Evaluation of the antimicrobial susceptibility testing process in clinical microbiology laboratories at Niamey, Niger

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

Failure mode effects and criticality analysis of medical endoscopes / 国际生物医学工程杂志

Objective To determine the important functional units of medical endoscopes and provide a theoretical basis for improving the maintenance and repair of hospital medical equipment.Methods The units of medical endoscopes were analyzed by the failure mode effects and criticality analysis (FMECA) method to determine the important functional unit.The maintenance methods of the important functional units were proposed and compared with those obtained by a medical equipment repair company.Results According to the risk priority number (RPN) score＞ 36,the important functional units of the medical endoscope were determined as electrical interface,water bottle interface,suction interface,housing,chain,pliers pipeline,water gas pipeline,jacket,charge coupled device (CCD) glass,guided beam glass and nozzles.These units require clinical operators to focus on and perform regular maintenances.Compared with the results obtained by the company,human factors were considered as a greater impact on the reliability of medical endoscopes.Conclusions For clinical operators,the operation training of medical endoscopes should be strengthened to avoid human-induced failures.

A construction of training tasks about preventive maintenance for medical devices by multi-factor model and analytic hierarchy process / 中国医学装备

Objective: To construct the training tasks about preventive maintenance for medical devices based on multi-factor model and analytic hierarchy process(AHP). Methods: The preventive maintenance items of 8 general medical devices were analyzed in the research. Through carried out multi-factor model and analytic hierarchy process to design reasonable training subjects for preventive maintenance of medical devices, and through combined with decision-making tree model of criticality difficulty frequency (CDF) to implement the contrast with judgment standard. Multi-factor model set 2.5 score as the standard score of professional training subjects, and subject need carry out professional training if score ≥2.5, otherwise it needn't. Results: In the grading of 8 subjects of multi-factor model, the scores of 5 subjects were more than 2.5 score, and they need implement professional training. This result was coincidence with the analysis result of decision-tree model of CDF. Conclusion: The analysis method of multi-factor model and analytic hierarchy process has important value for setting reasonable training subject for preventive maintenance of medical device, and it can provide theoretical basis for setting standardized training subject in future.

Validación de procesos con análisis inicial de criticidad aplicado a la obtención del principio activo policosanol (PPG) / Processes validation with initial analysis of criticality applied to obtaining the active ingredient policosanol (PPG)

Resumen Identificar cuáles son los activos que se someterán al proceso de validación es una tarea prioritaria para cualquier empresa que implemente un Sistema de Gestión de la Calidad, lo cual repercute de manera directa en el éxito de cualquier empresa. Como consecuencia de esto en septiembre de 2014 se diseñó un procedimiento en el departamento de Aseguramiento de la Calidad, dirección de Producción, CNIC; con el objetivo de determinar aquellos equipos o sistemas de apoyo auxiliar que serán sometidos al proceso de validación en la fabricación del principio activo del Policosanol (PPG). Para darle cumplimiento a nuestro objetivo el método utilizado se basa en la combinación de técnicas de riesgos tradicionales como son los métodos comparativos, diagramas lógicos de fallas, estudios de riesgo y operatividad, análisis de modos de falla y efectos, y otros. Como resultado se obtuvo un procedimiento general para la aplicación de la técnica de criticidad, la cual denominamos HAZID (HAZard-IDentification), basado en el análisis de riesgos. Como conclusión fundamental se obtiene un criterio de partida para justificar la inclusión de un equipo o sistema al proceso de validación.

Abstract Identifying the assets that will be submitted to the validation process is a priority task for any company that implements a Quality Management System, wicth has a direct impact on the success of any company. Taking into account the previous approach, it was designed in September 2014 a procedure in the department of Quality Assurance, Production Management, CNIC; with the aim of identifying those equipment or auxiliary systems that will be included in the validation process in the manufacture of the active ingredient Policosanol (PPG). To meet the principal goal, it was used a method based on the combination of techniques traditional risks such as comparative methods, fault logic diagrams, risk studies and operability, analysis of failure modes and effects, and others. As a result, it was obtained a general procedure for the implementation of the technique of criticality, it was named HAZID (HAZard-IDentification), based on risk analysis. As a fundamental conclusion, it was obtained a starting point to justify the inclusion of an equipment or auxiliary system to the validation process.

In search of principles for a Theory of Organisms.

Lacking an operational theory to explain the organization and behaviour of matter in unicellular and multicellular organisms hinders progress in biology. Such a theory should address life cycles from ontogenesis to death. This theory would complement the theory of evolution that addresses phylogenesis, and would posit theoretical extensions to accepted physical principles and default states in order to grasp the living state of matter and define proper biological observables. Thus, we favour adopting the default state implicit in Darwin’s theory, namely, cell proliferation with variation plus motility, and a framing principle, namely, life phenomena manifest themselves as non-identical iterations of morphogenetic processes. From this perspective, organisms become a consequence of the inherent variability generated by proliferation, motility and self-organization. Morphogenesis would then be the result of the default state plus physical constraints, like gravity, and those present in living organisms, like muscular tension.

Implementación del análisis de riesgo en la industria alimentaria mediante la metodología AMEF: enfoque práctico y conceptual / Implementing Risk Analysis in Food Industry through Modal Analysis of Effects and Failures (MAEF): Practical and Conceptual Approach / Implementação da análise de risco na indústria alimentícia mediante a Análise Modal de Efeitos e Falhas (AMEF): enfoque prático e conceitual

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.

The ontological status of western science and medicine.

This paper traces the revolutionary changes that have transformed the ontological status of western physics and biology over the last thirty years, so as to show in detail how they have moved towards the perspective of the Vedic sciences. From this it appears that Ayurveda’s more holistic approach is no longer in opposition to the views of physics and biology. In physics, experimental verifi cation of phenomena associated with quantum correlations have forced scientists to accept that the macroscopic world is not strongly objective: traditional western scientifi c ontology stands rejected. One consequence is that the world is not necessarily reductionist i.e. based solely on the properties of its tiniest constituents. In biology, the 1930’s discovery of homeostasis has reached a natural climax: the feedback instabilities, identifi ed by Norbert Wiener as inevitably accompanying control processes, are now recognized to be states of optimal regulation, where organisms centre their function. The non-reductive properties of these states clearly distinguish the theory of control from previous physical theories; they now occupy the centre-stage of life. Possibly against expectation, their non-reductive nature makes their physics holistic: western biology seems to have broken free of reductionist physics. When Ayurveda and bioscience are compared in light of these little appreciated advances in fundamental science, the supposed differences between them are vastly reduced – they practically dissolve. Instead of being poles apart, the ontologies of western science and Ayurveda seem to have become almost identical.

Human reliability in high dose rate afterloading radiotherapy based on FMECA / 中华放射医学与防护杂志

Objective To put forward reasonable and feasible recommendations against the procedure with relative high risk during the high dose rate (HDR) afterloading radiotherapy,so as to enhance its clinical application safety,through studying the human reliability in the process of carrying out the HDR afterloading radiotherapy.Methods Basic data were collected by on-site investigation and process analysis as well as expert evaluation.Failure mode,effect and criticality analysis (FMECA) employed to study the human reliability in the execution of HDR afierloading radiotherapy.Results The FMECA model of human reliability for HDR afterloading radiotherapy was established,through which 25 procedures with relative high risk index were found,accounting for 14.1％ of total 177 procedures.Conclusions FMECA method in human reliability study for HDR afterloading radiotherapy is feasible.The countermeasures are put forward to reduce the human error,so as to provide important basis for enhancing clinical application safety of HDR afterloading radiotherapy.

Failure mode, effects and criticality analysis research on human factors in clinical PET application / 中华放射医学与防护杂志

Objective To identify the steps with potentially higher risk through the analysis of human factors in clinical PET application so as to provide the efficient measures to reduce the risk of potential exposures.Methods The basic data were obtained through field investigation, questionnaire,failure mode, risk identification, FMECA and expert's evaluation, with statistical analysis made.Comparison was made of the relative risk values of automatic encapsulation equipment and manual encapsulation ones.Results The 10 steps with potentially higher risks were identified through analyzing human factors of clinical PET application, of which 8 occurred in the phase of chemical synthesis.The measures to control risk were addressed for the steps with higher risk.The results show that the relative risk value of the clinical process with automatic encapsulation equipment was 2.28 ± 0.99 and the one with manual encapsulation equipment was 3.20 ± 2.01 ( t = 2.56, P ＜ 0.05 ), with the latter being 76% of the former.Conclusions Failure mode and FMECA are effective in risk evaluation of clinical PET application, which can provide important basis for risk control.

When relevance decenters criticality: the case of the South African National Crime, Violence and Injury Lead Programme / Cuando la relevancia desplaza a la crítica: el caso del Programa Nacional sobre Crimen, Violencia y Lesiones en Sudáfrica

Following the formal demise of political apartheid in South africa in 1994, critical and community-centred psychologists have tended to obtain relevance through alignment with the tenets of social justice and the larger democratic project. This article draws on the experiences of the Crime, Violence and Injury Lead Programme (CVI) to illustrate how particular formulations of scientific and social relevance function to marginalize criticality and critical scholarship. The author suggests that relevance without criticality produces forms of intellectual activity that privilege empiricist traditions, perpetrate a binary between research and research translation, and reproduce the myth that intervention work is atheoretical. The review of the CVI serves as a reminder of the challenges inherent in enactments of critical psychology. Among the many issues that critical psychology oriented initiatives like CVI have to contend with is the task of developing theoretical and other resources to move between co-operation and critique in the service of democratic development.

Tras la desaparición formal de las políticas de segregación (apartheid) en Sudáfrica, en 1994, los psicólogos críticos y comunitarios han tendido a ganar relevancia a través del alineamiento con principios democráticos y de justicia social. Este artículo recurre a las experiencias del Programa sobre Crimen, Violencia y Lesiones (CVI) para ilustrar cómo determinadas formulaciones de relevancia científica y social marginan la criticidad y la erudición crítica. El autor sugiere que la relevancia sin crítica produce formas de actividad intelectual que privilegian tradiciones empiristas que incurren en la disociación entre investigación y práctica y, así mismo, reproducen el mito de que el trabajo de intervención es ateórico. La revisión del CVI sirve para recordar los retos inherentes a las proclamas de la psicología crítica. Entre los muchos problemas a los que tienen que enfrentarse las iniciativas orientadas a la psicología crítica, como el CVI, se encuentra la tarea de desarrollar, entre otros, recursos teóricos para moverse entre la cooperación y la crítica en el servicio al desarrollo democrático.

Analysis of the Dietitian's Job description in the business and industry foodservice

The purpose of this study was to verify the dietitian's job description(2000) for dietitians working at business and industry foodservice. The survey was carried out for the frequency, criticality and difficulty of each job description with 4 point. The number of subject was 39 dietitians, who have been working over 3 years at their position. The results are following ; 1. Duties with high frequency and criticality were menu managements, purchasing, storage and inventory controls, food productions, meal services, waste managements and sanitation managements. 2. Duties with middle frequency and high criticality were managing equipments and facility, human resources managements, financial managements, self promotions. 3. Duties with low frequency and high criticality were nutrition assessment (life cycles, certain diseases, specific conditions), medical nutritional theraphy, nutrition education and public health nutrition. 4. For difficulty, duties related food service had lower points than that of nutrition service.

Analysis of the Dietitian's Job description in the hospital

The purpose of this study was to verify the dietitian's job description(2000) for dietitians working at hospitals. The survey was carried out for the frequency, criticality and difficulty of each job description with 4 point scales. The subject was 62 dietitians, who have been working over 3 years at their position. The results are following ; 1. Duties with high frequency and criticality were menu managements, food productions, meal services and self promotions. 2. Duties with middle frequency and high criticality in food service area were purchasing, storage and inventory controls, waste managements, sanitation managements, managing equipments and facility, human resources managements and financial managements. 3. Duties with middle frequency and high criticality in nutrition service area were nutrition assessment (life cycles, certain diseases, specific condition), medical nutritional theraphy and nutrition education. 4. For difficulty, duties related nutrition service had higher points than that of food service.

Analysis of the Dietitian's Job description in the school

The purpose of this study was to verify the dietitian's job description(2000) for dietitians working at schools. The survey was carried out for the frequency, criticality and difficulty of each job description with 4 point scales. The number of subject was 125 dietitians, who have been working over 3 years at their position. The results are following ; 1. Duties with high frequency and criticality were menu managements, purchasing, storage and inventory controls, food productions, meal services, managing equipments and facility, waste managements, sanitation managements and self promotions. 2. Duties with middle frequency and high criticality were human resources managements and financial managements. 3. Duties with low frequency and high criticality were nutrition assessment (life cycles, certain diseases, specific condition), medical nutritional theraphy, nutrition education and public health nutrition. 4. For difficulty, duties related food service had lower points than that of nutrition service.

Analysis of job characteristics by the Dietitian's Job description for dietitians in different practice areas

The purpose of this study was to compare the dietitian's job in dietitian' s practice area using the dietitians job description(2000). To do this the survey was carried out for the frequency, criticality and difficulty of each job discription with 3 point scales. Questionaires sent to 521 dietitians. The number of returened questionnaires was 252. The number of dietitians working at each area was 125 at the school foodservice, 39 at the institutional foodservice, 62 at the hospital, 13 at the public health center and 13 at the catering company. The results of this study can be summarized as followed ; Experiences, level of education and age were significantly different by dietitian's practice areas.(p<0.001) For frequency, duties of nutrition services had lower score than that of food services in all practice area. Frequency of each job description was significantly differences duties of all.(p<0.05) For criticality, duties except of meal services, financial managements, life cycle nutrition managements were significantly different by dietitian' s practice areas.(p<0.05) For difficulty, duties except of self promotions were significantly different by dietitian's practice areas .(p<0.05)

Analysis of the Frequency, Criticality and Difficulty of Each Job Task Elements for the Validity of the Dietitian`s Job Description

This study was conducted a part of the project developing the standards of national board test for the dietitian's licence. The purpose of this study was to verify the dietitian's job description. To do this the survey was carried out for the frequency, criticality and difficulty of each job description with 4 point scales. The subjects was 521 dietitians, who have been working over 3 years at their position. The results are following ; 1. The each duty, task and task elements are verified with survey results. 2. Duties with high frequency and criticality were menu management, purchasing, storage and stock management, operational management for cooking, system management for distribution and sanitation management. 3. Duties with middle frequency and high criticality were managing equipment and facility, food service management, human resources management and self-development. 4. Duties with low frequency and high criticality were nutritional assessment for life cycles, nutrition therapy, nutrition education and disease management. 5. For difficulty, food service area show lower than of nutrition service area.