Análisis causal integrado en la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera / Integrated causal analysis in radiosynoviorthesis and the myelosupressor treatment of polycythemia vera

Introducción: Con la matriz de riesgo se identifican las medidas de control relevantes. El análisis de modos y efectos de fallo posterga definir la efectividad de las medidas correctivas. El uso de uno solo de estos métodos limita el alcance al evaluar los riesgos y la toma de decisiones. Objetivos: Determinar la contribución individual de las causas básicas de fallo en el riesgo radiológico de la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera, a partir del modelo de la matriz y los reportes. Métodos: Se adaptó el análisis de la gestión de la calidad en radioterapia a las prácticas en estudio y la selección individual de las causas básicas más contribuyentes al riesgo radiológico. La base internacional de incidentes aportó las causas que completaron el listado de las derivadas de la aplicación del principio de Pareto. Resultados: Los subprocesos más contribuyentes al riesgo fueron, por orden de importancia, la administración del radiofármaco, su preparación y la prescripción clínica. Para estos se identificaron las etapas, modos de fallo y sus causas más importantes. Existieron causas que contribuyeron a varios modos de fallo. El incumplimiento de procedimientos, protocolos o prácticas, la falta de entrenamiento del personal y la fatiga del personal son las causas de los riesgos identificados. Conclusiones: Se caracterizó la efectividad de las medidas correctivas de las causas más contribuyentes, las que se adicionan a las derivadas de la matriz, en el plan de mejora en la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera en Cuba(AU)

Introduction: The risk matrix identifies the relevant control measures. Failure modes and effects analysis postpones defining the effectiveness of corrective measures. Using just one of these methods limits the scope when assessing risks and making decisions. Objectives: To determine the individual contribution of the basic causes of failure in the radiological risk of radiosynoviorthesis and the myelosupressor treatment of polycythemia vera, based on the matrix model and the reports. Methods: The analysis of quality management in radiotherapy was adapted to the practices under study and the individual selection of the basic causes most contributing to radiological risk. The international incident base provided the causes that completed the list of those derived from the application of the Pareto principle. Results: The sub-processes that contributed the most to risk were, in order of importance, the administration of the radiopharmaceutical, its preparation and the clinical prescription. For these, the most important, stages, failure modes and their causes were identified. There were causes that contributed to various failure modes. Non-compliance with procedures, protocols or practices, lack of staff training and staff fatigue are the causes of the identified risks. Conclusions: The effectiveness of the corrective measures of the most contributing causes, which are added to those derived from the matrix, was characterized in the improvement plan in radiosynoviorthesis and myelosupressor treatment of polycythemia vera in Cuba(AU)

Metodologías validadas para el análisis causal de eventos adversos de trascendencia clínica en la biomedicina / Methodologies validated for the causal analysis of adverse events of clinical relevance in biomedicine

Introducción: El análisis causal de los eventos adversos amerita metodologías validadas para establecer la dinámica de cómo se originan los incidentes que afectan la seguridad del paciente en los ambientes de prestación de servicios de salud. Objetivo: Describir las bases conceptuales y metodológicas de los sistemas de análisis causal de eventos adversos de trascendencia clínica en la biomedicina. Métodos: Se realizó una revisión documental empleando la bibliografía nacional e internacional actualizada. Se utilizó el motor de búsqueda Google Académico, se consultaron artículos de libre acceso en las bases de datos Pubmed y SciELO, desde marzo 2019 hasta igual mes de 2020. Se emplearon como palabras clave: eventos adversos, análisis de causas raíz, seguridad del paciente, según los Descriptores en ciencias de la salud (DeCS). Fueron seleccionados 25 artículos (20 en idioma español, 5 en inglés), de ellos, 18 (72,0 por ciento) corresponden a los últimos 5 años. Análisis e integración de la información: Las metodologías del análisis causa-raíz, el método ANCLA, el análisis modal de fallos y efectos (AMFE) y el protocolo de Londres, comparten como propósito su función de usar el evento o error para revelar las brechas que vulneran la seguridad del paciente y los aspectos inadecuados en el proceso de atención de la salud. Conclusiones: Los sistemas de análisis causal de eventos adversos constituyen herramientas para incrementar la cultura de seguridad del paciente, pues detectan fallas y errores latentes en el sistema, cuya corrección es esencial para implementar estrategias de prevención(AU)

Introduction: Causal analysis of adverse events requires validated methodologies to determine the origin of incidents affecting patient safety in health care settings. Objective: Describe the conceptual and methodological bases of the systems for the causal analysis of adverse events of clinical relevance in biomedicine. Methods: A document review was conducted of updated national and international bibliography. The search was carried out in the search engine Google Scholar, and open access papers were consulted in the databases PubMed and SciELO from March 2019 to March 2020. The key words used were adverse events, root cause analysis and patient safety, obtained from Health Sciences Descriptors (DeCS). A total 25 papers were selected (20 in Spanish and 5 in English), of which 18 (72.0 percent had been published in the last five years. Data analysis and integration: Root-cause analysis methodologies, the ANCLA score, the failure modes and effects analysis (FMEA) and the London Protocol share the common purpose of using events or errors to reveal gaps that weaken patient safety and inappropriate aspects of the health care process. Conclusions: Systems for the causal analysis of adverse events are tools to enhance patient safety culture, for they detect failures and errors latent in the system whose correction is essential to implement prevention strategies(AU).

Risk assessment to health and human safety in an urban basin in northeastern Brazil.

The purpose of this work was to carry out a risk assessment of human health and safety associated with the dangers encountered in an urban basin located in Campina Grande, the State of Paraíba, northeastern Brazil, called the Prado Basin, through the method of failure mode and effects analysis (FMEA). As a subsidy to the study, laboratory analyses of drainage water were performed at eight points distributed along the Prado Canal, a canal of the study area, to verify its quality and subsequent influence on the population's health. It was verified that the risk of effluent discharge pollution stood out from the others, accounting for almost 50% of the total risk of the system. In the risk ranges, this was classified in points six and seven as critical and in points two, three, and four as high risk, which implies the urgency of adopting measures that minimize or resolve this risk at these points. In general, it was found that points six and seven totaled the highest sum of individual risks, suggesting the adoption of short-term preventive and corrective measures in the aforementioned points.

Uso da Análise dos Modos de Falha e seus Efeitos (FMEA) como ferramenta para mapear os riscos em um estudo clínico / Use of Mode and Effects Analysis (FMEA) as a tool to map the risks involved in a clinical study

Introdução: O presente estudo descreve a aplicação da ferramenta de gerenciamento de riscos Análise de Modo e Efeito de Falha (Failure Mode Effects Analysis ­ FMEA) a uma pesquisa clínica que estabelecerá um tratamento de indivíduos simultaneamente infectados por HIV e tuberculose. Objetivo: Demonstrar a importância da análise de riscos associada aos protocolos de estudos clínicos na salvaguarda do participante e dos dados do estudo, e como padrão de qualidade do estudo. Método: Os procedimentos demandados na execução do protocolo clínico e os potenciais modos de falha a eles associados foram estipulados com base na programação de visitas do participante ao centro do estudo. Os modos de falha foram valorados entre 1 e 10 de acordo com: Gravidade, Ocorrência e Detectabilidade, calculando-se o Número de Prioridade de Risco (NPR) pela multiplicação dos três valores. Resultados: Num painel de 25 procedimentos e 60 modos de falha, 50% resultaram em NPR > 120; seis deles contendo mais de cinco modos de falha. Os maiores riscos foram associados à estratégia DOT (NPR 294), à coleta de sangue (NPR 288), ao Termo de Consentimento Livre e Esclarecido (NPR 270) e a coletas de dados do participante (NPR 240). Conclusões: Os resultados demonstraram a importância da FMEA como instrumento de avaliação de riscos em estudos clínicos, alinhando-se com recomendações de órgãos normalizadores internacionais.

Introduction: This study describes the application of the Failure Mode and Effects Analysis (FMEA) as a tool for risk management during clinical research to establish the treatment of patients simultaneously infected with HIV and tuberculosis. Objective: To demonstrate the importance of risk analysis associated with clinical trial protocols in safeguarding the participant and study data, and as a study's quality standard. Method: Procedures demanded by the clinical protocol were detailed and then associated with failure modes based on the programmed visits of the participant to the study center. The failure modes were rated between 1 and 10 according to: Severity, Occurrence and Detectability, and the Risk Priority Number (RPN) was calculated by multiplying the three values. Results: In a panel of 25 procedures and 60 failure modes, 50% resulted in RPN > 120; six of which contained more than five failure modes. The highest risks were associated with the DOT strategy (RPN 294), blood collection (RPN 288), the Informed Consent Term (RPN 270) and participant data collection (RPN 240). Conclusions: The results demonstrate the importance of FMEA as a tool to assess risks in clinical studies, in line with the recommendations of international standardization organizations.

Failure modes and effects analysis of total skin electron irradiation technique.

PURPOSE: Total skin electron irradiation (TSEI) is a radiotherapy technique which consists of an homogeneous body surface irradiation by electrons. This treatment requires very strict technical and dosimetric conditions, requiring the implementation of multiple controls. Recently, the Task Group 100 report of the AAPM has recommended adapting the quality assurance program of the facility to the risks of their processes. MATERIALS AND METHODS: A multidisciplinary team evaluated the potential failure modes (FMs) of every process step, regardless of the management tools applied in the installation. For every FM, occurrence (O), severity (S) and detectability (D) by consensus was evaluated, which resulted in the risk priority number (RPN), which permitted the ranking of the FMs. Subsequently, all the management tools used, related to the TSEI process, were examined and the FMs were reevaluated, to analyze the effectiveness of these tools and to propose new management tools to cover the greater risk FMs. RESULTS: 361 FMs were identified, 103 of which had RPN ≥80, initially, and 41 had S ≥ 8. Taking this into account the quality management tools FMs were reevaluated and only 30 FMs had RPN ≥80. The study of these 30 FMs emphasized that the FMs that involved greater risk were related to the diffuser screen placement and the patient's position during treatment. CONCLUSIONS: The quality assurance program of the facility has been adapted to the risk of this treatment process, following the guidelines proposed by the TG-100. However, clinical experience continually reveals new FMs, so the need for periodic risk analysis is required.

Practical aspects of the use of FMEA tool in clinical laboratory risk management / Aspectos práticos da utilização da ferramenta FMEA na gestão de riscos do laboratório clínico

INTRODUCTION: This paper presents the failure modes and effects analysis (FMEA) tool in a clinical laboratory through the introduction of new technology for blood gas and serum ionized calcium in multi-parameter analyzers such as Point of Care Testing (POCT). OBJECTIVE: To present FMEA as a tool for risk managing and improvement with the introduction of new technologies in a public laboratory. METHODS: The change of multiparameter gas analyzer type POCT was defined and described as a process. Subsequently, the criteria were presented to the risk assessment and its quantification. We studied the failure modes that might occur in this process. We established three action plans involving improvements to be made in the technological change. FMEA was applied in two stages: at the beginning of the project and after the implementation of the proposed measures. RESULTS: The first plan involved administrative measures related to the bidding process; the second preventive action involved the possibility of which supplier would win the bid by studying the efficiency of the analyzer and its impact on productivity; the third set of actions was directed to improvements in the relationship with the clinical staff in order to minimize occasional complaints. The last actions referred to employing new employees to meet the growing demand. CONCLUSION: FMEA proved to be a reliable tool for performance improvement, which proactively identifies, prioritizes and mitigates patient risks.

INTRODUÇÃO: O artigo apresenta a ferramenta de análise do modo e do efeito de falhas (FMEA) dentro de um laboratório clínico por meio da introdução de nova tecnologia para gasometria e cálcio iônico sérico em analisadores multiparâmetros do tipo testes laboratoriais remotos (TLR) ou point of care testing (POCT). OBJETIVO: Apresentar a FMEA como ferramenta de gestão de riscos e de melhoria em um laboratório público ao introduzir novas tecnologias. MÉTODOS: A mudança de analisadores de gases multiparâmetros do tipo POCT foi definida e descrita como um processo. A seguir, foram apresentados os critérios para a avaliação dos riscos e a sua quantificação. Foram estudados os modos de falha pelos quais algo poderia falhar nos componentes desse processo. Estabeleceram-se três planos de ações que envolviam melhorias a serem introduzidas na mudança de tecnologia. A FMEA foi aplicada em dois momentos: no início do projeto e após a implantação das medidas propostas. RESULTADOS: O primeiro plano envolveu medidas administrativas vinculadas ao processo licitatório; a segunda ação preventiva envolveu a possibilidade de qual fornecedor venceria a licitação, estudando-se a eficiência do analisador e seu impacto na produtividade; o terceiro conjunto de ações foi dirigido às melhorias no relacionamento com o corpo clínico para minimizar as eventuais reclamações. As últimas ações referiram-se à contratação de novos funcionários para atender à demanda crescente. CONCLUSÃO: A FMEA revelou-se um instrumento de melhoria de desempenho para o laboratório, que de maneira proativa identifica, prioriza e mitiga os riscos do paciente.