Characteristics and Burden of Diagnostic Error-Related Malpractice Claims in Neurosurgery.

BACKGROUND: Neurosurgery is a specialty associated with high risk of malpractice claims, which can be influenced by quality and safety of care. Diagnostic errors have gained increasing attention as a potentially preventable problem. Despite the burden of diagnostic errors, few studies have analyzed diagnostic errors in neurosurgery. We aimed to delineate the effect of diagnostic errors on malpractice claims involving a neurosurgeon. METHODS: This retrospective study used the national Japanese malpractice claims database and included cases closed between 1961 and 2017. To examine the effect of diagnostic errors in neurosurgery, we compared diagnostic error-related claims (DERCs) with non-DERCs in indemnity, clinical outcomes, and factors relating to neurosurgeons. RESULTS: There were 95 closed malpractice claims involving neurosurgeons during the study period. Of these claims, 36 (37.9%, 95% confidence interval [CI] 28.7%-47.9%) were DERCs. Patient death was the most common outcome associated with DERCs. Wrong, delayed, and missed diagnosis occurred in 25 (69.4%, 95% CI 53.1%-82.0%), 4 (11.1%, 95% CI 4.4%-25.3%), and 7 (19.4%, 95% CI 9.8%-35.0%) cases, respectively. The most common presenting medical condition in DERCs was stroke. Subarachnoid hemorrhage, accounting for 85.7% of stroke cases, led to 27.8% of the total indemnity paid in DERCs. CONCLUSIONS: DERCs are associated with higher numbers of accepted claims and worse outcomes. Identifying diagnostic errors is important in neurosurgery, and countermeasures are required to reduce the burden on neurosurgeons and improve quality. This is the first study to focus on diagnostic errors in malpractice claims arising from neurosurgery.

A Century in Review: Medicolegal Implications of Facial Nerve Paralysis.

Importance: It is important to recognize factors that may mitigate the risk of a potential lawsuit and increase knowledge and awareness of physicians. Objective: To evaluate and characterize facial nerve paralysis litigation claims and related potential causes. Design, Setting, and Participants: These data were extracted from the two main computerized legal databases: WestLaw and LexisNexis. The data were queried on April 2, 2020. The records from 1919 to 2020 were obtained from a population-based setting. A total of 186 cases were included. Data were gathered for all alleged cases of facial nerve paralysis. Main Outcomes and Measures: There was a continuous rise in the amount of malpractice payments with the highest mean amount being in the past decade. Results: From 1919 to 2020, a total of 186 malpractice cases for facial nerve damage were identified. A total amount of $89,178,857.99 was rewarded to plaintiffs in 66 cases. The mean amount of paid malpractice claim was $1,351,194.80. Improper performance/treatment was the most common reason for alleged litigation (n = 97). This was followed by misdiagnosis/delayed diagnosis (n = 47), and failure of informed consent (n = 34). The highest number of malpractice claims with a total of 53 cases was from 1991 to 2000. The highest mean amount per payment was in the past decade (2011-2020) with a mean of $3,841,052.68. Conclusions and Relevance: Over the past century, improper performance/procedure, delayed/misdiagnosis, and failure of informed consent were the most common reasons for litigations related to facial nerve paralysis.

Associated Factors With Acute Transfusion Reaction From Hospital Online Reporting Events: A Retrospective Cohort Study.

OBJECTIVES: In our hospital's hemovigilance system, a Wi-Fi-based vital signs monitor that automatically transmits data to ensure patient safety has been implemented. We derived the potential clinical characteristics for subsequent association of acute transfusion reactions (ATRs) using the hospital information system database. METHODS: We retrospectively analyzed multiple factors to identify the possible associations between clinical factors and developing ATRs. The following data were collected: recipient's pretransfusion and posttransfusion vital signs, clinical and laboratory characteristics, and presence of ATRs. RESULTS: In all, 44,691 events were analyzed. Of these, ATR events occurred in 1586 (3.5%). Logistic regression analysis revealed that leukopenia (<5×10/µL) before transfusion was shown a statistically associated with developing mild ATRs (odds ratio [OR] = 2.38, 95% confidence interval [CI] = 1.68-3.35, P < 0.001). The association between elevated body temperature (forehead temperature > 37.5°C) and moderate ATRs was significant (OR = 1.55, 95% CI = 1.22-1.98, P < 0.001). In addition, the association between high diastolic pressure (>90 mm Hg) and severe ATRs was significant (OR = 1.78, 95% CI = 1.06-2.99, P = 0.03). Therefore, evaluated patient's status such as vital signs before transfusion is very important. In addition, every hospital should established a complete hemovigilance program focus on effectively reporting and real-time monitoring ATRs to improve transfusion patient safety. CONCLUSIONS: Vital signs monitoring and leukocyte counts before transfusion were significantly associated with the subsequent risk of ATRs. When patients with elevated body temperature, leukopenia, and high diastolic pressure who are scheduled to receive transfusion, clinicians should be aware of increasing the risk of ATRs in these patients.

El error de no planificar las emergencias en salud pública / The error of not planning public health emergencies

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Intervention efficacy for eliminating patient misidentification using step-by-step problem-solving procedures to improve patient safety.

This study aimed to evaluate the efficacy of interventions to reduce patient misidentification incidents classified as level 2 and over (adverse events occurred for patients) with the step-by-step problem-solving method. All incidents related to patient misidentification were selected, and relevant information was collected from the original electronic incident reports. We then conducted an eight-step problem-solving process with the aim of reducing patient misclassification and improving patient safety. Step 1: the number of misidentification-related incident reports and the percentage of these reports in the total incident reports increased each year. Step 2: the most frequent misidentification type was sample collection tubes, followed by drug administration and hospital meals. Step 3: we set a target of an 20% decrease in patient misidentification cases classified as level 2 or over compared with the previous year, and established this as a hospital priority. Step 4: we found that discrepancies in patient identification procedures were the most important causes of misidentification. Step 5: we standardized the patient identification process to achieve an 10% reduction in misidentification. Step 6: we disseminated instructional videos to all staff members. Step 7: we confirmed there was an 18% reduction in level 2 and over patient misidentification compared with the previous year. Step 8: we intend to make additional effort to decrease misidentification of patients by a further 10%. Level 2 and over patient misidentification can be reduced by a patient identification policy using a step-by-step problem-solving procedure. This study aimed to evaluate the efficacy of interventions to reduce patient misidentification incidents with step-by-step problem-solving method. Continued seamless efforts to eliminate patient misidentification are mandatory for this activity.

Confronting Medical Error.

A new book makes the case for 'a culture shift of epic proportions.'

Spinal cord injury in infancy: activity-based therapy impact on health, function, and quality of life in chronic injury.

INTRODUCTION: Spinal cord injury (SCI) in infancy magnifies the complexity of a devastating diagnosis. Children injured so young have high incidences of scoliosis, hip dysplasia, and respiratory complications leading to poor health and outcomes. We report the medical history, progression of rehabilitation, usual care and activity-based therapy, and outcomes for a child injured in infancy. Activity-based therapy (ABT) aims to activate the neuromuscular system above and below the lesion through daily, task-specific training to improve the neuromuscular capacity, and outcomes for children with acquired SCI. CASE PRESENTATION: A 3-month-old infant suffered a cervical SCI from a surgical complication with resultant tetraplegia. Until age 3, her medical complications included scoliosis, kyphosis, and pneumonia. Even with extensive physical and occupational therapy, she was fully dependent on caregivers for mobility and unable to roll, come to sit, sit, stand or walk. She initiated ABT at ~3 years old, participating for 8 months. The child's overall neuromuscular capacity improved significantly, especially for head and trunk control, contributing to major advances in respiratory health, novel engagement with her environment, and improved physical abilities. DISCUSSION: From injury during infancy until 3 years old, this child's health, abilities, and complications were consistent with the predicted path of early-onset SCI. Due to her age at injury, severity and chronicity of injury, she demonstrated unexpected, meaningful changes in her neuromuscular capacity during and post-ABT associated with improved health, function and quality of life for herself and her caregivers.

Psychometric Design and Validation of an Adverse Event Vulnerability Scale in Prehospital Emergency Care.

OBJECTIVE: Care in prehospital emergencies presents differences in terms of safety with respect to that provided in the hospital setting, generating situations of high vulnerability in patients. Vulnerability is intimately related to the possibility of experiencing an adverse event. Currently, there is no validated system to evaluate this issue. The aim of this study was to design and validate an instrument to determine the level of vulnerability of patients treated in the emergency prehospital care. METHODS: A clinimetric validation study was conducted in patients who attended prehospital emergency services. RESULTS: An eight-item instrument with adequate content validity (0.93) was designed and empirically tested in a sample of 549 subjects (50.1% men and 49.9% women) with an average age of 61.56 years (standard deviation = 19.76). Cronbach α was 0.81, with a good interitem and item-total correlation and interobserver reliability, with an intraclass correlation coefficient of 0.90 (95% confidence interval = 0.87-0.93). The exploratory factor analysis identified a bifactorial model that explained 61.27% of the total variance, corroborated by confirmatory factor analysis (goodness-of-fit index = 0.97, normed fit index = 0.96, TLI = 0.92, and root mean square error of approximation = 0.093). Instrument scores showed a moderate and significant positive correlation with the age of the subjects (r = 0.31). CONCLUSIONS: The instrument shows a good reliability and validity for its use in the environment of prehospital emergency services, with a structure composed of a group of items related to condition characteristics safety (consciousness, patient communication, risk factors, and patient coping), and mobility, and a second factor including respiratory and medical interventions safety.

Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19).

A novel zoonotic coronavirus outbreak is spreading all over the world. This pandemic disease has now been defined as novel coronavirus disease 2019 (COVID-19), and is sustained by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the current gold standard for the etiological diagnosis of SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for collection, handling, transport and storage of the swabs, collection of inappropriate or inadequate material (for quality or volume), presence of interfering substances, manual errors, as well as specific aspects such as sample contamination and testing patients receiving antiretroviral therapy. Some analytical problems may also contribute to jeopardize the diagnostic accuracy, including testing outside the diagnostic window, active viral recombination, use of inadequately validated assays, insufficient harmonization, instrument malfunctioning, along with other specific technical issues. Some practical indications can hence be identified for minimizing the risk of diagnostic errors, encompassing the improvement of diagnostic accuracy by combining clinical evidence with results of chest computed tomography (CT) and RT-PCR, interpretation of RT-PCR results according to epidemiologic, clinical and radiological factors, recollection and testing of upper (or lower) respiratory specimens in patients with negative RT-PCR test results and high suspicion or probability of infection, dissemination of clear instructions for specimen (especially swab) collection, management and storage, together with refinement of molecular target(s) and thorough compliance with analytical procedures, including quality assurance.

Patient Safety Incidents Reported by the General Public in Korea: A Cross-Sectional Study.

OBJECTIVES: Previous studies have demonstrated that the general public can report various patient safety incidents (PSIs) that are not identified by other methods. In this study, we investigated the characteristics of PSIs that the general public experience in Korea. METHODS: In face-to-face surveys, participants were asked to report the frequency and type of PSIs, level of patient harm, and whether the PSIs were perceived as a medical error. We conducted logistic regression analysis to identify the sociodemographic factors of participants associated with their PSI experiences. Additionally, we analyzed relationships between the perception of PSIs as a medical error and both the type of PSIs and level of patient harm. RESULTS: Among the 700 participants surveyed, 24 (3.4%) and 37 (5.3%) individuals reported that they or their family members experienced PSIs, respectively. Participants with at least a college degree were more likely to report PSI experiences than those with a lower educational level (odds ratio, 3.54; 95% confidence interval, 1.86-6.74). Whereas approximately half of participants (48.2%) involved in PSI experiences that caused no harm thought that there were medical errors in their PSIs, all participants (100%) who experienced PSIs with severe harm responded that medical errors occurred in their PSIs. CONCLUSIONS: The general public can report their experiences with PSIs. Periodic surveys that target the general public will provide additional data that reflect the level of patient safety from the viewpoint of the general public.

A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department.

OBJECTIVE: Medical errors in the emergency department (ED) occur frequently. Yet, common adverse event detection methods, such as voluntary reporting, miss 90% of adverse events. Our objective was to demonstrate the use of patient-reported data in the ED to assess patient safety, including medical errors. METHODS: Analysis of patient-reported survey data collected over a 1-year period in a large, academic emergency department. All patients who provided a valid e-mail or cell phone number received a brief electronic survey within 24 hours of their ED encounter by e-mail or text message with Web link. Patients were asked about ED safety-related processes. RESULTS: From Aug 2012 to July 2013, we sent 52,693 surveys and received 7103 responses (e-mail response rate 25.8%), including 2836 free-text comments (44% of respondents). Approximately 242 (8.5%) of 2836 comments were classified as potential safety issues, including 12 adverse events, 40 near-misses, 23 errors with minimal risk of harm, and 167 general safety issues (eg, gaps in care transitions). Of the 40 near misses, 35 (75.0%) of 40 were preventable. Of the 52 adverse events or near misses, 5 (9.6%) were also identified via an existing patient occurrence reporting system. CONCLUSIONS: A patient-reported approach to assess ED-patient safety yields important, complementary, and potentially actionable safety information.

Does more medicine make us sicker? Ivan Illich revisited / ¿El uso de más medicina, nos vuelve más enfermos? Retorno a Ivan Illich

A proper understanding of health is a social and political challenge, the modern social medicine approach to public health and health approaches more generally tend to minimise this, making the isolated individual the primary unit of health. Ivan Illich, social critic and philosopher, was at the forefront of arguing for a collective health approach and challenging medical hegemony. His theories of institutional counter-productivity, proportionality and his critique of the medical model which he argued was entrenched within an economics of scarcity are as relevant today as they were at their height of popularity, in the 1970s. Applying his analysis to current trends in health approaches I conclude, as did he, that beyond a certain institutional scale or intensity more medicine is making us sicker. Therefore public health requires a dramatic shift away from a focus on individual deficits, lifestyle diseases, behaviour change and health promotion approaches towards genuine community building and significant political investment in the health creation of local communities. Moreover, there is need for more resolute regulation of the marketplace to prevent the health-harming behaviours of industrial and other institutional interests, including public sector and third sector organisations engaged in institutional overreach

La sanidad, propiamente entendida, es un reto social y político. La medicina social moderna apunta a la salud pública y, por lo general, los enfoques sanitarios tienden a minimizar este hecho, convirtiendo a la persona aislada en la unidad primaria de la salud. Ivan Illich, crítico social y filósofo, encabezó el debate a favor de un enfoque basado en la sanidad colectiva y la lucha contra la hegemonía médica. Sus teorías sobre contraproductividad y proporcionalidad institucional, y su crítica sobre el modelo médico, del que argumentó que estaba arraigado en una economía de escasez, son relevantes hoy en día, al igual que lo eran en la cima de su popularidad, en los años 1970. Aplicando su análisis a las tendencias actuales, yo concluyo, como hizo él, que más allá de una cierta escala o intensidad institucional, el uso de más medicina nos vuelve más enfermos. Por ello, la sanidad pública requiere un cambio drástico, alejando su objetivo de los déficits individuales, las enfermedades relacionadas con el estilo de vida, los cambios de comportamiento y la promoción de la salud, centrándose en cambio en el desarrollo comunitario genuino y la inversión política en la creación de salud en las comunidades locales. Además, existe una necesidad de regular firmemente el mercado para evitar los comportamientos nocivos para la salud provenientes de los intereses industriales y demás instituciones, incluyendo el sector público y las organizaciones del tercer sector, implicadas en las extralimitaciones institucionales

Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management.

Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of "transcription errors", for risk levels of "misidentified samples" and "not properly stored samples" and for the performance of "hemolyzed samples". "Not properly stored samples" had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.

Electronic health record as a panopticon: A disciplinary apparatus in nursing practice.

The specific arrangements of power/knowledge that characterize nurse interactions with the electronic health record form a panopticon. As health care moves into the 21st century, sophisticated technologies like the electronic health record shape the terrain of professional possibilities. The longer it is in use, the more it is possible to excavate the inherent disciplinary function of electronic health record. A panopticon is a generalizable, replicable apparatus of power that cultivates discipline when similar behaviours are desired from a group of people. This paper traces the arrangements of power/knowledge that characterize nurse interactions with the electronic health record rooted in a trauma critical care setting. Examining the apparatuses of power/knowledge enforced through panopticism in nursing makes the invisible visible. This in turn enables nurses to address the intended and unintended consequences of the electronic health record. If nurses are to effectively shape the direction of their own futures and the future of health care, nurses will need to unpack the invisible techniques of power such as the electronic health record as a panopticon. In the process of building a visible identity, contextualizing nursing knowledge to better care for patients on the one hand and understand the relationships of power that limit us on the other, nurses are neither apolitical nor powerless. Considering the dialectic of power/knowledge in the healthcare setting helps to illuminate spaces to recharacterize nursing, reveal the contributions and knowledge of nurses, and consolidate the professional power of nurses to affect meaningful change and self-governance in the healthcare setting.

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.