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Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series (2022)

Chapter: 5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care

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Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

5

Legal, Ethical, and Equity Considerations for Crisis Standards of Care

Critical legal, ethical, and equity aspects underlie the development and implementation of crisis standards of care (CSC) plans and processes. Providing legal and ethical support and guidance for providers can often alleviate much of the moral burden of making life-or-death decisions in a crisis or the uncertainty of delivering care in austere circumstances. In this chapter, speakers explore legal issues including liability protections and equity considerations related to the planning, activation, implementation, evaluation, and monitoring of CSC. Structured remarks from speakers are followed by a panel discussion and reflections on a way forward in these domains with the ongoing lessons gleaned from the COVID-19 pandemic.

LIABILITY PROTECTIONS: ISSUES AROUND MAKING TRIAGE DECISIONS

James Hodge, professor and director of the Center for Public Health Law and Policy at Arizona State University, began by restating IOM’s original definition of CSC as a substantial change in usual health care operations and level of care because of a catastrophic disaster. CSC is implemented when sustained scarcities warrant real-time resource allocation to protect public health because the increased level of patient needs outweighs the available resources, such as intensive care unit (ICU) beds, personal protective equipment (PPE), medications, or health care workers. Hodge explained that there are many different legal topics involved in CSC, such as licensure, scope of practice, and documentation concerns, but a persistent and primary focus is protecting hospitals and clinicians against unwar-

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

ranted risks of liability (Hodge et al., 2013). When navigating CSC and liability, there are many ethical and legal questions to consider, including:

  • How do we allocate limited resources across systems?
  • Who is responsible for life-or-death decisions?
  • Who is liable if claims arise?

To answer these questions, clinicians and lawmakers must consider legal ways to allocate scarce resources. Hodge provided examples of legally prohibited allocation factors such as race, ethnicity, sex, and gender, and legally allowed allocation factors such as short-term survival, equitable clinical assessment scores, and specific resource limitations or suitability (Hodge et al., 2022). Health care workers, hospitals, triage committees, labs, emergency medical services, and public health officials all play a role in the allocation of scarce resources, he said, and all are subject to a web of liability risks, including civil, administrative, and criminal liability.

Hodge outlined two major approaches to avoiding CSC liability claims. First, health care institutions can simply follow the evolving standard of care by addressing what may be seen as a liability issue based on the crisis standard as implemented. Second, institutions could provide enhanced liability protections. There are multiple liability protections applicable to health care workers and volunteers, such as the Public Readiness and Emergency Preparedness Act, the Volunteer Protection Act, and the Good Samaritan Act. These laws protect providers from acts of negligence, but not gross negligence or intentional misconduct, he said. Hodge concluded with a reminder that there are limits to liability protections. Many liability protections can be claim specific or position specific, there can be jurisdictional variances, and some liability protections may last only for the duration of an emergency while others may provide comprehensive immunity.

Panel Discussion

Monica Peek, professor of medicine at the University of Chicago, moderated a panel discussing health care worker fears of liability, standards in place for triggering CSC, and the use of COVID-19 vaccination status in triage protocols. Robert Onders, administrator to the Alaska Native Medical Center, began by stating that Alaska currently does not have a public health emergency or CSC protocols on record. Valerie Gutmann Koch, director of law and ethics at the University of Chicago MacLean Center for Clinical Medical Ethics, added that during the pandemic, at least 37 states passed immunity protections for health care providers, but there were large state-by-state variations in levels of protection. Doug White, director for the Program on Ethics and Decision Making in Critical Illness at the University

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

of Pittsburgh School of Medicine, discussed how many health care workers have concerns about lack of protections and fear the legal consequences that may arise when they must make difficult decisions of declining care to one patient to save another, even when such decisions explicitly follow state triage guidelines. He noted that while clinicians certainly need some protection when following legal triage guidelines, overly broad immunity can infringe on patient rights when a legitimate malpractice claim is raised.

Peek asked if standards for CSC are too high and whether clinicians operating under contingency standards of care may be more vulnerable to liability rather than those operating under crisis standards of care. Koch mentioned the vast amount of politicization that has surrounded CSC during the COVID-19 pandemic. There has been reluctance by some leaders to trigger CSC conditions or even acknowledge they exist, she said, something that has exacerbated inconsistencies in CSC between states. She pointed out that just because a state has signed off on implementing CSC, this does not mean it must be instituted at every hospital if conditions do not warrant it. Onders and White both agreed, and White added that there should be a prerequisite of load balancing before switching from contingency care to CSC. This would ensure that underfunded hospitals could receive resources from better equipped hospitals and potentially avoid needing to implement CSC, he explained.

Peek then asked about using COVID-19 vaccination status in triage protocols. White noted that, “while our quick emotional impulse is to consider vaccination status when triaging patients, we must consider the current political and social climate.” He recounted the story of a recent experience with an unvaccinated patient dying from COVID-19. While this patient’s family members were vaccinated, he said, the patient refused to be vaccinated because of reading information on Facebook stating there were “baby parts” in the vaccine. If patients were making truly informed decisions when deciding whether to get vaccinated against COVID-19, then it may be possible to consider vaccination status during triage, he said. However, considering vaccination status in a world with such toxic political discourse that allows people to make uninformed decisions may be an ethical gray area, whether these are caused by mistrust of the health system or poor health literacy.

A question from the audience asked about a USA Today article reporting 10,000 patients becoming infected with COVID-19 at a hospital while there for non-COVID-19 related appointments (Jewett, 2021). The article pointed to insufficient airborne precautions put in place by hospital administrators, placing patients infected with COVID-19 in rooms with patients who were negative for COVID-19, as well as a lack of infection control. A participant asked panelists if there are legal issues with the hospital’s decisions in regard to CSC. Hodge stated that the hospital in the article may be liable if it were negligent in failing to implement basic precautions,

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

and it is legally difficult to shield a hospital from liability in situations of gross negligence. Koch discussed how the standard of care is designed to be flexible and adapt to the current medical circumstances, including when resources are scarce or information about the pandemic is lacking. Onders provided an example of how his hospital shifted its standards of care during the COVID-19 pandemic by testing all admitted patients every 3 days and testing all patients prior to surgeries to ensure that patients sharing rooms were both negative for COVID-19.

Panelists also discussed the implications of the heterogeneity in CSC protocols at the local level across the country and the effects this has on both communities and physicians. Hodge stated that the antithesis of CSC is situations where multiple different hospitals in the same city are using entirely different CSC protocols when they are facing similar crisis conditions. This can create significant confusion at the local and regional level. Onders echoed this by sharing his experiences in Alaska, where hospitals with critical care capabilities varied in how they operated in contingency and CSC conditions, which created equity issues. White commented on hospitals’ failures to achieve load balancing, highlighting that there is no reason for a hospital on one side of town to have depleted resources and become forced to implement CSC while a hospital on the other side of town has adequate resources they could share. This ultimately comes down to the inability to provide equitable care, since hospitals that often need to triage patients first are social safety net hospitals with little funding and staff. These hospitals are often located in more rural areas where disadvantaged communities, including people of color and poorer communities, are likely to seek care.

EQUITY AND THE ALLOCATION OF SCARCE RESOURCES

Govind Persad, assistant professor at Sturm College of Law, discussed the ethics behind the allocation of scarce resources and how to legally and ethically incorporate them into CSC. He stated that there is a broad spectrum of scarce resources. Scarce resources may involve critical care, such as lack of ventilators, health care workers, dialysis, or extracorporeal membrane oxygenation circuits, while scarce resources related to prevention may include monoclonal antibodies, antivirals, or vaccines. Ultimately, the objectives involved in equity and resource allocation are to (1) prevent harm, (2) mitigate health inequities, and (3) show equal concern for all recipients of care. He continued by discussing how predictive criteria can be used to categorize these three objectives by legal risk. Using predictive criteria such as health metrics like the sequential organ failure assessment (SOFA) score, occupational and caregiver status, and societal vulnerability metrics such as the Social Vulnerability Index (SVI) are ways to allocate resources that carry low legal risk. Triage protocols based on vaccination

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

status, age, and specific health conditions carry a more moderate legal risk, he noted, while using criteria such as sex, gender, and race is legally prohibited, which Hodge noted earlier.

An alternative to predictive criteria, nonpredictive criteria, is another way to allocate scarce resources. Using a lottery or “first come, first served” approach is a way to randomly decide who receives care. However, Persad clarified, using nonpredictive criteria for resource allocation often fails to align or realize the objectives of preventing harm and mitigating health inequities as more disadvantaged groups die under the lottery approach (Tolchin et al., 2021). Finally, resource allocation can also be decided by combining criteria. Using priority point systems, where each criterion is assigned a point value, or categorized priority systems (e.g., 25 percent of monoclonal antibodies are prioritized for high SVI areas) are additional ways to ensure equity in resource allocation.

Persad also presented empirical findings to consider when aligning harm prevention and equity. When allocating ICU ventilators, taking an age-aware approach prevents more deaths and better mitigates racial inequities than using SOFA scores alone (Bhavani et al., 2021; Kesler et al., 2021; Raschke et al., 2021). As another example, for the COVID-19 vaccine allocation criteria, combining area deprivation measures with age better prevents harm and mitigates inequity than age alone (Wrigley-Field et al., 2021). COVID-19 has highlighted severe racial inequities in the U.S health care system as research shows racial minorities have died both of COVID-19 more often and earlier in life, Persad said, losing more years of life before age 65 than white victims (Bassett et al., 2020; Wortham et al., 2020). Generally speaking, he said, the public cares about saving lives during the COVID-19 pandemic, but opinions differ among older and younger generations regarding specific vaccination allocation criteria (Buckwalter and Peterson, 2020; Persad et al., 2021).

Persad concluded by suggesting areas of future research to improve equity during the allocation of scarce resources, such as ensuring fairness to non-COVID-19 patients. As the pandemic continues, non-COVID-19 patients have been denied care to make room for COVID-19 patients. He posed questions to be considered for future research to provide more insight into equitable resource allocation:

  • Should hospitals reserve beds for non-COVID-19 patients?
  • How does resource allocation change if a COVID-19 patient has refused the vaccine or other treatment such as monoclonal antibodies?
  • How would the courts and the public view efforts to mitigate health inequity, such as using SVI scores, Medicaid recipient status, or race?
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

Discussion of Equity and Scarce Resource Allocation

During the subsequent panel discussion, Nneka Sederstrom, chief health equity officer of Hennepin Healthcare, offered thoughts on race within the context of allocating resources, saying that although it is an uncomfortable topic to discuss, it should not be shied away from when analyzing ways to reduce inequities. Using a color blind ideology does not work, she argued, as ignoring race does not create more equal care, it simply exacerbates inequities (Sederstrom and Wiggleton-Little, 2021). Virginia Brown, assistant professor in the Department of Population Health at Dell Medical School, discussed the mistrust that black and brown communities have in the health care system because their history with the health care system has been fraught with abuse and neglect, making it difficult to establish trust. She added that increasing community input when creating CSC and resource allocation standards will create a more transparent and trustworthy system by giving marginalized groups a seat at the table.

Sederstrom critiqued methods of resource allocation she thought of as being a proxy for race, such as the SVI or patient zip codes, and suggested using race itself as an allocation criteria would be more effective in reducing inequities. Persad noted that he viewed SVI as an attempt to reconcile intersecting disadvantages that often result from structural racism. He also pointed out that demographers have argued that using the census is a more effective way of tracking SVI and disadvantage indices than patient zip codes.

Thomas Sequist, chief patient experience and equity officer at Mass General Brigham, offered his thoughts on the lottery approach to resource allocation and his experience with disadvantaged indigenous populations. He stated that when systems such as lottery allocation are used, the assumption is made that the individuals entered into the lottery have equal access to health care. But not all patients in the lottery system have easy and reliable access to health resources and may find it difficult to access them even if they win the lottery. He discussed how indigenous populations are largely deprived of health care resources by being underfunded. While the U.S government spends, on average, approximately $10,000 per American per year on health care costs, it only spends around $4,500 per person per year for indigenous populations, he said. Sequist added that structural factors like systemic racism and poverty not only allowed COVID-19 to run rampant in indigenous communities, but such factors also play a role in traditional scoring systems such as SOFA scores for resource allocation.

He used the example of black communities having a three times higher incidence of kidney disease than the total population, a factor that would likely play a role when using a scoring system. Sequist noted that it is unfair for a scoring system to use the higher incidence of kidney disease against

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

the black community, particularly when the reason for disease is because of hypertension, diet, and other factors that are a result of systemic racism. Systemic factors ultimately put black, brown, and poor communities at a disadvantage, he argued, both when trying to access health care resources and when a scoring system is used to allocate scarce resources.

Panelists were asked for their thoughts on how implicit bias and provider education on CSC perpetuates racism and ableism1 in health care. Sequist stated that it is necessary to involve medical ethicists, or similar professionals with equal standing, along with the critical care physicians when providing input for creating CSC guidelines. An antiracism lens must be taken to all work being implemented as part of the COVID-19 pandemic response in order to proactively identify patients at risk for poor outcomes. These at-risk patients should then be contacted and provided with the resources and support needed to eliminate the possibility of poor outcomes from COVID-19, he said. Persad added that he would be interested in seeing more psychology research about how providers can minimize implicit bias.

When institutions fail to have clear and explicit CSC guidelines, providers can more easily activate their implicit bias when making treatment decisions. Persad explained that some of the most troubling stories of bias were not situations where there was a biased standard of care, but where there was no standard of care, leaving clinicians to make choices that appeared to be based on race. Sederstrom concluded by stating that for any substantive change to occur, building empathy is needed. Without empathy, she said, biases and cultural norms can take hold. Including empathy in CSC guidelines and scarce resource allocation will allow clinicians to make informed, equitable decisions that are in the best interest of patients.

REFLECTIONS

Suzet McKinney, principal and director of Life Sciences; Jennifer Piatt, deputy director of the Network for Public Health Law–Western Region Office; and Cynda Rushton, professor and chair of Johns Hopkins School of Nursing, offered their thoughts on the legal and ethical discussions. McKinney shared her experience in Chicago where initially there was much hesitancy towards CSC planning because it was difficult to fathom a scenario where it would ever need to be implemented. The allocation of scarce resources has always been the elephant in the room when thinking about CSC, she noted, but COVID-19 has highlighted the need for robust planning and collaboration across all levels of government. Piatt added that lack of CSC planning leads to situations where providers are making

___________________

1 Ableism is defined as the discrimination or prejudice against individuals with disabilities.

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

ad hoc, nonuniform decisions that affect patients differently based on their location.

Rushton said that physicians have not been adequately prepared for the moral residue that comes with making CSC decisions. The COVID-19 pandemic has forced clinicians to make difficult decisions about the allocation of scarce resources, and it is essential that proper triage guidelines are in place and health care workers receive support when faced with making such tough decisions. Rushton also suggested considering if the threshold for implementing CSC is too high. She echoed Sederstrom’s previous comments about empathy. Because COVID-19 has depleted the workforce and drained health care workers of the ability to empathize, reevaluating the appropriate time to trigger CSC conditions and instituting them earlier may better preserve resources in all forms, including health care workers.

Piatt and Rushton offered their perspectives on the true reason providers and institutions are worried about liability: fear. Emergency circumstances highlight how important liability protections are when a crisis warrants all hands on deck. The COVID-19 pandemic has caused a shortage in health care workers and created a circumstance where any and all help from clinicians is needed. Without liability protections, some health care workers may be hesitant to step up in times of crisis owing to fear of legal repercussions. Liability protections will increase the willingness of providers to step up during an emergency, Piatt explained. However, she questioned if such protections will truly increase the reliance and implementation of CSC when the opportunity arises.

Rushton concluded by stating that the health care system has been relationally depleted by the COVID-19 pandemic. The key to getting through these difficult times is not to think our way through, she said, but to feel our way through and listen to one another wholeheartedly. Clinicians need a heavy dose of humility when it comes to CSC planning and allocation of scarce resources. By not letting go of professional expertise, not listening, and not engaging with the communities we aim to serve, their health and wellness may be jeopardized, Rushton concluded.

Eric Toner, senior scholar and scientist for the Center for Health Security at Johns Hopkins University, concluded by saying we all have the duty to plan and prepare. Many liability issues stem from the fact that institutions fail to do the work involved to prepare for CSC conditions. Many hospitals have also failed to achieve load balancing, a practice that when done correctly could save many lives. Evaluating when CSC situations are implemented is just as important as how they are implemented, he continued. CSC conditions should be triggered when institutions recognize that their resources have become limited, rather than when their state government recognizes it. When considering how to allocate scarce resources, health care workers must be included in those conversations and recognized

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

as a critical resource that must be used in the best way to avoid burnout. To establish more trust and create more equity, Toner emphasized community engagement and seeking community opinions on CSC planning rather than waiting for the community’s reaction to plans that have already been created. Communities are willing and able to have the tough discussions, he said, and they want to contribute.

Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×

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Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
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Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
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Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
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Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 50
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 51
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 52
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 53
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 54
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
Page 55
Suggested Citation:"5 Legal, Ethical, and Equity Considerations for Crisis Standards of Care." National Academies of Sciences, Engineering, and Medicine. 2022. Evolving Crisis Standards of Care and Ongoing Lessons from COVID-19: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/26573.
×
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Crisis Standards of Care (CSC) inform decisions on medical care during a large-scale crisis such as a pandemic or natural disaster, eliminating the need to make these decisions at the bedside without protections or guidance. Numerous points throughout the COVID-19 pandemic have demonstrated the necessity of this type of crisis planning. The National Academies of Sciences, Engineering, and Medicine Forum on Medical and Public Health Preparedness for Disasters and Emergencies convened a series of public workshops to examine the experiences of healthcare providers during the COVID-19 pandemic and identify lessons that can inform current and future CSC planning and implementation. The workshops examined staffing and workforce needs, planning and implementation of CSC plans, and legal, ethical, and equity considerations of CSC planning. Topics of discussion included improving coordination between the bedside and boardroom, increasing buy-in from elected officials, expanding provider engagement, and addressing health equity issues. This publication summarizes the presentation and discussion of the workshops.

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