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Addressing Challenges Associated with Operationalizing a Crisis Standards of Care Protocol for the Covid-19 Pandemic

In a novel pandemic, health care leaders are tasked with designing and implementing Crisis Standards of Care protocols to guide clinicians in the event that a surge of cases outpaces the supply of critical care resources. Leaders need to actively engage communities who will be impacted by these protocols, with particular attention to vulnerable groups, including racial and ethnic minorities, and those with disabilities.

In response to the 2009 H1N1 pandemic, the National Academies of Medicine (formerly the Institute of Medicine) released guidance for establishing CSC protocols for implementation during disaster events.2 These recommendations are based on the ethical principles of fairness, duty to care, duty to steward resources, transparency, consistency, proportionality, and accountability. 2 In the intervening decade, several states established CSC guidelines, though there is variation in the manner in which these guidelines have been operationalized.4 By March of 2020, the state of Massachusetts had not yet issued CSC guidelines. As Covid-19 infections grew in Italy and in New York City, hospitals in Massachusetts, including Brigham and Women's Hospital (BWH) in Boston, began working on CSC protocols, anticipating a massive surge in cases.5 , 6 There was widespread anxiety that the number of cases might outpace hospital capacity, particularly for critical care resources.

CSC Development Process
In the initial absence of state-based guidelines, individual hospitals in Massachusetts sought to develop their own CSC protocols. BWH worked in conjunction with the broader Mass General Brigham (MGB) health care system to establish a preliminary CSC protocol. Beginning in mid-March of 2020, this work was initiated by an interdisciplinary group, at the request of health care system leadership, with representation from leadership at the hospital and health care system levels. Drafting this protocol involved an iterative process that moved forward quickly, meeting daily and sometimes multiple times per day, in order to ensure that the MGB system and its constituent hospitals were prepared for the potential surge.

Formation of a CSC Working Group
As protocol drafting began, BWH immediately assembled an ad hoc CSC Working Group to help draft the system-wide protocol and subsequently strategize about a BWH-specific operationalization plan that the hospital could implement quickly should the need arise. Our hospital found an interdisciplinary working group to be an effective method for rapidly formulating and reviewing the CSC protocol, and for synthesizing existing literature in ethics, CSC, and disaster medicine.
The CSC Working Group was initially composed of members of the hospital's Ethics Service and Hospital Incident Command System and was expanded within a week to include broader representation from the organization. Ultimately, key members of the core CSC working group at BWH included: the Medical Director of Emergency Preparedness; the Executive Director of the Ethics Service; the Co-Chairs of the Ethics Committee; a Clinical Ethicist/Nurse Scientist; a Pulmonary and Critical Care Fellow with ethics expertise; the Chief of Medical Psychiatry; two project managers; and the Chief Medical Officer as needed.

CSC Approval
After three weeks and multiple revisions, an initial protocol was approved in early April 2020 at the system level by MGB leadership and then at the local level by BWH leadership, including the Chief Medical Officer and Chief Nursing Officer. The initial MGB protocol was informed by the University of Pittsburgh's CSC policy (originally published March 23, 2020), including its algorithm for assigning priority scores in triage decisions.7 The essential components of the initial MGB protocol were as follows: • A scoring process for allocating scarce resources that incorporated both the patients' Sequential Organ Failure Assessment (SOFA) score (representing acute illness burden) and an assessment of their major and severe comorbidities (representing the chronic illness burden) • The designation of a Triage Officer charged with making triage decisions based on priority scores • The formation of a Triage Team to support the Triage Officer in making these decisions • The formation of a Triage Review and Oversight Committee (TROC) to ensure that decisions were made in accordance with CSC principles The HCEC supported the team-based model of triage that avoided ad hoc, individual decisionmaking by bedside clinicians and the principles of transparency and accountability.

Community Engagement
After MGB approval, and subsequent BWH approval in early April 2020, the initial protocol was shared with the Harvard Community Ethics Committee (HCEC) for their review, which they were able to provide within 24 hours. The HCEC is a group of individuals with diverse backgrounds who "meet regularly to provide public input on the ethical aspects of health care." While the HCEC recognized the ethical challenges inherent to CSC decision-making, it endorsed the ethical framework underpinning the document. In particular, it supported the team-based model of triage that avoided ad hoc, individual decision-making by bedside clinicians and the principles of transparency and accountability. In addition, we solicited feedback from our Brigham Health Covid-19 Equity, Diversity, and Community Health Response Team, which was embedded within our Hospital Incident Command System.8 This multidisciplinary team's perspectives were critical and several designees became members of our core working group to voice the perspectives of various vulnerable populations.

Engagement of the Hospital Community
Dissemination of the protocol and engagement of the local hospital community began as soon as a CSC document was approved by hospital leadership in early April. At BWH, a series of live webinars, outlining key principles, roles, responsibilities, and the process schematic ( Figure 1) proved to be an effective method of rapid dissemination.

FIGURE 1
Webinars were presented by hospital leadership, including the Chief Medical Officer, the Medical Director of Emergency Preparedness, leadership from the Psychological Support Services team, and leadership from the Ethics Service. These webinars also provided an opportunity for clinicians to submit questions about the protocol and receive answers in real time by CSC leaders. Feedback from these sessions was helpful in improving the protocol's procedures, and communication and operationalization strategies.

Operationalization Plan and Execution
Once a draft protocol was approved in early April, the BWH CSC Working Group spearheaded an operationalization plan to rapidly implement the protocol in the event of a Covid-19 surge at BWH that necessitated CSC activation. Ultimately, as of August 1, 2020, BWH has not experienced a surge that would have triggered activation of the CSC.

Identification of Triage Officers and Triage Team Members
The CSC guidelines required identifying a group of physicians with critical care knowledge who would serve as Triage Officers and work in conjunction with a Triage Team. The Triage Team, which would help calculate triage priority scores and provide other needed support to the Triage Officer, would consist of an attending physician, a nurse, and an individual to provide administrative support. The CSC Working Group outlined descriptions for each role that included responsibilities and authority. A call schedule was also developed. Academic Chairs were asked to identify Triage Officers and the Chief Nursing Officer was asked to identify nursing leaders to serve on the team. Triage Officers and members of the Triage Team were quickly identified so that they could become familiar with the CSC protocol and the roles that they would fill should the protocol be activated.

Creation of a Triage Review and Oversight Committee (TROC)
A working group was convened, including representatives from the Ethics Committee, the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), the Office of the General Counsel, Risk Management, the pool of Triage Officers, Safety and Quality, and Diversity, Equity and Inclusion (DEI). This working group considered several possible iterations of the TROC and arrived at the following composition: CMO or designee, CNO or designee, off-duty Triage Officer, Ethics representative, Legal Officer, and DEI representative. The TROC's roles included 1) evaluating priority scores and hearing appeals of individual decisions to withhold or withdraw life-sustaining treatment, 2) reviewing the triage process to determine whether the triage and appeals processes are being conducted in a fair, effective, and timely manner, and 3) adjudicating disputes. The on-call schedule required TROC members to be available for a 24-hour period with Internet accessibility for rapid activation and support.

Tabletop exercises
In order to test the scoring and triage process, the BWH CSC Working Group organized a series of tabletop exercises with Triage Officers and Triage Teams using real patient data to practice progressing through the steps outlined in the CSC document, including calculating priority scores. These were begun early in the process (even prior to system-wide approval) but were expanded and intensified after system-wide approval. Tabletop exercises also provided participants with the opportunity to role-play difficult conversations, prompting conversations and reflections about the challenges that triage would create. The tabletop exercises proved to be essential in identifying and ameliorating difficulties in operationalizing the CSC process. These groups also helped members of the Triage Team gain familiarity and comfort with the protocol.
Individuals selected for the Triage Team (n=42) were surveyed following their participation in tabletop exercises in order to garner feedback about the tabletop exercises and to assess their effectiveness ( Figure 2).

FIGURE 2
The results were encouraging: 64% reported a decrease in anxiety related to the CSC process; 72% reported an increase in their confidence with the CSC process; and 83% reported an increased understanding of the CSC process. Overall, these survey data suggest that the tabletop exercises were an effective way to orient members of the Triage Team to the CSC protocol.

Development of an Electronic Medical Record (EMR) Integrated Dashboard
Timely and accurate calculation of triage priority scores was critical for the success of the CSC framework. Manual calculation of these scores would require mining data from each patient's EMR, which could be challenging when faced with the need for rapid triage decisions. Thus, a SOFA calculator was created that would pull patient-specific data from the EMR. The Triage Team could then use this information to validate the SOFA Score, review comorbidities with the primary team, and calculate the priority score. This priority score would then be used to inform triage decisions, should the CSC be activated. A CSC dashboard was then created to display each element needed for decision-making, including: 1) individual priority scores 2) current ventilator/ICU bed availability and 3) a 48-hour projection of ventilator/ICU bed availability. This dashboard was refined over the course of our tabletop exercises based on feedback from participants ( Figure 3).

FIGURE 3
In recognizing the profound psychological distress that implementation of CSC guidelines might cause, a Psychological Support Service was developed at BWH."

Psychological Support Team
In recognizing the profound psychological distress that implementation of CSC guidelines might cause, a Psychological Support Service (PSP) was developed at BWH. This interdisciplinary service included members from Psychiatry, Social Work, Patient and Family Relations, Spiritual Care Services, Palliative Care, and the Employee Assistance Program. The service was designed to provide support at all levels of the hospital system. In particular, the team focused on supporting three populations: patients and families, the Triage Officer and Triage Team, and health care workers providing care to patients involved in triage. Plans included proactive check-ins with team members by the PSP and delineation of communication strategies for Triage Team members who would be relaying decisions to patients. These skills were practiced during several of our tabletop exercise sessions. As literature emerges about the lasting psychological impact of the Covid-19 pandemic on health care providers, we believe that this support system is a critically important component of our process.9

CSC Command Center
In a desire to support the Triage Team, a CSC command center was created to provide the team with a dedicated work area. Through guidance of PSP leadership, a pre-existing family waiting room was repurposed with adequate space for social distancing and relaxation when needed, including a lounge area. The area included telemonitoring capabilities for all patients in the hospital and several workstations for access to our EMR and dashboard.

Discussion
Here we consider the various challenges that we faced during the process and review major lessons learned.

Hurdles
Despite certain successes, the urgent need to develop a functioning process created many obstacles, including the limited opportunity for community engagement. As such, the voices of important stakeholders were not sufficiently incorporated in early CSC documents, resulting in operationalization challenges. A critical missing piece of early CSC documents was the additional perspectives of the diversity, equity, inclusion, and disability communities.
As described, in early April 2020, the Massachusetts DPH released state CSC guidelines.10 , 11 These guidelines were subsequently revised in response to feedback from the public, primarily surrounding concerns that the guidelines, as written, would disproportionately and unfavorably impact communities of color, persons with disabilities, and others who are already vulnerable to " health inequities.12 Major changes to the DPH guidelines included reframing the ethical goal of the document to focus solely onlives saved rather thanlife-years saved. Additional language was incorporated to address the concerns about vulnerable populations. Many other states are also rethinking guidelines in response to robust public feedback and, in some cases, litigation.12 The MGB protocol is currently undergoing revision to be consistent with the state-issued guidance and to incorporate additional community feedback. Ongoing engagement with stakeholders has revealed further challenges to creating an implementable process.13

Ethical Challenges
Several ethical questions remain unanswered. First is the debate over the focus on lives saved versus life-years saved. Concerns have been raised that a focus on life-years saved, by deprioritizing those with pre-existing conditions, may be subject to both implicit and overt biases in clinician assessments.12 , 14 , 15 This concern underpins the Massachusetts DPH revising its initial focus onlife years.
A related issue is whether, and how, to incorporate considerations of comorbid conditions and long-term prognosis into scoring schemes. Though there is general consensus that short-term prognosis (i.e., expected survival <1 year) is an acceptable consideration, considerations of longterm prognosis (i.e., 5-year life expectancy) raise concern. For example, how are such assessments to be made objectively and in a way that minimizes variability in judgment across clinicians?
Can an exhaustive list of conditions be developed? How should scoring mechanisms account for conditions, such as chronic kidney disease and hypertension, that disproportionally impact communities of color? If CSC guidelines do not incorporate co-morbidities and instead rely on short-term measures alone such as SOFA score, patients will often end up with the same scores. Depending upon how algorithms are designed to break ties, prioritization scoring may default to considerations of age, lottery, or first-come, first-served principles, each of which has its own ethical challenges. 16 The most recent Massachusetts guidelines incorporate scoring deprioritization for both 1-year and 5-year prognosis. Whether such co-morbidities will remain in these guidelines is an area of ongoing debate.
If CSC guidelines do not incorporate co-morbidities and instead rely on short-term measures alone such as SOFA score, patients will often end up with the same scores. Depending upon how algorithms are designed to break ties, prioritization scoring may default to considerations of age, lottery, or first-come, first-served principles, each of which has its own ethical challenges." A second challenge concerns the role of prioritizing health care workers. While arguments have been made in favor of their prioritization on the basis of quid pro quo considerations, meaning they have earned a right to care as a result of their service, andinstrumental value considerations, meaning the person, if treated, could return to work and aid in the public health response, others " have raised concerns thatonly prioritizing health care workers may, again, worsen existing health inequities and further disadvantage vulnerable populations.4 , 17 The revised Massachusetts DPH document prioritizes individuals who "are vital to the public health response, including all those whose work supports the provision of care to others."11 Nevertheless, questions remain about how decisions of prioritization are to be made. Who counts as "vital to the public health response?" Should this consideration be incorporated into the calculation of the initial priority scores, used only as a tie breaker, or eliminated entirely?
As a result of these challenges, the BWH CSC Working Group expanded to include broader representation from experts in diversity, equity and inclusion, and disability. Ongoing work with these groups is underway in an effort to develop a document that can be implemented if CSC is activated but that takes into account and compensates for existing inequities.

Practical Challenges
Additionally, there are practical challenges to consider. Though webinars proved to be an effective method for timely dissemination of information, the crisis evolved rapidly during March and April, necessitating changes to the CSC protocol in real time. This meant that information given to the hospital community changed over time. For example, the Massachusetts DPH guidelines were released shortly after the webinar series. Though the MGB protocol and DPH guidelines were closely aligned, there were subtle differences, including the scoring of health care workers and considerations around comorbidities, which required clarification and dissemination of updated information.
Facilitating tabletop exercises in the midst of a pandemic also proved challenging, as social distancing requirements prevented large groups from gathering in one room. A hybrid approach using in-person and video calling was attempted, though ultimately the group found serial meetings in small groups to be the more effective method.

Lessons Learned
One of the major lessons learned in this crisis was the importance of preparedness. BWH did not reach the point of needing activate the CSC, in large part due to extensive work to increase capacity during the "contingency phase" of the crisis. We recommend the early formation of a small interdisciplinary working group. The BWH CSC Working Group helped move the process forward by developing and modifying the CSC protocol based on feedback. Additionally, we recommend the early use of tabletop exercises to familiarize those who would be participating in the process with the process and identify challenges for operationalization. As described, these exercises decreased clinician anxiety and increased confidence and understanding in the CSC protocol at BWH.
Above all, it is critical to involve community stakeholders early in the process, and to ensure representation from vulnerable groups, including racial and ethnic minorities, and those with disabilities. Without input from these groups, CSC protocols miss critical considerations and risk perpetuating existing inequities." Above all, it is critical to involve community stakeholders early in the process, and to ensure representation from vulnerable groups, including racial and ethnic minorities, and those with disabilities. Without input from these groups, CSC protocols miss critical considerations and risk perpetuating existing inequities.14 Though BWH has not, as of August 1, 2020, activated the CSC protocol during the Covid-19 pandemic, the hospital continues to work on CSC guidelines. Many questions remain and will require engagement with members of the public to ensure that standards are responsive to the concerns of our communities, implementable if needed, and grounded in sound ethical principles.