The Risk of Not Being Ready: A Novel Approach to Managing Constant Readiness of a High-Level Isolation Unit During Times of Inactivity

Abstract

The biocontainment unit at Johns Hopkins Hospital is a specially designed, inactive high-level isolation unit designated to care for patients infected with high-consequence pathogens. The unit team designed a facility-specific readiness scale and checklist that focus on infrastructure, consumable supplies, and staffing to assess activation readiness of the biocontainment unit. Over a period of 50 days and 14 days, these tools were used as part of a routine risk assessment to first identify barriers and then tier the impact of these barriers into activation categories of “Ready,” “Ready with Considerations,” and “Not Ready.” The assessment identified the greatest risks to activation readiness were staffing and waste management capabilities. Assessing threats to activation readiness and the risk of not being ready should be a priority for maintaining facility, regional, and national capacity to safely isolate and care for patients infected with high-consequence pathogens while maintaining healthcare worker safety.

Introduction

In response to the 2014-2016 West African Ebola outbreak, the US Department of Health and Human Services Assistant Secretary for Preparedness and Response created a national network of 10 regional Ebola and special pathogen treatment centers. These high-level isolation units (HLIUs) were designed to provide care for patients infected with high-consequence pathogens including viral hemorrhagic fevers (eg, Ebola, Lassa, Marburg) and highly pathogenic respiratory infections (eg, severe acute respiratory syndrome, Middle East respiratory syndrome, novel influenzas)^1,2 while simultaneously providing an optimized setting to decrease the risk of healthcare worker infection. The ongoing Ebola outbreak in the Democratic Republic of Congo highlights the importance of having HLIUs in the United States that can potentially provide care for repatriated healthcare workers or returning travelers who might be infected.^3,4

The design, staffing, and operations of HLIUs require unique considerations. These units need to maintain a rostered staff of specially trained nurses, physicians, and other healthcare providers who can step away from their usual clinical duties to participate in unit activation. The units also require environmental considerations such as specialized air-handling systems to contain potentially airborne pathogens within the patient care space and waste handling procedures for the sterilization—using steam sterilizers or autoclaves—or disposal of infectious waste. HLIUs must also maintain onsite laboratory capabilities to minimize transport of infectious specimens outside of the unit and should maintain sufficient quantities of essential supplies such as personal protective equipment onsite in order to be ready for the initial phases of activation and patient care.^1,5-8 During times of inactivation, HLIUs can be used for staff training as well as research on improving clinical care and healthcare worker safety in HLIU environments.^9-16

The biocontainment unit (BCU) at Johns Hopkins Hospital is the regional Ebola and special pathogen treatment center HLIU for Health and Human Services Region 3, serving Delaware, Maryland, Pennsylvania, Virginia, West Virginia, and Washington, DC. The BCU participates in annual readiness drills with local, state, regional, and federal partners as well as routine training for all team members. While the goal of the unit is to maintain the ability to activate quickly at any time, the annual drills do not provide an accurate picture of the unit's ability to activate immediately on a 24-hour basis throughout the entire year. To that end, we created 2 tools to assess the ability of the BCU to rapidly activate for 1 patient with Ebola virus disease within 8 hours of notification of an anticipated admission. These tools, the BCU readiness scale and readiness checklist, can be used daily to rapidly assess the ability to activate the BCU and to identify and mitigate potential barriers to unit activation. To our knowledge, this is the first activation readiness checklist that has been developed for an HLIU.

Methods

Readiness Scale and Checklist Development

The readiness scale was developed by reviewing facility-specific unit activation and care protocols to determine factors essential to successful patient care and staff safety. Key stakeholders from emergency management, facilities engineering, environmental health services, and hospital epidemiology and infection control, along with the BCU leadership team, reviewed the readiness scale to provide feedback on included metrics. The scale provides a tiered approach to determining readiness based on a review of essential unit functions, clinical protocols, physical facilities, staffing capacity, and consumable supplies needed for the care of 1 adult patient in the BCU. The readiness scale has 3 defined “stoplight” color-coded tiers: “Ready” (green), “Ready with Considerations” (amber), and “Not Ready” (red). Figure 1 shows the tiers and the associated metrics required to achieve each tier. This color-cued approach has been successfully used in other settings, such as project management, where a rapid and universally understood message is needed.¹⁷

Figure 1.

Activation Readiness Scale for the Biocontainment Unit at the Johns Hopkins Hospital. The activation readiness scale for the biocontainment unit at the Johns Hopkins Hospital is divided into 3 color-coded tiers. For sample size and data analysis purposes, only data on nursing staff availability are presented throughout this article. Other staff, such as hospital epidemiology and infection control trained observers, registered respiratory therapists, providers, and laboratory technicians, are also essential to unit activation even though their data are not shown here. Abbreviations: HEIC, hospital epidemiology and infection control; PPE, personal protective equipment; RN, registered nurse; RRT, registered respiratory therapists; TO, trained observers.

“Ready” on the BCU readiness scale is defined as fully functional basic facilities that have running water, overhead lights, normal negative air pressure readings, fully functional autoclaves, onsite 24-hour and 7-day personal protective equipment par levels, and full and validated staffing for 1 patient with Ebola virus disease.

“Ready with Considerations” on the BCU readiness scale is defined as suboptimal but likely enough facilities and staffing for a patient admission within 8 hours. Repairs for facilities, including autoclaves, lights, and running water, will be evaluated by key stakeholders and incident command officers to elevate the readiness designation to “Ready.” The incident command team will also initiate communication protocols to recruit enough staffing to achieve a designation of “Ready.”

“Not Ready” on the BCU readiness scale is defined as lack of capacity for basic facilities, staffing, and/or supplies. When a “Not Ready” designation is made, a safe patient admission to the BCU within an 8-hour window is deemed not feasible.

The BCU readiness scale was adapted into a checklist that takes 15 to 20 minutes to complete. The checklist is divided into 4 functional domains (Table 1) and evaluates the different capacities and functions within the unit. The checklist is designed so that any member of the BCU team can complete it. The goal of the BCU readiness checklist is to identify gaps and barriers to unit activation and to inform policies and procedures to improve activation readiness.

Table 1.

Functional Domains of the Biocontainment Unit at the Johns Hopkins Hospital

Functional Domain	Elements to Be Checked
Waste handling	• Operational readiness of autoclaves
Facilities	• Lights in entryways, common areas, autoclave rooms, laboratory, and donning and doffing areas for the laboratory and patient room #1
	• Running water in sinks and showers in the biocontainment unit entryway, dirty utility room, medication room, hallway eye wash stations, donning and doffing rooms, autoclave room, and patient room
	• Air handling system ability to maintain appropriate negative pressure
	• Biosafety cabinet functionality
	• Unit entry security using badge swipe stations
Personal protective equipment	• Adequate levels of personal protective equipment onsite 24 hours a day and 7 days a week
Staffing	• Adequate nurse staffing to activate and admit 1 patient

Development Stage I: Initial Testing

The BCU readiness checklist was piloted from November 2 to 9, 2018, to assess ease of use and ability to quickly identify deficiencies. The checklist was then modified to make it easier to complete, although the data elements remained the same. A comments sections was added to make it easier to capture more specific data about potential failure points. The data were then collected daily for an additional 43 days—from November 16 to December 26, 2018—by a group of 4 BCU team members, with 1 team member walking through the unit and manually filling out the checklist for the first 7 domains. Staffing availability and rostered staff validation compliance were assessed retrospectively after all daily data collection was complete.

Nurses were the only healthcare workers assessed for activation readiness because the greatest number of nurses are needed to staff the unit. The BCU utilizes a self-selector model in which nurses from various departments and units across the hospital volunteer to join the BCU team and commit to the frequent training and personal preparedness required to maintain BCU activation readiness, including schedule changes. Staffing availability for BCU activation of 1 adult patient was initially assessed by checking for on-call “shadow shifts” through the central scheduling system. When a BCU nurse schedules a shift in their home unit, they are asked to also schedule a corresponding “shadow shift” on the dates and shifts in which they would be able to activate and staff a patient on the BCU. Shadow shifts mirror prescheduled shifts on home units, typically in 6-week intervals, and upon activation, the shadow shifts are moved from staffing home units to the BCU. As these shadow shifts are dependent on user input, the data collected through this method were incomplete. As a result, nursing staff availability was then defined by whether a nurse was onsite working a shift in their home unit on the day the checklist was completed.

Autoclave functionality was assessed based on a combination of factors: the successful and immediate start of a cycle, the successful completion of a cycle, complete door closure, quarterly validation of all cycles with biological indicators, and internal temperature.⁵

Development Stage II: Reassessment

After the initial 50 days of data collection was completed, 2 additional exhaust vents were added to the autoclaves to decrease the likelihood of autoclave failure. An additional 14 days of daily data collection was performed from June 30 to July 13, 2019, to evaluate if these changes affected BCU activation readiness.

Results

During the initial 50-day assessment period, the BCU was considered “Ready” or “Ready with Considerations” 40% of the time (20 days) and was “Not Ready” 60% of the time (30 days) (Table 2). The components assessed in the BCU readiness checklist were grouped into 4 domains—autoclaves; staffing; supplies, including personal protective equipment; and facilities—to allow for root cause analysis.

Table 2.

Frequency of Readiness Status by Component (initial assessment, 50 days)

Domain	Component	Ready (%)	Ready with Considerations (%)	Not Ready (%)
Overall readiness	All components	0	40	60
Waste handling	Autoclaves	24	70	6
Personal protective equipment	Supplies and personal protective equipment	100	0	0
Staffing	Day shift staffing	60	32	8
	Night shift staffing	10	38	52
	Rostered staff validated	100	0	0
Facilities	Air handling	96	4	0
	Lights	98	2	0
	Water	98	2	0
	Badge access	100	0	0
	emocha Health app	100	0	0
	Lab	100	0	0

Two domains were identified as potential barriers to activation during the initial 50 days of readiness assessments: staffing and autoclaves. Staffing capacity was the largest barrier to activation, and stratification of staffing availability by shift revealed that night shift staffing was the largest contributor to “Not Ready” status. Overall, day shift readiness was classified as “Not Ready” 8% of the time (4 days), while night shift readiness was “Not Ready” 52% of the time (26 days).

Interestingly, staffing availability for both shifts varied by day of the week, with Friday to Sunday less likely to be staffed sufficiently (Table 3). On Fridays, Saturdays, and Sundays, day shift availability was “Ready” or “Ready with Considerations” 82% of the time compared to 100% on Monday through Thursday. Readiness ranged from a minimum of 71% on Sundays to a maximum of 100% Monday through Thursday. Due to a smaller roster of night nurses, night shift availability was typically lower than the day shift, with availability on Fridays, Saturdays, and Sundays averaging 41% “Ready” or “Ready with Considerations” compared to 54% Monday through Thursday. Additionally, the range of average readiness varied from a minimum of 25% on Fridays to a maximum of 86% on Wednesdays.

Table 3.

Frequency of Biocontainment Unit Readiness^a by Day of Week (initial assessment, 50 Days)

Domain	Component	Mon (%)^b	Tues (%)	Wed (%)	Thurs (%)	Fri (%)	Sat (%)	Sun (%)
Overall readiness	All components	29	29	86	57	13	29	43
Waste handling	Autoclaves	100	100	100	86	88	100	86
Personal protective equipment	Supplies and personal protective equipment	100	100	100	100	100	100	100
Staffing	Day shift staffing	100	100	100	100	88	86	71
	Night shift staffing	29	29	86	71	25	43	57
	Rostered staff validated	100	100	100	100	100	100	100
Facilities	Air handling	100	100	100	100	100	100	100
	Lights	100	100	100	100	100	100	100
	Water	100	100	100	100	100	100	100
	Badge access	100	100	100	100	100	100	100
	emocha Health app	100	100	100	100	100	100	100
	Laboratory	100	100	100	100	100	100	100

Readiness in this table is defined as “Ready” or “Ready with Considerations.”

The frequency that each component of the biocontainment unit of the Johns Hopkins Hospital was ^b “Ready” or “Ready with Considerations” during the initial 50 days of assessments, stratified by day of the week, is shown as a percentage. Each day has a sample size of 7 days, except Friday, which has a sample size of 8 days.

The second activation barrier identified was autoclave functionality. Autoclaves were assessed as “Ready with Considerations” 70% of the time (35 days) and “Not Ready” 6% of the time (3 days). The most common reasons for the autoclaves not being ready were cold interior, delayed cycle initiation, complete door opening and closing failures, and validation of only 1 autoclave on all cycles.

Following the initial 50 days of readiness assessments, 2 new exhaust vents were added to the autoclaves to reduce the likelihood of overheating. Following the installation of the vents, another 14 days of readiness assessments were conducted to evaluate the impact of those changes (Table 4). During the 14-day assessment period, staffing was the only potential barrier to activation and was the sole driver of “Not Ready” status; staffing was “Ready with Considerations” 29% of the time (4 days) and “Not Ready” 71% of the time (10 days). Further evaluation showed that all the “Not Ready” days were attributable to night shift staffing capacity. Autoclave functionality, the focus of the second 14 days of assessments, dramatically improved and was “Not Ready” 0% of the time (compared to 6% previously) and “Ready” 92% of the time (compared to 24% previously) (Table 5).

Table 4.

Frequency of Readiness Status by Component (Second Assessment, 14 Days)

Domain	Component	Ready (%)	Ready with Considerations (%)	Not Ready (%)
Overall readiness	All components	0	29	71
Waste handling	Autoclaves	93	7	0
Personal protective equipment	Supplies and personal protective equipment	100	0	0
Staffing	Day shift staffing	64	36	0
	Night shift staffing	0	29	71
	Rostered staff validated	100	0	0
Facilities	Air handling	100	0	0
	Lights	50	50	0
	Water	50	50	0
	Badge access	100	0	0
	emocha Health app	100	0	0
	Laboratory	100	0	0

Table 5.

Top 3 Barriers: Frequency of Readiness Status During Initial and Second Assessments

Component	Assessment	Ready (%)	Ready with Considerations (%)	Not Ready (%)
Autoclaves	Initial assessment (50 days)	24	70	6
Autoclaves	Second assessment (14 days)	93	7	0
Day shift coverage	Initial assessment (50 days)	60	32	8
Day shift coverage	Second assessment (14 days)	64	36	0
Night shift coverage	Initial assessment (50 days)	10	38	52
Night shift coverage	Second assessment (14 days)	0	29	71

Discussion

The BCU readiness scale and checklist are the first tools developed to identify potential barriers to successful activation for HLIUs. At the BCU at the Johns Hopkins Hospital, these tools identified 2 major potential barriers to activation: autoclave functionality and staffing availability. The checklist highlighted the frequent need for autoclave repairs related to overheating, which led to collaborations between BCU leadership, the autoclave service company, and facilities engineering to improve autoclave operations. The installation of additional exhaust vents reduced the likelihood of overheating and eliminated autoclave functionality issues during the follow-up assessment period. This demonstrates that the BCU readiness scale and checklist can identify activation-related issues and inform unit modifications that improve capabilities.

In order to effectively combat infectious disease outbreaks, HLIUs like the BCU at the Johns Hopkins Hospital must be ready to manage highly infectious patients with little to no notice. In today's healthcare climate, significant financial and operational challenges can impede securing dedicated high-containment clinical space needed to accomplish this. For example, a 2017 survey found several HLIUs closed their units because they needed the unit for other resources.¹⁸ The same study also found that a key perceived benefit of having an HLIU was the ability to maintain a constant state of readiness. The challenge is balancing the perceived benefit with resource budgeting and allocation. The BCU readiness scale and checklist can provide a consistent and systematic readiness verification for not only dedicated space and care teams but also HLIU management broadly.

Our current methodology underestimates the availability of nursing staff to activate the unit, since it only considers nurses who are physically onsite for a clinical shift in their home unit. This does not account for nurses who may be offsite but available to report to the BCU within the 8-hour activation window. Additionally, the timeframe of staffing assessments included holidays—Thanksgiving and Christmas during the first and July 4th during the second—which may have also affected readiness designation as staffing numbers and availability are typically lower during major holidays.

During times of unit activation, all rostered staff receive an electronic communication asking them to indicate if they are available to staff the unit. This system has been tested in 3 prior exercises and 3 live activations, and adequate staffing was secured beyond the nurses already scheduled to be in the hospital that day for regular clinical shifts. Therefore, it is likely that the unit could have successfully been activated on most days where the checklist indicated a “Not Ready” due to staffing issues. However, the realization that staffing capacity, particularly at night, is a potential barrier to unit activation led to an ongoing long-term effort aimed at recruiting night shift nursing staff. It also provided an opportunity to work with nursing leadership and the office of emergency management to ensure that adequate protocols are in place to provide backfill for the home units of BCU nurses when the unit is activated.

The BCU readiness scale and checklist were developed using the specific capabilities and protocols of the BCU at the Johns Hopkins Hospital. While the 4 domains in the checklist are applicable to all HLIUs, specific items on the checklist would likely need to be modified for use in other locations, particularly the criteria evaluating staffing and waste management capabilities. The tools were developed to determine if the BCU at the Johns Hopkins Hospital was capable to activate for a single adult patient. The ability to care for additional patients with Ebola virus disease or to provide care for up to 10 patients with severe respiratory illnesses, is not addressed by the current tools. As a regional treatment center, the BCU at the Johns Hopkins Hospital must be able to care for any patient across the lifespan, including neonatal, pediatric, and obstetric patients infected with a high-consequence pathogen. Specialty staffing availability was not assessed during the data collection timeframe (eg, pediatricians, obstetricians, respiratory therapists), nor was the expected substantial increase in staffing and consumables related to multiple patient activations. The ability to meet those demands is not currently assessed by these tools.

It is important to note that onsite waste sterilization is only necessary for waste contaminated with Category A pathogens such as viral hemorrhagic fevers.¹⁹ Based on the pathogen of concern, autoclave functionality may not be needed for an activation. If autoclave operations are not needed, this also reduces the number of staff needed for activation.

The BCU readiness scale and checklist are novel tools that can assess the ability of a clinical unit to immediately provide care for a patient infected with a high-consequence pathogen at any given time and gauge the readiness of a unit for activation, identifying potential barriers to activation and informing improvements in unit functionality and overall preparedness.

References

Garibaldi

, Kelen

, Brower

, et al. The creation of a biocontainment unit at a tertiary care hospital. The Johns Hopkins Medicine experience. AnnAm Thorac Soc. 2016; 13(5):600-608.

U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. HHS selects nine regional Ebola and other special pathogen treatment centers. HHS website. Last revised June 12, 2015. Accessed May 8, 2020. http://www.hhs.gov/about/news/2015/06/12/hhs-selects-nine-regional-ebola-and-other-special-pathogen-treatment-centers.html

Tuite

, Watts

, Khan

, Bogoch

. Ebola virus outbreak in North Kivu and Ituri provinces, Democratic Republic of Congo, and the potential for further transmission through commercial air travel. J Travel Med. 2019; 26(7):taz063.

Uyeki

, Mehta

, Davey

Jr , et al. Clinical management of Ebola Virus Disease in the United States and Europe. N Engl J Med. 2016; 374(7):636-646.

Garibaldi

, Reimers

, Ernst

, et al. Validation of autoclave protocols for the successful decontamination of Category A medical waste generated from the care of patients with serious communicable diseases. J Clin Microbiol. 2016; 55(2):545-551.

Lenaghan

, Schwedhelm

. Nebraska biocontainment unit design and operations. J Nurs Adm. 2015; 45(6):298-301.

Smith

, Anderson

, Christopher

, et al. Designing a biocontainment unit to care for patients with serious communicable diseases: a consensus statement. Biosecur Bioterror. 2006; 4(4):351-365.

Bannister

, Puro

, Fusco

, Heptonstall

, Ippolito G; EUNID Working

Group

. Framework for the design and operation of high-level isolation units: consensus of the European Network of Infectious Diseases. Lancet Infect Dis. 2009; 9(1):45-56.

Drewry

DG 3rd

, Sauer

, Shaw-Saliba

, et al. Identifying potential provider and environmental contamination on a clinical biocontainment unit using aerosolized pathogen simulants. Health Secur. 2018; 16(2):83-91.

10.

Garibaldi

, Ruparelia

, Shaw-Saliba

, et al. A novel personal protective equipment coverall was rated higher than standard Ebola virus personal protective equipment in terms of comfort, mobility and perception of safety when tested by health care workers in Liberia and in a United States biocontainment unit. Am J Infect Control. 2019; 47(3):298-304.

11.

Therkorn

, Drewry D

III

, Pilholski

, et al. Impact of air-handling system exhaust failure on dissemination pattern of simulant pathogen particles in a clinical biocontainment unit. Indoor Air. 2019; 29(1):143-155.

12.

Therkorn

, Drewry

, Andonian

, et al. Development and comparison of complementary methods to study potential skin and inhalational exposure to pathogens during personal protective equipment doffing. Clin Infect Dis. 2019; 69(suppl 3):S231-S240.

13.

Andonian

, Kazi

, Therkorn

, et al. Effect of an intervention package and teamwork training to prevent healthcare personnel self-contamination during personal protective equipment doffing. Clin Infect Dis. 2019; 69(suppl 3):S248-S255.

14.

Andonian

, Galusha

, Maragakis

, Garibaldi

. The impact of high-level isolation units beyond high-consequence pathogen preparedness. Health Secur. 2019; 17(1):69-73.

15.

Kogutt

, Sheffield

, Whyne

, et al. Simulation of a spontaneous vaginal delivery and neonatal resuscitation in a biocontainment unit. Health Secur. 2019; 17(1):18-26.

16.

Boyce

, Garibaldi

. Genomics and high-consequence infectious diseases: a scoping review of emerging science and potential ethical issues. Health Secur. 2019; 17(1):62-68.

17.

Tjan

AK.

Communication. Making priorities clear with green, yellow and red. Harvard Business Review website. Published April 12, 2013. Accessed May 8, 2020. https://hbr.org/2013/04/winning-with-green-yellow-and

18.

Herstein

, Biddinger

, Gibbs

, et al. Sustainability of high-level isolation capabilities among US Ebola treatment centers. Emerg Infect Dis. 2017; 23(6):965-967.

19.

Occupational Safety and Health Administration (OSHA). Safe handling, treatment, transport and disposal of Ebola-contaminated waste. OSHA website. Published March 2016. Accessed May 8, 2020. https://www.osha.gov/Publications/OSHA_FS-3766.pdf