Healthcare Failure Mode and Effect Analysis (HFMEA) as an Effective Mechanism in Preventing Infection Caused by Accompanying Caregivers During COVID-19-Experience of a City Medical Center in Taiwan.

BACKGROUND AND OBJECTIVES: In response to the COVID-19 pandemic outbreak and to ensure the safety of epidemic prevention in the hospital, the hospital has established mitigation strategies in advance including risk assessment and effect analysis to control hospital visitors and accompanying persons. The study aims to assess the effectiveness of mitigation strategies implemented to effectively prevent the invasion and spread of the virus. METHOD: Conduct a status analysis in accordance with the Healthcare Failure Mode and Effect Analysis (HFMEA) 4-step model, construct a response workflow, confirm the failure mode and potential causes, perform hazard matrix analysis and decision tree analysis, and formulate risk control management measures. RESULTS: For the 4 main processes and 9 subprocesses of the accompanying carers and contract caregivers entering the hospital, 26 potential failure modes and 42 potential causes of failure were analyzed. Following implementing improvement measures including strategies targeting the accompanying person, mitigation workflow failure rates decreased from 42 to 13 items, the pass rate for the maximum body temperature cutoff increased from 53.1% to 90.8%, and the compliance rate of hand washing increased from 89.5% to 100%. CONCLUSION: The HFMEA model can effectively implement preventive risk assessment and workflow management of high-risk medical procedures. The model can adjudicate the health of hospital visitors during the epidemic/pandemic, provide epidemic/pandemic education training and preventive measure health education guidance for hospital visits, and improve their epidemic prevention cognition. When combined, these strategies can prevent nosocomial infection to achieve the best anti-epidemic effect.

[Prospective risk analysis in a retrocession unit: Focus on drug dispensation process]. / Analyse des risques a priori en unité de rétrocession hospitalière : focus sur le processus de dispensation.

OBJECTIVES: Failure mode effect analysis (FMEA) improves safety in the drug life cycle. As the drug dispensation by hospital's pharmacy can be at risk, the FMEA tool has been used to evaluate and enhance the process. METHODS: After detailing the process, a first FMEA has been run in 2015. Corrective actions were implemented every time criticality indexes (CI) were above 15. One year later, we have evaluated potential impacts of these actions by running a new FMEA. RESULTS: In 2015, 11 failure modes were prioritized (CI>15) and the total CI for the overall process was 397. Corrective actions were implemented and one year later this amount has decreased by 14% (340) with 6 failure modes still prioritized. Thus, thanks to the FMEA, risks could be identified in year "y", they were taken into account and corrected and then effectively reassessed in year "y+1". CONCLUSION: This study showed us the interest of performing FMEA analysis in the drug dispensation process by hospital. The renewal of this risk analysis after a year helped us to monitor corrective actions, to evaluate their effectiveness and to improve safety. Finally, FMEA seems to be an effective way to steer the drug dispensation process.

Using Proactive Risk Assessment (HFMEA) to Improve Patient Safety and Quality Associated with Intraocular Lens Selection and Implantation in Cataract Surgery.

BACKGROUND: A proactive risk assessment using the Healthcare Failure Mode and Effect Analysis (HFMEA) process was completed on the intraocular lens (IOL) selection and implantation process to analyze system vulnerabilities that could cause patient harm. The three largest ophthalmology clinics based on patient surgical volume were studied in the analysis. The analysis included in-clinic eye measurements needed for IOL selection through the actual implantation of the lens in the operating room. METHODS: The HFMEA process was used for the analysis. A detailed process and subprocess diagram was created through interviews and observations. A multidisciplinary team met 12 times over a 14-week period, evaluating 170 discrete process and subprocess steps and identifying 177 failure modes and 75 failure mode causes for analysis. RESULTS: A high degree of process variability and lack of a robust quality assurance process was found. Areas for improvement included reducing variability between and within clinics, reducing variability in processes used by surgeons, modifying equipment and software to better support the work processes, and implementing a quality assurance program requiring observation of staff performing their routine work as opposed to relying on self-reports of quality metrics. CONCLUSION: The HFMEA process provided a more complete understanding of all of the processes associated with cataract surgery. This allowed for the identification of a variety of risk factors to patient safety that had not previously been identified by the more traditional reactive analysis methods, which tend to focus only on vulnerabilities identified by a specific event.

The Utility of Failure Modes and Effects Analysis of Consultations in a Tertiary, Academic, Medical Center.

BACKGROUND: Failure modes and effects analysis (FMEA) is a tool used to identify potential risks in health care processes. We used the FMEA tool for improving the process of consultation in an academic medical center. METHODS: A team of 10 staff members-5 physicians, 2 quality experts, 2 organizational consultants, and 1 nurse-was established. The consultation process steps, from ordering to delivering, were computed. Failure modes were assessed for likelihood of occurrence, detection, and severity. A risk priority number (RPN) was calculated. An interventional plan was designed according to the highest RPNs. Thereafter, we compared the percentage of completed computer-based documented consultations before and after the intervention. RESULTS: The team identified 3 main categories of failure modes that reached the highest RPNs: initiation of consultation by a junior staff physician without senior approval, failure to document the consultation in the computerized patient registry, and asking for consultation on the telephone. An interventional plan was designed, including meetings to update knowledge of the consultation request process, stressing the importance of approval by a senior physician, training sessions for closing requests in the patient file, and reporting of telephone requests. The number of electronically documented consultation results and recommendations significantly increased (75%) after intervention. CONCLUSION: FMEA is an important and efficient tool for improving the consultation process in an academic medical center.

Mejora en la seguridad de un proceso clínico utilizando el análisis modal de fallos y efectos: profilaxis de la enfermedad tromboembólica venosa en pacientes críticos / Improvement of the safety of a clinical process using failure mode and effects analysis: Prevention of venous thromboembolic disease in critically ill patients

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Practical Implementation of Failure Mode and Effects Analysis for Extracorporeal Membrane Oxygenation Activation.

Extracorporeal membrane oxygenation (ECMO) is used to treat severe hypoxemic respiratory failure and as a rescue therapy for patients with cardiopulmonary arrest within a narrow window of time. A failure modes and effects analysis (FMEA) was conducted to analyze the clinical and operational processes leading to delays in initiating ECMO. FMEA determined these highest-risk failure modes that were contributing to process failure: (1) ECMO candidacy not determined in time, (2) no or incomplete evaluation for ECMO prior to consult or arrest, (3) ECMO team not immediately available, and (4) cannulation not completed in time. When implemented collectively, a total of 4 interventions addressed more than 95% of the system failures. These interventions were (1) ECMO response pager held by a team required for decision, (2) distribution of institutionally defined inclusion/exclusion criteria, (3) educational training for clinicians consulting the ECMO team, and (4) establishment of a mobile ECMO insertion cart.

Estrategias para aumentar la seguridad del paciente en hemodiálisis: Aplicación del sistema de análisis modal de fallos y efectos (sistema AMFE) / Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system)

Antecedentes: La población en hemodiálisis (HD) es de alto riesgo. En estos pacientes un fallo puede tener consecuencias catastróficas, por lo que son necesarios sistemas que garanticen su seguridad en un entorno con alta tecnología y gran interacción del factor humano. Objetivos: Mostrar una sistemática de trabajo, reproducible en cualquier unidad de HD, que consiste en registrar las complicaciones y fallos ocurridos durante la sesión, definir cuáles de estas complicaciones podrían ser consideradas eventos adversos (EA) y, por tanto, prevenibles y realizar un análisis sistemático tanto de ellos como de los fallos reales o potenciales subyacentes, evaluando su gravedad, frecuencia y detección, y estableciendo prioridades de actuación (sistema de análisis modal de fallos y efectos [AMFE]). Métodos: Examen retrospectivo de las gráficas de diálisis de todas las sesiones practicadas durante un mes (octubre de 2015) en 97 pacientes, y análisis de las complicaciones registradas. La consideración de estas complicaciones como EA se basó en el consenso entre 13 profesionales y 2 pacientes. Se valoró la severidad, frecuencia y detección de cada fallo real o potencial mediante el sistema AMFE. Resultados: Se practicaron 1.303 sesiones de HD en 97 pacientes en las que se registraron un total de 383 complicaciones (1 cada 3,4 tratamientos). De ellas, el 87,9% fueron consideradas EA y el 23,7% complicaciones relacionadas con la enfermedad de base. Se detectó un EA cada 3,8 tratamientos. Los EA más frecuentes fueron la hipertensión y la hipotensión (42,7 y 27,5% del total de EA registrados, respectivamente). Los EA relacionados con el acceso vascular fueron uno de cada 68,5 tratamientos. Se registraron un total de 21 fallos en la asistencia (1 cada 62 tratamientos), los cuales estaban relacionados con fallos en la aplicación de la técnica y en la administración de la medicación. El mayor número de prioridad de riesgo lo obtuvieron los fallos relacionados con errores en el peso, disfunción o rotura del catéter y salida de agujas. Conclusiones: Las complicaciones en HD son frecuentes y la consideración de algunas de ellas como EA podría mejorar la seguridad en la asistencia, al poner en marcha medidas preventivas. La implementación del sistema AMFE permite estratificar y priorizar los posibles fallos de las unidades de diálisis, y actuar con mayor o menor premura, desarrollando las acciones de mejora necesarias (AU)

Background: Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. Objectives: To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Methods: Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. Results: We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients'underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. Conclusions: HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures (AU)

Análisis modal de fallos y efectos de la utilización de jeringas orales para administrar medicamentos líquidos / Failure mode and effects analysis applied to the administration of liquid medication by oral syringes

Objetivo: Realizar un análisis modal de fallos y efectos (AMFE) aplicado a la utilización de jeringas orales. Métodos: Un grupo multidisciplinar dentro del Comité de Seguridad analizó las etapas en la administración oral de los medicamentos líquidos, identificándose las más críticas y estableciendo modos potenciales de fallo que podrían producir un error. El riesgo asociado a cada modo de fallo se calculó utilizando el número de prioridad de riesgo (NPR). Se sugirieron acciones preventivas. Resultados: Se identificaron cinco modos de fallo, todos clasificados de alto riesgo (NPR>100). Siete de las ocho recomendaciones fueron implementadas. Conclusiones: La aplicación de la metodología AMFE ha sido una herramienta muy útil que ha permitido conocer los riesgos, analizar las causas que los pueden provocar y saber los efectos que tienen en la seguridad del paciente; todo ello con el fin de implantar acciones para reducirlos (AU)

Objective: To carry out a Failure Mode and Effects Analysis (FMEA) to the use of oral syringes. Methods: A multidisciplinary team was assembled within the Safety Committee. The stages of oral administration process of liquid medication were analysed, identifying the most critical and establishing the potential modes of failure that can cause errors. The impact associated with each mode of failure was calculated using the Risk Priority Number (RPN). Preventive actions were proposed. Results: Five failure modes were identified, all classified as high risk (RPN> 100). Seven of the eight preventive actions were implemented. Conclusions: The FMEA methodology was a useful tool. It has allowed to know the risks, analyse the causes that cause them, their effects on patient safety and the measures to reduce them (AU)

Implementación de la sedación con propofol: utilidad del análisis modal de fallos y efectos. Calidad y seguridad centrada en el paciente / Propofol sedation Quality and safety. Failure mode and effects analysis

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Failure mode and effect analysis: improving intensive care unit risk management processes.

Purpose Failure modes and effects analysis (FMEA) is a practical tool to evaluate risks, discover failures in a proactive manner and propose corrective actions to reduce or eliminate potential risks. The purpose of this paper is to apply FMEA technique to examine the hazards associated with the process of service delivery in intensive care unit (ICU) of a tertiary hospital in Yazd, Iran. Design/methodology/approach This was a before-after study conducted between March 2013 and December 2014. By forming a FMEA team, all potential hazards associated with ICU services - their frequency and severity - were identified. Then risk priority number was calculated for each activity as an indicator representing high priority areas that need special attention and resource allocation. Findings Eight failure modes with highest priority scores including endotracheal tube defect, wrong placement of endotracheal tube, EVD interface, aspiration failure during suctioning, chest tube failure, tissue injury and deep vein thrombosis were selected for improvement. Findings affirmed that improvement strategies were generally satisfying and significantly decreased total failures. Practical implications Application of FMEA in ICUs proved to be effective in proactively decreasing the risk of failures and corrected the control measures up to acceptable levels in all eight areas of function. Originality/value Using a prospective risk assessment approach, such as FMEA, could be beneficial in dealing with potential failures through proposing preventive actions in a proactive manner. The method could be used as a tool for healthcare continuous quality improvement so that the method identifies both systemic and human errors, and offers practical advice to deal effectively with them.

A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.

PURPOSE: To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA). METHODS AND MATERIALS: The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed. RESULTS: We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN. CONCLUSIONS: This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis.