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Abstract
Background Reporting adverse clinical events is essential to a culture of safety in healthcare. However, self-reporting such events is generally not widely prevalent in a typical academic anaesthesia department.
Methods We set out to create a self-reporting tool to securely accept data from multiple anaesthesia service locations, including data linked to our electronic anaesthesia record, and combine them into an accessible database.
We created a web-based database module for incident reporting integrated into the department’s intranet. The system was also designed to actively prompt anaesthesia providers for reports following each day of clinical work.
Results 478 events were recorded in the database in the first year of implementation. There were 33 347 anaesthesia encounters in that period, translating to a reporting rate of 1.43% (95% CI 1.31% to 1.57%). In the second year, which coincided with the second phase of implementation, 608 events were reported out of 45 985 anaesthesia encounters, for a reporting rate of 1.32% (95% CI 1.22% to 1.43%). Approximately 40% of events entered into the database occurred in a non-operating room location. The annual reporting rates for 2014, 2015, 2016, 2017, 2018 and 2019 were 1.26% (95% CI 1.16% to 1.37%), 1.15% (95% CI 1.05% to 1.25%), 1% (95% CI 0.9% to 1.1%), 0.6% (95% CI 0.53% to 0.68%), 0.5% (95% CI 0.44% to 0.57%), 0.4% (95% CI 0.3% to 0.5%), respectively.
Conclusions Our incident reporting system facilitated reporting of events within and outside the operating room. The system captured event data valid for quality improvement within the anaesthesia department.
- Anaesthesia
- Near miss
- Patient safety
- Quality improvement
- Risk management
Data availability statement
Data are available upon reasonable request. Not Applicable.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
There is a need for a consistent and efficient tool for collecting clinical incident reports in anaesthesiology, but most existing systems need to be improved in their utility. The aim was to develop a self-reporting tool to securely accept data from multiple anaesthesia service locations, including data linked to their electronic anaesthesia record, and combine them into an accessible database.
WHAT THIS STUDY ADDS
This study shows that a solicited but voluntary self-reporting tool, a web-based database module, effectively facilitated reporting of events and captured data valid for quality improvement within the anaesthesia department.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study could encourage healthcare organisations to consider implementing self-reporting systems to improve their anaesthesiology incident reporting and quality improvement processes.
Introduction
Safety and quality in healthcare depend partly on collecting contemporaneous data on clinically relevant events (adverse or otherwise) and near misses. Reporting such events is widely considered an essential behaviour of the ‘culture of safety’ or ‘just culture’ and a component of professionalism. However, there is yet to be a generally accepted tool for collecting clinical incident reports consistently and efficiently, particularly given the different patient care activities encountered within a typical department of anaesthesiology. While systems involving active surveillance have been developed, most organisations rely on some form of self-reporting (with varying kinds of ‘mandatory reporting’ rules).1–4 Previous studies have shown that self-reporting of adverse events and near misses can identify most adverse events if barriers to self-reporting are eliminated.5
Many anaesthesia clinical incident reporting systems are linked solely to the anaesthesia records; the provider is asked to complete some form of reporting questionnaire (either on paper or as part of the electronic record) at the end of each case completed.1 3 6 However, these systems are of limited utility, since they cannot capture events that are unrelated to an anaesthesia record. For example, a complication of a regional anaesthetic block might result in the cancellation of a case—meaning that no anaesthesia record is generated. Other events occurring in the pain clinic, intensive care unit, preoperative clinic or even several days after surgery are not linked to an anaesthetic record and hence not readily reported.
Our goal was to create a self-reporting tool that could securely accept data from multiple anaesthesia service locations, including data linked to our electronic anaesthesia record, and combine them into an accessible database to review, categorise, and, if needed, follow-up by designated department quality personnel.
Methods
This was a quality improvement project aimed at facilitating event reporting in an academic anaesthesia department and adheres to the format of The Standards for Quality Improvement Reporting Excellence V.2.0.7 Before 2011, our department had no common repository of reported events or a systematic method for gathering and managing such information. A web-based database module was developed and integrated into the department’s online intranet. The application was implemented in Microsoft ASP.NET (Microsoft Corporation, Redmond, Washington, USA) and housed on a secure server, with Microsoft SQL Server serving as the backend of the database.
The reporting system was predicated on the belief that while anaesthesia providers might choose not to report an event or near miss because it was ‘unimportant’ or ‘not related to my actions,’ they would be less likely to actively deny that an event had occurred when asked directly and required to certify that ‘nothing happened’. The system was designed to actively prompt anaesthesia providers for reports following each day of clinical work, thereby reducing the likelihood of forgetting to report an event. Unlike systems linked to individual anaesthesia records (eg, to be completed at the end of each case or before post anaesthesia care unit discharge), the system focused on individual anaesthesia providers, not on cases done. As such, any event occurring under any circumstances at any time during the working day in any location could be reported.
Intervention
Each morning, the system examines the department’s electronic scheduling software. It identifies all individuals (faculty anaesthesiologists, residents and fellows, certified registered nurse anaesthetists, student nurse anaesthetists) who, according to that schedule, worked in any clinical capacity (main operating room, ambulatory surgery centre, intensive care unit, labour and delivery unit, pain clinic, other non-operating room anaesthesia locations) during the prior 24 hours. Each anaesthesia provider received an email containing the assigned clinical activity and a few questions.
For faculty and residents, the two questions were: ‘click here to go to the call reporting system’ and ‘click here to submit a quality assurance (QA) report’. If the individual clicked on the ‘submit a QA report’ link, they were taken directly to the QA reporting system. If they clicked the ‘call reporting system’ link, they were presented with another screen requiring them to check a box for each listed workday, testifying that ‘nothing reportable happened on the listed date’. If the box(es) was/were not checked and‘submit’ was clicked, they were taken to the QA reporting system. If boxes were checked and ‘submit’ clicked, an additional screen opened that asked a series of questions related to medication errors, near miss events and non-medication related events, asking, ‘did any of these events occur…’ (figure 1). When the individual confirmed that none of the listed events occurred and clicked the ‘submit’ button, they were allowed access to the call reporting system. Neither faculty nor residents could access their time reporting pages without giving a response to these questions. For faculty, quarterly incentive payments are based on time reporting, and for residents, time reporting is tied to their Accreditation Committee for Graduate Medical Education hours reporting requirements. A slightly different but conceptually similar email and serial queries were used for certified registered nurse anaesthetists and student nurse anaesthetists.
Follow-up questions soliciting a report of specific events. QA, quality assurance.
In addition to this ‘prompted’ reporting system, any clinician in the department could directly access the QA reporting system via a direct link on the department’s intranet.
The QA reporting page (figure 2) provides a template where a narrative of the event, the outcome, patient identifiers (if applicable), the identity of the faculty anaesthesiologists and other anaesthesia providers associated with the event are recorded. The anaesthesia provider submitting the report has an hour to complete the submission before the system is timed-out to protect patient privacy. Before implementing the reporting system, there was a department-wide effort to educate all clinicians on the use of the reporting system. In the initial implementation phase, no ‘hard stop question’ required a response before the user could proceed directly to the call reporting system from the alert email. The event reports were housed on a secure database accessible to a select group of faculty anaesthesiologists and an administrative assistant via a two-stage password-protected authentication. The reports database could be accessed only on a computer linked to the institutional network or via the hospital’s virtual private network. The database allows the categorisation of entries based on multiple criteria, including keywords, event date, priority (low, medium or high) for presentation at the weekly clinical case conference, American Society of Anesthesiologists physical status, and patient outcomes.
Quality assurance (QA) database event entry template.
Measures
The outcomes measured were the trend in event reporting after implementation, categories of events, location of events, and if the anaesthesia provider submitting the report is a faculty or non-faculty provider. The database has built-in data management tools which includes a sort and search engine, trend graph charting of reported events, scheduler for weekly clinical case conference (morbidity and mortality) meetings and links to the event reviewer summaries. Descriptive statistics were used as appropriate to analyse outcome measures.
Results
In the 6 months following the first phase of implementation of the reporting system, 212 events were reported, and at the end of 12 months, a total of 478 events had been recorded in the database. There were 33 347 anaesthesia encounters in that period, translating to a reporting rate of 1.43% (95% CI 1.31% to 1.57%). In the second year, which coincided with the second phase of implementation, 608 events were reported out of 45 985 anaesthesia encounters, for a reporting rate of 1.32% (95% CI 1.22% to 1.43%). The annual reporting rates for 2014, 2015, 2016, 2017, 2018 and 2019 were 1.26% (95% CI 1.16% to 1.37%), 1.15% (95% CI 1.05% to 1.25%), 1% (95% CI 0.9% to 1.1%), 0.6% (95% CI 0.53% to 0.68%), 0.5% (95% CI 0.44% to 0.57%) and 0.4% (95% CI 0.3% to 0.5%), respectively. Figure 3 is a time series of quarterly event reports and the moving average from the first quarter of 2012 to the fourth quarter of 2019. Figure 4 summarises commonly reported events categorised as keywords from 2012 to 2019. Online supplemental appendix 1 has a complete list of events included in each keyword category. We did not include data for 2020 due to the disruption in clinical activities during the COVID-19 pandemic. The number of reports entered into the database decreased in the fifth year after implementation, and this trend was sustained over time. Approximately 40% of events entered into the database occurred in a non-operating room location. There are approximately 170 anaesthesia providers (60 faculty anaesthesiologists, 39 residents, 51 certified registered nurse anaesthetists and 20 student nurse anaesthetists) in our department and each category of anaesthesia provider entered an event report in the database. However, 50% of reported events were submitted by the faculty anaesthesiologists, a trend which has been sustained. The average time from solicitation for a report to confirming no event occurred or entering a report into the database throughout the review was 2.5–2.7 days (±3.3 to 3.9).
Supplemental material
Time series of quarterly event reports.
Events reported each year.
Discussion
Implementing a solicited but voluntary event reporting system resulted in increased reporting by all clinical providers in the anaesthesia department. An anaesthesia department QA reporting system should be robust enough to facilitate reporting of events occurring within the operating room and non-operating anaesthesia locations. Such a system should have built-in mechanisms to maintain the confidentiality of the clinician entering the report and the patient if a patient is involved. We were able to build a system that has these attributes. Our event reporting system is easily accessible via a secure network and requires minimal training. The user acceptance of the system after implementation was high, as evident by the high response rate to event solicitation by all levels of clinical providers, which often resulted in double reporting of a single event because all providers involved entered a report. The review system allowed the database administrators to identify the double entry and merge the reports quickly. Studies have shown that clinicians are more likely to report events that result in adverse outcomes and if reporting will improve care.6 8 9 However, it is crucial for errors that do not result in adverse outcomes and ‘near miss’ events to be reported because the data is helpful for targeted quality improvement.10 Our reporting system with built-in closed and open-ended questions, in our opinion, encourages reporting of ‘near miss’ events. These events are weak signals of underlying issues that require attention. Decoupling the reporting system from the anaesthesia information management system allowed the capture of events that would otherwise not be reported if the system was linked solely to an anaesthesia information management system. Barriers to adverse event reporting have been identified in previous reports; this includes a need for more education in reportable event recognition and the availability of a user-friendly system for event reporting that does not interfere with the clinical workflow.11 Our quality improvement officer regularly educated clinicians on reportable events during weekly departmental case conferences. Also, based on user feedback, the reporting system has a user-friendly interface and does not interfere with the clinical workflow.
Our results show a gradual decrease in the total number of events reported starting from the fourth year after implementation of the reporting system. The department’s quality and safety team reviews all the events in the database. Depending on the severity or potential severity of the (near miss) event, the frequency or the educational value, the event is scheduled for presentation at the weekly clinical case conference. The goal of the presentation is to allow for learning about the event and discuss strategies to prevent future events. We regularly invite to these meetings non-anaesthesia healthcare practitioners from the surgical team, internal medicine and nursing involved in the patient’s care or with expertise in preventing certain events. For example, due to a cluster of submitted reports on corneal abrasions, we have had ophthalmologists attend the clinical case conference to offer recommendations on preventing these injuries. Another intervention resulting from submitted reports in the database was mandating that all patients administered a neuromuscular blocking agent (NMBA) have quantitative neuromuscular function monitoring (NMT) to confirm the reversal of muscle paralysis. The department leadership held multiple educational events to share information on the benefits of using quantitative NMT, how to use it and troubleshooting the device when not functioning as expected. The department also purchased these monitors for all anaesthesia locations in the institution and audited the utilisation. Other initiatives resulting from reporting in the database were getting the pharmacy to compound intraoperative drug infusions instead of the anaesthesia providers doing it, programming dose ranges and alert alarms when it exceeds the recommended range on the drug infusion pumps and introducing bar code scanning of drugs before administration. The department’s quality and safety officer also gives a quarterly presentation on event trends and discusses strategies for reducing events. These efforts led to a significant reduction in cases of residual paralysis in patients who received NMBA, a reduction in corneal abrasions, a reduction in events due to miscommunication or consent and a reduction in drug administration errors. Also, education on event reporting and a better understanding of which events are reportable may have led to a reduction in the number of unnecessary entries by clinicians. For example, in the early phases of the reporting system, clinicians would report a case because it was clinically challenging due to the patient’s comorbidities, although for educational purposes. In a study investigating the trends in adverse events reporting after implementing a mandatory reporting system at two academic hospitals, the authors reported a significant decline in reporting rate.12 The authors concluded that the decrease was due to a decline in preventable adverse events and that mandatory reporting may improve safety in anaesthesia care. Though there was a decrease in reporting of unequivocally preventable events like drug administration errors and positioning-related injuries in our database, we also noted a decrease in reported non-preventable events (eg, cardiac arrest, arrhythmias and stroke). Before creating the department’s event reporting system, our hospital did not have a facility-wide, readily accessible electronic event reporting system. However, 3 years later, the hospital had a more accessible reporting portal available. With the decreased reported events in the department database, we questioned whether clinicians reported to the hospital database instead. Data retrieved from the hospital-wide reporting system showed a steady increase in reporting by anaesthesia clinicians (online supplemental appendix 2). However, it did not necessarily account for the decreased reporting in the department’s database. In a large department like ours with regular staff turnovers (incoming/departing residents, certified registered nurse anaesthetists, student nurse anesthetistss, and faculty), we may not have kept up with educating new staff members on the importance of event reporting. There is also the possibility of reporting fatigue, especially with increased clinical workload and staffing shortages in recent years, leading to less priority given to event reporting by clinicians. We are yet to ascertain what is responsible for the overall decrease in reporting. Over the 8 years, our operative and non-operative case numbers increased at an annual rate of approximately 10% with little to no change in case mix or complexity.
Supplemental material
The main limitation of our reporting system is that the solicitation for event reporting does not occur contemporaneously, and it is possible that 24 hours after a busy clinical schedule, a clinician may need to remember events that occurred, especially if these were minor events or near misses. Furthermore, because our reporting system is voluntary, it is subject to selection bias compared with direct observation or medical record review. However, a recent study showed that most event reporting in anaesthesia requires self-reporting due to the inability of electronic anaesthesia records to capture these events.13
In conclusion, we developed an event reporting system that facilitates reporting of events within and outside the operating room, not linked solely to anaesthesia intraoperative records. The system captured event data valid for quality improvement within the anaesthesia department.
Data availability statement
Data are available upon reasonable request. Not Applicable.
Ethics statements
Patient consent for publication
Ethics approval
The project was determined not to meet the regulatory definition of human subjects research and was exempt from review by the institutional review board (IRB ID# 202002416).
References
Supplementary materials
Supplementary Data
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Footnotes
Contributors UI: Conceptualisation, methodology, writing of original draft, review and editing of final manuscript, and is responsible for the overall content as the guarantor of this work. RM: Writing and review of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.