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Background: Risk assessment is the means of identifying and evaluating potential errors or problems that may occur in testing process. The aim of this study was to perform risk assessment of antimicrobial susceptibility testing (AST) process in clinical microbiology laboratories of Niamey, Niger Republic. Methodology: We conducted a descriptive cross-sectional study from October 1 to December 31, 2019, to evaluate AST performance in seven clinical microbiology laboratories at Niamey, the capital city of Niger republic. The evaluation focused on the determination of the criticality index (CI) of each critical point (frequency of occurrence of anomalies, severity of the process anomaly, and detectability of the anomaly during the process) in the AST process and the performance of the AST through an observation sheet using two reference strains; Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 29213. Results: The criticality index (CI) was greater than 6 for most of the critical points related to material, medium, equipment, method and labour for the AST process in all the laboratories. A range of 18-100% errors on the inhibition zone diameters of the reference strains were observed. Major and/or minor categorization (Sensitive S, Intermediate I and Resistance R) discrepancies were found at all the laboratories for either one or both reference strains. The antibiotics most affected by the S/I/R discrepancies were trimethoprim (100%), vancomycin (100%), amoxicillin (80%) and amoxicillin + clavulanic acid (70%). Conclusion: This study showed a deficiency in the control of critical control points that impacts the performance of the AST reported by the laboratories in Niger. Corrective actions are needed to improve the performance of AST in clinical microbiology laboratories in Niger
Тема - темы
Humans , Quality Control , Microbial Sensitivity Tests , Medical Laboratory Science , Microbiology , Critical Illness , NigerРеферат
El análisis de riesgo mediante el Análisis Modal de Efectos y Fallas (AMEF) se aplicó y se incorporó en conjunto con el Análisis de Peligros y Puntos Críticos de Control (HACCP) para establecer la evaluación de riesgos en una maquiladora de pavo deshuesado. En este trabajo se calculó y se predijo, por medio de la significancia del riesgo, la importancia de establecer medidas preventivas en las etapas de proceso más vulnerables. El cálculo de la significancia se realizó obteniendo el Índice de Criticidad (IC). Los puntos críticos de control se establecieron con la metodología del árbol de decisiones, que se enfocó en aquellas etapas que mostraron tener los valores más altos relativos al IC. Las principales causas posibles que generan una desviación de los puntos críticos de control fueron enlistadas y analizadas a través de un análisis causa-raíz, con el uso del diagrama de Ishikawa. La integración del análisis de riesgo dentro de un plan HACCP demostró proveer amplias ventajas que facilitan el control de los procesos de manufactura y el aseguramiento de la salud pública a los consumidores finales, al generar alimentos inocuos y de alta calidad, al tiempo que mejora el desempeño operacional del ciclo productivo. Se identificaron las etapas de almacenamiento y descongelación como los principales segmentos con tendencia a mostrar altos valores de IC. Las acciones correctivas sugeridas bajaron notablemente los valores del IC por debajo del límite aceptable. Los resultados del presente estudio muestran claramente la importancia de la incorporación de un buen sistema de control sistemático para la gestión de riesgos en la industria avícola.
Risk Analysis through the Modal Analysis of Effects and Failures (MAEF) was applied and incorporated together with the Hazard and Critical Control Points Analysis (HCCPA) in order to establish the assessment of risk in a maquiladora of boneless turkey. Through risk significance, the importance of establishing preventive measures during the most vulnerable stages of the process was calculated and predicted in this paper. Significance was calculated by obtaining the Criticality Index (CI). The critical control points were established using the decision tree methodology, which was focused on those stages showing the highest values related to the CI. The main possible causes that generate a deviation from the critical control points were listed and analyzed through a root-cause analysis, using Ishikawa's diagram. The integration of risk analysis in a HCCPA plan proved to offer advantages that facilitate the control of manufacturing processes and the assurance of public health to final consumers, by generating innocuous and high quality food products and at the same time improving the operational performance of the productive cycle. The storing and thawing stages were identified as the main segments tending to show high CI values. The suggested corrective actions significantly lowered the CI values below the acceptable limit. The results of this study clearly show the importance of incorporating a good system of systematic control for risk management in the poultry industry.
A análise de risco mediante a Análise Modal de Efeitos e Falhas (AMEF) se aplicou e se incorporou em conjunto com a Análise de Perigos e Pontos Críticos de Controle (HACCP) para estabelecer a avaliação de riscos em uma maquiladora de peru desossado. Neste trabalho se calculou e se previu, através da significância do risco, da importância de estabelecer medidas preventivas nas etapas de processo mais vulneráveis. O cálculo da significância se realizou obtendo o Índice de Criticidade (IC). Os pontos críticos de controle se estabeleceram com a metodologia árvore de decisões, que se focou naquelas etapas que mostraram ter os valores mais altos relativos ao IC. As principais causas possíveis que geram um desvio dos pontos críticos de controle foram elencadas e analisadas através de uma análise causa-raiz, com o uso do diagrama de Ishikawa. A integração da análise de risco dentro de um plano HACCP demonstrou prover amplas vantagens que facilitam o controle dos processos de manufatura e a garantia da saúde pública aos consumidores finais, ao gerar alimentos inócuos e de alta qualidade, ao mesmo tempo em que melhora o desempenho operacional do ciclo produtivo. Identificaram-se as etapas de armazenamento e descongelação como os principais segmentos com tendência a mostrar altos valores de IC. As ações corretivas sugeridas bajaram notavelmente os valores do IC por baixo do limite aceitável. Os resultados deste estudo mostram claramente a importância da incorporação de um bom sistema de controle sistemático para a gestão de riscos na indústria avícola.