Abstract
The Ebola outbreak of 2014-2016 highlighted the need for the development of a more robust healthcare infrastructure in the United States to provide isolation care for patients infected with a highly hazardous contagious disease. Routine exercises and skills practice are required to effectively and safely prepare care teams to confidently treat this special population of patients. The Nebraska Biocontainment Unit (NBU) at Nebraska Medicine in Omaha has been conducting exercises since 2005 when the unit was opened. Previous activities and exercises conducted by the Nebraska Biocontainment Unit have focused on transporting and caring for up to 3 patients with Ebola virus disease or other special pathogens. Changes in regional and national mandates, as well as the increased potential for receiving multiple patients at once, at a single location, have resulted in a greater demand to exercise protocols for the treatment of multiple patients. This article discusses in detail the planning, execution, and outcomes of a full-scale exercise involving 10 simulated patients with a highly infectious pathogen transmitted by the airborne route.
This article discusses in detail the planning, execution, and outcomes of a full-scale exercise at the Nebraska Biocontainment Unit involving 10 simulated patients with a highly infectious pathogen transmitted by the airborne route.
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The Nebraska Biocontainment Unit (NBU) at Nebraska Medicine in Omaha has been conducting exercises since 2005 when the unit was opened. 3 The NBU has experience in treating patients with Ebola virus disease (EVD) and was designated as 1 of 10 Regional Ebola and other Special Pathogen Treatment Centers (RESPTCs) by the US Department of Health and Human Services. The mission of the regional treatment centers includes the ability to provide care for up to 10 patients with a highly hazardous contagious respiratory illness. 4 Previous activities and exercises conducted by the NBU have focused on the transport and care of up to 3 patients with EVD or other special pathogens. 5 Changes in regional and national mandates as well as the increased potential for receiving multiple patients at a single time, at a single location, have resulted in a greater demand to exercise protocols for the treatment of multiple patients.
The exercise described in this article was conducted in January 2016, simulating the admission of 10 patients with Middle East respiratory syndrome coronavirus (MERS-CoV). This presented an opportunity to practice with a disease transmitted via the droplet/airborne route, supplementing recent NBU experience with a disease spread primarily by contact (EVD).
The NBU is not alone in needing to exercise this scenario. The 10 regional treatment centers all have a responsibility to provide safe and effective care for up to 10 patients with a highly hazardous contagious illness, including respiratory illnesses. Additionally, in the event that any regional treatment center is called on to admit 10 patients with a highly hazardous contagious disease, there will likely be many more patients needing care. Regional relationships with the additional state-designated treatment centers must be established and expanded to form a network of hospitals capable of providing care to patients in the event of a widespread respiratory illness.
Highlighting the importance of exercising the transport and admission of multiple patients simultaneously is paramount. While most facilities in the United States and Europe dealt with a single EVD patient at a time, preparations to care for large numbers of patients with a highly hazardous contagious disease is an important part of pandemic planning. This article describes a recent exercise involving the NBU, Nebraska Medicine, and local public health partners to coordinate the admission and care of 10 simulated patients with a highly infectious respiratory disease to the NBU.
Methods
The NBU maintains a multidisciplinary exercise committee that is composed of clinical personnel, researchers, and educators. Nurses, physicians, and ancillary staff members were all actively involved in planning the exercise. A needs assessment was completed, and the exercise committee identified the need for an exercise to test the capacity of the NBU in the event of an outbreak of a highly hazardous contagious respiratory disease necessitating activation to accommodate a full census.
The committee discussed at length multiple scenarios that might include the need to admit up to 10 patients simultaneously. In light of the ongoing international MERS-CoV outbreak, priority was given to exercising the response for a respiratory illness. 6 The NBU has 5 rooms, which provides the capacity to accommodate 10 patients in the event of an airborne outbreak (ie, an outbreak transmitted via droplet nuclei). To date, the NBU has admitted 3 EVD patients, who were all cared for in single occupancy status. This experience provided the opportunity to review, revise, and develop many specific detailed policies and procedures, but the need to test the protocols related to caring for multiple patients was acknowledged.
The exercise committee initiated planning meetings 3 months in advance and met regularly to determine the key elements needing to be addressed in the exercise. The committee decided to execute both a tabletop and full-scale exercise to maximize both NBU and external partner agency response capabilities. The tabletop exercise would include outside agencies in addition to the internal departments that would have key roles in identifying and caring for patients with a highly hazardous contagious disease. These agencies were identified by using an activation checklist for the NBU as well as a comprehensive review of previous activation procedures.
The purpose of the tabletop exercise was to evaluate communication between the local health department and the NBU as well as between the NBU and internal departments crucial to implementation of the established activation checklist. The full-scale exercise addressed the execution and evaluation of donning and doffing, waste processing, work flow of airborne isolation care, staffing matrix effectiveness, and provision of routine care to patients. All rostered NBU staff members were invited to the exercise, and staffing assignments were made based on expected attendance.
Objectives of the exercise were developed by the exercise committee members and refined by the NBU clinical program coordinator. Objectives were determined based on the need to evaluate current untested protocols, the need to refine existing tested protocols, and the identification of gaps requiring the need for new protocols. Ancillary hospital departments and local public health officials whose services were identified as critical to the success of the mission of caring for 10 patients were contacted in advance and invited to participate in the exercise.
Components of the Exercise
Tabletop Exercise
The tabletop exercise was a 2-hour event held at Nebraska Medicine. An exercise outreach specialist from the Center for Preparedness Education was engaged as a neutral third-party facilitator for the exercise. Exercise play included partners who would be expected to participate during an emergency response. The primary desired outcome of the tabletop exercise was to clarify and refine the activation process in the NBU for a full census of 10 patients. Players included representatives from Douglas County Public Health, Nebraska Public Health Laboratory (NPHL), and Nebraska Medicine departments, including the emergency department, radiology, representatives from the equipment-supply chain, environmental services, biomedical services, infection control, NBU staff nurses, NBU leadership team, and physicians from infectious diseases and critical care medicine.
The objectives of the tabletop exercise addressed specific areas of the activation process affected by the admission of multiple patients. The objectives included the evaluation of processes in the emergency department related to multiple highly infectious disease patients presenting from the community, the communication plan for the activation of the NBU, and the capacity of Nebraska Medicine to support the activation of the NBU with equipment and supplies for 10 patients with a highly hazardous contagious disease.
Finally, the NPHL maintains a satellite laboratory in the NBU in 1 of the patient rooms. An additional evaluated protocol dealt with relocation of this NPHL satellite lab to an offsite location within 4 hours to free space for additional patients.
The tabletop exercise consisted of 4 individual modules (Table 1), each accompanied by a facilitated group discussion of key issues as well as a response and problem-solving session involving the various teams represented during the exercise. Assumptions and artificialities for this exercise were disclosed to the participants before beginning the tabletop exercise. The participants were asked to assume that the scenario was plausible and events occurred as they were presented, that there were no “hidden agendas” or trick questions, that all players received information at the same time, and that cooperation and support from other responders and agencies was available.
Tabletop Exercise Modules
Middle East respiratory syndrome coronavirus
Module 1 began with the hypothetical presentation of a family of 4 to the Nebraska Medicine Emergency Department (ED). On presentation to the triage desk, the family was identified as meeting the case definition for isolation measures secondary to possible MERS-CoV exposure, and all parties were isolated appropriately. Additional history obtained after isolation involved the presence of extended family members staying in the home—an additional 6 individuals. As the tabletop progressed, all 10 individuals were processed through the ED and confirmed to have MERS-CoV. The NBU was activated for admission of all presenting patients using the established activation process. The successful admission of all 10 patients signified the end of the tabletop exercise.
Full-Scale Exercise
The full-scale exercise occurred over 6 hours and took place exclusively within the NBU. The decision to focus this exercise on the logistics of activating the unit, providing staff, and the complexity of providing care for a full-capacity unit was made based on a gap analysis that revealed the need to prioritize internal operations versus external operations. As part of a comprehensive training and exercise program, the NBU had previously exercised inter-hospital and intra-hospital transport of single and multiple patients in separate exercises. The preceding tabletop exercise format was designed to allow discussion and consensus on key issues that could then be tested in the full-scale exercise. Vulnerabilities and areas needing additional exploration were incorporated into the situation manual for this portion of the exercise.
Assumptions and artificialities for this exercise included the fact that the designated time period for the exercise covered a full 12-hour shift, all rooms were set up for double occupancy, and all patients had been successfully transported to the NBU from the ED. Three standardized patients were played by volunteer staff members, and the additional 7 patients were assumed to be present; all coordinating departments were assumed to be cooperative, and ancillary support was assumed to be made available throughout the exercise. The full-scale exercise was developed to test the existing plan to provide care for 10 patients, confirmed to be infected with MERS-CoV, in the NBU (Table 2).
NBU Processes Exercised
NBU staff were recruited in advance to ensure that adequate numbers of staff would be available to participate the day of the exercise. Staff were asked to request time off from their home units but were not provided any additional details about the exercise. On the designated day, NBU staff were notified of the exercise start using an established emergency alert network and asked to report to the unit at a specific time. The response rate of NBU staff, including length of time to respond to the notification and the length of time it would take to report to the NBU, was recorded, and any updates needed to contact information were made as part of the exercise improvement plan.
On arrival staff members received a briefing detailing the scenario and the objectives of the exercise. Assumptions, artificialities, and guidelines for the exercise were discussed, and all participants were advised to use the term “real-world emergency” in the event that any staff duress was noted during the exercise. Key portions of the activation checklist were completed, and then participating staff received patient assignments and status reports, including the approved level of personal protective equipment (PPE) to be used. Staff members donned a version of NBU high-level PPE appropriate for use with an airborne pathogen (Table 3).
Levels of PPE Used in the NBU
Once appropriate PPE was donned, activity was confined to the scripted events outlined in the master scenario events list. Staff members were asked to complete tasks including patient assessments, assisting with obtaining x-rays, medication delivery and administration, responding to call lights, cleaning up spills, and processing waste out of the rooms. Facilitators were present to direct activity and deliver injects, while observers served to record real-time feedback from staff and adherence to, or deviation from, protocols. All observations were recorded on provided forms.
After 90 minutes of scripted activity, a time lapse of 4 hours was announced, and staff members began the process of reporting to their replacements and doffing out of the patient care area. Once all incoming staff had received the report and the original care providers were successfully processed out of the unit, the exercise was terminated. Immediately following the full-scale exercise, NBU leaders, participating staff members, observers, and facilitators engaged in an interactive debriefing.
A debriefing was held immediately after the exercise for all participating personnel. Strengths and vulnerabilities were acknowledged and discussed during this time, and all participants were given the opportunity to provide written and verbal feedback. NBU staff provided feedback on proposed protocols being tested during the exercise. Protocols that were tested for efficacy were either validated or suggestions for improvements were received and revisions made as necessary.
Results and Discussion
The strengths, vulnerabilities, and action items identified as a result of the tabletop exercise were included in the after-action report. This report was made available to participating parties for review, and follow-up was conducted at 3 and 6 months to ensure progress on, or completion of, identified action steps. The strengths identified in the tabletop exercise included a high level of engagement and participation by internal and outside agencies, a robust communications plan that key stakeholders were knowledgeable of, and collaborative discussion regarding resources and asset allocation. Of note, the proposed protocol that involved moving the satellite lab as well as that which detailed the capability of the ED to care for 10 patients needing airborne isolation were agreed to be sound, based on consensus of the group.
Every facility will have its unique challenges, and for our facility, movement of the satellite lab was necessary to make all 10 beds available (Figure 1) and led to adjustments by many exercise participants. The vulnerabilities identified were directly related to activities requiring a full-scale exercise to test them. Areas that were identified included the proposed NBU waste processing plan for agents not classified as category A waste, identifying specific storage areas for mobile equipment, and enhancing the PPE protocols for healthcare workers providing care in the NBU.
Nebraska Biocontainment Unit Floorplan
The design, conduct, and evaluation of the tabletop exercise benefited from collaborative planning that involved personnel from the local public health department and an exercise facilitator from an outside participating agency. While this exercise identified both strengths and vulnerabilities in preparedness for the emergence of a highly contagious disease, additional work is needed to enhance preparation for an incident requiring multiple admissions to a single unit.
Analysis of the observation notes scribed during the exercise and debriefing resulted in the after-action report. Substantive findings were relayed to Nebraska Medicine and NBU leadership teams, and resultant changes were implemented as appropriate. Three areas were identified that warranted additional attention and were felt to likely be applicable to other isolation units across the country: staffing, PPE donning and doffing, and waste processing.
Staffing
Developing staffing ratios for a unit designed to care for patients with highly infectious diseases requires specific considerations beyond those applicable to standard inpatient hospital units. Attention must be paid to the acuity of the patient being admitted, the length of time staff will tolerate wearing the necessary PPE, and the number of staff needed to provide care safely in the unit.
The scenario exercised required staffing for 10 patients who were all presenting in groups in the emergency department. Staff were designated into care teams before the start of the exercise based on experience and area of expertise. Staff modeling was decided on using organizational standards and past experience in the NBU.7,8 Using the staffing model of the NBU and accounting for modifications based on acuity and census, total staff proposed to be scheduled for the admission of 10 patients needing to be admitted simultaneously would consist of 10 staff members: a minimum of 4 nurses and 6 ancillary support team members for a 12-hour shift. Additionally, 2 nurses and 2 ancillary support members would be scheduled for a 4-hour shift mid-day to allow a significant break for the other staff members, for a total of 14 staff members over the course of a standard 12-hour shift. A clinical program coordinator or unit manager would be present and available for consultation at all times.
The proposed staffing matrix that was tested was found to be insufficient to adequately meet the needs for a full census. All simulated patients were assumed to be clinically stable, requiring minimal intervention, thus leading to the implementation of a nurse-to-patient ratio similar to that of a medical/surgical telemetry unit. Despite this assumption, direct staff feedback indicated a gap that decreasing the patient load per nurse could mitigate.
Nurses reported challenges when coordinating care for up to 4 patients in the NBU related to communication, length of time needed to respond to patient requests, and the increased energy expended by wearing the required PPE. Consideration must be given to the safety of the staff, and the nurse-to-patient ratio should reflect the additional burden of performing routine patient care while wearing PPE for extended periods of time. The need to provide staff a break at or before 4 hours emphasized the need to incorporate a more robust nurse staffing matrix. This must be considered when determining the minimum number of employees to keep on staff.
Vulnerability was also noted when staff simulated changing positions at the 4-hour mark, which is the prescribed consecutive length of time for NBU staff to remain in PPE based on subjective observations made by staff during previous activations and exercises. The presence of a single shower-out station caused a significant problem of staff waiting to leave the patient care area, resulting in longer than anticipated time spent in PPE.
The configurations of units and intrinsic elements that cannot easily be altered have the potential to meaningfully affect the workflow of the patient care team. Suggestions brought forward in the debriefing to mitigate this issue included implementing staggered shift starting times to cut back on the number of staff leaving the patient care area at the same time as well as considering the use of an 8-hour shift model.
PPE Donning and Doffing
Developing protocols for the use of PPE for highly hazardous contagious diseases requires extensive research and meticulous training. There are unique challenges when selecting PPE ensembles for patients in a specialized containment unit. Changes made to PPE protocols in the NBU for the admission of 10 patients with an airborne disease were specific to the architectural space in which the NBU is housed. The areas in the NBU designated for donning and doffing for an airborne illness were moved to alternative locations to ensure staff safety during these activities.
Each designated regional treatment center is unique in configuration and in the amount of functional space available for patient care and thus will face individual challenges. However, each unit must be able to provide safe care within its designated area. The identification and delineation of hot, warm, or cold zones in the containment area is essential to minimizing inadvertent cross contamination. The need to have defined areas for doffing that are easily decontaminated, as well as areas in the clean zone with no risk of exposure for donning, are critical components. Due to the layout of the NBU and the absence of an anteroom for each patient care room (only 2 of 5 rooms include an anteroom), the approach to zone delineation was modified from the established approach previously used to safely provide care for patients with EVD. The scenario involving an airborne disease necessitated that the entire unit be considered warm and the patient care rooms be considered hot, thus making the area outside the nurses' station the cold zone (Figure 1). This change in zone designation mandated the use of a respirator for all staff entering the unit and entailed the doffing area being moved to a separate enclosed area, when compared to EVD procedures.
The proposed PPE for this type of disease included the use of an N95 respirator or a powered air-purifying respirator (PAPR). 9 This change in zone delineation required staff to wear at minimum an N95 respirator for potentially 10 to 12 hours. Feedback from staff after the exercise included reports of discomfort and the beginning of skin breakdown on the bridge of the nose. Observers also noted difficulty adhering to infection control techniques, mainly citing the need to readjust the respirator and touching the face as areas of concern.
These observations led to ongoing discussion at the executive leadership level. Changes to policy related to PPE ensembles, duration of shifts, donning and doffing strategies, and proposed space enhancements were presented for consideration. These discussions led to the decision to install an additional set of doors in the NBU. This installation provided another barrier between the nurses' station and the patient care rooms, thus negating the need to wear respirators at the nurses' station in the NBU. Facilities that design units for patients with highly hazardous contagious diseases must be meticulous in their planning and the implementation of engineering and environmental controls to allow for safe delivery of care.
Executing an exercise involving the admission of a full census of 10 patients for an airborne disease provides valuable insight into ubiquitous challenges but also those unique to individual units. The need to exercise scenarios in which units charged with providing care for patients with highly hazardous contagious diseases would be operating at full census is evident. PPE chosen must not only account for protection from the infectious agent, but also for staff comfort and endurance. Consideration must be given to the space in which PPE will be donned, what ensemble will be worn, the length of time staff can remain in the ensemble, and where staff can safely doff their PPE.
Waste Processing
The patients who were cared for in the United States during the Ebola outbreak of 2014-2016 produced substantial amounts of waste that required meticulous handling because of its designation as category A waste infectious substance. 10 The lack of this designation for waste when caring for patients with MERS-CoV, or any agent not meeting criteria for this label, necessitated the development of a separate waste processing plan. The use of all 5 rooms in the NBU for patient admissions eliminated the luxury of dedicating one whole patient room to waste storage. This was necessary when caring for patients infected with Ebola virus disease, as waste needed to be held while awaiting the use of the sterilizer for inactivation of the infectious agent. The generation of large volumes of waste when caring for patients placed in isolation is a universal concern, and the idea of processing waste from 10 patients can be daunting. The development of a plan for processing waste of this nature should include conversations with environmental services and individuals with expertise in infection control.
The process proposed for this exercise in the NBU included the implementation of a coordinated schedule for trash pick-up times using environmental services staff. The waste generated in the patient care areas would be double bagged and placed in the designated area for pick-up at the appropriate time. Waste generated outside of the patient care areas would be single bagged and collected with the rest of the waste. Environmental services staff would collect all waste, and it would be absorbed into the standard hospital waste stream. The autoclaves present on the NBU were not used to process out the waste in this exercise.
When establishing protocols for waste processing, attention should be given to the legal requirements and infection control standards; additionally, consideration should be given to the perception of those being asked to process it outside of the containment unit staff. The ability to craft and practice these protocols with input from external departments provides valuable insight and creates stronger interdepartmental relationships.
Conclusions and Future Direction
The need to continue to expand the level of preparedness related to infectious disease outbreaks is reinforced with every new outbreak. Hospitals planning to provide care for patients with highly hazardous contagious diseases must include exercises for multiple simultaneous admissions in their training and exercise plan. The scope and complexity of each exercise should build progressively to allow for consistent expansion of the criteria being tested. The use of both tabletop and full-scale exercises in preparedness planning provide the opportunity to gather valuable knowledge that can be used to create and refine standard operating procedures. The ability to provide accommodation for multiple patients requiring negative pressure isolation and strict adherence to airborne isolation techniques may present many challenges.
There were multiple areas that warranted additional scrutiny when escalating from the admission of a single patient to 10 patients. Protocols that required alterations included those that address staffing, waste management, transportation, admission processes, and the use of PPE. The exercise demonstrated that protocols related to the provision of care for multiple patients should be drafted in advance of the planned exercise, and staff should have working knowledge of the protocol prior to participating in the exercise and prior to patient care. The ability to practice the protocols allows for direct and timely feedback from staff members in varying roles. Feedback gathered during the hotwash after the exercise is invaluable in efforts to strengthen programs and improve preparedness.
Exercises that test multiple protocols and patient scenarios require long-term planning and collaboration by both internal and external partners. The implementation of an interprofessional exercise committee that meets regularly to plan and facilitate training allows for significant depth and insight in the scheduled exercises. The exercise committee members contribute to the development of the objectives, define the exercise scope and focus, create the master scenario events list, identify key internal and external partners, and assist in facilitating the full-scale exercise. It can be beneficial to engage a neutral third party to assist in the facilitation of a tabletop exercise. The use of an exercise facilitation specialist provides more opportunity for key members of the staff and exercise committee to participate in the exercise. Inclusion of executive-level leaders during the planning and execution of these exercises is a consideration that provides occasions for broader dialogue and refinement of global response planning and garners ongoing support for the mission of providing more robust care for highly infectious patients in the event of an outbreak.
Efforts to enhance preparedness to provide safe and effective care in the face of widespread outbreaks must continue to evolve and advance, including training exercises that account for substantial numbers of affected individuals. Preparedness planning for multiple patients requires that additional attention be paid to many factors, including architectural constraints, work flow patterns, waste processing plans, and staffing. Resource management, medication delivery, equipment allocation, reorganization of existing space, and PPE donning and doffing strategies may all be significantly affected by the volume of patients needing to be admitted.
In the event that a single containment unit is tasked with admitting 10 patients, there will likely be many more potential patients that are in need of treatment. The incorporation of the transportation of multiple patients into exercises requires significantly more resources than those needed for a single patient event. Consideration must be given to the number of emergency medical services staff and the amount of equipment needed, the law enforcement support available, the timing of the ambulance departure and arrivals, the acuity of the patients, and the ability of the medical staff to complete admission requirements in the time allotted before the next patient arrives. Preparedness training and exercises that include the transportation of multiple patients provide depth of insight into protocol development that cannot be attained in any other way. Future training should focus on the inclusion of alternative patient care sites, including inter-state transport scenarios, the incorporation of simulation equipment to train staff on patient care interventions in the containment environment, immersive scenarios with scripted expectations and measured outcomes performed over a more realistic period of time, and an ongoing focus on proper PPE donning and doffing practices.
Barriers to exercise planning and execution include financial constraints, along with significant staffing and time commitments, which may stress the healthcare system. However, it is precisely this type of controlled stressor that can provide the best type of preparation for the communication needs and patient care activities that will tax the system in the event of an actual large outbreak setting. The need for ongoing federal funding is vital to support the US network of Regional Ebola and other Special Pathogen Treatment Centers and state-by-state infrastructure initially developed in 2015. The extent of education and training that is required to safely provide care for those patients with highly hazardous contagious diseases demands that ongoing attention be paid to the need for a more developed infrastructure and training programs for healthcare providers around the world. Incorporating a robust training program comprised of complex full-scale exercises is a critical component to optimizing this preparedness. The current era of global travel illustrates the necessity for increased global health security and advanced domestic preparedness. It is paramount to maintain a state of readiness to respond swiftly and effectively to any threat that becomes reality, including those posed by highly hazardous contagious diseases.
Footnotes
Acknowledgments
We thank the Nebraska Biocontainment Unit's staff members for their hard work, dedication, professionalism, and attention to detail that makes the unit successful. We also thank those who support the Nebraska Biocontainment Unit on a daily basis to make sure it runs effectively. Special acknowledgment is given to the Center for Preparedness Education for their collaboration in facilitating the tabletop exercise for this complex exercise.