The Inside Story: How New York Nephrologists, National Suppliers Made Creative Adaptations to Cope with COVID-19 Surge

As COVID-19 patients began to flood New York City area hospitals in February, they developed acute kidney injury (AKI) at rates much higher than anyone expected from a respiratory virus. By mid-April, the need for renal replacement therapy in these patients was pushing the system to the breaking point, as healthcare providers and manufacturers scrambled to find equipment and supplies.

Hospitals used creative means to cope—including contacting the top decision-makers at the largest companies directly to plead for help and finding ways to treat more patients with a limited number of machines.

Because COVID-19 is categorized as a respiratory infection, a great deal of attention was given to the need for ventilators early on. Reports from China and Italy did not indicate that AKI was a major concern, so American nephrologists were taken by surprise at the high rate of AKI when COVID-19 patients poured in.

A Kidney International study of COVID-19 patients admitted to the 23 hospitals in New York’s Northwell Health system reported that of 5449 patients admitted, 36.6% developed AKI, and 5.2% of the total—some 285 patients—required dialytic support.

A study in CJASN that included several hospital systems reported: “An informal survey of our intensive care units (ICUs) this week demonstrates that 20%–40% of intubated ICU patients have AKI that necessitates kidney replacement therapy.”

Steven N. Fishbane, MD, chief of the division of nephrology at Northwell Health, said he tried to plan ahead and order equipment for 10 of the hospitals in the system: “About two weeks before the wave really hit us, we modeled out what it would look like if this hit us a soft glancing blow, if it hit us medium, or if it hit us with complete fierce intensity. I remember looking at it and thinking, oh God, in the worst model, we would need about 60 new portable dialysis machines, 60 new portable reverse osmosis machines, [and] 24 new CRRT machines. I spoke to our procurement people and they said to order the entire thing.” The machines arrived in time to be put into use before the biggest wave of patients arrived—and that wave proved to be about 10% worse than even his worst-case scenario, Fishbane said.

Finding ways to stretch resources

As the patient census grew so much that they were running out of continuous renal replacement therapy (CRRT) machine capacity, Fishbane emailed CRRT experts around the country for suggestions on how best to use his resources. One expert suggested adapting hemodialysis machines to provide CRRT in the ICU through sustained low-efficiency dialysis (SLED)—providing dialysis over eight hours instead of the normal three- or four-hour session. “You make it gentle enough and slow enough, so that very sick patients can tolerate it,” Fishbane said. Having the machine in the ICU with several patients receiving treatment helps ease the nurse-to-patient ratio, Fishbane said, “because each of the ICU nurses has responsibility over the patient and a little bit of responsibility overseeing the dialysis. Then you have one hemodialysis nurse who walks around the unit and oversees the whole operation.” If the ICU nurse encounters an alarm, they can find the hemodialysis nurse for help.

Another adjustment that saved staffing was cohorting, Fishbane said. When the dialysis unit could not accommodate the overflow of patients, dialysis patients were grouped together in a room where one dialysis nurse could provide their care needs. Staffing was a constant problem with not only the increased number of patients, but staff becoming unavailable when they were out with their own COVID-19 infections.

Jai Radhakrishnan, MD, clinical director of nephrology at Columbia University Irving Medical Center, said that his institution also ordered some 40 NxStage machines for CRRT as well as hemodialysis machines for the various hospitals in his system. But even those new machines could not keep up with demand.

Many patients received prolonged intermittent RRT rather than CRRT. “You would give patients either a 12- or 24-hour and then flip the machine to the next patient,” so one machine could serve two patients, Radhakrishnan said.

Radhakrishnan’s team also used SLED with hemodialysis machines, a move that enabled them to remove three or four patients a day from the CRRT census. For patients well enough to receive hemodialysis, their treatment frequency was reduced from three times a week to two.

Fishbane and Radhakrishnan both avoided using peritoneal dialysis because of staff unfamiliarity with the procedure and potential incompatibility with the need for a prone position for patients on ventilators, but some institutions found it helpful.

“Peritoneal dialysis has a long history as a successful modality for the treatment of acute kidney injury, but it has gone out of favor over the last 20 years,” said David S. Goldfarb, MD, clinical chief of nephrology at New York University Langone Health and chief of nephrology and director of hemodialysis at the New York Harbor Veterans Administration Medical Center. “We were able to put together teams of people who were not dialysis technicians or dialysis nurses, people deployed from other services, who learned how to do manual exchanges of PD. The advantage of PD is that it is relatively low tech [and] is easy to teach people how to do it.” The CJASN paper reported that 22 patients were on PD at Bellevue Hospital Center, six at the New York campus of the New York VA Healthcare system, and four at the NYU Langone-Manhattan campus.

A critical need for fluids

Goldfarb said the use of PD helped remove pressures on their hemodialysis staff and CRRT supplies. As the surge in patients continued, the need for—and difficulty finding—dialysis supplies was a growing challenge.

Radhakrishnan said that although his institution ordered more machines, it did not occur to them to stock up on fluids. When manufacturers found it difficult to meet the unexpected needs, his institution did what it could to reduce fluid use. They reduced prescriptions in CRRT from the standard flow of 20 to 25 milliliters per kilogram per hour to 15. The use of prolonged intermittent renal replacement therapy (PIRRT) and the reduction in hemodialysis frequency also saved supplies.

Radhakrishnan said that an “Excel genius” in his division calculated the optimum number of bags to use at a certain fluid rate per hour to utilize the bags most efficiently. “This spreadsheet would tell you that for this fluid prescription, hang so many bags, and don’t exceed that, so that led to a drop in the consumption from wastage,” he said.

They even found a significant way to save both fluid and cartridges by working with hematologists to change a blood test. COVID-19 is associated with a remarkable amount of blood clotting, despite heparin treatment. Radhakrishnan’s hospital switched from monitoring heparin efficacy using the standard activated partial thromboplastin time to using an anti-factor Xa test, which Radhakrishnan called a more specific target of heparin efficacy. He said the new tests revealed that many patients needed “a heck of a lot more heparin. We circulated this protocol across the campuses and there was an immediate drop in the number of wasted cartridges.”

Columbia Medical Center also went outside its usual supply chain and ordered home dialysis fluid from B. Braun and adapted it for use. They held weekly meetings with their suppliers, but there was only so much the suppliers could do when New York City hospitals were using five times as much dialysis solutions as usual.

Easter crisis

As supplies dwindled and patients continued to fill the wards, on April 11, 2020, the day before Easter, Radhakrishnan tweeted a call for help that began: “Dire straits in NYC!!. Shortage of dialysis nurses, CRRT machines and fluids across all hospitals.”

That tweet received a lot of media attention, but there was a flurry of activity that Easter weekend happening behind the scenes. ASN had formed a COVID-19 Response Team several weeks before to work with the Centers for Disease Control and Prevention and dispense information and expert advice. The team’s co-chair, Alan S. Kliger, MD, clinical professor of medicine at Yale School of Medicine said: “Several hospitals in New York came to the realization that, with the explosion they were experiencing in the need for renal replacement therapy, in the coming week or two they wouldn’t have enough to treat all of the patients unless something could be done to increase their supplies. They had spoken with their suppliers, [who] had said, ‘We can give you some increase in supplies, but we have to continue supplying other places in the country for their needs.’”

Baxter customers were running up against a March 25 “protective allocation” directive limiting the increase in supplies their customers could order to about 110% of their normal use. The policy was designed to prevent hoarding and ensure delivery of at least some product to all customers, but it caused consternation among New York facilities that needed several times their usual consumption.

The ASN team shared their contacts and strategized about how to respond. “What we at the ASN did was to contact directly the chief medical officers and the chief operating officers of the companies that supply those fluids to the hospitals,” Kliger said. “So this is a step way above the local suppliers that the hospitals had spoken to, and their response was fabulous. Their response was, ‘Of course we have to figure out how to get fluids and supplies to them, and let’s work together to do that.’ But they also shared with us the dilemma that they couldn’t simply turn on a spigot and dramatically increase manufacture of the supplies, which meant that any substantial increase to the New York area would mean diverting supplies that were destined and contracted to go to other hospitals and cities around the country.”

“The companies were remarkably collaborative,” Kliger said, and within 24 hours more supplies began arriving at the hospitals experiencing the most critical shortages. At the manufacturers’ request, the ASN team began surveying the hospitals “to figure out and model what over the next few weeks the needs would be. Arms of the government were also really interested in what we were doing,” Kliger said.

Federal response

It took some time for the urgency and severity of the kidney treatment needs—when everyone went into the fight against this respiratory virus thinking only about ventilators—to become clear to federal agencies, said Kristen Finne, who works in the office of emergency management and medical operations in the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).

But after the Easter weekend calls, one concrete contribution the federal government made was to expedite shipping from Europe, where much of the manufacture of dialysis fluid takes place. “If the fluid that was so critically needed were to go through its normal process of traveling, it would take weeks to get to a port and get on a ship, which would take about three weeks, and then have to be trucked again to its final destination,” Finne said. “We said [to manufacturers], whatever you can offer as you are trying to increase your production, we will help expedite and fly it to the U.S.” using flight contracts associated with the strategic national stockpile. These flights brought in about 300,000 liters of dialysis fluid.

Largely in response to the devastation of hurricanes Irma and Maria, the federal government had leased 50 of Outset Medical’s Tablo devices for the strategic national stockpile. These devices were selected for the stockpile in large part for their versatile ability to deliver conventional hemodialysis as well as handle both water purification and dialysate production. The stockpiled devices were deployed to New York hospitals in early May.

Many hospitals purchased the relatively new Tablo in preparation for COVID-19 thanks to its versatility and ease of use, said Chad Hoskins, general manager of home and vice president of strategy at Outset Medical: “We saw a number of situations where hospitals were taking staff who were not dialysis-trained. In one facility, an OR team was sitting idle because all elective procedures had been cancelled. They trained those nurses on Tablo to deliver dialysis, and that freed up their dialysis nurses to [concentrate on] the more critically ill patients.”

The VA’s Goldfarb said his facility brought in several Tablos, and he was the first staff member to operate it “because I didn’t have dialysis staff to do it that day.” He joked that it is so easy, “even a doctor can do it,” but noted that they trained two primary care nurses who had never done dialysis to use the Tablo.

Largest suppliers adjust

The two largest manufacturers of dialysis equipment and supplies made some major adjustments in their operations in the weeks after Easter weekend.

In mid-April, Fresenius formed its own National Intensive Renal Care Reserve consisting of “approximately 150 pieces of equipment ready for rapid deployment to hospitals,” said Joe Turk, president of home and critical care therapies. The equipment included a pool of NxStage critical care units, which can be used for CRRT and PIRRT, as well as NxStage System One Cyclers, which are typically used in homes or skilled nursing units, but which can provide additional capacity in ICUs.

The Food and Drug Administration provided an emergency use authorization allowing the importation and use of supplies and machines approved in Europe, and on May 11 Fresenius announced it was preparing its first shipment of the European-approved multiBic dialysate solution for CRRT.

As many critically needed supplies went to New York, hospitals in other parts of the country experienced unexpected changes in their orders, according to Anitha Vijayan, MD, a member of the ASN COVID-19 Response Team and director of acute dialysis services at Barnes-Jewish Hospital in St. Louis: “Because NxStage was experiencing shortages in bicarbonate solutions, they had to send lactate solutions to certain high-volume institutions like mine. The diversion of resources to New York meant that other institutions across the country, including mine, had to make changes in how we do continuous renal replacement therapy. Lactate solutions are not ideal to be used as a CRRT solution because lactate may be associated with more hemodynamic instability for patients who are already critically ill.”

Vijayan’s hospital had to draw up a policy to select which patients could be safely treated with lactate instead of bicarbonate solutions, but the change never compromised patient care, she said. That hospital was not hit as hard as those in New York, but at one point they had three COVID ICUs, and had to cross-train nurses to help with the care.

For its part, Baxter said in a statement that it has “delivered significantly more product to our hospital customers” by ramping up production of CRRT products to maximum levels. “The company has added multiple work shifts, with all facilities manufacturing products used in COVID-19 patient care running 24 hours a day, seven days a week. Baxter has partnered with its logistics providers to fly critically needed medical devices and medicines back and forth between the U.S. and Europe,” a spokesperson said.

Staffing in an infectious setting

Another big challenge for the New York hospitals was simply maintaining staff levels—the huge patient census called for all hands on deck, but many key staff members contracted the highly infectious disease. Fishbane’s division had seven nurses out at one point, and hospitals welcomed volunteers from other parts of the country as key contributors.

Goldfarb benefited from the VA’s internal volunteer program that led to a nephrologist from New Hampshire coming to lend a hand for three weeks. The addition was especially needed because one of Goldfarb’s colleagues was down with a COVID-19 infection.

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Fresenius also sent volunteers, which were particularly valuable because of their familiarity with dialysis. The chief physician at New York Presbyterian, Columbia University Medical Center publicly thanked Fresenius for providing 12 trained nurses and technicians.

The hospitals also shared capacity, Goldfarb said: “The New York VA and the Brooklyn VA were back-ups for peripheral hospitals, and this has never happened in my 39 years in this hospital. We took nonveterans here because one of the VA’s missions is to back up the community. There were patients coming from Elmhurst Hospital, which was hit very badly in the middle of Queens. That was kind of the epicenter of the epicenter.”

Fishbane and Radhakrishnan said that a key part of staffing was having someone who could take the time to coordinate care. Radhakrishnan participated in daily video conference calls among his institution’s various campuses to discuss who had the most patients, and whether there was a need to move machines and supplies among hospitals. “The hospital was very gracious in supplying a coordinator who was normally an extracorporeal membrane oxygenation coordinator,” he said. “She would make sure that everyone in this task force was on the email chain, provide updates, and ensure that specific tasks were assigned to one or more of the members so they would be completed before the next call. She kept the whole operation together.”

Fishbane cited the importance of having someone to provide the “situational awareness at the start of every day—of understanding, I’ve got this number of patients who are on dialysis, I’ve got this many machines, this many dialysis nurses and nephrologists. So how is this going to work? It is important having somebody who you can pull back a little bit to be able to stay aware of your resources and to be able to manage them.”

Ready for the future?

Northwell Health’s Fishbane said he plans to use the summer to be ready for a potential second wave in the fall. His system purchased 10 new Baxter Prismax machines for CRRT and several Tablos that “we are trying to get a lot of experience on. Better to do training when things are slower and people have time to think,” he said.

There is general agreement that the experience in responding to the crisis in New York left the U.S better prepared to deal with future large COVID-19 outbreaks—if only because the kidney impacts are now known and can be anticipated. The reserves and supplies of renal replacement therapy equipment are larger, in both government and manufacturer hands.

“We stepped up manufacturing of equipment and dialysis solutions, so we now have an even more robust supply chain in place in case of future spikes,” said Fresenius’ Turk.

Columbia’s Radhakrishnan said: “We are prepared. We have means to deal with it in the future, as long as it doesn’t exceed the numbers that we saw.”

ASN’s Kliger would like to see a better international plan and cooperation, which would avoid hoarding by states and countries and provide for more efficient distribution of supplies and equipment. “In March, equipment and supplies needed to be directed to Italy and Spain. In April things needed to be directed to New York. And maybe next month, they’ll need to go to Florida and Arizona,” Kliger said. “We need a much more thoughtful global approach of how to deal with pandemics and how to deal with urgent needs that make requirements go up fivefold all of a sudden in one place or another. The answer isn’t to say to everybody, well, you better think about this and be prepared for emergencies [because that leads] to nothing but hoarding and inefficient use of equipment.”

July 2020 (Vol. 12, Number 7)