Abstract
This article describes a large-scale scenario designed to test the capabilities of a US biocontainment unit to manage a pregnant woman infected with a high-consequence pathogen, and to care for a newborn following labor and spontaneous vaginal delivery. We created and executed a multidisciplinary functional exercise with simulation to test the ability of the Johns Hopkins Hospital biocontainment unit (BCU) to manage a pregnant patient in labor with an unknown respiratory illness and to deliver and stabilize her neonate. The BCU Exercise and Drill Committee established drill objectives and executed the exercise in partnership with the Johns Hopkins Simulation Center in accordance with Homeland Security and Exercise Program guidelines. Exercise objectives were assessed by after-action reporting and objective measurements to detect contamination, using a fluorescent marker to simulate biohazardous fluids that would be encountered in a typical labor scenario. The immediate objectives of the drill were accomplished, with stabilization of the mother and successful delivery and resuscitation of her newborn. There was no evidence of contamination when drill participants were inspected under ultraviolet light at the end of the exercise. Simulation optimizes teamwork, communication, and safety, which are integral to the multidisciplinary care of the maternal-fetal unit infected, or at risk of infection, with a high-consequence pathogen. Lessons learned from this drill regarding patient transportation, safety, and obstetric and neonatal considerations will inform future exercises and protocols and will assist other centers in preparing to care for pregnant patients under containment conditions.
Keywords: Biocontainment unit, Simulation, Spontaneous vaginal delivery, Neonatal resuscitation
This article describes a large-scale scenario designed to test the capabilities of a US biocontainment unit to manage a pregnant woman infected with a high-consequence pathogen, and to care for a newborn following labor and spontaneous vaginal delivery.
Infectious disease outbreaks, such as the Ebola virus disease (EVD) outbreak of 2014-2016, have prompted renewed interest in the development of high-level isolation units—that is, biocontainment units—as well as protocols to provide care for patients with high-consequence pathogens. International travel increases the likelihood that patients infected with pathogens like EVD or avian influenza will present for care in nonendemic areas. In 2014, 68.2 million US citizens crossed international borders, compared with 28.5 million in 2010. The frequency of women traveling during pregnancy is also on the rise.1 Hence, the US healthcare system must be prepared to treat and manage pregnant women infected with a high-consequence pathogen.
In response to the Ebola outbreak, the Office of the Assistant Secretary for Preparedness and Response (ASPR) funded the creation of a network of 10 Regional Ebola and Special Pathogen Treatment Centers.2 ASPR stipulated that each of these centers should be prepared to provide care for a pregnant woman infected with a high-consequence pathogen. This mandate requires the capability to provide safe and prompt obstetric care, including treatment of the disease itself as well as commonly encountered acute pregnancy conditions, such as spontaneous vaginal delivery, cesarean section, and spontaneous abortion,3 in addition to having the capability to resuscitate a newborn post-delivery. Building capacity to care for pregnant patients in this unique situation also necessitates developing a plan for neonatal resuscitation and care if the baby is infected with the high-consequence pathogen or suffers adverse events because of the mother's illness.
Experts in the field of emergency preparedness have called for the identification of a network of obstetricians and pediatricians in advance of public health emergencies to provide the appropriate infrastructure and a timely, efficient response.4 However, training for such high-risk, low-frequency clinical events represents a logistical challenge. Simulation exercises can provide an optimal tool to improve familiarity, teamwork, communication, and testing of system-based resources to maximize the safe response to real-time events.5
This article describes a large-scale functional exercise designed to test the capabilities of a US biocontainment unit to manage a pregnant woman infected with a high-consequence pathogen, and to provide newborn care following labor and spontaneous vaginal delivery.
Methods
The Johns Hopkins Biocontainment Unit
The Johns Hopkins Hospital (JHH) Biocontainment Unit (BCU) is the US Department of Health and Human Services (HHS)–designated Region 3 Ebola and Special Pathogen Treatment Center. The JHH BCU is a 4-bed containment unit built in response to the 2014-2016 Ebola outbreak. The unit is designed to promote unidirectional flow of patients, providers, and materials through the space to minimize the risk of cross-contamination. Each patient room has designated donning (putting on) and doffing (taking off) areas, providing ample space for providers to manage personal protective equipment (PPE). Additionally, the unit has a specially designed air-handling system to provide care for patients infected with pathogens transmitted by droplet or airborne routes.6 Finally, the unit also has a dedicated waste handling area with pass-through autoclaves to sterilize potentially infectious medical waste (see Figure 1).7
Figure 1.
Johns Hopkins Biocontainment Unit
The biocontainment unit is staffed by a multidisciplinary team of nurses and physicians from various hospital departments who have undergone special training in highly infectious diseases, including quarterly validations of PPE donning and doffing practices, and BCU operational procedures.6
Exercise Planning
The biocontainment unit maintains an active multidisciplinary exercise committee that conducts frequent drills and simulations. Stakeholders include the JHH BCU team, Hospital Epidemiology and Infection Control (HEIC), Health Safety and the Environment (HSE), the Johns Hopkins Office of Critical Event Preparedness and Response (CEPAR), Lifeline transport services, Safety and Security, the JH Outpatient Center (JHOC), Emergency Management, and the Johns Hopkins Simulation Center. The committee also includes providers from the Johns Hopkins University School of Medicine departments of medicine, emergency medicine, pathology, gynecology and obstetrics (division of maternal fetal medicine), pediatrics (division of neonatology), and anesthesia and critical care medicine.
The planning phase of the exercise included 4 committee meetings, beginning 6 months in advance of the drill. In total, 72 individuals were involved in the design, execution, and evaluation of this exercise. The committee identified the need to test the BCU's capacity to handle the internal transportation and acceptance of a pregnant patient in labor with an illness from an unknown high-consequence pathogen, in addition to navigating the complexities of the delivery of a neonate in the BCU. The BCU had performed drills with simulated pregnant patients in the past; however, delivery and neonatal care were not previously exercised. The BCU activation protocols were initially designed to accept a patient from an outside facility or from the emergency department. Transfer from the outpatient center presented new challenges, including the time pressure of transfer, as well as the participation of outpatient clinical staff, who had not participated in previous BCU exercises.
This exercise also provided the opportunity to test the implementation of incident command system (ICS) structure for BCU activation and operations. This structure was tailored for the BCU and implemented with the assistance of the JHH Office of Emergency Management and Johns Hopkins CEPAR to improve the effectiveness of BCU operations and to facilitate integration of BCU activities with the existing JHH incident command system. The exercise further allowed for testing of the BCU's “just-in-time” training protocols, since a number of key exercise participants from labor and delivery, neonatology, and the outpatient center had not previously trained with the BCU team.
The committee planned and executed the exercise using the principles outlined in the Homeland Security Exercise and Evaluation Program (HSEEP).8 Figure 2 lists the objectives of the full-scale exercise.
Figure 2.
Objectives of Full-Scale Exercise
Simulation Components
The Johns Hopkins Medicine Simulation Center (JHMSC) was directly involved in the exercise from planning to final execution. In collaboration with the BCU Exercise and Drill Committee, the JHMSC developed a unique patient scenario and trained a standardized patient to play the role of a pregnant woman. Once the patient actor was transported successfully to the BCU, the delivery was simulated with a state-of-the-art mannequin (Victoria Model S2200, Gaumard Scientific, Miami, FL) that simulates labor with expulsion of amniotic fluid, blood, delivery of the infant, and delivery of the placenta in the third stage of labor. Vital signs, contractions, and verbal communication were used to make the simulation as realistic as possible. The infant simulator (Newborn Tory Model S2210, Gaumard Scientific, Miami, FL) also allowed the neonatal team to practice providing newborn care immediately following delivery.
In order to assess for possible healthcare worker and environmental contamination during the exercise, a fluorescent marker (Glogerm, Moab, UT) was added to all simulated fluids and rubbed on the mannequin and hospital bed prior to the beginning of the drill. After healthcare workers doffed their PPE, a drill evaluator examined each staff member with an ultraviolet light to look for evidence of contamination. The evaluation team also used ultraviolet light to examine the outpatient center environment to assess the effectiveness of cleaning and decontamination efforts following transfer of the patient to the hospital.
Administration of the Exercise
The BCU Exercise Committee administered the drill using HSEEP principles for exercise conduct. Briefings were held prior to the drill to ensure all participants understood their roles and responsibilities, the exercise objectives, safety protocols, and real-life emergency procedures. The committee ensured that all questions were answered appropriately.
Key roles were assigned prior to the drill to ensure the exercise met objectives while maintaining a safe environment. Participant roles included evaluators, controllers, safety officers, simulator, observers, players, and an actor simulating the pregnant patient. The drill also included a designated incident command team with the following key roles: incident commander, operations chief, planning chief, logistics chief, and safety officer. Color-coded vests and armbands were distributed with titles to easily identify each participant. Individuals functioning in incident command wore armbands labeled with their specific roles. The exercise director made announcements at both the start and the completion of the exercise. (See Figure 3 for exercise timeline.)
Figure 3.
Exercise Timeline
Drill Scenario
The complete Master Scenario Event List (MSEL) for the drill is available in the appendix (https://www.liebertpub.com/doi/suppl/10.1089/hs.2018.0090). Briefly, the MSEL outlined a drill scenario in which a 36-year-old, gravida 4, para 3 pregnant female (gestational age was 36 weeks, 0 days) presented to the JHOC Women's Health Clinic for a routine prenatal visit. Prior to presentation, she reportedly had had normal, uncomplicated prenatal care. According to the MSEL, 8 days prior to her presentation, her male partner had returned from a business trip to Asia, including travel to Vietnam and China. The drill scenario specified that 4 days prior to our patient's presentation, the World Health Organization (WHO) had released a travel warning for Vietnam due to discovery of a new respiratory pathogen with high morbidity and mortality, with 50 cases actively under investigation. Within 24 hours of returning to the United States, the woman's partner became ill and was admitted to another local hospital. Twelve hours after his admission, he developed respiratory failure and died. As part of the scenario, the Maryland Department of Health was investigating his death at the time of our simulated patient's arrival at JHOC.
On presentation, our simulated patient complained of myalgias, fever, headache, chills, coryza, and sore throat. She was asked to wear a mask and escorted to a private consultation room, according to standard JHOC procedures for a patient with a suspected respiratory viral illness (Figure 4). From an obstetric perspective, she reported a dull ache in her back and lower abdomen, along with pelvic pressure for the past 12 hours. On initial evaluation, the outpatient OB staff documented increasingly painful contractions, occurring every 10 to 12 minutes. The patient denied any vaginal bleeding or leakage of fluid. The JHOC medical staff considered the clinical situation and deemed the simulated patient was in labor and needed to be admitted. The obstetric providers, in consultation with the on-call BCU physician, activated the BCU and prepared to admit the patient (on the basis of the stated constellation of symptoms, recent exposure, and the WHO warnings).
Figure 4.
Patient in outpatient clinic
The Lifeline transport team was instructed to pick up the patient from the outpatient center and transport her directly to the BCU as soon as the unit was ready for activation. In the interim, the simulated patient's labor was noted to be progressing more rapidly, and her amniotic sac ruptured. To minimize the risk of environmental contamination during transport, the medical team transported the patient in an isopod (ISOPod Advantage POD-A4-ADV, Immediate Response Technologies, Landover, MD). Simultaneously, the labor and delivery and neonatology teams arrived in the BCU and began receiving just-in-time training. Fifteen healthcare workers—2 obstetricians, 2 labor and delivery nurses, 2 labor and delivery technicians, 1 neonatologist, 1 neonatal nurse practitioner, 2 neonatal intensive care unit (NICU) respiratory therapists, 2 NICU nurses, and 3 BCU nurses—with varying levels of experience in containment care underwent the same donning and doffing procedures with enhanced PPE (Airmate Powered Air Purifying Respirators [PAPRs] [3M], fluid-impermeable thigh high boot covers, AAMI level 4 surgical gowns with double gloves, and a fluid impermeable isolation outer gown).
Once the BCU activation protocols were completed, the simulated patient was transported via ambulance from the outpatient center to a secure loading dock in the main hospital. A second Lifeline transport team accepted the patient at the loading dock and prepared for transport to the BCU. When the simulated patient arrived at the BCU, the BCU and labor and delivery teams assumed care of the patient (Figure 5). The patient actor was replaced by the simulator mannequin, and the care team was briefed regarding the patient's clinical status. Labs were collected and transported to the onsite BCU lab for analysis. Intra- and peripartum medications were prepared, including pitocin, additional uterotonics, and intravenous fluids. Approximately 30 minutes after the patient's arrival at the BCU, the infant was delivered and handed to the waiting neonatal resuscitation team (Figures 6 and 7). The third stage of labor concluded with simulated delivery of the placenta, which was contained and transported to the BCU pathology team. Upon transfer to the neonatal team, the infant was successfully resuscitated.
Figure 5.
Patient arrives in BCU
Figure 6.
Simulator mannequin in BCU
Figure 7.
Infant simulator delivered in BCU
Drill Hotwash and Postevent Analysis
Immediately following the completion of the drill, a postevent hotwash and debriefing were conducted, with all participants encouraged to attend. A postevent analysis was conducted using HSEEP principles to summarize the findings and recommendations from the exercise and inform the formal after-action report. The after-action report was prepared by the co-chairs of the BCU Exercise and Drill Committee.
Results
Assessment of Contamination
Our drill incorporated a fluorescent marker to simulate biohazardous fluids that would be encountered in a typical labor scenario. Following doffing, each staff participant was analyzed under black light for evidence of contamination. None of the 16 staff who provided care for the pregnant mother and neonate on the BCU had signs of contamination, including 8 providers who underwent “just-in-time” training. There was also no visible contamination in the outpatient center following environmental cleaning. These data suggest that the current protocols were effective in minimizing the risk of healthcare worker and environmental contamination with a pathogen that may undergo blood-borne or contact transmission.
Of note, our BCU PPE ensemble is designed to handle pathogens transmitted by multiple routes, including airborne, droplet, and contact. We have chosen to use this enhanced-level PPE for all BCU activations, in order to standardize protocols and to minimize the need to train with multiple types of PPE. In this drill scenario, the patient was infected with a novel pathogen that was presumed to be respiratory in nature. However, taking into account the uncertainty surrounding a novel pathogen, as well as the large volumes of bodily fluids encountered during a delivery, we felt that enhanced PPE was most appropriate for this scenario. If the protocol had specified a known pathogen transmitted solely through a respiratory pathway, a less rigorous PPE procedure would have been acceptable per CDC guidelines.9
Postevent Analysis and Discussion
Several pertinent findings and recommendations were discussed in the postevent analysis and are summarized below.
BCU Activation
The BCU was designed to activate within 4 to 8 hours of being notified of a patient suspected of or confirmed as having a highly infectious disease; however, the simulated patient in our scenario was in labor and needed immediate care. For the purposes of the drill, the timeline of BCU activation was accelerated to complete the exercise in a reasonable timeframe. The BCU team will need to explore alternative care areas where a patient could safely receive care during BCU activation, if other backup areas, such as the emergency department or medical intensive care unit, are not immediately available.
Patient Transportation
Transportation of a patient from the outpatient to the inpatient setting highlighted several challenges. For instance, the use of the isopod imposes unique care limitations, such as limited access to the patient and the ability to maintain patient comfort. The Lifeline transport team will continue to drill using the isopod to refine their care protocols during transportation.
Patient-Centered Care
Healthcare personnel can lose track of patient concerns during critical care and emergent situations. For example, patients may be scared, nervous, or in need of additional information about clinical processes and protocols.10 We were privileged to have a patient actor to inform and remind the care team that patient-centered care and communication should be at the forefront of care efforts, even when emergency concerns, PPE, and isolation precautions reduce our ability to communicate. The BCU team will continue to work to improve patient-centered care for adult, pediatric, and obstetric patients admitted to the unit.
Equipment
During the transport of the patient actor, the isopod fan malfunctioned, resulting in the patient actor feeling overheated. Due to safety concerns, the isopod was opened during transport to improve air circulation. The drill was paused to allow rehydration of the actor and ensure overall safety prior to resuming the drill. The cause of the isopod failure is under investigation. This failure highlighted the need to develop backup transportation protocols in the event of isopod failure, which might include placing a surgical mask on the patient and transporting the patient with a backup isopod that is immediately available.
Safety and PPE
This drill required the movement of a patient through 3 separate clinical domains: the outpatient clinic, the hospital, and finally the BCU. Personnel may be exposed to potentially infectious material at any point along this route. This drill highlighted the need to examine specific PPE requirements for all personnel who are involved in transport, including security officers and other staff not in direct contact with the patient or isopod.
In addition, longer transport times can lead to personnel being in PPE for longer times. Concern for overheating and dehydration are paramount despite continuous efforts to maintain optimal temperatures for people in PPE.11 During the drill, the safety officer implemented pre- and post-PPE assessment of vital signs for providers and ensured that food and water were available for all exercise participants to avoid dehydration. Our simulated patient was inspected by BCU team members to ensure they could safely complete the exercise. Both food and water were provided to the patient after the isopod malfunction was identified. No healthcare workers experienced signs or symptoms of dehydration or overheating during the exercise. Further work will explore the appropriate lengths of time that providers can safely remain in the PPE used in this exercise.
Obstetric Considerations
One particular concern in the obstetric context is the amount of potential infectious biological fluid that may be encountered during a delivery. Up to 1 L of amniotic fluid and 500 cc of blood is typically lost during a routine spontaneous vaginal delivery,12 which represents a large, potentially infectious burden. This drill employed fluorescent markers in the “amniotic fluid” and postpartum blood products to indicate whether the BCU and labor and delivery providers' PPE were contaminated. No contamination was found, but the possibility of exposure highlights the need to continue routine and more frequent practice to become comfortable with PPE donning and doffing and BCU protocols. The BCU exercise committee plans to establish an annual exercise for obstetrics and neonatal staff. The BCU team is also conducting ongoing research using other infectious simulants, such as aerosolized fluorescent microbeads, to further examine the safety of BCU equipment and protocols.13
Neonatal Considerations
This simulation was the first time in which the neonatology team was involved in a simulated delivery in the BCU. Their participation highlighted several important issues. For example, the team identified the need for a larger work surface for their instruments and equipment. Additionally, following the birth of the neonate, a question arose about the potential need to isolate a possibly uninfected newborn from a mother with a confirmed highly infectious disease. Additional preparation and protocols for intra-unit transport of the neonate to a separate, designated clean space need to be developed for such a contingency.
While the BCU has a “just-in-time” process to stock the unit with obstetrics and neonatal supplies, urgent delivery of additional supplies from the neonatal intensive care unit or the pediatric pharmacy (eg, thoracostomy tubes, surfactant, etc) also must be considered. Additionally, there was no oxygen tank holder available for the neonatal radiant heat warmer, which led to difficulties in resuscitation. Finally, the team needs to establish a staffing and care plan for transfer of a critically ill neonate to an appropriate neonatal intensive care unit.
Training
There were many individuals and departments involved in this drill that are not typically involved in the quarterly BCU PPE validation process. Fortunately, the “just-in-time” training process was successful during this exercise. One possible source for improvement would be to identify those providers and individuals at greater risk for infectious exposure (eg, the delivering obstetric provider will be exposed to large amounts of amniotic fluid and blood) and tailor their PPE training accordingly. This might involve more frequent PPE validation sessions, as well as participation in skill-specific exercises on the unit. The relationship between frequency of PPE training and skills decay is an important one that warrants further research.
Communication
Communication in the containment environment is challenging. The JHH BCU developed a custom telecommunications system to facilitate communication between staff on the unit, as well as communication with individuals outside the unit.6 The system uses wall-mounted cameras and a mobile telecommunications cart equipped with a microphone and speakers. This was the first exercise to test the communications system while providing care for 2 patients in the same room at the same time. It was challenging to direct specific communications to the appropriate care team. This was compounded by the lack of familiarity with the system by new providers, as well as the difficulty of communicating through the noise of PAPR hoods. The BCU team is considering adding headsets under their PPE to improve the performance of the system. Specific policies and protocols surrounding effective communication in the containment environment will need to be developed and tested.
Incident Command Structure
This was the first BCU exercise to incorporate a formal incident command structure for BCU activation and operations. Overall, the newly implemented incident command structure improved communication with the JHH incident command team and led to a more efficient use of BCU resources and personnel. Incident command structure is now part of standard BCU operating procedure and will be included in all subsequent BCU exercises and activations.
Conclusion
This large-scale exercise tested the abilities of a US biocontainment unit to care for a pregnant woman infected with a high-consequence pathogen and deliver her baby successfully. The exercise provided valuable insights regarding patient transportation, patient care, specialized equipment considerations, safety and PPE, obstetric and neonatal considerations, and communication.
Given the risk of high-consequence pathogen transmission, it is imperative that hospitals prepare for the inevitability of a pregnant patient who needs containment care. The complexities of labor and delivery, as well as the high risk of healthcare worker infection from a large volume of contaminated fluid, require specialized training for obstetrics and neonatal professionals. Similarly, BCU healthcare workers who are not frequently exposed to the obstetric population need experience working with this patient group. A large-scale simulation provided an excellent opportunity to improve multidisciplinary teamwork, protocol development, and communication, as well as to bring together a diverse team that will be able to provide excellent maternal and neonatal care in the future.
Training for high-risk yet infrequent clinical events is a challenge. Simulation can provide an optimal tool to improve familiarity, teamwork, communication, and testing of system-based resources in order to maximize a safe response to real-time events.5 This scenario required multidisciplinary collaboration, as well as complex communication and decision making, to achieve the goal of a safe delivery while optimizing health for the mother and child. This exercise highlights the need for regularly scheduled tabletops and functional exercises to optimize the care of special populations in the containment environment. The lessons learned from this exercise can inform obstetric and neonatal protocols at other centers preparing to provide care for pregnant patients infected with high-consequence pathogens.
Acknowledgments
We would like to thank the JHH BCU team for their hard work, dedication, professionalism, and attention to detail. We would also like to thank the faculty and staff in the following departments: Hospital Epidemiology and Infection Control, Health Safety and the Environment, the Johns Hopkins Office of Critical Event Preparedness and Response, Lifeline transport services, Safety and Security, JH Outpatient Center, the Office of Emergency Management, the Johns Hopkins Simulation Center, Pathology, Gynecology and Obstetrics, Maternal Fetal Medicine, Neonatology, and Anesthesia and Critical Care. We would like to extend a special acknowledgment to Dr. Redonda Miller, president of Johns Hopkins Hospital, and the rest of the Johns Hopkins Hospital leaders for their continued support of the biocontainment unit.
This work was supported by the Office of the Assistant Secretary for Preparedness and Response, Hospital Preparedness Program (HPP), Ebola Preparedness and Response Activities (no. U3R2015002863), in collaboration with the Maryland Department of Health Office of Preparedness and Response.
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