Employing Crisis Standards of Care in Response to the COVID-19 Pandemic
The number of confirmed COVID-19 cases is expected to rise dramatically over the next few weeks. With this increase, the United States health care system may be confronted with patients who will require hospitalization and critical care support in numbers that may overwhelm our current surge capacity. Although suppression efforts are being ordered in jurisdictions throughout the country to “flatten the curve,” it appears that some cities will need to implement crisis standards of care in response to this unprecedented public health crisis.
Study from Imperial College London Provides Ominous Data
The potential trajectory of the pandemic is ominous. Researchers at the Imperial College London released a report on March 16, 2020, which precipitated a major shift in the thinking of the U.S. and British governments on the extent of suppression efforts needed to combat the COVID-19 outbreak. The lead researcher, Professor Neil Ferguson, stated that “the world is facing the most serious public health crisis in generations.”
According to the study, in the absence of any control measures or changes in individual behavior, peak mortality would occur after approximately three months, with approximately 80% of the U.S. population infected over the course of the epidemic and 2.2 million predicted deaths. This does not account for potential additional mortality and other negative effects caused by the health system being overwhelmed. For an uncontrolled epidemic, the study predicts that critical care bed capacity would be exceeded as early as the second week in April 2020, with an eventual peak in ICU beds more than 30 times greater than the maximum supply available.
The study, therefore, recommended strong suppression efforts that include a combination of case isolation, home quarantine, school closures and social distancing. Without social distancing of the entire population, however, this strategy still would result in approximately 1.2 million deaths and an 8-fold higher peak demand on critical care beds than the present available surge capacity in the United States. The report bluntly makes clear that these measures are assumed to be in place for a five month duration to avoid inundation of the health care system, and that once interventions are relaxed infections will begin to rise and will result in a predicted peak epidemic later in the year, meaning that it may be necessary to institute an adaptive policy of "on" and "off" periods where these suppression efforts are enforced and relaxed over a period of about 18 months, or until a vaccine can be developed. Researchers will watch the situation in China and South Korea in the coming weeks to help further inform the recommended strategy for responding to the epidemic.
Shortfall in the Supply of Ventilators and Respiratory Therapists
Ventilators are the main supportive treatment for patients who are critically ill with COVID-19. A study by the Lancet medical journal reported on February 24, 2020, that the mortality rate is 61.5% for COVID-19 patients who require ventilation support. The typical ventilator is reported to cost between $25,000 and $50,000. A study published in 2015 estimated that the United States may have a maximum of approximately 135,000 ventilators available in the event of a public health crisis, which includes an estimated 10,000 ventilators maintained in reserve by the federal government. It is nevertheless widely expected that even with robust suppression efforts, there will be a significant shortage of ventilators to meet anticipated surge demand in areas throughout the United States that will be hard-hit by COVID-19 cases. Among the states, New York alone is reported to have a potential shortfall as high as 18,000 ventilators.
Another important factor is the anticipated shortage of respiratory therapists needed to operate the equipment. There are currently approximately 150,000 licensed respiratory therapists in the United States.
The Crisis in Italy
The initial two-week surge in COVID-19 hospitalizations in Italy forced physicians to make difficult decisions about which patients would receive life-saving therapy and which would be left to die. The New England Journal of Medicine reported the Italian College of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) disseminated guidelines for Italian health care providers to use in determining how to allocate health care resources properly when demand exceeds supply. Most critically, the SIAARTI guidelines recommended “maximizing the benefits for the largest number” and instructed that “the allocation criteria need to guarantee that those patients with the highest chance of therapeutic success will retain access to intensive care.”
These crisis guidelines are unfamiliar territory for many health care providers in developed nations. Health care providers in the United States soon may seek similar direction if presented with clinical decisions regarding the distribution of limited resources to a patient population that is increasingly inflicted by the COVID-19 pandemic. Given that President Trump recently invoked the Defense Production Act to expand production of necessary medical supplies, such as personal protective equipment and ventilators, additional supplies of this critical medical equipment may be available in the coming months. It nevertheless appears that our medical system is reaching a crucial period where difficult treatment decisions must be made.
Crisis Standards of Care
As the pandemic unfolds, government officials and hospitals throughout the country are discussing revised guidelines to ration scarce resources such as ventilators and implementing “crisis standards of care” (CSC) that may be triggered in a public health emergency. Upon initiating CSC, the focus of medical care shifts from the primary obligation of promoting the well-being of individual patients to the thoughtful use of limited resources to achieve the best possible health outcome for the population as a whole.
The Duty to Plan and AMA Guidelines
Medical facilities and providers have a duty to plan for providing essential services during a disaster, including how the delivery of care will transition from the conventional standards of care to a crisis surge response. The American Medical Association (AMA) has issued a medical ethics opinion on procedures that allocate scarce health care resources fairly among patients and has recommended that certain criteria be considered. The AMA recommends that resources should be allocated based on the urgency of need, the likelihood and anticipated duration of benefit, and the change in quality of life. It is not appropriate to base allocation policies on certain subjective factors such as social worth, the patient’s contribution to the illness or other non-medical characteristics. Priority should be given to those patients for whom treatment will avoid premature death or extremely poor outcomes, followed by patients who will experience the greatest change in quality of life. The AMA recommends use of an objective and transparent mechanism to determine which patients will receive the scarce resources, particularly when there are not substantial differences among patients in need. Finally, the allocation procedure must be explained to patients who are denied access to the scarce resources.
State CSC Plans
It has been reported that 36 states have worked on plans for rationing care during emergencies since Hurricane Katrina in 2005. Minnesota’s plan, for example, emphasizes that in a medical surge, “healthcare facilities must utilize an incident management system and attempt to move as rapidly as possible from a reactive stance – relying on frontline personnel utilizing job aids and applying their training – to a proactive stance – managing the event by objectives using an incident action plan.” With regard to triage decision processes and other modifications to clinical practice, medical facilities “should not allow it to fall to the individual clinician to make such decisions.” Principles that underlie triage decisions include fairness of the process, transparency in design and decision-making, consistency in application, proportionality with the scale of the emergency and degree of scarce resources, and accountability of decision-makers.
Limits on ICU Surge Capacity
The American College of Chest Physicians (CHEST) issued guidance on ICU surge in 2014, recommending that critical care facilities should be able to “surge 200% of usual ICU capacity within days using regional, state or federal assets.” Minnesota’s CSC plan candidly acknowledges that “planning for a 200% surge is daunting,” and that “few hospitals will have the ventilator and cardiac monitor resources to achieve a 100–200% surge.” As noted above, predictive modeling in the Imperial College study shows an ICU surge of 800% in the United States without social distancing of the entire population.
Legal CSC Planning
Many states do not have a statute that directly relieves the health care provider responding to a disaster of liability for injury or death resulting from the delivery or withholding of medical care. Depending on the jurisdiction and whether emergency orders are in place, health/safety regulations and practice standards may remain unaltered in a medical surge event. Lawyers and emergency managers responding to a public health crisis may be confronted with an altered legal environment in which they must provide real-time solutions to complicated medical decision-making where existing statutes or laws provide only guidance but no solid authority or direction.
Civil Tort Exposure
Although medical malpractice lawsuits arising from services provided during a catastrophe are relatively rare, medical professionals who respond in a crisis situation should nevertheless understand the potential for civil tort exposure whenever there is a deviation from the ordinary standard of care. The Minnesota CSC plan comments on this issue, stating: “Because the legal standard of care is a flexible and fact-specific concept that ordinarily takes into account the circumstances under which care was provided, courts evaluating the conduct of a healthcare provider should take into account the particular circumstances surrounding an emergency event where resources may be scarce and healthcare systems and providers may be overwhelmed.”
During a public health emergency, the medical provider will be held to the standard of care that a “reasonable” medical provider would have given in that same or a similar situation, and accounting for the availability of resources. One way to protect individual clinicians from tort liability is to ensure that emergency protocols are followed for triage decision-making and other modifications to clinical practice.
Typically, it will be the province of a jury to decide whether the medical provider deviated from the relevant standard of care. In the context of the COVID-19 pandemic, it is reasonably certain that any juror in a future potential malpractice trial will have been personally affected by the crisis.
Emergency Orders and Disaster Declarations
Various types of emergency orders and disaster declarations made by state and local officials are available under state law. The effect of these orders and declarations varies widely depending on their nature and scope. All states have some authority to modify, alter or suspend state health and safety regulations that impact the provision of medical care in a crisis. For example, on March 4, 2020, California’s Governor Gavin Newsom issued an emergency order that among other things waives relevant licensing provisions of state health facilities to ensure they “are able to adequately treat patients legally isolated as a result of COVID-19.”
Other Statutory Protection
Other potential statutory protections may exist in a crisis, including Good Samaritan laws and liability protection for registered volunteers. Federal statutes such as the Public Readiness and Emergency Preparedness (PREP) Act also provide certain protections. On February 4, 2020, the Secretary of the Department of Health and Human Services used his authority under the PREP Act to issue a declaration that provides liability immunity to drug and medical device manufacturers, distributors and users relating to the implementation of countermeasures to the COVID-19 pandemic.
As this unprecedented public health crisis unfolds, health care providers in the United States will likely be confronted with grim decisions on how to allocate scarce health care resources fairly among patients. This may mean choosing in some cases between which patients live or die. How to handle this type of Sophie’s Choice in the medical setting has been debated for years among emergency planners and medical ethicists. When confronted with crisis conditions and medical equipment shortages, medical professionals should be allowed flexibility to provide real-time solutions to complicated medical decision-making, including difficult triage decisions and necessary modifications to clinical practice. These decisions, however, should be made within a crisis standards of care framework that incorporates elements of fairness, transparency, consistency, proportionality and accountability, consistent with AMA and state guidelines.