Compensated Patient Injuries in the Treatment of Abdominal Aortic and Iliac Artery Aneurysms in Finland: A Nationwide Patient Insurance Registry Study.

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.

CIRSE Standards of Practice on Conducting Meetings on Morbidity and Mortality.

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.

Low-frequency avoidable errors during transcarotid artery revascularization.

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.

The patient died: What about involvement in the investigation process?

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.

Morbidity and mortality conferences in general surgery: a narrative systematic review.

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.

Contexte: Dans les services de médecine et de chirurgie du monde entier, les conférences sur la morbidité et la mortalité (CMM) jouent 2 rôles : elles forment la pierre angulaire des programmes d'amélioration de la qualité de soins et fournissent l'occasion de faire de l'enseignement dans le contexte même des soins cliniques immédiats. Malgré la popularité grandissante des CMM, le nombre d'événements indésirables et d'erreurs évitables demeure élevé ou mal caractérisé et on perd beaucoup d'occasions d'apprendre de ces événements et d'apporter les changements qui s'imposent. La présente revue analyse la littérature publiée sur les stratégies d'amélioration des CMM en chirurgie. Méthodes: Nous avons interrogé OVID Medline, PubMed, Embase et CENTRAL. Nous avons défini nos combinaisons de mots clés à l'aide du modèle PICO (population, intervention, comparaison et résultat [outcome]), en mettant l'accent sur l'utilisation des CMM en chirurgie générale. Résultats: La littérature sur les CMM se concentrait sur 5 thèmes : valeur didactique, analyse des erreurs, sélection et représentation des cas, participation et dissémination. Les stratégies utilisées pour accroître la valeur didactique incluaient limiter la durée des présentations de cas à 15­20 minutes, présenter de brèves revues de la littérature, favoriser les interactions avec l'auditoire et standardiser les présentations au moyen de modèles PowerPoint ou SBAR (situation, background, assessment, recommendation). Les interventions visant à améliorer l'analyse des erreurs incluaient une discussion sur les facteurs causaux et l'analyse des erreurs taxonomiques. La sélection des cas a été améliorée au moyen d'un registre clinique électronique comme le National Surgery Quality Improvement Program, pour mieux suivre l'incidence de la morbidité et de la mortalité. Les systèmes de téléconférences ont amélioré la participation. Parmi les stratégies de dissémination, mentionnons les bulletins sur les CMM, leur intégration aux cycles planifier/faire/vérifier/agir et les relevés de notes des chirurgiens. Conclusion: Une meilleure standardisation des pratiques optimales pourrait améliorer davantage la qualité des soins et augmenter l'impact didactique des CMM en plus d'offrir une base de référence pour mesurer l'effet des nouvelles mesures appliquées aux CMM sur le rendement clinique et didactique des systèmes chirurgicaux.

Death in low-risk cardiac surgery revisited.

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.

Jury verdicts and outcomes of malpractice cases involving arteriovenous hemodialysis access.

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.

Mortalidad por complicaciones médicas y quirúrgicas, impacto de la crisis y gasto sanitario en España, 2002-2013 / Mortality due to medical and surgical complications, economic crisis and health spending in Spain, 2002-2013

Objetivo: Describir la evolución de los riesgos de mortalidad por complicaciones debidas a la atención médica o la cirugía entre los periodos anterior (2002-2007) y posterior (2008-2013) al inicio de la crisis económica, en España y por comunidades autónomas, y analizar la relación entre los cambios en los riesgos de muerte y el impacto socioeconómico de la crisis y la variación del gasto sanitario. Método: Estudio ecológico basado en tasas de mortalidad estandarizadas por edad, índice sintético de vulnerabilidad como indicador socioeconómico y variación del gasto sanitario como indicador del gasto en salud. Se estimó el riesgo relativo de muerte entre periodos con modelos de regresión de Poisson. Resultados: El número de muertes aumentó para España en el periodo estudiado. Aunque la relación entre el incremento en la inversión pública en salud y la disminución de la mortalidad por esta causa no ha quedado claramente demostrada, sí ha podido determinarse que aquellas comunidades autónomas con menor incremento del gasto sanitario presentaron mayores tasas que el resto a lo largo de todo el periodo, y que las más vulnerables a la crisis y con menor incremento del gasto presentaron un mayor incremento de riesgo de muerte entre periodos. Conclusión: Dado el incremento de las muertes debidas a fallos evitables del sistema, es necesario seguir investigando sobre esta causa de mortalidad

Objective: To describe the evolution of mortality risks for complications due to medical care or surgery between the periods prior to (2002-2007) and after (2008-2013) the beginning of the economic crisis for Spain and by autonomous region, and to analyse the relationship between the changes in the risks of death and the socioeconomic impact of the crisis and the variation in health spending. Method: Ecological study based on age-standardized mortality rates, synthetic index of vulnerability as a socioeconomic indicator and variation in health expenditure as an indicator of health expenditure. The relative risk of death between periods was estimated with Poisson regression models. Results: The number of deaths increased for Spain in the period studied. Although the relationship between the increase in public investment in health and the decrease in mortality due to this cause has not been clearly demonstrated, it was possible to determine that the autonomous regions with the lowest increase in health expenditure had rates higher than the rest throughout the period, and that the most vulnerable to the crisis and with the lowest increase in spending presented the greatest increase in the risk of death between the periods. Conclusions: Given the increase in these deaths, due to avoidable failures of the system, it is necessary to continue investigating this cause of mortality

The Patient's Role in Patient Safety.

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.

Association of Adverse Effects of Medical Treatment With Mortality in the United States: A Secondary Analysis of the Global Burden of Diseases, Injuries, and Risk Factors Study.

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.

Aggregate analysis of sentinel events as a strategic tool in safety management can contribute to the improvement of healthcare safety.

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.

Preventable deaths in a French regional trauma system: A six-year analysis of severe trauma mortality.

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.

Medication administration errors and mortality: Incidents reported in England and Wales between 2007 ̶ 2016.

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.

[Safety of patients and adverse events related thereto in medicine]. / Bezopasnost' patsientov i sviazannye s nei neblagopriiatnye sobytiia v meditsine.

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.

Different Harm and Mortality in Critically Ill Medical vs Surgical Patients: Retrospective Analysis of Variation in Adverse Events in Different Intensive Care Units.

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.

Keep Them From Harm and Injustice?

Fear remains a major barrier to transparency of hospital errors.