Determinación de variabilidad interlaboratorio y desempeño mediante comparación interlaboratorio de glucosa y colesterol basado en programa de control externo de calidad, estudio realizado con los participantes del Programa Prevecal del período 2010 y 2011
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2011
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Universidad de Guayaquil. Facultad de Ciencias Médicas. Carrera de Tecnología Médica
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La participación de los laboratorios en esquemas de ensayos de aptitud como los denominados Programas de Evaluación Externa de la Calidad (PEEC) son una comparación interlaboratorio cuyo propósito principal es evaluar y demostrar la confiabilidad de los datos que produce un laboratorio clínico y determinar el desempeño técnico por un método objetivo. La necesidad de confianza constante en el desempeño de los laboratorios no solo es esencial para los laboratorios y sus pacientes sino también para otras partes interesadas, tales como las autoridades reguladoras, los organismos de acreditación y otras organizaciones que especifican requisitos para los laboratorios. En varios países, los programas funcionan permanentemente con la participación obligatoria de los laboratorios. Actualmente, los programas involucran sustancias químicas, celulares, microbiológicas, enzimáticas e inmunológicas. La COLABIOCLI y OPS clasifican a Ecuador en un grupo de países donde todavía no se han generalizado y sistematizado los Programas de Evaluación Externa de la Calidad, así como los Controles Internos de sus determinaciones analíticas. Nuestros objetivos fueron realizar comparaciones interlaboratorio a participantes del programa de control externo PREVECAL determinando variabilidad interlaboratorio y desempeño de dos (2) analitos estudiados rutinariamente en el laboratorio como son glucosa y colesterol. Se utilizó los datos que los laboratorios proporcionaron al analizar sueros controles de diferentes niveles de concentración conocida. Se categorizo la información por año de participación y analito estudiado. Los resultados encontrados fueron la confirmación de variabilidad de los datos reportados entre laboratorios al analizar los sueros controles a pesar de que, para colesterol todos los laboratorios participantes usan el mismo método de determinación, para glucosa solo 2 laboratorios difieren en método y la mayoría de laboratorios (79%) utilizan sistemas automatizados. Se observó que son pocos los laboratorios que muestran un buen desempeño, confirmando la necesidad de establecer un programa de control externo de calidad a nivel nacional.
The participation of laboratories in aptitude testing schemes such as so-called External Quality Assessment Programs (PECEs) is an interlaboratory comparison whose primary purpose is to assess and demonstrate the reliability of the data that produces a clinical laboratory and determine technical performance by an objective method. The need for constant trust in laboratory performance is essential not only for laboratories and their patients but also for other stakeholders, such as regulatory authorities, accreditation bodies and other organizations specifying requirements for laboratories. In several countries, programmes operate permanently with mandatory laboratory participation. Currently, the programs involve chemicals, cell, microbiological, enzymatic and immunological substances. COLABIOCLI and PAHO classify Ecuador into a group of countries where External Quality Assessment Programs, as well as internal controls of their analytical determinations, have not yet become widespread and systematized. Our objectives were to make interlaboratory comparisons to participants of the preveCAL external control program determining interlaboratory variability and performance of two (2) analytes routinely studied in the laboratory such as glucose and Cholesterol. The data that the laboratories provided were used when analyzing serum controls of different known concentration levels. The information is categored by year of participation and analyte studied. The results found were confirmation of variability of data reported between laboratories when analyzing control serums even though, for cholesterol all participating laboratories use the same method of determination, for glucose only 2 laboratories differ in method and most laboratories (79%) use automated systems. It was noted that few laboratories show good performance, confirming the need to establish an external quality control program at the national level.
The participation of laboratories in aptitude testing schemes such as so-called External Quality Assessment Programs (PECEs) is an interlaboratory comparison whose primary purpose is to assess and demonstrate the reliability of the data that produces a clinical laboratory and determine technical performance by an objective method. The need for constant trust in laboratory performance is essential not only for laboratories and their patients but also for other stakeholders, such as regulatory authorities, accreditation bodies and other organizations specifying requirements for laboratories. In several countries, programmes operate permanently with mandatory laboratory participation. Currently, the programs involve chemicals, cell, microbiological, enzymatic and immunological substances. COLABIOCLI and PAHO classify Ecuador into a group of countries where External Quality Assessment Programs, as well as internal controls of their analytical determinations, have not yet become widespread and systematized. Our objectives were to make interlaboratory comparisons to participants of the preveCAL external control program determining interlaboratory variability and performance of two (2) analytes routinely studied in the laboratory such as glucose and Cholesterol. The data that the laboratories provided were used when analyzing serum controls of different known concentration levels. The information is categored by year of participation and analyte studied. The results found were confirmation of variability of data reported between laboratories when analyzing control serums even though, for cholesterol all participating laboratories use the same method of determination, for glucose only 2 laboratories differ in method and most laboratories (79%) use automated systems. It was noted that few laboratories show good performance, confirming the need to establish an external quality control program at the national level.
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Control de calidad, Glucemia, Colesterol, Laboratorios Clinicos, Cantón Guayaquil, Ecuador, Control de calidad, Estudio comparativo