Patient transfers from emergency departments to other in-hospital areas: a failure mode and effects analysis. / Análisis modal de fallos y efectos en las transferencias de pacientes de urgencias a hospitalización.

OBJECTIVES: To perform an in-depth analysis of the process of transferring patients from an emergency department (ED) to other areas inside a hospital and identify possible points of failure and risk so that strategies for improvement can be developed. MATERIAL AND METHODS: We formed a multidisciplinary group of ED and other personnel working with hospitalized adults. The group applied failure mode and effects analysis (FMEA) to understand the in-hospital transfer processes. A risk priority scoring system was then established to assess the seriousness of each risk and the likelihood it would appear and be detected. RESULTS: We identified 8 transfer subprocesses and 14 critical points at which failures could occur. Processes related to administering medications and identifying patients were the components that received the highest risk priority scores. Improvement strategies were established for all risks. The group created a specific protocol for in-hospital transfers and a checklist to use during handovers. CONCLUSION: The FMEA method helped the group to identify points when there is risk of failure during patient transfers and to define ways to improve patient safety.

OBJETIVO: Este estudio analiza en profundidad el proceso de transferencia de pacientes de urgencias a hospitalización y posibles fallos para evitar problemas de seguridad mediante la identificación de líneas de mejora. METODO: Se conformó un grupo de trabajo multidisciplinar compuesto por profesionales asistenciales de urgencias y hospitalización de adultos que, mediante la metodología de análisis modal de fallos y efectos (AMFE), analizó pormenorizadamente el proceso de transferencia de pacientes de urgencias a hospitalización. Para los puntos críticos identificados se estableció el índice de prioridad del riesgo (IPR) en base a su gravedad, probabilidad de aparición y de detección. RESULTADOS: Se identificaron 8 subprocesos y 14 puntos críticos que podrían generar fallos en el proceso de transferencia. Los aspectos relacionados con la administración de medicamentos y el proceso de identificación fueron los que obtuvieron mayores puntuaciones de IPR. Para todos ellos se establecieron acciones de mejora. Se elaboró un procedimiento específico de transferencia de pacientes entre estas áreas y un listado de verificación de ingresos en hospitalización. CONCLUSIONES: Con la metodología AMFE se ha conseguido desgranar un proceso de especial vulnerabilidad como es la transferencia de pacientes de urgencias a hospitalización y definir acciones de mejora en aras de incrementar la seguridad de los pacientes.

Análisis modal de fallos y efectos en las transferencias de pacientes de urgencias a hospitalización / Patient transfers from emergency departments to other in-hospital areas: a failure mode and effects analysis

Objetivo: Este estudio analiza en profundidad el proceso de transferencia de pacientes de urgencias a hospitalización y posibles fallos para evitar problemas de seguridad mediante la identificación de líneas de mejora. Método: Se conformó un grupo de trabajo multidisciplinar compuesto por profesionales asistenciales de urgencias y hospitalización de adultos que, mediante la metodología de análisis modal de fallos y efectos (AMFE), analizó pormenorizadamente el proceso de transferencia de pacientes de urgencias a hospitalización. Para los puntos críticos identificados se estableció el índice de prioridad del riesgo (IPR) en base a su gravedad, probabilidad de aparición y de detección. Resultados: Se identificaron 8 subprocesos y 14 puntos críticos que podrían generar fallos en el proceso de transferencia. Los aspectos relacionados con la administración de medicamentos y el proceso de identificación fueron los que obtuvieron mayores puntuaciones de IPR. Para todos ellos se establecieron acciones de mejora. Se elaboró un procedimiento específico de transferencia de pacientes entre estas áreas y un listado de verificación de ingresos en hospitalización. Conclusiones: Con la metodología AMFE se ha conseguido desgranar un proceso de especial vulnerabilidad como es la transferencia de pacientes de urgencias a hospitalización y definir acciones de mejora en aras de incrementar la seguridad de los pacientes. (AU)

Objectives: To perform an in-depth analysis of the process of transferring patients from an emergency department (ED) to other areas inside a hospital and identify possible points of failure and risk so that strategies for improvement can be developed. Methods: We formed a multidisciplinary group of ED and other personnel working with hospitalized adults. The group applied failure mode and effects analysis (FMEA) to understand the in-hospital transfer processes. A risk priority scoring system was then established to assess the seriousness of each risk and the likelihood it would appear and be detected. Results: We identified 8 transfer subprocesses and 14 critical points at which failures could occur. Processes related to administering medications and identifying patients were the components that received the highest risk priority scores. Improvement strategies were established for all risks. The group created a specific protocol for in-hospital transfers and a checklist to use during handovers. Conclusion: The FMEA method helped the group to identify points when there is risk of failure during patient transfers and to define ways to improve patient safety. (AU)

Implementación del análisis modal de fallos y efectos en una Unidad de Radiofarmacia Hospitalaria / Implementation of the failure modes and effects analysis in a Hospital Radiopharmacy Unit

Objetivo El objetivo de este estudio es la implementación en una Unidad de Radiofarmacia Hospitalaria de una metodología de análisis de riesgos para poder identificar de forma proactiva los posibles modos de fallo y priorizar medidas correctivas. Material y métodos Mediante el análisis modal de fallos y efectos (AMFE) se identificaron los posibles modos de fallo de cada una de las etapas de los procesos de prescripción, preparación y administración de los radiofármacos de diagnóstico y de terapia. A partir de las variables de severidad, probabilidad y detectabilidad se cuantificó el riesgo mediante el número de prioridad de riesgo (NPR) para cada modo de fallo, subproceso y tipo de radiofármaco. Se establecieron medidas de mejora y se calculó la reducción en el NPR. Resultados Se identificaron 96 modos de fallos (58 para los radiofármacos de diagnóstico y 38 para los de terapia). La identificación biunívoca del paciente con el radiofármaco es el modo de fallo con mayor NPR (60) y el subproceso de marcaje celular el que presenta mayor riesgo (NPR 286). Como resultado de las medidas de mejora se disminuyó el NPR global en un 22% para los radiofármacos de diagnóstico y 20% para los de terapia. Esta reducción sería del 46 y el 31%, respectivamente, si se implantara un software de radiofarmacia y tecnología de código de barras en la administración. Conclusiones La aplicación de la metodología AMFE como herramienta de análisis de riesgos permite identificar los puntos críticos de los procesos relacionados con los radiofármacos y priorizar medidas para disminuir el riesgo (AU)

Aim The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. Materials and methods By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. Result A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. Conclusions The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk (AU)

Implementation of the failure modes and effects analysis in a Hospital Radiopharmacy Unit.

AIM: The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. MATERIALS AND METHODS: By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. RESULTS: A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. CONCLUSIONS: The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk.

Análisis modal de fallos y efectos y análisis de minimización de costes de tres programas de entrega de medicamentos / Healthcare failure mode and effects analysis and cost minimization analysis of three pharmaceutical services

Objetivo: El objetivo principal fue evaluar y comparar tres programasde entrega de medicamentos requeridos por los pacientes atendidosen las consultas externas de farmacia hospitalaria: mediante centros desalud, empresa de mensajería externa y oficinas de farmacia. El objetivosecundario fue analizar el coste económico desde la perspectiva delsistema público de salud.Método: Se utilizó el análisis modal de fallos y efectos para el objetivoprincipal. El análisis económico se realizó mediante un estudio de minimización de costes.Resultados: Los resultados en índice de probabilidad de riesgo fueron184 puntos para la entrega mediante centros de salud, 170 mediantemensajería y 126 mediante oficina de farmacia. El estudio económicomostró que actualmente el programa con menor coste económico fue ladispensación mediante oficina de farmacia respecto a mensajería y centros de salud (7.986,52 € versus 18.434,52 € y 11.417,08 €).Conclusiones: La entrega mediante oficina de farmacia tiene el menoríndice de probabilidad de riesgo debido en gran parte al papel delfarmacéutico en la custodia y conservación del medicamento. (AU)

Objective: The main purpose of this study was to analyze and comparethree different medication delivery methods used by the outpatient careunit of a hospital pharmacy, namely health center collection, communitypharmacy collection and home delivery. The secondary purpose was tocompare the economic cost of those methods for the Spanish health service.Method: A failure mode and effects analysis was carried out to attain theprimary objective. For the secondary objective, an in-depth analysis wasperformed of the economic costs associated with each program using acost-minimization analysis.Results: The failure mode and effects analysis resulted in scores of184, 170 and 126 points for the health center collection, home deliveryand community pharmacy collection programs, respectively. The economic evaluation, for its part, rendered estimated costs of €18,434.52,€11,417.08 and €7,986.52 for home delivery, health center collectionand community pharmacy collection services, respectively.Conclusions: The results of the study indicated that collection at the community pharmacy was the program associated to the lowest risk, most likely dueto the crucial role of the pharmacist regarding the custody and preservation of medicines. (AU)

[Failure mode effect analysis for safety improvement in the automatic drug dispensing systems]. / Aplicación de un análisis modal de fallos y efectos para la mejora de la seguridad en la utilización de los sistemas automatizados de dispensación de medicamentos.

OBJECTIVE: To identify the risks in automated dispensing cabinet use in order to improve routine procedure safety. METHODS: We used the Failure Mode Effect Analysis (FMEA) methodology. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. We assessed the impact associated with each failure mode with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for failure modes with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated. RESULTS: The process was divided into five sub-processes: automatic delivery of order replacement, to prepare order in a pyramidal cart, transport of the pyramidal cart from the pharmacy service to the automated dispensing cabinet, replacement of the automated dispensing cabinet by the pharmacy technician and dispensing/returning by nursing staff. Twenty-two failure modes, with 25 cases and with varying effects (severity 2-8) were evaluated. The sub-process with more failure modes with NPR>100 was dispensing/returning by nursing staff. CONCLUSIONS: The FMEA methodology was a useful tool when applied to automated dispensing cabinet system use. The implementation of improvement actions significantly reduced the risk.

[Modal analysis of failures and effects in intra-hospital transfers]. / Análisis modal de fallos y efectos en las transferencias intrahospitalarias.

OBJECTIVES: To identify gaps in patient safety during intra-hospital transfers. MATERIAL AND METHODS: A working group was set up and patient transfers carried out in the different healthcare areas of a hospital were identified. Using the Modal Failure and Effects Analysis (FMEA), the risks of each failure mode identified were quantified using the Risk Prioritisation Index (RPI) and establishing improvement measures for all RPIs with scores greater than 100. RESULTS: There were 31 critical points that could lead to failures / deficiencies in 20 types of transfers. A total of 35 safety improvement measures were proposed for the transfers in the different areas analysed. CONCLUSIONS: The use of FMEA has made it possible to objectify the risks for patient safety during internal hospital transfers by providing information to prioritise improvement strategies.

[Failure mode and effects analysis to improve quality in clinical trials]. / Análisis modal de fallos y efectos para mejorar la calidad en los ensayos clínicos.

INTRODUCTION: The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. METHODS: A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. RESULTS: Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. DISCUSSION: The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD.

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

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.

Improvement of the safety of a clinical process using failure mode and effects analysis: Prevention of venous thromboembolic disease in critical patients. / 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.

OBJECTIVE: To improve critical patient safety in the prevention of venous thromboembolic disease, using failure mode and effects analysis as safety tool. DESIGN: A contemporaneous cohort study covering the period January 2014-March 2015 was made in 4 phases: phase 1) prior to failure mode and effects analysis; phase 2) conduction of mode analysis and implementation of the detected improvements; phase 3) evaluation of outcomes, and phase 4) (post-checklist introduction impact. SETTING: Patients admitted to the adult polyvalent ICU of a third-level hospital center. PATIENTS: A total of 196 patients, older than 18 years, without thromboembolic disease upon admission to the ICU and with no prior anticoagulant treatment. INTERVENTIONS: A series of interventions were implemented following mode analysis: training, and introduction of a protocol and checklist to increase preventive measures in relation to thromboembolic disease. VARIABLES OF INTEREST: Indication and prescription of venous thrombosis prevention measures before and after introduction of the measures derived from the failure mode and effects analysis. RESULTS: A total of 59, 97 and 40 patients were included in phase 1, 3 and 4, respectively, with an analysis of the percentage of subjects who received thromboprophylaxis. The failure mode and effects analysis was used to detect potential errors associated to a lack of training and protocols referred to thromboembolic disease. An awareness-enhancing campaign was developed, with staff training and the adoption of a protocol for the prevention of venous thromboembolic disease. The prescription of preventive measures increased in the phase 3 group (91.7 vs. 71.2%, P=.001). In the post-checklist group, prophylaxis was prescribed in 97.5% of the patients, with an increase in the indication of dual prophylactic measures (4.7, 6.7 and 41%; P<.05). There were no differences in complications rate associated to the increase in prophylactic measures. CONCLUSIONS: The failure mode and effects analysis allowed us to identify improvements in the prevention of thromboembolic disease in critical patients. We therefore consider that it may be a useful tool for improving patient safety in different processes.

[Failure mode effect analysis applied to preparation of intravenous cytostatics]. / Análisis modal de fallos y efectos aplicado a la elaboración de citostáticos intravenosos.

OBJECTIVE: To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. MATERIAL AND METHODS: Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. RESULTS: A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes. CONCLUSIONS: This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling.

Mejora de la calidad del proceso quirúrgico en el Servicio de Cirugía General en el Hospital Aeronáutico Central mediante la realización de un AMFE / Improvement of the quality of the surgical process in the General Surgery Service at the Hospital Aeronáutico Central by means of an AMFE

Introducción: Se deben identificar y analizar los fallos existentes en el sistema para detectar los errores cometidos y aprender de ellos buscando así las causas que los originan y rediseñando los procesos en función de los resultados del análisis. El Análisis Modal de Fallos y Efectos (AMFE) es un estudio prospectivo de los riesgos y tiene por objetivo analizar áreas y servicios de alto riesgo con el fin de detectar dónde se pueden producir incidentes y establecer sistemas para evitar que ocurran. Objetivos: Optimizar la calidad del proceso quirúrgico en el Servicio de Cirugía General del Hospital Aeronáutico Central mediante la realización de un AMFE. Identificar y eliminar precozmente los fallos potenciales del proceso quirúrgico y desarrollar un Plan de Mejora de la Calidad del mismo.Material y Método: Estudio prospectivo de tipo AMFE realizado en el Servicio de Cirugía General del Hospital Aeronáutico Central durante el período enero -abril de 2016. Resultados: Se identificaron como posibles fallos críticos con mayor índice probabilístico de riesgo a: caída del paciente de la mesa-camilla (IPR 423), falta de CO2 (IPR 280), reacción alérgica medicamentosa (IPR 160), paso incorrecto de camilla-mesa, mesa-camilla (IPR 90), quemaduras por electrobisturí (IPR 80), no controlar / cuantificar diuresis (IPR 80), no iniciar tolerancia digestiva en su debido momento (IPR 72) y falta de materiales laparoscópicos, protésicos o materiales inadecuados (IPR 40).Conclusiones: Los fallos en los procesos ocurren en todos los niveles de la organización, y su impacto es mayor cuanto más tardía es su detección. La aplicación de esta metodología fue de gran utilidad para la confección de un "Plan de mejora" con el fin de lograr

Introduction: Should be identified and analyzed the faults in the system to detect the commited mistakes and learn from them, looking for de causes that originate them and redesigning the processes in function of the analysis results. The Failure Mode and Effects Analys is (FMEA) is a prospective study about the risks and its objective is to analyze high risk areas and services with the porpouse of dectecting where the failures can be made and establish systems to avoid them. Objectives: Optimize the quality of surgical process in the General Surgery Department from Hospital Aeronáutico Central through an FMEA. Identify and eliminate in an early time the potential faults of the surgical process and develop a Quality Improvement Plan. Material and method: A FMEA prospective study carried out in the General Surgery Department from Hospital Aeronáutico Central during January-April 2017. Results: They were identified as possible critical failures with greater probabilistic index: patient ́s fall from table-stretcher (IPR 423), lack of CO2 (IPR 280), allergic drug reaction (IPR 160), wrong tranfer table-stretcher, stretcher-table (IPR 90), electrocautery burn (IPR 80), not controlling / quantifying diuresis (IPR 80), do not start digestive tolerance in due time (IPR 72) and lack of laparoscopic, prosthetic materials, or inadequate materials. Conclusions: The failures in the processes occur at all organization levels, and its repercussion is bigger the later its detection. The application of this methodology was of great utility for an "improvement plan" confection, in order to achieve a proper quality culture in the surgical process in our department.

[Failure mode and effects analysis on computerized drug prescriptions]. / Análisis modal de fallos y efectos en las prescripciones farmacológicas informatizadas.

OBJECTIVE: To identify and analyze errors in drug prescriptions of patients treated in a "high resolution" hospital by applying a Failure mode and effects analysis (FMEA).Material and methods A multidisciplinary group of medical specialties and nursing analyzed medical records where drug prescriptions were held in free text format. An FMEA was developed in which the risk priority index (RPI) was obtained from a cross-sectional observational study using an audit of the medical records, carried out in 2 phases: 1) Pre-intervention testing, and (2) evaluation of improvement actions after the first analysis. An audit sample size of 679 medical records from a total of 2,096 patients was calculated using stratified sampling and random selection of clinical events. RESULTS: Prescription errors decreased by 22.2% in the second phase. FMEA showed a greater RPI in "unspecified route of administration" and "dosage unspecified", with no significant decreases observed in the second phase, although it did detect, "incorrect dosing time", "contraindication due to drug allergy", "wrong patient" or "duplicate prescription", which resulted in the improvement of prescriptions. CONCLUSIONS: Drug prescription errors have been identified and analyzed by FMEA methodology, improving the clinical safety of these prescriptions. This tool allows updates of electronic prescribing to be monitored. To avoid such errors would require the mandatory completion of all sections of a prescription.

Aplicación del análisis modal de fallos y efectos en el proceso de donación de sangre total / Application of modal analysis of failures and effects in the process of total blood donation

La búsqueda constante de medidas para garantizar la calidad y seguridad de la sangre y hemocomponentes constituye una necesidad para el logro de la seguridad transfusional. Aunque las buenas prácticas de producción tienen el objetivo de disminuir los riesgos para obtener productos puros, seguros y eficaces, es necesario complementarlas con herramientas que permitan prevenir los posibles fallos y detectar dichos riesgos. Tal es el caso de la aplicación del Análisis Modal de Fallos y Efectos en el Banco de Sangre Provincial de Villa Clara, donde se identificaron y evaluaron las posibles fallas del proceso de donación de sangre total, lo que permitió caracterizar este proceso, identificar sus variables críticas, proporcionar las bases para proponer nuevos puntos críticos de control y establecer las acciones necesarias para la reducción o eliminación de las fallas detectadas. Esto contribuyó al aumento de la satisfacción de los servicios de transfusión hospitalarios y de los pacientes

The constant search of measures to guarantee the quality and the safe of blood and hemocomponents is a need to achieve the transfusion safe. Although the aim of the good practices of production was to decrease the risks to obtain pure, safe and effective products, it is necessary its fulfillment with tools allowing to prevent the potential failures and to detect such risks. That is the case of the application of the Modal Analysis of Failures and Effects in the Provincial Blood Bank of Villa Clara where the potential failures in the process of total blood donation were identified and assessed, allowing to characterize it, to identify its critical variables, to lay the foundations to propose new critical points of control and to establish the actions necessary to reduce or to eliminate the failures detected. All this contributed to the satisfaction of hospital transfusion services and of patients

Aplicación del análisis modal de fallos y efectos en el proceso de donación de sangre total / Application of modal analysis of failures and effects in the process of total blood donation

La búsqueda constante de medidas para garantizar la calidad y seguridad de la sangre y hemocomponentes constituye una necesidad para el logro de la seguridad transfusional. Aunque las buenas prácticas de producción tienen el objetivo de disminuir los riesgos para obtener productos puros, seguros y eficaces, es necesario complementarlas con herramientas que permitan prevenir los posibles fallos y detectar dichos riesgos. Tal es el caso de la aplicación del Análisis Modal de Fallos y Efectos en el Banco de Sangre Provincial de Villa Clara, donde se identificaron y evaluaron las posibles fallas del proceso de donación de sangre total, lo que permitió caracterizar este proceso, identificar sus variables críticas, proporcionar las bases para proponer nuevos puntos críticos de control y establecer las acciones necesarias para la reducción o eliminación de las fallas detectadas. Esto contribuyó al aumento de la satisfacción de los servicios de transfusión hospitalarios y de los pacientes(AU)

The constant search of measures to guarantee the quality and the safe of blood and hemocomponents is a need to achieve the transfusion safe. Although the aim of the good practices of production was to decrease the risks to obtain pure, safe and effective products, it is necessary its fulfillment with tools allowing to prevent the potential failures and to detect such risks. That is the case of the application of the Modal Analysis of Failures and Effects in the Provincial Blood Bank of Villa Clara where the potential failures in the process of total blood donation were identified and assessed, allowing to characterize it, to identify its critical variables, to lay the foundations to propose new critical points of control and to establish the actions necessary to reduce or to eliminate the failures detected. All this contributed to the satisfaction of hospital transfusion services and of patients(AU)