Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

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Impacto del Programa de Evaluación Externa de la Calidad en Química Clínica en México de 2004 a 2008 / Impact of the Program of External Quality Assessment in Clinical Chemistry in Mexico from 2004 to 2008 / Impacto do Programa de Avaliação Qualidade Externa em Química Clínica no México de 2004 a 2008

Se valoró el impacto del Programa de Evaluación Externa de la Calidad, aplicable a laboratorios clínicos en el área de Química Clínica, en México, con base en resultados obtenidos por los laboratorios durante el ciclo marzo 2008-febrero 2009 y el periodo 2004-2008, mediante un estudio analítico, longitudinal y retrospectivo de los resultados obtenidos por los laboratorios que participaron en el Programa de Evaluación Externa de la Calidad de la Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí. El análisis estadístico se realizó con los programas Microsoft® Office Excel y Epi Info T. El porcentaje de laboratorios clínicos con desempeño aceptable (excelente y bueno) por analito, durante el ciclo de evaluación marzo 2008-febrero 2009, fue del 75% al 82%, que aumentó cuando se utilizaron métodos automatizados y semiautomatizados. Para el periodo 2004-2008, los laboratorios en 2004 tuvieron 3,02 veces mayor riesgo de no calificar con desempeño aceptable (p<0,05) que en 2008. En conclusión, el Programa de Evaluación Externa de la Calidad de la Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, ha tenido un impacto favorable en el desempeño global de los laboratorios clínicos, que permite asegurar su calidad analítica.

The impact of the External Quality Assessment Program, applicable to clinical laboratories in the area of Clinical Chemistry in Mexico, was studied, based on laboratory results during the March 2008-February 2009 cycle and the 2004-2008 period, through analytical, longitudinal, retrospective analyses of the results obtained by the laboratories that participated in the External Quality Assessment Program of the School of Chemical Sciences of Universidad Autónoma de San Luis Potosí. Statistical analysis was performed with Microsoft® Office Excel and Epi Info T programs. The percentage of clínical laboratories with acceptable performance (excellent and good) by analyte during the evaluation cycle in March 2008-February 2009 was 75% to 82%, whích íncreased when automated and semíautomated methods were used. For the 2004-2008 period, the laboratories, in 2004, had 3.02 times greatet risk of not qualifying with acceptable performance (p<0.05) than in 2008. In conclusión, the External Qualíty Assessment of the School of Chemícal Sciences of Universidad Autónoma de San Luis Potosí has had a strong impact on the overall performance of clinical laboratories, whích ensures the latter's qualíty.

Quality assessment program for blood smear examination of health laboratories in Thailand.

OBJECTIVE: Evaluate laboratory performance on blood smear examination among public and private health laboratories. MATERIAL AND METHOD: External Quality Assessment Scheme (EQAS) for blood smear examination was organized by the Department of Medical Sciences. The scheme was run in 2005 by sending out six blood smears with normal and various abnormal types of blood cells. Participants were from 731 public and 181 private hospitals with hematology laboratories throughout Thailand RESULTS: Analysis showed good performance on identification and differentiation of leukemic blast cells and atypical lymphocytes. In addition, good performance was found in platelets reports. However, unsatisfactory performance was found on identification of red blood cells morphology. CONCLUSION: The present study suggested that the error reported of red blood cell morphology should be further investigated and the problems for improving laboratories performance solved.

El rol del bioquímico clínico en los comentarios interpretativos: Criterios para su desarrollo / The role of the clinical biochemist in the interpretative commentaries: Criteria for its development

El establecimiento de la Mejora Contínua de la Calidad en los servicios de los laboratorios, ha llevado a la fijación de estándares de trabajo, monitoreo de indicadores de gestión y a la creación de ambientes donde se trata de optimizar permanentemente la atención a los pacientes. La clarificación de la posible significación de los resultados y reportes y su adecuada comunicación es una parte de la etapa post-analítica cada vez más importante dentro de la tarea de los bioquímicos. Consideramos que los informes interpretativos deben ser emitidos en todos los casos por el profesional que valida el informe, convenientemente entrenado para este tipo de comunicaciones y con el conocimiento y supervisión de sus superiores. Para ser útiles, los comentarios interpretativos deben ser certeros, sucintos y estar adaptados a los conocimientos y experiencia del receptor a fin de proporcionar la mayor información clínicamente útil. Excepto en los casos en los que es posible un contacto directo con el médico para discutir los resultados o cuando se conoce la evolución de un caso, no existe oportunidad para el bioquímico de aprender por medio del feedback y así aumentar sus habilidades interpretativas. Si somos capaces de producir resultados útiles, de alta calidad analítica y de poder interpretarlos, debemos procurar que la comunicación con los demás integrantes del Equipo de Salud sea fluída para la mejor utilización de todo lo que el laboratorio puede ofrecer. Es parte de nuestra tarea la interpretación de los datos desde la visión bioquímica como aporte valioso para el desempeño de la labor médica y la armoniosa integración del Equipo de Salud.

The development of systematic quality control method using laboratory information system and unity program.

Quality control (QC) process is performed to detect and correct errors in the laboratory, of which systematic errors are repeated and affect all the laboratory process thereafter. This makes it necessary for all the laboratories to detect and correct errors effectively and efficiently. We developed an on-line quality assurance system for detection and correction of systematic error, and linked it to the Unity Plus/Pro (Bio-Rad Laboratories, Irvine, USA), a commercially available quality management system. The laboratory information system based on the client-server paradigm was developed using NCR3600 (NCR, West Columbia, USA) as the server and database for server was Oracle 7.2 (Oracle, Belmont, USA) and development tool was Powerbuilder (Powersoft Burlignton, UK). Each QC material is registered and gets its own identification number and tested the same way as patient sample. The resulting QC data is entered into the Unity Plus/Pro program by in-house data entering program or by manual input. With the implementation of in-house laboratory information system (LIS) and linking it to Unity Plus/Pro, we could apply Westgard's multi-rule for higher error detection rate, resulting in more systematic and precise quality assurance for laboratory product, as well as complementary to conventional external quality assessment.

Experience of the first survey of the pilot project of Asian Quality Assurance Survey program.

The Asian Network for Clinical Laboratory Standardization (ANCLS) decided to start her First Inter-laboratory Quality Assurance survey at the business meeting during the Second Asian Colloquium on October 21-22, 2000 in Kobe, Japan. The first survey materials of Asian Quality Assurance Survey (AQuAS) were distributed in July 2001 to 21 hospitals in the field of chemistry and 22 hospitals in the field of hematology among total 24 participating laboratories from seven Asian countries: Indonesia, Japan, Korea, Malaysia, Philippines, Singapore and Thailand. The survey methods in chemistry and in hematology were somewhat different. In chemistry the survey material was considered as unknown but handled similarly to the sample from the patient. Nineteen routine tests were performed only once. The hematology samples were considered as unknown but handled similarly to control or calibration material. Five parameters were tested five times repetitively and their average for each parameter was calculated. All the results were supposed to be sent back to the office within two weeks. Although it took more than two weeks, the return rate was 100%. The analysis was performed in several ways such as all the results together, by instruments and by methods. Mean, standard deviation (SD), standard deviation index (SDI), coefficient of variation (CV) and variance index score (VIS) were to be calculated in chemistry, and in hematology the same parameter were to be calculated except CV and VIS. In the first survey, the CV in chemistry was not calculated and the analysis by instrument or by methodology was also not attempted since there were not enough participating hospitals to do such analysis. In hematology the analysis was done by instrument only. The survey process was carried out successfully though there were some difficulties in communication tools, transportation methods and handling of specimens due to different weather conditions, and returning the report in the correct unit and to the correct place. The submitted data were acceptable for analysis. There were some differences in the units of measurement in different countries or laboratories. It was necessary to convert some of the units. Some laboratories apparently do not perform certain tests such as calcium, potasium and gamma-glutamyltransferase (gamma-GT). The gamma-GT is the most frequently not performed test. With the experience of this first survey, all the members involved in the survey have been trained well to do future surveys.

Thailand intensive external quality assessment schemes as dynamic tools for improving laboratory quality and standard.

The term 'external quality assessment (EQA)' has been recommended by WHO consultative meeting in 1980. It has been using to run the retrospective and com-parative statistic tests' reliability among the EQA participants of their organizers. EQA schemes in all fields of laboratory pathology should provide objective information as tools to assist laboratory analysts ensuring the test result quality and on the contrary deciding error-eradicated actions, or more or less improving national test performance quality and standard. Scoring assessment has been designed in the EQA schemes to assist monitoring, and encouraging quality and standard of laboratory performance in the long run of consecutive trials. The Faculty of Medical Technology of Mahidol University now as a collaborating WHO:SEARO EQA organizers, has provided wider EQA schemes, servicing participants all around Thailand, including 400 labs in clinical chemistry of EQAC scheme, 150 labs in clinical hormone of EQAH scheme, 200 labs in clinical microscopy of EQAM scheme, and 190 labs in clinical immunology and serology of EQAI schemes. Regular EQA newsletters, and yearly summer-time seminar and training prove to be the essential education tools promoting both laboratory quality and standard intensively.

Problems on national and locale external quality assurance schema (NEQAS and LEQAS); based on Japanese experience.

The quality and stability of surveillance materials is a critical issue to perform good external quality assessment schema. In the case of nationwide surveillance, more stable materials are required than those in the case of locale external quality control schema. For locale surveillance, fresh blood, plasma or serum materials are prepared for hematology and chemistry tests. On the other hand, dried materials are used for the chemistry test and semi-fixed blood is used for hematology tests in the national surveillance. However to evaluate automated white cell differential in hematology, there has been no good materials. We therefore prepared a mixture of EDTA and ACD solution for our locale surveillance. It gave us excellent results on the differential when we used it within 3 days after blood collection.

Situation of laboratory service and instruments in Thailand: a descriptive study from questionnaires.

Laboratory instruments are one of the main items in laboratory investment. To establish data for the situation of laboratory service and instruments in Thailand, questionnaires were randomly sent to one hundred and twenty laboratories. Sixty-three filled questionnaires from eleven university and affiliated hospitals, thirty-four government hospitals, and eighteen private hospital laboratories were sent back to the authors to be analyzed. Only the number of samples and instruments used during office hours were analyzed in this study by descriptive method. From the data it was found that the average number of personnel and tests of the university and affiliated hospital laboratories was the highest. To analyze the efficiency of the instruments used in the laboratories, the authors compared the average service number of samples or tests to the average number of samples or tests that was calculated from the instruments. The ratio of the average number of samples or tests that were calculated from the instruments and the average service number of samples or tests for chemistry and CBC were 2.13, 3.41, 5.24 and 2.33, 2.76, 3.71 in university and affiliated hospital laboratories, government hospital laboratories, and the private hospital laboratories, respectively. From the data, it was concluded that the instrument situation in laboratories of the university and affiliated hospitals was more appropriate than government hospital and private hospital laboratories. To improve the efficiency of using laboratory instruments, more concern must be given to the management of laboratory instruments and cooperation between hospitals could increase the efficiency of the instrument investment.

Normalización en el sector químico clínico: I) El contexto internacional / Standardization in clinical chemistry: I) The international environment

Durante los últimos 40 años, el esfuerzo de normalización del laboratorio clínico se ha basado en la convicción de ésta profesión de proporcionar servicios analíticos confiables y oportunos. En términos prácticos, la normalización del laboratorio clínico tiene distintas orientaciones y resultados. Dentro del proceso de normalización se incluye el desarrollo de materiales y métodos de referencia, la expedición de leyes, reglamentos y normas técnicas, así como el establecimiento de recomendaciones y lineamientos profesionales. El nivel y las actividades de normalización de la química clínica, no obstante, no se conocen de modo suficiente y claro. El objetivo de ésta serie de artículos es hacer una síntesis de los aspectos más relevantes del asunto en el mundo (primer parte) y en México (segunda parte), en modo de contar con un documento de referencia que pueda facilitar la actualización de los químicos clínicos en ésta materia y la modernización de los laboratorios clínicos de éste país acorde con el concierto internacional

Recomendaciones sobre muestreo en sangre entera, transporte y almacenamiento para la determinación simultánea de pH, gases en sangre y electrolitos / Recomendations on sampling, transport and storege for determination of pH, gases in blood and electrolytes

Las variables preanalíticas, por ejemplo, la obtención de la muestra, el transporte y almacenamiento pueden contribuir significativamente a inexactitudes en los valores de pH, gases en sangre y electrolitos. La IFCC, a través de su Comité en pH, gases en sangre y electrolitos ha desarrollado recomendaciones específicas para minimizar los efectos indeseables de las variables preanalíticas. El Comité ha tomado en cuenta la experiencia de sus propios miembros, así como datos publicados por otros investigadores. Específicamente, el comité a incluido las pautas pertinentes así como las sugerencias del "Grupo de trabajo sobre electrodos selectivos (WGSE)", el Comité Nacional sobre Estándares en el Laboratorio Clínico (NCCLS) y la División de Gases en Sangre y Electrolitos de la Asociación Americana para la Química Clínica (AACC). Este documento ha de familiarizar al lector con los diferentes tipos de contenedores de muestras y anticoagulantes. Se discuten aspectos importantes de los procedimientos de obtención de las muestras, que incluyen el estado del paciente y las precauciones especiales desde la obtención de las muestras a través de los catéteres o sondas. También se identifican diferentes requerimientos en el almacenamiento y transporte de muestras para análisis de gases en sangre y electrolitos

Influencia de los diuréticos en el resultado de los análisis clínicos / Influence of diuretics on the result of clinical analysis

En este trabajo se realizó una revisión de los principales grupos de diuréticos, sus sitios y mecanismos de acción y sus efectos sobre las pruebas de laboratorio. Se analizó el efecto de los diuréticos sobre: el estado ácido base, los electrolitos séricos y urinarios, el ácido úrico sérico y urinario y sobre la glucemia. También se describió la influencia de los diuréticos sobre los análisis de orina. Finalmente, los efectos hematológicos de los mismos. El objetivo de este trabajo fue estudiar la influencia de los diuréticos en los análisis clínicos, buscando los mecanismos fisiopatológicos o metodológicos de los casos citados