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In November 2022, the National Emerging Special Pathogens Training and Education Center hosted a virtual session with global high-level isolation unit (HLIU) representatives to discuss HLIU staffing challenges and approaches. Takeaways are relevant to healthcare institutions seeking solutions to recruit and retain their healthcare workforce amid unprecedented global staffing shortages.

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.

The need for well-controlled clinical trials is fundamental to advancing medicine. Care should be taken to maintain high standards in trial design and conduct even during emergency medical events such as an infectious disease outbreak. In 2020, SARS-CoV-2 emerged and rapidly impacted populations around the globe. The need for effective therapeutics was immediately evident, prompting the National Institutes of Health to initiate the Adaptive COVID-19 Treatment Trial. The Special Pathogens Research Network, made up of 10 Regional Emerging Special Pathogens Treatment Centers, was approached to participate in this trial and readily joined the trial on short notice. By trial closure, the Special Pathogens Research Network sites, making up 19% of all study sites, enrolled 26% of the total participants. The initial resources available and experience in running clinical trials at each treatment center varied from minimal experience and few staff to extensive experience and a large staff. Based on experiences during the first phase of this trial, the Special Pathogens Research Network members provided feedback regarding operational lessons learned and recommendations for conducting future studies during a pandemic. Communication, collaboration, information technology, regulatory processes, and access to resources were identified as important topics to address. Key stakeholders including institutions, institutional review boards, and study personnel must maintain routine communication to efficiently and effectively activate when future research needs arise. Regular and standardized training for new personnel will aid in transitions and project continuity, especially in a rapidly evolving environment. Trainings should include local just-in-time training for new staff and sponsor-designed modules to refresh current staff knowledge. We offer recommendations that can be used by institutions and sponsors to determine goals and needs when preparing to set up this type of trial for critical, short-notice needs.

The National Emerging Special Pathogens Training and Education Center (NETEC) was established in 2015 to improve the capabilities of healthcare facilities to provide safe and effective care to patients with Ebola and other special pathogens in the United States. Through NETEC, a collaborative network of 10 Regional Emerging Special Pathogen Treatment Centers (RESPTCs) undertook readiness activities that included potential respiratory pathogens. These preparations, which took place before the COVID-19 pandemic, established a foundation of readiness that enabled RESPTCs to play a pivotal role in the US COVID-19 pandemic response. As initial COVID-19 cases were detected in the United States, RESPTCs provided essential isolation capacity, supplies, and subject matter expertise that allowed for additional time for healthcare systems to prepare. Through the Special Pathogen Research Network, RESPTCs rapidly enrolled patients into early clinical trials. During periods of high community transmission, RESPTCs provided educational, clinical, and logistical support to a wide range of healthcare and nonhealthcare settings. In this article, we describe how NETEC and the RESPTC network leveraged this foundation of special pathogen readiness to strengthen the national healthcare system's response to the COVID-19 pandemic. NETEC and the RESPTC network have proven to be an effective model that can support the national response to future emerging special pathogens.

In our increasingly interconnected world, the potential for emerging infectious diseases (EIDs) to spread globally is of paramount concern. Travel bans--herein defined as the complete restriction of travel from at least one geographic region to at least one other international geographic region--are a potential policy solution to control the global spread of disease. The social, economic, and health-related consequences of travel bans, as well as the available evidence on the effectiveness of travel restrictions in preventing the global spread of influenza, have been previously described. However, the effectiveness of travel bans in reducing the spread of noninfluenza EIDs, characterized by different rates and modes of transmission, is less well understood. This study employs an integrative review approach to summarize the minimal evidence on effectiveness of travel bans to decrease the spread of severe acute respiratory syndrome (SARS), Middle Eastern respiratory syndrome (MERS), Ebola virus disease (EVD), and Zika virus disease (ZVD). We describe and qualify the evidence presented in six modeling studies that assess the effectiveness of travel bans in controlling these noninfluenza EID events. We conclude that there is an urgent need for additional research to inform policy decisions on the use of travel bans and other control measures to control noninfluenza EIDs in advance of the next outbreak.

Summary Background Functional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19. Methods We did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 μg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov , NCT04492475 . Findings Between Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87–1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3–7%) in the interferon beta-1a plus remdesivir group and 3% (2–6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69–2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group. Interpretation Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo. Funding The National Institute of Allergy and Infectious Diseases (USA).

Emerging and re-emerging infectious diseases pose growing global public health threats. However, research on and development of medical countermeasures (MCMs) for such pathogens is limited by the sporadic and unpredictable nature of outbreaks, lack of financial incentive for pharmaceutical companies to develop interventions for many of the diseases, lack of clinical research capacity in areas where these diseases are endemic, and the ethical dilemmas related to conducting scientific research in humanitarian emergencies. Hence, clinicians providing care for patients with emerging diseases are often faced with making clinical decisions about the safety and effectiveness of experimental MCMs, based on limited or no human safety, preclinical, or even earlier product research or historical data, for compassionate use. Such decisions can have immense impact on current and subsequent patients, the public health response, and success of future clinical trials. We highlight these dilemmas and underscore the need to proactively set up procedures that allow early and ethical deployment of MCMs as part of clinical trials. When clinical trials remain difficult to deploy, we present several suggestions of how compassionate use of off-label and unlicensed MCMs can be made more informed and ethical. We highlight several collaborations seeking to address these gaps in data and procedures to inform future clinical and public health decision making.

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.

Maintaining a public health emergency response for a sustained period of time requires availability of resources, physical and information technology infrastructure, and human capital. What perhaps is unprecedented is a medical center experiencing multiple disasters simultaneously. In this case study, the authors describe 2 separate disaster events experienced during the ongoing COVID-19 pandemic: (1) a cyberattack at Nebraska Medicine in Omaha, Nebraska, and (2) civil unrest following the murder of George Floyd in Minneapolis, Minnesota. Although these settings were very different, the following common themes can inform future disaster planning: the benefit of an already active incident command system, the prescient need for continuity of operations, and the anticipation of workforce fatigue. These dual-disaster experiences provide an opportunity to identify lessons learned that will drive improvements in emergency management through preparedness and mitigation measures and response innovations for future simultaneous disasters.

The early COVID-19 pandemic has been characterized by rapid global spread. In the United States National Capital Region, over 2,000 cases were reported within three weeks of its first detection in March 2020. We aimed to use genomic sequencing to understand the initial spread of SARS-CoV-2, the virus that causes COVID-19, in the region. By correlating genetic information to disease phenotype, we also aimed to gain insight into any correlation between viral genotype and case severity or transmissibility.We performed whole genome sequencing of clinical SARS-CoV-2 samples collected in March 2020 by the Johns Hopkins Health System. We analyzed these regional SARS-CoV-2 genomes alongside detailed clinical metadata and the global phylogeny to understand early establishment of the virus within the region.We analyzed 620 samples from the Johns Hopkins Health System collected between March 11-31, 2020, comprising 37.3% of the total cases in Maryland during this period. We selected 143 of these samples for sequencing, generating 114 complete viral genomes. These genomes belong to all five major Nextstrain-defined clades, suggesting multiple introductions into the region and underscoring the diversity of the regional epidemic. We also found that clinically severe cases had genomes belonging to all of these clades.We established a pipeline for SARS-CoV-2 sequencing within the Johns Hopkins Health system, which enabled us to capture the significant viral diversity present in the region as early as March 2020. Efforts to control local spread of the virus were likely confounded by the number of introductions into the region early in the epidemic and interconnectedness of the region as a whole.

Objective: To characterize the strengths and weaknesses of the current status of disaster research evidence; and to identify potential interventions specific to the disciplines of medicine, public health, and social sciences. Design: A mixed method study using nominal group technique and a strengths, weaknesses, opportunities, and threats (SWOT) analysis. Participants: Subject matter experts (SMEs) in the fields of medicine, public health, and social sciences who are engaged in disaster research. Results: The nominal group technique achieved 100 percent response rate. After coding and analysis, ten distinct disaster research evidence themes were identified: awareness; evidence quality; funding; human resources; interdisciplinary studies; politics; research process; research topics; sectoral collaboration; and “other.” Strengths in each area were limited but focused on quality and workforce pipeline. Weaknesses were limited funding and low research quality. Opportunities included improving methods and increased interdisciplinary collaboration. The threats most consistently identified were limited funding and political influences on disaster research funding. Conclusions: Disaster research experts from three disciplines identified a number of barriers and facilitators to improving disaster-related research. The limited, inconsistent, and episodic funding and the politics related to it were the greatest and most common barriers. This weakness needs to be strategically addressed to significantly advance the field of disaster research.

SARS-CoV-2 infection induces severe disease in a subpopulation of patients, but the underlying mechanisms remain unclear. We demonstrate robust IgM autoantibodies that recognize angiotensin converting enzyme-2 (ACE2) in 18/66 (27%) patients with severe COVID-19, which are rare (2/52; 3.8%) in hospitalized patients who are not ventilated. The antibodies do not undergo class-switching to IgG, suggesting a T-independent antibody response. Purified IgM from anti-ACE2 patients activates complement. Pathological analysis of lung obtained at autopsy shows endothelial cell staining for IgM in blood vessels in some patients. We propose that vascular endothelial ACE2 expression focuses the pathogenic effects of these autoantibodies on blood vessels, and contributes to the angiocentric pathology observed in some severe COVID-19 patients. These findings may have predictive and therapeutic implications.One-sentence summaryACE2 autoantibodies in severe COVID-19 have features of a T-independent immune response, and may mediate vascular damage.

BackgroundThe early COVID-19 pandemic has been characterized by rapid global spread. In the United States National Capital Region, over 2,000 cases were reported within three weeks of its first detection in March 2020. We aimed to use genomic sequencing to understand the initial spread of SARS-CoV-2, the virus that causes COVID-19, in the region. By correlating genetic information to disease phenotype, we also aimed to gain insight into any correlation between viral genotype and case severity or transmissibility.MethodsWe performed whole genome sequencing of clinical SARS-CoV-2 samples collected in March 2020 by the Johns Hopkins Health System. We analyzed these regional SARS-CoV-2 genomes alongside detailed clinical metadata and the global phylogeny to understand early establishment of the virus within the region.ResultsWe analyzed 620 samples from the Johns Hopkins Health System collected between March 11–31, 2020, comprising 37.3% of the total cases in Maryland during this period. We selected 143 of these samples for sequencing, generating 114 complete viral genomes. These genomes belong to all five major Nextstrain-defined clades, suggesting multiple introductions into the region and underscoring the diversity of the regional epidemic. We also found that clinically severe cases had genomes belonging to all of these clades.ConclusionsWe established a pipeline for SARS-CoV-2 sequencing within the Johns Hopkins Health system, which enabled us to capture the significant viral diversity present in the region as early as March 2020. Efforts to control local spread of the virus were likely confounded by the number of introductions into the region early in the epidemic and interconnectedness of the region as a whole.

Background The Centers of Excellence for Influenza Research and Surveillance (CEIRS) network, funded by the US National Institutes of Health, has been operational since 2007 and is tasked with conducting research to improve understanding of influenza viruses. Recently, CEIRS developed an Influenza Response Plan (IRP) to improve science preparedness for the network. Methods Development of the IRP involved a collaborative process between project staff, CEIRS center directors or their designees, and NIAID CEIRS leadership (referred to as the Pandemic Planning Advisory Committee [PPAC]). Project staff identified and summarized the response capabilities of each center and then worked with the PPAC to identify and rank research priorities for an emergency response using a modified Delphi method. Results Key elements of the response plan include tables of response capabilities for each CEIRS center, a framework that outlines and ranks research priorities for CEIRS during an emergency situation, and an operational strategy for executing the research priorities. Conclusions The CEIRS IRP highlights the importance of enhancing science preparedness in advance of an influenza pandemic or other influenza‐related zoonotic incident to ensure that research can be carried out expeditiously and effectively in emergency situations and to improve global health security.

Biocontainment units (BCUs) are facilities used to care for patients with highly infectious diseases. However, there is limited guidance on BCU protocols and design. This study presents the first investigation of how HVAC (heating, ventilation, air‐conditioning) operating conditions influence the dissemination of fluorescent tracer particles released in a BCU. Test conditions included normal HVAC operation and exhaust failure resulting in loss of negative pressure. A suspension of optical brightener powder and water was nebulized to produce fluorescent particles simulating droplet nuclei (0.5‐5 μm). Airborne particle number concentrations were monitored by Instantaneous Biological Analyzers and Collectors (FLIR Systems). During normal HVAC operation, fluorescent tracer particles were contained in the isolation room (average concentration = 1 × 104 ± 3 × 103/Lair). Under exhaust failure, the automated HVAC system maximizes airflow into areas adjacent to isolation rooms to attempt to maintain negative pressure differential. However, 6% of the fluorescent particles were transported through cracks around doors/door handles out of the isolation room via airflow alone and not by movement of personnel or doors. Overall, this study provides a systematic method for evaluating capabilities to contain aerosolized particles during various HVAC scenarios. Recommendations are provided to improve situation‐specific BCU safety.

The Johns Hopkins Hospital created a biocontainment unit (BCU) to care for patients with highly infectious diseases while assuring healthcare worker safety. Research to date for BCU protocols and practices are based on case reports and lessons learned from patient care and exercises. This study seeks to be the first to explore the influences of healthcare worker movement and personal protective equipment (PPE) doffing on the transport of simulant pathogen particles in a BCU. A cough device released 1 μm fluorescent polystyrene beads (PSLs) in the patient room. PSL transport was then examined under 2 scenarios: (1) PSL release only, no healthcare workers; and (2) PSL release during 5-minute simulated activity by healthcare workers. Airborne PSL concentrations were quantified every second for 30 minutes per scenario by 7 optical particle sensors located throughout the BCU. PSLs were not detected in the donning room at any time nor in the doffing room during the first test scenario where no healthcare worker was present. The main difference detected between the tested scenarios was the presence of PSLs in the doffing room when healthcare workers were removing PPE, potentially due to re-aerosolization of PSLs off the exterior PPE surface or opening of the patient room door. Future work will further explore the potential for re-aerosolization of particles off of PPE during doffing. The present study provides the groundwork for a systematic method for evaluating the BCU and doffing procedures for their respective safety, and it also pilots a systematic method for evaluating potential pathogen exposure pathways for BCU healthcare workers.

The National Center for the Study of Preparedness and Catastrophic Event Response (PACER) has created a publicly available simulation tool called Surge (accessible at http://www.pacerapps.org) to estimate surge capacity for user-defined hospitals. Based on user input, a Monte Carlo simulation algorithm forecasts available hospital bed capacity over a 7-day period and iteratively assesses the ability to accommodate disaster patients. Currently, the tool can simulate bed capacity for acute mass casualty events (such as explosions) only and does not specifically simulate staff and supply inventory. Strategies to expand hospital capacity, such as (1) opening unlicensed beds, (2) canceling elective admissions, and (3) implementing reverse triage, can be interactively evaluated. In the present application of the tool, various response strategies were systematically investigated for 3 nationally representative hospital settings (large urban, midsize community, small rural). The simulation experiments estimated baseline surge capacity between 7% (large hospitals) and 22% (small hospitals) of staffed beds. Combining all response strategies simulated surge capacity between 30% and 40% of staffed beds. Response strategies were more impactful in the large urban hospital simulation owing to higher baseline occupancy and greater proportion of elective admissions. The publicly available Surge tool enables proactive assessment of hospital surge capacity to support improved decision-making for disaster response. (Disaster Med Public Health Preparedness. 2018;12:513–522)

In response to the Ebola outbreak in 2014, many hospitals designated specific areas to care for patients with Ebola and other highly infectious diseases. The safe handling of category A infectious substances is a unique challenge in this environment. One solution is on-site waste treatment with a steam sterilizer or autoclave. The Johns Hopkins Hospital (JHH) installed two pass-through autoclaves in its biocontainment unit (BCU). The JHH BCU and The Johns Hopkins biosafety level 3 (BSL-3) clinical microbiology laboratory designed and validated waste-handling protocols with simulated patient trash to ensure adequate sterilization. The results of the validation process revealed that autoclave factory default settings are potentially ineffective for certain types of medical waste and highlighted the critical role of waste packaging in successful sterilization. The lessons learned from the JHH validation process can inform the design of waste management protocols to ensure effective treatment of highly infectious medical waste.

Background Fluorescent tracers are often used with ultraviolet lights to visibly identify healthcare worker self-contamination after doffing of personal protective equipment (PPE). This method has drawbacks, as it cannot detect pathogen-sized contaminants nor airborne contamination in subjects’ breathing zones. Methods A contamination detection/quantification method was developed using 2-µm polystyrene latex spheres (PSLs) to investigate skin contamination (via swabbing) and potential inhalational exposure (via breathing zone air sampler). Porcine skin coupons were used to estimate the PSL swabbing recovery efficiency and limit of detection (LOD). A pilot study with 5 participants compared skin contamination levels detected via the PSL vs fluorescent tracer methods, while the air sampler quantified potential inhalational exposure to PSLs during doffing. Results Average PSL skin swab recovery efficiency was 40% ± 29% (LOD = 1 PSL/4 cm2 of skin). In the pilot study, all subjects had PSL and fluorescent tracer skin contamination. Two subjects had simultaneously located contamination of both types on a wrist and hand. However, for all other subjects, the PSL method enabled detection of skin contamination that was not detectable by the fluorescent tracer method. Hands/wrists were more commonly contaminated than areas of the head/face (57% vs 23% of swabs with PSL detection, respectively). One subject had PSLs detected by the breathing zone air sampler. Conclusions This study provides a well-characterized method that can be used to quantitate levels of skin and inhalational contact with simulant pathogen particles. The PSL method serves as a complement to the fluorescent tracer method to study PPE doffing self-contamination., A new method is pilot tested against the fluorescent liquid tracer method for quantifying skin and inhalational exposure to pathogens during personal protective equipment doffing. The new method uses fluorescent polystyrene latex spheres to simulate pathogen particles.

The 2013-2016 epidemic of Ebola virus disease (EVD) that originated in West Africa underscored many of the challenges to conducting clinical research during an ongoing infectious disease epidemic, both in the most affected countries of Guinea, Liberia, and Sierra Leone, as well as in the United States and Europe, where a total of 27 patients with EVD received care in biocontainment units. The Special Pathogens Research Network (SPRN) was established in the United States in November 2016 to provide an organizational structure to leverage the expertise of the 10 Regional Ebola and Other Special Pathogen Treatment Centers (RESPTCs); it was intended to develop and support infrastructure to improve readiness to conduct clinical research in the United States. The network enables the rapid activation and coordination of clinical research in the event of an epidemic and facilitates opportunities for multicenter research when the RESPTCs are actively caring for patients requiring a biocontainment unit. Here we provide an overview of opportunities identified in the clinical research infrastructure during the West Africa EVD epidemic and the SPRN activities to meet the ongoing challenges in the context of Ebola virus and other special pathogens.

High-consequence pathogens create a unique problem. To provide effective treatment for infected patients while providing safety for the community, a series of 10 high-level isolation units have been created across the country; they are known as Regional Ebola and Special Pathogen Treatment Centers (RESPTCs). The activation of a high-level isolation unit is a highly resource-intensive activity, with effects that ripple across the healthcare system. The incident command system (ICS), a standard tool for command, control, and coordination in domestic emergencies, is a command structure that may be useful in a biocontainment event. A version of this system, the hospital emergency incident command system, provides an adaptable all-hazards approach in healthcare delivery systems. Here we describe its utility in an operational response to safely care for a patient(s) infected with a high-consequence pathogen on a high-level isolation unit. The Johns Hopkins Hospital created a high-level isolation unit to manage the comprehensive and complex needs of patients with high-consequence infectious diseases, including Ebola virus disease. The unique challenges of and opportunities for providing care in this high-level isolation unit led the authors to modify the hospital incident command system model for use during activation. This system has been tested and refined during full-scale functional and tabletop exercises. Lessons learned from the after-action reviews of these exercises led to optimization of the structure and implementation of ICS on the biocontainment unit, including improved job action sheets, designation of physical location of roles, and communication approaches. Overall, the adaptation of ICS for use in the high-level isolation unit setting may be an effective approach to emergency management during an activation.

Bioemergencies present unique ethical and operational challenges to performing clinical research with human subjects. Patient care, public health protection, and responder safety are paramount in these situations, which often involve high biosafety level pathogens and containment conditions. While working to halt the spread of disease, research is necessary to understand the ongoing outbreak as well as increase response capabilities in the face of future threats. Research in bioemergencies has novel and unexpected challenges that vary greatly depending on the type of studies being conducted and data being collected. This chapter will provide an understanding of basic principles, challenges, and regulatory components of human subjects research during bioemergencies, as well as ongoing practical components of these studies.

Clinicians are continuously looking for ways to improve the care they deliver, with the goals of optimizing patient outcomes, improving efficiency of health care delivery, and ultimately advancing the health of population. Optimization of clinical care can be particularly challenging for front-line providers (e.g. emergency, urgent care, family and primary care clinicians) who work in high volume, busy episodic care settings, where decisions must be made rapidly, patient throughput is critical, and follow-up is often not possible. One fundamental strategy which can aid in improving patient care is to arm clinicians with reliable diagnostics, which are adapted and customized for both the clinical need, and the setting in which they are intended to be utilized. Broadly speaking, tests that provide the greatest benefit are those with well-defined indications for use, which can provide accurate, reliable, and real-time results (actionable during the patient stay), and can contribute to critical clinical decisions – either therapeutic or disposition-related. Notably, from the front-line physician perspective, current diagnostic tools available for critical infectious disease conditions have lagged significantly behind those that have been advanced for other high impact clinical conditions (e.g. troponin testing for acute cardiac conditions). Although highly advanced high-throughput solutions have been developed for centralized laboratories, lesser focus has been put on the development of point-of-care solutions for bedside or satellite laboratory use. The study by Chen et al., published in this issue, represents another important and welcome advance in the developmental pipeline for infectious disease diagnostics, among front-line clinicians with an important new PCR-based diagnostic tool [1]. Influenza remains an important clinical condition, with regard to burden of disease and morbidity/mortality. Annual global attack rates are estimated at up to 10% for adults and 30% for children [2]. This translates to dramatic seasonal rises in outpatient visits, stressing already overcrowded episodic care sites such as emergency departments [3], producing even greater surges and associated challenges in rendering care during pandemics [4, 5]. In those circumstances, safe and appropriate clinical decision-making for patients with respiratory illnesses (e.g. regarding focused use of anti-virals, antibiotics, and inpatient admission) can be life-saving for some patients. Historically, appropriate treatment and patient disposition has been challenged by relying on either a clinical diagnosis (i.e. influenza-like illness), or traditional antigen based rapid influenza tests (RIDT), each of which suffer from poor to moderate sensitivity [6–7]. The adverse impact of these diagnostic shortfalls is evidenced by several recent emergency department-based studies which demonstrate remarkably low (less than 50%) [8] rates of antiviral treatment for those ultimately confirmed as having influenza, even for those with ‘high risk’ clinical characteristics and/ or co-morbidities, where recommendation to treat are definitive [9]. The early revolutionary innovations in molecular diagnostics have focused on the requirement of the centralized laboratory to provide such new assays. PCR was invented in the early 1980s, and by the late 1980s the first automated thermocyclers became available. While the first FDA-approved PCR-based test was approved in 1991 for Chlamydia trachomatis [10], it was not until the mid-2000s that the first fully automated PCR-instruments were introduced incorporating all steps from sample preparation to amplification and result generation [11, 12]. These developments reflected the move from individual instruments to total laboratory automation, which has now been achieved in centralized laboratories for clinical chemistry and immunoassays [13]. However, these dramatic advancements fall short of guiding front-line clinicians to make rapid decisions about infectious diseases for their patients. More intense recent focus on aligning technical advances with clinical needs has given way to significant new advancement, now opening the door for true practice change. Notable developments in the influenza diagnostic arena, which the report by Chen et al. builds upon, include optimization of assay performance, high sensitivity, speed of 20 minutes, and a small platform footprint. These advances, as well as innovations achieved by other rapid molecular platforms (such as the Cepheid GeneXpert) which permit random access loading and integration of rapid results with the electronic medical record, facilitate real-time resulting to clinicians [14]. The isothermal amplification-based assay (Alere i Influenza A and B) received CLIA waiver status by the FDA this past year, permitting true point of care use with improved turn-around-times (TAT) (15 min) [15]. In this report by Chen et al., another PCR-based molecular assay is introduced that delivers an influenza assay for clinicians combining short TAT (15 min), minimal sample handling (

The 2010 earthquake in Haiti was unprecedented in its impact. The dual loss of the Haitian government and United Nations (UN) leadership led to an atypical disaster response driven by the US government and military. Although the response was massive, the leadership and logistical support were initially insufficient, and the UN cluster system struggled with the overwhelming influx of nontraditional agencies and individuals, which complicated the health care response. Moreover, the provision of care was beyond the country's health care standards. The management of the US government resembled a whole-of-government domestic response, combined with a massive military presence that went beyond logistical support. Among the most important lessons learned were the management of the response and how it could be strengthened by adapting a structure such as the domestic National Response Framework. Also, mechanisms were needed to increase the limited personnel to surge in a major response. One obvious pool has been the military, but the military needs to increase integration with the humanitarian community and improve its own humanitarian response expertise. In addition, information management needs standardized tools and analysis to improve its use of independent agencies.(Disaster Med Public Health Preparedness. 2012;6:200–208)

Objectives: The southern California wildfires in autumn 2007 resulted in widespread disruption and one of the largest evacuations in the state’s history. This study aims to identify unmet medical needs and health care–seeking patterns as well as prevalence of acute and chronic disease among displaced people following the southern California wildfires. These data can be used to increase the accuracy, and therefore capacity, of the medical response.Methods: A team of emergency physicians, nurses, and epidemiologists conducted surveys of heads of households at shelters and local assistance centers in San Diego and Riverside counties for 3 days beginning 10 days postdisaster. All households present in shelters on the day of the survey were interviewed, and at the local assistance centers, a 2-stage sampling method was used that included selecting a sample size proportionate to the number of registered visits to that site compared with all sites followed by a convenience sampling of people who were not actively being aided by local assistance center personnel. The survey covered demographics; needs following the wildfires (shelter, food, water, and health care); acute health symptoms; chronic health conditions; access to health care; and access to prescription medications.Results: Among the 175 households eligible, 161 (92.0%) households participated. Within the 47 households that reported a health care need since evacuation, 13 (27.7%) did not receive care that met their perceived need. Need for prescription medication was reported by 47 (29.2%) households, and 20 (42.6%) of those households did not feel that their need for prescription medication had been met. Mental health needs were reported by 14 (8.7%) households with 7 of these (50.0%) reporting unmet needs. At least 1 family member per household left prescription medication behind during evacuation in 46 households (28.6%), and 1 family member in 48 households (29.8%) saw a health care provider since their evacuation. Most people sought care at a clinic (24, 50.0%) or private doctor (11, 22.9%) as opposed to an emergency department (6, 12.5%).Conclusions: A significant portion of the households reported unmet health care needs during the evacuations of the southern California wildfires. The provision of prescription medication and mental health services were the most common unmet need. In addition, postdisaster disease surveillance should include outpatient and community clinics, given that these were the most common treatment centers for the displaced population. (Disaster Med Public Health Preparedness. 2009;3(Suppl 1):S24–S28)

The 2007 southern California wildfires resulted in over 500,000 residents being displaced. A team from Johns Hopkins University and the American Red Cross surveyed 163 families at shelters and local assistance centers during the disaster. The responses were used to evaluate the needs and movement patterns of a displaced population.The data were also used to determine the risk factors associated with needing sheltering. There is a lower than expected reliance on public shelters, and displaced persons move frequently.

Objectives: Following Hurricane Katrina, nearly 1,400 evacuation shelters were opened in 27 states across the nation to accommodate the more than 450,000 evacuees from the gulf region.The levee breaks in New Orleans and storm surge in Mississippi brought about significant morbidity and mortality, ultimately killing more than 1,300 people. The purpose of this study was to summarize the health needs of approximately 30,000 displaced persons who resided in shelters in eight states, including prescription medication needs, dispersement of durable medical equipment, and referrals for further care.Methods: The first available 31,272 medical encounters forms were utilized as a convenience sample of displaced persons in Louisiana, Mississippi, Texas, Alabama, Georgia, Tennessee, Missouri, and Florida. This medical encounter form was completed by volunteer nurses, was standardized across all shelters, and included demographic information, need for acute or preventive care, pre-existing medical conditions, disposition referrals, need for prescription medication, and frequency of volunteer providers who providing care outside of their first-aid scope.Results: Sheltered persons who received only acute care numbered 11,306 (36.2 percent), and those who received only preventive/chronic care numbered 10,403 (33.3 percent). A similar number, 9,563 (30.6 percent) persons, received both acute and preventive/chronic care. There were 3,356 (10.7 percent) sheltered persons who received some form of durable medical equipment. Glasses were given to 2,124 people (6.8 percent of the total visits receiving them) and were the most commonly dispense item.This is followed by dental devices (495, 1.6 percent) and glucose meters (339, 1.1 percent). Prescriptions were given to 8,154 (29.0 percent) sheltered persons. Referrals were made to 13,815 (44.2 percent) of sheltered persons who presented for medical care. The pharmacy was the most common location for referrals for 5,785 (18.5 percent) of all sheltered persons seeking medical care. Referrals were also made to outpatient clinics 3,856 (12.3 percent), opticians 2,480 (7.9 percent), and public health resources 1,136 (4.3 percent). Only 1,173 (3.8 percent) sheltered persons who presented for medical care and were referred to the emergency department or hospital for further care.Conclusions: Hurricane Katrina illustrated the need to strengthen the healthcare planning and response in regard to sheltered persons with a particular focus on primary and preventive care services. This study has reemphasized the need for primary medical care and pharmaceuticals in sheltered persons and shown new data regarding the dispersement of durable medical equipment and the frequent need for healthcare beyond the shelter setting as evidenced by referrals.

Background Hospital surge capacity (HSC) is dependent on the ability to increase or conserve resources. The hospital surge model put forth by the Agency for Healthcare Research and Quality (AHRQ) estimates the resources needed by hospitals to treat casualties resulting from 13 national planning scenarios. However, emergency planners need to know which hospital resource are most critical in order to develop a more accurate plan for HSC in the event of a disaster. Objective To identify critical hospital resources required in four specific catastrophic scenarios; namely, pandemic influenza, radiation, explosive, and nerve gas. Methods We convened an expert consensus panel comprised of 23 participants representing health providers (i.e., nurses and physicians), administrators, emergency planners, and specialists. Four disaster scenarios were examined by the panel. Participants were divided into 4 groups of five or six members, each of which were assigned two of four scenarios. They were asked to consider 132 hospital patient care resources- extracted from the AHRQ's hospital surge model- in order to identify the ones that would be critical in their opinion to patient care. The definition for a critical hospital resource was the following: absence of the resource is likely to have a major impact on patient outcomes, i.e., high likelihood of untoward event, possibly death. For items with any disagreement in ranking, we conducted a facilitated discussion (modified Delphi technique) until consensus was reached, which was defined as more than 50% agreement. Intraclass Correlation Coefficients (ICC) were calculated for each scenario, and across all scenarios as a measure of participant agreement on critical resources. For the critical resources common to all scenarios, Kruskal-Wallis test was performed to measure the distribution of scores across all scenarios. Results Of the 132 hospital resources, 25 were considered critical for all four scenarios by more than 50% of the participants. The number of hospital resources considered to be critical by consensus varied from one scenario to another; 58 for the pandemic influenza scenario, 51 for radiation exposure, 41 for explosives, and 35 for nerve gas scenario. Intravenous crystalloid solution was the only resource ranked by all participants as critical across all scenarios. The agreement in ranking was strong in nerve agent and pandemic influenza (ICC= 0.7 in both), and moderate in explosives (ICC= 0.6) and radiation (ICC= 0.5). Conclusion In four disaster scenarios, namely, radiation, pandemic influenza, explosives, and nerve gas scenarios; supply of as few as 25 common resources may be considered critical to hospital surge capacity. The absence of any these resources may compromise patient care. More studies are needed to identify critical hospital resources in other disaster scenarios.

UNLABELLED: The 2010 Pakistan flood affected 20 million people. The impact of the event and recovery is measured at 6 months. METHODS: Cross-sectional cluster survey of 1769 households conducted six months post-flood in 29 most-affected districts. The outcome measures were physical damage, flood-related death and illness and changes in income, access to electricity, clean water and sanitation facilities. RESULTS: Households were headed by males, large and poor. The flood destroyed 54.8% of homes and caused 86.8% households to move, with 46.9% living in an IDP camp. Lack of electricity increased from 18.8% to 32.9% (p = 0.000), lack of toilet facilities from 29.0% to 40.4% (p=0.000). Access to protected water remained unchanged (96.8%); however, the sources changed (p=0.000). 88.0% reported loss of income (90.0% rural, 75.0% urban, p=0.000) with rural households loosing significantly more and less likely to recovered. Immediate deaths and injuries were uncommon but 77.0% reported flood-related illnesses. Significant differences were noted between urban and rural as well as gender and education of the head of houshold. DISCUSSION: After 6 months, much of the population had not recovered their prior standard of living or access to services. Rural households were more commonly impacted and slower to recover. Targeting relief to high-risk populations including rural, female-headed and those with lower education is needed. Citation: Kirsch TD, Wadhwani C, Sauer L, Doocy S, Catlett C. Impact of the 2010 Pakistan Floods on Rural and Urban Populations at Six Months. PLOS Currents Disasters. 2012 Aug 22. doi: 10.1371/4fdfb212d2432. Language: en

Objective Ascertain recipients9 level of satisfaction with humanitarian response efforts. Design A multi-stage, 80×20 cluster sample randomized survey (1800 households) with probability proportional to size of households affected by the 2010 Indus river floods in Pakistan. The floods affected over 18 million households and led to more than 8 billion USD in response dollars. Results Less than 20% of respondents reported being satisfied with response, though a small increase in satisfaction levels was observed over the three time periods of interest. Within the first month, receipt of hygiene items, food and household items was most strongly predictive of overall satisfaction. At 6 months, positive receipt of medicines was also highly predictive of satisfaction. The proportion of households reporting unmet needs remained elevated throughout the 6-month period following the floods and varied from 50% to 80%. Needs were best met between 1 and 3 months postflood, when response was at its peak. Unmet needs were the greatest at 6 months, when response was being phased down. Conclusions Access-limiting issues were rarely captured during routine monitoring and evaluation efforts and seem to be a significant predictor in dissatisfaction with relief efforts, at least in the case of Pakistan, another argument in favor of independent, population-based surveys of this kind. There is also need to better identify and serve those not residing in camps. Direct surveys of the affected population can be used operationally to assess ongoing needs, more appropriately redirect humanitarian resources, and ultimately, judge the overall quality of a humanitarian response.

During responses to disasters, the credibility of humanitarian agencies can be threatened by perceptions of poor quality of the responses. Many initiatives have been introduced over the last two decades to help address these issues and enhance the overall quality of humanitarian response, often with limited success. There remain important gaps and deficiencies in quality assurance efforts, including potential conflicts of interest. While many definitions for quality exist, a common component is that meeting the needs of the “beneficiary” or “client” is the ultimate determinant of quality. This paper examines the current status of assessment and accountability practices in the humanitarian response community, identifies gaps, and recommends timely, concise, and population-based assessments to elicit the perspective of quality performance and accountability to the affected populations. Direct and independent surveys of the disaster-affected population will help to redirect ongoing aid efforts, and generate more effective and comparable methods for assessing the quality of humanitarian practices and assistance activities.Kirsch TD, Perrin P, Burkle FM Jr, Canny W, Purdin S, Lin W, Sauer L. Requirements for independent community-based quality assessment and accountability practices in humanitarian assistance and disaster relief activities. Prehosp Disaster Med. 2012;27(3):1-6.

The 2007 southern California wildfires resulted in over 500,000 residents being displaced. A team from Johns Hopkins University and the American Red Cross surveyed 163 families at shelters and local assistance centers during the disaster. The responses were used to evaluate the needs and movement patterns of a displaced population. The data were also used to determine the risk factors associated with needing sheltering. There is a lower than expected reliance on public shelters, and displaced persons move frequently.

Following Hurricane Katrina, nearly 1,400 evacuation shelters were opened in 27 states across the nation to accommodate the more than 450,000 evacuees from the gulf region. The levee breaks in New Orleans and storm surge in Mississippi brought about significant morbidity and mortality, ultimately killing more than 1,300 people. The purpose of this study was to summarize the health needs of approximately 30,000 displaced persons who resided in shelters in eight states, including prescription medication needs, dispersement of durable medical equipment, and referrals for further care.The first available 31,272 medical encounters forms were utilized as a convenience sample of displaced persons in Louisiana, Mississippi, Texas, Alabama, Georgia, Tennessee, Missouri, and Florida. This medical encounter form was completed by volunteer nurses, was standardized across all shelters, and included demographic information, need for acute or preventive care, pre-existing medical conditions, disposition referrals, need for prescription medication, and frequency of volunteer providers who providing care outside of their first-aid scope.Sheltered persons who received only acute care numbered 11,306 (36.2 percent), and those who received only preventive/chronic care numbered 10,403 (33.3 percent). A similar number, 9,563 (30.6 percent) persons, received both acute and preventive/chronic care. There were 3,356 (10.7 percent) sheltered persons who received some form of durable medical equipment. Glasses were given to 2,124 people (6.8 percent of the total visits receiving them) and were the most commonly dispense item. This is followed by dental devices (495, 1.6 percent) and glucose meters (339, 1.1 percent). Prescriptions were given to 8,154 (29.0 percent) sheltered persons. Referrals were made to 13,815 (44.2 percent) of sheltered persons who presented for medical care. The pharmacy was the most common location for referrals for 5,785 (18.5 percent) of all sheltered persons seeking medical care. Referrals were also made to outpatient clinics 3,856 (12.3 percent), opticians 2,480 (7.9 percent), and public health resources 1,136 (4.3 percent). Only 1,173 (3.8 percent) sheltered persons who presented for medical care and were referred to the emergency department or hospital for further care.Hurricane Katrina illustrated the need to strengthen the healthcare planning and response in regard to sheltered persons with a particular focus on primary and preventive care services. This study has reemphasized the need for primary medical care and pharmaceuticals in sheltered persons and shown new data regarding the dispersement of durable medical equipment and the frequent need for healthcare beyond the shelter setting as evidenced by referrals.

No standard exists by which to evaluate a hospital’s compliance for the National Incident Management System (NIMS). The instruments available and in use today for the evaluation of hospital preparedness have variable adherence to the principles and elements set forth in NIMS. This is especially evident in the areas of command and management and communications and information management. The use of NIMS as a standard remains itself in question because of its lack of focus on the health care environment and incomplete list of pertinent elements. (Disaster Med Public Health Preparedness. 2009;3(Suppl 1):S83–S89)

The aim of this study was to determine which journals publish medical disaster-related work, their individual focus, and publication volume pre- and post-9/11.PubMed and Google Scholar were searched using key words to identify peer-review journals (print or electronic) publishing medical and public health disaster-related manuscripts. All medical journals with an average volume of at least five disaster-related publications per year over the 11-year study period (1996-2006) were selected. Identified journals were categorized as either general or specialty medical, or disaster health dedicated. All disaster-related articles in each journal were identified and classified according to 11 subtopics.Of 16 journals meeting entry criteria, 10 were disaster dedicated. Of these, only six existed pre-9/ 11. Only six general journals (JAMA, American Journal of Public Health, The Lancet, New England Journal of Medicine, Annals of Emergency Medicine, Academic Emergency Medicine) had sufficient publications for analysis. Of the 2899 disaster articles identified, 1769 (61 percent) were from the dedicated journals. Publications increased by 320 percent in the general/subspecialty journals and 145 percent for disaster-specific journals in the 5-year period post-9/11 (2002-2006) versus the previous 5-year period (1996-2000). Among the dedicated journals, Journal of Prehospital and Disaster Medicine published the most (21 percent), followed by Disaster Prevention and Management: An International Journal (18 percent). Among the general/subspecialty journals, The Lancet published the most (33 percent), followed by JAMA (28 percent) and Annals of Emergency Medicine (18 percent). These journals published the most pre- and post-9/11. Bioterrorism (36 percent) and Preparedness (18 percent) were the most frequent topic areas for the general/subspecialty journals, while General Disasters (38 percent) and Preparedness (27 percent) were of the highest interest for the dedicated journals. The greatest increase in the proportion of publications pre- and post-9/11 was by the New England Journal of Medicine (2340 percent) and Academic Emergency Medicine (1275 percent). Individual journals appear to emphasize particular subtopic areas.Interest in publishing medical disaster-related articles has increased tremendously since 9/11 in both general/subspecialty journals as well as disaster-dedicated medical journals. Some journals focus on certain topics. Details of this study should help authors identify appropriate journals for their manuscript submissions.