The entire All Facilities Letter (AFL) from the California Department of Public Health is available here.
Medical ethicists have developed three principles to frame rationing decisions: utilitarianism, egalitarianism, and prioritarianism. Utilitarianism emphasizes making decisions to maximize the good achievable with scarce resources. Egalitarianism focuses on trying to provide an equal opportunity for care to each individual. Prioritarianism stresses prioritizing the most vulnerable or disadvantaged groups when resources are scarce.
Although each framework has its proponents and opponents, physicians have used these three underlying principles at the bedside as they attempt to allocate resources.
Rationing decisions and policies are not created in a bubble; health care providers, consumers, and the government all participate to varying degrees. Health care providers often engage in some level of bedside rationing. Consumers self-ration by opting for less costly treatments or by refusing to seek treatment. The government is involved in the U.S. health system in many ways, and each interaction is an opportunity for the government, and therefore the public, to influence rationing decisions.
Step 1: Determine if the Patient Meets Inclusion Criteria for Critical Care:
1. Requirement for invasive ventilatory support
b. Clinical evidence of impending respiratory failure
c. Inability to protect or maintain airway
2. Hypotension with clinical evidence of shock
Step 2: Calculate the Patient’s Evaluation Score Using the Patient Evaluation Tool
The scoring system applies to all patients presenting with critical illness, not simply those with the disease or disorders that arise from the public health emergency. For example, in the setting of a severe pandemic, those patients with respiratory failure from illnesses not caused by the pandemic illness will also be subject to the allocation framework. Ethical goal of the allocation framework: Consistent with accepted standards during public health emergencies, a goal of the allocation framework is to achieve the most benefit for the entire populations of patients. It should be noted that this goal is different from the traditional focus of medical ethics, which is centered on promoting the wellbeing of individual patients. In addition, the framework is designed to achieve the following:
1. To create meaningful access for all patients. All patients who are eligible for ICU services during ordinary circumstances remain eligible, and there are no exclusion criteria based on age, disabilities, or other factors.
2. To ensure that all patients receive individualized assessments by clinicians, based on the best available objective medical evidence.
3. To ensure that no one is denied care based on stereotypes, assessments of quality of life, or judgments about a person’s "worth" based on the presence or absence of disabilities or other factors.
No use of categorical exclusion criteria: The allocation framework described in this document differs in two important ways from other allocation frameworks. First, it does not categorically exclude any patients who, in usual circumstances, would be eligible for critical care resources. Instead, all patients are treated as eligible to receive critical care resources and are prioritized based on potential to benefit from those resources; the availability of critical care resources determines how many priority groups can receive critical care. There are compelling reasons to not use exclusion criteria. Categorically excluding patients will make many feel that their lives are "not worth saving," leading to justified perceptions of discrimination. Moreover, categorical exclusions are too rigid to be used in a dynamic crisis, when ventilator shortages will likely surge and decline episodically during the pandemic. In addition, such exclusions violate a fundamental principle of public health ethics: use the means that are least restrictive to individual liberty to accomplish the public health goal. Categorical exclusions are not necessary because less restrictive approaches are feasible, such as allowing all patients to be eligible and giving priority to those most likely to benefit.
Second, within the context of keeping all patients eligible, the allocation framework also attempts to increase overall survival by giving some priority to patients who do not have a very limited near-term prognosis even if they survive the acute critical illness. There is precedent for using this criterion in allocation of scarce medical resources. The American Medical Association guidance on allocating scarce resources includes duration of benefit as a valid criterion. Frameworks for allocation of organs for transplantation, which is overseen by the U.S. Department of Health and Human Services, include near term duration of benefit as a criterion (e.g., the Lung Allocation Score). The National Council on Disability’s recent report on disabilities and organ transplantation did not recommend against using duration of benefit as a criterion. Extensive consultation with citizens, ethicists, and disaster medicine experts informed the principles and processes adopted in this document.
This allocation framework is based primarily on two considerations: 1) saving lives; and 2) saving lifeyears, both within the context of ensuring meaningful access for all patients and individualized patient assessments based on objective medical knowledge. Patients who are more likely to survive with intensive care are prioritized over patients who are less likely to survive with intensive care. Patients who do not have a severely limited near-term prognosis due to advanced underlying medical conditions are given priority over those who have such advanced conditions that they have a very limited near-term prognosis even if they survive the acute critical illness. As summarized in Table 1, the Sequential Organ Failure Assessment (SOFA) score (or an alternate, validated, objective measure of probability of survival to hospital discharge) is used to determine patients’ prognoses for hospital survival. The presence of conditions in such an advanced state that they limit duration of benefit within one to five years of the acute illness is used to characterize patients’ prognosis for near-term survival. Based on consultation with experts in disability rights and physical medicine and rehabilitation, we have intentionally not included a list of example conditions associated with life expectancy <1 year and <5 years. The rationale for this is that such lists run the risk of being applied as blanket judgments, rather than in the context of individualized assessments by clinicians, based on the best available objective medical evidence. For example, patients are assigned from 1 to 4 points according to the patient’s total calculated SOFA score (range 0-24). They are assigned points for the presence of underlying conditions that limit near-term prognosis (2 points if life expectancy is predicted to be less than five years, 4 points for life expectancy less than one year). These points are then added together to produce a total raw priority score, which ranges from 1 to 8. Lower scores indicate higher likelihood to benefit from critical care; priority will be given to those with lower scores.
When evaluating patients against criteria such as the SOFA score or evaluating underlying conditions, care should be given by providers to ensure that certain underlying health conditions that do not have an impact on the immediate or near-term survivability of the patient should NOT be factored into the assessment. Clinicians have an obligation to follow all applicable anti-discrimination laws and regulations.
Table 1. Patient Evaluation Tool to Allocate Critical Care/Ventilators During a Public Health Emergency
* SOFA = Sequential Organ Failure Assessment, which is used as an example of how to integrate an objective measure of acute severity of illness.
** Persons with the lowest cumulative score would be given the highest priority to receive mechanical ventilation and critical care services.
Step 3: Assign patients to color-coded groups
Once a patient’s evaluation score is calculated using the patient evaluation tool described in Table 1, each patient should be assigned to a color-coded triage group, which should be noted clearly on their chart/EHR (Table 2). This color-coded assignment of triage groups is designed to allow triage officers to create operationally clear groups to receive critical care resources. For example, individuals in the red group have the best chance to benefit from critical care interventions and should therefore receive priority over all other groups in the face of scarcity. The orange group has intermediate priority and should receive critical care resources if there are available resources after all patients in the red group have been allocated critical care resources. The yellow group has lowest priority and should receive critical care resources if there are available resources after all patients in the red and orange groups have been allocated critical care resources.
It is important to note that all patients will be eligible to receive critical care beds and services regardless of their priority score; there are no baseline exclusion criteria. The availability of critical care resources will determine how many eligible patients will receive critical care. Patients who are not able to receive critical care/ventilation will receive medical care that includes intensive symptom management and psychosocial support. They should be reassessed daily to determine if changes in resource availability or their clinical status warrant provision of critical care services. Where available, specialist palliative care teams will be available for consultation. Where palliative care specialists are not available, the treating clinical teams should provide primary palliative care.
Table 2. Assigning Patients to Color-coded Groups
Step 4: Make daily determination of how many groups can receive critical care resources
Hospital leaders and triage officers should make determinations twice daily, or more frequently if needed, about how many groups will have access to critical care services. These determinations should be based on real-time knowledge of the degree of scarcity of the critical care resources, as well as information about the predicted volume of new cases that will be presenting for care over the near-term (several days). For example, if there is clear evidence that there is imminent shortage of critical care resources (i.e, few ventilators available and large numbers of new patients daily), only patients in the highest group (Red group) should receive the scarce critical care resource. As scarcity subsides, more groups (e.g., first Orange group, then Yellow group) should have access to critical care interventions.
Other scoring considerations for adult patients:
Pregnant patients will be assigned a priority score based on the same framework used for non-pregnant patients. If a pregnant patient at or beyond usual standards for fetal viability, the patient will be given a two-point reduction in their priority score (e.g., from a raw patient prioritization score of 5 to 3).
2. Giving heightened priority to those who are central to the public health and health care response.
Individuals who are engaged in tasks that are vital to the public health and health care response, including all those whose work directly supports the provision of acute care to others, including those who provide wraparound supports to the provision of acute care to others, should be given heightened priority. Justifications for this prioritization include saving public health and health care responders so that they may help future patients, and to promote the effectiveness of their work by signaling that certain protections are in place for the risks these workers take during the public health emergency. This can be operationalized by subtracting one point from the priority score of critical workers (e.g., from a raw patient prioritization score of 5 to 4). This category should be broadly construed to include those individuals who play a critical role in the chain of treating patients and maintaining societal order. Importantly, it would not be appropriate to prioritize front-line physicians and not prioritize other front-line clinicians (e.g. paramedics, nurses and respiratory therapists) and other key personnel (e.g., the maintenance staff that disinfects hospital rooms, infection preventionists).
3. Categorical exclusion criteria:
A central feature of this allocation framework is that it avoids the use of categorical exclusion criteria to indicate individuals who should not have access to critical care services under any circumstances during a public health emergency. In a public health emergency, public trust will be essential to ensure compliance with restrictive measures. Thus, an allocation system should make clear that all individuals are "worth saving." We strive to accomplish this by keeping all patients who would receive mechanical ventilation during routine clinical circumstances eligible and allowing the availability of ventilators to determine how many eligible patients receive it. It should be noted that there are some conditions that lead to immediate or near-immediate death despite aggressive therapy such that during routine clinical circumstances clinicians do not provide critical care services (e.g., cardiac arrest unresponsive to appropriate ACLS, overwhelming traumatic injuries, massive intracranial bleeds, intractable shock). During a public health emergency, clinicians should still make clinical judgments about the appropriateness of critical care using the same criteria they use during normal clinical practice. It is accepted that this IPACSCPG Patient Prioritization Tool is not perfect. It is hoped that it fosters both dialogue and further research to develop and validate objective resource allocation tools in the future. However, should a massive disaster occur today, the members of this committee believe clinicians can be assured using this matrix, as it was developed and approved by knowledgeable clinicians and ethicists with extensive experience in public health emergencies.
4. Resolving “ties” in priority scores between patients
In the event that there are ‘ties’ in priority scores between patients and not enough critical care resources for all patients within the prioritized group, life-cycle considerations should be used as the first tiebreaker, with priority going to younger patients. We recommend the following categories, which roughly correspond to major life stages (age 12-40, age 41-60; age 61-75; older than age 75). The ethical justification for using the lifecycle principle as a tiebreaker is that it is a valuable goal to give individuals equal opportunity to pass through the stages of life—childhood, young adulthood, middle age, and old age. The justification for this principle does not rely on considerations of one’s intrinsic worth or social utility. Rather, younger individuals receive priority because they have had the least opportunity to live through life’s stages. Empirical data suggest that, when individuals are asked to consider situations of absolute scarcity of life sustaining resources, most believe younger patients should be prioritized over older ones. Public engagement about allocation of critical care resources during an emergency also supports the use of the lifecycle principle for allocation decisions. The moral argument in favor of life-cycle–based allocation is as follows: "It is always a misfortune to die . . . it is both a misfortune and a tragedy [for life] to be cut off prematurely."
If there are still ties after using the tiebreaker based on life cycle considerations, the raw score on the patient prioritization score should be used as a tiebreaker, with priority going to the patient with the lower raw score (e.g. a patient with a raw prioritization score of 1 should receive priority over a patient with a score of 3). If there are still ties after these two tiebreakers are applied, a lottery (i.e., random allocation) should be used to break the ties.
Criteria for Patient Assessment and Withdrawal of Critical Care
The purpose of this section is to describe the process the triage committee should use to conduct reassessments on patients who are receiving critical care services, in order to determine whether he/she continues with the treatment.
Ethical goal of reassessments of patients who are receiving critical care services
The ethical justification for such reassessment is that, in a public health emergency when there are not enough critical care resources for all, the goal of supporting population outcomes would be jeopardized if patients who were determined to be unlikely to survive were allowed indefinite use of scarce critical care services. In addition, periodic reassessments lessen the chance that arbitrary considerations, such as when an individual develops critical illness, unduly affect patients’ access to treatment.
Approach to reassessment
All patients who are allocated critical care services will be allowed a therapeutic trial of a duration to be determined by the clinical characteristics of the disease. The decision about trial duration will ideally be made as early in the public health emergency as possible, when data becomes available about the natural history of the disease. The trial duration should be modified as appropriate if subsequent data emerges which suggests the trial duration should be longer or shorter. Evaluation of patients undergoing critical care/ventilation for other medical conditions may also need to be reassessed at appropriate durations. However, patients who are utilizing personal (supplied by the patient, not supplied by the hospital where they present for care) ventilators for pre-existing respiratory conditions, should NOT be separated from their personally provided equipment for reallocation to other patients. The triage committee will conduct periodic reassessments of all patients receiving critical care/ventilation. These assessments will involve re-calculating SOFA scores, or other mortality predictive tool used, and consulting with the treating clinical team regarding the patient’s clinical trajectory. The assessments will necessarily involve the exercise of clinical judgment. Patients showing improvement will continue with critical care/ventilation until the next assessment. If there are patients in the queue for critical care services, then patients who upon reassessment show substantial clinical deterioration as evidenced by worsening SOFA scores or overall clinical judgment should not receive ongoing critical care/ventilation. Although patients should generally be given the full duration of a trial, if patients experience a precipitous decline or a highly morbid complication which portends a very poor prognosis (e.g., refractory shock and DIC, massive stroke) the triage team may make a decision before the completion of the specified trial length that the patient is no longer eligible for critical care treatment.
Patients who are no longer eligible for critical care treatment should receive medical care including intensive symptom management and psychosocial support. Where available, specialist palliative care teams will be available for consultation.
Patient Evaluation Model