergency to remain consistent with the evolving situation (Hodge and Anderson, 2008; Hodge et al., 2009). “It’s about prioritizing … legal issues in real time to construct a favorable legal environment … that facilitates legitimate public health responses during emergencies,” said Hodge. “Once an emergency has been declared, by design the legal landscape changes.… [I]t changes instantly and it can change drastically, and depending on how it changes, based on the type of emergency that we’re involved with, the legal responsibilities and liability protections and altered standards of care issues come into play.” Hodge noted that since September 11, 2001, many new laws have been put into place governing emergency response and disaster preparedness. Forty-two states now officially allow for a declaration of disaster, and 26 states specifically define a public health emergency. The peculiarities of how those disasters are declared and what the term “disaster” actually means, legally, varies in nearly every case. Quite often there are different levels of declaration. “Your deployment, your abilities, your authorities, your liabilities, immunities are all dependent upon that level of an emergency,” explained Hodge. In the midst of a disaster, having a legal team in place that is ready to respond to and interpret those evolving legal standards can be just as important as having the right medical triage and response teams. The message throughout the meetings was that if communities did not take care
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Crisis Standards of Care: Summary of a Workshop Series of the legal issues, much of the other planning would be significantly less effective. Education and Training As well-designed and thoughtful as any legal liability protections or other crisis standards laws may be, their effectiveness rests on whether hospital administrators and their legal counsel know they exist. A theme that emerged from the legal discussions was that the natural reaction at many hospitals is to protect against liability and limit activity, barring clear guidance otherwise. That will likely be the prevailing wisdom in the confusion sure to accompany a true healthcare disaster. Workshop participants repeatedly observed that significant work was needed to disseminate information about legal liability protections to healthcare providers, even in those states that have tackled the problem head-on. CONCLUSION How can healthcare providers and facilities, with the support of state and local public health officials, the federal government, and their communities, provide the best care possible during a crisis? What steps can the health system take to avoid resource scarcity, manage demand, and minimize impact on clinical care? If these steps become insufficient, how should resources be allocated fairly and consistently? How can these steps be taken in an ethical, legal, and effective manner? These were the questions that knitted together the four regional workshops in California, Florida, New York, and Illinois. While the individual approaches varied, participants were unified in recognizing that these were important questions, and that they were questions that had to be answered before it was too late. A great deal of progress has been made over the past decade, motivated in part by events such as September 11, 2001, the anthrax attacks, and Hurricane Katrina. Ten years ago, hospital administrators and healthcare officials wouldn’t touch the third rail of crisis standards of care; now working groups are approaching this problem in regions, states, and communities around the nation. The workshops presented dozens of approaches, many of which shared common basic principles,
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Crisis Standards of Care: Summary of a Workshop Series even if they differed on the specifics. National efforts from the CDC, AHRQ, and others were widely praised for laying the groundwork, even as participants identified more work that needs to be done. These are not easy issues. The scenarios addressed at these meetings are uncomfortable. Fearsome words like “rationing” and dire concepts like discontinuing life-sustaining treatment in critically ill patients must be considered and confronted head-on, at every level—from federal oversight to local administrations—and by every party—from politicians to lawyers to primary caregivers. Ultimately, the discussions are held with the aim of providing the best and most fair treatment to as many patients as possible during a crisis. Healthcare providers will not have time during an emergency to develop programs from a standpoint of fairness and equity. There will not be time to develop laws to facilitate information sharing, dramatically increase staff, or provide legal liability. Any on-the-spot efforts to develop triage protocols, conduct evidence-based studies, or build relationships of trust among hospitals in different regions and communities will be impossible. As a result, participants said, officials have a duty to plan for these scenarios. They have a duty to develop crisis standards of care protocols based on reasoned and ethical approaches that reflect the views and beliefs of the broader community. While much has been done, that work needs to be gathered into a central resource where other jurisdictions can reference and use it, and more evidence-based research is needed. Importantly, more work needs to be done to build relationships and ensure consistency in the approach of different regions and settings. But there is more work to do, especially in some areas that will be critical during crises: Palliative care planning: Caregivers and administrators need everything from simple definitions to detailed guidance on when and where it is given and who can provide it. Mental/behavioral health implications for the public as well as care providers. Preparedness planning for vulnerable populations, such as pediatric, geriatric, and mental health patients. Public and provider engagement in the planning process. Consistency across borders and regions.
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Crisis Standards of Care: Summary of a Workshop Series “How far do we need to get in standards?” asked Phillips, summarizing the Irvine meeting. “Are they general principles that we should all be adhering to? Do we need to be setting some national standards? Should we be just aiming toward principles that ensure consistency, but allowing individual flexibility?” Overall, participants said that the workshops had been helpful in highlighting how much work is going on around the nation on this issue, but also emphasized that much work remains to be done in order to ensure that the best care possible is provided under catastrophic circumstances.
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