Patient Safety Risks Research Articles

Effects of the Italian Law on Patient Safety and Health Professional Responsibilities Five Years after Its Approval by the Italian Parliament.

The application of the Italian law No. 24/2017, which focused on patient safety and medical liability, in the Italian National Health Service has been evaluated by a survey conducted five years after the promulgation of the law. The law required the establishment of healthcare risk management and patient safety centers in all Italian regions and the appointment of a Clinical Risk Manager (CRM) in all Italian public and private healthcare facilities. This study demonstrates that five years after the approval of the law, it has not yet been fully implemented. The survey revealed a lack of adequate permanent staff in all the Regional Centers, with two employees on average per Center. Few meetings were held with the Regional Healthcare System decision-makers with less than four meetings per year. This reduces the capacity to carry out functions. In addition, the role of the CRMs is weak in most healthcare facilities. More than 20% of CRMs have other roles in the same organization. Some important tasks have reduced application, e.g., assessment of the inappropriateness risk (reported only by 35.3% of CRM) and use of patient safety indicators for monitoring hospitals (20.6% of CRM). The function of the Regional Centers during the COVID-19 pandemic was limited despite the CRMs being very committed. The CRMs units undertake limited research and have reduced collaboration with citizen associations. Despite most of the CRMs believing that the law has had an important role in improving patient safety, 70% of them identified clinicians' resistance to change and lack of funding dedicated to implementing the law as the main barriers to the management of risk.

Interdisciplinary and interprofessional communication intervention: How psychological safety fosters communication and increases patient safety.

Effective teamwork and communication are imperative for patient safety and quality care. Communication errors and human failures are considered the main source of patient harm. Thus, team trainings focusing on communication and creating psychologically safe environments are required. This can facilitate challenging communication and teamwork scenarios, prevent patient safety risks, and increase team performance perception. The sparse research concerning communication interventions calls for an understanding of psychological mechanisms. Therefore, this study investigated mechanisms of an interpersonal team intervention targeting communication and the relation of psychological safety to patient safety and team performance perception based on the applied input-process-output model of team effectiveness. Before and after a 4-h communication intervention for multidisciplinary teams, a paper-pencil survey with N = 137 healthcare workers from obstetric units of two university hospitals was conducted. Changes after the intervention in perceived communication, patient safety risks, and team performance perception were analyzed via t-tests. To examine psychological mechanisms regarding psychological safety and communication behavior, mediation analyses were conducted. On average, perceived patient safety risks were lower after the intervention than before the intervention (MT1 = 3.220, SDT1 = 0.735; MT2 = 2.887, SDT2 = 0.902). This change was statistically significant (t (67) = 2.760, p =.007). However, no such effect was found for interpersonal communication and team performance perception. The results illustrate the mediating role of interpersonal communication between psychological safety and safety performances operationalized as perceived patient safety risks ( = -0.163, 95% CI [-0.310, -0.046]) and team performance perception ( = 0.189, 95% CI [0.044, 0.370]). This study demonstrates the psychological mechanisms of communication team training to foster safety performances and psychological safety as an important predecessor for interpersonal communication. Our results highlight the importance of teamwork for patient safety. Interpersonal and interprofessional team training represents a novel approach as it empirically brings together interpersonal communication and collaboration in the context of patient safety. Future research should work on follow-up measures in randomized-controlled trials to broaden an understanding of changes over time.

Widespread Misinterpretation of Advance Directives and Portable Orders for Life-Sustaining Treatments Threatens Patient Safety and Causes Undertreatment and Overtreatment.

Widespread Misinterpretation of Advance Directives and Portable Orders for Life-Sustaining Treatments Threatens Patient Safety and Causes Undertreatment and Overtreatment.

Leaving Without Being Seen From the Pediatric Emergency Department: A New Baseline

BackgroundLeft without being seen (LWBS) rates are an important quality metric for pediatric emergency departments (EDs), with high-acuity LWBS children representing a patient safety risk. Since July 2021, our ED experienced a surge in LWBS after the most stringent COVID-19 quarantine restrictions ended. ObjectiveWe assessed changes in LWBS rates and examined associations of system factors and patient characteristics with LWBS. MethodsWe performed a retrospective study in a large, urban pediatric ED for all arriving patients, comparing the following three time-periods: before COVID-19 (PRE, January 2018–February 2020), during early COVID-19 (COVID, March 2020–June 2021), and after the emergence of COVID-19 variants and re-emergence of seasonal viruses (POST, July 2021–December 2021). We compared descriptive statistics of daily LWBS rates, patient demographic characteristics, and system characteristics. Negative binomial (system factors) and logistic regression (patient characteristics) models were developed to evaluate the associations between system factors and LWBS, and patient characteristics and LWBS, respectively. ResultsMean daily LWBS rates changed from 1.8% PRE to 1.4% COVID to 10.7% during POST. Rates increased across every patient demographic and triage level during POST, despite a decrease in daily ED volume compared with PRE. LWBS rates were significantly associated with patients with an Emergency Severity Index score of 2, mean ED census, and staff productivity within multiple periods. Patient characteristics associated with LWBS included lower assigned triage levels and arrival between 8 pm and 4 am. ConclusionsLWBS rates have shown a large and sustained increase since July 2021, even for high-acuity patients. We identified system factors that may provide opportunities to reduce LWBS. Further work should develop strategies to prevent LWBS in at-risk patients.

Patient safety and sense of security when telemonitoring chronic conditions at home: the views of patients and healthcare professionals - a qualitative study

BackgroundChronic diseases are increasing worldwide, and the complexity of disease management is putting new demands on safe healthcare. Telemonitoring technology has the potential to improve self-care management with the support of healthcare professionals for people with chronic diseases living at home. Patient safety threats related to telemonitoring and how they may affect patients’ and healthcare professionals’ sense of security need attention. This study aimed to explore patients’ and healthcare professionals’ experiences of safety and sense of security when using telemonitoring of chronic conditions at home.MethodsSemi-structured interviews were conducted with twenty patients and nine healthcare professionals (nurses and physicians), recruited from four primary healthcare centers and one medical department in a region in southern Sweden using telemonitoring service for chronic conditions in home healthcare.ResultsThe main theme was that experiences of safety and a sense of security were intertwined and relied on patients´ and healthcare professionals´ mutual engagement in telemonitoring and managing symptoms together. Telemonitoring was perceived to increase symptom awareness and promote early detection of deterioration promoting patient safety. A sense of security emerged through having someone keeping track of symptoms and comprised aspects of availability, shared responsibility, technical confidence, and empowering patients in self-management. The meeting with technology changed healthcare professionals’ work processes, and patients’ daily routines, creating patient safety risks if combined with low health- and digital literacy and a naïve reliance on technology. Empowering patients’ self-management ability and improving shared understanding of the patient’s health status and symptom management were prerequisites for safe care and the patient´s sense of security.ConclusionsTelemonitoring chronic conditions in the homecare context can promote a sense of security when care is co-created in a mutual understanding and responsibility. Attentiveness to the patient’s health literacy, symptom management, and health-related safety behavior when using eHealth technology may enlighten and mitigate latent patient safety risks. A systems approach indicates that patient safety risks related to telemonitoring are not only associated with the patient’s and healthcare professionals functioning and behavior or the human-technology interaction. Mitigating patient safety risks are likely also dependent on the complex management of home health and social care service.

Preliminary efficacy and safety of camrelizumab plus metronomic oral vinorelbine as first-line therapy for people aged 70 and above with advanced non-small cell lung cancer (NSCLC) from a phase II trial.

e14677 Background: Traditional platinum-based combination chemotherapy used as the standard first‐line treatment for advanced NSCLC poses potential safety risk for patients (pts) aged 70 years and above. Moreover, data on immune checkpoint inhibitors treating older pts with lung cancer in the current pivotal trials is limited. Metronomic chemotherapy (MCT) is the frequent administration of chemotherapy drugs at lower doses each time. Compared with traditional chemotherapy, MCT shows better safety profile and antitumor angiogenesis and immunomodulatory effects. Camrelizumab, an anti-PD-1 inhibitor, demonstrated encouraging efficacy in NSCLC (CameL study and CameL-sq study). Here, we designed a phase II trial to evaluate the efficacy and safety of camrelizumab plus metronomic oral vinorelbine (mOV) as first-line therapy for Chinese older pts with advanced NSCLC. Methods: Key inclusion factors were pts aged 70 years and above, histologically or cytologically confirmed unresectable stage III and IV NSCLC without positive EGFR mutation, ALK fusions or ROS1 fusions, ECOG performance status 0-2, no previous systematic treatment. Pts received camrelizumab (200mg, D1, q3w) combined with mOV (30mg, tiw1, day 1-3-5 per week) for 6 cycles, followed by camrelizumab monotherapy maintenance until disease progression or intolerable side effects. The primary endpoint was progression free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety. Results: From March 2021 to November 2022, 12 pts were evaluable for inclusion in the study. The median age was 77 (range: 70-85) with 8 (67%) males. Median follow-up was 7.2 months (range 2.8 months-22.1 months). The median PFS was 9.3 months (95%CI: 3.9 months-14.7 months). The one-year OS rate was 66.3%. The ORR and DCR were 50% (95%CI: 25.4%-74.6%) and 83.3% (95%CI: 50.9%-90.1%), respectively. Pts with positive or negative PD-L1 responded similarly to the treatment (respectively at 5/8 and 1/2 on ORR). The median OS and DoR have not been reached. Adverse events (AEs) with any grade were observed in 10 (83.3%) pts, of which grade III-IV AEs were observed in 2 (16.7%) pts with neutropenia and interstitial pneumonia, respectively. Immune-related adverse events (irAEs) occurred in 3 (25%) pts, of which grade III-IV irAEs occurred in one (8.3%) patient with interstitial pneumonia. No grade 5 adverse event happened. Conclusions: The regimen of camrelizumab plus mOV for the first-line therapy for older NSCLC pts showed initial promising efficacy and safety profile, which suggests it is worth further exploration. Clinical trial information: ChiCTR2100049487 .

Patient Safety Risks and Measures for Pediatric Neurosurgery Nursing

The aim of this study was to determine the patient safety risks and measures for pediatric neurosurgery nursing. A total of 564 pediatric patients admitted to the hospital from June 2020 to June 2023 under the neurosurgery department were included in this study. We analyzed the safety incidents in pediatric neurosurgery nursing and their causes and proposed corresponding measures for pediatric neurosurgery nursing in hope to reduce the occurrence of patient safety incidents in pediatric neurosurgery nursing and establish harmonious nurse-patient relationships.

Burnout and associated factors among healthcare workers in acute care settings at a tertiary teaching hospital in Tanzania: An analytical cross-sectional study.

Healthcare worker burnout has been linked to increased patient safety risk, low work professionalism, and low satisfaction with the care encounter. This study aimed to find the prevalence and factors associated with burnout among healthcare workers in acute care settings at a national referral hospital in Tanzania. An analytical cross-sectional study was performed at a national referral hospital in Tanzania. Healthcare workers at the departments of Emergency Medicine, Intensive Care Unit, and Anesthesia at Muhimbili National Hospital were recruited from January 2021 to March 2021. A two-part questionnaire adopted from the Maslach Burnout Inventory (MBI) and MBI-Human Services Survey tool were administered to measure burnout. Categorical variables were summarized using frequencies and percentages, and variables were compared using logistic regression. A total of 174 healthcare workers were issued questionnaires to participate in the study. With a response rate of 78%, 135 healthcare workers were included in the study, 43.7% were from the intensive care unit; the majority were female (63.7%), and assistant nursing officers (42%). The prevalence of burnout among participants was 62%, with 90.4% of participants showing a high level of emotional exhaustion. A longer duration of a single-day shift was associated with increased burnout among work-related factors (p < 0.001). Fewer night-time sleeping hours, tobacco use, and lack of regular exercise were significantly associated with increased burnout among social-related factors (p < 0.001). The study showed an alarmingly high prevalence of burnout among healthcare workers in the acute care setting of Muhimbili National Hospital. Personal well-being and participation in wellness programs have been associated with a reduced prevalence of burnout. The hospital should address the issue of burnout among its healthcare workers. This also calls for immediate action, necessitating further studies at the regional and national levels to ascertain the burden and causes of burnout in this setting.

Patient safety advisory boards and risk evaluation

Patient safety advisory boards and risk evaluation

Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Patient safety risks associated with the online purchase of medications, especially in case of ophthalmic preparations, are significant. Our study aimed to carry out quality assessment of dorzolamide hydrochloride (DZA) and timolol maleate (TIM) eye drops preserved with benzalkonium chloride (BAC) via online test purchases.Three samples were purchased online, while control preparations were acquired through authorized national drug supply chain. Our method was based on the International Pharmaceutical Federation (FIP) Inspection Checklist and integrated the evaluation of packaging and labelling. Sterility was established according to the European Pharmacopoeia (Ph. Eur.), while qualitative and quantitative quality was assessed with high-performance liquid chromatographic (HPLC) analysis.Several signs of falsification were recognized upon visual inspection of the online samples. All the products were clear, colourless, slightly viscous solutions. They were free from visible contaminants. The samples were sterile as no evidence of microbial growth was found. A quick and inexpensive HPLC analysis, optimized by the authors showed that active ingredients and the preservative deviated significantly (p < 0,05) with more than 10% from the values stated on the labels for at least one component (DZA: 99.3–113.1%, TIM: 112.8–139.2%, BAC: 82.4–97.7%).Development of comprehensive and reliable quality assessment methods are vital to increase public safety of pharmaceutical products sold online. A complex approach, integrating visual inspection, labelling assessment, microbiological analysis coupled with qualitative and quantitative methods provide a most reliable method. Due to its limited feasibility and cost-effectiveness, raising public awareness and limiting illegal online sellers should be the primary approaches to protect patients from substandard and falsified medicinal products sold via the internet. Particularly important for health professionals to understand this market and its public health concern, and to raise patient awareness of the risks associated with uncontrolled online purchase of medication.

441 Understanding the unintended consequences of new healthcare technologies aimed at supporting patient safety: a qualitative study

Abstract Introduction Technologies such as electronic prescribing, clinical decision support systems, and electronic medication dispensers, are increasingly being introduced into healthcare. Existing toolkits focus on the implementation of such technologies, rather than identifying and mitigating any unintended consequences technologies may have on patient safety. They also focus on high-level organisational issues instead of those faced by end-users: frontline staff, patients and carers. Aim To identify and classify types of unintended consequences that may be encountered by technologies’ end-users, in order to inform development of a tool for identifying and preventing technology-related risks on patient safety. Methods Five focus group discussions with healthcare professionals, patients and carers were conducted through video-conferencing. Healthcare professionals with experience of using/implementing healthcare technologies and known to the research team via professional networks were invited to participate. Patient/carer participants were recruited using convenience sampling via an external research-participant organisation. Participants were asked to identify patient safety risks associated with the use of healthcare technologies, drawn from their own experiences and through consideration of hypothetical risks. Discussions were audio-recorded and transcribed verbatim. Transcripts were analysed by two researchers (NVivo R1.6) and two public partners (manually), using iterative inductive thematic analysis. Results Eleven healthcare professionals and 29 patients and carers participated in focus groups. Three focus groups comprised patients, carers, and healthcare professionals. Two involved solely patients and carers. Analysis revealed five areas of unintended consequences (Table 1). Most unintended consequences identified by patients and carers were similar to those described by healthcare professionals. Healthcare professionals also described additional unintended consequences associated with technologies designed specifically for their use. Conclusion A limitation of the study is that many of the unintended consequences identified related to virtual health technologies used during the COVID-19 pandemic, which may affect generalisability. A strength is that unintended consequences that have been overlooked in existing literature, such as the build-up of patients’ psychological dependence on technologies, were identified. Developing a tool based on these will allow implementers and users of healthcare technologies to consider such issues and address the potential risks they may have on patient safety before healthcare technologies are fully implemented in practice.

Evaluation of patient safety culture in community pharmacies

BackgroundThe majority of medical mistakes risking patient safety have been related to medication. Numerous international health organizations support assessing safety culture in healthcare organizations as a successful tactic for long-term safety development. ObjectiveThis study aimed to assess patient safety culture, investigate determinants of patient safety in community pharmacies and identify strengths and possible improvements concerning patient safety in the Lebanese community. MethodAn observational descriptive cross-sectional study was conducted using the Pharmacy Survey on Patient Safety Culture (PSOPSC). It was distributed among Lebanese community pharmacists. ResultsOne hundred forty-five community pharmacists completed the survey. High percent positive response (PPR) was seen in the domains of patient counseling (86.4%) and teamwork (83.9%). “Staffing, Work Pressure, and Pace” composite scored 41.2%. Female pharmacists were shown to be more dedicated to patient safety culture, namely in patient counseling skills (P < 0.05). Working for 32 to 40 h per week (β = 19.305), and for >40 h per week (β = 18.315) were significantly associated with increased patient safety score. ConclusionAn overall positive perception towards patient safety culture was seen among Lebanese community pharmacists.

Nurses’ knowledge regarding dysphagia: A cross-sectional study

BackgroundDysphagia has a high prevalence with associated complications, such as respiratory infections and recurrent institutionalizations, factors associated with the burden of malnutrition and dehydration that negatively affects the patient's quality of life and entails added health costs. ObjectiveTo assess the knowledge of a group of Portuguese nurses regarding dysphagia and perform the cross-cultural adaptation of the questionnaire used. MethodsCross-sectional descriptive study based on an online self-ministered questionnaire sent to nurses, regardless of the length of professional experience and area of clinical practice. Data treatment was performed using the IMB SPSS computer software, and the open responses were treated using the QDA Miner Lite. Results241 nurses were enrolled between May and June 2021, of which 192 (79.6%) were female, with an age of 37.8±8.3 years and a length of service of 14.4±8.5 years. Overall knowledge of dysphagia was high (80.1%). Participants were dissatisfied with their knowledge and expressed a need for further training, mainly in therapeutic intervention. ConclusionsIt is essential to understand why nurses still consider themselves to lack knowledge despite higher levels of knowledge. Future research should explore these aspects. These findings corroborate the gap between the nurses’ perceived knowledge and their actual knowledge about dysphagia, which may influence practice by influencing the decision-making process. Due to its high prevalence and complications, this gap may translate into increased patient safety risks.

Development and multi-institutional validation of a convolutional neural network to detect vertebral body mis-alignments in 2D x-ray setup images.

Misalignment to the incorrect vertebral body remains a rare but serious patient safety risk in image-guided radiotherapy (IGRT). Our group has proposed that an automated image-review algorithm be inserted into the IGRT process as an interlock to detect off-by-one vertebral body errors. This study presents the development and multi-institutional validation of a convolutional neural network (CNN)-based approach for such an algorithm using patient image data from a planar stereoscopic x-ray IGRT system. X-rays and digitally reconstructed radiographs (DRRs) were collected from 429 spine radiotherapy patients (1,592 treatment fractions) treated at six institutions using a stereoscopic x-ray image guidance system. Clinically-applied, physician approved, alignments were used for true-negative, "no-error" cases. "Off-by-one vertebral body" errors were simulated by translating DRRs along the spinal column using a semi-automated method. A leave-one-institution-out approach was used to estimate model accuracy on data from unseen institutions as follows: All of the images from five of the institutions were used to train a CNN model from scratch using a fixed network architecture and hyper-parameters. The size of this training set ranged from 5,700 to 9,372 images, depending on exactly which five institutions were contributing data. The training set was randomized and split using a 75/25 split into the final training/ validation sets. X-ray/ DRR image pairs and the associated binary labels of "no-error" or "shift" were used as the model input. Model accuracy was evaluated using images from the sixth institution, which were left out of the training phase entirely. This test set ranged from 180 to 3,852 images, again depending on which institution had been left out of the training phase. The trained model was used to classify the images from the test set as either "no-error" or "shifted", and the model predictions were compared to the ground truth labels to assess the model accuracy. This process was repeated until each institution's images had been used as the testing dataset. When the six models were used to classify unseen image pairs from the institution left out during training, the resulting receiver operating characteristic area under the curve values ranged from 0.976 to 0.998. With the specificity fixed at 99%, the corresponding sensitivities ranged from 61.9% to 99.2% (mean: 77.6%). With the specificity fixed at 95%, sensitivities ranged from 85.5% to 99.8% (mean: 92.9%). This study demonstrated the CNN-based vertebral body misalignment model is robust when applied to previously unseen test data from an outside institution, indicating that this proposed additional safeguard against misalignment is feasible. This article is protected by copyright. All rights reserved.

Reducing risks in complex care transitions in rural areas: a grounded theory

ABSTRACT Purpose Although previous research indicates that care transitions differ between rural and urban areas, the knowledge of challenges related to care transitions in rural areas appears limited. This study aimed to provide a deeper understanding of what registered nurses’ perceive as the main concerns in care transitions from hospital care to home healthcare in rural areas, and how they handle these during the care transition process. Methods A Constructivist Grounded Theory method based on individual interviews with 21 registered nurses. Results The main concern in the transition process was “Care coordination in a complex context”. The complexity stemmed from several environmental and organizational factors, creating a messy and fragmented context for registered nurses to navigate. The core category “Actively communicating to reduce patient safety risks” was explained by the three categories– “Collaborating on expected care needs”, “Anticipating obstacles” and “Timing the departure”. Conclusions The study shows a very complex and stressed process that includes several organizations and actors. Reducing risks during the transition process can be facilitated by clear guidelines, tools for communication across organizations and sufficient staffing.

Amplifiers and Dampeners of Patient Safety Risk in the Operating Room: Interim Analysis of Surgical Video Recorded with the Operating Room Black Box

Preventable intraoperative adverse events (iAEs) may emerge from interactions between multiple work system factors (WSFs) (e.g., technology design, organizational policy, physical environment); these interactions may amplify or dampen patient safety risk. We conducted an exploratory observational study using audiovisual data captured by the Operating Room Black Box to characterize the relationships between associated WSFs. Human factors specialists reviewed video recordings of surgical procedures before transcribing events of interest and classifying them into the relevant WSF categories as defined by the Systems Engineering Initiative for Patient Safety model. Each WSF code was categorized as either a safety threat (ST) or resilience support (RS), and their interactions with associated WSFs were characterized. We transcribed 706 events over 73.5 hours of surgery, and 32 iAEs were identified. We coded 382 STs and 312 RSs, and 249 co-occurring WSF pairings. Co-occurring team (e.g., clear communication, feedback, and leadership) RSs were found to be the most prevalent mechanism to dampen all categories of ST. Co-occurring task (e.g., challenging anatomy) and environment (e.g., disruptive working environments, suboptimal ergonomic monitor setups) STs were the most common risk amplifiers contributing to the occurrence of iAEs. By assessing WSFs in the context of other WSFs, future research may develop interventions that more precisely target risk reduction in the operating room.

Applying Failure Mode Effects Analysis (FMEA) to Improve Choking Risk Prevention in a Mental Health Setting: Analysis Outcomes and Lessons Learned on Human Factors Collaboration

This paper describes the collaborative work performed as part of a patient safety and quality improvement choking risk prevention initiative in a specialty mental health hospital in Ontario, Canada. In 2021, Ontario Shores Centre for Mental Health Sciences (Ontario Shores), in collaboration with the Healthcare Insurance Reciprocal of Canada (HIROC), conducted a Failure Modes and Effects Analysis (FMEA) to identify potential failure modes for their choking risk prevention process. “Failure modes” refer to states in a process that have the potential for unintended consequences. The interdisciplinary project team developed and validated a current-state process map, through which identified all opportunities for process improvement. A thematic analysis of the barriers revealed 14 distinct failure modes, each of which were rated along three scales (Severity, Occurrence, and Detectability) to form a ranked list based on Risk Priority Number. As part of a prospective analysis, several system-based and people-based mitigations were generated for each of the failure modes. As a result of the FMEA, Ontario Shores developed, and is in the process of, implementing a choking risk prevention and risk mitigation strategies action plan. In addition, the authors offer some reflections on the collaborative work between the two organizations, in recognition of the opportunity for healthcare organizations to benefit from human factors expertise and principles of applied safety science, usability engineering, and user-centered design.

Az agresszív magatartás rizikóját felmérő skála alkalmazása akut pszichiátriai felvételre kerülő betegeken

Aggressive behavior among psychiatric patients occurs the most frequently during acute inpatient treatment causing significant safety risk for patients and staff. As part of a risk-reducing project targeting the reduction of the frequency of physical aggression, a daily routine use of a risk evaluation tool was introduced in the acute psychiatric unit of the Jahn Ferenc South Pest Hospital. Selection of the appropriate risk evaluation tool was based on a thorough search of the literature. After preparing the Hungarian translation of V-RISK-10, all acutely admitted patients were assessed with this rating scale completed by the duty psychiatrist. To evaluate the predictive validity of the scale, the authors retrospectively surveyed the number and length of necessary physical restraints due to aggressive behavior in the first week after admission. The mean score on V-RISK-10 was 6.78 ± 3.36 points and the time patients spent under restraints was 6.96 ± 17.21 hours. The sum score of the V-RISK-10 showed a moderate strength, and significant correlation with the time spent under restraint (r = 0.447; p = 0.001). The results confirmed that V-RISK-10 is an appropriate tool for predicting physical aggression necessitating restraints in the first days following an acute psychiatric admission. History of violent behavior, drug use, and a psychiatric diagnosis and suspiciousness among current symptoms had the strongest predictive value. The V-RISK-10 is a risk assessment tool that is user-friendly in the context of acute psychiatric inpatient care and has a moderate power for predicting aggressive behavior. Patients with high risk of aggression can be identified with this tool at the time of admission. With careful monitoring and timely initiation of aggression prevention strategies, the occurrence of aggressive behavior can be minimized. Orv Hetil. 2023; 164(8): 293-299.

A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug- and Medical Device-Borne Endotoxin.

A thorough and systematic analysis of potential endotoxin-related safety issues from parenteral drugs and devices is important to ensure appropriate current Good Manufacturing Practices, compendial requirements, standards and regulatory guidance. Lately, the US Food and Drug Administration has been expecting pharmaceutical firms to apply an arbitrary safety factor to compendial compliant drug specifications for endotoxin, potentially causing manufacturing challenges, supply issues and additional unwarranted costs. The aim of this study was to evaluate data from three disparate sources over an extended period of time, from 2008 to 2021, to determine if there exists an industry-wide risk to patients from parenteral drugs and devices, thereby evaluating if changes to current Good Manufacturing Practices or compendial requirements are indeed warranted. Food and Drug Administration data from current Good Manufacturing Practices non-compliance observations, product recalls and the FDA Adverse Event Reporting System were used as the three sources of data. Parenteral products were separated into drugs and devices, potential endotoxin-related patient safety issues were characterised in terms of the available non-compliance information, the type and number of product recalls, and the type and number of potential adverse events. Descriptive statistics in Microsoft Excel 2019 and Pivot tables were used for the analysis and presentation of the data. From 2011 to 2021, a total of 188 endotoxin-related current Good Manufacturing Practices compliance observations were recorded, 70% and 30% were associated with laboratory and manufacturing origins, respectively. Finished drug product testing accounted for 56% of these. In contrast, 95% of all endotoxin-related product recalls were associated solely with medical devices. Over the years 2008-2021, approximately 1.4% of all adverse events (23,663,780) were recorded with some reference to pyrexia (fever); however, there are sparse data categorically attributing this to the administration of parenteral drugs or devices or combinations of these possessing high levels of endotoxin. Analysis of data concerning drug- and device-borne endotoxin obtained from FDA data from current Good Manufacturing Practices non-compliance observations, product recalls and the FDA Adverse Event Reporting System demonstrated the absence of industry-wide issues with endotoxin contamination. Based upon these data, changes to current Good Manufacturing Practices and the compendial methodology of setting endotoxin specifications (and hence the compendial methodology of testing for endotoxins) are unwarranted.

Erroneous Patient Tissue Contaminants in 1574 Surgical Pathology Slides: Impact on Diagnostic Error and a Novel Framework for Floater Management.

Tissue contaminants on histology slides represent a serious risk of diagnostic error. Despite their pervasive presence, published peer-reviewed criteria defining contaminants are lacking. The absence of a standardized diagnostic workup algorithm for contaminants contributes to variation in management, including investigation and reporting by pathologists. To study the frequency and type of tissue contaminants on microscopic slides using standardized criteria. Using these data, we propose a taxonomy and algorithm for pathologists on "floater" management, including identification, workup, and reporting, with an eye on patient safety. A retrospective study arm of 1574 histologic glass slides as well as a prospective study arm of 50 slide contamination events was performed. Using these data we propose a structured classification taxonomy and guidelines for the workup and resolution of tissue contamination events. In the retrospective arm of the study, we identified reasonably sized benign tissue contaminants on 52 of 1574 slides (3.3%). We found size to be an important parameter for evaluation, among other visual features including location on the slide, folding, ink, and tissue of origin. The prospective arm of the study suggested that overall, pathologists tend to use similar features when determining management of potentially actionable contaminants. We also report successfully used case-based ancillary testing strategies, including fluorescence in situ hybridization analysis of chromosomes and DNA fingerprinting. Tissue contamination events are underreported and represent a patient safety risk. Use of a reproducible classification taxonomy and a standardized algorithm for contaminant workup, management, and reporting may aid pathologists in understanding and reducing risk.