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BACKGROUND: Incident reporting systems (IRS) can improve care quality and patient safety, yet their impact is limited by clinician engagement. Our objective was to assess barriers to reporting in a hospital-wide IRS and use data to inform ongoing improvement of a specialty-specific IRS embedded in the electronic health record targeting anaesthesiologists. METHODS: This quality improvement (QI) evaluation used mixed methods, including qualitative interviews, faculty surveys and user data from the specialty-specific IRS. We conducted 24 semi-structured interviews from January to May 2023 in a large academic health system in Northern California. Participants included adult and paediatric anaesthesiologists, operating room nurses, surgeons and QI operators, recruited through convenience and snowball sampling. We identified key themes and factors influencing engagement, which were classified using the Systems Engineering Initiative for Patient Safety framework. We surveyed hospital anaesthesiologists in January and May 2023, and characterised the quantity and type of reports submitted to the new system. RESULTS: Participants shared organisation and technology-related barriers to engagement in traditional system-wide IRSs, many of which the specialty-specific IRS addressed-specifically those related to technological access to the system. Barriers related to building psychological safety for those who report remain. Survey results showed that most barriers to reporting improved following the specialty-specific IRS launch, but limited time remained an ongoing barrier (25 respondents out of 44, 56.8%). A total of 964 reports with quality/safety concerns were submitted over the first 8 months of implementation; 47-76 unique anaesthesiologists engaged per month. The top safety quality categories of concern were equipment and technology (25.9%), clinical complications (25.3%) and communication and scheduling (19.9%). CONCLUSIONS: These findings suggest that a specialty-specific IRS can facilitate increased physician engagement in quality and safety reporting and complement existing system-wide IRSs.

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IMPORTANCE: Adequate situational awareness in patient care increases patient safety and quality of care. To improve situational awareness, an innovative, low-fidelity simulation method referred to as Room of Improvement, has proven effective in various clinical settings. OBJECTIVE: To investigate the impact after 3 months of Room of Improvement training on the ability to detect patient safety hazards during an intensive care unit shift handover, based on critical incident reporting system (CIRS) cases reported in the same hospital. METHODS: In this educational intervention, 130 healthcare professionals observed safety hazards in a Room of Improvement in a 2 (time 1 vs time 2)×2 (alone vs in a team) factorial design. The hazards were divided into immediately critical and non-critical. RESULTS: The results of 130 participants were included in the analysis. At time 1, no statistically significant differences were found between individuals and teams, either overall or for non-critical errors. At time 2, there was an increase in the detection rate of all implemented errors for teams compared with time 1, but not for individuals. The detection rate for critical errors was higher than for non-critical errors at both time points, with individual and group results at time 2 not significantly different from those at time 1. An increase in the perception of safety culture was found in the pre-post test for the questions whether the handling of errors is open and professional and whether errors are discussed in the team. DISCUSSION: Our results indicate a sustained learning effect after 12 weeks, with collaboration in teams leading to a significantly better outcome. The training improved the actual error detection rates, and participants reported improved handling and discussion of errors in their daily work. This indicates a subjectively improved safety culture among healthcare workers as a result of the situational awareness training in the Room of Improvement. As this method promotes a culture of safety, it is a promising tool for a well-functioning CIRS that closes the loop.

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Objetivo: analisar a gestão de riscos proativa do processo de administração de anti-infecciosos em Unidade de Terapia Intensiva. Método: estudo qualitativo, em pesquisa-ação, com observação participante e grupo focal, realizado de 2019 a 2021. Foi mapeado o processo, analisados os riscos, planejadas ações de melhorias e redesenhado o processo. Resultados: a prescrição ocorria em sistema eletrônico e os registros da administração em impressos. O processo de administração de anti-infecciosos possuía 19 atividades, dois subprocessos, 16 modos de falhas e 23 causas potenciais. Os modos de falhas foram relacionados à assepsia e erro de dose no preparo de anti-infecciosos e as causas apontadas foram a falha humana na violação das técnicas e o lapso de memória. Cinco especialistas redesenharam o processo resultando em alterações de atividades e no sistema. Conclusão: a gestão de riscos proativa aplicada ao processo de administração de anti-infecciosos propiciou identificar riscos, suas causas e priorizar ações de melhorias, o que pode viabilizar tomadas de decisões apropriadas(AU)

Objective: to analyze the proactive risk management of the anti-infective administration process in an Intensive Care Unit. Method: qualitative study, in action research, with participant observation and focus group, from 2019 to 2021. The process was mapped, risks analyzed, improvement actions planned and the process redesigned. Results: the prescription occurred in an electronic system and the administration records in printed form. The anti-infective administration process had 19 activities, two sub-processes, 16 failure modes and 23 potential causes. The failure modes were related to asepsis and dose error in the preparation of anti-infectives and the identified causes were human error in violating techniques and memory lapse. Five specialists redesigned the process resulting in changes in activities and in the system. Conclusion: proactive risk management applied to the anti-infective administration process was effective in identifying risks, their causes and prioritizing improvement actions(AU)

Objetivo: analizar la gestión proactiva de riesgos del proceso de administración de antiinfecciosos en una Unidad de Cuidados Intensivos. Método: estudio cualitativo, en investigación-acción, con observación participante y grupo focal, que tuvo lugar del 2019 al 2021. Se mapeó el proceso, se analizaron los riesgos, se planificaron acciones de mejora y se rediseñó el proceso. Resultados: la prescripción ocurrió en sistema electrónico y los registros de administración en forma impresa. El proceso de administración de antiinfecciosos tuvo 19 actividades, dos subprocesos, 16 modos de falla y 23 causas potenciales. Los modos de falla estuvieron relacionados con la asepsia y error de dosis en la preparación de antiinfecciosos y las causas identificadas fueron error humano por violación de técnicas y lapsus de memoria. Cinco especialistas rediseñaron el proceso generando cambios en las actividades y en el sistema. Conclusión: la gestión proactiva de riesgos aplicada al proceso de administración de antiinfecciosos fue efectiva para identificar riesgos, sus causas y priorizar acciones de mejora, lo que puede factibilizar la toma de decisiones adecuadasa(AU)

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OBJECTIVES: to investigate the reasons for low patient safety incident reporting among Indonesian nurses. METHODS: this qualitative case study was conducted among 15 clinical nurses selected purposively from a public hospital in Lampung, Indonesia. Interview guidelines were used for data collection through face-to-face in-depth interviews in July 2022. The thematic approach was used to analyze the data. RESULTS: in this present study, seven themes emerged (1) Understanding incident reporting; (2) The culture; (3) Consequences of reporting; (4) Socialization and training; (5) Facilities; (6) Feedback; and (7) Rewards and punishments. FINAL CONSIDERATIONS: these findings should be considered challenges for the patient safety committee and hospital management to increase patient safety incident reporting, particularly among nurses in the hospital.

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Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)

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PURPOSE OF REVIEW: It is important for ophthalmologists to keep current with up-to-date recommendations for screening, treating, and follow-up of infants with retinopathy of prematurity (ROP). This paper will review updated ROP Safety Net protocols and Policy Statements to stress that following risk management principles can avoid claims that could arise from poor visual outcomes. RECENT FINDINGS: Ophthalmic Mutual Insurance Company (OMIC) has been proactive in ROP risk management with development of the ROP Safety Net in 2006. The most recent updates in 2018 and 2019 address OMIC's claims experience and the factors leading to these claims. Clinical, systems, physician, and parent factors will be clarified. In addition, when to stop ROP screening has evolved and will be delineated and discussed to further aid in the process of care of these high-risk infants. SUMMARY: Ophthalmologists that screen and treat infants with ROP must keep updated with safety net protocols and institute them in their Neonatal Intensive Care Units (NICU) and offices as they take care of these babies to minimize legal risks from a claim. In addition, keeping up with policy statements is essential to successfully following these infants in the most appropriate fashion.

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Internal medicine (IM) residents frequently perform invasive bedside procedures during residency training. Bedside procedure training in IM programs may compromise patient safety. Current evidence suggests that IM training programs rely heavily on the number of procedures completed during training as a proxy for resident competence instead of using objective postprocedure patient outcomes. The authors posit that the results of procedural training effectiveness should be reframed with outcome metrics rather than process measures alone. This article introduces the as low as reasonably achievable (ALARA) approach, which originated in the nuclear industry to increase safety margins, to help assess and reduce bedside procedural risks. Training program directors are encouraged to use ALARA calculations to define the risk trade-offs inherent in current procedural training and assess how best to reliably improve patient outcomes. The authors describe 5 options to consider: training all residents in bedside procedures, training only select residents in bedside procedures, training no residents in bedside procedures, deploying 24-hour procedure teams supervised by IM faculty, and deploying 24-hour procedure teams supervised by non-IM faculty. The authors explore how quality improvement approaches using process maps, fishbone diagrams, failure mode effects and analyses, and risk matrices can be effectively implemented to assess training resources, choices, and aims. Future research should address the drivers behind developing optimal training programs that support independent practice, correlations with patient outcomes, and methods that enable faculty to justify their supervisory decisions while adhering to ALARA risk management standards.

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Incident Reporting Systems (IRS) continue to be an important influence on improving patient safety. IRS can provide valuable insights into how to prevent patients from being harmed at the organizational level. But inadequate expectations and misuse, for performance assessment, patient safety measurement or research, have hindered the full IRS potential. Health care organizations need to develop effective strategies built on trust and truth telling to improve the impact of IRS. This requires strategies to address the limited resources to analyse the near-misses or adverse events; avoid the punitive drift through maintaining the anonymity and protective legislation; integrating IRS and avoiding its confusion with mandatory adverse event response systems; training data analysts to focus on the system instead of the individual through a balanced simple taxonomy; combine the analyses at the local level, to reinforce effective and personalized feedback, with the potential of a national or supranational learning platform.

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PURPOSE: To identify factors in community pharmacy that facilitate error recovery from medication incidents (MIs) and explore medication safety prevention strategies from the pharmacist perspective. METHODS: Thirty community pharmacies in Sydney, Australia, participated in a 30-month prospective incident reporting program of MIs classified in the Advanced Incident Management System (AIMS) and the analysis triangulated with case studies. The main outcome measures were the relative frequencies and patterns in MI detection, minimisation, restorative actions and prevention recommendations of community pharmacists. RESULTS: Participants reported 1013 incidents with 831 recovered near misses and 165 purported patient harm. MIs were mainly initiated at the prescribing (68.2%) and dispensing (22.6%) stages, and most were resolved at the pharmacy (76.9%). Detection was efficient within the first 24 h in 54.6% of MIs, but 26.1% required one month or longer; 37.2% occurred after the patient consumed the medicine. The combination of specific actions/attributes (85.5%), appropriate interventions (81.6%) and effective communication (77.7%) minimised MIs. An array of remedial actions were conducted by participants including notification, referral, advice, modification of medication regimen, risk management and documentation corrections. Recommended prevention strategies involved espousal of medication safety culture (97.8%), better application of policies/procedures (84.6%) and improvements in healthcare providers' education (79.9%). CONCLUSION: Incident reporting provided insights on the human and organisational factors involved in the recovery of MIs in community pharmacy. Optimising existing safeguards and redesigning certain structures and processes may enhance the resilience of the medication use system in primary care.

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BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

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Health care organizations have had to respond to the Coronavirus disease 2019 (COVID-19) pandemic in unprecedented ways. In the United States, where health risk management is an established profession, health care risk managers (HRMs) contributed to the response by supporting organizations and frontline workers. HRMs advised administrative and clinical leadership on decisions and policies aimed at addressing the medico legal, ethical, and operational dilemmas raised by this public health emergency. This article describes these challenges from the perspective of a New York City (NYC) public hospital located in the "epicenter within the epicenter" of the pandemic and aims to provide practical guidance for HRMs on the front lines of this crisis.

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BACKGROUND: Investigators conducting studies that include potentially suicidal individuals are obligated to develop a suicide risk management (SRM) protocol. There is little available in the literature to guide researchers in SRM protocol development. OBJECTIVES: The aim of the study was to describe an SRM protocol developed for a randomized controlled trial (RCT) currently enrolling cardiac patients who report moderate to severe levels of hopelessness. METHODS: The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale risk factor questions. Based on responses, study participants are deemed safe or at low, moderate, or high risk for suicide. The SRM protocol guides research staff through a plan of action based on risk level. The protocol further guides staff through a plan over the course of this prospective study-from hospital enrollment to home-based visits. RESULTS: Research staff are well trained to identify suicidal ideation risk factors, initiate specific questioning about suicidal intent, determine level of risk, identify protective factors and a safe environment, and make referrals if needed. Of the 51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and 8 scored at low risk. Thirty-five of the 51 patients enrolled in the RCT. Of the 35 participants who received home visits to date, there have been three instances of low and one instance of moderate suicide risk. The SRM protocol has been consistently and accurately used by research personnel in both hospital and home settings. One modification has been made to the protocol since study activation, namely, the addition of an assessment of counseling history and encouragement of continued counseling. Booster training sessions of research staff will continue throughout the course of the RCT. DISCUSSION: Use of the SRM protocol identifies study participants who are safe or at risk for suicide in both hospital and home settings, and research staff can refer participants accordingly. CONCLUSION: The SRM protocol developed for this RCT can serve as a model in the development of SRM protocols for future research in acute care, community, or home-based settings.

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BACKGROUND: Shortages of personal protective equipment during the coronavirus disease 2019 (COVID-19) pandemic have led to the extended use or reuse of single-use respirators and surgical masks by frontline healthcare workers. The evidence base underpinning such practices warrants examination. OBJECTIVES: To synthesize current guidance and systematic review evidence on extended use, reuse, or reprocessing of single-use surgical masks or filtering face-piece respirators. DATA SOURCES: We used the World Health Organization, the European Centre for Disease Prevention and Control, the US Centers for Disease Control and Prevention, and Public Health England websites to identify guidance. We used Medline, PubMed, Epistemonikos, Cochrane Database, and preprint servers for systematic reviews. METHODS: Two reviewers conducted screening and data extraction. The quality of included systematic reviews was appraised using AMSTAR-2. Findings were narratively synthesized. RESULTS: In total, 6 guidance documents were identified. Levels of detail and consistency across documents varied. They included 4 high-quality systematic reviews: 3 focused on reprocessing (decontamination) of N95 respirators and 1 focused on reprocessing of surgical masks. Vaporized hydrogen peroxide and ultraviolet germicidal irradiation were highlighted as the most promising reprocessing methods, but evidence on the relative efficacy and safety of different methods was limited. We found no well-established methods for reprocessing respirators at scale. CONCLUSIONS: Evidence on the impact of extended use and reuse of surgical masks and respirators is limited, and gaps and inconsistencies exist in current guidance. Where extended use or reuse is being practiced, healthcare organizations should ensure that policies and systems are in place to ensure these practices are carried out safely and in line with available guidance.

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PURPOSE: The comprehensive complication index (CCI) is a new tool for reporting the cumulative burden of postoperative complications on a continuous scale. This study validates the CCI for urological surgery and its benefits over the Clavien-Dindo-Classification (Clavien). MATERIAL AND METHODS: Data from a prospectively maintained data base of all consecutive patients at a university care-center was analyzed. Complications after radical cystectomy (RC), radical prostatectomy (RP), and partial nephrectomy (PN) were classified using the CCI and Clavien system. Differences in complications between the CCI and the Clavien were assessed and correlation analyses performed. Sample size calculations for hypothetical clinical trials were compared between CCI and Clavien to evaluate whether the CCI would reduce the number of required patients in a clinical trial. RESULTS: 682 patients (172 RC, 297 RP, 213 PN) were analyzed. Overall, 9.4-46.6% of patients had > 1 complication cumulatively assessed with the CCI resulting in an upgrading in the Clavien classification for 2.4-32.4% of patients. Therefore, scores between the systems differed for RC: CCI (mean ± standard deviation) 26.3 ± 20.8 vs. Clavien 20.4 ± 16.7, p < 0.001; PN: CCI 8.4 ± 14.7 vs. Clavien 7.0 ± 11.8, p < 0.001 and RP: CCI 5.8 ± 11.7 vs. Clavien 5.3 ± 10.6, p = 0.102. The CCI was more accurate in predicting LOS after RC than Clavien (p < 0.001). Sample size calculations based in the CCI (for future hypothetical trials) resulted in a reduction of required patients for all procedures (- 25% RC, - 74% PN, - 80% RP). CONCLUSION: The CCI is more accurate to assess surgical complications and reduces required sample sizes that will facilitate the conduction of clinical trials.

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The objective of this work is to present the key elements in the design of emergency management and response plans in scenarios where there has been loss of containment of chemical agents of acute effect focused in the protection of not routinely exposed in a determined occupational environment. To this purpose, a validation of the current criteria for the management of accidental releases is carried out, taking into account hypothetical risk scenarios. The essential elements of the emergency management system are stated, from a systemic perspective and the corresponding risk control actions; recommendations for their implementation are showed, taking as prototype hydrogen sulfide, a highly toxic gas. Non controlled emissions of toxic gases of acute effect from an occupational standpoint represents a priority because of their human and financial high toll. Design and implementation of an appropriate emergency plan for uncontrollable emissions of toxics chemical agents must be addressed.

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Objetivo: analisar o plano de contingência para infecção humana pelo Covid-19 e apresentar um modelo conceitual de gestão de risco para o Covid-19. Método: estudo de avaliação executiva, com análise seguindo os passos: Descrição da política; diagnóstico do problema; desenho da política; implementação; governança; resultados e impactos; que permitiu estabelecer o panorama geral acerca do Plano de Contingência Nacional para Infecção Humana pelo novo Coronavírus. Resultados: foram utilizados os passos metodológicos para apontar pontos positivos e fragilidades do plano de contingência e a construção de um modelo conceitual sobre a gestão de risco para o COVID-19. Conclusão: o cenário nacional enriquecido de condições socioambientais desfavoráveis, expõe o quão é vulnerável a nossa população e o sistema de saúde. Além disso, o estudo apontou para déficits de pessoal, materiais e preparação prévia para situações de risco como fatores a serem tratados dentro do processo de mitigação dos riscos.

Objective: to examine the contingency plan for human infection by Covid-19 and present a conceptual model of risk management for Covid-19. Method: in this executive evaluation study, the analysis followed the steps: policy description; problem diagnosis; policy design; implementation; governance; results and impacts; to establish an overall panorama of the National Human Infection Contingency Plan for the new Coronavirus. Results: the methodological steps were used to highlight the strengths and weaknesses of the contingency plan, and to construct a conceptual model of risk management for COVID-19. Conclusion: the scenario in Brazil, enhanced by unfavorable socio-environmental conditions, exposed how vulnerable its population and the health system are. The study also indicated that deficits in personnel, material and prior preparation for risk situations were factors to be addressed in the risk mitigation process.

Objetivo: examinar el plan de contingencia para la infección humana por Covid-19 y presentar un modelo conceptual de gestión de riesgos para Covid-19. Método: en este estudio de evaluación ejecutiva, el análisis siguió los pasos: descripción de la política; diagnóstico de problemas; diseño de políticas; implementación; gobernancia; resultados e impactos; Establecer un panorama general del Plan Nacional de Contingencia de Infección Humana por el nuevo Coronavirus. Resultados: los pasos metodológicos se utilizaron para resaltar las fortalezas y debilidades del plan de contingencia y para construir un modelo conceptual de gestión de riesgos para COVID-19. Conclusión: el escenario en Brasil, potenciado por condiciones socioambientales desfavorables, expuso la vulnerabilidad de su población y el sistema de salud. El estudio también indicó que los déficits en personal, material y preparación previa para situaciones de riesgo fueron factores a ser abordados en el proceso de mitigación de riesgos.

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Clinical risk management is a key area in terms of healthcare quality, especially within intensive-care settings and in the case of pediatric patients. The objective of this review is to assess the impact of tools for clinical risk management in pediatric intensive-care settings. Pubmed and Web of Science were queried to carry out a systematic review, using the PICO methodology (June 2019). Primary studies of applicative experiences of clinical risk management that had impacts in pediatric intensive care units were included. A total of 1178 articles were reviewed and 20 were included. Reactive risk management tools were used in 10 studies; proactive tools in 7; both reactive and proactive tools in 3. Sixteen studies out of 20 concerned drugs; other topics included: transition from hospital to primary care, hand hygiene, organizational aspects, human milk administration. Seven studies (35%) reported organizational impacts; Ten studies (50%) reported clinical and organizational impacts; Three studies (15%) reported organizational, clinical and economic impacts. The introduction of clinical risk management tools resulted in changes within the setting considered; combined use of reactive and proactive methodologies was highlighted in various studies, as well as an increasing focus on proactive tools, both drawing a growing trend over time.

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