Abstract
Hospital infection disease preparedness gaps were brought to the forefront during the 2013-2016 Ebola virus disease (EVD) outbreak. The ability of US hospitals to rapidly identify, isolate, and manage patients with potentially high-consequence pathogens is a critical component to health security. Since the EVD cases in Dallas, Texas, the continuity of hospital preparedness has been questionable. While certain hospitals were designated as EVD treatment facilities, the readiness of most American hospitals remains unknown. A gap analysis of a hospital system in Phoenix, Arizona, underscores the challenges of maintaining infectious disease preparedness in the existing US healthcare system.
The 2013-2016 Ebola virus disease (EVD) outbreak devastated West Africa and, in the fall of 2014, revealed a lack of infectious disease preparedness across American hospitals. A single patient (Patient A) with EVD effectively turned healthcare preparedness on its head by challenging not only hospital communication, but also hospitals' inadequate infection control capabilities. In an effort to better prepare US hospitals, a tiered approach was created to help ease the burden of preparing for the next patient with a high-consequence pathogen like EVD.
While hospitals designated as EVD treatment centers and assessment hospitals continue to receive funding and engage in preparedness efforts, the readiness of frontline hospitals has often been forgotten. Frontline hospitals are defined as all other accredited healthcare facilities that are not designated by the Centers for Disease Control and Prevention (CDC) as either EVD treatment centers or assessment hospitals, which accounts for a majority of the hospitals in the United States. In late 2014, CDC announced that 35 hospitals around the country were designated as EVD treatment centers, including the Johns Hopkins Medical Center and Nebraska's Biocontainment Unit.1,2 As of June 2017, this number had increased to 56 hospitals. 3 The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response now cites 69 state or jurisdictional Ebola treatment centers, 10 of which are designated as regional Ebola and special pathogens centers, and approximately 170 assessment hospitals. 4
The strategy of establishing 3 tiers for hospital preparedness and response was a means not only of ensuring preparedness across the country, but an effort to reduce the burnout that was occurring in acute care facilities. The new strategy established 3 tiers for EVD response: frontline healthcare facilities, which are able to quickly identify and isolate possible EVD patients and notify proper authorities, while stockpiling enough PPE for 12 to 24 hours of patient care; EVD assessment hospitals, which safely receive and isolate possible EVD patients, providing immediate laboratory evaluation and caring for a patient for up to 5 days; and the EVD treatment centers, which safely receive and isolate confirmed EVD patients, care for them for at least 7 days or for the duration of illness, and have sustained staffing and supply plans to manage a patient for weeks.
The tiered approach emphasized the role of all US acute healthcare facilities in responding to EVD, but ultimately shifted the larger burden of sustained patient care to the designated treatment facilities. These designated hospitals worked to ensure not only adequate staffing and personal protective equipment (PPE), but also continued readiness for the challenges of treating a patient with EVD or other high-consequence pathogen.
Historically, infectious disease preparedness in health care has focused on an influx of infectious patients from a bioterrorist event or pandemic flu. The 2014 EVD cases in Dallas, Texas, changed the dynamics of healthcare infectious disease preparedness and infection control. The notion that a disease often considered a distant and unlikely threat could walk through the door of an emergency department was startling. Until Patient A was admitted in Dallas, Texas, and confirmed to have EVD, most hospitals were not actively preparing for treatment of a patient with EVD. Following the news that he not only had the disease, but had been seen and discharged from the emergency department, American hospitals and infection control programs ramped up response efforts through education.2,5
The guidance surrounding PPE had been inconsistent and continually evolving to account for the invasiveness of medical care in the hospitals treating patients (ie, changes to respiratory protection, number of gloves needed, additional coveralls, etc). 6 As CDC and the Occupational Safety and Health Administration (OSHA) worked to improve recommendations, hospitals and infection prevention programs were working to roll out training programs and resource allocation efforts. The news that 2 of Patient A's nurses had contracted the disease further motivated hospitals to acquire the necessary PPE for education, training, and response.7-10 During this time, hospitals' efforts and resources were significantly strained, as such a level of readiness is extremely taxing and costly. In response to this situation, the United States established the tiered hospital response approach to managing biological events.
Unfortunately, as with many infectious disease threats, once the immediate danger was deemed over, the resources and attention began to wane. For those of us working in frontline facilities, it is comforting to see the hard work being done at treatment facilities to ensure readiness, but the state of preparedness in frontline facilities is likely more bleak.
Among the issues that threaten hospitals nationally and across the world are the post-hurricane drug shortages, a severe 2017-18 flu season, reemergence of EVD in the Democratic Republic of the Congo, growing antimicrobial resistance, and concerns about emerging infectious diseases. Such events may require additional resources and support, but their emergence will not be limited to top-tier healthcare facilities.
Realities of Hospital Preparedness
There are a total of 5,534 registered hospitals in the United States, including pediatric, community, nongovernment, federal, and other facilities. 11 Across these hospitals, there are 894,574 staffed hospital beds that account for more than 33 million admissions. Of the hospitals, 4,840 are community hospitals (ie, nonfederal hospitals), of which 0.7% are designated EVD treatment facilities.
While the designated treatment hospitals continue to prepare for high-consequence pathogens like EVD, the concern is that there is little attention being paid to or incentive for the frontline hospitals to maintain heightened levels of preparedness. The cost for enhanced PPE, continued education, training, and staffing makes such efforts burdensome on the American healthcare system in a time when cost reduction is a primary driver. While these designated treatment hospitals are required to have advanced capabilities (ie, able to fully treat a patient with EVD), the incurred cost that was reported for 45 of these facilities was considerable:
The 45 ETCs [Ebola treatment centers] reporting total costs incurred a cumulative total of $53,909,701 (mean $1,197,993/ETC) to establish the ETCs. The most costly activity was facility construction and modifications. Costs incurred to provide initial training for staff averaged $267,075 (range $10,000–$1,624,639). Each ETC spent $172,581 (mean per facility; range $3,000–$560,000) on other expenses not included in the 5 specified categories. Examples of additional costs included computer hardware and software, nonmedical equipment, office supplies, and employee apparel.
12
(p351)
It is also estimated that the cost of treating 2 EVD patients is roughly $1 million.13,14 Dr. Jeffrey Gold noted that, for the Nebraska Medical Center, this is the cost of providing patient care, but it does not include loss of beds. He stated that the cost is roughly $30,000 per day per patient, and it is not known if private insurance will cover the costs related to EVD treatment.
14
While there is little information on the actual costs related to US hospital response to EVD, there is even less for the hospitals that are considered frontline. One report noted:
The average amount spent by hospitals on combined supply and overtime labor costs was $80,461 (n = 133; 95% confidence interval [CI], $56,502–$104,419). Multivariate analysis indicated that small hospitals (mean, $76,167) spent more on staff overtime costs per 100 beds than large hospitals (mean, $15,737; P < .0001). The overall cost for acute-care hospitals in the United States to prepare for possible EVD cases was estimated to be $361,108,968.
15
(p405)
Staff overtime needed for EVD preparedness in smaller hospitals reportedly was more than 3 times that in larger hospitals. Unfortunately, most of the data on the cost of EVD response and preparedness is focused on the designated treatment facilities and not the frontline hospitals. Decreasing the financial and overall burden of readiness for frontline hospitals may have been the goal for the tiered hospital approach, but the lack of resources and attention to these hospitals does a disservice to understanding their challenges and current state.
There are several challenges for frontline hospitals to continue efforts for high-consequence pathogen preparedness. Unlike treatment facilities, there is little funding to support such efforts. There is available training through the Center for Domestic Preparedness, but it is only for 3 days, while that of the National Ebola Training and Education Center (NETEC), funded by CDC and ASPR, requires hospitals to cover the costs of travel and lodging. NETEC also provides resources, like exercise templates, that frontline hospitals can access online. Hospitals can receive emergency preparedness funding through the Department of Health and Human Services' Hospital Preparedness Plan (HPP), but these funds are not specific to infection control preparedness.
In 2017, the Centers for Medicare and Medicaid Services (CMS) implemented a new emergency preparedness rule that required hospitals to perform a certain amount of training and exercise each year, in an effort to encourage hospitals to strengthen emergency preparedness. While this was in many ways a response to the issues that occurred following the Dallas EVD experiences, it does not require exercises or training that are specific to infectious disease preparedness—that is, it is open to the hospital's interpretation for threats and vulnerabilities. These threats and vulnerabilities are frequently assessed in a Hazards Vulnerability Assessment (HVA), which is reported as a CMS requirement, but it is a mixture of local (eg, weather related) threats and large-scale vulnerabilities (eg, pandemic preparedness, cyber threats, etc).
Internally, hospitals have little incentive to allocate additional funds for what is considered a low-probability event, especially in a climate of tightening budgets. The high cost of EVD response stressed many hospitals across the United States, and much of the materials allocated have been discarded, repurposed, or neglected, while training is outdated and forgotten. 2
A recent report from the Office of the Inspector General found that while hospitals reported improved preparedness to infectious disease threats since the Ebola outbreak in 2013-2016, there were competing interests for resources. 16 These administrators also noted the need to focus on more common hazards, like natural disasters, and further noted that a third did not know their facility's role in the tiered approach to Ebola management. 17 Of these administrators, 82% cited competing priorities for funding and other resources, meaning that not sustaining infectious disease preparedness is a deliberate choice being made by hospital administrators. Moreover, the rapid requirements of preparing a hospital to identify, isolate, and medically manage (even temporarily) a patient with EVD directed efforts and resources away from daily infection control responsibilities. 17
While there is room for some of the infection prevention duties (eg, education on isolation precautions, hand hygiene, etc) to overlap and also prepare staff to care for patients with highly infectious diseases, a majority of staff time is spent on healthcare-associated infection surveillance and reporting.18,19 A recent study found that during the outbreak, EVD preparation dominated the time of hospital epidemiologists and infection prevention and control programs. The survey found that 80% of hospital epidemiology time was spent on EVD preparations, with 70% of other infection control duties neglected during this time. 2 In the 158 medical centers surveyed, 62.1% of EVD patient management preparedness was coordinated by the infection prevention and control program, and these efforts required extraordinary resources and heavily diverted from daily infection control responsibilities.
This diversion of resources and infection prevention efforts poses a patient safety issue for the daily challenges of reliable patient care and infection control. Not only did infection control responsibilities suffer during this period, but for many hospitals, administrative support for the overtime and resources needed waned over time. Such levels of preparedness are costly, and as the threat of EVD dissipated and designated treatment hospitals were established, there was even less incentive to continue these costly readiness efforts.
Another study performed by the Association for Professionals in Infection Control and Epidemiology (APIC) found that while infection prevention and control professionals reported that they felt their facilities were more prepared in 2015 than in the previous year, more than half also reported that their facilities have not provided additional resources to support the infection prevention and control programs as a result of the EVD outbreak. 20 For many, the focus of emergency preparedness efforts tends to shift with what hospital administration deems threatening—for example, the current focus is on active shooter scenarios.
Lastly, one of the challenges for frontline hospitals in maintaining infectious disease readiness is the staff turnover that plagues health care. While healthcare job growth is considerable, hospital turnover in 2017 was found to be 18.2%, the highest it has been in a decade. The 2018 National Health Care Retention & RN Staffing Report found that in 2017, the turnover rate for bedside registered nurses rose from 2% to 16.8% and the rate for certified nursing assistants rose to 27.7%. 21 The turnover rates in healthcare translate to a constantly revolving workforce that makes education and training extremely difficult. Maintaining competencies for PPE, infectious disease preparedness, and other infection control efforts requires continuous work when healthcare worker turnover is so high. Unfortunately, given the lack of additional resources for many infection control programs to maintain high-consequence pathogen preparedness, it is unlikely that frontline hospitals will be able to ensure healthcare worker competencies for such an event.
Ultimately, these challenges reveal unprepared and stressed healthcare systems in the face of biological threats. Frontline hospitals represent a gap in healthcare infectious disease preparedness; the tiered approach to EVD response established designated care facilities, but the diminished attention to frontline hospitals places our nation's hospitals at risk.
Sampling Frontline Hospital Readiness
To assess the underlying inadequacy of frontline hospital infectious disease preparedness, a gap analysis was conducted by an infection prevention and control team across a multi-hospital system in Maricopa County, Arizona (see Supplemental Material at https://www.liebertpub.com/doi/suppl/10.1089/hs.2018.0089). Maricopa County is the nation's third largest local public health jurisdiction, and it contains more than 4 million residents. During the EVD outbreak in 2013-2016, the county had several returning healthcare workers and travelers from affected regions.22-25 The hospital system assessed is categorized as a nonprofit private health system, and it is not affiliated with state or federal hospitals.
This survey was done internally by the infection prevention staff to assess the existing readiness of their hospital system in order to effectively build a training and education strategy for infectious disease preparedness. Staff had not received training for high-consequence pathogen response since 2014, meaning that such efforts were in response to EVD and had not been expanded. As such, the gap analysis focused on EVD to represent high-consequence pathogen readiness. And since it has been the only training to occur for such a disease, it bettered the chances of staff recalling information and protocols.
The assessed hospital system accounts for 1,341 in-patient hospital beds and 3 level 1 trauma centers, all of which are categorized as frontline hospitals. To address existing readiness and competencies, staff were surveyed in the emergency departments, laboratory, environmental services, materials and supply management, patient management, infection control, information technology, and security/transportation services. Questions were formulated based on CDC guidance for management of patients under investigation in frontline hospitals, as well as previously established algorithms provided by the Arizona Department of Health Services and those created internally for the movement of patients under investigation. The gap analysis was designed to be the first of many assessments, which would establish a baseline for the healthcare system. While relatively broad, the initial questions were designed to identify highly vulnerable areas in the hospitals that would need more immediate and in-depth attention. These questions were designed to be high-level, with detailed assessments and training to be established after the initial gap analysis findings.
Clinical staff were questioned regarding the response, communication strategy, and management of a patient under investigation for EVD. The survey mimicked the admission process for such a patient, from administration in the emergency department, to triage, intake, isolation, and laboratory testing. Staff in the emergency department were asked a range of questions that tested their knowledge of response algorithms, communication, which patient rooms were to be used, PPE, waste management, and the like. Ultimately, the goal of the gap analysis was to address how staff would respond to a patient who had traveled to an EVD-affected region (in this case, the Democratic Republic of the Congo) and who had a fever. Our findings, while expected, nonetheless highlight the current state of readiness in frontline hospitals that do not receive additional funding for infectious disease preparedness efforts.
The gap analysis survey at each hospital in the system found that the most glaring failures were in the emergency department. While there was a question in the electronic health record patient intake assessment that asked for travel history, answering it positively did not trigger notifications to infection control or other necessary parties. Staff were therefore required to determine the appropriate communication channels, which varied. While travel screening questions were asked in triage, we found that it was not uncommon for the question to be asked based on symptoms, rather than of all patients. Intake staff in the emergency departments (n = 42) were aware of the importance of documenting travel history, but no staff at any of the facilities could speak to how they would respond if a patient had a relevant travel history and symptoms that could indicate EVD or another high-consequence pathogen. Only 60% of the surveyed individuals could describe a proper communication strategy, and only 20% thought to call the infection prevention and control team. Staff were aware of an algorithm for response but could not describe its location or a mechanism for acquiring it. No staff were confident or comfortable in their ability to don or doff the appropriate PPE, and all requested additional training. A majority of staff were able to indicate the designated rooms for patients under investigation, but only 80% of these rooms were negative pressure rooms, and all spaces required the construction of a containment wall to block off the area and allow for enough space for PPE donning, doffing, and patient care in a designated, sectioned area. Only 1 hospital had a non-negative pressure room designated for a patient under investigation, and staff said that this was chosen because of the direct route from triage to the room, thus minimizing exposure during transport.
Each hospital had been supplied with an enhanced PPE cart during the 2013-2016 EVD outbreak (called “the EVD cart”). This cart included necessary PPE and guidance for donning and doffing and patient assessment. Across all hospitals, there was an inability to describe the location of the cart, with 80% of the carts being held in a locked room in the basement of materials management. Ownership of the cart and responsibility for ensuring it was stocked with non-expired goods was a consistent failure, as no single person was responsible for it. Each party thought it was managed by another department, which left the carts inaccessible, out of date, and often with limited supplies.
Outside of the emergency department, the biggest challenges came in staffing, as the hospitals either follow a volunteer model for such patients or could not speak to plans for medical management. If the patient needed to be transported to another treatment area, there were no plans or protocols in place to safely move them. Also, these algorithms and procedures were not assessed annually, nor did the infection preventionists feel confident in their ability to effectively communicate the necessary protocols without further review. There had been no additional resources or training performed since the 2013-2016 outbreak to prepare for high-consequence pathogens. Moreover, there were no exercises planned in the immediate future, despite requests from the infection prevention and control program.
Fortunately, the logistics of acquiring additional PPE within 24 hours were in place, and existing waste management containers and contracts for EVD-associated waste removal were available. Laboratory staff were able to report the process and materials for shipping samples to the CDC or state laboratory, as well as point-of-care testing equipment for use in the patient's room. While there was administrative support to perform the gap analysis, there were no established plans for necessary efforts to correct these shortcomings.
The gap analysis of this multi-hospital healthcare system revealed considerable deficiencies in the preliminary stages of identifying, isolating, and managing a patient under investigation for EVD (or other high-consequence pathogens). The majority of the deficiencies existed in the emergency departments and in healthcare workers' PPE competence and proper management of a patient under investigation. While the gap analysis was in the context of EVD response, the deficiencies likely apply to any high-consequence pathogen or emerging infectious disease that healthcare workers are untrained for or unfamiliar with.
Following the findings of the gap analysis, the infection prevention team began plans to respond to immediate deficiencies through an education plan, PPE procurement, and a large-scale strategy for handling patients with highly infectious diseases. Fundamentally, the rapid response to EVD during 2013-2016 exposed American hospitals' vulnerabilities in managing patients under investigation or infected with high-consequence pathogens. The CDC designation of specific treatment and assessment hospitals helped focus these efforts, but in many ways created a situation in frontline hospitals in which preparedness could be neglected, as other hospitals would bear the burden of managing such patients.
Despite the inherent benefit of infectious disease preparedness, even for low-probability events, such efforts require considerable investment from hospitals. There is no requirement for hospitals to maintain infectious disease readiness beyond having policies. Preparedness for high-consequence pathogens and other infectious diseases tends to be lumped in with other emergency preparedness, further de-incentivizing additional investments. The findings of this gap analysis suggest that there is much work to be done in healthcare, and the focus on frontline infectious disease preparedness needs to be reinvigorated.
Recommendations
The findings of this survey reveal significant deficiencies in frontline hospitals and in staff competence to identify, isolate, and manage a patient with EVD or a high-consequence pathogen. These discoveries likely represent the current state of American frontline hospitals that have received no additional funds or support to maintain infectious disease readiness. Following this analysis, the following recommendations are made to improve frontline hospital infectious disease response:
Establish designated infectious disease readiness components in existing hospital emergency preparedness requirements through CMS regulations and the Hospital Preparedness Plan. Inclusion of specific infectious disease preparedness efforts in existing hospital regulatory requirements would ensure standardization. Create easily accessible and comprehensive preparedness exercises, checklists, and quality metrics for hospitals to use in their efforts to improve and maintain readiness. Access to developed tools and education kits would increase the chance of use, but also leave little room for interpretation. While CDC and NETEC provide guidance on EVD response in hospitals, having access to a range of tabletop exercises, checklists for monitoring existing practices, and other such tools would be beneficial to the hospital departments tasked with preparedness. Resources on communication of the importance of drills to gain administrative support would also be beneficial. Encourage hospital coalitions to work more closely with infection prevention programs and include infectious disease preparedness in their agendas. There are several strong existing hospital coalitions—for example, in New York City and Texas—but these represent unique initiatives that have support that may not be found in other cities.
The creation of the tiered hospital network represents a reaction to an urgent situation in which hospitals were stressed in their efforts to prepare for a patient with EVD. While the designation of EVD treatment hospitals and their biocontainment units is a significant achievement, such facilities are limited in location and patient beds. In the event of a large-scale outbreak of a highly contagious disease, the limited biocontainment beds (roughly 130) will be filled quickly, and frontline hospitals will be required to care for patients while maintaining enhanced isolation precautions.
Ultimately, it falls on the frontline hospitals to rapidly identify, isolate, and manage a patient with a high-consequence pathogen. For those hospitals, the responsibility of preparing for a high-consequence pathogen often falls on the infection prevention and control program. Maintaining readiness through training, education, and materials is significantly time consuming and costly, which does little to incentivize hospital administrators to support additional efforts.
The findings of this gap analysis shed light on the state of acute care hospitals in the United States and the need to encourage and support efforts to prepare for infectious disease threats. Without additional funding or designated efforts to prepare for such events, frontline hospitals are vulnerable to the failures that occurred in Dallas during the care of a patient with EVD in 2014. It behooves us to invest in and realign hospital regulatory requirements, funding, and training opportunities to ensure that frontline hospitals prepare for infectious disease events and patients with high-consequence pathogens.
References
Supplementary Material
Please find the following supplemental material available below.
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