Application of FMEA model and 6S management method in reducing dispensing errors in PIVAS of children’s hospitals / 中国药房

OBJECTIVE To reduce dispensing errors in pharmacy intravenous admixture service （PIVAS） of children’s hospitals. METHODS The risk of dispensing procedures in our PIVAS was identified by applying failure mode and effect analysis （FMEA） model. Potential failure modes that might lead to dispensing errors in each link were determined， and failure causes were analyzed. The severity， incidence and detection degree of potential failure modes were quantitatively scored， and their risk priority number （RPN） was calculated to screen failure modes that needed to be improved in priority； the corresponding improvement measures were developed by 6S management method from six aspects， namely， finishing （seiri）， rectifying （seiton）， sweeping （seiso）， sanitation （seiketsu）， literacy （shitsuke） and safety. The effect of intervention before and after rectification was evaluated. RESULTS Based on the RPN， 32 potential failure modes were selected， of which a total of 18 critical failure modes that needed to be improved in priority. After implementing corresponding measures according to 6S management method， the RPN of 18 critical failure modes decreased. The total RPN decreased from 497 to 142 with a decrease rate of 71.43%. The error rates of 15 critical failure modes were significantly lower than before implementation （P＜0.05）. CONCLUSIONS Applying FMEA model and 6S management method to the risk control of all aspects of PIVAS workflow can effectively reduce the risk of PIVAS dispensing errors and ensure the safety of children’s intravenous medication.

Administração de anti-infecciosos em pacientes críticos: gestão proativa de riscos / Administration of anti-infectives in critically ill patients: proactive risk management / Administración de antiinfecciosos en pacientes críticos: gestión proactiva del riesgo

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.

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.

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.

Failure mode and effect analysis for risk management of unplanned extubation after esophageal cancer surgery / 中国胸心血管外科临床杂志

@#Objective 聽 聽 To explore the application value of failure mode and effect analysis (FMEA) in the risk management of unplanned extubation after esophageal cancer surgery. Methods 聽 聽 A total of 1 140 patients who underwent esophageal cancer surgery in our department from January 2015 to May 2017 were selected as a control group, including 948 males and 192 females with an average age of 64.45卤4.53 years. FMEA was used to analyze the risk management process of unplanned extubation. The potential risk factors in each process were found by calculating the risk priority number (RPN) value, and the improvement plan was formulated for the key process with RPN>125 points. Then 1 117 patients who underwent esophageal cancer surgery from June 2017 to December 2019 were selected as a trial group, including 972 males and 145 females with an average age of 64.60卤5.22 years, and the FMEA risk management mode was applied. Results 聽 聽 The corrective measures were taken to optimize the high-risk process, and the RPN values of 9 high-risk processes were reduced to below 125 points after using FMEA risk management mode. The rate of unplanned extubation in the trial group was lower than that in the control group (P<0.05). Conclusion 聽 聽 The application of FMEA in the risk management of unplanned extubation after esophageal cancer surgery can reduce the rate of unplanned extubation, improve the quality of nursing, and ensure the safety of patients.

Application of health failure mode and effect analysis for the airbag pressure management of patients with artificial airways / 中华危重病急救医学

Objective:To analyze the application effect of health failure mode and effect analysis (HFMEA) model in patients with artificial airways in the cardiovascular surgery intensive care unit (CSICU) by establishing a HFMEA project team, and to develop targeted improvement measures and processes.Methods:The patients undergoing cardiovascular surgeries and with established artificial airways in the Shandong Provincial Hospital Affiliated to Shandong First Medical University were recruited from October 2021 to March 2022. The enrolled patients were divided into the conventional management group and the HFMEA model management group according to random number table method. The conventional management group applied the conventional procedures for monitoring the air bag pressure. The HFMEA model management group used the HFMEA model to implement and improve the airbag pressure monitoring process. The efficacy of HFMEA was assessed by comparing the incidence of ventilator-associated pneumonia (VAP), the pass rate of airbag pressure monitoring, the duration of endotracheal intubation and the length of CSICU stay between two groups. The practicability of HFMEA model was evaluated by analyzing the theoretical assessment scores and practical skill scores of nurses and their satisfaction scores with HFMEA.Results:Compared with the conventional management group, the patients in the HFMEA mode management group had a significantly higher rate of passing airbag pressure monitoring [94.99% (2 994/3 152) vs. 69.97% (1 626/2 324), P < 0.01], shorter duration of endotracheal intubation and length of CSICU stay [duration of endotracheal intubation (hours): 6 (7, 12) vs. 6 (8, 13), length of CSICU stay (hours): 40 (45, 65) vs. 41 (46, 85), both P < 0.05], but the incidences of VAP between the two groups were similar. The theoretical assessment scores and practical skill scores of nurses were significantly higher (theoretical assessment score: 44.47±2.72 vs. 37.59±6.56, practical skill score: 44.56±2.66 vs. 40.03±4.32, total score: 89.03±3.07 vs. 77.63±9.56, all P < 0.05) in the HFMEA mode management group. And the satisfaction scores with airbag pressure management were also significantly higher in the HFMEA mode management group (7.72±1.11 vs. 6.44±1.32, P < 0.05). Conclusions:The application of the HFMEA can improve the airbag pressure measures and standardize the monitoring procedures in patients with artificial airways, and reduce the risk of clinical nursing. It is safe and effective for patients with invasive mechanical ventilation in the CSICU.

Application of catheter information platform based on failure mode and effect analysis in preventing central venous catheter-related infection in intensive care unit / 中国实用护理杂志

Objective:To investigate the effect of failure mode and effect analysis (FMEA) based catheter information platform in preventing catheter-related bloodstream infection (CRBSI) in intensive care unit to improve the current status of CRBSI.Methods:In this study, a retrospective cohort study was conducted using the purposive sampling method, and 140 patients with indwelling central venous catheters admitted to the ICU of Peking University Shenzhen Hospital from August to December 2021 were set as the control group; the 140 patients with indwelling central venous catheters admitted to the ICU from January to May 2022 were set as the observation group. The control group used electronic forms to record and manage at the bedside after CRBSI cluster nursing measures were given, and the observation group used the catheter information platform based on FMEA to conduct information management on catheter evaluation and maintenance process after CRBSI cluster nursing measures were given. Compared the implementation rate (6 items), implementation time, qualification rate, and incidence of CRBSI in ICU patients between two groups of ICU nurses.Results:The implementation rate of CRBSI cluster nursing measures among ICU nurses in the observation group: strict hand hygiene by nurses was 87%(122/140), maximum aseptic barrier during puncture was 97%(136/140), aseptic operation during catheter maintenance was 91%(128/140), 75% alcohol disinfection of connectors was 84%(118/140), 24-hour change of infusion lines was 95%(133/140), and timely change of patches/dressings was 89%(125/140), they were greater than those in the control group 70%(98/140), 87%(122/140), 71%(100/140), 61%(86/140), 71%(99/140), 69%(96/140), the differences were statistically significant ( χ2 values were 9.67 to 29.07, all P<0.05); the execution time and qualification rate among ICU nurses in the observation group were (9.11 ± 2.83) minutes and 91.4% (128/140), the control group were (10.00 ± 2.84) minutes and 60.7% (85/140), with statistically significant differences ( t value was -2.64, χ2 values was 36.28, all P<0.05). Conclusions:The FMEA-based catheterization information platform can help enhance the efficiency of the implementation of CRBSI clustering nursing measures by ICU nurses, improve the quality of care, and thus reduce the occurrence of CRBSI, and the feasibility of clinical promotion is high.

Application of healthcare failure mode and effect analysis in preventing nursing interruption with negative outcome in operating room / 中国实用护理杂志

Objective:To explore the effect of healthcare failure mode and effect analysis (HFMEA) in reducing the incidence of nursing interruption with negative outcome in operating room, so as to maximize the smooth progress of the surgical process.Methods:This was a quasi experimental study. The gastrointestinal surgery room of Shandong Provincial Hospital Affiliated to Shandong First Medical University was selected for the study. According to the surgical sequence, 38 surgeries performed in the gastrointestinal surgery suite from August 15-30, 2021 were set as the control group, and the conventional healthcare cooperation model process was implemented; 42 surgeries performed from September 15-30, 2021 were set as the intervention group, and the operating room under the HFMEA model was implemented negative outcome care disruption event management process.A video tracking method combined with a surgical care disruption event register was used to investigate the occurrence of negative outcome care disruption events in the operating room, comparing the number, duration, source of disruption events and the incidence of near miss events in the operating room between the control group and the intervention group.Results:In the control group, there were 38 observed surgeries, 190 negative outcome care interruptions, negative outcome interruptions of (5.26 ± 1.02) min duration, and no near misses; in the intervention group, there were 42 observed surgeries, 84 negative outcome care interruptions, negative outcome interruptions of (2.06 ± 0.08) min duration, and no near misses. There were statistically significant differences in the number, duration of negative outcome care interruptions between the intervention group and the control group ( χ2 = - 18.71, t = - 20.28; all P<0.01). There was statistically significant difference in the source of negative outcome care interruptions between the intervention group and the control group ( χ2 = - 12.71, P<0.01). Conclusions:HFMEA model can effectively reduce the number of negative nursing interruptions in the operating room, shorten the duration of interruptions, and minimize potential safety hazards caused by nursing interruptions, which is conducive to ensuring the safety of patients.

Using healthcare failure mode and effect analysis to reduce the emergency waiting risk / 中国实用护理杂志

Objective:To explore the application of effect of healthcare failure mode and effect analysis (HFMEA) in emergency waiting risk management.Methods:From May 2020 to April 2021, totally 87 902 emergency waiting patients from the First Affiliated Hospital of Anhui Medical University were assigned to control group by cluster sampling method. From May 2021 to April 2022, 80 594 emergency waiting patients were assigned to observed group. The patients in the control group received routine emergency waiting of itinerant management mode. In contrast, the patients in the observed group received emergency waiting risk management mode based on HFMEA. The process risk priority number (RPN) and waiting risk management index between two groups were compared.Results:The mean RPN of the observed group was (98.48 ± 8.27) points, significantly lower than that of the control group (251.27 ± 16.95) points. The nurses′ pre-identification rates of changes in the condition and adverse reaction in the observed group were 10.77%(8680/80 594) and 13.37%(10 775/80 594), which were higher than those in the control group, 5.77%(5072/87 902) and 8.12%(7134/87 902), the differences were statistically significant ( χ2 values were 1402.32 and 1221.66, all P<0.05). Conclusions:The application of HFMEA to optimize the emergency waiting management process can effectively reduce the risk of emergency waiting and improve the quality of emergency waiting management.

The Healthcare Failure Mode and Effect Analysis as a tool to evaluate care protocols / El Healthcare Failure Mode and Effect Analysis como herramienta de evaluación de protocolos asistenciales / O Healthcare Failure Mode and Effect Analysis como ferramenta de avaliação de protocolos assistenciais

ABSTRACT Objectives: to identify, classify, and analyze modes of failure in the medication process. Methods: evaluative research that used the Healthcare Failure Mode and Effect Analysis (HFMEA) in a service of bone marrow transplant from June to September 2018, with the participation of 35 health workers. Results: 207 modes of failure were identified and classified as mistakes in verification (14%), scheduling (25.6%), administration (29%), dilution (16.4%), prescription (2.4%), and identification (12.6%). The analysis of risk showed a moderate (51.7%) and high (30.9%) need of intervention, leading to the creation of an internal quality assurance group and of continued education activities. Conclusions: the Healthcare Failure Mode and Effect Analysis showed itself to be a tool to actively identify, classify, and analyze failures in the process of medication, contributing for the proposal of actions aimed at patient safety.

RESUMEN Objetivos: identificar, clasificar y analizar modos de fallos en el proceso de medicación. Métodos: investigación evaluativa que utilizó el Healthcare Failure Mode and Effect Analysis (HFMEA) en Servicio de Trasplante de Médula Ósea, de junio a septiembre de 2018, con la participación de 35 profesionales de salud. Resultados: han sido identificados 207 modos de fallos, clasificados en errores de chequeo (14%); aplazamiento (25,6%); administración (29%); dilución (16,4%); prescripción (2,4%) e identificación (12,6%). El análisis del riesgo evidenció la necesidad de intervención moderada (51,7%) y alta (30,9%), resultando en la creación del equipo interno de calidad y actividades de educación continua. Conclusiones: el Healthcare Failure Mode and Effect Analysis demostró ser herramienta para identificar, clasificar y analizar, activamente, fallos en el proceso de medicación, contribuyendo para la proposición de acciones con objetivo de seguridad del paciente.

RESUMO Objetivos: identificar, classificar e analisar modos de falhas no processo de medicação. Métodos: pesquisa avaliativa que utilizou o Healthcare Failure Mode and Effect Analysis (HFMEA) em Serviço de Transplante de Medula Óssea, de junho a setembro de 2018, com a participação de 35 profissionais de saúde. Resultados: foram identificados 207 modos de falhas, classificados em erros de checagem (14%); aprazamento (25,6%); administração (29%); diluição (16,4%); prescrição (2,4%) e identificação (12,6%). A análise do risco evidenciou a necessidade de intervenção moderada (51,7%) e alta (30,9%), resultando na criação do grupo interno de qualidade e atividades de educação continuada. Conclusões: o Healthcare Failure Mode and Effect Analysis demonstrou ser ferramenta para identificar, classificar e analisar, ativamente, falhas no processo de medicação, contribuindo para a proposição de ações com vistas à segurança do paciente.

Effect of individualized teaching method based on FMEA on operating room interns / 中华医学教育探索杂志

Objective:To explore the role of individualized teaching method based on failure mode and effect analysis (FMEA) in the teaching of rotation interns in operating room.Methods:Twenty-three operating room rotation interns received by Zhongnan Hospital, Wuhan University from February 2019 to September 2019 were selected as the control group, and another 23 operating room rotation interns received from October 2019 to May 2020 were selected as the research group. The control group adopted the conventional teaching method, while the research group adopted the individualized teaching method based on FMEA. The theoretical knowledge and practical operation examination results before and after teaching, self-directed learning ability before and after teaching and teaching satisfaction of interns after teaching were compared between the two groups. SPSS 25.0 was used for t test, chi-square test and rank sum test. Results:After teaching, the scores of theoretical knowledge [(91.13±6.35) vs. (84.26±5.94)] and practical operation [(89.39±5.45) vs. (79.78±5.65)], self-directed learning ability of each dimension and total scores [(280.63±23.39) vs. (248.17±20.68)] of the two groups were higher than those before teaching, and the scores of theoretical knowledge and practical operation, self-directed learning ability of each dimension and total score of the research group were higher than those of the control group ( P<0.05). After teaching, the satisfaction scores on the professional quality of the teachers, the rationality of the teaching mode and the effectiveness of the teaching mode of the interns in the research group were higher than those in the control group ( P<0.05). Conclusion:In the teaching of rotation interns in operating room, the individualized teaching method based on FMEA can not only improve the examination results of interns, enhance their self-directed learning ability, but also improve their teaching satisfaction.

Application research on risk management of postoperative delirium in elderly patients with hip fragility fracture based on FMEA theory / 中国实用护理杂志

Objective:To explore the effect of postoperative delirium risk management in elderly patients with hip fragility fracture based on failure mode and effect analysis (FMEA) theory, and to provide a basis for reducing the incidence of postoperative delirium.Methods:A total of 50 patients admitted to the First Affiliated Hospital of Sun Yat-sen University due to hip fragility fractures from January to December 2019 were selected as the control group, and 50 patients admitted to the First Affiliated Hospital of Sun Yat-sen University for hip fragility fractures from January to December 2020 were selected as the observation group. The control group received routine care, and the observation group implemented risk control intervention measures based on FMEA theory on the basis of the control group. The risk priority number (RPN) value, incidence of delirium, duration of delirium, pain score, satisfaction, and average length of hospital stay were compared between the two groups of patients in each link of failure risk.Results:The RPN values of each link failure risk of the observation group were 100.80 ± 13.39, 103.96 ± 9.96, 103.76 ± 8.04, delirium duration was (36.33 ± 9.07) min, pain scores were 1.86 ± 0.76, 4.16 ± 1.17, average length of stay was (8.98 ± 4.64) days, and incidence of delirium was 6.0% (3/50), the RPN values of each link failure risk of the control group were 274.10 ± 8.48, 291.00 ± 10.10, 287.78 ± 11.64, delirium duration (78.70 ± 20.10) min, pain scores 2.26 ± 1.02, 4.74 ± 1.19, average length of stay was (11.50 ± 7.66) days, and incidence of delirium was 22.0% (11/50). The differences between two groups showed significant differences ( t values were 1.99-93.24, χ2=4.07, P<0.05). The patient satisfaction score of the observation group was 99.36 ± 1.01, which was higher than that of the control group 89.63 ± 2.62, and the difference was statistically significant ( t=24.50, P<0.05). Conclusions:The perioperative implementation of postoperative delirium risk management model based on FMEA theory in elderly patients with hip fractures can reduce the incidence of postoperative delirium, relieve pain, shorten hospital stay, and improve satisfaction degree. It is worthy of clinical promotion.

Information realization of nursing quality sensitive index data based on failure mode and effect analysis / 中国实用护理杂志

Objective:To monitor and collect data information through failure mode and effect analysis (FMEA) and establish a data information system for nursing quality sensitive indicators.Methods:From July 2019 to July 2021, FMEA was used to evaluate the formation process of nursing quality sensitive index data, formulate specific improvement measures, and compare the proportion of risk priority index (risk priority number, RPN) value and index data informatization before and after the implementation.Results:Before the application of FMEA in nursing quality sensitive index data information management, the RPN value of index data element confirmation, index definition understanding, record specification, problem solving limitation, information communication and system data integration were (362.00 ± 101.56), (539.90 ± 174.39), (603.20 ± 128.71), (395.10 ± 184.83), (448.90 ± 185.58), (334.80 ± 107.74) points, while those after the intervention were (17.10 ± 9.96), (30.90 ± 31.66), (42.40 ± 28.99), (30.30 ± 33.94), (16.30 ± 17.02), (18.90 ± 19.27) points, with statistical significance ( t values were 9.11 to 14.74, all P<0.05). The proportion of sensitive index data informatization increased from 46.43% (39/84) to 95.51%(85/89). Conclusions:Using FMEA mode to manage the data information is effective and feasible for the realization of sensitive index information data.

Construction of a risk prediction and evaluation system for postoperative incisional infection after spinal surgery / 中华创伤骨科杂志

Objective:To construct a risk prediction and assessment system for incisional infection after spinal surgery.Methods:Based on the failure mode and effect analysis (FMEA), risk factors and assessment indicators of postoperative incisional infection in spinal surgery were sorted out through literature search followed by expert consultation using the Delphi expert consultation method. After three-level assessment indicators were selected according to their importance and expert opinions and assigned by different scores, a risk prediction and evaluation system was constructed for postoperative incisional infection after spinal surgery.Results:The 2 rounds of expert consultation questionnaire resulted in an effective response rate of 100%. The degree of expert consultation authority was 0.85, showing high reliability; the Kendall coordination coefficients of expert consultation ranged from 0.525 to 0.686, showing good coordination ( P<0.05). The three-level assessment indicators consisted of 3 primary, 18 secondary and 54 tertiary ones. After statistical analyses of the important risk indicators selected which consisted of 6 preoperative evaluation ones and 18 postoperative evaluation ones, 6 preoperative and 12 postoperative predictive indicators were obtained. The values of risk priority number (RPN) were calculated for high, medium and low risks for postoperative incisional infection using a semi-quantitative method. Conclusion:A self-designed system has been constructed for risk prediction and assessment of incisional infection after spinal surgery based on expert consultation and FMEA method.

Ferramentas para a organização do processo de trabalho na segurança do paciente / Herramientas para organizar el proceso de trabajo en seguridad del paciente / Tools to organize the work process in patient safety

RESUMO Objetivo discutir acerca da utilização das ferramentas de Análise de Modo e Efeitos de Falha e sua aplicação na assistência à saúde. Método trata-se de um artigo de reflexão visando à apresentação do formato próprio de aplicação de ambas as ferramentas seguida das suas diferenças de execução nos processos de trabalho. Resultados ambos os modelos possuem a mesma finalidade, sendo direcionados para a detecção de falhas antes mesmo da sua manifestação, auxiliando diretamente na promoção da segurança. A análise do erro, com a participação das equipes e a geração de índices de falhas, repercute no planejamento e na implementação de ações práticas voltadas à segurança do paciente. Conclusão e implicações para a prática embora semelhantes, existem, entre eles, distinções quanto à priorização das falhas para elencar ações práticas corretivas, principalmente no cálculo do Índice de Prioridade de Risco relacionado à gravidade, na probabilidade de ocorrência e na detecção das falhas. Ambas as ferramentas se mostram como importantes aliadas dos gestores de saúde para a detecção de falhas graves que colocam em risco a assistência livre de eventos adversos.

RESUMEN Objetivo discutir el uso de las herramientas de Análisis de Modos y Efectos de Falla y su aplicación en la atención médica. Método este es un artículo de reflexión, con el objetivo de presentar el formato propio de aplicación adecuado para ambas herramientas, seguido de sus diferencias de ejecución en los procesos de trabajo. Resultados ambos modelos tienen el mismo propósito, dirigidos a la detección de fallas incluso antes de su manifestación, ayudando directamente en la promoción de la seguridad. El análisis del error con la participación de los equipos y la generación de tasas de fracaso tiene repercusiones en la planificación e implementación de acciones prácticas dirigidas a la seguridad del paciente. Conclusión e implicaciones para la práctica aunque son similares, existen distinciones con respecto a la priorización de fallas para enumerar acciones correctivas prácticas, principalmente en el cálculo del Índice de Prioridad de Riesgo relacionado con la gravedad, la probabilidad de ocurrencia y la detección de fallas. Se ha demostrado que ambas herramientas son aliadas importantes para los gerentes de salud para la detección de fallas graves que ponen en riesgo la atención libre de eventos adversos.

ABSTRACT Objective to discuss the use of Failure Mode and Effects Analysis tools and their application in health care. Method this is a reflection article, aiming at presenting the proper application format for both tools, followed by their differences in execution in the work processes. Results both models have the same purpose, being directed to the detection of failures even before their manifestation, directly assisting in the promotion of safety. The analysis of the error with the participation of the teams and the generation of failure rates has repercussions on the planning and implementation of practical actions aimed at patient safety. Conclusion and implications for the practice although similar, there are distinctions regarding the prioritization of failures to list practical corrective actions, mainly in the calculation of the Risk Priority Index related to severity, probability of occurrence and failure detection. Both tools are shown to be important allies to health managers for the detection of serious failures that put care free from adverse events at risk.

Root Cause Analysis, Failures and Effects in pediatric total quality management: a scoping review / Análisis de Causa Raiz, Fallas y Efectos en la gestión total de la calidad pediátrica: revisión del alcance / Análise de Causa Raiz, Falhas e Efeitos na gestão da qualidade total pediátrica: scoping review

ABSTRACT Objectives: to analyze the applicability of Root Cause Analysis and Failure Mode and Effect Analysis tools, aiming to improve care in pediatric units. Methods: this is a scoping review carried out according to the Joanna Briggs Institute guidelines, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes extension for Scoping Reviews. Search took place in May 2018 on 15 data sources. Results: search totaled 8,254 studies. After using the relevant inclusion and exclusion criteria, 15 articles were included in the review. Of these, nine were published between 2013 and 2018, 12 used Failure Mode and Effect Analysis and 11 carried out interventions to improve the quality of the processes addressed, showing good post-intervention results. Final Considerations: the application of the tools indicated significant changes and improvements in the services that implemented them, proving to be satisfactory for detecting opportunities for improvement, employing specific methodologies for harm reduction in pediatrics.

RESUMEN Objetivos: analizar la aplicabilidad de las herramientas Análisis de Causa Raiz y Análisis de Fallas Modales y Efectos, con el objetivo de mejorar la atención en las unidades pediátricas. Métodos: revisión de alcance, realizada de acuerdo con las directrices del Instituto Joanna Briggs, siguiendo la lista de verificación de los Ítems Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. La búsqueda se realizó en mayo de 2018 en 15 fuentes de datos. Resultados: la búsqueda totalizó 8.254 estudios. Después de utilizar los criterios de inclusión y exclusión relevantes, se incluyeron 15 artículos en la revisión. De estos, nueve fueron publicados entre 2013 y 2018, 12 utilizaron; Análisis de Fallas Modales y Efectos y 11 realizaron intervenciones para mejorar la calidad de los procesos abordados, mostrando buenos resultados post-intervención. Consideraciones Finales: la aplicación de las herramientas indicó cambios y mejoras significativas en los servicios que las implementaron, resultando satisfactorias para detectar oportunidades de mejora, empleando metodologías específicas para la reducción de daños en pediatría.

RESUMO Objetivos: analisar a aplicabilidade das ferramentas Análise de Causa Raiz e Análise Modal de Falhas e Efeitos, visando à melhoria da assistência em unidades pediátricas. Métodos: scoping review, realizada conforme orientações do Instituto Joanna Briggs, seguindo o checklist do Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. A busca ocorreu em maio de 2018 em 15 fontes de dados. Resultados: busca totalizou 8.254 estudos. Após a utilização dos critérios de inclusão e exclusão pertinentes, incluíram-se 15 artigos na revisão. Desses, nove foram publicados entre 2013 e 2018, 12 utilizaram Análise Modal de Falhas e Efeitos e 11 realizaram intervenções para melhoria da qualidade nos processos abordados, mostrando bons resultados pós-intervenções. Considerações Finais: a aplicação das ferramentas indicou mudanças e melhorias significativas nos serviços que as implementaram, mostrando-se satisfatórias para detectar oportunidades de melhorias, empregando metodologias específicas para a redução de danos em pediatria.

Analysis and process improvement concerning adverse events to insufficient plasma transfusion / 中国输血杂志

【Objective】 To analyze the root causes of adverse events to insufficient plasma transfusion, so as to explore improvement measures, optimize the transfusion strategy and avoid such adverse events. 【Methods】 The root causes of insufficient plasma transfusion were analyzed by health care failure mode and effect analysis, the targeted improvement measures were formulated and the effect was evaluated. 【Results】 After the improvement, the incidence of adverse events to insufficient plasma transfusion decreased significantly.The risk priority value affecting the safety of blood transfusion decreased from 70 to 8, and the proportion of coagulation function test after blood transfusion increased from 44.61%(1 309/2 934)in 2012 to 80.55% (2 187/2 715)in 2019, and plasma transfusion volume per capital increased from 300 mL to 528 mL. PT and APTT values after plasma transfusion in 2019 significantly increased compared with those in 2012. Meanwhile, the proportion of plasma transfusion in hospitalized patients decreased from 3.16% (2 934/92 838)to 2.12%(2 715/128 352). 【Conclusion】 Risk management of quality and safety of blood transfusion by combing healthcare failure mode, effect analysis and root cause analysis(RCA) can improve the risk awareness of clinical blood transfusion, optimize the proportion of plasma transfusion, and is essential to ensure the safety and effectiveness of blood transfusion and improve the prognosis of transfused patients.

Research on Bayesian fault diagnosis model of traditional Chinese medicine dry granulation based on failure model and effect analysis (FMEA) / 中国中药杂志

This paper aims to construct a Bayesian(BN) fault diagnosis model of traditional Chinese medicine dry granulation based on the failure model and effect analysis(FMEA), effectively control risk factors and ensure the quality of granules.Firstly, the risk ana-lysis of dry granulation process was carried out with FMEA, and the selected medium and high risk factors were taken as node variables to establish corresponding BN network with causality.According to the mathematical reasoning method of probability theory, the model was accurately inferred and verified by Netica, and the granule nonconformance was used as the evidence for reversed reasoning to determine the most likely cause of the failure that affected the granule quality.The BN fault diagnosis model of traditional Chinese medicine dry gra-nulation was established based on the medium and high risk factors of process, prescription and equipment screened out by FMEA, such as roller pressure, raw material viscosity, clearance between rollers in the paper.The fault diagnosis of traditional Chinese medicine dry granulation process was then carried out according to the model, and the posterior probability of each node under the premise of nonconforming granule quality was obtained.This method could provide strong support for operators to quickly eliminate faults and make decisions, so as to improve the efficiency and accuracy for fault diagnosis and prediction, with innovation in its application.

Risk Analysis of Radiotherapy Implementation Process Based on Failure Mode and Effect Analysis / 中国医疗器械杂志

OBJECTIVE@#Providing a risk assessment method for the implementation of radiotherapy to identify possible risks in the implementation of the treatment process, and proposing measures to reduce or prevent these risks.@*METHODS@#A multidisciplinary expert evaluation team was developed and the radiotherapy treatment process flow was drawn. Through the expert team, the failure mode analysis is carried out in each step of the flow chart. The results were summarized and the (risk priority ordinal) score was obtained, and the quantitative evaluation results of the whole process risk were obtained.@*RESULTS@#One hundred and six failure modes were obtained, risk assessment of (20%) high risk failure model are 22 and severity (≥ 8) high risk failure model are 27. The reasons for the failures were man-made errors or hardware and software failures.@*CONCLUSIONS@#Failure mode and effect analysis can be used to evaluate the risk assessment of radiotherapy, and it provides a new solution for risk control in radiotherapy field.

Research on Fault Risk Identification and Control of CT Simulator Based on FMEA / 中国医疗器械杂志

OBJECTIVE@#To explore the high-risk fault risk of CT simulator and the main causes of the risk, and to put forward effective risk management strategies.@*METHODS@#The failure mode and effect analysis method was used to identify and control the operational fault risk of CT simulator.@*RESULTS@#5 major fault components, 8 fault failure models and 17 failure causes were analyzed. The top 5 failure causes are:anode target surface burn caused by direct scanning without warming up the tube (590.4), tube failure (518.2), burnout of joints caused by aging of high voltage cables (424.2), motor carbon brush wear (304.8) and belt break (296.4).@*CONCLUSIONS@#The failure mode and effect analysis method can effectively identify the risk of equipment failure, and thus specifically formulate risk management and control measures to ensure the normal operation of equipment and the safety of doctors and patients.

Utilidad de análisis modal de fallos y efectos para mejorar la seguridad en el movilización del paciente crítico intubado / Usefulness of failure mode and effects analysis for improving mobilization safety in critically ill patients

Abstract Introduction: Patient safety has become a core value in health organizations, requiring the use of significant resources in order to avoid accidents during hospital stay. Health care can create risks, and patient safety is the most important objective in care quality. Failure Mode and Effects Analysis (FMEA) is a preventive tool that helps anticipate potential errors and adverse events, setting up barriers to prevent them from happening, or mitigating their effects or, in the event they do happen, mitigating their impact on the most vulnerable link in health care, namely, the patient. Objectives: To analyze, using the FMEA tool, mobilization of intubated critical ill patients in the Intensive Care Unit. Method: A brainstorming session was held within the service to identify the most frequent potential errors in the process. Subsequently, the FMEA method with its different phases was applied, prioritizing risk according to the RPN (Risk Priority Number) index and selecting improvement actions for those with an RPN greater than 300. Results: The result was the identification of 101 failure modes, of which 46 exceeded the RPN of 300. As a result of this work, 63 improvement actions have been proposed for those failure modes with NPR scores above 300. Conclusion: The conclusion of the study is that FMEA was a useful tool for anticipating potential failures in the process and proposing improvement actions for those that exceeded an RPN of 300.

Resumen Introducción: La seguridad del paciente ha adquirido un valor estratégico en las organizaciones sanitarias, empleando numerosos recursos para evitar accidentes durante la estancia hospitalaria. La asistencia sanitaria puede generar un riesgo y la seguridad del paciente es el objetivo más importante de la calidad asistencial. AMFE es una herramienta preventiva, lo que supone una anticipación a los posibles errores y eventos adversos, poniendo barreras para que no sucedan o si lo hacen mitigar sus efectos sobre la parte más vulnerable de la atención sanitaria, el paciente. Objetivos: Analizar, a través de la herramienta AMFE (Análisis Modal de Fallos y Efectos), la movilización del paciente crítico intubado en la Unidad de Cuidados Intensivos. Método: Para ello se realizó una tormenta de ideas dentro del servicio para decidir los posibles errores más frecuentes en el proceso. Posteriormente, se aplicó el método AMFE, con sus fases, priorizando el riesgo conforme al índice NPR (Numero de Priorización de Riesgo), seleccionando acciones de mejora en los que tienen un NPR mayor de 300. Resultados: Como resultado hemos obtenido 101 modos de fallo de los cuales 46 superaban el NPR de 300. Tras nuestro resultado, se han propuesto 63 acciones de mejora en aquellos modos de fallo con puntuaciones NPR superiores a 300. Conclusiones: La conclusión del estudio es que AMFE permite anticiparnos a los posibles fallos del proceso para proponer acciones de mejora en aquellos que superan un NPR de 300.

Application evaluation of failure mode and effect analysis in optimization of vascular recanalization process / 中华危重病急救医学

Objective@#To investigate the clinical application and effect evaluation of failure mode and effect analysis (FMEA) in the optimization of vascular recanalization in patients with ST-segment elevation myocardial infarction (STEMI).@*Methods@#A total of 389 STEMI patients admitted to the emergency department of the Fifth Central Hospital in Tianjin from January 2014 to January 2015 were served as the control group, and 398 STEMI patients admitted to the chest pain center of the Fifth Central Hospital in Tianjin from January 2016 to October 2017 were served as the experimental group. In the control group, routine emergency treatment was used. At the same time, the intervention room was 24-hour prepared for emergency vascular recanalization. The experimental group used FMEA. Through the usage of FMEA, the main factors those caused the delay in revascularization treatment were determined, and the revascularization process was optimized for these influencing factors, thereby shortening the "criminal" blood vessel opening time of patients. The door-to-balloon dilatation time (D-to-B time), troponin testing time, placement time of the catheterization room, initiation of the catheterization room to balloon dilatation time, and preoperative and 1 week postoperative N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, heart function parameters [left ventricular ejection fraction (LVEF), left ventricular short axis shortening rate (FS), left ventricular end-systolic diameter (LVESD), and left ventricular end-diastolic diameter (LVEDD)] within 1 week, 3 months and 6 months after intervention, and the incidence of main cardiovascular adverse events within 1 month after intervention, hospital mortality, the length of hospital stay, and readmission within 1 year in the patients of two groups were recorded.@*Results@#D-to-B time (minutes: 70.6±3.6 vs. 79.4±8.7), troponin testing time (minutes: 17.1±2.3 vs. 65.2±6.5), placement time of the catheterization room (minutes: 28.9±9.8 vs. 52.3±12.2) and activation of the catheterization room to balloon expansion time (minutes: 47.3±9.3 vs. 65.1±7.2) in the experimental group were significantly shorter than those in the control group (all P < 0.01). The NT-proBNP levels at 1 week after intervention in the two groups were lower than the preoperative levels, slightly lower in the experimental group, but the difference was not statistically significant. There was no significant difference in cardiac function at 1 week and 3 months after intervention between the two groups. The LVEF and FS at 6 months after intervention in the experimental group were significantly higher than those in the control group [LVEF: 0.622±0.054 vs. 0.584±0.076, FS: (38.1±4.3)% vs. (35.4±6.2)%, both P < 0.01], and LVESD and LVEDD were decreased significantly [LVESD (mm): 31.2±3.8 vs. 34.7±4.2, LVEDD (mm): 49.2±5.3 vs. 52.4±5.6, all P < 0.01]. The length of hospital stay in the experimental group was significantly shorter than that in the control group (days: 8.3±3.2 vs. 13.2±6.8, P < 0.01), the incidence of major cardiovascular adverse events within 1 month after intervention [13.6% (54/398) vs. 19.8% (77/389)], hospital mortality [1.8% (7/398) vs. 4.9% (19/389)], and readmission rate within 1 year [9.5% (38/398) vs. 14.5% (56/389)] in the experimental group were significantly lower than those in the control group (all P < 0.05).@*Conclusion@#The usage of FMEA to optimize the vascular recanalization procedure can shorten the emergency treatment time of STEMI patients, reduce the occurrence of adverse events, and improve the prognosis.