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Patient Safety Events Involving Simulation in Pennsylvania
Pa Pat Saf Advis 2016 Dec;13(4):166-168. 
 

Ellen S. Deutsch, MD, MS, FACS, FAAP, CPPS
Editor, Pennsylvania Patient Safety Advisory
Medical Director, Pennsylvania Patient Safety Authority

Although many organizations collect and analyze information about Serious Events,* it is unusual to collect and analyze information about healthcare incidents that do not result in patient harm. Providing opportunities to learn from a wide spectrum of patient care events is an important requirement of Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act.1 Compared with other states, Pennsylvania requires reporting the broadest range of events.2 Identifying and reporting hazardous conditions allows facilities such as hospitals and ambulatory surgical facilities to manage risks that might result in patient harm even before an individual patient is impacted. Notably, reporting is based on patient harm, which may or may not involve patient care errors. Facilities submit reports, which include harm scores,3 through the Pennsylvania Patient Safety Reporting System (PA-PSRS).
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* Serious Event as defined in the MCARE Act: “an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.”1

Incident as defined in the MCARE Act: “an event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.”1
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During simulations, such as when a team gathers to practice managing a simulated patient during a simulated medical crisis, hazardous conditions may be identified. Before opening a new or renovated patient care unit, simulations can be used to intentionally probe the availability and placement of equipment, signage, electronic access, or other features, as well as to refine patient care protocols. Even when not designed as intentional probes, simulations conducted in situ, in actual patient care settings, may serendipitously reveal hazardous conditions, such as missing or broken equipment, or impractical protocols. If simulations reveal a specific widespread knowledge deficit (e.g., unfamiliarity with using an epinephrine auto-injector), that could also be considered a system-wide unsafe condition. Because simulation, including in situ simulation, is becoming more widely used in healthcare settings and could be a source of data for improving patient safety, analysts searched the PA-PSRS database for event reports associated with simulation.

Methods

Analysts queried the database for events reported during the 11-year period from July 1, 2006, through June 30, 2016, in which the event details contained terms which might be associated with simulation; 2,431 reports were identified (Figure 1). The details in each event report were reviewed, and reports that were irrelevant were excluded, leaving 22 relevant event reports.

Figure 1. Flowchart for Analysis of Simulation Events Reported through PA-PSRS  Figure 1. Flowchart for Analysis of Simulation
  Events Reported through PA-PSRS

 

 


The 22 reports were analyzed with respect to the relationship between simulation and the event, harm score, and whether the simulation involved a process or protocol or an object (e.g., supplies, patient care equipment, calibration devices).

Results

The term “simulation” was often, but not always, associated with an equipment calibration process, rather than an educational or training process. Simulations involving objects such as equipment, supplies, or products comprised two-thirds (15 of 22) of the reports; the remaining reports involved processes or protocols.

The relationships between simulation and events were complex; in eight reports, simulations were used in response to events, and in three reports each, simulation may have prevented or contributed to events (Figure 2). In the reports in which the event reached the patient and the patient required monitoring or intervention to prevent harm, simulation identified or prevented an event for a specific patient in one report, simulation was conducted in response to an event for four patients, and simulation may have contributed to an event for one patient. Analysts identified no reports in which simulation contributed to harm, or in which simulation was used in response to harm.

Figure 2. Relationship between Simulation, Event, and Harm Score as Reported through PA-PSRS, July 2006 through June 2016  Figure 2. Relationship between Simulation, Event,
  and Harm Score as Reported through PA-PSRS,
  July 2006 through June 2016

 


Deidentified examples of event reports follow:*
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* Details of PA-PRSR event narratives in this article have been modified to preserve confidentiality.
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  • Simulation identified or prevented an event for a specific patient: During a mock review of patient-care processes, a hazard relevant for a specific patient was identified.
  • Simulation as routine test of device function prior to use indicated a problem: Device error message received before use on patient.
  • Simulation may have contributed to event: Device intended for practicing a procedure was used on a real patient; simulation distracted from patient care.
  • Simulation conducted in response to an event: Simulation was used to investigate a device malfunction after device use on a patient.

Discussion

Analysts have identified Incident reports that reference simulation in the PA-PSRS database. Although small in number, PA-PSRS reports involving simulation cover a broad range of relationships between simulation and patient care, with simulation potentially contributing to, preventing, and being used to investigate and mitigate hazardous conditions. The small number of reports about simulation in PA-PSRS may reflect limited use of simulation as an intentional probe to improve system safety, or it may reflect a lack of understanding that hazards identified in simulations that do not involve a specific patient can be reported through PA-PSRS.

The use of healthcare simulation to enhance the capabilities of both individuals and teams has blossomed over the past decade. Simulation experts are also beginning to appreciate the value of simulation for improving the social and technical systems that are integrated with healthcare providers4-6 as these systems support—or constrain—safe healthcare delivery. In Pennsylvania, unsafe conditions identified during simulations can be reported through PA-PSRS in a manner similar to other hazards; if the circumstance does not involve a specific patient, harm score A (circumstances that could cause an adverse event) might be appropriate.

Conclusion

Patient safety events involving simulation can be reported through PA-PSRS, but analysts identified few reports of simulation contributing to, or being used to mitigate or prevent patient safety events and no reports of patient harm related to simulation reported through PA-PSRS during the past 11 academic years. Analysts reviewing reports involving simulation look for patterns, generalizable knowledge, and risk reduction strategies as they do for other events reported through PA-PSRS. Reporting unsafe conditions identified during simulation through PA-PSRS may expand our knowledge and advance patient safety.

Notes

  1. Medical Care Availability and Reduction of Error (MCARE) Act. Act of March 20, 2002, P.L. 154, No 13. (2002). http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2002&sessInd=0&act=13
  2. Hanlon C, Sheedy K, Kniffin T, Rosenthal J. 2014 guide to state adverse event reporting system. National Academy for State Health Policy; 2015 Jan. Also available: http://www.nashp.org/2014-guide-state-adverse-event-reporting-systems/
  3. Pennsylvania Patient Safety Authority harm score taxonomy. [internet]. Pennsylvania Patient Safety Authority; 2015 [accessed 2015 Sep 21]. Available: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2015/mar;12(1)/PublishingImages/taxonomy.pdf
  4. Dunn W, Murphy JG. Simulation: about safety, not fantasy. Chest. 2008 Jan;133(1):6-9. Also available: http://dx.doi.org/10.1378/chest.07-1719. PMID: 18187737.
  5. Aggarwal R, Mytton OT, Derbrew M, Hananel D, Heydenburg M, Issenberg B, MacAulay C, Mancini ME, Morimoto T, Soper N, Ziv A, Reznick R. Training and simulation for patient safety. Qual Saf Health Care. 2010 Aug;19 Suppl 2:i34-43. Also available: http://dx.doi.org/10.1136/qshc.2009.038562. PMID: 20693215.
  6. Kaji AH, Bair A, Okuda Y, Kobayashi L, Khare R, Vozenilek J. Defining systems expertise: effective simulation at the organizational level--implications for patient safety, disaster surge capacity, and facilitating the systems interface. Acad Emerg Med. 2008 Nov;15(11):1098-103. Also available: http://dx.doi.org/10.1111/j.1553-2712.2008.00209.x. PMID: 18717649.
 
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THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS  
PSA LOGO The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web site at www.patientsafetyauthority.org .      
ECRI LOGO ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology.      

ISMP Logo The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.      
 
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