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RESUMEN Introducción: la Evaluación Externa de la Calidad es un componente esencial para mantener y mejorar la calidad de los laboratorios clínicos en instituciones de salud. Objetivo: validar el servicio de laboratorio clínico del Hospital Provincial Dr. León Cuervo Rubio de Pinar del Río, como Unidad Rectora de un Sistema de Control Externo de la Calidad a nivel provincial. Métodos: se realizó una investigación documental, descriptiva-longitudinal-retrospectiva a partir de fuentes secundarias de información. Se utilizaron como variables de calidad, el índice de variación y el desvío estándar (Z- Score); la primera para la evaluación del desempeño histórico (1985-1995) y la segunda para la internacional (2018) y provincial (2018-2019). Los resultados se presentaron a través de medidas de tendencia central (media y media recortada al 5 %), de posición (percentil), y dispersión (amplitud intercuartílica). Resultados: de 1985-1995, hubo estabilidad en el valor medio anual, para una evaluación histórica Aceptable. En la evaluación internacional, obtuvo una media anual de Z-score = 0,788; por debajo del percentil 27. En el desempeño provincial, una media recortada al 5 % del Z-score inferior al resto de las unidades y la más pequeña amplitud intercuartílica. Con excepción del ácido úrico, las demás determinaciones obtuvieron la evaluación de Aceptable en el histórico y en el control internacional y provincial, todas resultaron Satisfactorias. Conclusiones: tanto los resultados históricos como los recientes del control externo del laboratorio clínico del Hospital Dr. León Cuervo Rubio, lo validan como Unidad Rectora del Sistema de Control Externo de la Calidad a nivel provincial.
ABSTRACT Introduction: External Quality Assessment is an essential component to maintain and improve the quality of clinical laboratories in health care institutions. Objective: to validate the clinical laboratory service at Dr. León Cuervo Rubio Provincial General Teaching Hospital in Pinar del Río as a governing unit for an External Quality Control System, at a provincial level. Methods: a documentary, descriptive-longitudinal-retrospective research was carried out from secondary sources of information. The index of variation and the standard deviation (Z- Score) were used as quality variables; the first one for the assessment of historical performance (1985-1995), and the second one for international (2018) and provincial (2018-2019). The results were presented through measures of central propensity (mean and mean cut to 5%), position (percentile), and dispersion (inter-quartile amplitude). Results: during 1985-1995, there was stability in the annual mean value, for an acceptable historical assessment. In the international assessment, it obtained an annual mean of Z-score = 0.788; below the 27th percentile. In the provincial performance, a mean cut to 5 % of the Z-score lower than the rest of the units and the smallest inter-quartile amplitude. With the exception of uric acid, the other determinations obtained were the assessment of Acceptable in the historical one, but in the international and provincial controls all the assessments were Satisfactory. Conclusions: both historical and recent results of the external control for the clinical laboratory at Dr. León Cuervo Rubio Provincial General Teaching Hospital in Pinar del Río, validate it as a Governing Unit of the System of External Quality Control at provincial level.
Résumé
RESUMO Os resultados da medicina laboratorial influenciam uma alta porcentagem das decisões tomadas pelos médicos. A globalização requer que os resultados obtidos por métodos diferentes sejam concordantes, garantindo a segurança do paciente. É necessário haver colaboração internacional para difundir essa exigência. Essa colaboração deve basear-se na rastreabilidade da medicina laboratorial, bem como na adoção de procedimentos de medição e materiais de referência de alta hierarquia metrológica e que sejam comutáveis internacionalmente. A aplicação da cadeia de rastreabilidade metrológica facilita essa abordagem universal. A quantificação de colesterol no soro e Hemoglobina sanguínea A1c (HbA1c) no sangue serve como exemplo do processo de padronização de métodos com impacto demonstrado nos resultados clínicos. Por outro lado, a quantificação de paratormônio (PTH) e hemoglobina A2 (HbA2) no sangue revela a variabilidade entre os métodos atualmente em uso, que compromete o tratamento do paciente e demanda, portanto, a harmonização e/ou padronização dos métodos. Os desafios à difusão da rastreabilidade em medicina laboratorial incluem fatores como disponibilidade de materiais e métodos de referência, diferenças geográficas, uso de unidades de medida variadas, ensaios de analitos complexos e coordenação mundial limitada. Uma colaboração abrangente requer o envolvimento das partes interessadas no âmbito mundial, desde especialistas gerais a aqueles com particular experiência em medicina laboratorial, com vivência em laboratórios clínicos de rotina. Um plano de coordenação é apresentado neste artigo com ações atribuídas a cada um dos envolvidos.
ABSTRACT Laboratory medicine results influence a high percentage of all clinical decisions. Globalization requires that laboratory medicine results should be transferable between methods in the interests of patient safety. International collaboration is necessary to deliver this requirement. That collaboration should be based on traceability in laboratory medicine and the adoption of higher order international commutable reference materials and measurement procedures. Application of the metrological traceability chain facilitates a universal approach. The measurement of serum cholesterol and blood HbA1c serve as examples of the process of method standardization where an impact on clinical outcomes is demonstrable. The measurement of plasma parathyroid hormone and blood HbA2 serve as examples where the current between method variability is compromising patient management and method standardization and/or harmonization is required. Challenges to the widespread adoption of traceability in laboratory medicine include the availability of reference materials and methods; geographical differences; the use of variable units; complex analytes and limited global coordination. The global collaboration requires the involvement of several different stakeholder groups ranging from international experts to laboratory medicine specialists in routine clinical laboratories. A coordinated action plan is presented with actions attributable to each of these stakeholder groups.
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Se realizó un estudio analítico transversal en el departamento de química clínica del Hospital Universitario "Manuel Ascunce Domenech" durante el año 2005, se investigó el aseguramiento de la calidad en la etapa analítica al valorar la precisión de los métodos de ensayos mediante la aplicación de la reproducibilidad como técnica del control interno con el objetivo con el objetivo de asegurar la calidad de los ensayos de química clínica en el laboratorio central. Los datos se recogieron en registros de reproducibilidad y fueron procesados en una microcomputadora, se encontraron medidas de tendencia central (media) y de dispersión (desviación estándar y coeficiente de variación). Casi la totalidad de las determinaciones presentaron coeficientes de variación aceptables y adaptando el control de calidad a las condiciones se confeccionaron procedimientos normalizados de operación e instructivos de trabajo.
A cross-sectional analytic study in the clinical chemistry department at "Manuel Ascunce Domenech" University Hospital was conducted during the year 2005, the quality assurance in the analytic stage to assess the accuracy of testing methods through the application of the reproducibility as a technique of internal control was investigated with the objective to assure the quality of the tests of clinical chemistry in the central laboratory. Data were collected in registrations and were processed in a microcomputer, measures of central tendency (average) and dispersion (standard deviation and coefficient of variation) were found. Almost the totality of determinations presented coefficients of acceptable variation and adapting quality control to the conditions normalized procedures of operation and work instructions were accomplished.
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Objective To judge method performance of routine biochemistry parameters on Roche Modular PPI testing system by using westgard's method evaluation decision chart.Methods We assessed imprecision(CV)from internal quality control and inaccuracy(bias)from external quality control evaluation.Combined estimates of imprecision and inaccuracy by plotting imprecision as the x-coordinate and inaccuracy as the y-coordinate to locate an expected operating point of every item on the chart.By comparing this operating point with allowable total errors(TEa),we can decide whether the performance is acceptable or not.Results In the 27 different parameters tested,imprecision and bias of calcium were 0.08 mmol/L and 0.06 mmol/L respectively,its performance was marginal.The imprecision of creatinine,urea,glucose, sodium,chloride and phosphorus were 3.20%,2.13%,1.52%,0.89 mmol/L,1.10% and 1.55%,the bias were 4.79%,0.96%,4.63%,0.80 mmol/L,1.74% and 4.13% respectively,their performance was good.M1 other 20 items were of excellence performance.Conclusions Routine biochemistry parameters on Roche Modular PPI testing system possessed good precision and accuracy,and their performance were acceptable.To judge method performance of biochemistry testing system by using westgard' s method evaluation decision chart was easy to do and suited for clinical laboratory.
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10% was found in 5 patients (16%). Mesothelial hyperplasia was found to be significantly higher in patients with PTE than that in the control group (P