Evaluación de la calidad en el laboratorio en la fase preanalítica: un estudio multicéntrico / Quality assessment for preanalytical phase in clinical laboratory: a multicentric study

Introducción. El objetivo del trabajo es mostrar y analizar los resultados de errores preanalíticos en las muestras de laboratorio remitidas desde atención primaria a 7 laboratorios de la Comunidad Valenciana que atienden a 7 departamentos de salud. Material y métodos. Se realizó un estudio transversal mediante la evaluación y el análisis de los errores preanalíticos de 7 laboratorios. El error preanalítico se definió como muestra que no puede ser analizada por no cumplir los criterios de aceptabilidad o que no se recibe en el laboratorio. Se diseñaron indicadores de proporción que cuantifican cada incidencia respecto al total de cada muestra (hematología, coagulación, bioquímica y orina). Los errores preanalíticos y las muestras se recogieron automáticamente del Sistema de Información del Laboratorio, y también se calcularon los indicadores a tiempo real mediante un software basado en data warehouse y cubos OLAP. Resultados. La variabilidad de los resultados entre los diferentes centros fue elevada, evidenciándose que el mayor porcentaje de incidencias se debió a la falta de disponibilidad de las muestras, en especial de coagulación y de orina. Conclusiones. Existe una gran variabilidad de errores preanalíticos dependiendo del Departamento de Salud. Existe una necesidad de homogeneizar la práctica de la extracción de muestras(AU)

Purpose. To show the number of preanalytical sample errors in seven laboratories attending seven health departments of Valencian Community (Spain). Methods. Cross-sectional study of the number of preanlytical errors in samples obtained in primary care centers. An error is defined as a rejected specimen: any blood or urine sample, which cannot be successfully tested as it does not meet the acceptability criteria of the laboratory or if the sample is not received. We collected preanalytical errors from the tests requested for hematology, coagulation, chemistry, and urine samples. Registers were collected and indicators calculated automatically through a data warehouse and OLAP cubes software. Results. Larges differences in the results of preanalytical errors were observed between health departments. The highest percentage of errors occurred in coagulation samples, followed by urine, hematology and biochemistry. With regard to the type of error, the largest proportion of errors was due to failures of process. Conclusions. The high incidence of preanalytical errors and variability between health departments suggests that there is a need to standardize the drawing practice(AU)

[Quality assessment for preanalytical phase in clinical laboratory: a multicentric study]. / Evaluación de la calidad en el laboratorio en la fase preanalítica: un estudio multicéntrico.

PURPOSE: To show the number of preanalytical sample errors in seven laboratories attending seven health departments of Valencian Community (Spain). METHODS: Cross-sectional study of the number of preanlytical errors in samples obtained in primary care centers. An error is defined as a rejected specimen: any blood or urine sample, which cannot be successfully tested as it does not meet the acceptability criteria of the laboratory or if the sample is not received. We collected preanalytical errors from the tests requested for hematology, coagulation, chemistry, and urine samples. Registers were collected and indicators calculated automatically through a data warehouse and OLAP cubes software. RESULTS: Large differences in the results of preanalytical errors were observed between health departments. The highest percentage of errors occurred in coagulation samples, followed by urine, hematology and biochemistry. With regard to the type of error, the largest proportion of errors was due to failures of process. CONCLUSIONS: The high incidence of preanalytical errors and variability between health departments suggests that there is a need to standardize the drawing practice.

Estudio piloto regional en la Comunidad Valenciana. Indicadores financieros del laboratorio clínico / No disponible

El objetivo del trabajo es proponer un sistema de indicadores de gestión a partir de los datos normalizados del Sistema de Información conómico ( SIE) de la Agencia Valenciana de Salud que aplica a los laboratorios públicos de la Comunidad Valenciana. Como resultados se obtienen indicadores de costes, de complejidad, de rendimiento de personal y de rendimiento de material y se establece una comparación con los datos del SIE 2008 de los 9 laboratorios participantes. En conclusión, la obtención de los indicadores de gestión a partir del Sistema de Información Económico, no supone ningún trabajo adicional para el laboratorio; la información es homogénea y la comparación interlaboratorios proporciona una información de gran utilidad para la gestión de los laboratorios (AU)

No disponible

Estudio piloto regional de evaluación del tiempo de respuesta de laboratorio según el tipo de cliente / Regional pilot study to evaluate the laboratory turnaround time according to the client source

Objetivo. Presentar los resultados del tiempo de respuesta relacionado con el tipo de cliente en ocho laboratorios clínicos de la Comunidad Valenciana que atienden a ocho departamentos de salud (2.014.475 habitantes). Material y métodos. Se utilizaron registros internos (fecha/hora de registro y validación de la prueba) y registros diarios (tipo de paciente) del Sistema Informático del Laboratorio para construir los indicadores. Estos indicadores muestran el porcentaje de pruebas clave (hemograma y glucosa y tirotropina séricas) solicitadas que son validadas en el mismo día de la extracción de muestra (pacientes ingresados o de atención primaria) y/o antes de las 12.00 a.m. (pacientes ingresados). El tiempo de respuesta de pruebas urgentes se refirió a pruebas clave (troponina y potasio séricos) y se expresó en minutos. La recogida de registros y el cálculo de indicadores se realizó de forma automática mediante una aplicación informática basada en data warehouse y cubos OLAP. Resultados. Se observaron grandes diferencias en los porcentajes de validación antes de las 12.00 a.m. para pacientes ingresados y en el día de la extracción para pacientes de atención primaria. La variabilidad observada en los tiempos de respuesta de pruebas urgentes se relacionó con el tamaño del hospital, actividad y validación por el facultativo del laboratorio. Conclusiones. El estudio de benchmarking ha servido para mostrar la gran disparidad de tiempos de respuesta en ocho departamentos de salud de la Comunidad Valenciana. La atención en el laboratorio a distintos tipos de clientes crea la necesidad de la continua adaptación de los procesos para conseguir su satisfacción(AU)

Purpose. To show turnaround time to client source in eight laboratories covering eight Health Areas (2,014,475 inhabitants) of the Valencian Community (Spain). Material and methods. Internal Laboratory Information System (LIS) registers (test register and verification date and time), and daily LIS registers were used to design the indicators, These indicators showed the percentage of key tests requested (full blood count and serum glucose and thyrotropin) that were validated on the same day the blood was taken (inpatients and Primary Care and/or at 12 a.m. (inpatients). Urgent (stat) tests were also registered as key tests (serum troponin and potassium) and were recorded in minutes. Registers were collected and indicators calculated automatically through a Data Warehouse application and OLAP cube software. Results. Long turnaround time differences were observed at 12 a.m. in inpatients, and in the day of sample extraction in primary care patients. The variability in turnaround of stat tests is related to hospital size, activity and validation by the laboratory physician. Conclusions. The study results show the large turnaround time disparity in eight Health Care Areas of Valencian Community. The various requesting sources covered by the laboratories create the need for continuous mapping processes redesign and benchmarking studies to achieve customer satisfaction(AU)

[Regional pilot study to evaluate the laboratory turnaround time according to the client source]. / Estudio piloto regional de evaluación del tiempo de respuesta de laboratorio según el tipo de cliente.

PURPOSE: To show turnaround time to client source in eight laboratories covering eight Health Areas (2,014,475 inhabitants) of the Valencian Community (Spain). MATERIAL AND METHODS: Internal Laboratory Information System (LIS) registers (test register and verification date and time), and daily LIS registers were used to design the indicators, These indicators showed the percentage of key tests requested (full blood count and serum glucose and thyrotropin) that were validated on the same day the blood was taken (inpatients and Primary Care and/or at 12 a.m. (inpatients). Urgent (stat) tests were also registered as key tests (serum troponin and potassium) and were recorded in minutes. Registers were collected and indicators calculated automatically through a Data Warehouse application and OLAP cube software. RESULTS: Long turnaround time differences were observed at 12 a.m. in inpatients, and in the day of sample extraction in primary care patients. The variability in turnaround of stat tests is related to hospital size, activity and validation by the laboratory physician. CONCLUSIONS: The study results show the large turnaround time disparity in eight Health Care Areas of Valencian Community. The various requesting sources covered by the laboratories create the need for continuous mapping processes redesign and benchmarking studies to achieve customer satisfaction.

Aplicación de una técnica de lavado seminal en pacientes infectados por VHC y coinfectados con VIH / Application of a technique of seminal washing in patients infected by VHC and co-infected with HIV

Objetivo Estudiar el aclaramiento de la carga viral en muestras de semen en pacientes con VHC y coinfectados con VIH tras realizar dos lavados seguidos de swim-up. Diseño experimental Estudio longitudinal prospectivo Pacientes Once pacientes con serología VHC positiva, seis de ellos coinfectados por VIH. Métodos Las muestras de semen se recogieron por masturbación, extrayéndose el mismo día muestras sanguíneas a los pacientes para la determinación de carga viral plasmática (CVP), genotipaje VHC, poblaciones linfocitarias CD4/CD8, anticuerpos anti-VHC y serología VIH: En una alícuota inicial se hizo el seminograma y al resto del semen se le realizaron dos lavados con medio de cultivo, seguidos de un swim-up determinándose CV seminal en todas las fracciones plasmáticas y celulares en el Cobas Amplicor HIV monitor 1.5 y Cobas TaqMan HCV. Resultados Grupo VHC (edad 37,2 años; 60% genotipo 3; anticuerpos anti VHC: 35,3; CVP-VHC: 1xl06 copias ARN/ml. Grupo coinfección (edad 34,5 años; 80% genotipo 3; media anticuerpos anti-VHC: 34,8, CVP-VHC: 4xlOS copias ARN/ml. No se detectó CV seminal- VHC en ninguna de las muestras de semen detectándose CV seminal- VIH en el 85% de las muestras, siendo sus medias en las distintas fracciones seminales: Sedimento celular inicial: 1,8xl03 copias ARN+ADN/ml; Plasma seminal inicial: 8,9xl03 copias ARN/ml; Primer lavado: 4, 7xl 04 copias ARN/ml; Segundo lavado: 876 copias ARN/ml; Swim-up: Indetectable en todos los pacientes. Conclusiones El protocolo de dos lavados seguido de swim-up nos permite eliminar hasta límites indetectables la CV seminal en los pacientes a estudio. Los resultados del estudio deben ser completados con una casuística mayor

Objective To study the clearance of the viralload in samples of semen in patients with VHC and co-infected with HIV alter two washings followed by swim-up. Experimental design Prospective longitudinal study. Patients Eleven patients with positive serology VHC, six of them co-infected by HIV: Methods The samples of semen were laten by masturbation. The same day, blood samples were extracted from patients for the determination of plasmatic viral load (CVP), genotype VHC, linfocyte populations CD4/CD8, antibodies anti-VHC and HIV serology. In an initial sample a seminograme was carried out.To the rest of the semen samples the following was carried out: two washings to culture medium followed by a swim-up finding out the seminal CV in all the plasmatic and cellular fractions in the Cobas Amplicor HIV 1,5 monitor and Cobas TaqMan HCV: Results Group VHC (age 37,2 years; 60% genotype 3; antibodies anti VHC: 35.3,. CVP-VHC: lxl06 copiesRNA/mililiter: Group co-infection (age 34,5 years; 80% genotype 3; average antibodies anti VHC:34.8, CVP-VHC: 4xl05 copies RNA/mililiter: lt was not detected CV seminal- VHC in any of the samples of semen detecting itself CV seminal- VIH in 85% of the samples being its averages in the different seminal fractions: lnitial cellular sediment: 1.8xl03 copies RNA+DNAmililiter; lnitial seminal plasma: 8.9xl03 copies RNA/mililiter; First washing: 4.7xl04 copies RNA/mililiter; Second washing: 876 copies RNA/mililiter; Swim-up: Indetectable in all the patients. Conclusions The protocol of the two washings followed by a swim-up allows us to reduce below detectable levels the seminal CV in the population of the study. The result must be completed with a greater number of patients

New electrochemiluminescent immunoassay for the determination of CYFRA 21-1: analytical evaluation and clinical diagnostic performance in urine samples of patients with bladder cancer.

BACKGROUND: A new electrochemiluminescent immunoassay (ECLIA) has been developed for the determination of cytokeratin 19 (CYFRA 21-1) in the Elecsys 2010 immunoassay system. Urinary CYFRA 21-1 might have a role in the diagnosis of bladder cancer. METHODS: We performed an analytical evaluation of the CYFRA 21-1 ECLIA for serum and urine samples. The clinical value of urinary CYFRA 21-1 for the detection of bladder cancer was evaluated through its measurement in 226 urine samples from symptomatic and asymptomatic controls. RESULTS: At concentrations of 2-30 microg/L, within-assay imprecision (CV) was below 2.1% for sera and 3.3% for urines, with interassay CVs below 3.3% for sera and 4.9% for urines. The day-to-day CV was <20% at concentrations >0.2 microg/L (functional sensitivity). Measurement of diluted samples showed that the assay estimated CYFRA 21-1 between 98% and 103% for sera and 98% and 105% for urines. Recovery of added CYFRA 21-1 was 99-105% for sera and 96-115% for urines. We separately compared serum and urine CYFRA 21-1 ECLIA results with those obtained with an IRMA (CIS bio international). Regression analysis for sera was: CYFRA 21-1 (ECLIA) = 0.520 + 1.018 CYFRA 21-1 (IRMA); [95% confidence interval (CI) (y-intercept), -0.260 to 1.309]; 95% CI (slope), 0.978-1.060; n = 100; S(y|x) = 3.242; r(2) = 0.987. For urine samples it was: CYFRA 21-1 (ECLIA) = 0.716 + 0.966 CYFRA 21-1 (IRMA); 95% CI (y-intercept), 0.009-1.422; 95% CI (slope), 0.956-0.976; n = 100; S(y|x) = 4.136; r(2) = 0.986. In urine samples voided by patients with and without bladder cancer, the best ROC analysis discrimination provided 81.0% (95% CI, 72.7-87.7%) sensitivity and 97.2% (95% CI, 90.2-99.6%) specificity at a threshold value of 5.7 microg/L. CONCLUSIONS: Our initial evaluation showed reliable analytical performance for urinary CYFRA 21-1, which might assist urologists in the detection of bladder cancer as a noninvasive adjunct to cystoscopy.

Initial evaluation of the diagnostic performance of the new urinary bladder cancer antigen test as a tumor marker for transitional cell carcinoma of the bladder.

PURPOSE: We evaluated the diagnostic performance of the new noninvasive bladder cancer test on voided urine samples from patients with transitional cell carcinoma compared to symptomatic and asymptomatic controls. MATERIALS AND METHODS: Urinary bladder cancer antigen was measured in urine from 86 patients with active transitional cell carcinoma of the bladder (group 1), 76 patients free of transitional cell carcinoma as confirmed by cystoscopy at followup (group 2), 25 patients with other benign urological diseases (group 3), 25 patients with other malignant pathological conditions (group 4) and 30 healthy subjects free of urological diseases (group 5). RESULTS: Mean urinary bladder cancer antigen concentrations were 104.84, 4.57, 11.79, 48.87 and 1.38 microg/l, for groups 1 to 5, respectively, which was statistically different (p = 0.00005) except for groups 1 and 4 (p = 0.187). Sensitivity was 87.0% (95% confidence interval 79.2 to 92.7) and specificity was 86.8% (77.1 to 93.5%), and both were optimized by receiver operating characteristics plot analysis at a threshold value of 9.74 microg/l using asymptomatic (group 2) compared to known cancer (group 1) cases. CONCLUSIONS: Urinary bladder cancer antigen might have a role as a potential tumor marker for diagnosing transitional cell carcinoma of the bladder.