Safety Event Reports Research Articles

Impact of targeted education on adverse drug reaction documentation in cancer center sites.

395 Background: Allergic and infusion-related reactions represent a significant portion of reported adverse drug reactions (ADRs) at The University of Kansas Health System (TUKHS) Cancer Center sites. According to the TUKHS Allergy Documentation policy, all observed reactions are required to be documented in the electronic health record (EHR) and reported to the responsible provider. Insufficient documentation may result in preventable patient harm due to continued exposure to medications after known ADRs. An audit of patient EHRs demonstrated notable variability in documentation practices, which served as the impetus to implement a standardized ADR documentation workflow at Cancer Center sites. Methods: This multi-center, retrospective study included patients with ADRs submitted via safety reports from July 1st, 2022 to April 1st, 2023. Categorical data was analyzed using the chi-squared test. Duplicate reports and ADRs identified as side-effects were not included in the final analysis. Targeted education was provided via two online video modules, a workflow tips sheet, and an educational infographic. The primary outcome was frequency of allergy lists updated following submission of a safety event report. Secondary outcomes included frequency of standardized progress note writing, note routing, and accurate reaction type differentiation. Results: Targeted education significantly improved allergy list updating from 34.2% to 84.0% (P < 0.001), use of a standardized progress note from 47.4% to 64.2% (P = .008), and correct differentiation of reaction type from 57.7% to 76.4% (P = .02). Progress notes were routed to the responsible provider 58.5% of the time. Smaller community-based Cancer Center sites were significantly less likely to update allergy lists (7.5% vs. 24.5%, P = .017) and more likely to document incorrect reaction types (35.0% vs. 14.3%, P = .022). Conclusions: Targeted education for a standardized documentation workflow increased adherence to ADR documentation, ensuring future treatment plans are updated for patients with a history of reaction and the EHR accurately reflects ADR history. There is an opportunity to strengthen targeted education surrounding ADR documentation workflows for smaller community-based sites.

A text mining approach to categorize patient safety event reports by medication error type

Patient safety reporting systems give healthcare provider staff the ability to report medication related safety events and errors; however, many of these reports go unanalyzed and safety hazards go undetected. The objective of this study is to examine whether natural language processing can be used to better categorize medication related patient safety event reports. 3,861 medication related patient safety event reports that were previously annotated using a consolidated medication error taxonomy were used to develop three models using the following algorithms: (1) logistic regression, (2) elastic net, and (3) XGBoost. After development, models were tested, and model performance was analyzed. We found the XGBoost model performed best across all medication error categories. ‘Wrong Drug’, ‘Wrong Dosage Form or Technique or Route’, and ‘Improper Dose/Dose Omission’ categories performed best across the three models. In addition, we identified five words most closely associated with each medication error category and which medication error categories were most likely to co-occur. Machine learning techniques offer a semi-automated method for identifying specific medication error types from the free text of patient safety event reports. These algorithms have the potential to improve the categorization of medication related patient safety event reports which may lead to better identification of important medication safety patterns and trends.

Radiation Treatment Preparation Safety Risk Prediction.

To determine the effect of delays in radiation treatment preparation task timeliness on reported safety events. For 2022, all patients treated at four community-based radiation oncology clinics were included for analysis. Safety reports which occurred during treatment preparation tasks (i.e., between CT simulation and the first treatment) were included for this analysis. Patients with a reported safety event were the report cohort and those without were the control cohort. Treatment preparation tasks are completed sequentially and included contouring, treatment planning, Radiation Oncologist review, Medical Physicist review, Therapist quality check. At baseline, each task was scheduled a standard interval for completion based on treatment technique. The time taken to complete each task was captured using ARIA v16.0 Care Path module (Varian Medical Systems, Palo Alto, CA) and extracted through database query. For each task, two metrics were quantified: Task (1) Completion Timeliness: the time (hours) to complete each task, relative to the time allocated to each task. A negative value indicated more time taken than scheduled. (2) Overall Timeliness: specific task timeliness (hours) relative to overall timeliness for the whole Care Path. A negative value indicated the tasks were behind schedule. A student's t-test with an alpha of 0.05 was used to indicate significance. Over the study period, 66 courses had a reported treatment preparation safety event (report) and 2690 did not (control). Techniques include 54% and 56% 3DCRT, 35% and 35% IMRT, 3% and 3% SRS, and 6% and 8% SBRT, for the report and control groups, respectively. Disease sites include breast, GU, GI, head and neck, CNS, thoracic, skin, secondary, gynecological, sarcoma, and heme. Table 1 displays the timeliness for each of the five tasks. Of the courses with safety events, overall timeliness was significantly behind the control group from the in contouring, treatment planning, Radiation Oncologist review, and Medical Physicist review. Courses with safety events took significantly more time than scheduled early in treatment preparation with a significant increase at treatment planning and significantly less time towards the end with the therapist quality check. Patient courses with reported safety events had significantly longer treatment planning times, and as a result inadequate time to perform each downstream pre-treatment activity. The implication of this analysis is that a flag could be created to indicate risk of a safety event early in the treatment preparation process.

Characterization of Safety Events Involving Technology in Primary and Community Care.

The adoption of technology in health care settings is often touted as an opportunity to improve patient safety. While some adverse events can be reduced by health information technologies, technology has also been implicated in or attributed to safety events. To date, most studies on this topic have focused on acute care settings. To describe voluntarily reported safety events that involved health information technology in community and primary care settings in a large Canadian health care organization. Two years of safety events involving health information technology (2016-2018) were extracted from an online voluntary safety event reporting system. Events from primary and community care settings were categorized according to clinical setting, type of event, and level of harm. The Sittig and Singh sociotechnical system model was then used to identify the most prominent sociotechnical dimensions of each event. Of 104 reported events, most (n = 85, 82%) indicated the event resulted in no harm. Public health had the highest number of reports (n = 45, 43%), whereas home health had the fewest (n = 7, 7%). Of the 182 sociotechnical concepts identified, many events (n = 61, 59%) mapped to more than one dimension. Personnel (n = 48, 46%), Workflow and Communication (n = 37, 36%), and Content (n = 30, 29%) were the most common. Personnel and Content together was the most common combination of dimensions. Most reported events featured both technical and social dimensions, suggesting that the nature of these events is multifaceted. Leveraging existing safety event reporting systems to screen for safety events involving health information technology, and applying a sociotechnical analytic framework can aid health organizations in identifying, responding to, and learning from reported events.

Mortality in the Emergency Department and the Effectiveness of Conventional Safety Event Reporting.

Background Patient mortality reviews identify care, system, and process deficiencies. Patient deaths undergo quarterly review in our academic emergency department (ED), whereas in other departments, mortality reviews are requested by the pronouncing physician within 24 hours. In the ED, individual physicians encounter barriers to 24-hour reviews, including feasibility, the perception of futility, re-exposure to traumatic events, and a high frequency of pre-hospital and non-preventable deaths. This quality review aimed to determine the preventable death rate, contributing factors to ED patient mortality, cases requiring further review, and the capture rate of individual case submissions into the patient safety reporting system. Methods A retrospective chart review was performed on all patient deaths occurring in our ED from July 2019 to February 2020. All patients 18 years or older who were pronounced dead in the ED during our data collection period were included. Patients declared deceased pre-hospital, on an inpatient floor, or in the operating room were excluded. Deaths were assessed for characteristics such as sex, presence of a pulse upon arrival, diagnostics and interventions performed, and whether the cause of death was traumatic or medical. Deaths were categorized on a 5-point Likert scale ranging from "not preventable" to "likely preventable." The presence or absence of contributing factors and the need for further review were recorded. Results Of the 166 reviewed cases, 87% (n=144) were non-preventable due to a terminal condition upon arrival, 12% (n=20) were non-preventable despite maximal efforts, 0.6% (n=1) were non-preventable despite a medical or systems error, and 0.6% (n=1) were possibly preventable due to a medical or systems error. No cases were definitively preventable. Only 1.2% (n=2) of cases required further safety review. In 55% (n=91) of cases, the patient arrived without a pulse. Medical deaths (60%, n=100) outnumbered traumatic deaths (39%, n=64). The most utilized diagnostic test was ultrasound (67%, n=111), and the most utilized intervention was advanced cardiac life support (59%, n=98). Conclusion There is a high prevalence of unpreventable deaths in the ED (99%, n=164). Only two cases (1.2%) were identified for further patient safety review. Standard safety event reporting practices correctly identified all possibly preventable ED deaths.

Bringing the Equity Lens to Patient Safety Event Reporting

Bringing the Equity Lens to Patient Safety Event Reporting

When Illegitimate Tasks Threaten Patient Safety Culture: A Cross-Sectional Survey in a Tertiary Hospital.

Objectives: The current study investigates the prevalence of illegitimate tasks in a hospital setting and their association with patient safety culture outcomes, which has not been previously investigated. Methods: We conducted a cross-sectional survey in a tertiary referral hospital. Patient safety culture outcomes were measured using the Hospital Survey on Patient Safety Culture questionnaire; the primary outcome measures were a low safety rating for the respondent's unit and whether the respondent had completed one or more safety event reports in the last 12months. Analyses were adjusted for hospital department and staff member characteristics relating to work and health. Results: A total of 2,276 respondents answered the survey (participation rate: 35.0%). Overall, 26.2% of respondents perceived illegitimate tasks to occur frequently, 8.1% reported a low level of safety in their unit, and 60.3% reported having completed one or more safety event reports. In multivariable analyses, perception of a higher frequency of illegitimate tasks was associated with a higher risk of reporting a low safety rating and with a higher chance of having completed event reports. Conclusion: The prevalence of perceived illegitimate tasks was rather high. A programme aiming to reduce illegitimate tasks could provide support for a causal effect of these tasks on safety culture outcomes.

Relationships among psychological safety, the principles of high reliability, and safety reporting intentions in pediatric nursing

PurposeThe purpose of this study was to explore relationships among psychological safety, the principles of high reliability, and safety reporting intentions in pediatric nursing. Patient safety events are underreported and costly. To promote reporting, many healthcare organizations have adopted the high reliability framework with strategies to foster team psychological safety. DesignA web-based survey was distributed through the Society of Pediatric Nurses and the National Pediatric Nurse Scientist Collaborative. Data were collected from 244 pediatric nurses using a demographic form, Safety Organizing Scale, Team Psychological Safety Scale, and Intention to Report Safety Events Scale. Data were analyzed using logistic and linear regression. ResultsPsychological safety and perception of working in a high reliability organization (HRO) showed positive statistically significant relationships with reporting intentions (p = 0.034). Odds of nurses achieving highest reporting intention scores increased by a factor of 0.3 with each practice year. ConclusionsPsychological safety was found to be a predictor for intention to report safety events among pediatric nurses. Findings also demonstrated that nurses' perceptions of whether they worked in a high reliability setting also profoundly affect their attitude towards reporting. Practice implicationsFocusing organizational efforts on cultivating psychological safety and embedding the high reliability framework into professional practice may significantly affect attitudes towards safety event reporting.

Improving Patient Safety Event Report Classification with Machine Learning and Contextual Text Representation.

Adverse events caused by medical errors pose a significant threat to patient safety, with estimates of 251,454 deaths and a cost of $17.1 billion to the healthcare system annually in the United States. Patient safety event (PSE) reports play a vital role in identifying measures to prevent adverse events, but their utility is dependent on the accurate classification of PSE reports. Recent studies have used static natural language processing (NLP) and machine learning (ML) techniques to automate PSE report classification. However, the use of static NLP has limitations in differentiating the meaning of words in disparate contexts, which can lead to inferior classification results. Thus, this study proposes to utilize contextual text representation produced from neural NLP methods to improve the accuracy of PSE report classification. The results suggest that the contextual text representation can further improve the performance of PSE classifiers. The best-performing classifier, a support vector machine trained with contextual text representation (Roberta-base) reaches an accuracy of 0.75 and a ROCAUC score of 0.94, surpassing all ML classifiers trained with static text representations. Furthermore, the confusion matrix of the best classifier exposes latent deficiencies in the PSE reports' classification taxonomy, such as the multi-class nature of PSE and conceptually related event types. The study's findings can save time for PSE reclassification, enhance the learning capabilities of the reporting system, ultimately improve patient safety.

Project AVIAN: Implications of Utilizing the Novel AVIAN-S Machine Learning Model in Analyzing Aviation Safety Event Reports

Voluntary Safety Reporting Programs (VSRPs) create an opportunity for actively identifying potential safety issues within aviation operations. However, manually reading and analyzing these reports can be labor-intensive and heavily relies on subject-matter experts. The full potential of VSRP data is difficult to achieve due to limited resources available to extract meaningful human factors (HF) data from reports. New machine learning (ML) techniques involving natural language processing (NLP) offer opportunities to label factors of interest within safety reports more efficiently and effectively. A novel ML model was developed to identify HF issues within aviation safety reports. The AVIAN-S model was trained on over 50,000 rows of manually classified VSRPs. The model uses ML and NLP to automate the process of labeling aviation safety reporting data and coding reporter narratives according to an established HF taxonomy. Preliminary results and implications for using the AVIAN-S model for analyzing aviation safety event reports are described.

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018.

There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE). A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases. A total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals' deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer. These findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions.

Transferring critical pediatric patients from emergency department to intensive care: A quality improvement initiative

BackgroundTransfer of care, moving hospitalized patients between care areas, is a critical point of vulnerability for healthcare organizations. Patient information handoff is an essential activity occurring frequently in hospital environments. Poor communication has been linked with adverse events and poor patient outcomes. This evidence-based quality project aimed to enhance the handoff process between the Emergency Department (ED) and Pediatric Intensive Care Unit (PICU) by standardizing transfer of care steps. This was accomplished through customizing a reporting tool to contain all the information the receiving department deemed necessary for safe patient care. MethodsA customized situation, background, assessment, recommendation (SBAR) form handoff tool was developed for ED to PICU transfers. This SBAR tool included information that PICU nurses identified as critical to transfer of care. Nurse perceptions were surveyed pre- and post-implementation. Patient safety event reports were tracked to evaluate events related to transfer of care before and after the practice change. FindingsAn increased number of PICU nurses agreed the customized handoff tool was complete and organized. Additionally, more nurses agreed that handoff gave all information needed to safely care for critically ill patients transferred from the ED. Lastly, bedside patient checks increased, and patient safety events related to transfer of care decreased. DiscussionThis project demonstrated that implementation of a standardized transfer of care process coupled with a customized handoff tool increased PICU nurse perceptions that handoff was organized, and all information needed to safely care for critically ill patients was conveyed. Application to practiceTransfer of care processes between the ED and PICU should be standardized. The use of customized tools may improve information exchange between nurses and ensure that all vital patient information is communicated.

Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids

BackgroundEpidemic increases in opioid deaths prompted policies limiting access to prescription opioids in North America. Consequently, the over-the-counter opioids loperamide (Imodium A-D) and mitragynine, the herbal ingredient in kratom, are increasingly used to avert withdrawal or induce euphoria. Arrhythmia events related to these nonscheduled drugs have not been systematically studied. ObjectivesIn this study, we sought to explore opioid-associated arrhythmia reporting in North America. MethodsThe U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), and Canada Vigilance Adverse Reaction (CVAR) databases were searched (2015-2021). Reports involving nonprescription drugs (loperamide, mitragynine) and diphenoxylate/atropine (Lomotil) were identified. Methadone, a prescription opioid (full agonist), served as a positive control owing to its established arrhythmia risk. Buprenorphine (partial agonist) and naltrexone (pure antagonist), served as negative controls. Reports were classified according to Medical Dictionary for Regulatory Activities terminology. Significant disproportionate reporting required a proportional reporting ratio (PRR) of ≥2, ≥3 cases, and chi-square ≥4. Primary analysis used FAERS data, whereas CAERS and CVAR data were confirmatory. ResultsMethadone was disproportionately associated with ventricular arrhythmia reports (PRR: 6.6; 95% CI: 6.2-7.0; n = 1,163; chi-square = 5,456), including 852 (73%) fatalities. Loperamide was also significantly associated with arrhythmia (PRR: 3.2; 95% CI: 3.0-3.4; n = 1,008; chi-square = 1,537), including 371 (37%) deaths. Mitragynine demonstrated the highest signal (PRR: 8.9; 95% CI: 6.7-11.7; n = 46; chi-square = 315), with 42 (91%) deaths. Buprenorphine, diphenoxylate, and naltrexone were not associated with arrhythmia. Signals were similar in CVAR and CAERS. ConclusionsThe nonprescription drugs loperamide and mitragynine are associated with disproportionate reports of life-threatening ventricular arrhythmia in North America.

Understanding the Root Cause Analysis Process to Increase Safety Event Reporting.

AORN JournalVolume 117, Issue 6 p. 399-402 Safety First Understanding the Root Cause Analysis Process to Increase Safety Event Reporting Kathleen A. Dudley BSN, RN, Corresponding Author Kathleen A. Dudley BSN, RN [email protected] Search for more papers by this author Kathleen A. Dudley BSN, RN, Corresponding Author Kathleen A. Dudley BSN, RN [email protected] Search for more papers by this author First published: 26 May 2023 https://doi.org/10.1002/aorn.13935 0.8: https://aorn.us/Jun23-sf Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Volume117, Issue6Special Focus Issue: AORN Post‐ConferenceJune 2023Pages 399-402 RelatedInformation

Medication Safety Event Reporting: Factors That Contribute to Safety Events During Times of Organizational Stress.

Incident reports submitted during times of organizational stress may reveal unique insights. To understand the insights conveyed in hospital incident reports about how work system factors affected medication safety during a coronavirus disease-2019 (COVID-19) surge. We randomly selected 100 medication safety incident reports from an academic medical center (December 2020 to January 2021), identified near misses and errors, and classified contributing work system factors using the Human Factors Analysis and Classification System-Healthcare. Among 35 near misses/errors, incident reports described contributing factors (mean 1.3/report) involving skill-based errors (n = 20), communication (n = 8), and tools/technology (n = 4). Reporters linked 7 events to COVID-19. Skill-based errors were the most common contributing factors for medication safety events during a COVID-19 surge. Reporters rarely deemed events to be related to COVID-19, despite the tremendous strain of the surge on nurses. Future efforts to improve the utility of incident reports should emphasize the importance of describing work system factors.

A natural language processing approach to categorise contributing factors from patient safety event reports

ObjectivesThe objective of this study was to explore the use of natural language processing (NLP) algorithm to categorise contributing factors from patient safety event (PSE). Contributing factors are elements in...

Long-Term Care Healthcare-Associated Infections in 2022: An Analysis of 20,216 Reports

Background The Pennsylvania Patient Safety Reporting System (PA-PSRS) is the largest database of patient safety event reports in the United States. In addition to over 4.5 million acute care reports, the PA-PSRS database contains more than 396,000 long-term care (LTC) healthcare-associated infection (HAI) reports. Methods LTC HAI data from PA-PSRS were extracted on March 1, 2023. Reports submitted by LTC facilities and specific care areas were included for infection rates each month if resident and device days were also entered in PA-PSRS for the facility and care area. Results A total of 20,216 infections were reported in 2022, representing a 12.5% increase from 2021. Overall, the reporting rate from LTC facilities increased from 0.77 in 2021 to 0.87 in 2022. Over half (56%) of the increase in overall rate is due to an increase in the respiratory tract infection rate, with another 27% due to an increase in the gastrointestinal infection rate. All six regions of the state had an increase in overall infection rate from 2021 to 2022. The North Central region of the state had the highest overall rate, as well as the largest increase in rate, with 1.14 reports per 1,000 resident days in 2022, which is an increase of 21.3% over the 2021 rate of 0.94. The Southeast region had the lowest overall rate, at 0.67, which is an 8.1% increase from 2021. The number of reports increased for all five infection types from 2021 to 2022, with gastrointestinal infections increasing the most percentagewise, by 67.7%. Of the 14 infection subtypes, 11 had an increase in number of reports from 2021 to 2022, with influenza showing the largest increase of 857 reports. Norovirus had a larger percentage increase of 942.9%, going from 70 reported infections in 2021 to 730 in 2022. The three subtypes that decreased in number had relatively smaller changes than the increases, with the largest of the decreases occurring with C. diff, which dropped by 29 reports from 2021 to 2022. Conclusions There was an increase in the total number and rate of infections reported to PA-PSRS in 2022. Patient Safety Authority infection preventionists continue to note operational challenges in LTC facilities and are providing ongoing education and guidance to enhance infection prevention and surveillance strategies and improve reporting of HAIs.

Patient Safety Trends in 2022: An Analysis of 256,679 Serious Events and Incidents From the Nation’s Largest Event Reporting Database

Background Pennsylvania is the only state that requires acute care facilities to report all events of harm or potential for harm. The Pennsylvania Patient Safety Reporting System (PA-PSRS) is the largest repository of patient safety data in the United States and one of the largest in the world, with over 4.5 million acute care event reports dating back to 2004. Herein, we examine patient safety event reports submitted to the PA-PSRS acute care database in 2022 and compare them to prior years. Methods We extracted data from PA-PSRS and obtained data from the Pennsylvania Health Care Cost Containment Council (PHC4). Counts of reports were calculated based on report submission date, and rates were calculated based on event occurrence date and calculated per 1,000 patient days for hospitals or 1,000 surgical encounters for ambulatory surgical facilities (ASFs). Results A total of 256,679 reports were submitted to PA-PSRS in 2022, representing an 11.1% decrease from 2021. Three facilities collectively submitted 18,601 fewer reports in 2022 compared to 2021, which accounted for 57.8% of the overall decrease. Reports of serious and high harm events increased by 7.7% and 11.1%, respectively. Of the 256,679 reports submitted, 95.9% were from hospitals, 3.9% were from ambulatory surgical facilities, and 0.2% were from birthing centers and abortion facilities. The vast majority of the 2022 reports were incidents (96.2%) as opposed to serious events (3.8%). For each of the past five years, the most frequently reported event type was Error Related to Procedure/Treatment/Test, accounting for 32.8% of all submitted acute care event reports in 2022. The second, third, and fourth most frequently reported event types in 2022 were Complication of Procedure/Treatment/Test, Medication Error, and Fall, accounting for 15.6%, 13.2%, and 12.8% of submitted reports, respectively. The reported event rate based on occurrence date for hospitals in the first half of 2022 was 27.5 reports per 1,000 patient days. For ASFs, the reported event rate for the first half of 2022 was 9.4 reports per 1,000 surgical encounters. Conclusions There was a decrease in the number of incident reports submitted to PA-PSRS in 2022 and an increase in serious and high harm event reports. PSA will continue to work with facilities, monitor reporting, and take further action as needed.

Assessing Equipment, Supplies, and Devices for Patient Safety Issues

Background: Medical equipment, supplies, and devices (ESD) serve a critical function in healthcare delivery and how they function can have patient safety consequences. ESD-related safety issues include malfunctions, physically missing ESDs, sterilization, and usability. Describing ESD-related safety issues from a human factors perspective that focuses on user interactions with ESDs can provide additional insights to address these issues. Methods: We manually reviewed ESD patient safety event reports submitted to the Pennsylvania Patient Safety Reporting System to identify ESD-related safety issues using a taxonomy that was informed by the Food and Drug Administration Manufacturer and User Facility Device Experience taxonomy. This taxonomy consisted of the following high-level categories: malfunctions, physically missing, sterilization, and usability. The type of ESD and associated components or ESD subtypes, event classification, and care area group were noted for each report. Results: Of the 450 reports reviewed, the most frequent ESD-related safety issue coded was malfunction (n=365 of 450, 81.1%) followed by sterilization (n=40 of 450, 8.9%), usability (n=36 of 450, 8.0%), and physically missing (n=9 of 450, 2.0%). Among the coded malfunctions, software/output problem (n=122 of 365, 33.4%) was the most frequent, followed by general malfunction (n=103 of 365, 28.2%); material integrity (n=72 of 365, 19.7%); and activation, positioning, or separation (n=68 of 365, 18.6%). The most frequent ESDs noted were infusion pump, instrument set, and intravenous, and the most frequent components/subtypes noted were alarm/alert, tubing, and tray. Conclusion: ESD-related patient safety issues, especially malfunctions, impact patient care despite current policies and practices to address these issues. Healthcare facilities may be able to address some ESD-related patient safety issues during procurement through use of the accompanying procurement assessment tool.

Outcomes in quality improvement and patient safety training: moving from in-person to synchronous distance education

BackgroundThe COVID-19 pandemic necessitated increased synchronous distance education (SDE) in graduate medical education, presenting challenges for Quality Improvement and Patient Safety (QIPS) best practices, which call for integration with daily...