Kimberly P. Stone, Lennox Huang, Jennifer R. Reid and Ellen S.
Deutsch
© Springer International Publishing Switzerland 2016
V. J. Grant, A. Cheng (eds.), Comprehensive Healthcare Simulation: Pediatrics, Comprehensive Healthcare Simulation, DOI 10.1007/978-3-319-24187-6_6 K. P. Stone () · J. R. Reid
Department of Pediatrics, Division of Emergency Medicine, Univer- sity of Washington School of Medicine, Seattle Children’s Hospital, Seattle, WA, USA
e-mail: [email protected] J. R. Reid
e-mail: [email protected] E. S. Deutsch
Department of Anesthesiology, Department of Critical Care Medicine, The Children’s Hospital of Philadelphia, Philadelphia, PA, USA e-mail: [email protected]
E. S. Deutsch
Pennsylvania Patient Safety Authority, Plymouth Meeting, PA, USA e-mail: [email protected]
L. Huang
Department of Pediatrics, McMaster University, McMaster Children’s Hospital, Hamilton, ON, Canada
e-mail: [email protected]
Simulation Pearls
1. Health care is a complex, interconnected system with in- terrelationships. A systems approach seeks to understand both the components and the whole, and their interac- tions.
2. Simulation can focus on identifying systems properties that are problematic, contributing to defects or problems, or properties such as resilience, which contribute to safe, effective, and efficient healthcare delivery.
3. Lean, Six Sigma, Safety I and Safety II principles provide different frameworks and perspectives for understanding and improving healthcare delivery systems.
4. The integration of simulation into efforts to improve or- ganizational safety and communication infrastructure can optimize change.
A Systems-Based Approach to Health Care Consider what might happen if you are a member of a code team called to an emergent resuscitation: a child with anaphylaxis. Each team member, including you, has great knowledge and technical skills. The team has practiced to- gether and quickly establishes the leader and support roles, the correct diagnosis, a shared mental model, and closed- loop communication. You resuscitate the child, start the ap- propriate treatments, and the child improves. You are not just a team of experts, but an expert team!
Now consider an alternate scenario with the same team:
Someone is sent to get the code cart, but does not return for a prolonged period of time. After three failed attempts to es- tablish intravenous access, the drill is retrieved to place an intraosseous line, but the drill does not work. Once the code cart arrives, the team struggles to calculate how to dilute the contents of the 1:1000 vial of epinephrine to achieve the de- sired weight-based dose. The team is still a team of experts, but without effective systems to support them, they are not functioning as an expert team.
Each of these problems likely has many contributory fac- tors. Attempts to correct or resolve these problems may well identify other problems. A systems approach recognizes that systems—such as our complex care processes—are consist- ed of many components, with interrelationships between the components and the whole. Definitions of systems vary, with an underlying common thread: A system is a collection of parts forming a greater whole. The International Council of Systems Engineering (INCOSE) offers the following defini- tion of a system:
A construct or collection of different elements that together, pro- duce results not obtainable by the elements alone. The elements, or parts, can include people, hardware, software, facilities, poli- cies, and documents; all things required to produce systems- level results. Results include system level qualities, properties, characteristics, functions, behavior and performance. The value added by the system as a whole, beyond that contributed inde- pendently by the parts, is created by the relationship among the parts; how they are interconnected [1].
A systems approach recognizes that there must be integra- tion between the components and the whole. In health care, this integration is dynamic, complex, and not always predict- able. One way to conceptualize the complex relationships between the user, tool, task, environment, and processes is illustrated in Fig. 6.1.
In our case example above, the task could be resuscitat- ing the patient, with subtasks of assembling the appropri- ate team, making an accurate diagnosis, retrieving neces- sary equipment, administering the correct medications, and so on. Our users are the physicians, nurses, and respiratory therapists who provide direct care, as well as social workers, security personnel, pharmacists, radiology technicians, unit clerks, environmental service personnel, and others who pro- vide support services. The patient is also the user, as the sys- tem is intended to function for his/her benefit, but in this par- ticular case his/her participation is mostly passive; actions are done to or for him/her. Our tools are broadly defined, including supplies and medications, and equipment, such as the intraosseous drill. Tools could also include knowledge and past experiences.
The environment in which our resuscitation occurs is, in its simplest form, the physical space that we are working within. In our example, the code cart is located too far away, interfering with timely retrieval of equipment. Changing the physical environment, such as moving the code cart closer, could improve the team’s ability to provide timely care. Our working environments are more than the physical spaces we inhabit; our activities are impacted by the availability of all resources: equipment, supplies, information, and people.
There are also less tangible components, including interper- sonal interactions and organizational culture.
Processes surround and underpin the environment and its contents. Processes may be codified and formal (e.g., poli- cies, procedures, clinical care pathways, and checklists) or informal (e.g., learning what works by trial and error). For example, scarcity of supplies may stimulate hoarding. Pre- vious experiences with success—or with pushback—may stimulate looking for alternative paths to obtain resources such as equipment or even knowledge. We learn who or where to ask for equipment, supplies, and information, and sometimes seek these resources outside of formalized path- ways.
Patient care activities can be divided conceptually (see Fig. 6.1), but the interactions between those components are important and unavoidable. A system is a set of inter- related components functioning together toward some com- mon objective(s) or purpose(s). Systems are composed of components, attributes, and relationships [2]. A systems approach involves understanding the whole, the parts, and their interrelationships. Health care can be characterized as a diverse collection of multiple imperfect systems with complicated, dynamic interactions. Components include people, tools, resources, and the environment. The products of these systems include direct and indirect patient care, documents, behavior and performance of healthcare profes- sionals, errors, and adverse events. These systems exist at all levels: from individual clinics all the way up to com- plex organizations coordinating care across the spectrum of health and illness.
Applying a systems approach to health care creates a framework for understanding and changing behaviors and clinical outcomes. This approach is especially important in the area of patient safety as noted in the 1999 Institute of Medicine report To Err is Human:
Preventing errors and improving safety for patients require a systems approach in order to modify the conditions that con- tribute to errors. People working in health care are among the most educated and dedicated work force in any industry. The problem is not bad people; the problem is that the system needs to be made safer [3].
In our example, we do not really know why the intraosseous drill failed. One possibility is that the user was deficient. A systems approach challenges us to look deeper. Training may contribute to earlier recognition of problems with the tool, prompting a request for another drill. But no amount of indi- vidual or team training, practice or experience, will directly contribute to making the drill work. Potential contributors to tool failure include tool factors (e.g., limited durability and battery failure), environmental or organizational factors (e.g., limitations in funding priorities, oversight, protocols, staffing, or training), and process factors (e.g., insufficient testing or maintenance and lack of availability of replace- ment units) [4].
Processes
Environment
Task
Tool User
Fig. 6.1 Systems integration: a schematic representation depicting the independence, overlap, and dependence of different systems elements (task, tool, user, environment, and processes) related to the overall system
Similarly, we do not really know why it was difficult to calculate the correct dose of epinephrine. Potential contribu- tory causes could be ergonomic (e.g., the contents of the vial are listed in a microscopic font) or cognitive (e.g., it is diffi- cult, particularly under stress, to calculate correctly and ten- fold calculation errors are common; epinephrine is a scary drug to make a mistake with).
Human factors expertise can help. Human factors is sometimes misunderstood as “the weaknesses of humans”
contributing to system failures. Since all healthcare systems have been created by humans:
The search for a human in the path of a failure is bound to succeed. If not directly at the sharp end—as a ‘human error’
or unsafe act—one can usually be found a few steps back. The assumption that humans have failed therefore always vindicates itself [5].
Human factors addresses characteristics of human beings that are applicable to the design of systems and devices [6].
Human factors design takes into account the capabilities of people (physical, cognitive, or other) to create a work sys- tem that takes advantage of our capabilities and, conversely, builds in support where our capabilities are limited. The sci- ence of human factors uses knowledge of human functions and capabilities to maximize compatibility in the design of interactive systems of people, machines, and environments:
ensuring their effectiveness, safety and ease of performance [6]. Human factors expertise encompasses science and ex- ploration related to perception and performance, augmented cognition, decision-making, communication, product de- sign, virtual environments, aging, macroergonomics, and other areas [7].
Role of Simulation in Systems Integration If we look at Fig. 6.1 again, from the perspective of a simu- lation educator or researcher, rather than a healthcare pro- vider, we can make similar analogies. Our tools include the mannequins, task trainers, virtual simulators, standardized patients, even our knowledge of simulation and healthcare content. Our users are the learners or assessees, who par- ticipate in the simulation. Our task is to help individuals, teams, or organizations learn, or demonstrate competence or skills proficiency. Our environment could be a simulation center, in situ simulation location, or spaces such as confer- ence rooms, or outdoor environments in which simulations can occur. Processes may include equipment management, protocol development, informational interface with potential simulation users, etc. Each of these components is an inter- related component of our simulation program.
The anaphylaxis case example at the start of the chapter can be replicated as a simulation scenario. The responses of
simulation participants and problems encountered may not be exactly the same, but, if we conduct our simulation with real teams, in real settings, using real equipment, we will have the opportunity to better understand and improve the real systems. Debriefing can focus on understanding the con- text in which we provide patient care. Focused questions can intentionally and explicitly seek to better understand system capacities and constraints.
Specific variations can be made, altering the age of the patient or the clinical location, to identify systems issues that prevent optimal resuscitation of different types of patients in different settings. Simulated intentional probes create an opportunity to identify real-world challenges before there is a near miss or patient harm event. Pediatric simulations in North Carolina EDs were performed to assess the quality of pediatric trauma resuscitations. Although the goal of the sim- ulations was to identify educational interventions, systems issues were identified that would need to be addressed before any educational intervention would be successful, such as the lack of child-sized cervical collars in many of the EDs and the inability to identify IO needles due to mislabeling [8].In situ simulation, using care team members, existing equipment, resources, and patient care sites, offers the op- portunity to evaluate the system of care and identify latent safety threats (LSTs) that could predispose to medical error.
LSTs have been defined as systems-based threats to patient safety that can materialize at any time and are previously unrecognized by healthcare providers [9]. Categorizations of LSTs have included medication, equipment, resource, and knowledge gaps. A greater number of LSTs were identified per scenario during simulations conducted in situ versus in a simulation lab (1.8 vs. 0.8, respectively) [10]. Identifica- tion of LSTs in simulation allows for system-level fixes be- fore patient harm as demonstrated in the pediatric emergen- cy department [11], obstetrical unit [12], and with ECMO (Extracorporeal Membrane Oxygenation) simulations [13].
Simulation incorporates an opportunity to debrief to under- stand the rationales for observed behaviors and the context in which care is provided, a luxury not often available in real patient care. Whether the goal of the simulation is iden- tification of LSTs or not, a structured debrief often elicits underlying systems constraints that contribute to observed behaviors. Thus, identification of LSTs may be intentional or serendipitous. And asking participants to identify and con- sider LSTs is one way to take the focus off the individual (user) performance. Some programs have embedded simula- tion LSTs into their formal organizational safety reporting systems.
The same anaphylaxis simulation case can be replicated with a variety of ages of infant, pediatric and adolescent mannequins in different hospital locations, yielding new and distinct systems issues in dealing with pediatric patients
across the age spectrum, or identifying challenges that span larger systems. Skilled simulation educators or researchers may pause the action, restart, repeat, and rework scenarios to stress the system and understand capabilities and constraints.
Team members can observe parts of the care continuum they may not generally have the opportunity to witness, adding to the larger team’s understanding of vital processes and ul- timately, breaking down silos in which healthcare providers often work.
Because simulation provides opportunities to bring stake- holders together, repeat scenarios as needed and observe potentially infrequent events, simulation is a natural partner in the Plan-Do-Study-Act (PDSA) cycle of improvement.
Simulation can be incorporated in the planning phase, in the application of learnings, and then processes can be tested and retested iteratively using simulation. Figure 6.2 provides an example of how simulation can be used throughout the PDSA cycle to address identified systems issues.
Iterative series of in situ simulations to evaluate and refine process
New massive bleeding emergency process developed with stakeholders Develop new process to obtain blood products in massive bleeding emergency Recruit stakeholders Simulation teasted
and refined process implemented
Act Plan
Study Do
Root Cause Analysis identifies lack of standard process for obtaining blood
products in an emergency Patient with massive bleeding emergency
dies Fig. 6.2 Example of simulation
integration with the PDSA cycle.
Also incorporates a combined Safety I and Safety II application
Frameworks Lean
There are several approaches to taking a closer look at sys- tems-related issues. Lean methodology offers a collection of tools and principles that may assist in identifying and solv- ing problems related to process and environment. Lean is a management strategy with the goal of minimizing waste and maximizing efficiency, with the assumption that this will also improve safety and quality. The origin of Lean can be traced to the Toyota Production System developed in the 1950s–
1970s by Taiichi Ohno and Shigeo Shingo. James Womack’s 1990 book The Machine That Changed the World is largely credited with the popularizing Lean terminology and produc- tion principles [14]. In Lean, value is always defined from the customer’s (patient’s) perspective. Any step or activity that helps a patient achieve their ultimate goal is considered valuable. Waste is anything that consumes resources or time but does not help a patient achieve their desired goal or out- come. A key goal of Lean is to eliminate nonessential waste and maximize value. The eight types of waste and examples are provided in Table 6.1. While debriefing a simulation, asking participants to identify and consider sources of waste is one way to take the focus off the individual (user) and begin to consider the task, tool, environment, and processes that define the system of care.
One of the basic workplace organization tools in Lean is termed 5S or 6S. The name derives from a list of five Japa- nese words used as a guide to organizing the work environ- ment. The original 5S tool has been modified in health to include an important sixth S—safety. The 6S framework can be integrated with simulation activities to examine and change the clinical environment (see Table 6.2)
In our opening example, the 6S tool provides a system- atic framework for examining issues. Sort challenges us to
determine whether the most relevant tools are easily acces- sible and identifiable, such as whether the code cart is clut- tered with non-emergent equipment. Set in order challenges us to ask whether the code cart should be in a different lo- cation and whether there are clear visual cues to efficiently guide people to critical equipment. Sweep or Shine questions whether there are older pieces of equipment, materials or even protocols that need to be removed. Standardize challenges us to ask if there are routines around who, when and how the drill and equipment are inspected and whether all carts and rooms have similar organization. Sustain challenges us to ask what is in place to ensure changes from the previous 4S are maintained, guaranteeing the drill is always findable and functional. Safety challenges us to ask what additional LSTs are present, but have yet to be uncovered and mitigated. In addition to the drill, is there another piece of equipment at risk for failure? Each element in the 6S tool can assist teams to examine issues, whether in real patient care or in simula- tion, from a systems perspective.
Six Sigma
Six Sigma offers another framework, consisting of princi- ples and tools, for examining systems and improving quality [15, 16]. Six Sigma and its primary tool, define, measure, analyze, improve, and control (DMAIC), are used to im- prove the quality of processes by identifying and removing defects (errors) and minimizing variability. Six Sigma was developed in the 1980s by Motorola and became central to General Electric’s business strategy in the 1990s [16]. In Six Sigma, quality is always defined from the customer (patient) perspective. A key goal is to eliminate defects (errors) and develop processes that function error free 99.99966 % of the time.
DMAIC is the acronym for a five-phase, data-driven qual- ity tool used to improve processes: define, measure, analyze, improve, and control. In our opening example, DMAIC pro- vides a systematic approach for examining our anaphylaxis case examples. Define challenges us to specify the problem or the goal: an error-filled resuscitation, with the opportu- nity to decrease the number or errors and delays. Measure
Table 6.1 Eight types of waste [20]
Type of waste Example
Inventory Excess stocked equipment that is not used regularly
Waiting or delays Waiting to be treated in a clinic
Overproduction Drawing up extra doses of medications that are not used
Transportation Patients needing to go to geographically distant areas of a hospital for tests/procedures during a single clinic visit
Motion Excessive movement of team members in a clinical care area during a resuscitation Errors/mistakes Having to repeat or redo a task because of
an error
Over-processing Unnecessarily repeating tests/documentation Underutilized human
capacity High-skilled individuals performing low-skill activities
Table 6.2 Lean Healthcare 6S tool [20]
6S
Sort Useful from necessary
Set in order (straighten) Everything in its place, with visual cues Sweep/shine “Spring cleaning”
Standardize Make cleaning, inspection, safety part of the routine job
Sustain Establish an environment including audits/
cues to ensure 6S sticks
Safety Proactively look for potential safety issues, make the environment safe