Maintaining Standards of Care in the Era of Special Pathogens

Abstract

Introduction

As COVID-19 spreads throughout the world, many hospitals face the challenges of healthcare delivery in a time of great uncertainty and resource shortages. Shortages of key resources and deviations from standards of care are topics that have become common among discussions of patient care delivery complicated by rapidly evolving information about prognosis, evidence of differential racial group impact, and issues of age and frailty. In addition, the contagious nature of the virus, initial uncertainty on modes of transmission, and unclear guidance on personal protective equipment (PPE) contributed not only to difficult ethical choices but also impacted delivery of care to special pathogens patients—at a scale not previously experienced and which exceeded the capacity of all biocontainment units. In this article, we focus on the hospital application and understanding of crisis standards of care (CSC) in the setting of special pathogens, which are infections that are rapidly transmissible with a potential for high morbidity and mortality that may prompt the use of a biocontainment unit.

Standard of Care

The legal concept of standard of care can be defined as the level at which a reasonable and similarly qualified provider would manage a patient's care under similar circumstances.¹ The term crisis standards of care refers to “a substantial change in the usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive (eg, pandemic influenza) or catastrophic (eg, earthquake, hurricane) disaster.”¹ This system details an approach to managing situations and challenges that may arise in the context of planning for surge capacity and capability challenges where available resources needed to deliver usual and expected care may not be available. CSC emphasizes the duty to care and to steward resources with a focus on fairness, transparency, accountability, proportionality, and consistency when resource allocation decisions are required.^2,3 The Institute of Medicine CSC framework had been largely theoretical until the emergence of the COVID-19 pandemic.

CSC occur when the degree of resource shortage requires decisions that place a patient or provider at substantial risk of a poor outcome. These situations may affect only 1 resource or many at a time and the impact on care may fluctuate rapidly. Underlying CSC is an ethical foundation that primarily is guided by utilitarianism—the principle of doing the greatest good for the greatest number. This principle should be identity-blind, and many states have made that fact explicit, believing that barring consideration of race and social factors will yield a fairer outcome.⁴

The foundation of CSC planning focuses on the recognition of a continuum of standard of care related to the degree of response required in a disaster or crisis. These different levels of care are defined as³:

Conventional care – the spaces, staff, and supplies used are consistent with daily practices within the institution.

Contingency care – the spaces, staff, and supplies used are not consistent with daily practices but maintain or have minimal impact on usual patient care practices, providing functionally equivalent care. These spaces or practices may be used temporarily during a major mass casualty incident or on a more sustained basis during a disaster (ie, when the demands of the incident exceed community resources).

Crisis care – adaptive spaces, staff, and supplies are not consistent with usual standards of care but provide sufficiency of care in the setting of a catastrophic disaster (ie, provide the best possible care to patients given the circumstances and resources available). The line between functionally equivalent care and that which poses a substantial risk is blurred, and realistically requires a commitment to a “graceful degradation” of care in proportional steps.

The COVID-19 pandemic brought to light the severe and unique impacts of special pathogens on standard of care delivery. Many hospital systems across the United States faced unprecedented challenges in delivering appropriate care for their patients.

Conventional Special Pathogens Patient Management

Special pathogens pose a substantial risk to healthcare personnel and require specific healthcare facility processes to ensure early identification and isolation of infected patients. Effective infection control practices are used to prevent disease transmission while a patient is further evaluated. Outside of a biocontainment unit, highly specific infection control practices to a special pathogen are uncommon, and thus unfamiliar to the majority of staff. The defining characteristics of a special pathogen include those associated with high morbidity and mortality, a high likelihood of causing secondary cases (ie, person-to-person spread), the absence of an effective treatment or prophylaxis, and those for which clinical or public concerns may prompt the use of a biocontainment unit. Special pathogens include viral hemorrhagic fevers (eg, Ebola virus disease, Marburg virus disease) and highly pathogenic respiratory viruses (eg, MERS-CoV, SARS-CoV-1, SARS-CoV-2). Once a special pathogen is suspected or confirmed, hospitals should apply appropriate transmission-based precautions and follow disease-specific guidance. Outside of a global pandemic, such as COVID-19, facilities must maintain awareness of current special pathogen outbreaks, the risk of cases presenting to their facility, and current disease-specific guidance. This preparation is key in ensuring adequate staff training and facility policy for identification of suspect cases, triaging them appropriately, and maintaining standard of care.

The US Department of Health and Human Services established a tiered format for response to highly infectious diseases across the country in 2015.⁵ This approach used frontline healthcare facilities, assessment hospitals (ie, hospitals that would care for patients under investigation during testing when a treatment center was not immediately available), state or jurisdictional Ebola treatment centers, and Regional Emerging Special Pathogen Treatment Centers to form a robust regionalized response caring for 1 or more patients with a potential special pathogen or highly infectious disease.^6,7 This culminated in the development of the National Emerging Special Pathogens Training and Education Center, which oversees preparedness and response for special pathogens across healthcare systems in the United States.

The aim of this approach is to triage patients with special pathogens to appropriate centers to maintain standard of care at each facility and focus special pathogen care delivery at centers equipped to do so (Figure).⁷ These centers have specialized teams composed of core teams of physicians, nurses, respiratory therapists, and other healthcare workers, with expertise caring for patients with serious communicable diseases.

Figure.

An example of guidance for hospital preparedness for evaluation, testing, and management of patients under investigation or with confirmed special pathogens such as Ebola virus disease.⁷ Abbreviations: EVD, Ebola virus disease; PPE, personal protective equipment.

Frontline hospitals should be prepared to implement the 3-step approach to the “Identify, Isolate, Inform” strategy developed by the US Centers for Disease Control and Prevention (CDC).⁸ This strategy relates to the role of frontline facilities in preparedness in the tiered approach of the US Department of Health and Human Services.⁷ Additionally, frontline hospitals should be able to initiate appropriate infection control protocols for a suspect case and rapidly inform internal (eg, specialty consultants, infection prevention staff) and external (eg, state or local health officials) stakeholders of a suspect case. Usually, however, the frontline hospital would provide appropriate care only while awaiting transfer to a specialized center. In the case of COVID-19, however, all hospitals became treatment centers as capacity for hospitalizing patients in isolation environments was overwhelmed.

COVID-19 and Logistics

The COVID-19 pandemic led to many centers preparing for an influx of patients with a special pathogen. The rapidly evolving data on the infectiousness of COVID-19 led to hospital systems prioritizing an adequate supply of PPE, examining staffing, and evaluating and expanding intensive care unit (ICU) isolation capacity. However, the reality of the impact of the COVID-19 pandemic at many hospitals was more complex, especially at the beginning stages of the pandemic. Multiple efforts were made to stay in contingency mode and avoid crisis care; however, there were instances when options were exhausted and formal or informal crisis care was operationalized.

Personal Protective Equipment

The initial stages of COVID-19 planning required collaboration with infection control staff, hospital epidemiologists, nurses, and physicians, in conjunction with CDC guidance, to determine the appropriate PPE, understand which procedures would require specialized PPE, and to clarify the rapidly changing guidelines and recommendations.^9-11 Infection control and hospital staff rapidly educated frontline workers on appropriate donning and doffing procedures.^9,10

The shortages of PPE resulted in immediate CSC for providers rather than patients at most hospitals, as staff were reasonably at “significant risk.”¹² This presented an unexpected challenge that was not well described in the CSC framework. Many staff became ill early in the COVID-19 pandemic, so assessment of efficacy of PPE was in question. Providers were fearful and anxious.¹² Extraordinary conservation actions, such as reuse of respirators for multiple shifts, disinfection of respirators using a variety of techniques, and adapting rain ponchos and even garbage bags for barrier precautions, were examples of the crisis measures implemented to try to protect workers. As the supply situation improved, proportional changes were made to restore PPE use toward conventional practices and the data became clear that the PPE used was effective at preventing transmission. Although the supply chain currently has permitted most facilities to return to near-conventional status (ie, most continue to use N95 respirators across a shift rather than per patient encounter), it is clear that developing reusable high-efficiency respirators for healthcare environments is required for future epidemic response as supply chains will never be able to cope with the global increases in demand driven by a pandemic. Substantial advances in powered air-purifying respirator and controlled air-purifying respirators are possible to make them lighter, easier to clean, and easier to don and doff. Elastomeric respirators need to be redesigned for healthcare applications to be less industrial looking, reduce chafing, and not use an exhalation valve. N95 masks should be redesigned to be cleanable and reusable. Incentives need to be offered to develop and market these technologies as market forces will continue to drive single-use masks as the primary means of respiratory protection. Reusable and inexpensive barrier gowns are also imperative to develop.

Staff

Inpatient staff at most hospitals were unfamiliar with special pathogen infection prevention protocols that combine several levels of protection (eg, airborne and droplet). In addition to CDC guidance, the Regional Emerging Special Pathogen Treatment Centers and the National Emerging Special Pathogens Training and Education Center served as valuable resources to help train providers on appropriate donning and doffing and guide practices at other facilities in their areas. Regional centers will continue to have immense value as centers of training and expertise that can be leveraged to expand patient care as safely as possible. Given the rapid expansion of ICU space and the number of providers involved in the care of COVID-19 patients, communication and training were key. Staff with noncritical care and noninternal medicine backgrounds were rapidly uptrained to routinely care for these patients.⁹

Members of the hospital systems facilities staff also played an important role in expanding care capacity, either by developing innovative barriers or expanding negative-pressure rooms.¹³ The environmental services staff members were instrumental in rapidly turning over rooms in an efficient and safe manner, especially ones used for aerosolizing procedures.

Infection prevention and control staff were an integral part of the incident command team across many institutions; they were tasked with (1) ordering supplies, (2) rationing PPE and ensuring safe practices, (3) managing screening and isolation practices, and (4) creating new policies for outpatient and inpatient care isolation practices applying to areas of the facility that were never previously envisioned.^9,10

All members of a hospital staff play a critical role in delivering care, especially in a crisis situation where standards of care are being encroached on. By providing adequate PPE and training, hospital staff can continue to function in their capacity and the hospital system can maintain adequate preparedness and delivery of care. The establishment of care teams such as proning teams, procedure teams, and airway teams that were well versed in specific interventions required by COVID-19 patients is also a best practice that may be extrapolated to future events.^9,10 The policies and checklists used by these teams may also have application for care of individual special pathogens patients.

Virtual staff engagement and incident management, as well as expansion of telemedicine practices, are welcome additions to our ability to manage incidents and patients and will be durable additions to our response capabilities. They may also enable improved coordination with facilities that are caring for smaller numbers or individual isolated patients, as well as improve communications between patients and family members when isolation is required.

Supplies

In additional to PPE, many supplies rapidly went into shortage or required adaptive strategies due to demand. Purchases of ventilators were prioritized early on, with some advocating multiple patients per ventilator—obviously a last-ditch and short-term strategy. More basic and necessary supplies such as in-line HEPA filters for the exhalation valves of bag-valve devices and ventilators went into shortage in many areas. These inexpensive but critical devices help filter exhaled air and can greatly reduce risk to providers. High-flow nasal cannula units were initially suspected to increase aerosolization risk, but this was not confirmed and these units became a staple of treatment. These units and their circuits were in shortage nationally. Ventilator and high-flow nasal cannula unit circuit availability and the ability to decontaminate and reuse these circuits are important for future epidemic response. Fortunately, despite interruption in global supply chains and limited domestic manufacturing of pharmaceuticals, there were no prolonged or severe shortages of common medications including antibiotics, sedation, paralytics, or analgesia, but the potential for shortages to severely compromise critical care is real, and requires immediate attention as effective and humane care cannot be provided without core medications.

Space

Healthcare systems took a variety of approaches to expanding isolation areas. In some cases, entire facilities were made COVID-19 hospitals enabling full control of the environment of care and conservation of PPE. In most hospitals, COVID-19 units were designated as cohorting, which enabled the hospitals to focus training on the staff for those units. Staff wearing PPE throughout multiple patient contacts is not usually a recommended practice for special pathogen care, but given the number of patients requiring inpatient and critical care, this afforded substantial savings of time and PPE. Critical care space was particularly challenging to expand. In some cases, large open areas were converted to patient care. In other cases, closed units or monitored/step-down units were converted to COVID-19 cohort ICU care. Often, ventilation systems had to be retrofitted or modified to provide negative airflow to these units. Novel solutions such as running intravenous pump lines from the patient to the door, which enabled nursing staff to adjust pump rates without entering the room, were other examples of contingency measures that conserved PPE. In the future, remote adjustment of pumps and ventilators could reduce workload and the need to enter patient rooms. Flexible space that can be configured to either accommodate more than 1 patient per room or that can be appropriate for monitored ICU care is important. To enhance safety during future infectious emergencies, the entry and exits to ICUs should be designed to be 1-way, with buffer spaces for donning and doffing PPE and maintaining hand hygiene, and with waste disposal on the exit side.

Patient Care Challenges

Surge conditions contribute to mortality.¹⁴ In fact, 1 in 4 COVID-19 deaths may be related to surge conditions at the hospital rather than to the disease itself.¹⁵ It is possible, if not likely, that this excess mortality is greater than would be experienced in disasters where special pathogens considerations and long durations of care do not add substantial burdens.

A disproportionate tendency toward triage of resources occurred with COVID-19. In some cases, COVID-19 care strategies relegated infected patients to alternate care areas that were not properly equipped or supported. Calls to deprioritize older adults based on limited information from overseas along with “universal do not resuscitate (DNR)” orders for any COVID-19 suspected patient were ethically concerning, particularly when many of the suspected cases would not actually have had COVID-19.^15,16 In all situations, the special pathogens patient should be offered the standard of care that is available to other patients with the only exception that risk to caregivers may be considered. For example, when a code team responds to a COVID-19 patient, they must take the time to don appropriate PPE before initiating care, which places the patient at higher risk of death. And there is still risk that providers could be exposed, which led to many hospitals deciding not to offer resuscitation to COVID-19 patients due to perceived risk to the provider and lack of benefit to the patient. But the risk to providers must be weighed proportionally. COVID-19 patients at the end of their critical care journey do not often benefit from additional resuscitation, but fears of COVID-19 should not preclude usual resuscitation of a patient for which the cause of the arrest is unclear. At all times, providers must guard against “implicit triage,” which occurs with relative frequency when a provider makes a decision not to offer an intervention based on a subjective interpretation of the resources available or a subjective interpretation of risk vs benefit that is colored by disproportionate fear of a special pathogen. Similar issues were seen during Ebola response planning as suspected cases were relegated to trailers and nonstandard care areas and many common therapeutics such as dialysis were considered “too risky to offer” in early emergency plans. COVID-19 has highlighted that frontline healthcare workers need current information about prognosis and the resource situation. Usual care should be offered except where clear risk to providers exceeds benefit. Restrictions on care should be clearly justified based on the available evidence. Is the care dangerous to the providers or nonbeneficial to the patient, or both? It is rare for care to be truly futile, and therefore, unless resources are in shortage or there is a clear danger, rationing is not justified. When an unfamiliar challenge is encountered, a systematic process should be put in place to initiate critical clinical prioritization and avoid the rationing of available resources. It is just as important to make these decisions in concert with other hospitals in the area. The tenets of fairness, consistency, and proportionality require that hospitals in a given region coordinate to balance the load. This builds upon regional baseline constructs for special pathogen management and should be a focus for future planning efforts.

There is much to be done before the next epidemic. COVID-19 has demonstrated that our hospitals and providers are capable of immense courage and imagination. We owe it to them to improve PPE, staff training, the flexibility of our regional systems and hospital infrastructure to safely accommodate a wide range of special pathogen care, and information sharing between hospitals and public agencies. We also owe it to them to refine our frameworks for crisis care to assure that caregivers have access to the right expertise and best practices when confronted with an unfamiliar situation.

Conclusion

Global travel has changed the spectrum and threat of special pathogens in every nation. The high morbidity and mortality of special pathogens put healthcare workers at increased risk, while also having a potentially significant impact on care delivery. The provision of care for these diseases is also extremely resource and training intensive, and the collaboration between frontline facilities and special pathogen treatment centers can maximize the ability to scale the response from a single case to a pandemic. As we have learned from the COVID-19 pandemic, special pathogens can lead to the implementation of CSC techniques. The goal must be to avoid these situations through planning and coordinated response (Table). In nonpandemic times, a tiered approach to care, hospital and staff readiness and availability, and adequate PPE and supply sources, can ensure safe and standard care delivery that is capable of substantial expansion based on our COVID-19 experiences.

Table.

Planning and Coordinated Responses to Avoid Crisis Standards of Care

Regional structures	Healthcare coalition or other regional coordinating entity for information sharing, resource management, and common policy development Regional special pathogen training, consultation, and referral structure
Training and education	Staff training on special pathogen patient care and PPE use, including baseline and just-in-time training Training staff to “step up” to patient care roles they may not have on a daily basis Self-care and resilience reinforcement
Plans	Surge capacity plans detail facility and provider actions during crisis conditions, including available consultation for bedside providers and how best practices/guidelines will be developed and circulated when resources are in shortage Integrate clinical providers and infection prevention with emergency management and administration during planning and response
Staff	Staff surge plan should detail how shifts and supervision will change in a phased manner based on demand Staff surge plan details redeployment of staff Training parallels redeployment plan Support of staff (eg, transportation, housing) should be planned Staff should understand the ethics of special pathogen patient care, crisis care, and triage Develop checklists for PPE use, safe patient care practices, and critical care (eg, operations/troubleshooting of pumps, general shift checklist) Assure rapid onboarding process for contract/outside staff including orientation to infection prevention practices and care practices on the unit Assure adequate mentoring and supervision of redeployed staff
Space	Sequential expansion plans for space when patients require isolation (ie, from individual rooms to units to floors, etc.) Surge capacity plans detail expansion of critical care Design future space to be configured flexibly for a variety of levels of care, include entry/exit anterooms to units, isolate ventilation systems and increase air exchanges, increase oxygen supply pipe size to units and master tank supplies
Supplies	Assure adequate communication supplies for team and family use (eg, portable radios, electronic stethoscopes, tablet devices, phones, telemedicine hubs) Assure adequate supplies of PPE and a regional plan for caching, purchasing, and distribution that includes high-level PPE for special pathogens Purchase and maintain adequate par levels of HEPA filters for ventilators, circuits for respiratory equipment, ventilators in excess of daily needs, high-flow nasal cannula machines, oxygen/nebulizer masks and tubing Pharmacy should maintain adequate levels of common critical care medications and antibiotics that may be urgently needed and for which there are few substitutes (eg, paralytic and sedative medications)

Abbreviation: PPE, personal protective equipment.

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