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Objectives: Data on inpatient safety are documented by hospital staff through incident reporting (IR) systems. Safety observations from families or patients are rarely captured. The Family Input for Quality and Safety (FIQS) study created a mobile health tool for pediatric patients and their families to anonymously report safety observations in real time during hospitalization. The study objectives were to describe these observations and identify domains salient to safety., Methods: In this observational study, we analyzed pediatric patient safety reports from June 2017 to April 2018. Participants were: English-speaking family members and hospitalized patients ≥13 years old. The analysis had two stages: (1) assessment of whether narratives met established safety event criteria and whether there were companion IRs; (2) thematic analysis to identify domains., Results: Of 248 enrolled participants, 58 submitted 120 narrative reports. Of the narratives, 68 (57%) met safety event criteria, while only 1 (0.8%) corresponded to a staff-reported IR. Twenty-five percent of narratives shared positive feedback about patient safety efforts; 75% shared constructive feedback. We identified domains particularly salient to safety: (1) patients and families as safety actors; (2) emotional safety; (3) system-centered care; and (4) shared safety domains, including medication, communication, and environment of care. Some domains capture data that is otherwise difficult to obtain (#1-3), while others fit within standard healthcare safety domains (#4)., Conclusions: Patients and families observe and report salient safety events that can fill gaps in IR data. Healthcare leaders should consider incorporating patient and family observations-collected with an option for anonymity and eliciting both positive and constructive comments., (© 2024 The Authors. Journal of Hospital Medicine published by Wiley Periodicals LLC on behalf of Society of Hospital Medicine.)

Aim: This study aimed to assess the risk management of drug safety in an operating theater setting within a hospital-based treatment facility., (This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The integration of Artificial Intelligence (AI) in healthcare signifies a substantial shift, offering benefits to patients and healthcare systems while also introducing new risks. The emphasis on patient safety and performance standards is pivotal, especially with the European Union's strides towards regulating AI through the AI Act. This act focuses on classifying AI systems based on risk levels, mandating stringent requirements for high-risk AI, enhancing transparency, and ensuring ethics in AI applications. The concept of an "AI passport" is introduced as a living document detailing the AI system's purpose, ethical declarations, training, evaluation, and potential biases. This passport aims to enhance transparency and safety in medical AI applications, serving as a comprehensive record for patients, clinicians, and stakeholders. The AI passport, structured in JSON format, encapsulates key information about the AI system as a mechanism for continuous performance evaluation and transparency. This initiative may represent a significant step towards mitigating the risks associated with AI in healthcare, emphasizing the importance of accountability, transparency, and patient safety in the development and application of AI technologies.

Patient safety reporting and learning systems (PSRLS) are tools to promote patient safety culture in healthcare organisations (HCO). Many PRSLS are locally developed. WHO Global Action Plan on Patient Safety 2021-2030 urges governments to deploy policies for healthcare risk management including PSRLS. The Ministry of Health of Catalonia (MHC) faced challenges in addressing quality and patient safety (Q&PS) issues due to disparate information systems. To address these challenges, the MHC developed a territorial PSRLS and embedded it in the Quality and Patient Safety Strategic Plan of Catalonia 2023-2027 (QPSS Plan Cat)., Methods: Four-step process: (1) creation of a governance model, a web platform and reporting forms for a PSRLS in Catalonia (SNiSP Cat); (2) SNiSP Cat roll out; (3) embed SNiSP Cat information in the accreditation model for HCO and the PS scorecard; (4) Development of SNiSP Cat within the QPSS Plan Cat 2023-2027., Results: The SNiSP Cat is in use by 63/64 acute care hospital (ACH), 376/376 primary healthcare teams (PCT) and 17/98 long-term care facilities (LTCF). 1335/109 273 professionals were trained. Until 2022, 127 051 incidents have been migrated and reported (2013-2022). The system has generated three comprehensive risk maps for HCO: one for ACH, including patients' falls, medication, clinical process and procedures; second for PCT, including clinical process and procedures, clinical administration and medication; and a third for LTCF, included patients' falls, medication, digital/analogical documentation. SNiSP Cat provided information to support 53 standards out of 1312 of the ACH accreditation model and 14 standards out of 379 of PCT one. Regarding the MHC patient safety scorecard, 14 indicators out of 147 of ACH and 4 out of 41 of PCT are supported by SNiSP Cat data., Conclusions: The availability of a territorial PSRLS (SNiSP Cat) allows MHC leads the Q&PS policy with direct information, risk maps and data support to the standards for the Catalan accreditation models and PS scorecard linked to incentivisation, turning the SNiSP Cat into a driven tool to implement the Quality and Patient Safety Strategic Plan of Catalonia 2023-2027., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Identifying ways to ensure resident safety is increasingly becoming a priority in residential settings and nursing homes. The aim of this qualitative systematic review was to identify, describe, and assess research evidence on managers' perceptions regarding the barriers and facilitators of daily resident and patient safety work in residential settings and nursing homes. A qualitative systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis checklist. Published studies were sought through academic databases: Academic Search Premier, CINAHL, PubMed (MEDLINE), Scopus, SocINDEX, and Web of Science Core Collection in April 2023. Finally, 12 studies were included. The results of the included studies were synthesized using thematic synthesis after data extraction. According to the results, (1) competent staff and material resources; (2) management and culture; (3) communication, networks, optimal use of expertise; and (4) effective use of guidelines, rules, and regulations play a significant role in the success of resident and patient safety work. The findings revealed that promoting resident safety should not be seen solely as the responsibility of individual residential or nursing home personnel, as it requires multiprofessional cooperation and access to wider networks. Staff and managers must be receptive to learning, changing, and improving safety. Moreover, to ensure resident safety, it is essential to ensure that the organizations support safety work in residential and nursing home units., (© 2024 The Authors. Research in Nursing & Health published by Wiley Periodicals LLC.)

This study delves into the impact of Information Technology (IT) on nursing practice in Japan, focusing on patient safety within the 2021-2022 Japanese Medical Accident Report Data. The research aims to understand how IT factors contribute to nursing-related medical incidents in a healthcare landscape rapidly integrating IT. The study identifies IT-related incidents through a retrospective analysis of medical incident reports, primarily in nursing, by analyzing categorized data and free-text descriptions for IT-related keywords. The findings indicate significant IT-related issues, with 'Other EHR Related' problems (36%) and 'EHR Reporting' errors (25%) being the most prevalent. These incidents often involve challenges in patient identification and medication management. The study suggests improvements like enhanced verification processes and automated systems to mitigate these risks. Conclusively, it underscores the dual nature of IT in nursing: while it holds the potential to enhance patient care, it also introduces challenges that necessitate specialized informatics expertise to ensure its beneficial integration into nursing practices.

Patient safety incident reports are a key source of safety intelligence. This study aimed to explore whether information contained in such reports can elicit facilitators of safety, including responding, anticipating, monitoring, learning, and other mechanisms by which safety is maintained. The review further explored whether, if found, this information could be used to inform safety interventions. Anonymized incident reports submitted between August and October 2020 were obtained from two large teaching hospitals. The Systems Engineering Initiative for Patient Safety (SEIPS) tool and the resilience potentials (responding, anticipating, monitoring, and learning) frameworks guided thematic analysis. SEIPS was used to explore the components of people, tools, tasks, and environments, as well as the interactions between them, which contribute to safety. The resilience potentials provided insight into healthcare resilience at individual, team, and organizational levels. Sixty incident reports were analysed. These included descriptions of all the SEIPS framework components. People used tools such as electronic prescribing systems to perform tasks within different healthcare environments that facilitated safety. All four resilient capacities were identified, with mostly individuals and teams responding to events; however, monitoring, anticipation, and learning were described for individuals, teams, and organizations. Incident reports contain information about safety practices, much of which is not identified by traditional approaches such as root cause analysis. This information can be used to enhance safety enablers and encourage greater proactive anticipation and system-level learning., (© The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Quality in Health Care.)

Background: While patient safety incident reporting is of key importance for patient safety in primary care, the reporting rate by healthcare professionals remains low. This study aimed to assess the effectiveness of a risk management program in increasing the reporting rate within multiprofessional primary care facilities., Methods: A nation-wide cluster-randomised controlled trial was performed in France, with each cluster defined as a primary care facility. The intervention included professional e-learning training, identification of a risk management advisor, and multidisciplinary meetings to address incident analysis. In the first observational period, a patient safety incident reporting system for professionals was implemented in all facilities. Then, facilities were randomised, and the program was implemented. Incidents were reported over the 15-month study period. Quasi-Poisson models were used to compare reporting rates., Results: Thirty-five facilities (intervention, n = 17; control, n = 18) were included, with 169 and 232 healthcare professionals, respectively, involved. Overall, 7 out of 17 facilities carried out the entire program (41.2%), while 6 did not hold meetings (35.3%); 48.5% of professionals logged on to the e-learning website. The relative rate of incidents reported was 2.7 (95% CI = [0.84-11.0]; p = 0.12). However, a statistically significant decrease in the incident rate between the pre-intervention and post-intervention periods was observed for the control arm (HR = 0.2; 95% CI = [0.05-0.54]; p = 0.02), but not for the intervention arm (HR = 0.54; 95% CI = [0.2-1.54]; p = 0.23)., Conclusion: This program didn't lead to a significant improvement in the patient safety incident reporting rate by professionals but seemed to sustain reporting over time. Considering that the program was fully implemented in only 41% of facilities, this highlights the difficulty of implementing such multidisciplinary programs in primary care despite its adaptation to the setting. A better understanding of how risk management is currently organized in these multiprofessional facilities is of key importance to improve patient safety in primary care., Trial Registrations: The study has been registered at clinicaltrials.gov (NCT02403388) on 30 March 2015., (© 2024. The Author(s).)

There is growing recognition that patients can and should be engaged in the identification of patient safety incidents arising during their experiences across health systems. In this article, we describe the benefits that can be harnessed from engaging patients in reporting patient safety incidents; identify opportunities to support patient engagement in reporting and learning from patient safety incidents; and describe the potential role of health leaders in connecting patient experience and patient safety using patient-reported patient safety incident data., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: With the rise in medical errors, establishing a strong safety culture and an effective incident reporting system is crucial. As part of the Saudi National Health Transformation Vision of 2030, multiple projects have been initiated to periodically assess healthcare quality measures and ensure a commitment to continuous improvement. Among these is the Hospital Survey on Patient Safety Culture National Project (HSPSC), conducted regularly by the Saudi Patient Safety Center (SPSC). However, comprehensive tools for assessing reporting culture are lacking. Addressing this gap can enhance reporting, efficiency, and health safety., Objective: This paper aims to investigate the reporting practices among healthcare professionals (HCPs) in Saudi Arabian hospitals and examine the relationship between reporting culture domains and other variables such as hospital bed capabilities and HCPs' work positions., Methods: The study focuses on measuring the reporting culture-related items measures and employs secondary data analysis using information from the Hospital Survey on Patient Safety Culture conducted by the Saudi Center for Patient Safety in 2022, encompassing hospitals throughout Saudi Arabia. Data incorporated seven items in total: four items related to the Response to Error Domain, two related to the Reporting Patient Safety Events Domain, and one associated with the number of events reported in the past 12 months., Results: The sample for the analyzed data included 145,657 HCPs from 392 hospitals. The results showed that the average positive response rates for reporting culture-related items were between 50% and 70%. In addition, the research indicated that favorable response rates were relatively higher among managerial and quality/patient safety/risk management staff. In contrast, almost half had not reported any events in the preceding year, and a quarter reported only 1 or 2 events. Pearson correlation analysis demonstrates a strong negative correlation between bed capacity and reporting safety events, response to error, and number of events reported (r = -0.935, -0.920, and - 0.911, respectively; p < 0.05), while a strong positive correlation is observed between reporting safety events and response to error (r = 0.980; p < 0.01)., Conclusions: Almost 75% of the HCPs reported fewer safety events over the last 12 months, indicating an unexpectedly minimal recorded occurrence variance ranging from 0 to 2 incidents., (© 2024. The Author(s).)

Aims: To explore adverse event reporting in the surgical department through the nurses' experiences and perspectives., Design: An exploratory, descriptive qualitative study was conducted with a theoretical-methodological orientation of phenomenology., Methods: In-depth interviews were conducted with 15 nurses, followed by an inductive thematic analysis., Results: Themes include motives for reporting incidents, consequences, feelings and motivational factors. Key facilitators of adverse event reporting were effective communication, knowledge sharing, a non-punitive culture and superior feedback., Conclusion: The study underscores the importance of supportive organisational culture for reporting, communication and feedback mechanisms, and highlights education and training in enhancing patient safety., Implications: It suggests the need for strategies that foster incident reporting, enhance patient safety and cultivate a supportive organisational culture., Impact: This study provides critical insights into adverse event reporting in surgical departments from nurses' lived experience, leading to two primary impacts: It offers specific solutions to improve adverse event reporting, which is crucial for surgical departments to develop more effective and tailored reporting strategies. The research underscores the importance of an open, supportive culture in healthcare, which is vital for transparent communication and effective reporting, ultimately advancing patient safety., Reporting Method: The study followed the Standards for Reporting Qualitative Research and the Consolidated Criteria for Reporting Qualitative Research guidelines., Patients or Public Contribution: No patients or public contribution., (© 2024 John Wiley & Sons Ltd.)

Background and Objectives : Healthcare facilities are complex systems due to the interaction between different factors (human, environmental, management, and technological). As complexity increases, it is known that the possibility of error increases; therefore, it becomes essential to be able to analyze the processes that occur within these contexts to prevent their occurrence, which is the task of risk management. For this purpose, in this feasibility study, we chose to evaluate the application of a new safety walkaround (SWA) model. Materials and Methods : A multidisciplinary working group made up of experts was established and then the subsequent phases of the activity were divided into three stages, namely the initial meeting, the operational phase, and the final meeting, to investigate knowledge regarding patient safety before and subsequently through visits to the department: the correct compilation of the medical record, adherence to evidence-based medicine (EBM) practices, the overall health and the degree of burnout of the various healthcare professionals, as well as the perception of empathy of staff by patients. Results : This working group chose to start this pilot project in the vascular surgery ward, demonstrating the ability of the tool used to capture the different aspects it set out to collect. In detail, the new version of SWA proposed in this work has made it possible to identify risk situations and system vulnerabilities that have allowed the introduction of corrective tools; detect adherence to existing company procedures, reschedule training on these specific topics after reviewing, and possibly update the same procedures; record the patient experience about the doctor-patient relationship and communication to hypothesize thematic courses on the subject; evaluate workers' perception of their health conditions about work, and above all reassure operators that their well-being is in the interest of the management of the healthcare company, which is maintained. Conclusions: Therefore, the outcome of the present study demonstrates the versatility and ever-present usefulness of the SWA tool.

Background: The Global Patient Safety Action Plan, an initiative of the World Health Organization (WHO), draws attention to patient safety as being an issue of utmost importance in healthcare. In response, the World Federation of Chiropractic (WFC) has established a Global Patient Safety Task Force to advance a patient safety culture across all facets of the chiropractic profession. This commentary aims to introduce principles and call upon the chiropractic profession to actively engage with the Global Patient Safety Action Plan beginning immediately and over the coming decade., Main Text: This commentary addresses why the chiropractic profession should pay attention to the WHO Global Patient Safety Action Plan, and what actions the chiropractic profession should take to advance these objectives. Each strategic objective identified by WHO serves as a focal point for reflection and action. Objective 1 emphasizes the need to view each clinical interaction as a chance to improve patient safety through learning. Objective 2 urges the implementation of frameworks that dismantle systemic obstacles, minimizing human errors and strengthening patient safety procedures. Objective 3 supports the optimization of clinical process safety. Objective 4 recognizes the need for patient and family engagement. Objective 5 describes the need for integrated patient safety competencies in training programs. Objective 6 explains the need for foundational data infrastructure, ecosystem, and culture. Objective 7 emphasizes that patient safety is optimized when healthcare professionals cultivate synergy and partnerships., Conclusions: The WFC Global Patient Safety Task Force provides a structured framework for aligning essential considerations for patient safety in chiropractic care with WHO strategic objectives. Embracing the prescribed action steps offers a roadmap for the chiropractic profession to nurture an inclusive and dedicated culture, placing patient safety at its core. This commentary advocates for a concerted effort within the chiropractic community to commit to and implement these principles for the collective advancement of patient safety., (© 2024. The Author(s).)

Introduction: Clinical guidelines can contribute to medication errors but there is no overall understanding of how and where these occur., Objectives: We aimed to identify guideline-related medication errors reported via a national incident reporting system, and describe types of error, stages of medication use, guidelines, drugs, specialties and clinical locations most commonly associated with such errors., Methods: Retrospective analysis of reports to the National Reporting and Learning System for England and Wales. A hierarchical task analysis (HTA) was developed, describing expected practice when using guidelines. A free-text search was conducted of medication incident reports (2016-2021) using search terms related to common guidelines. All identified reports linked to moderate-severe harm or death, and a random sample of 5100 no/low-harm reports were coded to describe deviations from the HTA. A random sample of 500 cases were independently double-coded., Results: In total, 28,217 reports were identified, with 608 relating to moderate-severe harm or death. Fleiss' kappa for interrater reliability was 0.46. Of the 5708 reports coded, 642 described an HTA step discrepancy (including four linked to a death), suggesting over 3200 discrepancies in the entire dataset of 28,217 reports. Discrepancies related to finding guidelines (n = 300 reports), finding information within guidelines (n = 166) and using information (n = 176). Discrepancies were most frequently identified for guidelines produced by a local organisation (n = 405), and most occurred during prescribing (n = 277) or medication administration (n = 241)., Conclusion: Difficulties finding and using information from clinical guidelines contribute to thousands of prescribing and medication administration incidents, some of which are associated with substantial patient harm., (© 2024. The Author(s).)

Competing Interests: None declared

Background: Globally, increased occurrences of patient safety incidents have become a public concern. The implementation of Patient safety incidents reporting and learning guidelines is fundamental to reducing preventable patient harm. To improve the implementation of these guidelines in specialised care units in KwaZulu-Natal, the views of healthcare professionals were unearthed., Aim: This study explores the healthcare professionals' views toward the implementation of Patient safety incident reporting and learning guidelines in specialised care units., Methods: A descriptive, explorative qualitative approach was used to collect qualitative data from healthcare professionals working in specialised care units. The study was conducted in specialised care units of three purposely selected public hospitals in two districts of KwaZulu-Natal. Group discussions and semi-structured interviews were conducted from August to October 2021. Content data analysis was performed using Tesch's method of analysis process., Results: The main themes that emerged during data analysis were; ineffective reporting system affecting the communication of Patient safety incident guidelines, inadequate institutional and management support for the healthcare professionals, insufficient education and training of healthcare professionals, and poor human resources affecting the implementation of Patient Safety Incident guidelines. The findings highlighted that there were more major barriers to the implementation of the Patient safety incident reporting and learning guidelines., Conclusion: This study confirmed that the Patient safety incident reporting and learning guidelines are still not successfully implemented in the specialised care units and the barriers to implementation were highlighted. For rigorous implementation in South Africa, the study recommends revised Patient safety incident reporting and learning guidelines, designed in consultation with the frontline healthcare professionals. These must consist of standardised, simple- user-friendly reporting process as well as a better implementation strategy to guide the healthcare professionals. Continuous professional development programmes may play an important role in the facilitation of the implementation process., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Gqaleni, Mkhize. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: An adverse event is defined as an unwanted and unexpected occurrence in a medical process that may end in harm to the patient. In the USA the number of deaths due to failures reaches 253,000 per year. In Israel, over 10,000 deaths occur per year due to errors in the medical treatment of hospitalized patients, the third most common cause of death after heart disease and cancer. The main cause of failures in medical diagnosis and treatment is the complexity of the medical profession. A large number of caregivers in different medical disciplines are needed to treat one patient, therefore there are many errors, especially regarding communication between therapists. The Israeli health system has been operating with a budget deficit for many years and an addition of at least NIS 20 billion is needed to bring it to optimal functioning. The number of doctors, nurses, and hospital beds per 1000 inhabitants is significantly less than the average of the OECD countries. When there was a 30% increase in the population of Israel it was necessary to enhance the existing situation, with the addition of 7700 hospital beds, but only 1400 were added. This caused a decrease from 2.1 beds per 1000 residents to 1.8 beds per 1000 residents. There is an urgent need to change the elements of treatment safety in the Ministry of Health's strategic plan. An administration for quality, treatment safety, risk management in medicine, and accreditation should be established which, in addition to the care quality division, will include a safety division with investigation and monitoring units and will prepare strategic improvement plans, and a university-level research institute with researchers, computing, statistics, and information gathering units. The institute will receive all reports of adverse events, results of investigations, inspection committees, control and quality committees, relevant verdicts, and updated literature reviews, for research and systemic learning. Strategic plans will be prepared to prevent failures in diagnosis and medical treatment, leading to a decrease in mortality due to adverse events and the significant expenses involved.

Background: The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways., Methods: Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams., Results: The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm., Conclusions: The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Despite advances in understanding and reducing the risk of endoscopic procedures, there is little consideration of the safety of the wider endoscopy service. Patient safety incidents (PSIs) still occur. We sought to identify nonprocedural PSIs (nPSIs) and their causative factors from a human factors perspective and generate ideas for safety improvement., Methods: Endoscopy-specific PSI reports were extracted from the National Reporting and Learning System (NRLS). A retrospective, cross-sectional human factors analysis of data was performed. Two independent researchers coded data using a hybrid thematic analysis approach. The Human Factors Analysis and Classification System (HFACS) was used to code contributory factors. Analysis informed creation of driver diagrams and key recommendations for safety improvement in endoscopy., Results: From 2017 to 2019, 1181 endoscopy-specific PSIs of significant harm were reported across England and Wales, with 539 (45.6%) being nPSIs. Five categories accounted for over 80% of all incidents, with "follow-up and surveillance" being the largest (23.4% of all nPSIs). From the free-text incident reports, 487 human factors codes were identified. Decision-based errors were the most common act prior to PSI occurrence. Other frequent preconditions to incidents were focused on environmental factors, particularly overwhelmed resources, patient factors, and ineffective team communication. Lack of staffing, standard operating procedures, effective systems, and clinical pathways were also contributory. Seven key recommendations for improving safety have been made in response to our findings., Conclusions: This was the first national-level human factors analysis of endoscopy-specific PSIs. This work will inform safety improvement strategies and should empower individual services to review their approach to safety., Competing Interests: H. Ashrafian is Chief Scientific Officer of Pre-emptive Medicine and Health Security at Flagship Pioneering. A. Darzi is Executive Chair of Pre-emptive Medicine and Health Security at Flagship Pioneering. S. Ravindran, M. Matharoo, M. Rutter, C. Healey, and S. Thomas-Gibson declare that they have no conflicts of interest., (Thieme. All rights reserved.)

Aim: To analyse the perception of patient safety culture among nursing students and to compare patient safety outcomes between the different year nursing groups., Design: A cross-sectional descriptive study was conducted with nursing students (n = 266) between first and fourth years from one university in Spain., Methods: The project was conducted during the 2020/21 academic year. The data were collected using a translated and adapted version of the "Hospital Survey on Patient Safety" developed by the Agency of Healthcare Quality (AHQR)., Results: Significant differences were found between the year of study of the nursing degree and whether or not specific training in patient safety culture had been received. The nursing students who had received specific training gave scores lower than anyone else in all questionnaire items, but only the indicators of "good practice" (p = 0.00) and "frequency of reported events" (p = 0.0012) showed significant differences. In some cases, fourth-year students had lower significant mean scores in their "perception of patient safety within unit/sector," "indicators of good practice" and "total score.", Public Contribution: Adverse events related to clinical practice continue to be a global problem. Improvements in patient safety require an increase in the patient safety culture of professionals and the promotion of development facilitators. Clinical practice and specific theoretical training foster greater awareness and demand related to patient safety, which is of interest when it comes to the development of new programmes that combine both methodologies and improve their effectiveness. Patient safety will continue to be a focus for all healthcare systems. The patient safety culture of future healthcare professionals should be developed at the university level in order to avoid unnecessary adverse events., (© 2023 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Background: Parenteral nutrition (PN)-related patient safety incidents have been associated with harm. Large-scale studies are scarce, and little is known about contributory factors. This study evaluated PN-related incident reports that described harm using a national database., Materials and Methods: A retrospective evaluation of incident reports involving PN in England and Wales reported to the National Reporting and Learning System between 2015 and 2020. We described frequency by degree of reported harm and incident characteristics. Content analysis was undertaken to understand contributory factors for reports related to moderate/severe harm or death., Results: 12,907 incident reports were identified. After screening, 2242 were evaluated; 1879 (83.8%) reported no harm, 309 (13.8%) low harm, 47 (0.02%) moderate harm, 4 (0.002%) severe harm, 3 (0.001%) deaths. The most reported age group, medication process, and error category were neonates (<28 days) (n = 570/1923, 29.6%), administration (n = 1126/2242, 50%), and omitted medication/ingredient (n = 291/2242, 13%), respectively. Content analysis of reports related to moderate/severe harm and death revealed patient age of <1 year, dependence on home PN (HPN), comorbidities, and staff errors as contributory factors., Conclusions: This is the first evaluation of PN-related incident reports in England and Wales to our knowledge. We demonstrated a low frequency of reports related to moderate or severe harm or death. More incidents were reported for neonates and during the administration processes. To reduce harm, systems/procedures that reduce errors in high-risk patients (eg, neonates, patients receiving HPN) need to be established within organizations. Database limitations of voluntary reporting systems were recognized., (© 2023 The Authors. Nutrition in Clinical Practice published by Wiley Periodicals LLC on behalf of American Society for Parenteral and Enteral Nutrition.)

Clinical record (CR) is a tool for recording details about the patient and the most commonly used source of information for detecting adverse events (AEs). Its completeness is an indicator of the quality of care provided and may provide clues for improving professional practice. The primary aim of this study was to estimate the prevalence of AEs. The secondary aims were to determine the completeness of CRs and to examine the relationship between the two variables. We retrospectively reviewed randomly selected CRs of patients discharged from the Academic Hospital of Udine (Italy) in the departments of general surgery, internal medicine, and obstetrics between July and September 2020. Evaluation was performed using the Global Trigger Tool and a checklist to evaluate the completeness of CRs. The relationship between the occurrence of AEs and the completeness of CRs was analyzed using nonparametric tests. A binomial logistic regression analysis was also performed. We reviewed 291 CRs and identified 368 triggers and 56 AEs. Among them, 16.2% of hospitalizations were affected by at least one AE, with a higher percentage in general surgery. The most common AEs were surgical injuries (42.6%; 24) and care related (26.8%; 15). A significant positive correlation was found between the length of hospital stay and the number of AEs. The average completeness of CRs was 72.9% and was lower in general surgery. The decrease in CR completeness correlated with the increase in the total number of AEs (R = -0.14; P = .017), although this was not confirmed by regression analysis by individual departments. Our results seem to suggest that completeness of CRs may benefit patient safety, so ongoing education and involvement of health professionals are needed to maintain professional adherence to CRs., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context., Methods: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript., Results: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose., Conclusions: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objectives: This study mainly examines the effects of patient safety culture dimensions on 4 outcomes (self-reported errors, witnessing errors, incident reporting, and patient safety grade)., Methods: The data were collected using the Turkish version of the Safety Attitudes Questionnaire, which consists of 6 dimensions (teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions). Of 1679 personnel working in 6 hospitals in Ankara, 860 were randomly selected. The data were analyzed using descriptive statistics, the Spearman correlation coefficient, and binary logistic regression analyses., Results: The response rate was 62.7%. When the overall patient safety culture score increased by 1 point; the probability of witnessing an error was 2 times lower (P < 0.001), the probability of incident reporting was 4.22 times higher (P < 0.001), and the probability of assessing the patient safety grade as excellent was 29.86 times higher (P < 0.001). The teamwork climate was negatively related to making errors and witnessing errors (P < 0.001). The safety climate and working conditions were positively related to incident reporting and patient safety grade (P < 0.001). Job satisfaction was negatively related to incident reporting (P < 0.001). Perceptions of management were positively related to making errors and patient safety grade (P < 0.001)., Conclusions: The patient safety culture scores were positively correlated with incident reporting and patient safety grade but negatively correlated with the occurrence of errors. Each dimension of the patient safety culture, except stress recognition, affected different outcomes. Therefore, managers should focus on different dimensions of patient safety culture to improve different outcomes., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: In industrialised countries, one in ten patients suffers harm during hospitalization. Critical Incident Reporting Systems (CIRS) aim to minimize this by learning from errors and identifying potential risks. However, a lack of interoperability among the 16 CIRS in Germany hampers their effectiveness., Methods: This study investigates reports' syntactic and semantic interoperability across seven different reporting systems. Syntactic interoperability was examined using WHO's Minimal Information Models (MIM), while semantic interoperability was evaluated with SNOMED concepts., Results: The findings reveal a low structural overlap, with only two terms correctly represented in the SNOMED CT terminology. In addition, most systems showed no syntactic interoperability., Conclusion: Improving interoperability is essential for increasing the effectiveness and usability of CIRS. The study suggests a unified data model such as MIM or using Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) resources and expanding SNOMED CT with patient safety-relevant terms for semantic interoperability. Given the current lack of both syntactic and semantic interoperability in CIRS, developing a patient safety ontology is recommended for efficient critical incident analysis too.

Background: There is no consensus for the role definition for Patient Safety Officers (PSOs) in healthcare during pandemics or other crises as opposed to their routine activities. This study aimed to examine the contribution of personality traits and systemic factors on the performance of PSOs during the pandemic, and to compare these variables during the first and third waves of the Covid-19 pandemic in Israel., Methods: This cross-sectional study invited 117 PSOs to complete a questionnaire addressing their role during the Covid-19 pandemic. The questionnaire included items concerning: Personal and socio-demographic characteristics; Uncertainty; Personal initiative; Burnout; Professional functioning; Patient Safety and Risk Management policies and practices; Organizational functioning; and Personal Involvement in risk management activities. Qualitative data was collected by two open-ended questions., Results: A total of 78 PSOs (67%) completed the questionnaire. The results revealed that many PSOs reduced their involvement in risk management processes or even left their position temporarily in order to return to their primary specialization as clinicians. Only 51.3% and 57.7% reported practicing risk management in the first and third waves, respectively. The three main factors that kept PSOs functioning were managerial support, mobilization of their team, and the belief in the importance of their position., Conclusions: A crisis generates uncertainty, a plethora of frequent and urgent tasks, and the need to adapt policy to changing circumstances and to the increased risks. The risk manager must be a member of the crisis management team and participate in every important discussion in order to represent essential staff and patient safety issues and ensure that these are fully addressed already in the early stages of planning., (© 2023. The Israel National Institute for Health.)

Many hospitals continue to use incident reporting systems (IRSs) as their primary patient safety data source. The information IRSs collect on the frequency of harm to patients [adverse events (AEs)] is generally of poor quality, and some incident types (e.g. diagnostic errors) are under-reported. Other methods of collecting patient safety information using medical record review, such as the Global Trigger Tool (GTT), have been developed. The aim of this study was to undertake a systematic review to empirically quantify the gap between the percentage of AEs detected using the GTT to those that are also detected via IRSs. The review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies published in English, which collected AE data using the GTT and IRSs, were included. In total, 14 studies met the inclusion criteria. All studies were undertaken in hospitals and were published between 2006 and 2022. The studies were conducted in six countries, mainly in the USA (nine studies). Studies reviewed 22 589 medical records using the GTT across 107 institutions finding 7166 AEs. The percentage of AEs detected using the GTT that were also detected in corresponding IRSs ranged from 0% to 37.4% with an average of 7.0% (SD 9.1; median 3.9 and IQR 5.2). Twelve of the fourteen studies found <10% of the AEs detected using the GTT were also found in corresponding IRSs. The >10-fold gap between the detection rates of the GTT and IRSs is strong evidence that the rate of AEs collected in IRSs in hospitals should not be used to measure or as a proxy for the level of safety of a hospital. IRSs should be recognized for their strengths which are to detect rare, serious, and new incident types and to enable analysis of contributing and contextual factors to develop preventive and corrective strategies. Health systems should use multiple patient safety data sources to prioritize interventions and promote a cycle of action and improvement based on data rather than merely just collecting and analysing information., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Quality in Health Care.)

Purpose: Risk management (RM) is a key component of patient safety in radiation oncology (RO). We investigated current approaches on RM in German RO within the framework of the Patient Safety in German Radiation Oncology (PaSaGeRO) project. Aim was not only to evaluate a status quo of RM purposes but furthermore to discover challenges for sustainable RM that should be addressed in future research and recommendations., Methods: An online survey was conducted from June to August 2021, consisting of 18 items on prospective and reactive RM, protagonists of RM, and self-assessment concerning RM. The survey was designed using LimeSurvey and invitations were sent by e‑mail. Answers were requested once per institution., Results: In all, 48 completed questionnaires from university hospitals, general and non-academic hospitals, and private practices were received and considered for evaluation. Prospective and reactive RM was commonly conducted within interprofessional teams; 88% of all institutions performed prospective risk analyses. Most institutions (71%) reported incidents or near-events using multiple reporting systems. Results were presented to the team in 71% for prospective analyses and 85% for analyses of incidents. Risk conferences take place in 46% of institutions. 42% nominated a manager/committee for RM. Knowledge concerning RM was mostly rated "satisfying" (44%). However, 65% of all institutions require more information about RM by professional societies., Conclusion: Our results revealed heterogeneous patterns of RM in RO departments, although most departments adhered to common recommendations. Identified mismatches between recommendations and implementation of RM provide baseline data for future research and support definition of teaching content., (© 2022. The Author(s).)

Background and Objectives: Slovenia lags behind international recommendations for reporting and learning from patient safety incidents and risk management in health care. To counter this, the country established the SenSys project, which receives technical support from the European Commission's Structural Reform Support Service, in cooperation with the Danish Patient Safety Authority, and pertains to an initiative to improve health care. A subproject of the SenSys project works to adapt and implement the International Classification for Patient Safety of the World Health Organization (ICPS-WHO). This article presents a case study of the national research process to identify the necessary Slovenian national adaptation and upgrade of the ICPS-WHO, the ICPS-SL, particularly regarding types of patient safety incidents. Our aim was to reflect on how we used the insights from different research elements and learned from different aspects of our project/system development., Methods: We used the SQUIRE 2.0 (Standards of Quality Improvement Reporting Excellence) to present our case study. The methods used to collect information on the necessary adaptations to establish an optimal ICPS-SL included a literature review, qualitative analysis of national consultation meetings, and a 2-cycle Delphi study. This process took place between January 2018 and August 2019, and we found 18 useful articles. Participants such as providers, users, and national bodies from national consultation meetings were all key stakeholders., Results: The relevant stakeholders agreed upon changes to the ICPS-WHO to implement in the ICPS-SL as an integrated part of a Slovenia's incident reporting and learning system. Notably, they implemented changes in terminology in the translation of some English terms. They also added or hierarchically reordered some patient safety incident types: for example, they added the nation-specific point "treatment of pain" as a type of patient safety incident. The stakeholders will also partially integrate the following indicators: monitoring systems, vigilance systems, and complaint systems., Conclusion: Different research elements contributed to the ICPS-SL's new knowledge and more reliable development. We emphasized a cooperative process with a consensus-building approach while linking the knowledge, experience, and needs of various stakeholders. All interested parties adopted this process, aiming to establish conditions for national learning from patient safety incidents and better preventive action for health care quality and safety. Vertical and horizontal multidisciplinary teamwork was a focal point as well. Technical assistance proved especially useful. It is now necessary to clinically test the ICPS-SL classification framework as Slovenia's internationally harmonized standard, and have the Health Council adopt it for use both online and in practice., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Adverse events (AEs) cause suffering for hospitalised children, a fragile patient group where the delivery of adequate timely care is of great importance., Objective: To report the incidence and characteristics of AEs, in paediatric inpatient care, as detected with the Global Trigger Tool (GTT), the Trigger Tool (TT) or the Harvard Medical Practice Study (HMPS) method., Method: MEDLINE, Embase, Web of Science and Google Scholar were searched from inception to June 2021, without language restrictions. Studies using manual record review were included if paediatric data were reported separately. We excluded studies reporting: AEs for a specific disease/diagnosis/treatment/procedure, or deceased patients; study protocols with no AE outcomes; conference abstracts, editorials and systematic reviews; clinical incident reports as the primary data source; and studies focusing on specific AEs only. Methodological risk of bias was assessed using a tool based on the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Primary outcome was the percentage of admissions with ≥1 AEs. All statistical analyses were stratified by record review methodology (GTT/TT or HMPS) and by type of population. Meta-analyses, applying random-effects models, were carried out. The variability of the pooled estimates was characterised by 95% prediction intervals (PIs)., Results: We included 32 studies from 44 publications, conducted in 15 countries totalling 33 873 paediatric admissions. The total number of AEs identified was 8577. The most common types of AEs were nosocomial infections (range, 6.8%-59.6%) for the general care population and pulmonary-related (10.5%-36.7%) for intensive care. The reported incidence rates were highly heterogeneous. The PIs for the primary outcome were 3.8%-53.8% and 6.9%-91.6% for GTT/TT studies (general and intensive care population). The equivalent PI was 0.3%-33.7% for HMPS studies (general care). The PIs for preventable AEs were 7.4%-96.2% and 4.5%-98.9% for GTT/TT studies (general and intensive care population) and 10.4%-91.8% for HMPS studies (general care). The quality assessment indicated several methodological concerns regarding the included studies., Conclusion: The reported incidence of AEs is highly variable in paediatric inpatient care research, and it is not possible to estimate a reliable single rate. Poor reporting standards and methodological differences hinder the comparison of study results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Safety incident (SI) reporting and learning via incident reporting systems (IRSs) is used to identify areas for patient safety improvement. The chiropractic patient incident reporting and learning system (CPiRLS) is an online IRS that was launched in the UK in 2009 and, from time to time, has been licensed for use by the national members of the European Chiropractors' Union (ECU), members of Chiropractic Australia and a Canada-based research group. The primary aim of this project was to analyse the SIs submitted to CPiRLS over a 10-year period to identify key areas for patient safety improvement., Method: All SIs reported to CPiRLS between April 2009 and March 2019 were extracted and analysed. Descriptive statistics were used to describe: (1) the frequency of SI reporting and learning by the chiropractic profession, and (2) the character of reported SIs. Key areas for patient safety improvement were developed following a mixed methods approach., Results: A total of 268 SIs were recorded on the database over the 10-year period, 85% of which originated from the UK. Evidence of learning was documented in 143 (53.4%) SIs. The largest subcategory of SIs related to post-treatment distress or pain (n = 71, 26.5%). Seven key areas for patient improvement were developed including: (1) patient trip/fall, (2) post treatment distress/pain, (3) negative effects during treatment, (4) significant post-treatment effects, (5) syncope, (6) failure to recognize serious pathology, and (7) continuity of care., Conclusion: The low number of SIs reported over a 10-year period suggests significant under-reporting, however, an upward trend was identified over the 10-year period. Several key areas for patient safety improvement have been identified for dissemination to the chiropractic profession. Improved reporting practice needs to be facilitated to improve the value and validity of reporting data. CPiRLS is important in identifying key areas for patient safety improvement., (© 2023. The Author(s).)

Objectives: Our study aimed to reveal the frequency of patient safety incidents (PSI) in dentomaxillofacial radiology (DMFR), including their mitigating and contributing factors, to help recognize and thus better prevent these adverse events (AE) in the future., Methods: Hospital District Helsinki and Uusimaa (HUS) and the City of Helsinki (HKI) use HaiPro, an anonymous web-based tool, for healthcare professionals to report PSI. Dentistry-related PSIs were evaluated individually to find any DMFR-related reports. Additionally, we searched the HaiPro-data using multiple dentistry- and DMFR-related keywords. We compartmentalized all DMFR-related PSI by their type and assessed their contributing factors, as well as their risk classification, severity, outcome, and possible corrective actions., Results: In HUS and HKI, 43 of the 195,589 HaiPro-reports filed during 2012-2017 were DMFR-related. The most prevalent event type of DMFR-related PSIs was laboratory-, medical imaging-, or other patient examination-related events (33%). The second most common event type was defined as being related to flow or control of information (26%). For both of these event types, the most common contributing factors were shortcomings of communication and flow of information. Risk classification showed only one AE to be of moderate risk, and all others were perceived as irrelevant or minor., Conclusions: PSI in DMFR are only rarely reported, and mostly, they are perceived of causing little or no harm. We detected a great difference in reporting activity between primary and secondary healthcare workers, but the underlaying causes remain unclear., (© 2022. The Author(s).)

The ability of any incident reporting system to improve patient care is dependent upon robust reporting practices. However, under-reporting is still a problem worldwide. We aimed to reveal the barriers experienced while reporting an incident through a nationwide survey in Japan. We conducted a cross-sectional survey. All first- and second-year residents who took the General Medicine In-Training Examination (GM-ITE) from February to March 2021 in Japan were selected for the study. The voluntary questionnaire asked participants regarding the number of safety incidents encountered and reported within the previous year and the barriers to reporting incidents. Demographics were obtained from the GM-ITE. The answers of respondents who indicated they had never previously reported an incident (non-reporting group) were compared to those of respondents who had reported at least one incident in the previous year (reporting group). Of 5810 respondents, the vast majority indicated they had encountered at least one safety incident in the past year (n = 4449, 76.5%). However, only 2724 (46.9%) had submitted an incident report. Under-reporting (more safety incidents compared to the number of reports) was evident in 1523 (26.2%) respondents. The most frequently mentioned barrier to reporting an incident was the time required to file the report (n = 2622, 45.1%). The barriers to incident reporting were significantly different between resident physicians who had previously reported and those who had never previously reported an incident. Our study revealed that resident physicians in Japan commonly encounter patient safety incidents but under-report them. Numerous perceived and experienced barriers to reporting remain, which should be addressed if incident reporting systems are to have an optimal impact on improving patient safety. Incident reporting is essential for improving patient safety in an institution, and this study recommends establishing appropriate interventions according to each learner's barriers for reporting., Competing Interests: The authors have no conflicts of interest to declare. All authors have reviewed and agree with the contents of the manuscript, and there are no financial interests to report., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Objectives: Patient safety events (PSEs) are unwanted or unexpected events that occur during medical care. High cognitive loads and frequent interruptions make emergency departments (EDs) uniquely error prone environments. Yet, frontline clinicians rarely report PSEs using incident reporting systems. The incidence, severity, and preventability of PSEs thus remain poorly understood, and contributing factors are understudied. We sought to understand ED staff beliefs and perceptions about their PSE reporting system and what features they believe are important in such a system., Methods: We conducted a qualitative study among healthcare providers working in the ED and departmental leadership. We recruited participants via email and held a series of interviews, focus groups, and participatory workshops. We iteratively analyzed the data using the constant comparative method and used thematic analysis to establish themes., Results: 50 participants attended at least one focus group, interview, or workshop. Participants perceived that PSE reporting through formal channels in the ED was challenging. Clinicians had an inherent desire to report PSEs and do so through numerous informal channels, yet underreported in formal reporting systems. The current PSE reporting system did not meet frontline staff needs and was viewed as ineffective in improving care quality and safety. We identified three key features for an improved PSE reporting system: (1) clear definitions; (2) transparency; and (3) simplicity., Conclusions: In this study, we have identified ideal features for PSE reporting processes to meet the needs of both frontline staff and departmental leadership based on perceptions of current PSE reporting practices. Improved PSE reporting processes have the potential to increase PSE reporting in the ED overall, increasing the availability of information about PSEs to support quality improvement and improve patient safety., (© 2022. The Author(s).)

Competing Interests: Competing interests: None declared.

Background and Aim: To determine the impact of the COVID-19 pandemic on the epidemiology of safety incidents (SI) and medication errors (ME) reported to the CISEMadrid notification system in the hospital and primary care settings of the Madrid Health Service (SERMAS)., Materials and Methods: Observational and descriptive study with a retrospective analysis of data including all CISEMadrid notifications from 01-Jan-2018 to 31-Dec-2020, from 33 hospitals and 262 health care centres of the SERMAS. The two periods in 2020 with the greatest increase in COVID-19 cases were identified to compare incidents reported in the pre-pandemic and pandemic periods., Results: 36,494 incidents were reported. Comparing both periods, an overall decrease in pandemic notifications of 60.7% was observed, being higher in primary care, falling to 33% of previous levels. The reduction in notifications was similar in the peaks and valleys of the waves. The three most frequent SIs in both periods and care settings were: diagnostic tests, medical devices/equipment/clinical furniture and organisational management/citations. In ME, dose failure and inappropriate selection were the most frequent in both settings and periods. There were no relevant differences in patient consequences in both periods., Conclusions: During the pandemic, patient safety notifications decreased although the most frequent types remained the same, as did their impact on the patient, both in hospitals and in primary care. The safety culture of organisations is a critical aspect for the maintenance of reporting systems., (Copyright © 2022 FECA. All rights reserved.)

Social factors that affect health are called social determinants. Social determinants may also carry risk, known as social risk. Management and patient safety professionals understand health care and enterprise risk. Social risk may add a new dimension for some. Social risks are probably amenable to the strategies patient safety and risk management professionals already employ, such as enterprise risk management, a culture of safety, and just culture. A large body of evidence suggests that social risks, particularly literacy and discrimination, strongly affect patient safety and well-being. This paper examines the relationship between social determinants of health and social risks and considers how health care organizations might address literacy and discrimination from the perspective of patient safety and risk management., (© 2022 American Society for Healthcare Risk Management of the American Hospital Association.)

Objective: To design a risk map (RM) as a tool for identifying and managing risks in the paediatric emergency department and to assess the impact of the improvement actions developed based on the identified risks in terms of the level of risk to patient safety., Methodology: A multidisciplinary working group reviewed the entire care process by applying the Failure Mode and Effects Analysis (FMEA) tool. Project phases: (1) RM 2017 and planning of improvement actions; (2) Development and implementation of improvement actions; (3) RM 2019; (4) Analysis: evolution of the RM and impact of improvement actions., Results: A total of 106 failure modes (FMs) were identified in the 2017 RM (54.7% high- or very high risk). We applied prioritization criteria to select the improvement actions to plan. Nineteen improvement actions were planned, with assigned responsible parties and deadlines, to address 46 priority FMs. One hundred percent were implemented. In the 2019 RM, we identified 110 FMs (48.2% high risk) and found an overall reduction of the risk level of 20%. Analysing the 46 priority FMs that had been addressed by the 19 planned improvement actions, we found that 60% had changed from high to medium risk level and that the risk level had decreased, both overall (-27.8%) and by process., Conclusion: The FMEA is a useful tool to identify risks, analyse the impact of improvement strategies and monitor the risk level of a complex clinical care department. The improvement actions developed succeeded in reducing the level of risk in the processes in our unit, improving patient safety., (Copyright © 2022. Published by Elsevier España, S.L.U.)

Background: Safety is one of the dimensions of healthcare quality and is core to achieving universal health coverage and healthcare delivery worldwide. In Ghana, the status of patient safety in the last 7 years has remained unknown. Therefore, this study aims to assess the patient safety status in selected hospitals in Ghana., Methods: Using the WHO Patient Safety Long Form, a mixed methodology was used to assess the patient safety status in 27 hospitals in Ghana. Data were analysed using descriptive statistics and axial codes for thematic analysis., Results: The average national patient safety score was high (85%). However, there were variations in the performance of the hospitals across the WHO patient safety action areas. Knowledge and learning in patient safety (97%) was the highest-rated patient safety action area. Patient safety surveillance, patient safety funding, patient safety partnerships and national patient safety policy had mean scores lower than the national average score (85%). Less than half (42%) of the hospitals had a dedicated budget for patient safety activities. The means of continuous education for health professionals include clinical sessions, and in-service training, while the system of clinical audits in the hospitals were maternal mortality, perinatal mortality, stillbirth and general mortality audits. The hospitals use posters, leaflets, public address systems and health education sessions to inform patients about their rights. Patient safety issues are reported through suggestion boxes, designated desks and the use of contacts of core management staff., Conclusion: The current patient safety status in the hospitals was generally good, with the highest score in the knowledge and learning in the patient safety domain. Patient safety surveillance was identified as the weakest action area. The findings of this study will form the scientific basis for initiating the development of a national patient safety policy in Ghana. This is crucial for ensuring resilient and sustainable health systems that guarantee safer care to all patients in Ghana., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

For nearly 20 years, prominent perfusionists have called for a perfusion-centric prospective incident-reporting system to collect near-miss and patient harm incidents that occur during clinical practice in the United States. In this article, we describe the development of a widely available prospective incident-reporting system for use by perfusionists in the United States. The system was developed in three phases: literature review, system incorporation, and submission for listing as a Patient Safety Organization (PSO). It is anticipated that the knowledge gained from analysis of events contributed to this PSO-protected reporting system will lead to improvements in safety and quality of perfusion services, as well as expanding the understanding of best practices in training, equipment use, system design, and simulation scenarios., (© Copyright 2022 AMSECT.)

Background: To reduce patient harm, healthcare has focused on improvement based on learning from errors and adverse events (Safety-I). Daily huddles with staff are used to support incident reporting and learning in healthcare. It is proposed that learning for improvement should also be based on situations where work goes well (Safety-II); daily safety huddles should also reflect this approach. A Safety-II-inspired model for safety huddles was developed and implemented at the Neonatal Care Unit at a regional hospital in Sweden. This study followed the implementation with the research questions: Do patient safety huddles with a focus on Safety-II affect the results of measurements of the patient safety culture? What are the experiences of these huddles amongst staff? What experiences of everyday work arise in the patient safety huddles?, Methods: A multi-method approach was used. The quantitative part consisted of a questionnaire (151 items), submitted on four different occasions, and analysed using Mann Whitney U-test and Kruskal Wallis ANOVA-test. The qualitative data were analysed using thematic content analyses of interviews with staff (n = 14), as well as answers to open questions in the questionnaires., Results: There were 151 individual responses to the questionnaires. The response rates were 44% to 59%. For most comparisons, there were no differences. There were minor changes in patient safety culture measurements. A lower rating was found in December 2020, compared to October 2019 (p < 0.05), regarding whether the employees pointed out when something was about to go wrong. The interviews revealed that, even though most respondents were generally positive towards the huddles (supporting factors), there were problems (hindering factors) in introducing Safety-II concepts in daily safety huddles. There was a challenge to understanding and describing things that go well., Conclusions: For patient safety huddles aimed at exploring everyday work to be experienced as a base for learning, including both negative and positive events (Safety-II); there is a need for an open and permissive climate, that all professions participate and stable conditions in management. Support from managers and knowledge of the underpinning Safety-II theories of those who lead the huddles, may also be of importance., (© 2022. The Author(s).)

Introduction: Health organisations should support healthcare workers who are physically and psychologically affected by patient safety incidents (second victims). There is a growing body of evidence which focuses on second victim support interventions. However, there is still limited research on the elements necessary to effectively implement and ensure the sustainability of these types of interventions. In this study, we propose to map and frame the key factors which underlie an effective implementation of healthcare worker support interventions in healthcare organisations when healthcare workers are physically and/or emotionally affected by patient safety incidents., Methods and Analysis: This scoping review will be guided by the established methodological Arksey and O'Malley framework, Levac and Joanna Briggs Institute (JBI) recommendations. We will follow the JBI three-step process: (1) a preliminary search conducted on two databases; (2) the definition of clear inclusion criteria and the creation of a list of search terms to be used in the subsequent running of the search on a larger number of databases; and (3) additional searches (cross-checking/cross-referencing of reference lists of eligible studies, hand-searching in target journals relevant to the topic, conference proceedings, institutional/organisational websites and networks repositories). We will undertake a comprehensive search strategy in relevant bibliographic databases (PubMed/MEDLINE, Embase, CINHAL, Web of Science, Scopus, PsycInfo, Epistemonikos, Scielo, Cochrane Library and Open Grey). We will use the Mixed Methods Appraisal Tool V.2018 for quality assessment of the eligible studies. Our scoping review will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews., Ethics and Dissemination: This study will not require ethical approval. Results of the scoping review will be published in a peer-review journal, and findings will be presented in scientific conferences as well as in international forums and other relevant dissemination channels., Trial Registration Number: 10.17605/OSF.IO/RQAT6.Preprint from medRxiv available: doi: https://doi.org/10.1101/2022.01.25.22269846., Competing Interests: Competing interests: This protocol is included in the PhD project of the corresponding author (SG-P) previously approved by the National School of Public Health from NOVA University of Lisbon. Some of the research team members are part of the European Researchers Network Working on Second Victims, COST Action 19113., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed at evaluating the impact of a combined-strategies intervention on ICUs nurses' attitudes toward AE reporting., Methods: We conducted a quasi-experimental study from January to October 2020 which consisted of an intervention to improve attitudes toward incident reporting among nurses working in 10 intensive care units at a university hospital using the Reporting of Clinical Adverse Events Scale. The intervention consisted of a 2-hour educational presentation for nurse unit managers and a 30-minute in-units educational training for intensive care unit nurses, which encompassed technical aspects of reporting, the reporting process, a nonpunitive environment, and the importance of submitting reports. The educational presentation was reinforced with distributing posters and brochures and biweekly patient safety rounds that inquired about events, reinforced education, and provided follow-up to incident reports., Results: All dimensions were significantly improved. Score increased from 27.4% to 42.1% ( P < 0.01) for perceived blame, from 35.2% to 52.5% for perceived criteria for identifying events that should be reported ( P < 0.01), from 34.3% to 46% for perceptions of colleagues' expectations ( P = 0.04), from 37.1% to 51.4% for perceived benefits of reporting ( P = 0.01), and from 29.2% to 51.4% for perceived clarity of reporting procedures ( P < 0.01)., Conclusions: Interventions using a combination of several strategies such as training, safety round, and messaging can be effective and should be considered by hospitals attempting to increase adverse events reporting. Results reinforce the assumption that a nonpunitive environment and the resulting feeling of safety and reassurance are crucial to foster the submission of reports., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: This study explored how just culture, authentic leadership, safety climate, patient safety knowledge, and safety motivation all affect military nurses' reporting of patient safety events., Methods: This study adopted a cross-sectional and descriptive correlational design. Data were collected from 303 nurses working across eight military hospitals under the jurisdiction of the Armed Forces Medical Command in South Korea, from June 17 to July 25, 2020. The hypothesized model was then validated using structural equation modeling., Results: The participating military nurses did not show any proactive attitudes toward reporting near misses when compared with their responses to adverse or no-harm events. The final model exhibited goodness of fit. Herein, both safety climate (β = 0.35, p = .009) and patient safety knowledge (β = 0.17, p = .025) directly influence patient safety event reporting. Moreover, just culture indirectly influences patient safety event reporting (β = 0.31, p = .002). The discovered influencing factors account for 22.9% of the variance in explaining patient safety event reporting., Conclusions: Our findings indicate that just culture, safety climate, and patient safety knowledge either directly or indirectly affected patient safety event reporting among military nurses. These findings then serve to provide a theoretical basis for developing more effective strategies that would then improve military nurses' patient safety behaviors., Competing Interests: Conflict of interest All authors declare that there are no conflicts of interest., (Copyright © 2022. Published by Elsevier B.V.)

Objective: The aim of this study was to analyze the strength of safety measures described in incident reports in outpatient care., Methods: An incident reporting project in German outpatient care included 184 medical practices with differing fields of specialization. The practices were invited to submit anonymous incident reports to the project team 3 times for 17 months. Using a 14-item coding scheme based on international recommendations, we deductively coded the incident reports and safety measures. Safety measures were classified as "strong" (likely to be effective and sustainable), "intermediate" (possibly effective and sustainable), or "weak" (less likely to be effective and sustainable)., Results: The practices submitted 245 incident reports. In 160 of them, 243 preventive measures were described, or an average of 1.5 per report. The number of documented measures varied from 1 in 67% to 4 in 5% of them. Four preventive measures (2%) were classified as strong, 37 (15%) as intermediate, and 202 (83%) as weak. The most frequently mentioned measures were "new procedure/policy" (n = 121) and "information/notification/warning" (n = 45)., Conclusions: The study provides examples of critical incidents in medical practices and for the first time examines the strength of ensuing measures introduced in outpatient care. Overall, the proportion of weak measures is (too) high, indicating that practices need more support in identifying strong measures., Competing Interests: The other authors disclose no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Reliable provision of emergency equipment in Critical Care is key to ensure patient safety during medical emergencies and transfers. A problem was identified in incident reports and external inspections of processes that ensured the provision of such equipment for use by critical care teams in non-critical care areas in the form of grab bags. A comprehensive project was undertaken to tackle this including the provision of a bespoke digital system.Existing systems were reliant on staff remembering to check equipment and document checks on paper and there was no formal ability to hand over ongoing problems. A local project management approach, '7 Steps to Quality Improvement', which integrated many of the philosophies and tools from Healthcare Improvement was used. A bespoke digital system was designed and implemented with integrated improvements in equipment stocking ergonomics.The reliability of documented equipment checks improved significantly, there was a significant reduction in the number of incident reports regarding emergency equipment and the time spent by staff doing equipment checks was reduced substantially with significant cost and resource improvements. This was so successful the format has been rapidly translated and spread to other areas such as operating theatres' difficult airway trolleys.Undertaking a structured quality improvement approach, using appropriate stakeholder engagement, digitalisation of systems and improvements in basic system ergonomics can have a substantial impact on the reliability and safety of emergency equipment provided for use by members of the critical care team., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)