Introduction

A comprehensive definition of simulation-based training incorporates “information, demonstration, and practice-based learning activities into a systematically designed and delivered a program of instruction.”[1]  Simulation-based medical training is a valid and effective strategy for teaching both technical and non-technical skills to individual providers and teams.[2][3][4][5] The Institute of Medicine (IOM) has promoted medical simulation for its ability to evaluate new technologies, enhance policies, and improve systems for the goal of improving patient safety.[6]  The IOM’s To Err is Human is frequently cited for its conclusion that medical errors are not a result of isolated individual actions but rather faulty systems, processes, and conditions that lead people to make mistakes.[7]  These reports have led to a greater examination of the systems approach to error management.  Research is evolving to examine how organizations and individuals can better approach medical error.  This review will discuss the systems approach for error management as it relates to a latent safety threat (LST), and the process of developing in situ simulation to expose LSTs and subsequently address medical error within organizations and teams.

Function

The systems paradigm of medical error, best described by James Reason, holds that healthcare is an inherently human process. As humans are subject to make mistakes, there should be an expectation of errors within any system.  A more reliable strategy to make the system more durable to potential error is to account for the underlying fallibility of humans. Reason states, “we cannot change the human condition; we can change the conditions under which humans work.”[8] He also makes an important distinction between "active errors" and "latent conditions."  Active errors are attributed to the immediate action of a human to cause an error, while latent conditions allow active errors to cause an adverse event or harm the patient. Addressing an active error may provide a temporary fix, but may not address the latent condition that allowed the mistake to have an impact.[9] In other words, LSTs in an organization are accidents waiting to happen, and focusing only on addressing active errors will not result in sustainable solutions.[10]

As may be apparent by the name, "in situ simulation" is simulation-based learning that occurs within the actual care setting as opposed to a designated multi-purpose simulation center. In situ simulation often involves an interprofessional team of practitioners on-duty and has the benefit of offering learners the opportunity to contextualize the actual process of work within their normal workflow and physical plant.[11] Adherents promote simulations conducted in the actual care setting for their affordability, ability to improve realism and that they elevate participant engagement of the broader medical team.[12][13][14] Furthermore, practitioners and teams get confronted with the same distractions, resource limitations, obstacles, and system flaws that they work with daily. These characteristics enable in situ simulation to be an effective vehicle to identify and mitigate medical error nascent within a department and its broader organization.[15][16][17]

Continuing Education

In situ simulation has been accepted as a valuable tool to identify latent hazards and practitioner knowledge gaps.  It is important to conduct scenarios in alignment with best practices to maximize outcomes and ensure participant engagement. Standardized approaches and protocols to conduct in situ simulation include pre-scenario planning, timing, setting, necessary personal, and criteria to cancel the simulation.[18][13][11][19] There can be some degree of variation in the development of in situ programs depending on the stated goals or the conditions challenged. However, the general considerations for executing an in situ simulation program should address patient safety, learner engagement, and record keeping.[13]  

Before beginning any in situ simulation, a supervisor or ward manager should be aware of the plan to ensure proper coverage of patient areas. Often "no-go" criteria are established to minimize risks to active or incoming patients to the unit. Patients and family members in the vicinity should be alerted to on-going training to ensure their psychological safety. Participants should have access to a safe training environment with an introduction to the ground rules of the simulation. Some in situ simulations are “unannounced,” in which case there should be some level of ongoing briefings to potential participants in the days or weeks before the initiation of a one time or longitudinal program. 

The final necessary component intrinsic to almost all medical simulation is a formalized debriefing. It can be a challenge to facilitate a debriefing among an interprofessional group of providers. It can be helpful to have an individual with formal debriefing experience be involved. Adequate time should be allotted to allow participants to identify LSTs and propose subsequent solutions. The seven most common descriptive categories of latent safety threats include staffing, medication, devices/equipment, knowledge-base, workspace/environment, protocols, and communication/teamwork.[6][11] Although these may be subdivided further, especially in regards to teamwork and communication, the broad categorization of potential safety threats allows systems to identify the most common vulnerabilities and direct resources accordingly. 

In collaboration with the clinical operations team, mechanisms should be in place in advance of performing in situ simulation to review and address revealed LSTs. One of the more comprehensive reviews on the role of in situ simulation in addressing latent safety threats advises a model for addressing issues using a Comprehensive Unit-based Safety Program.[1] These programs typically use a bi-directional approach between front line staff and administrative leaders who may have greater capability to address the needs identified during the simulations. These partnerships between staff and administrators help align routine processes with system-level structures. In 2010, the Society for Simulation in Healthcare (SSIH) established accreditation for simulation centers in System Integration for organizations committed to providing “a consistent, planned, collaborative, integrated and iterative application of simulation-based assessment and teaching activities with systems engineering and risk management principles to achieve excellent bedside clinical care, enhanced patient safety, and improved metrics across the healthcare system.” This concept is an important mechanism for providing sustainability and returns on investment for in situ simulation programs geared to exposing LSTs.  

Clinical Significance

At the time of this writing, a great deal of educational and investigative literature has been developed using in situ simulation for identifying latent safety threats. Some notable in situ simulation environments have included acute care settings, labor and delivery, pediatric care, and low-frequency high-risk scenarios.[19][20][21][22][23][24][25] Organizations with new facilities or new adaptations of their care setting have also used in situ simulation to assess the physical plant before opening their doors to patient care.[26][18] A review of this literature identifies qualitative measurements for the common categories that enumerate patient safety threats (e.g., medications, protocols, environment, staffing, and communication). Reported rates of the average LSTs identified per in situ simulation range from 1 to 7.[19][25] Evidence demonstrates that in situ simulation can be superior at identifying LSTs compared to standard institutional reporting systems.[23] Rosen’s systematic review concluded that effective in situ simulations "should include structured needs analysis and clearly defined assessment and feedback strategies to clarify learning objectives and support training transfer to daily practice."[1]  

To provide some concrete examples of simulation programs geared to exposing LSTs, the authors of this paper draw on individual experience conducting and gathering information from in situ simulations performed in a high volume urban emergency department. In the process of transitioning towards a formal Trauma designation, multiple in situ trauma simulations took place with interprofessional staff.  Simulations activated all levels of the system to mirror a real event (e.g., the use of the overhead hospital-wide paging system after a pre-hospital notification, formal patient registration into the electronic medical record, and involvement of ancillary services such as radiology to ensure our capacity to expedite diagnostic imaging). Debriefs revealed LSTs in various domains, including protocols, equipment, and organization of the clinical environment. The ultimate result was the implementation of multiple solutions. A few examples included codifying the massive transfusion protocol and adjusting the positioning of equipment within the room to make them more readily available for providers performing emergent resuscitative procedures. There was an enhancement of team dynamics by adding sticker role-identifiers for personal responding to the trauma notification, redesigning the trauma bay floor tiles to designate positions of resuscitation team members, and creating an illustration of team roles posted to the trauma bay wall. Regular inter-disciplinary team training exercises were developed to improve the ability of teams assembled on an ad hoc basis were prepared to perform highly reliable resuscitations. As the literature suggests, we found that frequent and goal-directed in situ simulations in coordination with operational, administrative committee meetings created an effective iterative process to diagnose and address LSTs.

Enhancing Healthcare Team Outcomes

Poor communication and teamwork inherently represent latent safety conditions. In situ simulation provides opportunities for the deliberate practice among teams and the opportunity for reflection on areas of improvement. Many validated scales are used to assess team performance for evaluation of in situ training.[27][28][26] Almost all the research evaluating in situ simulation report a positive impact on the non-technical skills of leadership, role clarity, decision-making, communication, and task management.[19][13][29][30] Studies also comment on the less tangible impacts of in situ simulation on organizations in the form of culture change. Frequent in situ simulation normalizes it as a training process and promote a culture of safety by engaging participants to identify LSTs as part of developmental team-based exercises.[18][19] The collaborative approach of in situ simulation can strengthen teamwork, and also empower healthcare providers to improve patient safety via a systems paradigm.