We offer the following practical steps for safety policy development, based on reflection on our experience, integrated with guidance from the literature.
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Form a STEERING GROUP for development and implementation of the simulation safety policy and identify RELEVANT STAKEHOLDERS required for advice and approval.
Simulation activities that are closely integrated into the operations of a health service will impact on a broad range of stakeholders, including pharmacy, occupational health and safety, clinical departments, biomedical engineering unit, hospital switchboard, porterage staff. We had formal and informal consultations with these groups and recommend a balance of targeted stakeholder input with broader invitations across an institution. External advice (e.g., from device manufacturers) should also be sought where applicable. A review date should be determined prior to policy approval.
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Identify existing safety procedures for the health service/ educational institution that are relevant for the simulation program.
Alignment and consistency with existing procedures is important, but challenging when health services are increasingly dynamic, and with hyperspecialized governance to match. Gold Coast Health has over 1200 procedure and policy documents covering over 220 services. Familiarity with niche policies saved invaluable time in drafting by establishing boundaries of scope and application, and early planning facilitated smoother integration of actions and accountabilities with existing safety systems.
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Incorporate simulation safety practices required in SSH accreditation processes and Raemer’s ‘Ten commandments’ [1].
Adapting generic resources to local context requires a granular approach. SSH has a template simulation policy [21] with a safety section (s19); however, much of the safety content is distributed throughout (s11 (psych), s20, s 22a, s23). Translational simulation programs will need to consider whether a single or separate policies are required for ‘center-based’ or in situ simulation activity. We opted for a single policy, with detailed content focused on ISS, based on our service profile.
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Consider the nature and extent of predicted safety risks, based on reports in the literature and local experience—adverse events and near misses.
Our ‘near misses’ were mostly inadvertent emergency call system activation by clinicians deeply engaged in a scenario. Another near miss we experienced related to simulated patient (SP) physical safety, when an SP was forcefully physically restrained during a behavioural emergency simulation in which protective services officers were unaware of the encounter being a simulation exercise involving an actor. Colleagues in other institutions and literature reviews suggested medication safety was a priority.
After 5 years of operation, we had identified the moments in time, environmental situations and human scenarios in which risk was higher. For example, in a large scale trauma simulation exercise there is a risk that a simulated narcotic drug is used in real clinical practice, but risk is highest immediately following the simulation where it is left on the bench as participants move to the debriefing, or compounded in the event of a rapid exodus from the resuscitation bay to accommodate an emergent real patient arrival. Active reflection on these potential risks, even in the absence of any adverse events, and documentation in our regular simulation event reporting was useful in this risk assessment. This reflective process included post simulation debriefings with the simulation faculty teams and during regular Simulation Service meetings.
Engagement with quality and safety units may yield data and/or incidents from standard hospital reporting systems that illuminate risks not recognized by simulation educators. This may need more specific keyword style extraction if coding systems do not include simulation (such as ours). An additional strategy could include an anonymized survey to gain insight into areas people are less willing to talk about in person.
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Prioritize medication safety and liaise with health service pharmacy representatives
Ensuring medication safety in simulated settings involves balancing risks [8]—bringing fake medications into real clinical areas versus using real drugs that may be subject to state or national legislation and have an associated cost. The benefits of translational simulation in identifying latent safety threats related to medication or testing new medication procedures are significant.
Our consultation process with pharmacy representatives was detailed and will be ongoing—as medication practices evolve, e.g., with the introduction of an electronic medical record, or changes to the contents of a resuscitation cart. We were grateful for existing work in this area, including the “Not for human Use” labels for medication, supplies and equipment as recommended by the Foundation for Simulation safety [11]
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Effectively communicate the existence of the simulation safety policy, and the need for staff involved in simulation delivery to comply with it.
This was led by our core simulation delivery team and network of educators throughout the hospital. The existence of the policy was highlighted in simulation faculty development workshops, and available on the health service intranet, published with other policy and procedures. Electronic communication with departments planning translational simulation activities including copies of the policy and pointing recipients to relevant sections.
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7.
Enable simulation faculty to conduct safe simulation sessions that are compliant with the policy, including structured briefings, cognitive aids and environmental cues.
We have developed a cognitive aid for simulation delivery teams conducting translational simulation activities (Fig. 2), as well as signage (Fig. 3) and staff uniforms to identify the simulation delivery team. A simulation safety officer is designated for each in situ simulation, and a safety briefing is incorporated into the overall simulation delivery team briefing and again during participant introductions and pre-briefing. These practical approaches were also integrated into faculty development programs.
Other examples of briefing tools and checklists are available on the Foundation for Healthcare Simulation Safety website [11].
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Develop a reporting process for simulation related adverse events or near misses, preferably integrated within the health service clinical adverse event reporting framework.
In a fully integrated translational simulation service, a close relationship with quality and safety units allows rapid ‘sensing’ of risks in the clinical environment that are illuminated in simulation activities, as well as the opportunity to design simulation strategies directly targeting high risk practice areas. Reporting safety incidents related to simulation activity would be streamlined. We have not yet achieved a perfect connection in this regard, due to limitations with our online clinical reporting systems. However, we include any adverse events or high risk issues in our standard simulation event reports, which are circulated to relevant Quality and Safety leads.