Response to COVID-19: The Outpatient Dialysis Setting

Introduction

Coronavirus disease 2019 (COVID-19) has profoundly affected outpatient dialysis. In the United States, patients requiring maintenance dialysis share many risk factors associated with poor outcomes from COVID-19: lower socioeconomic status, older age, hypertension, and diabetes mellitus.¹ Many dialysis-dependent patients have reduced immune responses, and the 85% of patients treating by in-center hemodialysis must congregate for care three times weekly.² Existing social disparities among the disproportionate number of patients from underrepresented minority groups and low-income settings were exacerbated by the pandemic.³ Owing to fewer patients starting dialysis combined with the high mortality rate from COVID-19, for the first time in the history of the Medicare End Stage Renal Disease program, the population of maintenance dialysis patients declined in 2020.⁴ We review our experiences in the United States and make suggestions to mitigate the impact of future events on patients receiving maintenance dialysis.

Personal Protective Equipment

Immediately after the first reported US death from COVID-19, a patient receiving maintenance hemodialysis, dialysis facilities took steps to minimize the risk to patients and those caring for them. Recognizing the respiratory spread, providers required masks for all individuals in their facilities well before the Centers for Disease Control and Prevention (CDC) recommended it. Safety protocols were hampered by limited availability of personal protective equipment (PPE) and inconsistencies in governmental regulations. US manufacturing was inadequate to meet the acute demand.⁵ Although the CDC recommended reserving PPE for the care of those with known or suspected COVID-19, the Occupational Safety and Health Administration required N-95 masks for all those providing care in dialysis facilities. Lessons learned: A pipeline of PPE is essential; US manufacturing capacity must increase and must be sufficiently flexible to accommodate demand in a public health emergency (PHE). Governmental agencies must provide consistent consensus communication.

Dialysis Facility Safety Inspections

Surveyor visits to ensure safety and adherence to infection prevention standards ironically hampered facilities from adhering to such standards. Survey activities required additional personnel in the dialysis facility, reduced physical distancing, and diverted staff time and attention away from caring for patients. Lesson learned: During a PHE, facility inspections should be limited to assessing patient safety and should be conducted remotely.

Facility Characteristics and Challenges

In response to the highly contagious nature of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), facilities needed to implement physical strategies to reduce the risk of transmission. Protocols to limit the presence of staff members who were not absolutely required in the treatment area included the use of telemedicine for patient encounters. Uncertainties persisted including whether plexiglass barriers provide sufficient protection against SARS-CoV-2 or whether facilities should be retrofitted with high-efficiency particulate absorbing filters.^6,7 Lessons learned: Protocols must be flexible and financial support must be available to make changes to protect patients and staff. Physical plant flexibility is needed to provide the right care at the right location.

Risk of Spread of COVID-19

Needed protocols were rapidly implemented to identify individuals with COVID-19 who had to be separated from the general population. Strategies depended on facility infrastructure, local prevalence of COVID-19, and partnerships with local or regional facilities. The goal was to provide the right care at the right location, allowing clinically stable patients to receive care at outpatient facilities rather than acute care hospitals. Depending on infection rates, the last treatment shift in a day could be designated for patients with COVID-19, allowing deep cleaning after the treatment day. Reflecting their inability to cohort patients, some facilities turned away patients with upper respiratory symptoms if they could not provide a negative PCR test. Early in the PHE, testing availability was limited and results were delayed, so patients missed treatments. Lesson learned: Priority is needed for assessing the infectious status of patients and staff in dialysis facilities.

Providers collaborated to develop the Dialysis Community Response Network, facilities dedicated to treating infected patients. Initially, two negative PCR tests were required to return to the general dialysis population (test-based strategy). Testing demonstrated continued positive PCR tests after symptoms resolved.⁸ Data sharing by Chief Medical Officers (CMOs) that patients shed incompetent virus particles confirmed the safety of a time-based protocol, allowing asymptomatic patients to return 10–20 days after symptom onset before confirmatory data were published. Lesson learned: Data sharing is critical to managing infectious outbreaks.

When vaccines and antiviral treatments became available, their use in kidney patients was hampered by a lack of safety and efficacy data, in part because patients with advanced kidney disease were excluded from clinical trials. Vaccine hesitancy was compounded by this lack of data and existing mistrust of the medical system and of new medications among many patients.⁹ Lessons learned: A mandatory congregate population, patients with kidney failure are moderately immunocompromised and should be treated like group home residents. The US Food and Drug Administration (FDA) must take active measures to facilitate inclusion of kidney patients in clinical trials.

Vaccines were distributed to all dialysis providers through a model established for this purpose with the support of the CDC and American Society of Nephrology (ASN) in March 2021. The CDC provided vaccines to DaVita and Fresenius who distributed them to all other US dialysis organizations who requested them. This exceptionally successful model leverages patients' thrice weekly treatments at clinics by staff with whom they have a trusting relationship.¹⁰ Lessons learned: The model should be replicated and extended for booster doses and reformulated vaccines to ensure that all patients have equal access.

Understanding the Impact of COVID-19

A lack of data specific to kidney patients affected patient, provider, and clinician education, with national data sources such as the United States Renal Data System unable to provide contemporary data. ASN sponsored numerous webinars throughout the pandemic with experts presenting early data. Dialysis organizations published data on preprint servers and in peer-reviewed journals, which expedited review. At meetings of the CMOs under ASN sponsorship, observational data were shared openly. Lesson learned: We need a data registry to allow real-time data sharing and to build infrastructure for rapid, pragmatic clinical trials.

Communication with Governmental Agencies

Communication with experts is critical to facilitate preparation for and management of emergencies. Infectious outbreaks and noninfectious emergencies such as hurricanes and the ice storm that affected Tennessee and Texas in 2021 demonstrate that regular communication is essential to protect the health of patients requiring maintenance dialysis. Lessons learned: Regular meetings of dialysis leaders should continue. Meetings with broader governmental representation such as the FDA and Administration for Strategic Preparedness and Response are critical.

Shortages of dialysis supplies and medications were exacerbated by global factors, including the war in Europe. A shortage of dialysis fluids threatened providers' ability to treat patients early in the pandemic, requiring some facilities to reduce flow rates. Lesson learned: Collaboration with government officials is essential in anticipating and addressing shortages.

Impact of the Pandemic on Health Care Workers

The mission of providing safe dialysis to all those who require it depends on dedicated, skilled, highly specialized professional health care workers (HCWs). The pandemic has challenged the dialysis workforce greatly because of the compounded stressors of concerns for their own safety, challenges of providing safe care and ongoing staffing shortages resulting in morale decline, compassion fatigue, and burnout. COVID-19 exacerbated preexisting mental health issues because of isolation and widespread illness. HCWs disregarded their own needs to care for the high volume of patients at times with unsafe staffing ratios. HCWs must care for patients who refuse vaccination. HCWs felt a lack of respect despite the praise heaped on them, and the impact on HCW numbers and morale will be felt for years to come. ASN developed mental health modules to support the nephrology work force.¹¹

Compounding the stress, many HCWs experienced COVID-19 or had to care for family members with COVID-19. Some HCWs refused to be vaccinated despite mandates, exacerbating staffing shortages. Some outpatient facilities are unable to accommodate patients starting dialysis because of insufficient staffing.

During the pandemic, shortages were exacerbated by financial incentives for nurses to travel. Many experienced nurses left outpatient dialysis in favor of inpatient care where salaries were higher. The paucity of dialysis nurses further stresses our vulnerable system and increases the risk of complications for our complicated patient population. It is unlikely that there will be sufficient numbers of HCWs to meet future emergencies any time soon. Lessons learned: Support for the financial, physical, and mental health of HCWs is vital. The finances of outpatient dialysis must allow for competitive salaries. Incentivizing self-care and home dialysis through patient empowerment and financial support is critical to provide broad access to care.

Lessons Learned

Emergency planning for dialysis must consider lessons learned from COVID-19. Flexibility is critical. Capacity for PPE manufacturing must be expanded. Facility inspections must be modified on the basis of emergency situations. Financial support must be provided to allow dialysis facilities to modify their physical plant to protect patients and HCWs. Dialysis organizations need to coordinate for real-time data analysis. Because they are immunocompromised and must congregate for life-sustaining dialysis treatments, patients with kidney failure must be part of clinical trials. The network administrator model must be expanded. Collaboration among dialysis providers and government representatives is essential. Support must be provided for the financial, physical, and mental health of HCWs.

Disclosures

D. Concepcion reports employment with St. Joseph Hospital; consultancy agreements with Antelope Valley Kidney Institute and Care Dialysis Center; ownership interest in Outset Medical; advisory or leadership roles for Nephrology News & Issues Editorial Advisory Board and Nephrology Nursing Certification Commission; and other interests or relationships with ESRD Network 18, National Kidney Foundation, Nephrology Nursing Certification Committee, and Renal Health Associates. D. Cukor reports research funding from NIH research funding and royalties from Elsevier—Academic Press. B. Schiller reports employment with Satellite Healthcare; consultancy agreements with Akebia, CVS, Quanta, and Rockwell Medical; ownership interest in Unicycive Therapeutics Inc.; an advisory or leadership role for Board of Directors at Unicycive; and speakers bureau for AstraZeneca. J. Silberzweig reports employment with The Rogosin Institute; consultancy work for Alkahest, Bayer, Honeywell, Kaneka, and St. Gobain; research funding from Kaneka Pharma America; and advisory or leadership roles for American Society of Nephrology: COVID-19 Response team, Emergency Partnership Initiative, and Nephrologists Transforming Dialysis Safety Current and Emerging Threats workgroup. J. Silberzweig is the National Principal Investigator for two clinical trials sponsored by Kaneka. One is using their Lixelle device for treatment of Beta-2-microglobulin amyloidosis in patients with ESKD; the other is using lipid apheresis for the treatment of focal glomerulosclerosis. J. Silberzweig and his spouse hold stock in American Express, AT&T, IBM, and Wells Fargo. J. Silberzweig's spouse is an employee of Anthem and holds stock in the company. M. Sinclair reports advisory or leadership roles for ASN COVID-19 Response Team (unpaid position) and ASN NTDS CET Workgroup (unpaid position). F. Speed reports employment with Fresenius Kidney Care. T. Watson reports employment with Nephrology Associates, PC; consultancy agreements with Fresenius Kidney Care; and ownership interest in Alabama Kidney Ventures, Clutch Health, DaVita Kidney Care, Evergreen Nephrology, Fresenius Kidney Care, Interwell Health, and Nephrology Associates, PC; and an advisory or leadership role for Fresenius Kidney Care. T. Watson's practice has joint venture partnerships with Azura Vascular Care, DaVita, Evergreen Nephrology, Fresenius, and Interwell Health. D. Weiner reports employment with Tufts Medical Center Physicians Organization; research funding from the following, with all compensation paid to Tufts MC: Bayer (site PI), Cara (site PI, pending start-up), CSL Behring (site PI, completed), Goldfinch Bio (site PI, completed), and Vertex (site PI, pending startup); and advisory or leadership roles as Co Editor-in-Chief of NKF Primer on Kidney Diseases, 8th Edition, Editor-in-Chief of Kidney Medicine, Medical Director of Clinical Research for Dialysis Clinic Inc., member of ASN Quality and Policy Committees and ASN representative to KCP, and member of Scientific Advisory Board of National Kidney Foundation. D. Weiner reports other interests or relationships as adjudications committee, Chair, and VALOR Trial (George Institute, CRO, sponsored by Tricida, completed); member of Data Monitoring Committee, Feasibility of Hemodialysis with GARNET in Chronic Hemodialysis Patients with a Bloodstream Infection Trial (Avania CRO); and member of Safety and Clinical Events Committee for A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis Trial (Avania CRO). N. Welder reports employment with and ownership interest in DaVita Inc. S. Wu reports employment with CapitalRx.

Funding

None.

Author Contributions

D. Cukor, B. Schiller, J. Silberzweig, M. Sinclair, F. Speed, T. Watson, D. Weiner, and J. Yee conceptualized the study; J. Silberzweig and J. Yee were responsible for project administration; J. Silberzweig provided supervision; D. Cukor, B. Schiller, J. Silberzweig, M. Sinclair, F. Speed, T. Watson, D. Weiner, N. Welder, and S. Wu wrote the original draft; and D. Concepcion, D. Cukor, B. Schiller, J. Silberzweig, M. Sinclair, F. Speed, T. Watson, D. Weiner, N. Welder, and S. Wu reviewed and edited the manuscript.