Healthcare Risk Management and Monitoring of patient falls in Italian National Service. The experience of a Local Health Authority.

Falls are a widespread concern in hospitals settings. In Italy, falls are the fourth frequent damage claim type after surgical, diagnostic and therapeutic error and 90% of falls are avoidable. The first necessary action for the prevention of falls consists in identifying the possible risk factors, in relation to the characteristics of the patient and those of the environment and the structure that hosts him, in terms of safety, organization and adequacy of the process welfare. In this work we wanted to evaluate the extent, frequency and characteristics of the phenomenon of falls in the population hospitalized at the Local Health Authority called "Roma 2", with the aim of analyzing the critical issues to allow the identification of possible preventive and improvement interventions as well as reducing the risk of falls.

Species-specific eDNA assay development for enhanced box jellyfish risk management in coastal environments.

Human interaction with marine creatures holds both positive and negative dimensions. Coastal communities benefit from marine environments, relying on them for sustenance and livelihoods. Fishing activities support economies, and marine biodiversity contributes to overall ecosystem health. However, challenges like overfishing, habitat destruction, and pollution pose threats to both marine life and human communities. Recently, there has been widespread concern regarding the potential increase in jellyfish populations across global marine ecosystems, attributed mainly to environmental factors such as climate drivers and anthropogenic forces, or their complex interactions. Encounters with hazardous marine species, such as box jellyfish, exemplify the dangers associated with coastal activities. Unintended interactions may lead to stings, injuries, and even fatalities, necessitating proactive measures and advanced technologies. This study addresses the inadequacies of existing measures in preventing box jellyfish incidents by introducing environmental DNA (eDNA) assays for detecting the deadly Chiropsoides buitendijki and focuses on developing qPCR and dPCR-based eDNA assays. Emphasising prevention over treatment, the study establishes a proactive system to assess C. buitendijki distribution across 63 tourist beaches in the Gulf of Thailand. Comparative analysis highlights the superior performance of dPCR over qPCR and traditional surveys. The dPCR experiment yielded positive results for all eDNA samples collected at sites where C. buitendijki had previously been identified. Remarkably, the eDNA testing also detected positive results in 16 additional sample locations where no physical specimens were collected, despite reported jellyfish stings at some of these sites. These findings underscore the precision and efficacy of the proposed eDNA detection technology in the early detection and assessment of box jellyfish distribution. This advancement therefore not only aids ecological research but also serves as a valuable tool for safeguarding public health, providing an early warning system for potential jellyfish encounters. Balancing positive human-marine interactions with effective risk mitigation strategies is crucial for sustainable coexistence, the preservation of marine ecosystems, and human well-being.

What is the effectiveness of reporting systems in promoting learning in healthcare?

Patient safety in healthcare remains a top priority. Learning from safety events is vital to move towards safer systems. As a result, reporting systems are recognised as the cornerstone of safety, especially in high-risk industries. However, in healthcare, the benefits of reporting systems in promoting learning remain contentious. Though the strengths of these systems, such as promoting a safety culture and providing information from near misses are noted, there are problems that mean learning is missed. Understanding the factors that both enable and act as barriers to learning from reporting is also important to consider. This review, considers the effectiveness of reporting systems in contributing to learning in healthcare.

A method for managing scientific research project resource conflicts and predicting risks using BP neural networks.

This study begins by considering the resource-sharing characteristics of scientific research projects to address the issues of resource misalignment and conflict in scientific research project management. It comprehensively evaluates the tangible and intangible resources required during project execution and establishes a resource conflict risk index system. Subsequently, a resource conflict risk management model for scientific research projects is developed using Back Propagation (BP) neural networks. This model incorporates the Dropout regularization technique to enhance the generalization capacity of the BP neural network. Leveraging the BP neural network's non-linear fitting capabilities, it captures the intricate relationship between project resource demand and supply. Additionally, the model employs self-learning to continuously adapt to new scenarios based on historical data, enabling more precise resource conflict risk assessments. Finally, the model's performance is analyzed. The results reveal that risks in scientific research project management primarily fall into six categories: material, equipment, personnel, financial, time, and organizational factors. This study's model algorithm exhibits the highest accuracy in predicting time-related risks, achieving 97.21%, surpassing convolutional neural network algorithms. Furthermore, the Root Mean Squared Error of the model algorithm remains stable at approximately 0.03, regardless of the number of hidden layer neurons, demonstrating excellent fitting capabilities. The developed BP neural network risk prediction framework in this study, while not directly influencing resource utilization efficiency or mitigating resource conflicts, aims to offer robust data support for research project managers when making decisions on resource allocation. The framework provides valuable insights through sensitivity analysis of organizational risks and other factors, with their relative importance reaching up to 20%. Further research should focus on defining specific strategies for various risk factors to effectively enhance resource utilization efficiency and manage resource conflicts.

Development of a scoring system to quantify errors from semantic characteristics in incident reports.

OBJECTIVES: Incident reporting systems are widely used to identify risks and enable organisational learning. Free-text descriptions contain important information about factors associated with incidents. This study aimed to develop error scores by extracting information about the presence of error factors in incidents using an original decision-making model that partly relies on natural language processing techniques. METHODS: We retrospectively analysed free-text data from reports of incidents between January 2012 and December 2022 from Nagoya University Hospital, Japan. The sample data were randomly allocated to equal-sized training and validation datasets. We conducted morphological analysis on free text to segment terms from sentences in the training dataset. We calculated error scores for terms, individual reports and reports from staff groups according to report volume size and compared these with conventional classifications by patient safety experts. We also calculated accuracy, recall, precision and F-score values from the proposed 'report error score'. RESULTS: Overall, 114 013 reports were included. We calculated 36 131 'term error scores' from the 57 006 reports in the training dataset. There was a significant difference in error scores between reports of incidents categorised by experts as arising from errors (p<0.001, d=0.73 (large)) and other incidents. The accuracy, recall, precision and F-score values were 0.8, 0.82, 0.85 and 0.84, respectively. Group error scores were positively associated with expert ratings (correlation coefficient, 0.66; 95% CI 0.54 to 0.75, p<0.001) for all departments. CONCLUSION: Our error scoring system could provide insights to improve patient safety using aggregated incident report data.

Racial disparities in breast cancer risk factors and risk management.

Racial disparities in breast cancer outcomes are well described across the spectrum of screening, diagnosis, treatment, and survivorship. Breast cancer mortality is markedly elevated for Non-Hispanic Black women compared with other racial and ethnic groups, with multifactorial causes. Here, we aim to reduce this burden by identifying disparities in breast cancer risk factors, risk assessment, and risk management before breast cancer is diagnosed. We describe a reproductive profile and modifiable risk factors specific to the development of triple-negative breast cancer. We also propose that screening strategies should be both risk- and race-based, given the prevalence of early-onset triple-negative breast cancer in young Black women. We emphasize the importance of early risk assessment and identification of patients at hereditary and familial risk and discuss indications for a high-risk referral. We discuss the subtleties following genetic testing and highlight "uncertain" genetic testing results and risk estimation challenges in women who test negative. We trace aspects of the obesity epidemic in the Black community to infant feeding patterns and emphasize healthy eating and activity. Finally, we discuss building an environment of trust to foster adherence to recommendations, follow-up care, and participation in clinical trials. Addressing relevant social determinants of health; educating patients and clinicians on factors impacting disparities in outcomes; and encouraging participation in targeted, culturally sensitive research are essential to best serve all communities.

Importance of Quality of Medical Record: Differences in Patient Safety Incident Inquiry Results According to Assessment for Quality of Medical Record.

BACKGROUND: Medical record review is the gold standard method of identifying adverse events. However, the quality of medical records is a critical factor that can affect the accuracy of adverse event detection. Few studies have examined the impact of medical record quality on the identification of adverse events. OBJECTIVES: In this study, we analyze whether there were differences in screening criteria and characteristics of adverse events according to the quality of medical records evaluated in the patient safety incident inquiry in Korea. METHODS: Patient safety incident inquiry was conducted in 2019 on 7500 patients in Korea to evaluate their screening criteria, adverse events, and preventability. Furthermore, medical records quality judged by reviewers was evaluated on a 4-point scale. The χ 2 test was used to examine differences in patient safety incident inquiry results according to medical record quality. RESULTS: Cases with inadequate medical records had higher rates of identified screening criteria than those with adequate records (88.8% versus 55.7%). Medical records judged inadequate had a higher rate of confirmed adverse events than those judged adequate. "Drugs, fluids, and blood-related events," "diagnosis-related events," and "patient care-related events" were more frequently identified in cases with inadequate medical records. There was no statistically significant difference in the preventability of adverse events according to the medical record quality. CONCLUSIONS: Lower medical record quality was associated with higher rates of identified screening criteria and confirmed adverse events. Patient safety incident inquiry should specify medical record quality evaluation questions more accurately to more clearly estimate the impact of medical record quality.

Moderate and severe adverse events in pediatrics: characteristics of incidents reported during the COVID-19 pandemic.

OBJECTIVE: To verify the characteristics of safety incident reports resulting in moderate and severe harm to pediatric patients in two hospitals during the COVID-19 pandemic. METHOD: Cross-sectional study conducted in two hospitals in southern Brazil. The sample consisted of 137 notifications from March 2020 to August 2021. The data were collected through the electronic records of the institutions' notification systems and analyzed using descriptive and inferential statistics. RESULTS: The most prevalent incidents were related to clinical processes or procedures (41.6%), affecting slightly more females (49.6%) and infants (39.4%). The majority of incidents (48.2%) occurred in inpatient units. The event sector (p=0.001) and the shift (p=0.011) showed statistically significant associations in both hospitals. CONCLUSION: The characteristics of the notifications are similar between the institutions surveyed, with a low number of moderate and severe incidents.

[17 years of the critical incident reporting and learning system "jeder-fehler-zaehlt.de" for primary care: Analysis of reports]. / 17 Jahre hausärztliches Fehlerberichts- und Lernsystem "jeder-fehler-zaehlt.de" ­ Analyse des Berichtsbestandes.

BACKGROUND: The topic of patient safety has been a subject of much discussion since the end of the last millennium. Ensuring patient safety is a central challenge in health care. An important tool to raise awareness for and learn from adverse events and thus promote patient safety are error-reporting and learning systems (Critical Incident Reporting System = CIRS). METHODS: More than 17 years after its establishment, the CIRS "jeder-fehler-zaehlt.de" (JFZ) for German primary care has undergone a revision in terms of content and technology. The revised web-based system can be used for reporting as well as for classifying and analyzing incident reports. During this process, a descriptive analysis of the current report inventory was carried out, with a focus on serious medication errors. This included all 781 valid incident reports received between September 2004 and December 2021. RESULTS: In 576 of the 781 reports (73.8%), the GP practice was directly involved in the critical incident. Among error types, process errors predominated (79.8% of the classifications, 99.1% of the reports) compared with knowledge and skills errors (20.2% of the classifications, 39.7% of the reports). Communication errors (63.0%) were the most common contributing factor to critical incidents, followed by flaws in tasks and measures (39.7%). Serious and permanent patient harm was rarely reported (8.3% of the reports), whereas temporary patient harm was more common (40.3% of the reports). Incident reports about medication errors with at least serious patient harm included, in particular, substances that affected blood clotting, corticosteroids, and opiates. DISCUSSION: Our results complement the rates that are reported internationally for error types, patient harm, and contributing factors. Serious but preventable adverse events, so-called never events, are frequently associated with the medication process in both JFZ reports and the literature. CONCLUSION: Critical incident reporting systems cannot provide accurate information about the frequency of errors in health care, but they can offer important insights into, for example, serious medication errors. Therefore, they offer both employees and healthcare institutions an opportunity for individual and institutional learning.

Implementation of a comprehensive clinical risk management system in a university hospital.

BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms. METHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement. RESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) . CONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.

The ERM experience of the Lombardy Region as a tool for improving the safety of the regional health care system.

The Regional Center for Healthcare Risk Management and Patient Safety of the Lombardy Region, with the technical partnership of Aon, designed an innovative Healthcare Enterprise Risk Management Model (hereafter HERM) to meet the following objectives: 1) Improve the safety of the Regional Healthcare System through the implementation of methods and tools aimed to identify, analyze and mange in an integrated way all the risks to which are exposed the healthcare companies. 2) Preserve the creation of social value in the medium-long term and the sustainable achievement of strategic and operational objectives. 3) Optimize risk management costs. 4) Reduce/mitigate adverse events in all business processes. 5) Enable the ability to anticipate and react to changes. 6) Establish sound long-term and risk-based strategies. This paper describes the structuring of the overall HERM Model Framework, and the related information flows, the tools supporting the Healthcare Enterprise Risk Management Methodology (such as the Risk Model and the Assessment Metrics) and presents the preliminary result of first experience of Healthcare ERM in Italy.

Nature and type of patient-reported safety incidents at a tertiary hospital in South Africa during the COVID-19 period (2018-2021)- A retrospective review.

The healthcare sector in South Africa has seen a rise in medical errors and negligence adversely affecting healthcare delivery. This study aimed to determine the nature and magnitude of Patient Safety Incidents at a tertiary hospital between April 2018 to March 2021 (the COVID-19 era). A retrospective review of Patient Safety Incidents forms and clinical records of inpatients above 12 years with a reported incident were included. The overall incidence of patient safety incidents was 4.40 PSIs per 10 000 patient-days. The majority of PSIs were harmful incidents (An incident that results in harm to a patient that is related to medical management, in contrast to disease complications or underlying disease) at 72.50% [145/200], followed by no harm incidents at 18.00% [36/200] and 9.50% [19/200] near-miss incidents. The five highest incident types were clinical process/procedure [83/200; 41.50%], behaviour [49/200; 24.50%], falls [28/200; 14%], complications [20/200; 10%], and pressure sores [11/200; 5.50%]. Incidents occurred more frequently within the week (83.50%) and during day shift (67.50%). Overall, the study showed low PSI reporting rates which is an inherent challenge with voluntary reporting. Notably, there has been an increasing trend in reporting. The results reflect a reporting culture more inclined to bring awareness to incidents that have negative outcomes.

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.

INTRODUCTION: In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union. METHODS: We established a cohort of medicinal products with aRMMs at marketing authorisation (MA) that were centrally authorised from July 2012-December 2021 using the European Public Assessment Reports. Evaluation studies were identified from the Risk Management Plans at the time of MA. Subsequently, we retrieved protocols, final study reports, Pharmacovigilance Risk Assessment Committee (PRAC) assessment reports, and PRAC minutes. We calculated the probability of completing an effectiveness evaluation within 60 months after MA using time-to-event analyses. Besides, we compared the planned final report with the actual final report date. RESULTS: We identified 134 medicinal products authorised with aRMMs, of which almost half (n = 63, 47.0%) had an effectiveness evaluation study. The probability of an evaluation for a medicinal product being completed within 60 months after MA was 20.7% (95% CI 6.8-32.6). Regarding study design, the probability of completing a study was higher for cross-sectional studies when compared to cohort studies (p = 0.002). Moreover, 81.0% of studies were delayed when compared to their planned final report date. CONCLUSION: The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed.

Multifaceted Intervention to Improve Patient Safety Incident Reporting in Intensive Care Units.

OBJECTIVES: Patient safety incident reporting in our institution's intensive care units (ICUs) had fallen 30% below national benchmarks during the COVID-19 pandemic. Underreporting diminishes awareness of risks and precludes organizational learning from near misses. We aimed to increase the ICU number of patient safety incident reports by 30% from 27 to 35 reports/1000 patient-days without negatively impacting culture of safety as measured by patient-care staff surveys. METHODS: Single-institution prospective interventional study with 9 ICUs receiving a multifaceted intervention developed using quality improvement methodology during February-April 2022. Study intervention involved creation of patient safety peer-leadership role, feedback process, interactive dashboards for patient safety data, and education resources accessible via quick response codes. Primary outcome was patient safety incident reports/1000 patient-days. Intensive care unit patient-care staff culture of safety was assessed with surveys. RESULTS: Intensive care unit patient safety incident reporting increased by 48% after intervention (40 versus 27 reports/1000 patient-days [ P = 0.136]). Near misses were the most common incident report. Intensive care unit patient-care staff ratings of patient safety did not change; 80% rated patient safety as good or better after intervention versus 78% at baseline ( P = 0.465). However, significant improvement was observed for subcomponents related to learning culture and support for staff involved in patient safety incidents. Most reports (>80%) were submitted by nurses. CONCLUSIONS: This multifaceted quality improvement intervention increased patient safety incident reporting in the ICUs. Increases in ratings of learning culture and support for staff underline the importance of a well-functioning patient safety incident reporting system in an institutional culture of safety.

Safety in radiation oncology (SAFRON): Learning about incident causes and safety barriers in external beam radiotherapy.

PURPOSE: Safety in Radiation Oncology (SAFRON) is a reporting and learning system on radiotherapy and radionuclide therapy incidents and near misses. The primary aim of this paper is to examine whether any discernible patterns exist in the causes of reported incidents and safety barriers within the SAFRON system concerning external beam radiotherapy. METHODS AND MATERIALS: This study focuses on external beam radiotherapy incidents, reviewing 1685 reports since the inception of SAFRON until December 2021. Reports that did not identify causes of incidents and safety barriers were excluded from the final study population. RESULTS: Simple two-dimensional radiotherapy or electron beam therapy were represented by 97 reports, three-dimensional conformal radiotherapy by 39 reports, modulated arc therapy by 12 reports, intensity modulated radiation therapy by 11 reports, stereotactic radiosurgery by 4 reports, and radiotherapy with protons or other particles by 1 report, while for 92 of them, no information on treatment method had been provided. Most of the reported incidents were minor incidents and were discovered by the radiation therapist. Inadequate direction/information in staff communication was the most frequently reported cause of incident, and regular independent chart check was the most common safety barrier. CONCLUSIONS: The results indicate that the majority of incidents were reported by radiation therapists, and the majority of these incidents were classified as minor. Communication problems and failure to follow standards/procedures/practices were the most frequent causes of incidents. Furthermore, regular independent chart checking was the most frequently identified safety barrier.

Thematic reviews of patient safety incidents as a tool for systems thinking: a quality improvement report.

Ensuring organisations learn from patient safety incidents is a key aim for healthcare organisations. The role that human factors and systems thinking can have to enable organisations learn from incidents is well acknowledged. A systems approach can help organisations focus less on individual fallibility and more on setting up resilient and safe systems. Investigation of incidents has previously been rooted in reductionist methodologies, for example, seeking to find the 'root cause' to individual incidents. While healthcare has embraced, in some contexts, the option for system-based methodologies-for example, SEIPS and Accimaps-these methodologies and frameworks still operate from a single incident perspective. It has long been acknowledged that healthcare organisations should focus on near misses and low harms with the same emphasis as incidents resulting in high harm. However, logistically, investigating all incidents in the same way is difficult. This paper puts forward an argument for themed reviews of patient safety incidents and provides an illustrative template for theming incidents using a human factors classification tool. This allows groups of incidents relating to the same portfolio, for example, medication errors, falls, pressure ulcer, diagnostic error, to be analysed at the same time and result in recommendations based on a larger sample size of incidents and based on a systems approach. This paper will present extracts of the themed review template trialled and argues that thematic reviews, in this context, allowed for a better understanding of the system of safety around the mismanagement of the deteriorating patient.

[Safety­II: a systemic approach for an effective clinical risk management]. / Safety­II: ein systemischer Ansatz für ein effektives klinisches Risikomanagement.

The healthcare system is an example of a complex sociotechnical system where the goal is the best possible individual treatment together with the cost-effective use of modern technology. Working in anesthesia requires medical knowledge as well as manual skills and the use of specialized technical equipment in an interdisciplinary and interprofessional setting. The susceptibility to errors and adverse events, especially in the care of critically ill patients, is high.In order to avoid unintentional hospital-induced patient harm, the healthcare system has recently taken the path of prescribing the best possible care for a large number of patients with the help of evidence-based guidelines and specific algorithms or instructions for action. Patient safety is defined accordingly as a state in which adverse events occur as rarely as possible (Safety­I).Following this approach clinical risk management is defined as the purposeful planning, coordination, execution and control of all measures that serve to avoid unintended hospital-induced patient harm or to limit its effects. For this purpose, the focus has recently been placed on instruments such as Critical Incident Reporting Systems (CIRS) or Morbidity and Mortality Conferences (M&MC); however, it is increasingly recognized that adverse events in complex sociotechnical systems such as the healthcare system arise situationally from the interaction of numerous components of the system. The effectiveness of CIRS and M&MC is limited because they do not comprehensively take situational effects into account. Thus, only selective changes are possible which, however, do not imply a sustainable improvement of the system. Newer approaches to strengthening safety in complex sociotechnical systems understand positive as well as negative events as being equally caused by the variable adaptation of behavior to daily practice. They therefore focus on the majority of positive courses of treatment and the necessary adaptations of the health professionals involved in daily practice (Safety­II). In this way, the adaptability of the system under unexpected conditions should be increased (Resilience Engineering). Taking this systemic approach into account, the Functional Resonance Analysis Method (FRAM) offers a variety of possibilities for the prospective analysis of a complex sociotechnical system or for retrospective incident analysis through modelling of actual everyday actions (work as done). Through interviews with the health professionals involved, document analyses and work inspections, processes and their functions as well as the associated variability are assessed and graphically presented. The FRAM models the collected information of the process as complexes of interconnected functions represented by hexagonal symbols. Each corner of the hexagon represents a given aspect, which together form the properties of the function (input, output, precondition, resource, time, control). Through this visualization and evaluation of the interview results, the actual everyday actions (work as done) can be compared with the predefined ones (work as imagined). The evaluation of the variability found in this way enables the strengths and weaknesses of processes to be uncovered. As a result, specific measures can be derived to strengthen the system. Increased consideration of the Safety­II approach within clinical risk management can be a valuable addition to existing clinical risk management methods.