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Background: Up to half of all surgical adverse events are due to non-technical errors, making non-technical skill assessment and improvement a priority. No specific tools are available to retrospectively identify non-technical errors that have occurred in surgical patient care. This original study aimed to develop and provide evidence of validity and inter-rater reliability for the System for Identification and Categorization of Non-technical Error in Surgical Settings (SICNESS)., Methods: A literature review, modified Delphi process, and two pilot phases were used to develop and test the SICNESS tool. For each pilot, 12 months of surgical mortality data from the Australian and New Zealand Audit of Surgical Mortality were assessed by two independent reviewers using the SICNESS tool. Main outcomes included tool validation through modified Delphi consensus, and inter-rater reliability for: non-technical error identification and non-technical error categorization using Cohen's κ coefficient, and overall agreement using Fleiss' κ coefficient., Results: Version 1 of the SICNESS was used for pilot 1, including 412 mortality cases, and identified and categorized non-technical errors with strong-moderate inter-rater reliability. Non-technical error exemplars were created and validated through Delphi consensus, and a novel mental model was developed. Pilot 2 included an additional 432 mortality cases. Inter-rater reliability was near perfect for leadership (κ 0.92, 95% c.i. 0.82 to 1.00); strong for non-technical error identification (κ 0.89, 0.84 to 0.93), communication and teamwork (κ 0.89, 0.79 to 0.99), and decision-making (κ 0.85, 0.79 to 0.92); and moderate for situational awareness (κ 0.79, 0.71 to 0.87) and overall agreement (κ 0.69, 0.66 to 0.73)., Conclusion: The SICNESS is a reliable and valid tool, enabling retrospective identification and categorization of non-technical errors associated with death, occurring in real surgical patient interactions., (© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.)

Objectives: Medical errors and complications pose a major threat to the safety of healthcare systems worldwide. This article was hence aimed at determining the current burden of complications of medical and surgical care in the US., Methods: We searched the latest version of the US Centers for Disease Control and Prevention (CDC) WONDER online database (years 2018-2022) using ICD-10 codes Y40-Y84 (complications of medical and surgical care)., Results: The age-adjusted death rate for complications of medical and surgical care increased from 1.17 × 100,000 in 2018 to 1.49 × 100,000 in 2021, but then declined to 0.85 × 100,000 in 2022. The gender-specific analysis showed a similar trend, with the age-adjusted death rate values always being higher in men than in women. A clear age-dependent relationship was also found in the crude mortality rate for complications of medical and surgical care, as higher death rates were observed in older patients., Conclusions: This analysis reveals that the burden of complications of medical and surgical care has increased over time, especially during the COVID-19 pandemic, but has then considerably declined in 2022. However, root cause analysis and actions are still needed for preventing the still noticeable consequences of medical complications., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: Patient injury claims data and insurance records provide detailed information on patient injuries. This study aimed to identify the errors and adverse events that led to patient injuries in vascular surgery for the treatments of abdominal aortic aneurysms (AAA) and iliac artery aneurysms (IAA) in Finland. The study also assessed the severity and preventability of the injuries., Materials and Methods: A retrospective analysis of Finnish Patient Insurance Centre's insurance charts of compensated patient injuries in the treatment of AAA and IAA. Records of all compensated patient injury claims involving AAA and IAA between 2004 and 2017 inclusive were reviewed. Contributing factors to injury were identified and classified. The injuries were assessed for their preventability by using the WHO Surgical Safety Checklist correctly. The degree of harm was graded by Clavien-Dindo classification., Results: Twenty-six patient injury incidents were identified in the treatment of 23 patients. Typical injuries involved delays in diagnosis or treatment, errors in surgical technique or injuries to adjacent anatomic organs. Three (13.0%) patients died due to patient injury. Two deaths were caused by delays in diagnosis of ruptured abdominal aortic aneurysm (RAAA) and the third death was due to missed diagnosis of post-operative myocardial infarction. Retained foreign material caused injuries to two (8.7%) patients. One (4.3%) patient had a severe postoperative infection. Three (13.0%) patients experienced an injury to an adjacent organ. One patient had a bilateral and another a unilateral above-the-knee amputation due to patient injury. Three injuries were considered preventable. Most harms were grade IIIb Clavien-Dindo classification in which injured patients required a surgical intervention under general anesthesia., Conclusions: Compensated patient injuries involving the treatment of AAA and IAA are rare, but are often serious. Injuries were identified during all stages of care. Most injuries involved open surgical procedures., (Copyright © 2021 Elsevier Inc. All rights reserved.)

This CIRSE Standards of Practice document is developed by an expert writing group under the guidance of the CIRSE Standards of Practice Committee. It aims to assist Interventional Radiologists in their daily practice by providing best practices for conducting meetings on morbidity and mortality.

Objective: Transcarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them., Methods: The U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA., Results: A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail., Conclusions: In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Patient and family involvement is high on the international quality and safety agenda. In this paper, we consider possible ways of involving families in investigations of fatal adverse events and how their greater participation might improve the quality of investigations. The aim is to increase awareness among healthcare professionals, accident investigators, policymakers and researchers and examine how research and practice can develop in this emerging field. In contrast to relying mainly on documentation and staff recollections, family involvement can result in the investigation having access to richer information, a more holistic picture of the event and new perspectives on who was involved and can positively contribute to the family's emotional satisfaction and perception of justice being done. There is limited guidance and research on how to constitute effective involvement. There is a need for co-designing the investigation process, explicitly agreeing the family's level of involvement, supporting and preparing the family, providing easily accessible user-friendly language and using different methods of involvement (e.g. individual interviews, focus group interviews and questionnaires), depending on the family's needs., (© The Author(s) 2020. Published by Oxford University Press in association with the International Society for Quality in Health Care.)

Background: In medical and surgical departments around the world, morbidity and mortality conferences (MMC) serve dual roles: they are cornerstones of quality-improvement programs and provide timely opportunities for education within the urgent context of clinical care. Despite the widespread adoption of MMCs, adverse events and preventable errors remain high or incompletely characterized, and opportunities to learn from and adjust to these events are frequently lost. This review examines the published literature on strategies to improve surgical MMCs., Methods: We searched OVID Medline, PubMed, Embase and CENTRAL. We defined our combination of search terms using a PICO (population, intervention, comparison, outcome) model, focusing on the use of MMCs in general surgery., Results: The MMC literature focused on 5 themes: educational value, error analysis, case selection and representation, attendance and dissemination. Strategies used to increase educational value included limiting case presentation time to 15-20 minutes, mandatory brief literature reviews, increasing audience interaction, and standardizing presentations using a PowerPoint template or SBAR (situation, background, assessment, recommendation) format. Interventions to improve error analysis included focused discussion on causative factors and taxonomic error analysis. Case selection was improved by using an electronic clinical registry, such as the National Surgery Quality Improvement Program, to better capture incidence of morbidity and mortality. Attendance was improved with teleconferencing. Dissemination strategies included MMC newsletters, incorporating MMCs into plan-do-check-act cycles, and surgeon report cards., Conclusion: Greater standardization of best practices may increase the quality improvement and educational impact of MMCs and provide a baseline to measure the effect of new MMC format innovations on the clinical and educational performance of surgical systems., Competing Interests: C. Ball is co-editor in chief of CJS; he was not involved in the review or decision to accept this paper for publication. No other competing interests were declared., (© 2020 Joule Inc. or its licensors.)

Objective: To analyze malpractice cases involving hemodialysis access to prevent future litigation and improve physician education., Methods: Jury verdict reviews from the WESTLAW database from 1 January 2005 to 1 January 2015 were reviewed. The search terms "hemodialysis," "dialysis," "graft," "fistula," "AVG," "AVF," "arteriovenous," "catheter," "permacatheter," and "shiley" were used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict., Results: Sixty-six cases involving the litigation pertaining to hemodialysis catheter, arteriovenous fistula (AVF) or arteriovenous grafts (AVGs) were obtained. Of these, 55% involved catheter-based hemodialysis access, 18% involved AVF, and 27% involved AVG. The most frequent physician defendants were vascular surgeons (36%), internists (14%), nephrologists (14%), general surgeons (9%), and interventional radiologists (6%). Of the patients, 38% involved were male and the average patient age was 56.3 (standard deviation (SD) = 20.1) years. Region of injury was 50% in the neck or chest, 42% in the arm, and 8% in the groin. Injury was listed as death in 79% of cases. Of the deaths, 95% involved bleeding at some point in the chain of events. The most common claims related to the cases were failure to perform the surgery or procedure safely (44%), failure to diagnose and treat in a timely manner (30%), and negligent hemodialysis treatment (11%). The most common complications cited were hemorrhage (62%), loss of function of limb (15%), and ischemia due to steal syndrome (11%). A total of 26 cases (39%) were found for the plaintiff or settled. The median award was US$463,000 with a mean of US$985,299 (SD = US$1,314,557)., Conclusion: While popular opinion may indicate that steal syndrome is a commonly litigated complication, our data reveal that the most common injury litigated is death which may frequently be the result of a hemorrhagic episode. In addition to hemorrhage, the remaining most common complications included steal syndrome and loss of limb function. Therefore, steps to better prevent, diagnose and treat bleeding, nerve injury, and steal syndrome in a timely manner are critical to preventing hemodialysis-access-associated litigation.

Background: A systematic review of low-risk death has been shown successful in identifying system weaknesses. The aim was to analyse early mortality in low-risk patients undergoing cardiac surgery and to determine the cause of death, classify if they were unavoidable or potentially preventable as a result of technical or system errors., Methods: We included all low-risk patients who underwent cardiac surgery at our institution from 1 September 2009 to 31 August 2019. In patients operated between 2009 and 2011, we defined low risk as an additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) I less than or equal to 3, and from 2012 and onwards as a EuroSCORE II less than or equal to 1.5. The medical records for the patients who died within 30 days of surgery were thoroughly examined and the cause of death was classified as cardiac or non-cardiac. Furthermore, deaths were categorised as not preventable, preventable (technical error) or preventable (system error)., Results: During the study period 3103 low-risk patients underwent surgery, and 11 patients died within 30 days of the operation (0.35%). Six of these (55%) were classified as preventable and five non-preventable. Four of the preventable deaths were classified as technical errors and two were due to system errors., Conclusions: A repeated systematic review of deaths in patients with a low preoperative risk showed that a majority of deaths were preventable, and therefore potentially avoidable. Similar to the previous assessment at our unit, mortality was very low and failure to communicate remains a modifiable factor that should be addressed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Medication administration errors may contribute to patient mortality, thus additional understanding of such incidents is required., Objectives: To analyse medication administration errors reported in acute care resulting in death, to identify the drugs concerned, and to describe medication administration error characteristics (location of error, error type, patient's age) by drug group., Methods: Medication administration errors reported in acute care in 2007 ̶ 2016 (n = 517,384) were obtained from the National Reporting and Learning System for England and Wales. Incidents reported as resulting in death (n = 229) were analysed. Drugs were classified by two researchers using the British National Formulary. Drug categories were described by medication administration errors' year, location, patient age, and error category based on the incidents' original classification., Results: Errors were most often reported on wards (66.4%, n = 152), and in patients aged over 75 years (41.5%, n = 95). The most common error category was omitted medicine or ingredient (31.4%, n = 72); most common drug groups were cardiovascular (20.1%, n = 46) and nervous system (10.0%, n = 23). Most errors in patients under 12 years concerned drugs to treat infection; cardiovascular drugs were most common among other age groups., Conclusions: In order to prevent these most serious of medication administration errors, interventions should focus on avoiding dose omissions, and administration of drugs for patients over 75 years old, as well as safe administration of parenteral anticoagulants and antibacterial drugs., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Keeping patients safe while they receive medical care is essential. Yet current systems designed to ensure patient safety are not enough, because medical error is the third leading cause of preventable deaths in the United States. Clinicians can partner with the patient to enhance patient safety. Pulse Center for Patient Safety proposes patient- and family-driven processes designed to improve a patient's chances of avoiding harm. This article discusses highlights of the role of patient safety through a grassroots lens, summarizes the factors that influence the patient's role in patient safety and reviews recommendations on how clinicians can partner with patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To examine if clustering of root causes of sentinel events (SEs) can contribute to organisational improvement of healthcare and patient safety by providing insight into organisational risk factors, patterns and trends., Design: Retrospective, cross-sectional review of SEs from a hospital database reported to the Board of directors in 2016., Setting: A regional teaching hospital in the Netherlands., Intervention(s): Clustering of characteristics and variables of SEs to establish vulnerabilities and patterns of failure factors of the organisation., Main Outcome Measure(s): Characteristics and contributory causes of failure of SEs identified via root cause analysis (RCA). Outcomes reported using descriptive statistics., Results: A total of 21 events were included involving 21 patients. Mean age was 56.7 years (SD 24.4), 71.4% were above 50 years of age. In 81.8%, the care was multi-disciplinary and in 76.2% the event resulted in permanent harm or injury. Of the 132 identified contributory root causes, most were related to human factors (53.8%) and organisational factors (40.2%). Technical and patient-related factors were identified in 3.0%. Organisational improvement strategies focused on the care of elderly patients, patients subjected to multi-disciplinary care and on improving knowledge, protocols and coordination of care., Conclusion: Clustering variables of SEs and contributory factors of failure through RCA helps to delineate a hospital-specific profile by providing a detailed insight into risk factors, patterns and trends in an organisation and to determine the best strategies for improvement by drawing lessons across events., (© The Author(s) 2018. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Analyzing mortality in a mature trauma system is useful to improve quality of care of severe trauma patients. Standardization of error reporting can be done using the classification of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). The aim of our study was to describe preventable deaths in our trauma system and to classify errors according to the JCAHO taxonomy., Methods: We performed a six-year retrospective study using the registry of the Northern French Alps trauma network (TRENAU). Consecutive patients who died in the prehospital field or within their stay at hospital were included. An adjudication committee analyzed deaths to identify preventable or potentially preventable deaths from 2009 to 2014. All errors were classified using the JCAHO taxonomy., Results: Within the study period, 503 deaths were reported among 7484 consecutive severe trauma patients (overall mortality equal to 6.7%). Seventy-two (14%) deaths were judged as potentially preventable and 36 (7%) deaths as preventable. Using the JACHO taxonomy, 170 errors were reported. These errors were detected both in the prehospital setting and in the hospital phase. Most were related to clinical performance of physicians and consisted of rule-based or knowledge based failures. Prevention or mitigation of errors required an improvement of communication among caregivers., Conclusions: Standardization of error reporting is the first step to improve the efficiency of trauma systems. Preventable deaths are frequently related to clinical performance in the early phase of trauma management. Universal strategies are necessary to prevent or mitigate these errors., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Importance: More than 20 years have passed since the first publication of estimates of the extent of medical harm occurring in hospitals in the United States. Since then, considerable resources have been allocated to improve patient safety, yet policymakers lack a clear gauge of the progress made., Objectives: To quantify the cause-specific mortality associated with adverse effects of medical treatment (AEMT) in the United States from 1990 to 2016 by age group, sex, and state of residence and to describe trends in types of harm and associations with other diseases and injuries., Design, Setting, and Participants: Cohort study using 1990-2016 data on mortality due to AEMT from the Global Burden of Diseases, Injuries, and Risk Factors (GBD) 2016 study, which assessed death certificates of US decedents., Exposures: Death with International Classification of Diseases (ICD)-coded registration., Main Outcomes and Measures: Mortality associated with AEMT. Secondary analyses were performed on all ICD codes in the death certificate's causal chain to describe associations between AEMT and other diseases and injuries., Results: From 1990 to 2016, there were an estimated 123 603 deaths (95% uncertainty interval [UI], 100 856-163 814 deaths) with AEMT as the underlying cause. Despite an overall increase in the number of deaths due to AEMT over time, the national age-standardized mortality rate due to AEMT decreased by 21.4% (95% UI, 1.3%-32.2%) from 1.46 (95% UI, 1.09-1.76) deaths per 100 000 population in 1990 to 1.15 (95% UI, 1.00-1.60) deaths per 100 000 population in 2016. Men and women had similar rates of AEMT mortality, and those 70 years or older had mortality rates nearly 20-fold greater compared with those aged 15 to 49 years (mortality rate in 2016 for both sexes, 7.93 [95% UI, 7.23-11.45] per 100 000 population for those aged ≥70 years vs 0.38 [95% UI, 0.34-0.43] per 100 000 population for those aged 15-49 years). Per 100 000 population, California had the lowest age-standardized AEMT mortality rate at 0.84 deaths (95% UI, 0.57-1.47 deaths), whereas Mississippi had the highest mortality rate at 1.67 deaths (95% UI, 1.19-2.03 deaths). Surgical and perioperative events were the most common subtype of AEMT, accounting for 63.6% of all deaths for which an AEMT was identified as the underlying cause., Conclusions and Relevance: This study's findings suggest a modest reduction in the mortality rate associated with AEMT in the United States from 1990 to 2016 while also observing increased mortality associated with advancing age and noted geographic variability. The annual GBD releases may allow for tracking of the burden of AEMT in the United States.

Introduction: We aimed to determine how serious adverse events in obstetrics were assessed by supervision authorities., Material and Methods: We selected cases investigated by supervision authorities during 2009-2013. We analyzed information about who reported the event, the outcomes of the mother and infant, and whether events resulted from errors at the individual or system level. We also assessed whether the injuries could have been avoided., Results: During the study period, there were 303 034 births in Norway, and supervision authorities investigated 338 adverse events in obstetric care. Of these, we studied 207 cases that involved a serious outcome for mother or infant. Five mothers (2.4%) and 88 infants (42.5%) died. Of the 207 events reported to the supervision authorities, patients or relatives reported 65.2%, hospitals reported 39.1%, and others reported 4.3%. In 8.7% of cases, events were reported by more than 1 source. The supervision authority assessments showed that 48.3% of the reported cases involved serious errors in the provision of health care, and a system error was the most common cause. We found that supervision authorities investigated significantly more events in small and medium-sized maternity units than in large units. Eighteen health personnel received reactions; 15 were given a warning, and 3 had their authority limited. We determined that 45.9% of the events were avoidable., Conclusions: The supervision authorities investigated 1 in 1000 births, mainly in response to complaints issued from patients or relatives. System errors were the most common cause of deficiencies in maternity care., (© 2018 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Fear remains a major barrier to transparency of hospital errors.

The recent surge in medical disputes requires that more attention be paid to the voices of laypeople. This article explores the argumentative nature of the public discourse of the reported "malpractice mobs" that strive to convince members of the public (in the place of health or legal experts) that they have been victims of medical errors and injustice. This case-based qualitative empirical study uses a pragma-dialectical approach to suggest a prototypical pattern of such public appeals that contains a basic argumentative pattern and various types of extensions. The presence and influence of cultural factors are identified and discussed. The results of the analysis indicate that "malpractice mobs" largely display a tendency to target certain drugs, treatments or therapeutic methods based on folk interpretations of medical phenomena among individual ethnic groups, which may be regarded as cultural preferences in the medical domain. Although these preferences have little coercive power, in the absence of institutional restraints, they may have a powerful impact. The introduction of cultural preferences into pragmatic argumentation explains not only why some critical questions are emphasized (whereas others are invariably ignored) but also why certain types of support are repeatedly demanded in public appeals. The findings suggest the importance of paying greater attention to the argumentation of laypeople in medical disputes in China and the essential role of a culturally sensitive model of argumentation theory in improving health communication.

Background: The American Society of Anesthesiologists (ASA) physical classification system was developed for assessing anaesthetic risk, but is often also used to estimate surgical death risk. Patients with low ASA grades (ASA 1 or 2) are expected to have better surgical outcomes than patients with higher ASA grades (ASA ≥ 4). This study examined the course to death in patients classified as ASA 1 or 2 was examined, to investigate possible factors in unexpected deaths, in addition to evaluating the use of ASA grades by clinicians., Methods: Patient data from the national surgical mortality audit of Australian hospitals were examined. The patient group was listed as ASA grade 1 or 2 by surgeons. Patients over 60 or under 20 were excluded in the final analysis, as were cases from New South Wales due to data not being available. A total of 357 cases were examined. Assessor summaries of the cases were examined, and ASA score reassessed to determine accuracy., Results: More than 95% (n = 339) of cases listed as ASA 1 or 2 were found to have an incorrectly low grade, with 17.6% (n = 63) of cases listed as "expected" deaths., Conclusion: ASA grades appear to be misunderstood in the reporting of patient surgical risk. Many patient summaries list patients with severe systemic disease or expected deaths as ASA 1 or 2, contrary to the intended use of this classification system. Improved education on the use of the ASA grading system would be beneficial to clinicians.

Background: Search filter development for adverse effects has tended to focus on retrieving studies of drug interventions. However, a different approach is required for surgical interventions., Objective: To develop and validate search filters for medline and Embase for the adverse effects of surgical interventions., Methods: Systematic reviews of surgical interventions where the primary focus was to evaluate adverse effect(s) were sought. The included studies within these reviews were divided randomly into a development set, evaluation set and validation set. Using word frequency analysis we constructed a sensitivity maximising search strategy and this was tested in the evaluation and validation set., Results: Three hundred and fifty eight papers were included from 19 surgical intervention reviews. Three hundred and fifty two papers were available on medline and 348 were available on Embase. Generic adverse effects search strategies in medline and Embase could achieve approximately 90% relative recall. Recall could be further improved with the addition of specific adverse effects terms to the search strategies., Conclusion: We have derived and validated a novel search filter that has reasonable performance for identifying adverse effects of surgical interventions in medline and Embase. However, we appreciate the limitations of our methods, and recommend further research on larger sample sizes and prospective systematic reviews., (© 2018 The Authors Health Information and Libraries Journal published by John Wiley & Sons Ltd on behalf of Health Libraries Group.)

Background: Institutional harm reduction campaigns are essential in improving safe practice in critical care. Our institution embarked on an aggressive project to measure harm. We hypothesized that critically ill surgical patients were at increased risk of harm compared with medical intensive care patients., Methods: Three years of administrative data for patients with at least 1 Intensive Care Unit day at an urban tertiary care center were assembled. Data were accessed from the Henry Ford Health System No Harm Campaign in Detroit, MI. Harm was defined as any unintended physical injury resulting from medical care. Patients were deemed surgical if they had at least 1 procedure in the operating room. Univariate analysis was used to compare surgical patients with nonsurgical. Logistic regression was used for risk adjustment in predicting harm and death., Results: The study included 19,844 patients, of whom 7483 (37.7%) were surgical. The overall mortality was 7.8% (n = 1554). More surgical patients experienced harm than did nonsurgical patients (2923 [39.1%] vs 2798 [22.6%], odds ratio [OR] = 2.2, p < 0.001). Surgical patients were less likely to die (6.2% vs 8.8%, p < 0.001). Surgical patients were more likely to experience harm (OR = 2.1) but had lower mortalities (OR = 0.45) vs other harmed patients (OR = 3.8; all p < 0.001)., Conclusion: Most harm in surgically critically ill patients is procedure related. Preliminary data show that harm is associated with death, yet both surgical and African American patients experience more harm with a lower mortality rate.

The article deals with the analysis of retrospective and prospective studies dedicated to examining patient safety regarding epidemiology, frequency and severity of adverse events associated with rendering medical care. Electronic retrieval was carried out over the period from 1990 to 2017 using the following databases: MEDLINE, Cochrane Collaboration, EMBASE, SCOPUS, ISI Web of Science. The carried out meta-analysis made it possible to determine that cases of doing harm (adverse events) while rendering medical care are registered in 10.6% of patients. More than 80% of adverse events occur in hospital, with more than half of them revealed in the operating room and about third in a patient ward. While rendering medical care outside hospital, more often cases of doing harm are observed due to medical errors made in the physician's office and due to the patient's behaviour at home. The majority of adverse events appeared to be associated with performing an operation, manipulation, carrying out drug therapy, late or inappropriate treatment and diagnosis. Unexpected death secondary to unfavourable events is observed in 5.3% of patients. In the structure of in-hospital mortality, the proportion of deaths associated with rendering medical care accounts for 24.9% and in the structure of overall population mortality - for 9.7%, ranking third amongst all causes.

Background: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO). The goal of this study was to identify patient medical comorbidities and aberrant drug behaviors, as well as prescriber practices associated with patient injury and malpractice claims. Another objective was to identify claims most likely to result in payments and use this information to propose a strategy for reducing medicolegal risk., Methods: The CRICO Strategies Comparative Benchmarking System is a database of claims drawing from >350,000 malpractice claims from Harvard-affiliated institutions and >400 other academic and community institutions across the United States. This database was queried for closed claims from January 1, 2009, to December 31, 2013, and identified 37 cases concerning noninterventional, outpatient chronic pain management. Each file consisted of a narrative summary, including expert witness testimony, as well as coded fields for patient demographics, medical comorbidities, the alleged damaging event, the alleged injurious outcome, the total financial amount incurred, and more. We performed an analysis using these claim files., Results: The mean patient age was 43.5 years, with men representing 59.5% of cases. Payments were made in 27% of cases, with a median payment of $72,500 and a range of $7500-$687,500. The majority of cases related to degenerative joint disease of the spine and failed back surgery syndrome; no patients in this series received treatment of malignant pain. Approximately half (49%) of cases involved a patient death. The use of long-acting opioids and medical conditions affecting the cardiac and pulmonary systems were more closely associated with death than with other outcomes. The nonpain medical conditions present in this analysis included obesity, obstructive sleep apnea, chronic obstructive pulmonary disease, hypertension, and coronary artery disease. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The CRICO analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed., Conclusions: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage these medications in everyday practice will lead to both improved legal security and patient safety.

Background: This study was conducted to determine the risk factors, nature, and outcomes of "never events" following open adult cardiac surgical procedures. Understanding of these events can reduce their occurrence, and thereby improve patient care, quality metrics, and cost reduction., Methods: "Never events" for patients included in the Nationwide Inpatient Sample who underwent coronary artery bypass graft, heart valve repair/replacement, or thoracic aneurysm repair between 2003-2011 were documented. These events included air embolism, catheter-based urinary tract infection (UTI), pressure ulcer, falls/trauma, blood incompatibility, vascular catheter infection, poor glucose control, foreign object retention, wrong site surgery and mediastinitis. Analysis included characterization of preoperative demographics, comorbidities and outcomes for patients sustaining never events, and multivariate analysis of predictive risk factors and outcomes., Results: A total of 588,417 patients meeting inclusion criteria were identified. Of these, never events occurred in 4377 cases. The majority of events were in-hospital falls, vascular catheter infections, and complications of poor glucose control. Rates of falls, catheter based UTIs, and glucose control complications increased between 2009-2011 as compared to 2003-2008. Analysis revealed increased hospital length of stay, hospital charges, and mortality in patients who suffered a never event as compared to those that did not., Conclusions: This study establishes a baseline never event rate after cardiac surgery. Adverse patient outcomes and increased resource utilization resulting from never events emphasizes the need for quality improvement surrounding them. A better understanding of individual patient characteristics for those at risk can help in developing protocols to decrease occurrence rates.

This report describes the cases autopsied at B. P. Koirala Institute of Health Sciences- Nepal, during the period of two years in which the treatment provided falls below the accepted standard practice causing the death of the patient. Postmortem examination provides an opportunity to find out the actual cause of death in which the cause of death is suspicious. Sometimes the cause of death found through postmortem examination is different from the clinical cause of death. The autopsy finding on the cause of death will help doctors even to think about unusual conditions that lead to death and hence apply preventive measures for those unusual conditions. The cause of medical error is not always due to the doctor's mistake, but sometimes also due to the obsolete hospital protocol. The autopsy reporting of medical errors can be used to identify lacunae in hospital protocols, problem-prone clinical processes and suggest interventions that may reduce negligence.

Chart reviews have been used to assess the incidence and impact of adverse events, but most of them are not a nationally representative sample. In addition, the definition of adverse events is generally broad and covers unintended events; the relationship to outcome is often unclear, and official estimates have not matched those of medical practitioner's recognition. The number of patient deaths from adverse events remains unknown.This study aimed to investigate the number of adverse event related patient deaths and mortality rate as recognized by medical practitioners in Japan, and to reveal the applicability of our method for estimating the number of adverse event related patient death as an alternative to a chart review.In 2015, a mail survey of 3270 hospitals asked how many patient deaths had been caused by adverse events at the hospital in the last 3 years. The hospitals were selected by stratified random sampling according to the number of beds. The number of patient deaths caused by adverse events and the mortality rate were estimated, with adjustments for the hospital type and the number of beds.The mail survey response rate was 22.4% (731/3270). The number of patient deaths caused by adverse events in a year was estimated to be between 1326 and 1433. The mortality rate was estimated at 8.81 to 9.52 cases per 100,000 discharged patients, and 2.65 to 2.87 cases per 1,000,000 person-days. The mortality rate was high at acute care hospitals with ≥500 beds and at psychiatric hospitals.The nationwide number of patient deaths recognized by medical practitioners as caused by adverse events and its mortality rate were estimated. In comparison with a chart review, a mail survey was a faster and a cheaper way, and was able to cover a wide range of hospitals for estimating mortality rate of adverse events.

Background: The fifth Millennium Development Goal (MDG-5) aimed to improve maternal health, targeting a maternal mortality ratio (MMR) reduction of 75% between 1990 and 2015. The objective of this study was to identify all maternal deaths in Suriname, determine the extent of underreporting, estimate the reduction, audit the maternal deaths and assess underlying causes and substandard care factors., Methods: A reproductive age mortality survey was conducted in Suriname (South-American upper-middle income country) between 2010 and 2014 to identify all maternal deaths in the country. MMR was compared to vital statistics and a previous confidential enquiry from 1991 to 1993 with a MMR 226. A maternal mortality committee audited the maternal deaths and identified underlying causes and substandard care factors., Results: In the study period 65 maternal deaths were identified in 50,051 live births, indicating a MMR of 130 per 100.000 live births and implicating a 42% reduction of maternal deaths in the past 25 years. Vital registration indicated a MMR of 96, which marks underreporting of 26%. Maternal deaths mostly occurred in the urban hospitals (84%) and the causes were classified as direct (63%), indirect (32%) or unspecified (5%). Major underlying causes were obstetric and non-obstetric sepsis (27%) and haemorrhage (20%). Substandard care factors (95%) were mostly health professional related (80%) due to delay in diagnosis (59%), delay or wrong treatment (78%) or inadequate monitoring (59%). Substandard care factors most likely led to death in 47% of the cases., Conclusion: Despite the reduction in maternal mortality, Suriname did not reach MDG-5 in 2015. Steps to reach the Sustainable Development Goal in 2030 (MMR ≤ 70 per 100.000 live births) and eliminate preventable deaths include improving data surveillance, installing a maternal death review committee, and implementing national guidelines for prevention and management of major complications of pregnancy, childbirth and puerperium.

This study aimed to assess the pattern of sentinel events reported to Ministry of Health of Saudi Arabia from January 2012 to June 2015. Sentinel event reports were examined for patient characteristics, type of event, outcome, cause and preventability. There were 433 sentinel events: 58.2% were deaths, 14.8% were unexpected loss of a limb or a function, 7.4% major medication errors and 7.4% retained instruments or sponges. Among the reported events, 44% were associated with surgical interventions and most were classified as preventable (91.6%). Age 19-64 years was significantly associated with death as an outcome (P = 0.02). Non-preventable sentinel events were significantly more likely among women than men (P = 0.01). Unavailability of policy and procedures and/ or failure to implement them (55%), and lack of proper communication (35%) and training (33%) were the main causes for the adverse events. Efforts should focus on enhancing the National Sentinel Events Reporting System, adopting criteria for effective reporting and ensuring availability and implementation of policies and procedures.

Competing Interests: Competing interestsNone declared.

Purpose: To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period., Methods and Materials: Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression., Results: There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included "improper performance" (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), "errors in diagnosis" (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and "no medical misadventure" (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. "Improper performance" was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment., Conclusions: Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against radiation oncologists may help direct efforts to improve quality of care and minimize the risk of being sued., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Morbidity and mortality conferences (MMCs) have three potential aims-to improve patient safety by reducing adverse events and preventable deaths, to improve overall quality of care as part of the hospital governance structure and as educational learning events. At present, medical MMCs vary widely in format and attendance from hospital to hospital. The evidence for MMCs actually reducing adverse events and preventing avoidable deaths is disappointing. There is better evidence for their educational role. The majority of medical deaths in hospitals are frail older people with poor life expectancy in whom inadequate care is more likely to be due to errors of omission rather than commission. Medical MMCs should be multidisciplinary and led by a senior clinician to encourage discussion and reflection in a 'blame-free' environment. They should be learning events for both clinicians and the organisation as a whole with a structure to support this., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

The authors present a viewpoint regarding the quality of data used in estimating the number of preventable hospital deaths in the United States. Data derived from countries with a nationalized healthcare system with well-defined and near uniform implementation of standards may not be applicable to the fragmented noncentralized delivery system found in the United States. Although U.S. studies evaluating preventable mortality have based their projections on a small sample size, it is unlikely that this observation is due to chance, because other studies evaluating adverse events, a precursor to preventable mortality, have a much larger sample size and also report an unacceptably high number of events. In addition, although these estimates involved adult and Medicare-eligible patients who may have a higher incidence of events and create a bias, but they also did not capture all events, taken into account of mortality, which occurs after hospitalization or from misdiagnoses. It is also important not to mitigate adverse events in patients whose death is imminent. Medicine does not have the moral authority to place differing values on days, weeks, or years of life. The contention that there are approximately 200,000 preventable hospital-related deaths each year in the United States is not unreasonable. Not all hospital systems in the United States make the same investment in patient safety. Recently, the Agency for Healthcare Research & Quality has demonstrated a decline in adverse events in hospitals, but until uniform implementation of safety standards takes place, our healthcare system as a whole may well lag behind other industrialized nations.

Studies estimate that 6% to 27% of deaths in hospitals might be prevented with higher quality care. These estimates may be inaccurate because they fail to account for the uncertainty associated with classifying preventability. The purpose of this study was to measure the prevalence of preventable deaths, accounting for the uncertainty in preventability ratings.We created standardized structured case abstracts for all deaths at a multisite academic teaching hospital over a 3-month period. Each case abstract was evaluated independently by 4 reviewers who rated death preventability on a 100-point scale ranging from 0 ("Definitely not preventable") to 100 ("Definitely preventable"). Ratings were categorized into a 4-level ordinal scale and latent class analysis was used to measure the prevalence of each preventability class and estimate the probability that deaths in each class were preventable.There were 480 deaths (3.4% of all admissions) during the study period. The latent class model (LCM) found that 91.6% (95% CI: 88.4-94.8%) of deaths were "nonpreventable" and 8.4% (5.2-11.6%) were "possibly preventable." "Possibly preventable" deaths could be identified with 90% certainty, but due to error in reviewer ratings, a "possibly preventable" death had a 50% probability of being receiving a rating of less than 25/100 by any single reviewer. Only 5 of 31 deaths classified as a "possibly preventable" (1.0% of all deaths) were judged to likely be alive in 3 months with perfect care.After accounting for uncertainty associated with rating the preventability of hospital deaths, we found that 8.4% of deaths were deemed possibly preventable. There was only moderate probability that these deaths were truly preventable.

This study sought to evaluate the occurrence of adverse events and their impacts on length of stay and mortality in an intensive care unit (ICU). This is a prospective study carried out in a teaching hospital in Rio de Janeiro, Brazil. The cohort included 355 patients over 18 years of age admitted to the ICU between August 1, 2011 and July 31, 2012. The process we used to identify adverse events was adapted from the method proposed by the Institute for Healthcare Improvement. We used a logistical regression to analyze the association between adverse event occurrence and death, adjusted by case severity. We confirmed 324 adverse events in 115 patients admitted over the year we followed. The incidence rate was 9.3 adverse events per 100 patients-day and adverse event occurrence impacted on an increase in length of stay (19 days) and in mortality (OR = 2.047; 95%CI: 1.172-3.570). This study highlights the serious problem of adverse events in intensive care and the risk factors associated with adverse event incidence. Resumo: Este estudo teve como objetivo avaliar a ocorrência de eventos adversos e o impacto deles sobre o tempo de permanência e a mortalidade na unidade de terapia intensiva (UTI). Trata-se de um estudo prospectivo desenvolvido em um hospital de ensino do Rio de Janeiro, Brasil. A coorte foi formada por 355 pacientes maiores de 18 anos, admitidos na UTI, no período de 1º de agosto de 2011 a 31 de julho de 2012. O processo de identificação de eventos adversos baseou-se em uma adaptação do método proposto pelo Institute for Healthcare Improvement. A regressão logística foi utilizada para analisar a associação entre a ocorrência de evento adverso e o óbito, ajustado pela gravidade do paciente. Confirmados 324 eventos adversos em 115 pacientes internados ao longo de um ano de seguimento. A taxa de incidência foi de 9,3 eventos adversos por 100 pacientes-dia, e a ocorrência de evento adverso impactou no aumento do tempo de internação (19 dias) e na mortalidade (OR = 2,047; IC95%: 1,172-3,570). Este estudo destaca o sério problema dos eventos adversos na assistência à saúde prestada na terapia intensiva e os fatores de risco associados à incidência de eventos.

This paper presents a review of risk analyses in radiotherapy (RT) processes carried out by using Healthcare Failure Mode Effect Analysis (HFMEA) methodology, a qualitative method that proactively identifies risks to patients and corrects medical errors before they occur. This literature review was performed to provide an overview of how to approach the development of HFMEA applications in modern RT procedures, comparing recently published research conducted to support proactive programs to identify risks. On the basis of the reviewed literature, the paper suggests HFMEA shortcomings that need to be addressed.

Background: Recommendations that may help reduce adverse events outside the perioperative period are uncommon. We identified the primary factors that contributed to patient injury in neurosurgical practice both within the perioperative period and outside the perioperative period., Methods: Medical malpractice claims (n = 355) from The Doctors Company that were closed over 7 years were reviewed by neurosurgical medical experts. Objective neurosurgical expert analysis of the cases identified patient injuries and the primary factor that contributed to the patient injury., Results: Continued pain, nerve damage, and need for additional surgery were the most common injuries. In 145 cases (40.8%), the primary factor that contributed to patient injury occurred outside the perioperative period: assessment (evaluation and diagnosis), selection and management of therapy, and communication between the physician and patient/family. In 138 (38.9%) cases, the primary factor that contributed to patient injury occurred within the perioperative period. Surgical complication (a known risk of the procedure) was the primary factor in 99 cases (27.9%), and technical performance of surgery was the primary factor in only 39 cases (11.0%)., Conclusions: In addition to excellent surgical technique, checklists, teamwork, outcomes measurement, and regionalization of subspecialty care, improving patient safety in neurosurgical practice requires careful attention to care provided outside the perioperative period. Differential diagnosis, consideration of all relevant clinical data, active pursuit of good physician-patient relationships, and adequate monitoring of patients receiving nonsurgical treatment may also help improve patient safety in neurosurgical practice., (Copyright © 2016 Elsevier Inc. All rights reserved.)

We analysed 1743 patient safety incidents reported between 2004 and 2014 from critical care units in England and Wales where the harm had been classified as 'severe' (1346, 77%) or 'death' (397, 23%). We classified 593 (34%) of these incidents as resulting in temporary harm, and 782 (45%) as more than temporary harm, of which 389 (22%) may have contributed to the patient's death. We found no described harm in 368 (21%) incidents. We classified 1555 (89%) of the incidents as being avoidable or potentially avoidable. There were changes over time for some incident types (pressure sores: 10 incidents in 2007, 64 in 2012; infections: 60 incidents in 2007, 10 in 2012) and some changes in response to national guidance. We made a comparison with a dataset of all incidents reported from units in North-West England, and this confirmed that the search strategy identified more severe incidents, but did not identify all incidents that contributed to mortality., (© 2016 The Association of Anaesthetists of Great Britain and Ireland.)

Background: We modified the departmental mortality and morbidity (M&M) meetings to evaluate whether patient safety incident review as a part of this meeting was associated with reduced patient safety incidents., Method: A pilot programme of peer review of patient safety incidents (PSI) supported by education relevant to that event and follow-on action plan was introduced as a part of an extended morbidity and mortality meeting in a university hospital orthopaedic department. The pilot programme was conducted over six months (January 2012-June 2012). This programme involved junior and senior doctors including consultants although multidisciplinary groups were invited to attend. We investigated PSI rate/1000 hospital admissions for trauma and elective surgery, which were collected prospectively and independently between Jan 2011 to June 2013. We noted if the incident was caused by a medical or a nursing error and compared PSI rates., Results: Rates of PSI (33/1000) were 7.8 times higher in trauma cases (80.2/1000) than in elective admissions (11.2/1000). There was 18% reduction in trauma and 27% reduction in planned elective admissions. The rate increased after the pilot programme finished but there was still a 7% reduction compared to the pre-pilot period. This study found a significant reduction in the PSI rate for medical error but no change in the rate of nursing error., Conclusion: This continuous reflection, education and action process, where safety events are reviewed as a part of the extended morbidity and mortality meeting, is associated with reduction of patient safety incidents. We recommend that PSI reflection should be introduced in Mortality and Morbidity meetings with mandated attendance of the entire multidisciplinary health care team.

John Tingle discusses a special report by the Parliamentary and Health Service Ombudsman (PHSO) into how the NHS failed to investigate properly the death of a 3-year-old child.

Background: Unrecognised endotracheal tube misplacement in emergency intubations has a reported incidence of up to 17%. Current detection methods have many limitations restricting their reliability and availability in these circumstances. There is therefore a clinical need for a device that is small enough to be practical in emergency situations and that can detect oesophageal intubation within seconds. In a first reported evaluation, we demonstrated an algorithm based on pressure waveform analysis, able to determine tube location with high reliability in healthy patients. The aim of this study was to validate the specificity of the algorithm in patients with abnormal pulmonary compliance, and to demonstrate the reliability of a newly developed small device that incorporates the technology., Materials and Methods: Intubated patients with mild to moderate lung injury, admitted to intensive care were included in the study. The device was connected to the endotracheal tube, and three test ventilations were performed in each patient. All diagnostic data were recorded on PC for subsequent specificity/sensitivity analysis., Results and Discussion: A total of 105 ventilations in 35 patients with lung injury were analysed. With the threshold D-value of 0.1, the system showed a 100% sensitivity and specificity to diagnose tube location., Conclusion: The algorithm retained its specificity in patients with decreased pulmonary compliance. We also demonstrated the feasibility to integrate sensors and diagnostic hardware in a small, portable hand-held device for convenient use in emergency situations., (Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Objective: "Never events" refers to harmful hospital-acquired conditions that the Centers for Medicare and Medicaid Services identified in 2008 as largely preventable and that would no longer be reimbursed. Our goal was to identify the incidence, predictive factors, temporal trend, and associated consequences of never events after major open vascular surgery procedures., Methods: The Nationwide Inpatient Sample (NIS) (2003-2011) was queried to identify never events applicable to vascular surgery patients, including air embolism, catheter-based urinary tract infections (UTIs), stage 3 and 4 pressure ulcers, falls/trauma, blood incompatibility, vascular catheter infections, complications of poor glucose control, retained foreign objects, and wrong-site surgery. We specifically evaluated open abdominal aortic aneurysm repair, carotid endarterectomy, and lower extremity bypass/femoral endarterectomy. Multivariable logistic regression was used to predict never events based on preoperative variables. Multivariable logistic and gamma regression models were used to study mortality, hospital length of stay (LOS), and charges., Results: Never events were identified in 774 of 267,734 patients. The distribution of never events were falls/trauma (59%), pressure ulcers (19%), catheter-based UTI (9%), vascular catheter infection (6%), complications of poor glucose control (5%), and retained objects (4%). Rates of falls and catheter-based UTIs have increased since 2008. Multivariable predictors of any never event included lower extremity bypass, abdominal aortic aneurysm, weight loss, nonelective admission, paralysis, repair, congestive heart failure, altered mental status, renal failure, weekend admission, diabetes, female gender, and age. Race, insurance, hospital type, income level, geography, July to September admission, and other comorbidities were not predictive. After risk factor adjustment, never events were associated with increased perioperative mortality (odds ratio, 2.7; 95% confidence interval [CI], 1.5-34.8; P < .001), LOS (means ratio, 1.9; 95% CI, 1.7-2.0; P < .001), and total charges (means ratio, 1.7; 95% CI, 1.6-1.8; P < .001)., Conclusions: Never events after major vascular surgery are associated with a number of perioperative factors and are predictive of increased charges, LOS, and mortality. Falls and catheter-based UTIs have increased in frequency since the Centers for Medicare and Medicaid Services announced that it would no longer reimburse for these complications. This study establishes baseline never event rates in the vascular surgery patient population and identifies high-risk patients to target for quality improvement., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)