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

At the request of the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services, the Institute of Medicine convened the Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations to develop guidance that state and local public health officials can use to establish and implement standards of care that should apply in disaster situations—both naturally occurring and manmade—under scarce resource conditions. Specifically, the committee was asked to identify and describe the key elements that should be included in crisis standards of care protocols, to identify potential indicators and triggers, and to develop a template matrix that can be used by state and local public health officials as a framework for developing specific guidance for healthcare provider communities to develop and implement crisis standards of care. This appendix provides a summary of the committee’s recommendations, findings, and practical guidance. A complete copy of the report is available through www.iom.edu/disasterstandards.

Based on a review of the currently available state standards of care protocols, published literature, and testimony provided at its workshop, the committee concluded that there is an urgent and clear need for a single national set of guidance for states with crisis standards of care that can be generalized to all crisis events and is not specific to a certain event. However, the committee recognizes that within such a single general framework, individual disaster scenarios may require specific considerations, such as differences between no-notice events and slow-onset events, while the key elements and components remain the same.

For the purpose of developing recommendations for situations in which healthcare resources are overwhelmed, the committee defined the



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 69
B Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report At the request of the Office of the Assistant Secretary for Prepared- ness and Response in the Department of Health and Human Services, the Institute of Medicine convened the Committee on Guidance for Estab- lishing Standards of Care for Use in Disaster Situations to develop guidance that state and local public health officials can use to establish and implement standards of care that should apply in disaster situa- tions—both naturally occurring and manmade—under scarce resource conditions. Specifically, the committee was asked to identify and de- scribe the key elements that should be included in crisis standards of care protocols, to identify potential indicators and triggers, and to develop a template matrix that can be used by state and local public health officials as a framework for developing specific guidance for healthcare provider communities to develop and implement crisis standards of care. This ap- pendix provides a summary of the committee’s recommendations, findings, and practical guidance. A complete copy of the report is avail- able through www.iom.edu/disasterstandards. Based on a review of the currently available state standards of care protocols, published literature, and testimony provided at its workshop, the committee concluded that there is an urgent and clear need for a sin- gle national set of guidance for states with crisis standards of care that can be generalized to all crisis events and is not specific to a certain event. However, the committee recognizes that within such a single gen- eral framework, individual disaster scenarios may require specific considerations, such as differences between no-notice events and slow- onset events, while the key elements and components remain the same. For the purpose of developing recommendations for situations in which healthcare resources are overwhelmed, the committee defined the 69

OCR for page 69
70 CRISIS STANDARDS OF CARE 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 pro- tections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations. The committee emphasized that, in an important ethical sense, enter- ing a crisis standard of care mode is not optional—it is a forced choice, based on the emerging situation. Under such circumstances, failing to make substantive adjustments to care operations—that is, not to adopt crisis standards of care—is very likely to result in greater death, injury, or illness. THE VISION In order to ensure that patients receive the best possible care in a catastrophic event, the nation needs a robust system to guide the public, healthcare professionals and institutions, and governmental entities at all levels. To achieve such a system of just care, the committee set forth the following vision for crisis standards of care: • Fairness—standards that are, to the highest degree possible, 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 maintaining the trust of patients and the community

OCR for page 69
71 APPENDIX B • 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 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 DEVELOPING CRISIS STANDARDS OF CARE PROTOCOLS Throughout the report, the committee emphasized the need for states to develop and implement consistent crisis standards of care protocols both within the state and through work with neighboring states, in col- laboration with their partners in the public and private sectors. The committee’s intent was to provide a framework that allows consistency in establishing the key components required of any effort focused on cri- sis standards of care in a disaster situation. It also hoped that by suggesting a uniform approach, consistency will develop across geo- graphic and political boundaries so that the guidance will be useful in contributing to a single, national framework for responding to crises in a fair, equitable, and transparent manner.

OCR for page 69
72 CRISIS STANDARDS OF CARE Recommendation 1: Develop Consistent State Crisis Standards of Care Protocols with Five Key Elements State departments of health, and other relevant state agencies, in partnership with localities should de- velop crisis standards of care protocols that include the key elements—and associated components— detailed in this report: • A strong ethical grounding; • Integrated and ongoing community and provider en- gagement, education, and communication; • Assurances regarding legal authority and environ- ment; • Clear indicators, triggers, and lines of responsibility; and • Evidence-based clinical processes and operations. The report also contains guidance to assist state public health authorities in developing these crisis standards of care. This guidance includes criteria for determining when crisis standards of care should be implemented, key elements that should be included in the crisis stan- dards of care protocols, and criteria for determining when these standards of care should be implemented. The five key elements that should be in- cluded in crisis standards of care protocols, along with associated components, are summarized in Table B-1. TABLE B-1 Five Key Elements of Crisis Standards of Care Pro- tocols and Associated Components Key Elements of Crisis Standards of Care Protocols Components • Ethical considerations Fairness • Duty to care • Duty to steward resources • Transparency • Consistency • Proportionality • Accountability • Community and provider en- Community stakeholder identification with gagement, education, and delineation of roles and involvement with at- communication tention to vulnerable populations • Community trust and assurance of fairness and transparency in processes developed

OCR for page 69
73 APPENDIX B Key Elements of Crisis Standards of Care Protocols Components • Community cultural values and boundaries • Continuum of community education and trust building • Crisis risk communication strategies and situational awareness • Continuum of resilience building and mental health triage • Palliative care education for stakeholders • Legal authority and Medical and legal standards of care environment • Scope of practice for healthcare professionals • Mutual aid agreements to facilitate resource allocation • Federal, state, and local declarations of: o Emergency o Disaster o Public health emergency • Special emergency protections (e.g., PREP Act, Section 1135 waivers of sanctions under EMTALA and HIPAA Privacy Rule) • Licensing and credentialing • Medical malpractice • Liability risks (civil, criminal, Constitutional) • Statutory, regulatory, and common-law liabil- ity protections Indicators and triggers Indicators for assessment and potential manage- ment • Situational awareness (local/regional, state, national) • Event specific o Illness and injury—incidence and sever- ity o Disruption of social and community functioning o Resource availability Triggers for action • Critical infrastructure disruption • Failure of “contingency” surge capacity (re- source-sparing strategies overwhelmed) o Human resource/staffing availability o Material resource availability o Patient care space availability

OCR for page 69
74 CRISIS STANDARDS OF CARE Key Elements of Crisis Standards of Care Protocols Components Clinical process and Local/regional and state government processes to operations include: • State-level “disaster medical advisory com- mittee” and local “clinical care committees” and “triage teams” • Resource-sparing strategies • Incident management (NIMS/HICS) princi- ples • Intrastate and interstate regional consistencies in the application of crisis standards of care • Coordination of resource management • Specific attention to vulnerable populations and those with medical special needs • Communications strategies • Coordination extends through all elements of the health system, including public health, emergency medical services, long-term care, primary care, and home care Clinical operations based on crisis surge response plan: • Decision support tool to triage life-sustaining interventions • Palliative care principles • Mental health needs and promotion of resil- ience The letter report states that “state authorities have the political and constitutional mandate to prepare for and coordinate the response to dis- aster situations throughout their state jurisdictions” and outlines a process by which states should begin to develop crisis standards of care protocols. These steps include the following: 1. Outline Ethical Considerations: Convene a “Guideline Develop- ment Working Group” of appropriate stakeholders to establish ethical principles that will serve as the basis for the crisis stan- dards of care. 2. Review Legal Authority for Implementation of Crisis Standards of Care: Review existing legal authority for the implementation of crisis standards of care and address legal issues related to the successful implementation of these standards, such as liability

OCR for page 69
75 APPENDIX B protections or temporary changes in licensure or certification status or scope of practice. 3. Develop Guidance for Provision of Medical Care Under State Crisis Standards of Care: Establish an “Advisory Committee” that will find a comprehensive set of materials to inform its de- liberations in the “Indicators and Triggers” and “Clinical Process and Operations” sections of the report. 4. Conduct a Public Stakeholder Engagement Process: Although representatives of various healthcare and other interested profes- sional groups and the public have been involved in drafting the ethical principles and crisis standards of care, a robust engage- ment process is also necessary to provide an opportunity for review and comment by the provider and public community at large. Particular attention should be paid to conduct outreach to and gather input from vulnerable populations, including those with medical special needs. 5. Establish a Medical Disaster Advisory Committee: During a dis- aster, this committee will provide ongoing advice to the state authority regarding changes to the situation and potential corre- sponding changes in the implementation of crisis standards of care. ETHICAL FRAMEWORK An ethical framework serves as the bedrock for public policy and cannot be added as an afterthought. Hence, ethical principles underlie the committee’s vision for crisis planning, outlined above. In addition, 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 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,

OCR for page 69
76 CRISIS STANDARDS OF CARE including during crises. When resource scarcity reaches catastrophic lev- els, 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 ig- nore 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 actions that violate ethical norms. COMMUNITY AND PROVIDER ENGAGEMENT, EDUCATION, AND COMMUNICATION The committee strongly recommended extensive engagement with community and provider stakeholders. Such public engagement is neces- sary not only to ensure the legitimacy of the process and standards, but more importantly to achieve the best possible result. The letter report discusses considerations for engaging with community and provider stakeholders prior to the event, during the event, and after the event. The report also notes that although there are likely to be substantive popula- tion-level mental health risks from a mass casualty public health emergency that requires crisis standards of care, there is also an opportu- nity to promote resilience at the individual and population levels to mitigate these risks. Thus it is important to develop a national platform to support resilience that can customized by communities at the local level. The report also emphasizes that building trust is particularly important in more vulnerable populations, including those with preexisting health in- equities and those with unique needs related to race, ethnicity, culture,

OCR for page 69
77 APPENDIX B immigration, limited English proficiency, and lower socioeconomic status. Recommendation: Seek Community and Provider En- gagement State, local, and tribal governments should partner with and work to ensure strong public engagement of community and provider stakeholders, with particular attention given to the needs of vulnerable populations and those with medical special needs, in: • Developing and refining crisis standards of care protocols and implementation guidance; • Creating and disseminating educational tools and messages to both the public and health professionals; • Developing and implementing crisis commu- nication strategies; • Developing and implementing community re- silience strategies; and • Learning from and improving crisis stan- dards of care response situations. LEGAL ISSUES IN EMERGENCIES The letter report also addressed issues related to the implementation of crisis standards of care, including legal considerations. Questions of legal empowerment of various actions to protect individual and commu- nal health are pervasive and complicated by interjurisdictional inconsistencies. The law should clarify prevailing standards of care and create incentives for actors to respond to protect the public’s health and respect individual rights. Recommendation: Provide Necessary Legal Protections for Healthcare Practitioners and Institutions Imple- menting 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

OCR for page 69
78 CRISIS STANDARDS OF CARE practice for licensed or certified healthcare practitio- ners, and alter licensure and credentialing practices as needed in declared emergencies to create incentives to provide care needed for the health of individuals and the public. OPERATIONAL IMPLEMENTATION OF CRISIS STANDARDS OF CARE Clinical Care in Disasters An important consideration regarding the framework for the imple- mentation of crisis standards of care in a disaster includes the recognition that it will never be an “all or none” situation. Disasters will have vary- ing impacts on communities, based on many different variables that might affect the delivery of health care during such events. Response to a surge in demand for healthcare services will likely fall along a contin- uum ranging from “conventional” to “contingency” and “crisis” surge responses (Figure B-1; Hick et al., 2009). Conventional patient care uses usual resources to deliver health and medical care that conforms to the expected standards of care of the community. The delivery of care in the setting of contingency surge response seeks to provide patient care that remains functionally equivalent to conventional care. Contingency care adapts available patient care spaces, staff, and supplies as part of the re- sponse to a surge in demand for services. Although this may introduce minor risk to the patient compared to usual care (e.g., substituting less familiar medications for those in short supply, thereby potentially leading to medication dosage error), the overall delivery of care remains mostly consistent with community standards. Crisis care, however, occurs under conditions in which usual safeguards are no longer possible. Crisis care is provided when available resources are insufficient to meet usual care standards, thus providing a transition point to implementing crisis stan- dards of care.

OCR for page 69
79 APPENDIX B Incident demand/resource imbalance increases Risk of morbidity/mortality to patient increases Recovery Conventional Contingency Crisis Usual patient Patient care areas repurposed (PACU, Facility damaged/unsafe or Space care space fully monitored units for ICU-level care) non-patient care areas utilized (classrooms, etc.) used for patient care Usual staff Staff extension (brief deferrals of Trained staff unavailable or Staff called in and non-emergent service, supervision of unable to adequately care for utilized broader group of patients, change in volume of patients even with responsibilities, documentation, etc.) extension techniques Cached and Conservation, adaptation, and substitution Critical supplies lacking, Supplies usual supplies of supplies with occasional reuse of possible reallocation of select supplies used life-sustaining resources Crisis standards of carea Usual care Functionally equivalent care Standard of care Usual operating Austere operating conditions conditions Indicator: potential Trigger: crisis for crisis standardsb standards of carec FIGURE B-1 Continuum of incident care and implications for standards of care. NOTE: Post-anesthesia care unit (PACU); intensive care unit (ICU). a Unless temporary, requires state empowerment, clinical guidance, and pro- tection for triage decisions and authorization for alternate care sites/techniques. Once situational awareness achieved, triage decisions should be as systematic and integrated into institutional process, review, and documentation as possible. b Institutions consider impact on the community of resource use (consider “greatest good” versus individual patient needs—e.g., conserve resources when possible), but patient-centered decision making is still the focus. c Institutions (and providers) must make triage decisions balancing the avail- ability of resources to others and the individual patient’s needs—shift to community-centered decision making. SOURCES: Adapted from Hick et al. (2009); Wynia (2009). The goal for the health system is to increase the ability to stay in conventional and contingency categories through preparedness and an- ticipation of resource needs prior to serious shortages, and to return as quickly as possible from crisis back across the continuum to conven- tional care (Tables B-2 and B-3).

OCR for page 69
84 CRISIS STANDARDS OF CARE Institution/ Indicators Agency Region State Contingency care being Any hospital Any hospital Any hospital provided and unable to reporting reporting reporting rapidly address shortfall Resource-specific shortage Notification by Notification Notification by (e.g., antibiotic, immu- supplier by hospitals hospitals/ noglobulin, oxygen, suppliers vaccine) Outpatient care Marked increase in appointment demand or un- able to reach clinic due to call volume Staff illness rate > 10% > 10% > 10% School Not applicable > 20% > 20% Absenteeism Disruption of facility or Utility or system > 1 hospital > 5 hospitals community infrastructure failure affected affected or criti- and function cal access hospital affected a The indicators in this table should be developed in relation to usual resources in the area and usage patterns—numbers are examples only. TABLE B-5 Possible Triggers for Adjusting Standards of Care Category Trigger Space/structure Non-patient care locations used for patient care (e.g., cot- based care, care in lobby areas) or specific space resources overwhelmed (operating rooms) and delay presents a signifi- cant risk of morbidity or mortality; or disrupted or unsafe facility infrastructure (damage, systems failure) Staff Specialty staff unavailable in timely manner to provide or adequately supervise care (pediatric, burn, surgery, critical care) even after callback procedures have been implemented Supply Supplies absent or unable to substitute, leading to risk to patient of morbidity (including untreated pain) or mortality (e.g., absence of available ventilators, lack of specific antibi- otics)

OCR for page 69
85 APPENDIX B Crisis Standards of Care Implementation Criteria Prior to implementation of formal resource triage, the following con- ditions must be met or in process (Devereaux et al., 2008): • Identification of critically limited resources and infrastructure • Surge capacity fully employed within healthcare facility • Maximal attempts at conservation, reuse, adaptation, and substi- tution performed • Regional, state, and federal resource allocation insufficient to meet demand • Patient transfer or resource importation not possible or will occur too late to consider bridging therapies • Request for necessary resources made to local and regional health officials • Declared state of emergency (or in process) Crisis Standards of Care Triage Triage occurs routinely in medicine, when resources are not evenly distributed or temporarily overwhelmed. These decisions are generally ad hoc, based on provider expertise, and have minimal effects on patient outcome. Thus standards of care are routinely adjusted to resources available to the provider without requiring a formal process or declara- tions. However, the situation in disasters is more complex, as services may not be available due to demand, with severe consequences to the patient who does not receive these resources. Reactive triage involves the ad hoc decisions made by clinical or administrative personnel to an exi- gent circumstance to allocate available resources in the face of an unanticipated shortfall. These decisions must be accountable to general principles of ethical resource allocation, but do not follow a structured, systematic process. Situational awareness is not available. Proactive tri- age involves systematic decisions made by clinical or administrative personnel to a situation requiring resource triage where situational awareness is available and the decision making is accountable to the in- cident management process. Additional details about reactive and proactive triage are available in the letter report.

OCR for page 69
86 CRISIS STANDARDS OF CARE Prerequisite Command, Control, and Coordination Elements The implementation of crisis standards of care and fair and equitable resource allocation requires attention to the core elements of incident management, including situational awareness, incident command, and adequate communication and coordination infrastructure and policies. Without this foundation, medical care will be inconsistent, and resources will not be optimally used (Hick et al., 2009). All healthcare systems must also understand how their incident management system interacts with that of jurisdictional emergency management and any coalition hos- pital response partners, including the process for obtaining assistance during an emergency (Figure B-2).

OCR for page 69
87 APPENDIX B • Fulfills resource requests (as possible) Federal Government, • Provides guidance and situational awareness Other States (may include federal agency guidance) Jurisdictional Emergency Management/ Multi-Agency Coordination (MAC) Group State EOC (SEOC) • Provides declarations and • Assist with resource request and fulfillment • regulatory relief via governor’s Information management • office for crisis standards of care Situational awareness • Maintains situational awareness • Policy assistance • Resource requests to other • (MAC role versus emergency management states/federal is defined by preplan) Regional Medical Healthcare State Public Health Dept Coordination Center Facility • Convenes SDMAC and (RMCC) • Incident command system broader guideline group • Situational awareness of • Maintains and provides situational • Provides situational facility capability/capacity awareness of healthcare system awareness to SEOC and • Implement surge capacity • Acts as “clearinghouse” for healthcare RMCC/facilities plans issues and manages resources • Requests declarations • Recognize need for existing/ according to coalition agreements and regulatory relief possible crisis care – • In some areas, takes active role with based on event convene clinical care other agencies developing policies • Assures interstate/ committee and guidance necessary for regional regional consistency • Make resource/other response requests to RMCC • May implement regional triage State Disaster Medical and/or review processes during crisis Advisory Committee (SDMAC) Clinical Care Committee event such as a pandemic • Review resource availability • Develops guidance (pre- and requests Regional Disaster event and during event) • Develop strategies to meet Medical Advisory per operational plan clinical demand with • Acts as expert advisory Committee resources available group for state response • Develop and issue clinical • If convened by RMCC, assists issues guidance as appropriate • with interpretation of state Reviews RMCC and (usually based on state) guidance to operational interstate processes • Appoint triage team if regional system/context and tools to assure ventilators or other definitive • reasonable consistency May organize/staff regional care triage required triage team and/or provide • Review triage decisions and process review improve process • Provides subject-matter expertise to RMCC and coalition facilities Triage Team (facility or regional) • Review guidance approved by clinical care committee (or RDMAC if regional team) • Obtain data from clinical units • Make triage decisions consistent with guidance FIGURE B-2 Overview of relationships among agencies, committees, and groups. NOTE: Depending on the organization of the state, the functional layout, details, and relationships among the units might vary. Crisis Standards of Care Operations When crisis care becomes necessary, a threshold has been crossed requiring that the affected institution(s) either quickly address the situa- tion internally, or, more likely, appeal to partner facilities and agencies for assistance in either transferring patients to facilities with resources or bringing needed resources to the facility. If these strategies cannot be

OCR for page 69
88 CRISIS STANDARDS OF CARE carried out, or if partner facilities are in the same situation (e.g., a pan- demic influenza scenario), then systematic implementation of crisis standards of care at the state level may become necessary in order to cod- ify and provide guidance for triage of life-sustaining interventions as well as to authorize care provided in non-traditional locations (alternate care facilities). The state has an obligation to ensure consistency of medical care to the highest degree possible when crisis care is being provided. Usual co- ordination and resource requests outlined above are used to minimize healthcare service disruption and/or to provide the most consistent level of care across the affected area and the state as a whole. When prolonged or widespread crisis care is necessary, the state should issue a declaration or invoke emergency powers empowering and protecting providers and agencies to take necessary actions to provide medical care and should accompany these declarations with clinical guidance, developed by the State Disaster Medical Advisory Committee, to provide a consistent ba- sis for life-sustaining resource allocation decisions. The state, through its emergency powers, resource allocation, and provision of clinical guid- ance, attempts to “level the playing field” at the state level, as well as provide legal protections for providers making difficult triage decisions and provide relief from usual regulations that might impede coping strategies such as alternate care facilities. Some hospital coalitions cover large metropolitan areas and thus the Regional Medical Coordination Center (RMCC) acts as liaison between the state and its constituents. The RMCC may be an agency, such as pub- lic health, or a hospital or other facility designated by the system. The RMCC attempts to ensure regional medical care consistency and may do so by acting as a resource “clearinghouse” between the healthcare facili- ties and emergency management and coordinating policy and information to meet regional needs. This may involve a Regional Disas- ter Medical Advisory Committee or at least a medical advisor or coordinator with access to technical experts in the area, particularly in large metropolitan areas because the specific needs of the area may not be well addressed by state guidance. However, the regional guidance cannot be inconsistent with that of the state. Individual hospitals and healthcare facilities should work through tactical mutual aid agreements with other local facilities and at the re- gional level to ameliorate conditions that might force crisis standards of care. When these strategies have been exhausted, healthcare facilities, working through local public health authorities, should request a state

OCR for page 69
89 APPENDIX B emergency declaration recognizing that crisis conditions are at hand, that a change in acceptable standards of care are required, and that crisis standards of care must be initiated. The individual healthcare institution surge capacity plan should in- corporate the use of a “clinical care committee” that is composed of clinical and administrative leaders who can focus a hospital or hospital system approach to the allocation of scarce, life-saving resources (Phillips and Knebel, 2007; Hick and O’Laughlin, 2006; O’Laughlin and Hick, 2008). A clinical care committee is activated by the facility inci- dent commander when the facility is practicing contingency or crisis care due to factors that are not readily reversible. This committee is responsi- ble for making prioritization decisions about the use of resources at the relevant healthcare institution (e.g., hospital, primary care, emergency medical services agency, and others). A sample institutional process is included in the letter report. Decision Tools and Resource Use Guidance Although the most examined decision tools revolve around 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, including blood products, elective surgery triage, trauma care, radiation, burn care, and cancer (Box B-2, Figure B-3). See the letter report for additional details.

OCR for page 69
90 CRISIS STANDARDS OF CARE BOX B-2 Exclusion Criteria Prompting Possible Reallocation of Life- Saving Interventions Severe, chronic disease with a short life Sequential Organ Failure Assess- expectancy ment (SOFA) score criteria: patients A. Severe trauma excluded from critical care if risk of B. Severe burns on patient with hospital mortality > 80% any two of the following: A. SOFA > 15 i. Age > 60 yr B. SOFA > 5 for >5 d, and with ii. > 40% of total body surface flat or rising trend area affected C. > 6 organ failures iii. Inhalational injury C. Cardiac arrest i. Unwitnessed cardiac arrest ii. Witnessed cardiac arrest, not responsive to electrical therapy (defibrillation or pacing) iii. Recurrent cardiac arrest D. Severe baseline cognitive im- pairment E. Advanced untreatable neuro- muscular disease F. Metastatic malignant disease G. Advanced and irreversible neu- rologic event or condition H. End-stage organ failure (for de- tails see Devereaux et al., 2008) I. Age > 85 yr (see Lieberman et al., 2009) J. Elective palliative surgery SOURCE: Adapted from Devereaux et al. (2008).

OCR for page 69
91 APPENDIX B 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 B-3 Triage algorithm process. a Example exclusion criteria include severe, irreversible organ failure (congestive heart failure, liver, etc.), severe neurologic compromise, extremely high or not improving SOFA scores, etc. SOURCE: Adapted from Devereaux et al. (2008). Finally, throughout the letter report, the committee emphasized the importance of consistent implementation of crisis standards of care in a disaster situation within and among states. Recommendation: Ensure Consistency in Crisis Standards of Care Implementation State departments of health, and other relevant state agencies, in partnership with localities should ensure consistent implementation of crisis standards of care

OCR for page 69
92 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 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, geriatrics, and persons with disabilities; and • Implementing robust situational awareness capabilities to allow for real-time information sharing across affected communities and with the “disaster medical advisory committee.” Recommendation: Ensure Intrastate and Interstate Consistency Among Neighboring Jurisdictions States, in partnership with the federal government, tribes, and localities, should initiate communications and develop processes to ensure intrastate and inter- state consistency in the implementation of crisis standards of care. Specific efforts are needed to en- sure that the Department of Defense, Veterans Health Administration, and Indian Health Service medical facilities are integrated into planning and re- sponse efforts.

OCR for page 69
93 APPENDIX B CONCLUSION Crisis standards of care, as described in the report, will be required when the intent and ability to provide usual care is simply no longer 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, the committee was greatly en- couraged by the search for solutions taking place. In studying this issue, the committee’s intent was 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 intended that, by suggesting such uniformity, consistency will develop across ju- risdictions, regions, and states so that this guidance will be useful in contributing to a uniform national framework for responding to crisis in a fair, equitable, and transparent manner.

OCR for page 69