Journal of Patient Safety最新文献

{"title":"Compensated Patient Injury Cases Due to Medication Errors in Finland During 2021 to 2023: A Cross-Sectional Register-Based Study.","authors":"Morag Tolvi, Lasse Rämö, Lotta Schepel","doi":"10.1097/PTS.0000000000001591","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001591","url":null,"abstract":"<p><strong>Objectives: </strong>To analyze follow-up data on medication errors (ME) in compensated patient claims in Finland from 2021 to 2023 and to discuss whether medication safety has improved since 2013 to 2014.</p><p><strong>Methods: </strong>This was a cross-sectional retrospective register-based study analyzing the case files of the Finnish Patient Insurance Centre (PIC) involving compensated patient injuries due to MEs. A descriptive quantitative analysis and a qualitative content analysis were conducted.</p><p><strong>Results: </strong>During the 3-year period, 1363 ME claims were filed, of which 262 (19%) were compensated. Most patients were female (n=156, 60%) and 60 to 69 years old (n=48, 18%). Errors occurred most during prescribing (n=164, 63%), monitoring (n=34, 13%), and administration phases (n=29, 11%). The most frequent types of errors were omission (n=49, 19%), incorrect diagnosis (n=33, 13%), and incorrect dosage (n=30, 11%). High-alert medications were involved in 104 (40%) cases. Severe harm was caused in 96 cases (37%) and death in 18 cases (7%). There was a significant association between high-alert medications and severe patient outcomes (χ2=26.6, P<0.001).</p><p><strong>Conclusions: </strong>Compared with the years 2013 to 2014, both the severity and the average annual number of compensated medication-related injuries have decreased. However, prescribing and monitoring remain the most error-prone phases of the medication process.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149018425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compliance With the World Health Organization Surgical Safety Checklist in the Operating Room at the National Referral Hospital, Bhutan: A Cross-Sectional Quality Assessment.","authors":"Karma Sherub, Yin M Than, Yeshey Dorjey, Tashi Norbu","doi":"10.1097/PTS.0000000000001593","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001593","url":null,"abstract":"<p><strong>Objectives: </strong>This quality assessment was conducted to determine the compliance rate of the modified WHO Surgical Safety Checklist at the National Referral Hospital, Bhutan.</p><p><strong>Methods: </strong>A cross-sectional study was conducted as a quality improvement assessment in the Operating Room (OR) at the National Referral Hospital, Bhutan. All the elective surgical procedures performed under general and/or spinal anesthesia were included. Compliance with the Sign In, Time Out and Sign Out domains was assessed.</p><p><strong>Results: </strong>In the Sign In domain, patient identity was confirmed in 76.4% of cases, and the anesthesia safety checklist was appropriately completed in 75.2% of procedures. In the Time Out domain, the status of preoperative antibiotic prophylaxis was verbally confirmed in only half of the cases. In the Sign Out domain, correct counting of instruments and gauze and complete specimen labeling were ensured in merely one-fourth of the procedures (24.8%). The composite compliance rates for the surgical safety checklist domains were 46.4% for Sign In, 24.8% for Time Out, and 5.2% for Sign Out. Compliance varied significantly across checklist domains and surgical specialties. Compliance also declined significantly as checklist administration progressed, from 76.4% for the first item to 6.4% for the final item (r=-0.93, P<0.001). This decline in the Sign Out domain was consistent across surgical specialties (χ2=8.26, df=5, P=0.142).</p><p><strong>Conclusion: </strong>The surgical safety checklist is underutilized, with overall compliance being low, particularly in the Sign Out domain, underscoring the need for targeted interventions to improve adherence.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149013218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blind Spots in Safety: A Qualitative Document Review of Incident Analysis Frameworks-Implications and Practice Recommendations.","authors":"Light B Chiotu","doi":"10.1097/PTS.0000000000001592","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001592","url":null,"abstract":"<p><p>Although incident analysis frameworks guide the investigation of safety events and foster organizational learning, few studies have evaluated the extent to which they incorporate social factors [Diversity, Equity, Inclusion, and Belonging (DEIB)] and Just Culture principles. A qualitative document analysis was used to evaluate 6 healthcare incident analysis frameworks published between 2012 and 2025 (M=2019.7, SD = 4.61). Frameworks were evaluated using a purpose-built JUST-DEIB Assessment Integration Tool (J-DAIT) against 10 predefined criteria. The analysis used both thematic and descriptive approaches. Findings revealed recurring inconsistencies in how DEIB and Just Culture principles were operationalized across frameworks. Only 2 of the 6 frameworks explicitly addressed cultural safety and health equity, while attention to culturally responsive practice, structural inequities, and the inclusion of marginalized groups was limited. While the frameworks demonstrated strengths in supporting system-level learning, the majority often fail to fully embed equity, psychological safety, and culturally responsive practices. Incident analysis frameworks must explicitly integrate cultural safety and health equity; strengthen mechanisms for meaningful engagement of patients, families, and other service users as active partners; prioritize the inclusion of racialized and historically marginalized populations; and incorporate structured processes for recognizing and mitigating cognitive and systemic bias. Including these factors results in more equitable safety outcomes, since certain groups experience a higher incidence of recurrent and unrecognized harm.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Safety Gaps in Rheumatology: A Mixed-Methods Study.","authors":"Catherine Nasrallah, Cherish Wilson, Jessica Fitzpatrick, Alicia Hamblin, Gabriela Schmajuk, Jinoos Yazdany","doi":"10.1097/PTS.0000000000001586","DOIUrl":"10.1097/PTS.0000000000001586","url":null,"abstract":"<p><strong>Objectives: </strong>To identify facilitators and barriers to implementing patient safety measures in rheumatology practice by integrating national performance data with the Consolidated Framework for Implementation Research (CFIR)-guided interviews. Findings will yield practical, actionable recommendations to improve implementation and reduce preventable gaps in patient safety across US rheumatology practices.</p><p><strong>Methods: </strong>We conducted an explanatory mixed-methods study using data from the American College of Rheumatology's (ACR) Rheumatology Informatics System for Effectiveness (RISE) registry and semistructured interviews with practice personnel, guided by CFIR. Practice-level performance on patient safety measures was quantified, and RISE practices were purposively sampled across performance strata for interviews. Supplemental interviews were conducted at academic medical centers (AMCs) and Veterans Affairs (VA) sites not represented in RISE. Between June and December 2024, we interviewed 21 participants across 19 rheumatology practices regarding clinical workflows, barriers, facilitators, and opportunities for improvement related to medication safety. Transcripts were thematically analyzed using both CFIR-based deductive and inductive coding.</p><p><strong>Results: </strong>The study included 11 RISE community practices, 5 AMCs, and 3 VA practices. Implementation of safety measures was shaped by workflow design, staffing, organizational support, and electronic health record (EHR) functionality. Facilitators included previsit chart review, protocolized workflows, pharmacist involvement, EHR alerts, automated dose calculations, and performance feedback. Barriers included limited access to external test results, unstructured documentation, manual data entry, workload pressures, and incomplete patient testing.</p><p><strong>Conclusions: </strong>Reliable implementation of rheumatology safety measures depends on strong workflows, team-based accountability, and robust data infrastructure. Improving safety will require investment in structured documentation, interoperable EHR tools, and systems to support patient follow-up.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148992043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mapping Compounding Medication Errors and Contributing Factors in Hospital Pharmacy: A Scoping Review.","authors":"Renata Barbosa, Susana Fraga, Fátima Baltazar, Fernando Fernandez-Llimos","doi":"10.1097/PTS.0000000000001580","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001580","url":null,"abstract":"<p><p>Medication errors in hospital pharmacy compounding pose a significant patient safety risk due to complex workflows, high-risk products, and system-level vulnerabilities encompassing human, technological, and organizational factors. Compounding errors may lead to clinically significant patient harm, including treatment failure, toxicity, prolonged hospitalization, irreversible morbidity, and death. Understanding incident types and their contributing factors is essential for designing targeted safety interventions. Accordingly, this scoping review aimed to map incidents reported in the literature, including medication errors and near misses, and to identify contributing factors associated with the medicine compounding process in hospital pharmacy. A systematic scoping review was conducted following the Joanna Briggs Institute and PRISMA-ScR guidelines and was previously registered on the Open Science Framework. Searches in PubMed, Scopus, and Web of Science were performed without date restrictions. Titles, abstracts, and full texts were screened independently by 2 reviewers, with disagreements resolved through discussion or by including a third reviewer. Data extraction used a standardized template to capture incident and drug type, pharmaceutical form, compounding stage, and contributing factors, and to categorize them according to international patient safety frameworks. From the 763 identified articles, 58 were included. Errors most frequently involved incorrect formulation, incorrect drug or ingredient selection, and dose or concentration deviations. Incidents were concentrated in early and intermediate stages of the compounding process, particularly prescription validation, formulation, and preparation. Staff-related issues, including attention, fatigue, and emotional factors, as well as work environment and organizational factors, were the most frequently reported. In conclusion, compounding errors mainly arise from vulnerabilities in key stages of the compounding process and from interacting staff-related, environmental, and organizational factors. Systematic screening of compounded errors and their contributing factors highlights the need for continuous improvement, thereby strengthening patient safety in hospital pharmacy practice.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Workplace Distractions and Patient Safety Culture in Operating Rooms: A Cross-Sectional Study.","authors":"Sinem Gecit, Alper Akyuz, Meryem Yavuz van Giersbergen","doi":"10.1097/PTS.0000000000001576","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001576","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this study was to examine the association between operating room distractions and patient safety culture among multidisciplinary perioperative professionals.</p><p><strong>Methods: </strong>This cross-sectional study was conducted in the operating rooms of a university hospital in western Türkiye between October and December 2025. Data were collected from 80 health care professionals (30 nurses, 30 physicians, and 20 anesthesia technicians) using the Operating Room Distractions Index and the Hospital Survey on Patient Safety Culture 2.0. Descriptive statistics, one-way analysis of variance, and Pearson correlation analysis were performed.</p><p><strong>Results: </strong>Nurses reported significantly higher distraction frequency than anesthesia technicians and physicians across several operating room distraction dimensions, with moderate to large effect sizes (η2=0.16-0.29). Communication-related distractions showed significant differences in contribution to error and target blocking, suggesting that communication interruptions may disrupt thought processes and increase the potential for error. Overall distraction frequency was negatively associated with organizational learning-continuous improvement (r=-0.229, P=0.041) and patient safety support from supervisors and clinical leaders (r=-0.233, P=0.037). No significant correlations were observed between distraction frequency and other patient safety culture dimensions.</p><p><strong>Conclusions: </strong>Perceived operating room distractions varied across professional roles and were selectively associated with key dimensions of patient safety culture, particularly organizational learning. Communication-related interruptions may be especially important because they can disrupt thought processes and task progression. Addressing modifiable environmental and communication-related disruptions and strengthening system-level safety processes may contribute to safer surgical care.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of Safety Incidents and Implementation of Recommendations in Spanish Pediatric Emergency Departments: Results of a Multicenter Study.","authors":"Maria Garcia de Oteyza, Yordana Acedo Alonso, Leticia Bueso-Inchausti García, María Suárez-Bustamante Huélamo, Carmen Campos Calleja, Rocio Rodrigo García, Marta Plata Gallardo, Sofía Mesa García, Carmen Solano Navarro, Esther García Requena, Abel Martínez Mejías, Monica Hortiguela Aparicio, Isabela Adelina Albiciuc, Victoria López Corominas, Jose Lorenzo Guerra Diez, Mariano Plana Fernández, Estíbaliz Garrido García, Ana Jové-Blanco, Rafael Marañón","doi":"10.1097/PTS.0000000000001587","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001587","url":null,"abstract":"<p><strong>Objectives: </strong>There are few studies in the literature that analyze which methods are most commonly used to analyze safety incidents in pediatric emergency departments (PEDs) and which recommendations are established. The main objective of this study was to identify the incidents most frequently reported in PEDs and their characteristics. The secondary objectives were to analyze the factors that may influence the occurrence of adverse events, identify the tools most commonly used in incident analysis, and analyze the safe practices most frequently recommended.</p><p><strong>Methods: </strong>A retrospective multicenter study was conducted involving hospitals belonging to the RISEUP network. Incidents that occurred between January and December 2024 in the different participating centers reported through a computerized registration system were included.</p><p><strong>Results: </strong>A total of 580 incidents were reported, involving 17 hospitals. The most frequently reported incidents were miscellaneous, followed by medication, with dosing errors being the most common subtype. A total of 190 adverse events occurred. A recommendation was made in 397 (68.4%) of the reported incidents; most of them were weak in terms of strength, based on communication with staff, new operating procedures, and health education. When stratifying the strength by harm severity, weak recommendations remained the predominant in all the categories of harm. A total of 86.1% of the recommendations were implemented.</p><p><strong>Conclusions: </strong>In most of the reported incidents, a recommendation was made and implemented. However, most recommendations were classified as weak in terms of their potential to improve patient safety, highlighting the need for the development and adoption of more robust safety interventions in pediatric emergency departments.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pulmonary Function Test Order Redesign: A Quality Improvement Initiative.","authors":"Saurabh Sujanyal, Elcin Omercikoglu, Heba Alazab, Angie Griffin, Tapendra Koirala, Charles Burger, Lisa Beagle, Shannon Atkins, Scott A Helgeson","doi":"10.1097/PTS.0000000000001590","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001590","url":null,"abstract":"<p><strong>Objectives: </strong>Pulmonary function tests (PFTs) are essential for diagnosis, management, and follow-up of a wide range of respiratory conditions as they provide quantitative insights into various aspects of lung function. Precision in ordering and scheduling PFTs, like any test, is crucial as errors can lead to misdiagnoses, delayed treatments, unnecessary retesting, inflated healthcare costs, and potentially compromised patient care. Hence, the aim of this quality improvement initiative was to reduce the PFT ordering error rate to below 5% by redesigning the ordering workflow and implementing a standardized order set tailored to specific clinical scenarios.</p><p><strong>Methods: </strong>The quality improvement initiative was implemented from August 2023 to March 2024. Data was collected from the electronic medical record (EMR) using predefined operational definitions to identify incorrect PFT orders and scheduling errors. A redesigned orderset was created to align with specific clinical presentations, including symptoms, suspected diagnosis, confirmed diagnosis, and presurgical evaluation. Scheduling was also restructured to match the expected testing time for each category. Education sessions were conducted with ordering providers, and ongoing feedback loops were established.</p><p><strong>Results: </strong>Among 575 preintervention PFT orders, 130 (22.6%) contained errors. Following implementation, review of 607 postintervention orders showed a reduction in error rates to 4.1%, representing an ∼80% improvement (P<0.01). There was no increase in unnecessary testing, supporting the effectiveness of the intervention without unintended negative consequences.</p><p><strong>Conclusions: </strong>Implementation of a knowledge-based CDSS with standardized order sets significantly reduced PFT ordering errors and variability, improving guideline adherence and care quality. Continued refinement and integration with evolving technologies are essential for broader applicability.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reported Transfusion-related Patient Safety Incidents in South Korea: A Nationwide Analysis of a Voluntary Reporting System, 2016 to 2024.","authors":"Eunyoung Hong, Youngmi Kang","doi":"10.1097/PTS.0000000000001589","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001589","url":null,"abstract":"<p><strong>Objective: </strong>This study analyzed transfusion-related patient safety incidents reported to the Korea Patient Safety Reporting and Learning System by tertiary and general hospitals between 2016 and 2024 to characterize national reporting trends, describe nurse involvement characteristics, and identify factors associated with harm among reported incidents.</p><p><strong>Methods: </strong>The 285 reported incidents were analyzed using statistical process control, Poisson and Joinpoint regression, and Firth penalized logistic regression. As no transfusion episode denominator exists, measures are proportions of reported incidents, not incidence rates.</p><p><strong>Results: </strong>The number of reported incidents increased from 2 in 2016 to 47 in 2023, although their proportion among all reported patient safety incidents declined; the crude reporting rate for 2017 to 2024 was 0.84 per 100,000 blood components supplied. Outcomes encompassed near miss (15.4%), no harm (48.8%), mild harm (26.3%), and moderate harm or worse (9.5%), with special-cause variation observed only in 2017. Following the 2021 amendment, harm reports decreased from 41.9% to 30.7% but were unchanged excluding near misses (41.9% vs. 41.8%), whereas moderate harm or worse increased from 5.1% to 16.4% (P=0.009). Nurses accounted for 59.8% of 425 involvements; high-risk locations independently predicted harm (adjusted odds ratio=2.49, 95% CI: 1.29-4.86).</p><p><strong>Conclusions: </strong>Transfusion-related patient safety incidents in Korea are concentrated in high-acuity settings, comprising a significant proportion of nursing personnel. Translating these results into safer transfusion practices will necessitate shifting from individual vigilance to structural resilience through setting-specific safety protocols in high-risk locations, enhanced nursing support and competency building, and improved national hemovigilance infrastructure.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immune Checkpoint Inhibitor-related Adverse Events in Publicly Accessible United States Malpractice Records: A Systematic Legal Database Review, 2015 to 2026.","authors":"Jessica B Almeida, Glen J Weiss","doi":"10.1097/PTS.0000000000001585","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001585","url":null,"abstract":"<p><strong>Objectives: </strong>By 2023, an estimated 56.7% of US patients with advanced or metastatic cancer were eligible for immune checkpoint inhibitor (ICI) therapy. Grade 3 to 4 immune-related adverse events (irAEs) occur in ∼14% to 21% of patients depending on regimen, yet publicly accessible malpractice records involving ICI administration or irAE management have not been systematically described.</p><p><strong>Methods: </strong>We searched Lexis+ and Westlaw Advantage for publicly accessible US malpractice records filed from January 1, 2015, through March 31, 2026. Sources included jury verdicts and settlement databases, federal and state dockets, and briefs, pleadings, and motions databases. Cases were included only when ICI administration, indication selection, toxicity counseling, toxicity recognition, toxicity monitoring, or irAE management was causally central to the alleged negligence.</p><p><strong>Results: </strong>Among 38 legal matters identified after cross-platform deduplication, 4 met eligibility criteria. These matters reflected 4 pleaded negligence theories: inappropriate ICI indication, toxicity counseling and informed-consent failure, irAE mismanagement, and treatment-related multiorgan toxicity. Publicly visible irAE-centered malpractice records were rare relative to the clinical burden, but the data do not support a national litigation incidence estimate.</p><p><strong>Conclusions: </strong>Publicly accessible irAE-centered malpractice records appear rare. As ICI use expands, litigation risk may increasingly focus on indication documentation, individualized toxicity counseling, and structured monitoring.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}