Application of HACCP for development of quality risk management in a water purification system

Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

When Safety Event Reporting Is Seen as Punitive: "I've Been PSN-ed!"

STUDY OBJECTIVE: Reporting systems are designed to identify patient care issues so changes can be made to improve safety. However, a culture of blame discourages event reporting, and reporting seen as punitive can inhibit individual and system performance in patient safety. This study aimed to determine the frequency and factors related to punitive patient safety event report submissions, referred to as Patient Safety Net reports, or PSNs. METHODS: Three subject matter experts reviewed 513 PSNs submitted between January and June 2019. If the PSN was perceived as blaming an individual, it was coded as punitive. The experts had high agreement (κ=0.84 to 0.92), and identified relationships between PSN characteristics and punitive reporting were described. RESULTS: A total of 25% of PSNs were punitive, 7% were unclear, and 68% were designated nonpunitive. Punitive (vs nonpunitive) PSNs more likely focused on communication (41% vs 13%), employee behavior (38% vs 2%), and patient assessment issues (17% vs 4%). Nonpunitive (vs punitive) PSNs were more likely for equipment (19% vs 4%) and patient or family behavior issues (8% vs 2%). Punitive (vs nonpunitive) PSNs were more common with adverse reactions or complications (21% vs 10%), communication failures (25% vs 16%), and noncategorized events (19% vs 8%), and nonpunitive (vs punitive) PSNs were more frequent in falls (5% vs 0%) and radiology or laboratory events (17% vs 7%). CONCLUSION: Punitive reports have important implications for reporting systems because they may reflect a culture of blame and a failure to recognize system influences on behaviors. Nonpunitive wording better identifies factors contributing to safety concerns. Reporting systems should focus on patient outcomes and learning from systems issues, not blaming individuals.

Patient safety incidents in radiology: frequency and distribution of incident types.

BACKGROUND: Patient safety incidents may be a valuable source of information to learn from and to prevent future errors. PURPOSE: To determine the distribution of patient safety incident types in radiology according to the International Classification for Patient Safety (ICPS), and to comprehensively review those incidents that were either harmful or serious in terms of risk of patient harm and reoccurrence. MATERIAL AND METHODS: The most recent five-year database (2014-2019) of a radiology incident reporting system was evaluated. RESULTS: A total of 480 patient safety incidents were included. Top three ICPS incident types were clinical administration (119/480, 24.8%), resources/organizational management (112/480, 23.3%), and clinical process/procedure (91/480, 19.0%). Harm severities were none in 457 (95.2%) cases, mild in 14 (2.9%), moderate in 4 (0.8%), severe in 3 (0.6%), and unknown in one case. Subsequent Prevention Recovery Information System for Monitoring and Analysis (PRISMA) reviews were performed in 4 (0.8%) cases. The three patient safety incidents that caused severe harm (of which one underwent PRISMA review) involved resources/organizational management (n = 1), clinical process/procedure (n = 1), and medication/IV fluids (n = 1). Three other cases (with no harm in two cases and moderate harm in one case) that underwent PRISMA review involved resources/organizational management (n = 2) and medical device/equipment/property (n = 1). CONCLUSION: Radiology-related patient safety incidents predominantly occur in three ICPS domains (clinical administration, resources/organizational management, and clinical process/procedure). Harmful/serious incidents are relatively rare. The standardly and transparently reported findings from this study may be used for healthcare quality improvement, benchmarking purposes, and as a primer for future studies.

A systematic review of natural language processing for classification tasks in the field of incident reporting and adverse event analysis.

CONTEXT: Adverse events in healthcare are often collated in incident reports which contain unstructured free text. Learning from these events may improve patient safety. Natural language processing (NLP) uses computational techniques to interrogate free text, reducing the human workload associated with its analysis. There is growing interest in applying NLP to patient safety, but the evidence in the field has not been summarised and evaluated to date. OBJECTIVE: To perform a systematic literature review and narrative synthesis to describe and evaluate NLP methods for classification of incident reports and adverse events in healthcare. METHODS: Data sources included Medline, Embase, The Cochrane Library, CINAHL, MIDIRS, ISI Web of Science, SciELO, Google Scholar, PROSPERO, hand searching of key articles, and OpenGrey. Data items were manually abstracted to a standardised extraction form. RESULTS: From 428 articles screened for eligibility, 35 met the inclusion criteria of using NLP to perform a classification task on incident reports, or with the aim of detecting adverse events. The majority of studies used free text from incident reporting systems or electronic health records. Models were typically designed to classify by type of incident, type of medication error, or harm severity. A broad range of NLP techniques are demonstrated to perform these classification tasks with favourable performance outcomes. There are methodological challenges in how these results can be interpreted in a broader context. CONCLUSION: NLP can generate meaningful information from unstructured data in the specific domain of the classification of incident reports and adverse events. Understanding what or why incidents are occurring is important in adverse event analysis. If NLP enables these insights to be drawn from larger datasets it may improve the learning from adverse events in healthcare.

¿Debe incluirse la función pulmonar en la estratificación de riesgo de la enfermedad pulmonar obstructiva crónica propuesta por GesEPOC? / Should Lung Function Be Included in the Risk Stratification of Chronic Obstructive Pulmonary Disease Proposed by GesEPOC?

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Anatomy of Mine Rescue Teams' Casualty Incidents: A Basis for Medical Emergency Preparedness and Injury Prevention.

OBJECTIVE: Mine rescue teams bear a high risk of injury. To improve medical emergency preparedness and injury prevention, this work analyzed the causes and severity of mine rescue teams' casualty incidents, the primary injuries, and the link between the causes and the occurrences of the casualty incidents. METHODS: A total of 81 cases from 1953 to 2013 were used to analyze the casualty incidents of mine rescue teams based on the frequency of accidents. A panel with 4 rescue experts was set up to ensure the accuracy of the analysis. RESULTS: The 81 casualty incidents occurred in 7 types of rescue work and were due to 6 causes. Organizational and personal factors were the leading cause, followed by rescue skill and equipment factors. Problems with decision-making and command have gradually become the primary inducement of casualty incidents in recent years, with an average death toll reaching up to 6 to 7 people. The main injuries causing death to team members were blast injury, burns, poisoning, suffocation, blunt trauma, and overwork injury. Some of the injured died because of medical emergency response failure. CONCLUSION: The construction of emergency medical teams and the preparedness of disaster medicine need to be improved to reduce the mortality of the injured team members. Actions according to the causes of casualty incidents should be adopted for injury prevention. (Disaster Med Public Health Preparedness. 2019;13:695-699).

Profile of blood donors who presented adverse reactions to the donation.

OBJECTIVE: identify the adverse reactions presented by blood donors and outline their sociodemographic profile. METHOD: a quantitative, cross-sectional retrospective study of 780 records of blood donors from a public hemocenter in the southern region of Brazil, from December 2015 to January 2016. For the analysis the descriptive statistics was used. RESULTS: it was identified that throughout 12 months, the total blood donors corresponded to 27,300 people, in which 780 developed at least one reaction. They were characterized by female and recurrent donors, single, with a complete average level of education, ranging from 16 to 30 years, who triggered between 1 and 3 reactions. Mild reactions were more frequent, followed by moderate and severe reactions. CONCLUSION: There is a high rate of adverse reactions from donors emphasizing the need for changes in hemotherapy care practices.

Profile of blood donors who presented adverse reactions to the donation / Perfil de los donantes de sangre que presentaron reacciones adversas a la donación / Perfil dos doadores de sangue que apresentaram reações adversas à doação

ABSTRACT Objective: identify the adverse reactions presented by blood donors and outline their sociodemographic profile. Method: a quantitative, cross-sectional retrospective study of 780 records of blood donors from a public hemocenter in the southern region of Brazil, from December 2015 to January 2016. For the analysis the descriptive statistics was used. Results: it was identified that throughout 12 months, the total blood donors corresponded to 27,300 people, in which 780 developed at least one reaction. They were characterized by female and recurrent donors, single, with a complete average level of education, ranging from 16 to 30 years, who triggered between 1 and 3 reactions. Mild reactions were more frequent, followed by moderate and severe reactions. Conclusion: There is a high rate of adverse reactions from donors emphasizing the need for changes in hemotherapy care practices.

RESUMEN Objetivo: identificar las reacciones adversas presentadas por los donantes de sangre y trazar su perfil sociodemográfico. Método: una investigación cuantitativa, retrospectiva transversal, realizada en 780 registros de donantes de sangre de un hemocentro público de la región sur de Brasil, en el período de diciembre de 2015 a enero de 2016. Para el análisis se procedió a la estadística descriptiva. Resultados: se identificó que, en el período de 12 meses, el total de donantes de sangre correspondió a 27.300 personas, en el cual 780 desarrollaron al menos una adversidad. Se caracterizaron por donantes de repetición, del género femenino, solteros, con nivel de escolaridad promedio completo, en el grupo de edad de 16 a 30 años, que desencadenaron entre 1 y 3 adversidades. Las reacciones lleves fueron más recurrentes, seguidas de las reacciones moderadas y graves. Conclusión: se señala un alto índice de reacciones adversas por parte de los donantes enfatizando la necesidad de cambios en las prácticas de los cuidados en hemoterapia.

RESUMO Objetivo: identificar as reações adversas apresentadas pelos doadores de sangue e traçar o seu perfil sociodemográfico. Método: pesquisa quantitativa, retrospectiva transversal, realizada em 780 registros de doadores de sangue de um hemocentro público da região sul do Brasil, no período de dezembro de 2015 a janeiro de 2016. Para análise procedeu-se à estatística descritiva. Resultados: identificou-se que, no período de 12 meses, o total de doadores de sangue correspondeu a 27.300 pessoas, no qual 780 desenvolveram ao menos uma adversidade. Caracterizaram-se por doadores de repetição, do gênero feminino, solteiros, com nível de escolaridade médio completo, na faixa etária de 16 a 30 anos, que desencadearam entre 1 e 3 adversidades. As reações leves foram mais recorrentes, seguidas das reações moderadas e graves. Conclusão: Aponta-se um alto índice de reações adversas por parte dos doadores enfatizando a necessidade de mudanças nas práticas dos cuidados em hemoterapia.

Problems with incident reporting: Reports lead rarely to recommendations.

AIM AND OBJECTIVE: To analyse trends in incident reporting over the last 5 years and determine how many reports led to recommendations? BACKGROUND: Patient safety incident reporting systems have been used in health care for years. However, they have a significant weakness in that reports often do not lead to any visible action. DESIGN: The study is a retrospective register study. STROBE checklist was applied in the preparation of the paper. METHODS: Data were collected from a web-based incident reporting database (HaiPro) for a social- and healthcare organisation in Finland, covering the period from 2011-2015. RESULTS: In total, 16,019 incident reports were analysed. In 2.7% (n = 426) of all reports, there was written recommendation to develop action that such incidents would not happen again. Those reports were classified into seven categories: education, introduction and information, introduction to work, patient care, guidelines, instruments and IT programmes, and the physical environment. CONCLUSIONS: Managers get major amount incident reports. There should be (a) a definition what kind of events should be reported, (b) a definition for how serious events managers have to make a recommendation and (c) control that recommendations are implemented. RELEVANCE TO CLINICAL PRACTICE: There is a need for more action to promote patient safety based on incident reports.

Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases.

BACKGROUND: The reporting of adverse events (AEs) in neurosurgery uses inconsistent definitions and subjective grading systems. A standardized system for recording and describing AEs would allow valid comparisons to be drawn between different institutions, using different technologies, at different times. The Spinal Adverse Events Severity System - Neuro (SAVES-N) system is a modification of the well-validated SAVES-V2 system that encompasses complications from both cranial and spinal surgery. The objective of this study was to assess the interobserver reliability of SAVES-N in spinal and cranial neurosurgery. METHODS: Ten vignettes, including cranial and spinal neurosurgical cases, were assessed by groups of consultant neurosurgeons (n = 5) and neurosurgical registrars (n = 5) using the SAVES-N system. Interobserver reliability for the presence of AEs, the type of AE, and the SAVES severity grade of the AE were calculated using Gwet's AC2 and Fleiss' kappa and were interpreted using the thresholds described by Landis and Koch. RESULTS: Neurosurgeons had almost-perfect agreement (Gwet AC2 = 0.93), whereas registrars had substantial agreement (Gwet's AC2 = 0.74) in determining the presence or absence of AEs. Both neurosurgeons (Fleiss' kappa = 0.78) and registrars (Fleiss' kappa = 0.70) demonstrated substantial agreement within their groups as to the type of AE. Similarly, neurosurgeons (Gwet's AC2 = 0.94) and registrars (Gwet's AC2 = 0.81) both graded the severity of the AE with almost perfect agreement. CONCLUSIONS: The results of this study demonstrate that the scope of the well-validated SAVES-V2 system may be broadened to cranial neurosurgical cases by SAVES-N with substantial to almost-perfect interobserver reliability.

Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework.

OBJECTIVES: To develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events. STUDY DESIGN: As part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework. RESULTS: The final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%). CONCLUSIONS: Distinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care. IMPLICATIONS: The PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first-trimester aspiration abortion procedures. Standardization will assist healthcare providers, researchers and policymakers to anticipate morbidity and prevent abortion adverse events, improve care metrics and enhance abortion quality.

Utility of 18F-FDG-PET/CT in patients suspected of paraneoplastic neurological syndrome: importance of risk classification

Purpose. To assess the diagnostic impact of 18F-FDG-PET/CT in patients suspected of paraneoplastic neurological syndrome (PNS) based on our own pre-test risk classification (PRC). Methods. A multicenter retrospective longitudinal study was conducted from 2006 to 2014. We designed a seven-point scoring system using the clinical syndrome characteristics [classical (CS) and non-classical syndromes (NCS)] and its location (central, peripheral, in the neuromuscular junction or combined), onconeural antibodies and tumor markers. Patients were classified as low (score 0-2), intermediate (3-4) and high (5-7) pre-test risk of PNS. FDG-PET/CT was classified as negative or positive. Final diagnosis according Graus’ criteria (definite, possible or no PNS) was established. Relations between clinical and metabolic variables with the final diagnosis were studied. Results. 73 patients were included, with a follow-up time of 33 months. Eleven (15 %) patients were finally diagnosed with neoplasm (8 invasive cancers). Ultimately, 13 (18 %) and 24 (33 %) subjects were diagnosed as definite or possible PNS. All the patients with final diagnosis of neoplasm had a CS (p = 0.005). PET/CT was helpful to diagnose 6/8 (75 %) invasive cancers. PET/CT findings were associated with the final diagnosis of neoplasm (p = 0.003) and the diagnosis of PNS attending to Graus’ criteria (p = 0.019). PRC showed significant association with the final diagnosis of neoplasm and PET/CT results. A majority of patients (10/11) diagnosed of neoplasm had intermediate/high-risk. Conclusions. Our PRC seems to be a valid tool to select candidates for PET/CT imaging in this setting. PET/CT detected malignancy in a significant proportion of patients with invasive cancer (AU)

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Identifying Predictive Factors for Incident Reports in Patients Receiving Radiation Therapy.

PURPOSE: To describe radiation therapy cases during which voluntary incident reporting occurred; and identify patient- or treatment-specific factors that place patients at higher risk for incidents. METHODS AND MATERIALS: We used our institution's incident learning system to build a database of patients with incident reports filed between January 2011 and December 2013. Patient- and treatment-specific data were reviewed for all patients with reported incidents, which were classified by step in the process and root cause. A control group of patients without events was generated for comparison. Summary statistics, likelihood ratios, and mixed-effect logistic regression models were used for group comparisons. RESULTS: The incident and control groups comprised 794 and 499 patients, respectively. Common root causes included documentation errors (26.5%), communication (22.5%), technical treatment planning (37.5%), and technical treatment delivery (13.5%). Incidents were more frequently reported in minors (age <18 years) than in adult patients (37.7% vs 0.4%, P<.001). Patients with head and neck (16% vs 8%, P<.001) and breast (20% vs 15%, P=.03) primaries more frequently had incidents, whereas brain (18% vs 24%, P=.008) primaries were less frequent. Larger tumors (17% vs 10% had T4 lesions, P=.02), and cases on protocol (9% vs 5%, P=.005) or with intensity modulated radiation therapy/image guided intensity modulated radiation therapy (52% vs 43%, P=.001) were more likely to have incidents. CONCLUSIONS: We found several treatment- and patient-specific variables associated with incidents. These factors should be considered by treatment teams at the time of peer review to identify patients at higher risk. Larger datasets are required to recommend changes in care process standards, to minimize safety risks.

Automated Classification of Clinical Incident Types.

We consider the task of automatic classification of clinical incident reports using machine learning methods. Our data consists of 5448 clinical incident reports collected from the Incident Information Management System used by 7 hospitals in the state of New South Wales in Australia. We evaluate the performance of four classification algorithms: decision tree, naïve Bayes, multinomial naïve Bayes and support vector machine. We initially consider 13 classes (incident types) that were then reduced to 12, and show that it is possible to build accurate classifiers. The most accurate classifier was the multinomial naïve Bayes achieving accuracy of 80.44% and AUC of 0.91. We also investigate the effect of class labelling by an ordinary clinician and an expert, and show that when the data is labelled by an expert the classification performance of all classifiers improves. We found that again the best classifier was multinomial naïve Bayes achieving accuracy of 81.32% and AUC of 0.97. Our results show that some classes in the Incident Information Management System such as Primary Care are not distinct and their removal can improve performance; some other classes such as Aggression Victim are easier to classify than others such as Behavior and Human Performance. In summary, we show that the classification performance can be improved by expert class labelling of the training data, removing classes that are not well defined and selecting appropriate machine learning classifiers.

An error taxonomy system for analysis of haemodialysis incidents.

OBJECTIVES: This paper describes the development of a haemodialysis error taxonomy system for analysing incidents and predicting the safety status of a dialysis organisation. METHODS: The error taxonomy system was developed by adapting an error taxonomy system which assumed no specific specialty to haemodialysis situations. Its application was conducted with 1,909 incident reports collected from two dialysis facilities in Japan. RESULTS: Over 70% of haemodialysis incidents were reported as problems or complications related to dialyser, circuit, medication and setting of dialysis condition. Approximately 70% of errors took place immediately before and after the four hours of haemodialysis therapy. Error types most frequently made in the dialysis unit were omission and qualitative errors. Failures or complications classified to staff human factors, communication, task and organisational factors were found in most dialysis incidents. Device/equipment/materials, medicine and clinical documents were most likely to be involved in errors. Haemodialysis nurses were involved in more incidents related to medicine and documents, whereas dialysis technologists made more errors with device/equipment/materials. CONCLUSIONS: This error taxonomy system is able to investigate incidents and adverse events occurring in the dialysis setting but is also able to estimate safety-related status of an organisation, such as reporting culture.

Therapeutic risk management of the suicidal patient: stratifying risk in terms of severity and temporality.

This column is the third in a series describing a model for therapeutic risk management of the suicidal patient. In the preceding column, we described augmenting clinical suicide risk assessment with structured instruments. In this column, we describe how clinicians can use the totality of available clinical data to offer a two-dimensional risk stratification that qualifies risk in terms of both severity and temporality. By offering two separate designations that reflect severity for both acute and chronic risk, conceptualizing and communicating a patient's risk for suicide is accomplished in a more nuanced way, providing the level of detail necessary when working with high risk individuals, especially those struggling with chronic suicidal ideation. Formulations reflecting suicide risk need to be accurate and facilitate good clinical decision-making in order to optimally balance the principles of autonomy, non-maleficence, and beneficence. Stratifying risk in terms of both severity and temporality helps identify situations in which involuntary hospitalization is warranted, while also helping to minimize unnecessary admissions. Hence, two-dimensional risk stratification that addresses both acute and chronic risk for suicide is an essential component of therapeutic risk management of the suicidal patient.

Experience of head and neck theatre staff and attitudes to human factors using an aviation-based analysis and classification system--a pilot survey.

The role that human factors have in contributing to air crashes is well known and is included as an essential part of training. Awareness of human factors in surgery is increasingly being recognised but surprisingly few papers have come from head and neck specialties. We circulated a questionnaire on human factors based on an aviation model to 140 head and neck medical and ancillary staff who work in operating theatres in 3 large UK hospitals. Most positive responses were found in the consultant group followed by trainee doctors and support staff. A significant difference was found in the subcategories of Unsafe Supervision (p=0.002) and Preconditions to Unsafe Acts (p=0.001). This work will help to identify multi-system deficiencies that can be corrected, and highlights aspects that may yield the greatest reduction in surgical errors.

Detecting effective classes of medical incident reports based on linguistic analysis for common reporting system in Japan.

The analysis of medical incident reports is indispensable for patient safety. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to conduct new findings using incident information, to clarify improvements that should be made to solve the root cause of an accident, and to ensure safe medical treatment through such improvements. We employed natural language processing (NLP) and network analysis to identify effective classes of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. After that, we compared the clustering results between Jichi Medical University and Osaka City University Hospital. By finding the common and different parts in medical incident report' s classes, we could show new perspectives on proposing a common reporting systems in Japan for improving patient safety.

An evaluation of departmental radiation oncology incident reports: anticipating a national reporting system.

PURPOSE: Systems to ensure patient safety are of critical importance. The electronic incident reporting systems (IRS) of 2 large academic radiation oncology departments were evaluated for events that may be suitable for submission to a national reporting system (NRS). METHODS AND MATERIALS: All events recorded in the combined IRS were evaluated from 2007 through 2010. Incidents were graded for potential severity using the validated French Nuclear Safety Authority (ASN) 5-point scale. These incidents were categorized into 7 groups: (1) human error, (2) software error, (3) hardware error, (4) error in communication between 2 humans, (5) error at the human-software interface, (6) error at the software-hardware interface, and (7) error at the human-hardware interface. RESULTS: Between the 2 systems, 4407 incidents were reported. Of these events, 1507 (34%) were considered to have the potential for clinical consequences. Of these 1507 events, 149 (10%) were rated as having a potential severity of ≥2. Of these 149 events, the committee determined that 79 (53%) of these events would be submittable to a NRS of which the majority was related to human error or to the human-software interface. CONCLUSIONS: A significant number of incidents were identified in this analysis. The majority of events in this study were related to human error and to the human-software interface, further supporting the need for a NRS to facilitate field-wide learning and system improvement.