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    COVID-19 Crisis Standards of Care: Frequently Asked Questions for Counsel

    Last updated: December 18, 2020

    What are crisis standards of care?
    Crisis standards of care guide decision-making designed to achieve the best outcome for a group of patients rather than focusing on an individual patient. According to a July 28. 2020 National Academies of Science Engineering & Medicine working group report, “[w]hen crisis conditions exist, the goal is to ‘gracefully degrade’ services to the minimum degree needed to meet the demands, maintaining the maximum patient and provider safety.”

    How do crisis standards of care differ from other standards of care?
    Standards of care fall along a continuum of three levels. Conventional, or everyday, care is the norm. Contingency care involves adjustments to everyday care but the level of care on an individual patient basis remains functionally equivalent. Crisis standards of care are applied when circumstances make it necessary to adjust the delivery of care.

    What goals drive crisis standards of care?
    According to a March 28, 2020 NASEM working group report, crisis standards of care have the joint goals of “extending the availability of key resources and minimizing the impact of shortages on clinical care.”

    What ethical principles are crisis standards of care grounded in?
    According to NASEM, crisis standards of care must uphold the following core principles:

    1. Fairness (e.g., ensure consideration of vulnerable groups);
    2. Duty to care (aided by distinguishing triage decision-makers from direct care providers);
    3. Duty to steward resources (balances duty to community with duty to individual patient);
    4. Transparency in decision making (candor and clarity about available choices as well as acknowledgement of the painful consequences of resource limitation);
    5. Consistency (treating like groups alike through institution/system/region policies, with careful deliberation and documentation when local practices do not follow common guidance);
    6. Proportionality (burdens should be commensurate with need and appropriately limited in time and scale); and
    7. Accountability (maximizing situational awareness and incorporating evidence into decision-making).

    What can be done to avoid needing to shift to crisis standards of care?
    It is inevitable that crisis standards of care mean an increase in morbidity and mortality, so planning and proactive resource adjustment (reuse, substitution, conservation, and administrative controls) should be employed to forestall the need for crisis standards of care as long as possible. One example is establishing Medical Operations Coordination Cells (MOCCs) to “load balance” patient surge among hospitals and regions. In another example from the Spring of 2020, health care professionals from other regions deployed to the Northeast to bolster capacity.

    What should crisis standards of care include?
    When it’s no longer possible to “surge” to maintain normal care, a crisis standards of care plan for a hospital or health system should describe the incremental changes to the way health care – particularly critical care – will be delivered. A crisis standards of care plan should --

    • provide expectations for how staff will be “stretched” to cover the demand for services as fairly as possible;
    • define the role of any centralized team (incident command team, allocation team);
    • direct how each facility will interact with other parts of the health system in its region;
    • identify just-in-time clinical and resource support for bedside providers, including evidence-based care guidelines.

    Is a Governor’s declaration necessary to deploy crisis standards of care?
    A Governor’s declaration can spur needed action among health departments and health care facilities, as well as aid in providing additional legal protections. However, the ability to provide care will change as demand outstrips available resources, even in the absence of a Governor’s declaration. A November 2020 “Lessons from New York City Hospitals’ COVID-19 Experience” report published by Johns Hopkins Center for Health Security recommends that crisis standards of care plans “must factor in that a formal declaration from the state may not be made in time and should include how to proceed without it.”

    What is situational awareness and why is it so important for effectively implementing crisis standards of care?
    Situational awareness is having a current and accurate understanding about the supply of key resources in relation to actual patient demand. It is important for decision-makers, whether at the bedside or as part of a group, to know the current status of resources in determining the care for each patient. Health systems and institutions should prioritize the sharing and updating of this critical information among hospitals, across systems, and across a region or state, as well as at all levels of an institution.

    What process for allocating insufficient resources or deciding whether an intervention like CPR is appropriate should be included in crisis standards of care?
    For each institution, ethical principles should be agreed upon and a decision-making process should be defined in advance, before allocation or intervention decisions are needed. The process and criteria should be clearly stated and widely shared, and an incident management team should be fully aware and in a position to make any needed adjustments. Guidance on critical care planning posted by HHS’s Assistant Secretary for Preparedness and Response advises that “[a]llocation decisions should ideally involve clinicians that are NOT the bedside provider.” The New York City Lessons Learned report New York City Lessons Learned report recommends that “[r]apid decision processes must be developed that involve the treating physician but also other physicians.”

    Do crisis standards of care involve the engagement of families?
    Communicating with families in real-time is important so that there is a common understanding of what can be expected in terms of treatment options. Palliative care departments should be involved in end-of-life discussions, especially when resource triage issues are involved. End-of-life wishes should be documented.

    How might crisis standards of care raise concerns about vulnerable and minority populations?
    The COVID-19 pandemic has disproportionately affected vulnerable and minority populations. To avoid disparities, most crisis standards of care guidelines explicitly prohibit prioritization of access to resources based on demographic factors. Plans should be especially careful in addressing factors that could seen as constituting an unfair categorical exclusion. In one recent instance, on August 20, 2020, the HHS Office of Civil Rights announced it had resolved a complaint about the State of Utah’s crisis standards of care. Utah agreed to stop using a patient’s long-term life expectancy as an allocation factor and agreed to remove age, disability, and functional impairment as bases for exclusion, in favor of requiring an individualized assessment based on the based available objective medical evidence.

    How are health care institutions managing legal liability in the context of crisis standards of care?
    Health care institutions are mitigating legal risk by developing and sharing widely a crisis standards of care plan that demonstrates a commitment to consistency in decision-making.

    What new liability protections may apply to decisions made under crisis standards of care?
    Some Governors and State legislatures have taken steps to extend liability protections in cases where resource constraints and patient demand attributable to the COVID-19 pandemic affect the delivery of care. 

    In April 2020, the Governor of Virginia issued Executive Order 60 declaring that “emergency and subsequent conditions caused by a lack of resources, attributable to the disaster [may] render the health care provider unable to provide the level or manner of care that otherwise would have been required in the absence of the emergency”, and explicitly referred to “implementation or execution of triage protocols necessitated by healthcare provider declaration of crisis standards of care.”

    New York provides immunity for any health care facility or professional from civil or criminal liability for providing COVID-19 care in good faith, Article 30-D of New York's Public Health Law provides that “acts, omissions or decisions … resulting from resource or staffing shortages” are within the scope of immunity. 

    Federal law provides additional liability protections to health care professionals who are serving as volunteers during the COVID-19 crisis (CARES Act, Pub. L. No. 116-136 (March 27, 2020)) or who are prescribe or dispense drugs and other covered products (referred to as “countermeasures”) to treat, diagnose, or prevent the onset of COVID-19 (PREP Act, 42 U.S.C. § 247d-6d).

    Where can I find additional information, including links to the NASEM, ASPR, and Johns Hopkins Center for Health Security reports?
    Additional resources are posted on the AAMC’s AAMC COVID-19 Clinical Guidance Repository.

    Note: This document is intended for informational purposes only and should not be understood as providing legal advice.