A qualitative study of the reasons for low patient safety incident reporting among Indonesian nurses.

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.

ROP Risk Management 2021.

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.

A Dynamic Risk Management Approach for Reducing Harm From Invasive Bedside Procedures Performed During Residency.

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.

Anaesthesia and perioperative incident reporting systems: Opportunities and challenges.

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.

Medication incident recovery and prevention utilising an Australian community pharmacy incident reporting system: the QUMwatch study.

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.

Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines.

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.

The effects of the COVID-19 pandemic on risk management practice: A report from the epicenter of the epicenter in New York City.

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.

Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness.

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.

Extended use or reuse of single-use surgical masks and filtering face-piece respirators during the coronavirus disease 2019 (COVID-19) pandemic: A rapid systematic review.

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.

Management of acute exposure to toxic gases in the oil & gas industry -a practical approach.

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.

The comprehensive complication index (CCI): proposal of a new reporting standard for complications in major urological surgery.

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.

Gestão de risco e as estratégias do plano de contingência para COVID-19 / COVID-19 contingency plan strategies and risk management / Gestión de riesgos y estratégias del plan de contingencia para COVID-19

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.

The impact of the implementation of clinical risk management tools in Pediatric or Neonatal Intensive Care Units: a systematic review.

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.

Leaving Hospital: A Step too Far for Risk-Based Regulation?

Discharges from hospital are internationally recognised as a dangerous time in the care pathway of a patient, posing a risk to both their physical wellbeing and dignity. This article examines the effectiveness of risk-based regulation as a tool to address patient safety incidents linked to the hospital discharge process within the English National Health Service. It examines how the risk of this process is identified, conceptualised, and prioritised amongst the relevant statutory regulators, and argues that the risk is neither uniformly recognised by the statutory regulators within the English NHS, nor sufficiently addressed. Professional regulators in particular appear to have a poor awareness of the risk and their role in addressing it. Until these issues are resolved, patients leaving hospitals will continue to be exposed to patient safety incidents which should be avoidable.

Training Load and Its Role in Injury Prevention, Part I: Back to the Future.

The purpose of this 2-part commentary series is† to explain why we believe our ability to control injury risk by manipulating training load (TL) in its current state is an illusion and why the foundations of this illusion are weak and unreliable. In part 1, we introduce the training process framework and contextualize the role of TL monitoring in the injury-prevention paradigm. In part 2, we describe the conceptual and methodologic pitfalls of previous authors who associated TL and injury in ways that limited their suitability for the derivation of practical recommendations. The first important step in the training process is developing the training program: the practitioner develops a strategy based on available evidence, professional knowledge, and experience. For decades, exercise strategies have been based on the fundamental training principles of overload and progression. Training-load monitoring allows the practitioner to determine whether athletes have completed training as planned and how they have coped with the physical stress. Training load and its associated metrics cannot provide a quantitative indication of whether particular load progressions will increase or decrease the injury risk, given the nature of previous studies (descriptive and at best predictive) and their methodologic weaknesses. The overreliance on TL has moved the attention away from the multifactorial nature of injury and the roles of other important contextual factors. We argue that no evidence supports the quantitative use of TL data to manipulate future training with the purpose of preventing injury. Therefore, determining "how much is too much" and how to properly manipulate and progress TL are currently subjective decisions based on generic training principles and our experience of adjusting training according to an individual athlete's response. Our message to practitioners is to stop seeking overly simplistic solutions to complex problems and instead embrace the risks and uncertainty inherent in the training process and injury prevention.

Ontological approach to the knowledge systematization of a toxic process and toxic course representation framework for early drug risk management.

Various types of drug toxicity can halt the development of a drug. Because drugs are xenobiotics, they inherently have the potential to cause injury. Clarifying the mechanisms of toxicity to evaluate and manage drug safety during drug development is extremely important. However, toxicity mechanisms, especially hepatotoxic mechanisms, are very complex. The significant exposure of liver cells to drugs can cause dysfunction, cell injury, and organ failure in the liver. To clarify potential risks in drug safety management, it is necessary to systematize knowledge from a consistent viewpoint. In this study, we adopt an ontological approach. Ontology provides a controlled vocabulary for sharing and reusing of various data with a computer-friendly manner. We focus on toxic processes, especially hepatotoxic processes, and construct the toxic process ontology (TXPO). The TXPO systematizes knowledge concerning hepatotoxic courses with consistency and no ambiguity. In our application study, we developed a toxic process interpretable knowledge system (TOXPILOT) to bridge the gaps between basic science and medicine for drug safety management. Using semantic web technology, TOXPILOT supports the interpretation of toxicity mechanisms and provides visualizations of toxic courses with useful information based on ontology. Our system will contribute to various applications for drug safety evaluation and management.

Cross-continental comparison of safety and protection measures amongst urologists during COVID-19.

OBJECTIVES: To determine the well-being of urologists worldwide during the coronavirus disease 2019 pandemic, and whether they have adequate personal protective equipment knowledge and supplies appropriate to their clinical setting. METHODS: Urologists worldwide completed a Société Internationale d'Urologie online survey from 16 April 2020 until 1 May 2020. Analysis was carried out to evaluate their knowledge about protecting themselves and others in the workplace, including their confidence in their ability to remain safe at work, and any regional differences. RESULTS: There were 3488 respondents from 109 countries. Urologists who stated they were moderately comfortable that their work environment offers good protection against coronavirus disease 2019 showed a total mean satisfaction level of 5.99 (on a "0 = not at all" to "10 = very" scale). A large majority (86.33%) were confident about protecting themselves from coronavirus disease 2019 at work. However, only about one-third reported their institution provided the required personal protective equipment (35.78%), and nearly half indicated their hospital has or had limited personal protective equipment availability (48.08%). Worldwide, a large majority of respondents answered affirmatively for testing the healthcare team (83.09%). Approximately half of the respondents (52.85%) across all regions indicated that all surgical team members face an equal risk of contracting coronavirus disease 2019 (52.85%). Nearly one-third of respondents reported that they had experienced social avoidance (28.97%). CONCLUSIONS: Our results show that urologists lack up-to-date knowledge of preferred protocols for personal protective equipment selection and use, social distancing, and coronavirus disease 2019 testing. These data can provide insights into functional domains from which other specialties could also benefit.