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.

Comparison of Fracture Resistance of Endodontically Treated Teeth Restored with Different Aesthetic Post and Core Systems Under All Ceramic Restoration Luted with Two Types of Cements

Context: Fracture of endodontically treated teeth is a grave sequela that a clinician should seriously ponder. Suitable selection of restorative materials is a requisite for long?term clinical success. Aims: To compare the fracture resistance of endodontically treated teeth restored with three different posts luted using two different cements under all ceramic crowns. Settings and Design: This in vitro study was conducted in the Department of Prosthodontics, Government Dental College, Kottayam, Kerala, India. Methods and Material: Thirty endodontically treated single?rooted mandibular premolars in which post spaces were prepared and divided into three different groups. Group 1 (n = 10): zirconia post group. Group 2 (n = 10): quartz fibre post group. Group 3 (n = 10): glass fibre post group. Each group is sub?divided into two based on the luting system: resin?modified glass ionomer cement (RMGIC) or dual?cure resin cement (DCRC). The fracture resistance testing was performed in a universal testing machine with a crosshead speed of 0.5 mm/min. Statistical Analysis Used: The mean fracture resistance were analysed using independent sample Student t?test and one?way ANOVA. Results: Within the zirconia post group, the mean fracture resistance was higher in DCRC sub?group compared to the RMGIC sub?group and the difference was statistically significant (p = 0.017). The difference in fracture resistance between three different post systems was not found to be statistically significant with respect to both the luting systems. Conclusions: It was observed that when zirconia post is used, the mean fracture resistance was higher in dual?cure resin group compared to the resin?modified GIC group.

Pre-hospitalization process reengineering based on the failure mode and effect analysis combined with process analysis method / 中华医院管理杂志

The pre-hospitalization service is an important initiative for medical institutions to implement the national reform of the medical security system. In 2018, Zhejiang province proposed the " most run once reform", requiring the establishment of an admission preparation center to carry out pre-hospitalization services. In June 2021, a certain maternal and child health hospital conducted a process reengineering for the pre admission process of the admission preparation center by applying the combined process analysis and failure mode and effects analysis, high-risk points of the hospitalization process were screened, the job value and job functions of each sector were sorted out, and the sector for improvement sector was evaluated, to launch an independent information system, establish a one click automatic import of pre hospital medical orders function, and remove on-site billing physicians from various specialties for improvement measures. The steps of the process had been optimized, inlcuding issuing pre hospital medical orders, waiting for pre-hospitalization, pre-hospitalization, and so on. The completeness rate of pre hospital medical orders, average waiting days before hospitalization, and patient satisfaction scores of pre hospitalization centers had changed from 91%, 2.99 days, and 93.46 points before process reengineering to 92%, 2.44 days, and 95.80 points after reengineering, respectively. This practice had achieved dual improvements in pre admission service quality and efficiency, so as to provide a reference for China′s medical institutions to carry out safe and efficient pre admission services.

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.

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.

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.

Analysis of the 10-year survival results of patients with esophageal squamous cell carcinoma achieving clinical complete remission after radical radiotherapy / 中华放射肿瘤学杂志

Objective:To investigate the long-term prognosis and failure mode of patients with esophageal squamous cell carcinoma who achieved clinical complete remission (cCR) after receiving radical radio (chemo) therapy.Methods:Clinical data of 183 patients with esophageal squamous cell carcinoma eligible for inclusion criteria who received treatment in our hospital from January 2009 to December 2012 were retrospectively analyzed. The factors that affected the long-term prognosis of patients were identified, and the failure mode of cCR patients and the prognosis after failure were analyzed. SPSS 19.0 statistical software was used for data analysis.Results:As of the follow-up date, the 1-, 3-, 5-, and 10-year overall survival (OS) rates and disease-free survival (DFS) rates of the entire group were 83.1%, 53.4%, 36.2%, 12.8% and 68.9%, 45.9%, 30.5%, 12.0%, respectively. The median OS and DFS were 41.3 months and 33.4 months. The results of multivariate analysis showed that cT staging, cN staging and prescribed dose were the independent factors affecting the OS ( P=0.001, <0.001, 0.003); hoarseness, lesion length, cT staging, cN staging and prescribed dose were the independent factors that affected the DFS ( P=0.002, 0.033, 0.009, <0.001, 0.003). In the whole group, 72 cases (39.3%) had local regional recurrence, 58 cases (31.7%) had distant metastasis, and 26 cases (14.2%) had local regional recurrence with distant metastasis. Among 104 patients after treatment failure, the prognosis of patients receiving salvage treatment was significantly better than that of their counterparts receiving maintenance treatment ( χ2=39.153, P<0.001). Conclusions:The long-term prognosis of patients with esophageal squamous cell carcinoma who achieved cCR after receiving radical radio (chemo) therapy is still unsatisfactory. Clinically, it is necessary to strengthen the clinical observation and follow-up of these patients. The main treatment failure mode of cCR patients is local regional recurrence. Active salvage treatment can significantly improve clinical prognosis of these patients.

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.

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.

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)

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.

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.

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.

Acoplamiento de métodos prospectivos y reactivos para análisis de riesgo en medicina con radiaciones ionizantes / Matching between prospective and reactive methods for risk analysis in ionizing radiation medicine

Resumen Entre los enfoques prospectivos más empleados a nivel mundial para la medicina con radiaciones ionizantes está la matriz de riesgo y los análisis de modos y efectos de fallo. Por otra parte, existen varios sistemas reconocidos a nivel mundial para análisis de riesgo reactivo en estas prácticas, destacándose ROSIS, SAFRON y ARIR. En la investigación se persigue desarrollar y aplicar una metodología de integración de los métodos referidos para el análisis de riesgo en la medicina con radiaciones ionizantes. Su informatización se realizó con el código cubano SECURE-MR-FMEA versión 3.0. Se propuso una taxonomía para la base de datos de incidentes (BDI) acoplada al software y se programó el análisis de correspondencia de los modelos estudiados de radioterapia para facilitar su selección por criterios de expertos. Los resultados de este acoplamiento permiten validar los modelos de estudios prospectivos empleados, analizando su cobertura y representatividad en la BDI, así como para el análisis de las causas raíces o básicas. Dentro de los patrones de riesgo más representados están los del acelerador lineal y cobaltoterapia. Los estudios realizados en este ámbito han sido comparados con algunos similares reportados, demostrándose la coherencia de los resultados. La BDI ha sido enriquecida con la consulta de reportes publicados sobre medicina nuclear y el transporte de material radiactivo, para poder aplicar las facilidades creadas. Esta investigación facilita la toma de decisiones más eficaz y efectiva, para la mejora de la seguridad y calidad de la medicina con radiaciones ionizantes.

Abstract The most useful prospective methods to risk analysis in ionizing radiation medicine are the risk matrix and the failure mode and effect analysis. In another hand, at the world level developed various systems for reactive risk analysis, for example ROSIS, SAFRON and ARIR. In the research will follow to development and use an integration methodology of these methods. This approach was introduced in the Cuban code SECURE MR-FMEA version 3.0. A specific taxonomy for the incident data base (IDB) coupled with the code was developed and it was created the correspondence analysis of studied models for radiotherapy for allows the selection by expert criteria. The result of this matching allows the validation of the risk patterns by risk matrix or FMEA approach, through the coverage or representative studies in the incident data base. The most representative risk patterns in the incident data base are the linear accelerator and cobalt therapy. The comparison between the results of the investigation and other similar studies are available in the paper. The IDB incorporated de radionuclide therapy and transport of radioactive materials events.This research facilitates the decision-making in improvements of safety and culture in the ionizing radiation medicine.