Evaluation of four quality indicators of the Pre-Analytical Phase External Quality Assessment Subprogram of the Fundación Bioquímica Argentina.

Pre-analytical phase external quality assessment programs contribute - through the interlaboratory comparison of quality indicators (QIs) - to the continuous improvement of the clinical laboratory total testing process. The purpose of the present work is to document the results derived from measuring four QIs within the framework of a pre-analytical phase external quality assessment subprogram in Argentina. The laboratories participating in this subprogram measured the following QIs: i) patients recalled for a new blood sample collection due to pre-analytical causes; ii) clotted samples from hemogram and coagulation tests; iii) clinical chemistry hemolyzed samples; and iv) requests with transcription errors entered into the laboratory information system. Results were expressed in percentage value and Sigma value. Databases were anonymized. A minimum acceptable quality level for the four QIs measured was recorded in the majority (75%) of the participating laboratories (Sigma > 3.0). It was nonetheless observed that the QIs of hemolyzed samples and requests with transcription errors entered into the laboratory information system deserve more attention. Through this pioneering experience in Argentina, the participating laboratories - some for the first time - could learn about their performance via interlaboratory comparison of results. This experience also proved to be motivating not only to improve the external assessment subprogram but also to continue working on the measurement of pre-analytical QIs for the continuous improvement of the clinical laboratory total testing process in Argentina.

Errores preanalíticos en la recolección de orina de 24 horas / Preanalytical errors in 24-hour urine collection

RESUMEN Introducción. La recolección de orina en el lapso de 24 horas es necesaria para la medición de constituyentes bioquímicos que presentan una excreción urinaria variable; sin embargo, dicho proceso no está exento de errores preanalíticos. Objetivos. Evaluar el nivel de cumplimiento de las instrucciones para recoger la muestra, identificar la recolección de orinas incompletas y conocer los procesos preanalíticos que aplica un grupo de profesionales. Métodos. Estudio de diseño observacional, en el que se realizó encuestas anónimas y voluntarias a 257 pacientes ambulatorios y 59 profesionales tecnólogos médicos, además de estimar la excreción urinaria de creatinina a 416 muestras. Resultados. El estudio evidenció recolecciones incorrectas (39,7%), uso de recipientes inadecuados (58,14%), mala conservación de las muestras (98,8%), cambio en los hábitos de ingesta de líquidos (23,7%), escasa información y retroalimentación a los pacientes sobre la preparación de la prueba, el 76,92% de muestras presentaron pérdidas o excesos en el volumen recolectado y una alta variabilidad de los criterios que utilizan los profesionales para rechazar las muestras mal colectadas. Conclusión. Se observó un bajo cumplimiento de los pacientes a las indicaciones para la recolección de la muestra, una alta proporción de recolecciones incompletas y discordancia en los procesos preanalíticos para el análisis de orina de 24 horas.

ABSTRACT Introduction. Urine collection within 24 hours is necessary for the measurement of biochemical constituents with variable urinary excretion, however, this process is not free of preanalytical errors. Objectives. To evaluate the level of compliance with the instructions for sample collection, identify the collection of incomplete urine and know the pre-analytic processes applied by a group of professionals. Methods. Observational design study, in which anonymous and voluntary surveys were conducted with 257 outpatients and 59 Medical Technologist professionals, in addition to estimating the urinary excretion of creatinine in 416 samples. Results. The study evidenced incorrect collections (39.7%), use of inappropriate containers (58.14%), poor preservation of samples (98.8%), change in fluid intake habits (23.7%), little information and feedback to patients on the preparation of the test, 76.92% of samples presented losses or excesses in the volume collected and a high variability of the criteria used by professionals to reject poorly collected samples. Conclusion. Low compliance of the patients to the indications for sample collection, a high proportion of incomplete collections, and discordance in the preanalytical processes for the 24-hour urinalysis were observed.

Monitoramento da qualidade da amostra para análise de RT-PCR da Covid-19 no LACEN-BA / Sample quality monitoring for Covid-19 RT-PCR analysis at LACEN-BA / Monitoreo de la calidad de la muestra para el análisis Covid-19 RT-PCR en LACEN-BA

A pandemia da Covid-19 tem se apresentado como um dos maiores desafios sanitários desse século. Em dezembro de 2019, na China, o agente etiológico foi identificado como um novo coronavírus, nomeado SARS-CoV-2. No Brasil, o primeiro caso confirmado da Covid-19 ocorreu em fevereiro de 2020 e, no mês seguinte, a Secretaria da Saúde do Estado da Bahia (Sesab) confirmou o primeiro caso na Bahia.O Laboratório Central de Saúde Pública Prof. Gonçalo Moniz (Lacen-BA) centralizou o diagnóstico laboratorial para confirmação dos casos suspeitos de Covid-19 dos 417 municípios baianos, utilizando a técnica de RT-PCR. Este estudo tem como objetivo identificar e analisar as não conformidades das amostras suspeitas de Covid-19 encaminhadas ao Lacen-BA. Trata-se de um estudo descritivo, cujos dados foram obtidos por meio de consulta aos relatórios de amostras e exames em desacordo, disponíveis no sistema Gerenciador de Ambiente Laboratorial (GAL), gerados mensalmente, no período de abril a outubro de 2020. Para garantir a qualidade das amostras recebidas, foram definidos critérios de aceitação/rejeição de amostras e criado o formulário de notificação de não conformidades, assegurando a rastreabilidade das amostras de Covid-19. Através de relatórios diários do sistema GAL, selecionou-se os nove principais motivos de não conformidades, sendo o mais frequente "requisição cancelada pela gerência do GAL devido à expiração do prazo de triagem", com 72,8% dos registros. A inserção da padronização de processos na etapa pré-analítica permite trabalhar com segurança, garantindo a qualidade da amostra a ser processada e, consequentemente, um resultado fidedigno, dentro do prazo acordado.

The Covid-19 pandemic is one of the greatest health challenges of this century. In December 2019, in China, the etiologic agent was identified as a new coronavirus, named SARS-CoV-2. In Brazil, the first case of Covid-19 was confirmed in February 2020 and, in the following month, the Department of Health of the State of Bahia (Sesab) confirms the first case in the state. The Central Public Health Laboratory Prof. Gonçalo Moniz (Lacen/BA) centralized the laboratory diagnosis to confirm the suspected cases of Covid-19 of the 417 municipalities of the state, using the RT-PCR technique. This study aims at identifying and analyzing the non-conformities of the suspected samples of Covid-19 sent to Lacen-BA. This is a descriptive study whose data were obtained by consulting there reports of samples and exams in disagreement, available in the Laboratory Environment Manager (GAL) system, generated monthly, from April to October,2020. To guarantee the quality of the samples received, acceptance / rejection criteria for the samples were defined and a form for the notification of non-conformities was created, ensuring the traceability of the Covid-19 samples. Daily reports from the Laboratory Environment Manager system based the selection of nine main reasons for non-conformities, among which "requisition canceled by the management of the GAL due to the expiration of the screening period" was present in 72.8% of the records. Process standardization, in the pre-analytical stage, allows working with security, guaranteeing the quality of the sample to be processed and a reliable result within the established period.

La pandemia del Covid-19 se ha presentado como uno de los desafíos de salud más grandes de este siglo. En diciembre de 2019, China identificó el agente etiológico del nuevo coronavirus llamado SARS-CoV-2. En Brasil, se notificó el primer caso del Covid-19 en febrero de 2020 y, al mes siguiente, la Secretaría de Salud del Estado de Bahía (Sesab) confirmaba el primer caso en Bahía. El Laboratorio Central de Salud Pública Prof. Gonçalo Moniz (Lacen/BA) centralizó el diagnóstico de laboratorio para confirmar los casos sospechosos del coronavirus de los 417 municipios de Bahía, mediante la técnica de RT-PCR. Este estudio tiene como objetivo identificar y analizar las no conformidades de las muestras sospechosas del Covid-19 enviadas al Lacen/BA. Este es un estudio descriptivo cuyos datos se obtuvieron consultando los informes de muestras y pruebas en desacuerdo disponibles en el sistema Laboratory Environment Manager (GAL), generados mensualmente, de abril a octubre/2020. Con el fin de garantizar la calidad de las muestras recibidas, se definieron criterios de aceptación/rechazo de las muestras y se elaboró un formulario para la notificación de no conformidades, asegurando la trazabilidad de las muestras. Por medio de informes diarios del sistema Laboratory Environment Manager, se seleccionaron nueve principales causas de no conformidades, de las cuales la más frecuente fue "requisición cancelada por la gerencia del GAL por vencimiento del período de cribado" con el 72,8% de los registros. La inserción de la estandarización de procesos en la etapa preanalítica permite trabajar con seguridad, garantizando la calidad de la muestra que procesar y, en consecuencia, un resultado confiable dentro del plazo acordado.

Brazilian laboratory indicators benchmarking program: three-year experience on pre-analytical quality indicators.

OBJECTIVES: In the laboratory medicine segment, benchmarking is the process in which institutions seek to compare with the macro environment (performance comparison and best practices with different laboratories) and improve their results based on quality indicators. The literature has highlighted the vulnerability of the pre-analytical phase in terms of risks and failures and the use of interlaboratory comparison as an opportunity to define a strategic performance benchmark aligned with the laboratory medicine sector, which has been a promising strategy to ensure continuous improvement, identifying within the pre-analytical process the critical activities to guarantee patient safety. In this context, this paper aims to present the three-year experience (2016-2018) of the Benchmarking Program and Laboratory Indicators - in Portuguese, Programa de Benchmarking e Indicadores Laboratoriais (PBIL) - with emphasis on pre-analytical indicators and their comparison against literature references and other programs of benchmarking in the area of laboratory medicine. PBIL is organized by the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML) in conjunction with Controllab and coordinated by a Brazilian group with representatives from different countries. METHODS: The data presented in this paper involving the performance results of 180 laboratories with active participation. Results are presented in percentage (%, boxplot graphical in quartiles) and Sigma metric, recognized as the metric that best indicates the magnitude of failures in a process. The Pareto Chart was used to facilitate ordering and to identify the main errors in the pre-analytical phase. The Radar Chart was made available in this work for the purpose of comparing the results obtained in Sigma by the PBIL and IFCC Working Group Laboratory Errors and Patient Safety (WG LEPS). RESULTS: In the study period, just over 80% of the pre-analytical failures are related to Blood culture contamination (hospital-based and non-hospital-based laboratories), Recollect and Non-registered exams, with failure rates of 2.70, 1.05 and 0.63%, respectively. The performance of the PBIL program participants was in line with the literature references, and allowed to identify benchmarks in the laboratory medicine market, target of PBIL, with best practices were observed for some indicators. CONCLUSIONS: The results of the program demonstrate the importance of an ongoing program comparative performance-monitoring program for setting more robust goals and consequently reducing laboratory process failures. Even with these promising premises and results, the contextualized analysis of the program indicators, point to a still significant number of failures in our market, with possibilities for improvement in order aiming to ensure more robust and effective processes.

Evaluation of urinalysis pre-analytical phase in a private laboratory of Maringá city, Paraná, Brazil / Avaliação da fase pré-analítica do exame de urina de rotina em laboratório privado da cidade de Maringá, Paraná, Brasil

ABSTRACT Introduction: Routine urinalysis is among the most requested exams in the clinical laboratory, assisting in the diagnosis of various diseases and treatment follow-up. In this case, the pre-analytical phase is extremely important because the quality of the sample directly influences the analysis and interpretation of the result. Objective: The aim of this study was to identify the main errors in the pre-analytical phase of routine urine examination in a private laboratory and their frequency of occurrence. Material and method: Data were collected from 2014 to 2018. In all, 107,277 urine samples were registered and 98 (0.09%) were sent for recollection. Results: Recollect requests were higher among females (81.6%), and the most affected age groups were 51 to 60 years old and 21 to 30 years old. The most common justification for recollection was insufficient material (48.0%), followed by confirmation of results in 24.5% of cases. The predominance of urine recollection in women was due to their having urine tests more often since they are more prone to urinary tract infections, especially in the sexually active and postmenopausal life stages. Conclusion: In general, the urine recollection rate obtained in the research was lower than the goal set by the laboratory; however, the main reasons that led to recollection request could be avoided or minimized if patients had been well educated on the correct collection procedures, indicating the need for constant training and training programs of the work team.

RESUMEN Introdución: El análisis de orina de rutina es una de las pruebas más solicitadas en el laboratorio clínico, pues ayuda en el diagnóstico de diversas enfermedades y en el seguimiento del tratamiento de los pacientes. En este caso, la fase preanalítica es fundamental, puesto que la calidad de la muestra influye directamente en el análisis y en la interpretación del resultado. Objetivo: El objetivo de este estudio fue identificar los principales errores en la fase preanalítica en la prueba de orina rutinaria de un laboratorio privado y su frecuencia de ocurrencia. Material y método: Se recopilaron datos entre 2014 y 2018. En total, se registraron 107.277 muestras de orina; 98 (0,09%) fueron enviadas para nueva extracción. Resultados: La solicitud de nueva extracción fue mayor entre las mujeres (81,6%); los grupos de edad más afectados fueron de 51 a 60 años y de 21 a 30 años. La justificación más común para la toma repetida fue cantidad insuficiente (48%), seguida de confirmación de resultado, en el 24,5% de los casos. El predominio de las muestras de orina en las mujeres ocurrió debido a la frecuencia de los análisis de orina en las mujeres, porque ellas son más propensas a las infecciones urinarias, especialmente en las etapas de la vida sexualmente activa y posmenopáusica. Conclusión: En general, la tasa de toma repetida de orina obtenida en la investigación fue menor que el objetivo estipulado por el laboratorio, pero las principales razones que llevaron a la solicitud de nueva extracción podrían evitarse o minimizarse si los pacientes hubieran sido bien instruidos sobre los procedimientos correctos de recolección, lo que indica la necesidad de programas de capacitación y entrenamiento constante para el equipo de trabajo.

RESUMO Introdução: O exame de urina de rotina está entre os exames mais solicitados no laboratório clínico, pois auxilia no diagnóstico de várias doenças e no acompanhamento do tratamento dos pacientes. Nesse caso, a fase pré-analítica é fundamental, uma vez que a qualidade da amostra influencia diretamente a análise e a interpretação do resultado. Objetivo: O objetivo deste estudo foi identificar os principais erros na fase pré-analítica no exame de urina de rotina de um laboratório privado e sua frequência de ocorrência. Material e método: Dados entre 2014 e 2018 foram coletados. Ao todo, 107.277 amostras de urinas foram cadastradas; 98 (0,09%) foram encaminhadas para recoleta. Resultados: A solicitação de recoletas foi maior no sexo feminino (81,6%); as faixas etárias mais acometidas foram de 51 a 60 anos e de 21 a 30 anos. A justificativa mais comum para recoleta foi material insuficiente (48%), seguida por confirmação de resultado, em 24,5% dos casos. O predomínio de recoletas de urina no sexo feminino ocorreu devido à frequência da realização dos exames de urina em mulheres, pois elas estão mais propensas a infecções urinárias, principalmente na fase de vida sexualmente ativa e na pós-menopausa. Conclusão: De forma geral, o índice de recoletas de urinas obtido na pesquisa foi menor que a meta estipulada pelo laboratório, mas os principais motivos que levaram à solicitação de recoleta poderiam ser evitados ou minimizados se os pacientes tivessem sido bem instruídos quanto aos corretos procedimentos de coleta, o que indica a necessidade de programas de capacitação e treinamento constantes da equipe de trabalho.

Stability of refrigerated whole blood samples for osmotic fragility test

ABSTRACT Background: The osmotic fragility test (OFT), conventionally used for assisting the diagnosis of many erythrocyte disorders, is a manual and time-consuming analysis not daily performed in many medical laboratories. This study was aimed at defining the stability of whole blood samples used for assessing erythrocyte osmotic resistance. Methods: Twenty-one consecutive routine whole blood samples collected into 5.4 mg K2EDTA were tested immediately after collection (day 0) and at different time intervals afterward (day 1, 2, 3, 4, 7, 10 and 14) after storage at 4 °C. The OFT was performed with the Osmored Monotest (1.3% glycerol; Eurospital, Trieste, Italy). Results at the different time points were compared with those obtained at day 0 and with the reference change value (i.e., 33%). Results: The median value of both hyperosmolar and hyposmolar resistance increased from baseline, reaching statistical significance at day 7 for hyperosmolar resistance and at day 1 for hyposmolar resistance, respectively. The median relative increase of hemolysis percentage values become greater than the reference change value at day 3 for hyposmolar resistance, while this limit was never overcome for hyperosmolar resistance. A significant inverse association was found between the mean increase in hyperosmolar resistance and the baseline value of hyperosmolar resistance (r = −0.92), mean corpuscular volume (MCV; r = −0.46) or mean corpuscular hemoglobin (MCH; r = −0.44), as well as between the mean increase in hyposmolar resistance and the baseline value of hyposmolar resistance (r = −0.86), or patient age (r = −0.56). Conclusions: The sample stability seems critical for the OFT. Whole blood specimens should not be stored refrigerated at 4 °C for >2 days before testing.

Stability of refrigerated whole blood samples for osmotic fragility test.

BACKGROUND: The osmotic fragility test (OFT), conventionally used for assisting the diagnosis of many erythrocyte disorders, is a manual and time-consuming analysis not daily performed in many medical laboratories. This study was aimed at defining the stability of whole blood samples used for assessing erythrocyte osmotic resistance. METHODS: Twenty-one consecutive routine whole blood samples collected into 5.4 mg K2EDTA were tested immediately after collection (day 0) and at different time intervals afterward (day 1, 2, 3, 4, 7, 10 and 14) after storage at 4 °C. The OFT was performed with the Osmored Monotest (1.3% glycerol; Eurospital, Trieste, Italy). Results at the different time points were compared with those obtained at day 0 and with the reference change value (i.e., 33%). RESULTS: The median value of both hyperosmolar and hyposmolar resistance increased from baseline, reaching statistical significance at day 7 for hyperosmolar resistance and at day 1 for hyposmolar resistance, respectively. The median relative increase of hemolysis percentage values become greater than the reference change value at day 3 for hyposmolar resistance, while this limit was never overcome for hyperosmolar resistance. A significant inverse association was found between the mean increase in hyperosmolar resistance and the baseline value of hyperosmolar resistance (r = -0.92), mean corpuscular volume (MCV; r = -0.46) or mean corpuscular hemoglobin (MCH; r = -0.44), as well as between the mean increase in hyposmolar resistance and the baseline value of hyposmolar resistance (r = -0.86), or patient age (r = -0.56). CONCLUSIONS: The sample stability seems critical for the OFT. Whole blood specimens should not be stored refrigerated at 4 °C for >2 days before testing.

Nonconformities in the pre-analytical phase identified in a public health laboratory / Não conformidades na fase pré-analítica identificadas em um laboratório de saúde pública

ABSTRACT Introduction: The nonconformities detected in the pre-analytical phase of laboratory tests sent to the Central Public Health Laboratories (Lacen) culminate in the loss of epidemiological data of great importance for public health and are detrimental to health surveillance. This study aimed to identify the most frequent pre-analytical nonconformities recorded by Lacen/PR and the major difficulties encountered by the primary and regional health units in the registration of exams in the Laboratory Environment Manager (GAL) system. Results: The analysis of data from the Paraná GAL system in 2017 identified 9,723 discards for disagreeing samples in a total of 132,567 tests performed in the same period. The most frequent nonconformities were: request canceled by the GAL management due to expiration of the screening period (28%), and sample unsuitable for the requested analysis (28%). Discussion: After identifying the vulnerabilities of this stage of the process, the greatest detected difficulty was requesting the correct test. Conclusion: Data indicate the need to strengthen training and improve the pre-analytical process in order to ensure patient safety and epidemiological data.

RESUMEN Introducción: Las no conformidades detectadas en la fase preanalítica de las pruebas enviadas a los laboratorios centrales (Lacen) del estado culminan en pérdida de datos epidemiológicos de gran importancia para la salud pública, además de perjudicar la vigilancia en salud. Objetivos: Este estudio intentó identificar las no conformidades preanalíticas más frecuentes registradas por el Lacen/PR y las mayores dificultades encontradas por unidades primarias y regionales de salud en el registro de pruebas en el sistema administrador del ambiente de laboratorio (GAL). Resultados: Del total de 132.765 pruebas realizadas en 2017, el análisis de datos del sistema GAL-Paraná identificó 9.723 descartes de muestras en desacuerdo. Las no conformidades más frecuentes fueron: solicitud rechazada por la gerencia de GAL pues la muestra está fuera de la fecha de caducidad (28%) y muestra inadecuada para el análisis solicitado (28%). Discusión: Al identificar los puntos débiles de esa etapa del proceso, la mayor dificultad detectada fue la solicitud de la prueba correcta. Conclusión: Los datos indican la necesidad de fortalecer las capacidades y la mejora del proceso preanalítico, para garantizar la seguridad del paciente y de los datos epidemiológicos.

RESUMO Introdução: As não conformidades detectadas na fase pré-analítica dos exames enviados aos laboratórios centrais (Lacen) do estado culminam em perda de dados epidemiológicos de grande importância para a saúde pública, além de prejudicar a vigilância em saúde. Objetivos: Este trabalho teve como objetivo identificar as não conformidades pré-analíticas mais frequentes registradas pelo Lacen/PR e as maiores dificuldades encontradas pelas unidades primárias e regionais de saúde no cadastro dos exames no sistema Gerenciador de Ambiente Laboratorial (GAL). Resultados: Do total de 132.567 exames realizados no ano de 2017, a análise dos dados do sistema GAL-Paraná identificou 9.723 descartes de amostras em desacordo. As não conformidades mais frequentes foram: requisição cancelada pela gerência do GAL devido à expiração do prazo de triagem (28%) e amostra imprópria para a análise solicitada (28%). Discussão: Ao identificar os pontos vulneráveis dessa etapa do processo, a maior dificuldade detectada foi solicitação do exame correto. Conclusão: Os dados indicam a necessidade de reforçar as capacitações e a melhoria do processo pré-analítico, a fim de garantir a segurança do paciente e dos dados epidemiológicos.

Estaciones automatizadas preanalíticas en el laboratorio de hemostasia. Estudio observacional descriptivo prospectivo, realizado en un hospital universitario de referencia entre el 15 de abril y 15 de julio de 2017 / Automated preanalytical units in the hemostasis laboratory: an observational descriptive prospective study developed in a university hospital between April 15 to July 15, 2017

RESUMEN Introducción: los errores del proceso de análisis de las muestras del laboratorio clínico, impactan negativamente a la práctica médica, la seguridad del paciente e incrementan los costos de atención en la salud. El uso de estaciones automatizadas demostró una disminución de los errores en los laboratorios clínicos de inmunoquímica y hematología. Se propone comparar las primeras estaciones automatizadas de hemostasia con el método manual para determinar los interferentes en las muestras de cinco servicios del hospital durante tres meses. Métodos: estudio observacional descriptivo prospectivo de corte trasversal. Las muestras que ingresaron al laboratorio clínico fueron analizadas por la estación automatizada y el método manual. Las interferentes bilirrubinas, hemoglobina, lipemia, volumen de llenado del tubo y obstrucción fluídica-coágulo se estudiaron con ambos métodos. Se realizó el análisis estadístico y se calculó el índice kappa para determinar la fuerza de la concordancia entre los métodos. Resultados: de 8.970 muestras analizadas, 29 % provinieron del servicio de urgencias. Las muestras aportadas por la unidad de cuidado intensivo reportaron más interferentes con ambos métodos; la estación automatizada reportó más interferentes que el método manual, con un índice kappa 0,52; la bilirrubina fue el interferente más detectado por ambos métodos. El método manual no evidenció el interferente volumen de llenado del tubo ni obstrucción fluídica-coágulo, los cuales fueron detectados por la estación automatizada. Conclusiones: la estación automatizada detectó más interferentes en comparación con el método manual. Los interferentes son errores preanalíticos en el laboratorio de hemostasia y son detectados con poca frecuencia de forma visual, especialmente los interferentes volúmenes de llenado del tubo y obstrucción fluídica-coágulo.

SUMMARY Introduction: Errors in the process of analyzing a clinical laboratory sample have a negative impact on medical practice, patient safety and health care cost. The use of automated units demonstrated the reduction of errors in the clinical laboratories of immunochemistry and hematology. The purpose of the study is to compare the first automated unit with a manual method and to determine the interferences informed in the samples provided by five services studied in the hospital for three months. Methods: A prospective descriptive study was developed. The automated unit and manual method analyzed all analytical requested samples received by the clinical laboratory. Interferences such as bilirubin, hemoglobin, lipemic, tube filling volume, and fluidclot obstruction were studied with both methods. The statistical analysis was performed and the kappa coefficient was calculated to determine the strength of agreement between both methods. Results: Of the 8.970 samples analyzed, 29 % came from the emergency service. The samples contributed by the intensive united care reported more interferences with both methods. The automated unit reported more interference than the manual method, with a kappa coefficient of 0,52. Bilirubin was the most commonly detected interference by both methods. The manual method did not show the interferences volume of tube filling or fluidic obstruction-clot, which have been detected by the automated unit. Conclusions: Automated unit detected more interference in comparison with the manual method. The interferences are preanalytical errors in the hemostasis laboratory and are less frequently detected by visual examination, especially interferences volume of tube filling or fluidic obstruction-clot.

Mejora de la calidad en el preanálisis de la Unidad Técnica de Patología Clínica / Improvement of quality processes in the preanalysis of the Clinical Pathology Technical Unit

INTRODUCCIÓN. El preanálisis es un proceso en el que se presenta el 71,0% de errores en el laboratorio clínico, por la presencia de factores como: la falta de automatización y la intervención de personal propio y ajeno al servicio, que lo convierte en vulnerable. OBJETIVO. Identificar, definir y estandarizar sub procesos preanalíticos en base a la norma ISO 15189:2012, identificar y realizar pilotaje de la aplicación de indicadores armonizados como elementos de mejora continua de la calidad. MATERIALES Y MÉTODOS. Estudio de tipo observacional, descriptivo en el que se identificó el proceso preanalítico actual y sus sub procesos; se los estandarizó previo a un pilotaje, definiendo los indicadores para su aplicación en la Unidad Técnica de Patología Clínica del Hospital de Especialidades Carlos Andrade Marín de la ciudad de Quito, Ecuador en el periodo junio a diciembre de 2018. RESULTADOS. Los subprocesos preanalíticos estandarizados fueron: Atención al Usuario, Identificación y generación de códigos, Toma de muestras, Transporte, preservación interna, separación y distribución de muestras; y, Referencia y contra referencia con sus procedimientos correspondientes y el tablero de indicadores. CONCLUSIÓN. Utilizar la norma de acreditación ISO15189:2012 para identificar y estandarizar sub procesos del proceso preanalítico, permitirá la mejora continua de la gestión de la calidad del laboratorio hospitalario de alta complejidad en su nivel de productividad.

INTRODUCTION. Pre-analysis is a process where 71,0% of errors made in the clinical laboratory, due to the existence of factors such as: lack of automation and in tervention of own personnel and other personnel non-related to the service, which render the process vulnerable. OBJECTIVE: To identify, define and standardize preanalytic sub processes, based on ISO 15189:2012 standard, identify and pilot the application of harmonized indicators as elements of continuous quality improvement. MATERIALS AND METHODS. Observational-descriptive study where the current preanalytical process and its sub processes were identified; they were standardized prior to piloting, defining the indicators in the Clinical Pathology Technical Unit of the Hospital de Especialidades Carlos Andrade Marín of the city Quito, Ecuador in the period from June to December 2018. RESULTS. The standardized pre-analytic processes were: Customer service, Identification and generation of codes, Sampling, Transportation Internal preservation, separation and distribution of samples; and, Reference and counter reference with their corresponding procedures and the indicator board. CONCLUSION. To use the accreditation standard ISO15189:2012 to identify and standardize pre-analytic sub-processes, will allow the continuous improvement of the quality management of the hospital laboratory of high complexity in its level or productivity.

Necesidad de armonizar la etapa preanalítica de la orina de 24 horas: evidencias de una encuesta / Need to harmonize the pre-analytical phase of 24-hour urine: evidence from a survey / Necessidade de harmonizar a fase pré-analítica da urina de 24 horas: evidência de uma pesquisa

El objetivo del trabajo consistió en evaluar el estado de armonización de la etapa preanalítica de la orina de 24 horas (orina-24h). Se realizó una encuesta anónima sobre la etapa preanalítica de la orina-24h a bioquímicos de Argentina. Respondieron 92 profesionales. Del análisis de las respuestas surge que el 95% de los bioquímicos facilita a los pacientes instrucciones escritas para la recolección; 11% incluye instrucciones con información visual gráfica además de escrita; 37% registra hora de inicio y finalización de la recolección; 59% recomienda que durante la misma la muestra se mantenga refrigerada; 73% suministra al paciente el recipiente para la recolección; 47% proporciona el envase con conservante, si corresponde; 100% solicita al paciente llevar al laboratorio la totalidad de la orina juntada; 4% solicita al paciente medir y anotar la diuresis y entregar al laboratorio una alícuota de la orina-24h; 78% realiza una o más acciones para evaluar la correcta recolección. Los criterios de rechazo seleccionados en orden decreciente fueron: pérdida de micciones, incumplimiento del tiempo de recolección, según la diuresis, según la eliminación diaria de creatinina y recipiente no apto. Esta encuesta evidenció que existen aspectos de la etapa preanalítica de la orina- 24h que requieren de mejora y armonización entre los laboratorios.

The objective of the present work was to evaluate the harmonization state of the pre-analytical phase of 24-hour urine. To this aim, an anonymous survey on the pre-analytical phase of 24-hour urine (Moreno-Carbonell, et. al) was carried out by biochemists from Argentina. A total of 92 professionals responded to the the survey. As a result, 95% provide patients with written instructions for collection; 11% include visual graphic instructions; 37% record starting and finishing time of collection; 59% recommend sample refrigeration during collection time; 73% supply the container; 47% provide the container with a preservative, if necessary; 100% ask the patient to take the complete 24-hour volume to the laboratory; 4% indicate to measure and record sample volume and to take an aliquot of it; and 78% perform one or more actions to evaluate the proper collection procedure. The rejection criteria selected in decreasing order were: loss of micturition, non-compliance with collection time, according to the volume and daily creatinine excretion, and improper container. To conclude with, this survey showed that there are aspects of the pre-analytical phase of 24-h urine that need improvement and harmonization between laboratories.

O objetivo do trabalho foi avaliar o estado de harmonização da fase pré-analítica da urina de 24 horas (urina-24h). Foi realizado um levantamento anônimo sobre a fase pré-analítica da urina-24h a bioquímicos da Argentina. Responderam 92 profissionais. Da análise das respostas surge que 95% fornecem aos pacientes instruções escritas para a coleta; 11% inclui instruções com informação visual gráfica além de escrita; 37% registra hora de início e finalização da coleta; 59% recomenda que durante a coleta a urina seja mantida refrigerada; 73% fornece o recipiente para a coleta; 47% fornece o recipiente com um conservante, se necessário; 100% solicita ao paciente que leve o volume completo de 24 horas ao laboratório; 4% indica ao paciente medir e registrar a diurese e entregar ao laboratório uma alíquota da urina-24h; 78% realiza uma ou mais ações para avaliar o procedimento apropriado de coleta. Os critérios de rejeição selecionados em ordem decrescente foram: perda das micções, descumprimento do tempo de coleta, de acordo com a diurese, conforme a eliminação diária de creatinina, e recipiente inadequado. Esta pesquisa mostrou que há aspectos da fase pré-analítica da urina de 24h que precisam ser melhorados e harmonizados entre os laboratórios.

Assessment of blood sample stability for complete blood count using the Sysmex XN-9000 and Mindray BC-6800 analyzers.

BACKGROUND: Different hematological analyzers have different analytical performances that are often reflected in the criteria for sample stability of the complete blood count. This study aimed to assess the stability of several hematological parameters using the XN-9000 Sysmex and BC-6800 Mindray analyzers. METHODS: The impact of storage at room temperature and 4°C was evaluated after 2, 4, 6, 8, 24, 36 and 48h using ten normal and 40 abnormal blood samples. The variation from the baseline measurement was evaluated by the Steel-Dwass-Critchlow-Fligner test and by Bland-Altman plots, using quality specifications and critical difference as the total allowable variation. RESULTS: Red blood cells and reticulocyte parameters (i.e. hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration, red blood cell distribution width, immature reticulocyte fractions, low-fluorescence reticulocytes, middle-fluorescence reticulocytes, high fluorescence mononuclear cells) showed less stability compared to leukocyte and platelet parameters (except for monocyte count and mean platelet volume). The bias for hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration and red blood cell distribution width coefficient of variation was higher than the critical difference after 8h using both analyzers. CONCLUSION: Blood samples measured with both analyzers do not show analytically significant changes in up to 2h of storage at room temperature and 4°C. However, the maximum time for analysis can be extended for up to 8h when the bias is compared to the critical difference.

Assessment of blood sample stability for complete blood count using the Sysmex XN-9000 and Mindray BC-6800 analyzers

Background: Different hematological analyzers have different analytical performances that are often reflected in the criteria for sample stability of the complete blood count. This study aimed to assess the stability of several hematological parameters using the XN-9000 Sysmex and BC-6800 Mindray analyzers. Methods: The impact of storage at room temperature and 4 ◦C was evaluated after 2, 4, 6, 8, 24, 36 and 48h using ten normal and 40 abnormal blood samples. The variation from the baseline measurement was evaluated by the Steel­Dwass­Critchlow­Fligner test and by Bland­Altman plots, using quality specifications and critical difference as the total allowable variation. Results: Red blood cells and reticulocyte parameters (i.e. hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration, red blood cell distribution width, immature reticulocyte fractions, low-fluorescence reticulocytes, middle-fluorescence reticulocytes, high fluorescence mononuclear cells) showed less stability compared to leukocyte and platelet parameters (except for monocyte count and mean platelet volume). The bias for hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration and red blood cell distribution width coefficient of variation was higher than the critical difference after 8h using both analyzers. Conclusion: Blood samples measured with both analyzers do not show analytically signifi- cant changes in up to 2h of storage at room temperature and 4 ◦C. However, the maximum time for analysis can be extended for up to 8h when the bias is compared to the critical difference

Antiphospholipid syndrome: a clinical and laboratorial challenge / Síndrome do anticorpo antifosfolípide: um desafio clínico e laboratorial

Antiphospholipid syndrome (APS) is an acquired autoimmune thrombophilia characterized by the presence of a heterogeneous family of antibodies that bind to plasma proteins with affinity for phospholipid surfaces. The two major protein targets of antiphospholipid antibodies are prothrombin and β2-glycoprotein I (β2GPI). APS leads to aprothrombotic state, and it is characterized by the occurrence of arterial, venous or microvascular thrombosis or recurrent fetal loss. The diagnosis of APS is based on a set of clinical criteria and the detection of lupus anticoagulant (LA), anticardiolipin antibodies (ACA) or anti-β2GPI in plasma. Although laboratory tests are essential for APS diagnosis, these tests have limitations associated with the robustness, reproducibility and standardization. The standardization of diagnostic tests for detection of APLAs has been a challenge and a variety of results have been obtained using different commercial kits and in-house techniques. An increased sensitivity of the ELISA kits for detection of ACA effectively has contributed to APS diagnosis. However, the lack of specificity associated with a high number of false-positive results is a clinical and laboratorial challenge, since such results may lead to mistaken clinical decisions, such as prescription of oral anticoagulant, leading to the risk of hemorrhaging. Furthermore, clinicians are often unfamiliar with these tests and have difficulty interpreting them, requiring interaction between clinical and laboratory professionals in order to ensure their correct interpretation.

A síndrome do anticorpo antifosfolípide (SAAF) é uma trombofilia autoimune adquirida, caracterizada pela presença de uma família heterogênea de anticorpos que se ligam a proteínas plasmáticas com afinidade, por superfícies fosfolipídicas. As duas principais proteínas-alvo dos anticorpos antifosfolípides (AAF) são a protrombina e a β2-glicoproteína 1 (β2GP1). A SAAF está associada a um estado protrombótico e é clinicamente caracterizada pela ocorrência de trombose arterial, venosa ou microvascular ou perda fetal recorrente. O diagnóstico da SAAF é baseado em um conjunto de critérios clínicos e na detecção plasmática de anticoagulante lúpico (AL), anticorpo anticardiolipina (ACA) ou antiβ2GP1. Embora os testes laboratoriais sejam de fundamental importância para o diagnóstico da SAAF, eles apresentam limitações associadas à robustez, à reprodutibilidade e à padronização. A padronização de testes diagnósticos para a pesquisa de AAF tem sido um desafio, pois uma variedade de resultados pode ser obtida utilizando diferentes kits comerciais e técnicas in-house. Um aumento da sensibilidade dos kits de ELISA para a detecção do ACA contribuiu efetivamente para o diagnóstico da SAAF. No entanto, a falta de especificidade, associada a um número elevado de resultados falso-positivos, é um desafio clínico e laboratorial, uma vez que tais resultados podem levar a decisões clínicas erradas, como a prescrição de anticoagulante oral, levando ao risco de hemorragia. Além disso, os clínicos muitas vezes não estão familiarizados com esses testes e têm dificuldade em interpretá-los, sendo necessária a interação da clínica e dos profissionais do laboratório para assegurar sua correta interpretação.

O laboratório clínico e os erros pré-analíticos / Clinical laboratory and pre-analytical errors

Os laboratórios de medicina diagnóstica auxiliam nas decisões médicas frente aos pacientes. Por essa razão os médicos e pacientes necessitam ter confiança e segurança nos laudos fornecidos pelos laboratórios clínicos. Porém, a fase do laboratório conhecida como pré-analítica, vem sendo apontada por diferentes estudos, como a grande responsável pelos erros laboratoriais. A principal razão para a alta frequência de erros nesta fase do processo está na dificuldade de controlar as variáveis pré-analíticas e em realizar melhoria nos processos, pois diversas variáveis encontram-se no preparo do paciente e no momento da coleta e identificação de amostras biológicas. Esta fase é mais suscetível a erros devido ser uma fase onde a maioria dos processos não é automatizada, envolvendo atividades manuais. Para alcançar as metas de redução dos erros e aumentar a segurança e confiabilidade dos processos pré-analíticos, se faz necessário implantar atividades que visem à educação continuada de todos os profissionais envolvidos nos processos de obtenção e manipulação de amostras biológicas.

Medical diagnostic laboratories can assist with medical decision making. For this reason, delivering reliable laboratory results is essential to providing physicians and patients with a sense of trust and safety. However, currently available evidence demonstrates that most laboratory errors are identified in the pre-analytical phase of the total testing process. The high frequency of errors at this stage is mainly attributable to the difficulty in monitoring all pre-analytical variables and in implementing improvement processes, particularly because several variables involve patient preparation and specimen collection and identification. This phase is more susceptible to errors because most pre-analytical steps involve manual rather than automated activities. To achieve the goal of error reduction and to increase the safety and reliability of pre-analytical processes, it is necessary to implement continuing education programs for all professionals involved in the process of collection and handling of biological samples.