key: cord-0684363-pwvtwxrd
authors: Ehmann, Michael R.; Zink, Elizabeth K.; Levin, Amanda B.; Suarez, Jose I.; Belcher, Harolyn ME.; Daugherty Biddison, Elizabeth L.; Doberman, Danielle J.; D’Souza, Karen; Fine, Derek M.; Garibaldi, Brian T.; Gehrie, Eric A.; Golden, Sherita H.; Gurses, Ayse P.; Hill, Peter M.; Hughes, Mark T.; Kahn, Jeffrey; Koch, Colleen G.; Marx, Jason J.; Meisenberg, Barry R.; Natterman, Jeffrey; Rushton, Cynda H.; Sapirstein, Adam; Selinger, Stephen R.; Stephens, R Scott; Toner, Eric S.; Unguru, Yoram; van Stone, Maureen; Kachalia, Allen
title: Operational recommendations for scarce resource allocation in a public health crisis
date: 2020-09-28
journal: Chest
DOI: 10.1016/j.chest.2020.09.246
sha: d32759063f1c16cf980de8c07d317c971cca23a3
doc_id: 684363
cord_uid: pwvtwxrd

The COVID-19 pandemic may require rationing of various medical resources if demand exceeds supply. Theoretical frameworks for resource allocation have provided much needed ethical guidance but hospitals still need to address objective practicalities and legal vetting to operationalize scarce resource allocation schemata. To develop operational scarce resource allocation processes for public health catastrophes, including the COVID-19 pandemic, five health systems in Maryland formed a consortium – with diverse expertise and representation – representing more than half of all hospitals in the state. Our efforts built on a prior statewide community engagement process, which determined the values and moral reference points of citizens and healthcare professionals regarding the allocation of ventilators during a public health catastrophe. Through a partnership of health systems, we developed a scarce resource allocation framework informed by citizens’ values and by general expert consensus. Allocation schema for mechanical ventilators, intensive care unit resources, blood components, novel therapeutics, extracorporeal membrane oxygenation, and renal replacement therapies were developed. Creating operational algorithms for each resource posed unique challenges; each resource’s varying nature and underlying data on benefit prevented any single algorithm from being universally applicable. The development of scarce resource allocation processes must be iterative, legally vetted, and tested. We offer our processes to assist other regions that may be faced with the challenge of rationing healthcare resources during public health catastrophes.

The World Health Organization's declaration of a coronavirus disease 2019 (COVID-19) pandemic triggered efforts to maximize healthcare surge capacity. 1 Early experiences in China, Italy, and New York suggested that rationing of medical resources might nevertheless become necessary. 2 Domestic healthcare systems moved quickly to plan for this dire eventuality but were faced with insufficiently detailed federal and variable state-level guidance. 3, 4 Through a partnership of Maryland health systems, we developed a scarce resource allocation framework informed by citizens' values and by general expert consensus. No universal allocation algorithm can be applied to every scarce resource; each has unique considerations. The development of scarce resource allocation processes must be iterative, legally vetted, and tested.

Three patients admitted with COVID-19 pneumonia have escalating oxygen requirements during their first 48 hours of hospitalization. All are determined to require intubation and mechanical ventilation.

The hospital has one available intensive care unit (ICU) bed and two remaining mechanical ventilators.

How should these resources be allocated?

Amidst the unprecedented circumstances of the COVID-19 pandemic, individual hospitals lacked a standardized foundation on which to develop scarce resource allocation (SRA) processes. To help fill this void, many ethical frameworks were published. 3, 5 These frameworks, well-grounded in established bioethical principles, provided initial steps in building fair allocation processes but did not address the objective practicalities and legal vetting required to operationalize SRA.

After a statewide call for collaboration, five Maryland health systems partnered to develop a consortium representing more than half of all Maryland hospitals: Johns Hopkins Medicine, Lifebridge Health, Luminis Health, MedStar Health, and University of Maryland Medical System. The goal of this partnership was to develop operational SRA processes which could engender community trust by assuring that allocation decisions were fair, consistent, legally permissible, and non-discriminatory across all participating hospitals.

Because the public bears the consequences of rationing decisions, the inclusion of public perspectives in the development of SRA frameworks is essential. 6 Fortuitously, a two-year (2012-2014) Maryland-wide community engagement process had been conducted to ascertain the values and moral reference points of citizens and healthcare professionals should the allocation of ventilators need to occur during a public health catastrophe. 7 The processes described herein are built upon this foundation.

Allocation schemata for mechanical ventilators, intensive care unit (ICU) resources, blood components, novel therapeutics, extracorporeal membrane oxygenation (ECMO), and renal replacement therapies were developed (see document in the online data supplement). Creating operational algorithms for each resource posed unique challenges that were managed with imperfect solutions inherent to the trying circumstances; no single algorithm could be applied equally to all scarce resources (Table 1) .

To date, none of the algorithms presented herein have required implementation. Rather, in an attempt to assist others facing the ongoing and unprecedented circumstances of the COVID-19 pandemic we share our processes and lessons learned so that they can be applied to the current or any future public health crisis.

J o u r n a l P r e -p r o o f

Consortium partners maintained internal groups of clinical, legal, ethics, and health system leaders to address the allocation of scarce resources and vet framework drafts. Each SRA group member had equal voice in process development. Leaders from each of the systems' working groups acted as consortium liaisons to achieve consensus.

The multidisciplinary SRA working group is comprised of physicians, nurses, lawyers, and scientists with expertise in anesthesiology, bioethics, critical care, cultural competency, disability law, disaster preparedness, human factors engineering, emergency medicine, health equity, health literacy, internal medicine, neonatology, nephrology, neurology, palliative medicine, pediatrics, public health, pulmonology, and transfusion medicine. For the first six weeks, tele-meetings were held once or twice daily. The work was shared with the Maryland Hospital Association and the Maryland governor's office so that, if necessary, plans could be adopted statewide without precipitating unforeseen legal restrictions. 6

The SRA working group utilizes ethical principles that include the duty to provide care, duty to steward resources, distributive and procedural justice, equitable and standardized practices, and transparency. 3, 4, [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] The principles of fair chance and prognosis for both short-and long-term survival are the primary considerations for maximizing treatment benefit and enhancing survival of the most patients.

The algorithms emphasize that every patient in need of a scarce resource would be assessed by the same standardized method. Patients would not be excluded or treated differently based upon their ability status, age, ethnicity, gender identity or expression, immigration status, language, national origin, race, religion, sex, sexual orientation, or ability to pay. Early framework drafts included life-cycle J o u r n a l P r e -p r o o f considerations, which can be regarded as a proxy for age; guidance from legal experts, including the governor's office, and the United States Department of Health and Human Services Office of Civil Rights highlighted the potential for such considerations to be discriminatory, so these criteria were removed. 7, 20, 21 All operational algorithms focus on first augmenting existing resources. Each algorithm identifies a threshold of remaining resource supply at which allocation processes would be implemented.

To enhance objectivity and limit moral distress of treating clinicians, the framework requires multidisciplinary Triage Teams distinct from the patients' providers to make resource allocation decisions. Triage Team composition would be proportional to institutional size but must include at least three voting members who would adjudicate allocation decisions by a simple majority.

If patients are triaged not to receive a potentially life-saving medical intervention, they (or their legal representative) and their treating clinician will be notified and may request an appeal by a Secondary Review Committee distinct from the Triage Team and the patients' providers (with few exceptions if time does not allow). Unconscious bias training is required for all Triage Team and Secondary Review Committee members.

Consortium partners agreed that hospitals will develop and implement mechanisms to support clinicians experiencing moral distress, psychological trauma, or burnout from providing care during the unprecedented circumstances that mandate deviation from routine standards. 22 J o u r n a l P r e -p r o o f

COVID-19 patients requiring prolonged mechanical ventilation in China and Italy led to a shortage of ventilators. 23 The mechanical ventilator allocation algorithm would be invoked when the supply of ventilators falls to 10% at an individual hospital (See Figure E1 in the online data supplement).

Ventilators would be allocated based on a combination of short-and long-term survival likelihood.

Short-term mortality is estimated by accepted tools (e.g., Sequential Organ Failure Assessment [SOFA] and Pediatric Logistic Organ Dysfunction). [24] [25] [26] [27] [28] [29] [30] Predictive tools for long-term survival are less robust; thus, any patient with a projected life expectancy of at least 12 months would be considered to have equal chance for long-term survival. 6 We evaluated the agreement of 11 physician raters assessing 20 patient profiles for 12 month projected life-expectancy revelaing an intra-class correlation coefficient of 0.957, 95% CI (0.921,0.981). After this calculation, patients on equal footing would be prioritized by clinical trajectory, with priority given to improving patients. If, after all triage assessments, multiple patients remain on equal footing, ventilators would be allocated by random selection (i.e., lottery).

When available, data abstractors with healthcare training and access to the electronic medical record (EMR) would manually validate the automated SOFA scores derived from the EMR and extract comorbidities. In a resource-constrained environment, the Triage Officer would perform data validation and abstraction to present to Triage Team members for scoring. In this scenario, the Triage Officer would vote only as a "tie-breaker" during allocation decisions. The number of patients requiring review determines the necessary data abstraction support and size of Triage Teams. 

The New York experience and various predictive models highlighted the likelihood for COVID-19 patient surges to exceed ICU capacity. 31, 32 If ICU resource utilization (i.e., beds, equipment, staff) reaches a threshold of 95% capacity, the ICU allocation algorithm would be triggered (see Figure E2 in the online data supplement).

We created a consensus-based scoring system to allocate ICU resources to patients most needing ICU care (See Table E1 in the online data supplement). Factors are weighted by urgency of ICU treatment and ICU monitoring; likelihood of short-term and long-term survival; and, for patients already in the ICU, length of time spent in the ICU and illness severity score trends. Low-scoring patients would either not be allocated an ICU bed or, if currently in the ICU, be downgraded to create capacity for a higherscoring patient. Typically, ICU triage decisions are not immediately life-or-death so there is no appeal process, although at least daily re-assessments of eligible patients would occur.

Initially, we considered assigning ICU allocation scoring system points to patients of "instrumental value," such as first responders and healthcare workers. 3 However, operational challenges, including determining who qualifies as a healthcare worker and the potential for perceived discrimination and subsequent loss of public trust were too great so this consideration was not included.

Blood scarcity became a concern early in the pandemic as social distancing measures led to widespread blood drive cancellation. 33, 34 Because transfused blood is not reusable, blood depletion within an individual hospital could be rapid.

Experts in transfusion medicine, obstetrics, pediatrics, and surgery joined the SRA working group ad hoc to develop the blood allocation algorithm due to the disproportionate effect a reduced blood supply might have on these specialists' patients (See Figure E3 in the online data supplement).

Each hospital, considering its typical services (i.e., trauma or obstetric centers versus hospitals with low procedural volumes), defines its own threshold for declaring blood scarcity. If a "Critical Blood Supply Alert" is triggered, clinicians whose patients traditionally require significant volumes of blood are notified and the Transfusion Triage Team (TTT) is activated.

To prevent potential conflicts of interest and delays in care, transfusion triage decisions would not be left to frontline clinicians or the blood bank. In emergencies, requested blood would be released while the TTT evaluates the patient's predicted survivability (both short-and long-term) and ongoing blood needs in relation to current supply. Within 30 minutes, the TTT would make a binding decision about whether additional blood component requests will be fulfilled. Because of time limitations, this decision is not reviewable.

Special consideration is given to patients with a higher likelihood of survival (e.g., children, patients with postpartum hemorrhage, those with high likelihood of achieving hemostasis, and transfusiondependent patients).

Multiple therapies, including hydroxychloroquine, convalescent plasma, and remdesivir have been proposed as treatments for COVID-19. 235-37 As anecdotal experience, small studies, and lay press coverage of these therapies emerged ahead of clinical efficacy trials, a unified and transparent ethical approach to their allocation became necessary.

Without high-quality evidence to guide decisions, the SRA working group favored the development of, and patient participation in, clinical trials while allowing for expanded access and guideline-driven "compassionate use." Efforts were made to identify patients most likely to benefit from these therapies. For example, before withdrawal of the Emergency Use Authorization (EUA), hydroxychloroquine, if limited in availability, would have been preferentially provided to patients with conditions known to benefit from it (e.g., systemic lupus erythematosus). 38 Conversely, without evidence-based guidelines to identify COVID-19 patients most likely to benefit from convalescent plasma, random selection was determined to be the fairest allocation process.

Remdesivir demonstrated benefit in patients with COVID-19 before its manufacture was scaled to meet demand. 39, 40 Ongoing trials remain an option for receiving remdesivir. 41 Patients unable to obtain J o u r n a l P r e -p r o o f remdesivir via a clinical trial or expanded access protocol must meet Food and Drug Administration EUA criteria to be eligible for allocation. 42 If demand for remdesivir exceeds supply, eligible patients would be assigned to one of three tiers developed by consensus opinion. Tier one patients are early in their disease course and theorized to have significant SARS-CoV-2 viremia most likely to benefit from therapy. Tier three patients have the most advanced COVID-19 disease and are considered least likely to benefit.

To ensure fair chance for all eligible patients, allocation within each tier would occur via random selection. Pregnant patients unable to receive remdesivir via an expanded access protocol receive priority for allocation within their assigned tier. Without evidence of superiority from a ten-day versus five-day treatment course, and to maximize treatment for the most patients, the algorithm allocates only five-day courses. 43 Dexamethasone, another potential therapy with evidence demonstrating a mortality benefit for patients with COVID-19, was not thought to be a limited resource. Therefore, the SRA working group has not yet addressed its allocation. 44 ECMO ECMO is a scarce resource even under normal conditions. Recognizing that demand during the pandemic could likely exceed capacity despite a lack of evidence that ECMO benefits patients with COVID-19, the SRA working group engaged ECMO specialists for developing an ECMO allocation algorithm (see Figure E4 in the online data supplement).

An ECMO Capacity Management Team defined hospital ECMO capacity based on available equipment and staff. The ECMO triage algorithm is activated when only two additional patients could be accommodated. One ECMO circuit is reserved at all times for a pediatric patient.

During ECMO scarcity, barring catastrophic clinical events, a patient placed on ECMO is given a minimum therapeutic trial of seven days before reallocation is considered. A secondary review can be requested for reallocation decisions that would remove a patient from ECMO support.

Unique considerations for ECMO allocation include that established ECMO mortality prediction scores may not apply to patients with COVID-19, and there are no mechanisms to compare disease trajectories for patients eligible for ECMO with those currently on ECMO. 45, 46 

The New York experience made clear that the incidence of COVID-19-related acute kidney injury had the potential to overwhelm existing dialysis resources. 47 The renal replacement therapy algorithm calls for aggressive conservation of equipment, supplies, and personnel (see Figure E5 in the online data supplement).

Unique to renal replacement is the ability to conserve resources or to provide less or different dialysis to enhance survival of more patients. For example, providing continuous dialysis in 12-hour instead of 24hour blocks, considering acute peritoneal dialysis, and geographically cohorting patients for simultaneous dialysis could stretch scarce resources, including dialysis personnel. A Dialysis Triage Team coordinates conservation efforts.

To lessen the cognitive burden of Triage Team members, we applied the Systems Engineering Initiative for Patient Safety framework to structure process implementation (Figure 1 ). 48 A human factors engineer provided expertise with process mapping, work system design, team science, and proactive risk assessment. Experts in Lean-Six Sigma methodology consulted on issues of efficiency and process redundancies. The health informatics team developed automated short-term survival scores, created data entry and reporting methods for the rapid collection of patient data, and masked patient information to reduce bias. Clinical members of the SRA working group vetted processes for usability and clinical relevancy through simulation.

Educational materials -including talking points for clinicians and handouts for patients -were developed to alert patients and families of the potential for SRA due to resource constraints, and to communicate clearly and consistently about specific allocation decisions. Individuals with disabilities and the SRA working group's health equity and disability experts reviewed all patient handouts for health literacy and readability. Materials were translated into the five languages most commonly encountered across the health systems.

As the COVID-19 pandemic evolves and more information becomes available, these processes will be continually updated and improved. The proposed algorithms will need assessment during this and future public health crises.

Although validated for multiple conditions, the performance of SOFA and other short-term mortality prediction tools for patients with COVID-19 has not been evaluated. Ongoing comprehensive evaluation of patients treated for COVID-19 within our systems may allow generation of improved predictive models to replace population-based scoring tools.

Utilizing co-morbidities to estimate long-term survival risks reinforces systemic disparities in health outcomes. However, in keeping with the findings of the statewide community engagement process, only patients with severe, advanced, and unrecoverable chronic illness resulting in a life expectancy of 12 months or fewer would be considered less eligible for ventilator allocation. 7 If implementation becomes necessary, the SRA working group will monitor for unintended consequences -including association of sociodemographic factors and resource allocation -to improve the algorithm. If, despite our efforts to ensure equity, review of aggregate data reveals disparate care, then the algorithms should be modified. Addition of a health equity adjustment factor has been proposed to facilitate equity in access to scarce resources. 49 Transparency and inclusion of public perspectives in the development of allocation frameworks are essential. The foundational Maryland ventilator allocation framework prior to the pandemic was built on public engagement. 7 The SRA working group recognizes that constant iteration is necessary and welcomes feedback to invite modifications.

Finally, our SRA working group hopes that current public health and hospital capacity efforts in response to the COVID-19 pandemic will prevent the need to implement these processes. If, however, implementation becomes necessary, monitoring the well-being of clinicians engaged in these unprecedented allocation decisions will also be essential.

No universal allocation algorithm can be applied to every scarce resource, as each has unique considerations. In our experience, the rapid pace of new data acquisition continues to require frequent J o u r n a l P r e -p r o o f adjustments to these algorithms. The development of SRA processes must be iterative, legally vetted, and tested.

Through a partnership of health systems in Maryland, we were able to develop a scarce resource allocation framework informed by citizens' values and consistent with the general consensus of experts.

We hope that this framework can serve as a guide for other regions that may be faced with the challenge of rationing healthcare resources during this unprecedented time and during future public health catastrophes. Tables   Table 1. Brief description of scare resource allocation algorithms 

WHO Director-General's opening remarks at the media briefing on COVID-19

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The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine

Serial evaluation of the SOFA score to predict outcome in critically ill patients

Validation of the paediatric logistic organ dysfunction (PELOD) score: prospective, observational, multicentre study

PELOD-2: an update of the PEdiatric logistic organ dysfunction score

A neonatal sequential organ failure assessment score predicts mortality to late-onset sepsis in preterm very low birth weight infants

SNAP-II for prediction of mortality and morbidity in extremely preterm infants

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Projecting hospital utilization during the COVID-19 outbreaks in the United States

Projecting demand for critical care beds during COVID-19 outbreaks in Canada

American Red Cross Faces Severe Blood Shortage As Coronavirus Outbreak Threatens Availability of Nation's Supply

The American Red Cross

Balancing Supply and Demand for Blood during the COVID-19

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Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma

Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial

State of Maryland Executive Department Order: Preserving the Supply of Necessary Drugs. Order of the Governor of the State of Maryland

Remdesivir for the Treatment of Covid-19 -Preliminary Report

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Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score

Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score

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Work system design for patient safety: the SEIPS model

Health equity and distributive justice considerations in critical care resource allocation