A Plan for the Unthinkable: Writing the Rules for Ventilator Rationing

By Sally Parker

As a palliative care doctor, Chin-Lin Ching (BA '01, MD '05, Res '08)is no stranger to agonizing life-and-death decisions. She helps families make them every day at Highland Hospital.

But when the pandemic hit, she felt as if she were living in a dystopian novel.

Like most of her colleagues in the University of Rochester’s Coronavirus Ethics Response Group (CERG), she saw that COVID-19 was unlike anything she had ever encountered. Her job was to come up with a protocol for allocating ventilators in case of a shortage. It meant considering the unthinkable: “Who would get a ventilator, and who would we remove?”

CERG decided right away that any plans around patient care would have to ensure nonbiased access. In a stand unique among its peers around the country, the team insisted community voices have a seat at the table from the start.

As the coronavirus approached, overwhelming medical teams first in China, then Italy and New York City, “it felt probably as close to war as any of us would ever know,” Ching recalls.

“In the spring, I would hear the phrase ‘We’re flying the plane as we’re building it.’ Not only that, we didn’t have instructions, and the plane was nosediving into the side of the mountain.”

In March 2020, with COVID-19 cases multiplying across the state, University of Rochester Medical Center and its affiliate hospitals quickly formed CERG to develop a triage protocol for allocating mechanical ventilators to patients in respiratory failure, and to do it in a fair and equitable way.

CERG’s goal from the start was to save the most lives and to protect bedside clinicians from making public health decisions. Physicians knew what their colleagues around the world were going through: With not enough ventilators for patients who needed them—and no protocol to support them—overwhelmed frontline providers were forced to choose who would get one and who wouldn’t. In the run-up to the virus’s arrival in the Rochester area, providers had a small window in which to prepare to do things differently.

“My feeling all along was we had to come up with a system that wasn’t going to be random,” says David Kaufman, MD (Flw ’93), director of adult critical care at Strong Memorial Hospital and a CERG member. “I wanted a system to be in place that would not require a clinician to say, ‘I’m looking at this person right now, and I can tell they’re not going to do well, so I’m not going to put them on a ventilator and I’m going to give it to someone else.’ We wanted a system that would allow for fairness and for equity.”

It felt probably as close to war as any of us would ever know.

In Service of Others

URMC physicians started planning for the pandemic in January and February, when the virus arrived in the U.S. By mid-March, with New York City under siege, the hospital was bracing for an onslaught—canceling elective surgeries, redeploying staff, and opening up hundreds of beds.

“We thought our beds would fill up totally, and so we had plans for a field hospital. We thought it was reasonably likely we would run out of equipment or beds or staff,” says Michael Apostolakos, MD (Res ’90, Flw ’93), chief medical officer at URMC. “Why would we think we would be any different from New York City?”

Fortunately, with time to prepare, the hospital averted a crippling onslaught. But knowing the virus can worsen rapidly, providers were concerned patients needing intubation could outnumber ventilators. When CERG started forming, leadership gave its full support.

The group came together under Richard Demme, MD, director of the Program for Clinical Ethics, who recruited co-chair Marjorie Shaw, JD (MA ’04, PhD ’11), associate professor of medical humanities and bioethics. In daily Zoom meetings, 20 core members brought expertise in medical and nursing specialties, bioethics, legal counsel, chaplaincy, diversity and inclusion, translational science, and community impact. All worked with additional volunteers on subcommittees that met daily.

“These are people who are volunteering their time. This is not in their job description,” Shaw says. “These same people are pulling double shifts because of COVID. Their work epitomizes a commitment to service of others.”

"We wanted to protect providers from the moral distress and burden of bedside decision making."

Members built the protocol from every angle: moral distress and staff support, internal (patient) communications, protocol development and assurance, triage, and translational data and informatics. More than 100 staff from across the medical system worked on it, often with colleagues they had never met.

“The whole process, including all the terrible aspects of COVID, has made us a tighter community,” Kaufman says. “A lot of the silos that exist in an academic institution have broken down a bit. I think there is just better communication, better understanding of what

"We wanted a system that would allow for fairness and for equity.”

other people might be going through.” Within two weeks of the first meeting in mid- March, the group had a plan to activate the adult triage protocol. A separate protocol was developed for pediatric and neonatal patients.

From Theory to Practice

Not long after Ching joined CERG, the gravity of the situation hit her. She had been asked to join in her capacity as co-chair of the ethics committee at Highland Hospital, where she is also medical director of the Palliative Care program. Shaw and Ching were acquainted through the Rochester Academy of Medicine Health Care Ethics Leadership Consortium, a regional group of medical ethicists who meet quarterly.

Ching’s role on CERG was specific and central to its mission: to analyze the URMC protocol using clinical data from current hospitalizations to ensure any ventilatorallocation protocol at all URMC hospitals and affiliates, in fact, saved the most lives.

With New York State’s existing ventilator guidelines as a starting point, Ching quickly formed a committee to collect and apply the clinical data to different allocation processes and compare potential outcomes. Unlike the state guidelines, the URMC protocol needed to be a practical tool ready to use at a moment’s notice.

“This 280-page document outlined the foundation of how you even begin to think about how to allocate a scarce resource like a ventilator,” Ching says. “I found myself wondering what this actually looks like in real life. The words looked pretty, and the ethics were clear. But we wanted to walk through what it meant for the patient who comes into the ER with life-threatening COVID symptoms and for the physician treating a patient who needs a ventilator.”

Making the protocol workable became the next important step in the process and is ongoing, Ching says. Collaborations between the Informatics team and the Clinical Translational Science Institute have been groundbreaking.

At the core of the state guidelines is a colorcoded ventilator priority chart based on SOFA (Sequential Organ Failure Assessment). That was a concern for the CERG team; SOFA is increasingly viewed as biased against disadvantaged and underrepresented populations. Some aspects of the system— particularly how the occurrence of sepsis is weighted—give Black people unfavorably higher SOFA scores.

The first step for the Protocol Development Committee was to translate the language in the state guidelines into a flow chart of decision making.

“It made us feel like we were writing out the instructions of a board game. That sounds

terrible because we’re talking about ventilators and lives,” Ching says. “But if your SOFA score is this, and your condition doesn’t improve, this is what happens to your color code.”

Ching and her committee—philosophy and bioethics professor Richard Dees (Flw ’10), director of the UR undergraduate major in bioethics; and pediatric hematologist Jessica Shand, MD (Res ’09), both members of the URMC ethics committee—worked for several hours every day for two months. Their task was to draw out the algorithm for informatics and translational scientists to translate into a computer program. By mid-May they had one in hand.

But Ching wondered how it would play out in practice. After a sleepless night questioning “how this would actually look if we did the protocol right now,” she started mining hospital data the next day. She looked at current adult COVID-19 patients and extrapolated what care they would have received if the algorithm— based solely on the state guidelines—were applied. Specifically, for patients who survived, would they have survived with the algorithm in place?

Right away she saw that the guidelines were not going to work for COVID-19. Designed to treat flu patients, they call for improvement checks every two days after intubation—much too soon to see progress in COVID-19 cases.

“We saw very quickly that if we followed the guidelines to a T, we would not be giving people enough time to improve. We found that five days instead of two made the most sense for treating COVID,” Ching says.

“These patients need at least two weeks on a ventilator. It’s finding that sweet spot between sitting on a ventilator, creating a parking lot situation by giving them too much time, and not giving them enough time. We were able to change the guidelines to fit COVID better.”

There are five steps to the protocols for both adult and pediatric/neonatal patients.

Invoking the protocol has not yet been needed, and hospital leaders are working hard to avoid the necessity of using it. The decision to invoke falls to the URMC chief medical officer or a designee.

While logistics are paramount, the plan’s beating heart is a focus on justice.

5 Step Guide

The protocols for both adult and pediatric/neonatal patients follow these steps:

1 The patient is screened for exclusion criteria (advance directives, very short life expectancy).

2 Patient’s risk of mortality is assessed using SOFA (adult patients) and P-OFS (neonatal/ pediatric).

3 Patient is assigned a color code designating their level of priority in ventilator allocation.

4 Patient eligible for ventilator support receives a trial of intubation to provide an opportunity for health status improvement.

5 Patient is reassessed, using SOFA and P-OFS scores, at predetermined intervals to determine whether the intubation trial will be continued.

Work on the protocol continues as fresh data emerges and new treatments take hold. It is constantly being re-evaluated and reimagined. For example, how can ventilators be shared among hospitals in URMC? How can different hospital systems collaborate? The hope is that knowledge gained with new approaches will not only reduce the need for ventilators altogether but lead to new efficiencies no one has yet imagined.

Fair Allocation

While logistics are paramount, the plan’s beating heart is a focus on justice. Community leaders had a seat at the table from the start, and one of the eight committees was devoted to engaging diverse perspectives. But justice wasn’t the work of just one committee: It permeated every decision at every level.

The Community Engagement Committee met weekly to develop suggestions for building the protocol and brought them to the larger group, says Adrienne Morgan (PhD ’13W), senior associate dean for equity and inclusion at the School of Medicine and Dentistry. Members are community leaders who represent diversity in race, ethnicity, religion, sexual identity, refugee and documentation status, and ability.

“Because COVID was disproportionately affecting people of color, we needed to have those voices at the table. This was assuring equity and inclusion in the process,” she says. (Read more about Morgan’s role and URMC’s Equity and Anti-Racism Plan on page 28.)

Early benchmarking showed it to be a novel strategy.

“At the time, we were unaware of any other institutions who were recommending or including community members to the degree that we were,” Shaw says. “The decision to ensure a welcoming and inclusive process on such an important community and public health question speaks volumes about the values of our leaders and our institution.”

The URMC protocol guards against the introduction of new bias. While it uses SOFA scores to assign each case to one of the six color-coded “buckets,” it removes all identifying patient information, such as name, race, age, gender, and ZIP code. Patients are all treated the same, moving from one bucket to another, depending on the results of scheduled SOFA assessments. All patients in need of ventilators are included, not just those with the coronavirus.

Bedside Support

CERG is a timely example of Rochester’s biopsychosocial model (BPS), an interdisciplinary approach that considers equally the biological, psychological, and social facets of patient health. In this case, the BPS mindset was applied to caregivers as well.

“If I’m going to ask my colleagues in the ER and ICU to do this, no matter how ethical we think it might be in a pandemic from a humanity perspective, it’d better be solid, and we’d better be saving the most lives,” Ching says.

“For me, it meant moving away from the philosophies of ethics and away from cerebral arguments very quickly to the bedside— where I belong.”

By taking the allocation decision away from frontline providers, the protocol becomes a kind of institutional life raft. If the plan needs to be invoked, a rotating team of on-call physicians and advanced practitioners skilled in supportive communication steps in to discuss treatment decisions and options with the patient’s family.

“We wanted to protect providers from the moral distress and burden of bedside decision making,” Shaw says. “They have enough of a burden. That is not a burden they should bear.”

Enduring Resilience

Staff are tired after a year long on hours and intense caregiving. Still, they step up when asked, Apostolakos says. During a recent staffing shortage, about 100 workers responded to a call to fill the gap.

“These people have full-time jobs, and they’re willing to come in and work overtime to relieve their colleagues. It’s just tremendous,” he says. “The people we have working here are so dedicated.”

Ching says when she spoke to a pediatric palliative care group about the need to mediate moral distress, she was surprised at first when some members started to cry. “I had become numb to it because I had been so eyeball-deep,” she says. “When you begin digging below the surface, a lot of us are used to compartmentalizing our emotions while at work. A lot of providers are scared to open that door because it’s almost like a flood.”

"Because COVID was disproportionately affecting peopleof color, we needed to have those voices at the table."

Hospitals in UR Medicine have set up safe spaces and special rounds, in which staff can share concerns. Shaw predicts the kind of support mapped out in the protocol for frontline staff will only become more crucial in the months and years to come. Ching agrees.

“The PTSD that providers are going to experience with this is going to be astronomical,” she predicts. “I think we as a society need to be prepared to deal with this.”

Regional Collaboration

CERG built on and accelerated efforts led by URMC to take a regional approach to ethics in the delivery of care. In late 2018, Shaw convened the bioethicists consortium at Rochester Academy of Medicine to cement the role of ethics in the delivery of health care in the region. It provided some of the juice that made BPS central to the protocol—and connected UR to kindred efforts in the local health care community.

By the time CERG took shape, consortium members were working closely together and discussing policies and cases. One member, Carl “Chris” Reynolds, MD, medical director of Rochester General Hospitalist Group and co-chair of the hospital’s ethics committee, served on CERG.

URMC and Rochester Regional Health are working on ways to offer as much continuity as possible in their ventilator protocols so community members receive consistent care no matter what hospital they go to, Shaw says.

In a wider geographic reach, talking to peers at health systems across upstate N.Y. gave Kaufman a sense of the bigger picture. He held weekly calls with intensivists in Buffalo, Syracuse, and Albany, many of them former URMC colleagues and fellows. The group became a kind of brain trust for sharing ideas and discussing cases.

“These were worthwhile, complex conversations, and they were playing out in the international community,” he says. The COVID-19 Task Force of the New York State Bar Association Health Law Section cited URMC’s protocol in its final report, including it in the appendix. Task force members felt the URMC work was an exemplar for the state for its thoughtful approach to using data to inform adaptation of the 2015 state guidelines, Ching says.

Changed for Good

The pandemic has forced tradition-bound health care systems to become nimble and creative, to be open to new ways of thinking and working. At URMC, specialty silos have broken down, and collaboration is up. Greater efficiencies developed during the first surge have helped teams continue to cope through the second.

Tested under pressure, the work behind CERG will have an impact long after the crisis is over, Apostolakos says.

“It’s just been an extraordinary year. Everything is just interconnected and has caused a lot of stress for everyone,” he says. “We’re going to look back at the resilience of the community. It’s going to be a story of heroes and workers who put themselves out there.”

As the vaccination rollout continues, CERG is helping community leaders tout the benefits of vaccines to a population with historical reasons to distrust it.

“I think our committee will have a huge role in that,” Morgan says. “We have a small and mighty committee made up of trusted leaders in our community. There are many, many groups working on this to engender trust to get people to step up and get the vaccine.”

The protocol is a living document that brings a mindful approach to managing the unthinkable—no matter what that might be down the road. Equity will be embedded in every decision.

“We want to have a solution for any therapy that might have to be rationed,” Kaufman says. “We want to approach it rationally and logically and fairly. The thought that goes into ventilatorallocation protocol will be useful for thinking about any limited resource going forward.”

“We’re going to look back at the resilience of the community.

It’s going to be a story of heroes and workers who put themselves out there.”

Remembering What We Found

In just two weeks, Match Day 2020 was transformed from a highly anticipated envelope-reveal celebration in the School of Medicine and Dentistry’s Class of ’62 Auditorium to a log-on-from-home livestream event during which soon-to-graduate medical students clicked open an email to discover their next career steps.

That hasty evolution is a fitting metaphor for the nascent days of the University of Rochester Medical Center’s COVID response. It’s one of a myriad of examples illustrating how an exploding global pandemic triggered a rapid remake across education, research, and patient-care missions.

What seemed unfathomable in 2019, despite reports of a deadly virus emerging in China and Europe, became all too real on March 1, 2020, when the first case of coronavirus was confirmed in New York state.

Eight days later, URMC launched a command center to address theapproaching threat. And on March 21, Strong Memorial Hospital reportedits first COVID case.

The past year has challenged URMC in ways no one could have imagined. Although our response mirrors the actions of academic medical centers across the country, there’s no denying the Rochester-strong courage, tenacity, and teamwork that got us through an unforgettably challenging year. A year that brought great loss and struggle, but also demonstrated the power of our calling—basic, translational, and clinical science; nimble and innovative clinical care; teaching future providers and researchers in entirely new ways—to reduce fear and bring healing to the Rochester community, our region, and the world.

It’s impossible to capture every contribution in a few magazine pages.Here are some highlights that reflect the commitment, talents, andresilience witnessed across our campus (and via Zoom) every day.

Learning Curve

On the heels of their virtual Match Day, with in-person learning halted and clerkship requirements met, the School of Medicine and Dentistry’s Class of 2020 received their medical degrees one month early in a virtual ceremony. In May, virtual commencement ceremonies were celebrated across the university.

Celebrations took creative turns—from online toasts to front-lawn serenades—and the new MDs had options for their unanticipated free weeks before starting their residencies. Some who stayed in Rochester chose to roll up their sleeves and fill temporary assignments bolstering Strong Memorial Hospital’s staff as COVID cases surged.

For trainees not ready to graduate, a sudden shift to online learning created many new challenges for faculty and students. Then came word that travel and gathering restrictions eliminated the possibility of in-person visits for residency and fellowship candidates—a vital part of recruiting the best and brightest talent to our programs. A multi-pronged approach helped people visit Rochester virtually through enhanced websites, video tours, and engaging social media strategies.

The Next Best Thing to Being There

Many residency and fellowship programs bolstered their recruiting efforts with virtual tours and social media engagement.

Take a virtual tour of the School of Medicine and Dentistry here:

http://md.urmc.edu/tour

And check out a sampling of Instagram accounts:

@urmc_familymed_residency @urmc_neurology_residency @urmc_pathology_residency @urmc_pccm_fellowships @urmc_pharm_phy s@urmc_toxicology

Graduate Education and Post-doc Affairs (GEPA) faced similar challenges. Unable to host applicants at in-person interview weekends, GEPA officials tapped a versatile conferencing platform and ingenuity from the enrollment team to transform visits into interactive online events. The new platform had a side benefit; no longer restricted by domestic travel, interview weekends opened up to an international audience.

Research Reimagined

Throughout the pandemic, URMC has played a lead role in the Coronavirus University Response Team, which closely monitors the evolving situation and develops policies to keep everyone safe. Research operations adopted specific precautions and made policy adjustments to assure safety in human-subject studies. Research faculty initiated new processes to manage laboratory work in the COVID era, leveraged changes in funding opportunities and resources, andmade adjustments for students to work remotely when possible.

These changes did not delay or diminish the ability of URMC scientists and clinicians to help lead the national response to COVID. URMC has been engaged in research on vaccines, treatments, immune responses, testing innovations, and disease patterns, as well as the virus's impact on nursing home residents, underrepresented populations, and nursing mothers.

ROCHESTER MEDICINE | 2021 SPECIAL EDITION 19

By the Numbers

Some Fast Facts from Our COVID Response

Days between first case in N.Y.S. and first case reported in Rochester: 11

Average number of COVID tests conducted each week: (March 16, 2020–Feb. 28, 2021): 15,000

COVID patients discharged from Strong Memorial Hospital through February 2021: 1,917

PPE usage March 1, 2020–Feb 28, 2021

Procedure masks: 6,184,122

N95 masks: 324,485

Gowns: 2,210,636

Vaccine doses distributed by URMC as of March 1, 2021: 43,000

Community-based organizations helped by URMC mobile vaccination clinics: 220+

Bottles of hand sanitizer compounded in-house monthly: 1,200+

Clinical studies participated in: 87

Volunteers registered for studies: 5,036

URMC’s COVID research includes investigations of:

• Vaccines, including clinical trials of the Pfizer/BioNTech and AstraZeneca products

• Related outreach with community partners to encourage participation in vaccine trials by people of color

• Treatments, including remdesivir and convalescent plasma

• Immune responses and the potential for previous colds to provide a measure of protection

• Nursing home impacts

• Testing, including phase 3 trials of a $5 test that gives results in 15 minutes

• Nursing mothers and the safety and potential benefits of breast milk

• Effects of COVID on child and adult lungs

• Disease patterns, through the New York State Emerging Infections Program

Caring in a Crisis

Around the world, images of overcrowded health care facilities and PPE-clad clinicians struggling to care for their patients dominated media coverage. In March 2020, as New York City hospitals became the global epicenter of the crisis, URMC leaders prepared for a surge in critically ill patients that could similarly overwhelm Rochester-area hospitals.

It began with a Grand Rounds on March 4, as clinicians met to comprehend the approaching risk, and infectious disease specialists shared the latest guidance on how to evaluate and treat COVID patients. Within days, a multidisciplinary COVID response team formed. At twice-daily command center meetings, they plotted how to brace for the imminent threat and protect frontline caregivers. Within a week, the virus reached Rochester, as the area’s first COVID-positive patient was tested at Highland Hospital. Cases increased exponentially at first, straining every facet of the UR Medicine clinical operation to address unique new pressures. Amid fears of ventilator, bed, staff, and PPE shortages, teams across the Medical Center joined forces to expand capacity and provide patient care while keeping everyone safe.

• A tent was erected outside the Emergency Department, later replaced with a larger engineered structure with climate controls, expanding ED capacity with improved privacy and physical distancing of patients.

Significant infrastructure changes and staff ingenuity helped create an exceptional environment to care for critically ill patients in highly infectious disease units.

• Thanks to extraordinary work by Facilities Engineering, entire units were converted to negative pressure to facilitate intubation and extubation without relocating patients, helping to preserve PPE.

• As demand for testing surged, a dedicated team of scientists and collaborators brought URMC’s Laboratory from zero to 1,000 tests a day in just two months. By January, capacity had increased to 4,000 tests per day.

• In early April, a “Dr. Chat Bot” self-screening online tool was launched to help review and track symptoms among

These measures and a strong community response caused COVID hospitalizations to plateau in May, then decline gradually during the summer months. Weary clinical teams had little time to catch their breath, however. A second surge came in early fall, quickly doubling the peak hospitalization numbers from the spring, then tripling and quadrupling them. Armed with COVID care experience and proven treatment regimens, clinical teams doubled down to maintain care for all patients, with minimal reductions in elective procedures.

Countless examples of heroism emerged along URMC’s COVID journey, from the first cases in spring to the launch of vaccine clinics at the end of the year. Physicians, APPs, and nurses—including recent retirees— stepped out of their comfort zones and eagerly trained for deployment where help was most needed. A team from Emergency Medicine spent a week in April supporting staff downstate at Northwell Health, returning with valuable insight and reassurance that the proper measures had been put in place in Rochester. Innovation led to the inhouse manufacturing of face shields and hand sanitizer, and a decontamination process to extend the life of N95 masks. A majority of providers quickly adopted telemedicine, whenever possible, to continue caring for patients with non- COVID issues while minimizing risk of exposure. And patient-care spaces were redesigned to support physical distancing and promote safety as patients were urged to seek care for urgent and chronic non-COVID health issues.

So many talented and tireless people sacrificed to put patients first, even when it meant extended time away from their loved ones. With a vast majority of patient-facing staff fully vaccinated, we can look toward the future with gratitude and hope—while remembering what we discovered in ourselves and our institution during the COVID pandemic.

A Plan for the Unthinkable: Writing the Rules for Ventilator Rationing