High-Level Isolation: A Landscape Analysis of Global Capabilities and Opportunities to Advance the Field.

High-level isolation units (HLIUs) have been established by countries to provide safe and optimal medical care for patients with high-consequence infectious diseases. We aimed to identify global high-level isolation capabilities and determine gaps and priorities of global HLIUs, using a multiple method approach that included a systematic review of published and gray literature and a review of Joint External Evaluations and Global Health Security Index reports from 112 countries. A follow-up electronic survey was distributed to identified HLIUs. The landscape analysis found 44 previously designated/self-described HLIUs in 19 countries. An additional 33 countries had potential HLIUs; however, there were not enough details on capabilities to determine if they fit the HLIU definition. An electronic survey was distributed to 36 HLIUs to validate landscape analysis findings and to understand challenges, best practices, and priorities for increased networking with a global HLIU cohort; 31 (86%) HLIUs responded. Responses revealed an additional 30 confirmed HLIUs that were not identified in the landscape analysis. To our knowledge, this was the first mapping and the largest ever survey of global HLIUs. Survey findings identified major gaps in visibility of HLIUs: while our landscape analysis initially identified 44 units, the survey unveiled an additional 30 HLIUs that had not been previously identified or confirmed. The lack of formalized regional or global coordinating organizations exacerbates these visibility gaps. The unique characteristics and capabilities of these facilities, coupled with the likelihood these units serve as core components of national health security plans, provides an opportunity for increased connection and networking to advance the field of high-level isolation and address identified gaps in coordination, build an evidence base for HLIU approaches, and inform HLIU definitions and key components.

The cardinal rules: Principles of personal protective equipment for high-consequence infectious disease events.

In recognition of an increasing number of high-consequence infectious disease events, a group of subject-matter experts identified core safety principles that can be applied across all donning and doffing protocols for personal protective equipment.

Literature review of physiological strain of personal protective equipment on personnel in the high-consequence infectious disease isolation environment.

BACKGROUND: Heat strain and dehydration can affect an individual's physical and mental performance. The purpose of this review was to examine the literature for the impact of heat strain on health care workers (HCWs) who care for patients with high-consequence infectious diseases (HCIDs) while wearing personal protective equipment (PPE), discuss the risks of impaired safety caused by heat strain and dehydration in HCID environments, identify attempts to combat PPE-related heat strain, recognize limitations, and provide suggestions for further research. METHODS: A literature search was performed in PubMed or MEDLINE and Google Scholar. Authors screened abstracts for inclusion criteria and reviewed articles if the abstracts were considered to include information relevant to the aim. RESULTS: The search terms yielded 30 articles that were sorted based on environment setting, physiological impact, and interventions. DISCUSSION: The safety of the HCWs and patients can be enhanced through the development and usage of cooler, more comfortable PPE materials and ensembles to help slow the rate of dehydration and support the regulation of core body temperature. CONCLUSIONS: Heat strain caused by wearing PPE is an occupational health concern for HCWs in the high-risk environment, that is, HCID care. Future studies are needed to develop innovative PPE ensembles that can reduce heat strain and improve well-being.

An Updated Review of Literature for Air Medical Evacuation High-Level Containment Transport During the Coronavirus Disease 2019 Pandemic.

OBJECTIVE: In 2019, our team conducted a literature review of air medical evacuation high-level containment transport (AE-HLCT) of patients infected with high-consequence pathogens. Since that publication, the coronavirus disease 2019 (COVID-19) pandemic has resulted in numerous air medical evacuations. We re-examined the new literature associated with AE-HLCTs to determine new innovations developed as a result of the pandemic. METHODS: A literature search was performed in PubMed/MEDLINE from February 2019 to October 2021. The authors screened abstracts for the inclusion criteria and reviewed full articles if the abstract was relevant to the aim. RESULTS: Our search criteria yielded 19 publications. Many of the early transports of patients with COVID-19 used established protocols for AE-HLCT, which were built from the most recent transports of patients with Ebola virus disease. Innovations from the identified articles are subdivided into preflight considerations, in-flight operations, and postflight operations. CONCLUSION: Lessons gleaned from AE-HLCTs of patients with COVID-19 in the early weeks of the pandemic, when little was known about transmission or the severity of the novel disease, have advanced the field of AE-HLCT. Teams that had never conducted such transports now have experience and processes. However, more research into AE-HLCT is needed, including research related to single-patient portable isolation units as well as containerized/multipatient transportation systems.

The utility and sustainability of US Ebola treatment centers during the coronavirus disease 2019 (COVID-19) pandemic.

OBJECTIVE: In response to the 2014-2016 West Africa Ebola virus disease (EVD) epidemic, the Centers for Disease Control and Prevention (CDC) designated 56 US hospitals as Ebola treatment centers (ETCs) with high-level isolation capabilities. We sought to determine the ongoing sustainability of ETCs and to identify how ETC capabilities have affected hospital, local, and regional coronavirus disease 2019 (COVID-19) readiness and response. DESIGN: An electronic survey included both qualitative and quantitative questions and was structured into 2 sections: operational sustainability and role in the COVID-19 response. SETTING AND PARTICIPANTS: The survey was distributed to site representatives from the 56 originally designated ETCs, and 37 (66%) responded. METHODS: Data were coded and analyzed using descriptive statistics. RESULTS: Of the 37 responding ETCs, 33 (89%) reported that they were still operating, and 4 had decommissioned. ETCs that maintain high-level isolation capabilities incurred a mean of $234,367 in expenses per year. All but 1 ETC reported that existing capabilities (eg, trained staff, infrastructure) before COVID-19 positively affected their hospital, local, and regional COVID-19 readiness and response (eg, ETC trained staff, donated supplies, and shared developed protocols). CONCLUSIONS: Existing high-level isolation capabilities and expertise developed following the 2014-2016 EVD epidemic were leveraged by ETCs to assist hospital-wide readiness for COVID-19 and to support responses by other local and regional hospitals However, ETCs face continued challenges in sustaining those capabilities for high-consequence infectious diseases.

COVID-19 Response Among US Hospitals with Emerging Special Pathogen Programs.

In February 2015, the US Department of Health and Human Services developed a tiered hospital network to deliver safe and effective care to patients with Ebola virus disease (EVD) and other special pathogens. The tiered network consisted of regional special pathogen treatment centers, state- or jurisdiction-designated treatment centers, assessment hospitals able to safely isolate a patient until a diagnosis of EVD was confirmed and transfer the patient, and frontline healthcare facilities able to identify and isolate patients with EVD and facilitate transport to higher-tier facilities. The National Emerging Special Pathogens Training and Education Center (NETEC) was established in tandem to support the development of healthcare facility special pathogen management capabilities. In August 2020, 20 hospitals that previously received an onsite readiness consultation by NETEC were surveyed to assess how special pathogen programs were leveraged for COVID-19 response. All surveyed facilities indicated their programs were leveraged for COVID-19 response in at least 1 of the following ways: NETEC-sponsored resources and training, utilization of patient isolation spaces, specially trained staff, and supplies. Personal protective equipment shortages were experienced by 95% of facilities, with 80% of facilities reporting that special pathogens program personal protective equipment was used to support facility response to COVID-19 admissions. More than half of facilities (63%) reported leveraging biocontainment unit staff to provide training and education to frontline staff during initial response to COVID-19. These findings have implications for planning and investments to avoid the panic-then-forget cycle that hinders sustained preparedness for future special pathogens.

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.

Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC: workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.

Treating Workers as Essential Too: An Ethical Framework for Public Health Interventions to Prevent and Control COVID-19 Infections among Meat-processing Facility Workers and Their Communities in the United States.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep this "essential industry" producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry's implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities.

The Evolution of the National Special Pathogen System of Care.

Infectious disease outbreaks and pandemics have repeatedly threatened public health and have severely strained healthcare delivery systems throughout the past century. Pathogens causing respiratory illness, such as influenza viruses and coronaviruses, as well as the highly communicable viral hemorrhagic fevers, pose a large threat to the healthcare delivery system in the United States and worldwide. Through the Hospital Preparedness Program, within the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, a nationwide Regional Ebola Treatment Network (RETN) was developed, building upon a state- and jurisdiction-based tiered hospital approach. This network, spearheaded by the National Emerging Special Pathogens Training and Education Center, developed a conceptual framework and plan for the evolution of the RETN into the National Special Pathogen System of Care (NSPS). Building the NSPS strategy involved reviewing the literature and the initial framework used in forming the RETN and conducting an extensive stakeholder engagement process to identify gaps and develop solutions. From this, the NSPS strategy and implementation plan were formed. The resulting NSPS strategy is an ambitious but critical effort that will have impacts on the mitigation efforts of special pathogen threats for years to come.

Best practices of highly infectious decedent management: Consensus recommendations from an international expert workshop.

With the increasing number of highly infectious disease incidents, outbreaks, and pandemics in our society (e.g., Ebola virus disease, Lassa fever, coronavirus diseases), the need for consensus and best practices on highly infectious decedent management is critical. In January 2020, a workshop of subject matter experts from across the world convened to discuss highly infectious live patient transport and highly infectious decedent management best practices. This commentary focuses on the highly infectious decedent management component of the workshop. The absence of guidance or disparate guidance on highly infectious decedent management can increase occupational safety and health risks for death care sector workers. To address this issue, the authorship presents these consensus recommendations on best practices in highly infectious decedent management, including discussion of what is considered a highly infectious decedent; scalability and storage for casualty events; integration of key stakeholders; infection control and facility considerations; transport; care and autopsy; psychological, ethical, and cultural considerations as well as multi-national care perspectives. These consensus recommendations are not intended to be exhaustive but rather to underscore this overlooked area and serve as a starting point for much-needed conversations.

Capabilities of global high-level isolation units: A pre-workshop survey.

OBJECTIVE: To assess experience, physical infrastructure, and capabilities of high-level isolation units (HLIUs) planning to participate in a 2018 global HLIU workshop hosted by the US National Emerging Special Pathogens Training and Education Center (NETEC). DESIGN: An electronic survey elicited information on general HLIU organization, operating costs, staffing models, and infection control protocols of select global units. SETTING AND PARTICIPANTS: The survey was distributed to site representatives of 22 HLIUs located in the United States, Europe, and Asia; 19 (86%) responded. METHODS: Data were coded and analyzed using descriptive statistics. RESULTS: The mean annual reported budget for the 19 responding units was US$484,615. Most (89%) had treated a suspected or confirmed case of a high-consequence infectious disease. Reported composition of trained teams included a broad range of clinical and nonclinical roles. The mean number of HLIU beds was 6.37 (median, 4; range, 2-20) for adults and 4.23 (median, 2; range, 1-10) for children; however, capacity was dependent on pathogen. CONCLUSIONS: Responding HLIUs represent some of the most experienced HLIUs in the world. Variation in reported unit infrastructure, capabilities, and procedures demonstrate the variety of HLIU approaches. A number of technical questions unique to HLIUs remain unanswered related to physical design, infection prevention and control procedures, and staffing and training. These key areas represent potential focal points for future evidence and practice guidelines. These data are important considerations for hospitals considering the design and development of HLIUs, and there is a need for continued global HLIU collaboration to define best practices.

The size and culturability of patient-generated SARS-CoV-2 aerosol.

BACKGROUND: Aerosol transmission of COVID-19 is the subject of ongoing policy debate. Characterizing aerosol produced by people with COVID-19 is critical to understanding the role of aerosols in transmission. OBJECTIVE: We investigated the presence of virus in size-fractioned aerosols from six COVID-19 patients admitted into mixed acuity wards in April of 2020. METHODS: Size-fractionated aerosol samples and aerosol size distributions were collected from COVID-19 positive patients. Aerosol samples were analyzed for viral RNA, positive samples were cultured in Vero E6 cells. Serial RT-PCR of cells indicated samples where viral replication was likely occurring. Viral presence was also investigated by western blot and transmission electron microscopy (TEM). RESULTS: SARS-CoV-2 RNA was detected by rRT-PCR in all samples. Three samples confidently indicated the presence of viral replication, all of which were from collected sub-micron aerosol. Western blot indicated the presence of viral proteins in all but one of these samples, and intact virions were observed by TEM in one sample. SIGNIFICANCE: Observations of viral replication in the culture of submicron aerosol samples provides additional evidence that airborne transmission of COVID-19 is possible. These results support the use of efficient respiratory protection in both healthcare and by the public to limit transmission.

Leveraging a Preexisting Global Infectious Disease Network for Local Decision Making During a Pandemic.

Emerging infectious disease epidemics require a rapid response from health systems; however, evidence-based consensus guidelines are generally absent early in the course of events. Formed in 2017 by 5 high-level isolation units spanning 3 continents, the experience of the Global Infectious Disease Preparedness Network (GIDPN) early in the course of coronavirus disease 2019 (COVID-19) provides a model for accelerating best practice development and improving decision-making in health emergencies. The network served as a platform for real-time, open and transparent information-sharing during unknowns of an active outbreak by clinicians caring for patients, by researchers conducting clinical trials and transmission and infection prevention studies, and by teams advising local and national policy makers. Shared knowledge led to earlier adoption of some treatment modalities as compared to most peer institutions and to implementation of protocols prior to incorporation into national guidelines. GIDPN and similar networks are integral in enhancing preparedness for and response to future epidemics/pandemics.

A pilot study of core body temperatures in healthcare workers wearing personal protective equipment in a high-level isolation unit.

Personal protective equipment used by healthcare workers to mitigate disease transmission risks while caring for patients with high-consequence infectious diseases can impair normal body cooling mechanisms and exacerbate physiological strain. Symptoms of heat strain (e.g., cognitive impairment, confusion, muscle cramping) are especially harmful in the high-risk environment of high-consequence infectious disease care. In this pilot study, the core body temperatures of healthcare workers were assessed using an ingestible, wireless-transmission thermometer while performing patient care tasks common to a high-level isolation unit setting in powered air purifying respirator (PAPR)-level. The objective was to determine the potential for occupational health hazard due to heat stress in an environmentally controlled unit. Maximum core temperatures of the six participants ranged from 37.4 °C (99.3 °F) to 39.9 °C (103.8°F) during the 4-hr shift; core temperatures of half (n = 3) of the participants exceeded 38.5 °C (101.3 °F), the upper core temperature limit. Future investigations are needed to identify other heat stress risks both in and outside of controlled units. The ongoing COVID-19 pandemic offers unique opportunities for field-based research on risks of heat stress related to personal protective equipment in healthcare workers that can lead to both short- and long-term innovations in this field.

Implementation of a COVID-19 cohort area resulted in no surface or air contamination in surrounding areas in one academic emergency department.

INTRODUCTION: As a result of the COVID-19 pandemic and highly contagious nature of SARS-CoV-2, emergency departments (EDs) have been forced to implement new measures and protocols to minimize the spread of the disease within their departments. The primary objective of this study was to determine if the implementation of a designated COVID-19 cohort area (hot zone) within a busy ED mitigated the dissemination of SARS-CoV-2 throughout the rest of the department. METHODS: In an ED of a tertiary academic medical center, with 64,000 annual visits, an eight room pod was designated for known COVID-19 or individuals with high suspicion for infection. There was a single entry and exit for donning and doffing personal protective equipment (PPE). Health care workers (HCW) changed gowns and gloves between patients, but maintained their N-95 mask and face shield, cleaning the shield with a germicidal wipe between patients. Staffing assignments designated nurses and technicians to remain in this area for 4 h, where physicians regularly moved between the hot zone and rest of the ED. Fifteen surface samples and four air samples were taken to evaluate SARS-CoV-2 contamination levels and the effectiveness of infection control practices. Samples were collected outside of patient rooms in 3 primary ED patient care areas, the reception area, the primary nurses station, inside the cohort area, and the PPE donning and doffing areas immediately adjacent. Samples were recovered and analyzed for the presence of the E gene of SARS-CoV-2 using RT-PCR. RESULTS: SARS-CoV-2 was not detected on any surface samples, including in and around the cohort area. All air samples outside the COVID-19 hot zone were negative for SARS-CoV-2, but air samples within the cohort area had a low level of viral contamination. CONCLUSION: A designated COVID-19 cohort area resulted in no air or surface contamination outside of the hot zone, and only minimal air, but no surface contamination, within the hot zone.