Quantification of Pre-analytical Quality Indicators in a Clinical Laboratory and Formulating the Lean Six Sigma DMAIC Strategy

Introduction : Quality control of the laboratory has gained increased importance in the present years. 70 % of the errors in the clinical laboratory occur in the pre-analytical phase. With various guidelines to gauge the quality of the laboratory, Six Sigma Metrics remains by far the most difficult benchmark that a laboratory can achieve. We aimed to quantify the performance of the quality indicators of the routine clinical Biochemistry laboratory in the pre-analytical phase in the form of sigma metrics and devise measures and identify steps to decrease the percentage of errors by defining the DMAIC approach. Materials and Methods : One year retrospective data was collected from January, 2020 to December, 2020 from the data entry register and pre-analytical variables were quantified. Defects Per Million and sigma metric were calculated for each pre-analytical indicator. DMAIC approach was applied and post intervention sigma scores for the month of Jananuary, 2021, February, 2021 and March, 2021 were calculated. Results : Postinterventional analysis was done on a month-to-month basis to monitor the trend and also to ensure corrective action can be taken without delay. Out of 5 quality indicators which were quantified, the pre versus post sigma scores (March’21) are as follows: missing location of the patient (Sigma 4 versus 3.6), missing registration number (Sigma 3.7 versus 4.3) and both registration number and location missing (Sigma 3.6 versus 4.0), Homolysed sample (4.2 versus 4.6), insufficient sample volume (sigma 3.9 versus 4.7). Encouraging results in the form of improved Sigma scores were seen in four of the quality indicators except for the fact that the patient location were still missing in the forms and hence warrants continuous monitoring.

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.

Establishment and application of sentinel indicators of pre-analytical phase in blood screening laboratory / 中国输血杂志

【Objective】 To analyze the quality level of the laboratory pre-analytical phase, so as to take effective quality improvement interventions to further standardize the operation and provide basis for ensuring the quality of blood testing. 【Methods】 Pre-analytical phase quality indicators of blood screening laboratory in Shanghai Blood Center were established, and those had serious impact on blood safety were defined as the sentinel indicators. The pre-analytical quality level of our laboratory from 2018 to 2020 was statistically analyzed in terms of four parts including sample collection, preservation and submission, centrifugation and quality inspection, which contained 17 indicators. 【Results】 Eleven sentinel indicators were established, and the order of peak value from high to low in three years was as follows: " label omission" rated at 0.000 62% (2020), " label error" 0.000 57% (2018), " inappropriate storage of samples before detection" 0.007 39 (2018), " unqualified application form for sample detection" 0.007 39 (2018). The causes were analyzed and relevant measures were taken. Six monitoring indicators were established, and the order of peak value from high to low in three years was as follows: " insufficient sample" rated at 0.002 59% (year 2018), " hemolysis" 0.002 80% (year 2020), " pale color of blood supernatant (diluted)" 0.000 86 (2018), " automatic sampling interfered by blood clot" 0.027 02% (2018). 【Conclusion】 The quality indexes of pre-analytical phase in our laboratory have reached the level of domestic and international clinical laboratories. The establishment of pre-analytical quality indicators and sentinel indicators, with effective analysis and application, can fully record and monitor the quality of each link before laboratory testing, which is helpful to timely identify risks, detect deviations, and quickly implement corrective and preventive measures, thus further ensure the safety of clinical blood use.

Evaluation of Blood Sample Rejection in a Clinical Laboratory of an Oncology Institute

@#Introduction: Error in blood sampling is of one the commonest causes of laboratory sample rejection and poses a great challenge particularly amongst oncology patients due to difficult venous access. This study aims to identify the main causes of blood sample rejection in the haematology and chemical pathology (CP) laboratories of an oncology institute. Method: All blood samples received and rejected in the CP and haematology laboratory from 2017 to 2019 were obtained from the laboratory information system (LIS) and sample rejection logbook. The rejection cause for each of the rejected samples was recorded and analysed. Results: Out of the total 39 495 blood samples received, 244 (0.6%) were rejected. The rejection rate in the CP was higher compared with that in the haematology laboratory (51.2% vs. 48.8%). The most frequent cause of rejection was haemolysis (49.6%), clotted sample (32.8%), and insufficient sample volume (6.1%). Conclusion: Haemolysis, clotted blood and insufficient sample were the main causes of sample rejection in our oncology centre. Effective and multidisciplinary targeted interventions to reduce blood sampling error are important to improve pre-analytical handling of blood samples from oncology patients.

Evaluation of the influence of pre-analytical factors on total testosterone levels in healthy young men / Avaliação da influência de fatores pré-analíticos nas dosagens de testosterona total em homens jovens saudáveis

ABSTRACT Introduction: Testosterone is the main hormone that regulates male reproductive functions, directly participating in spermatogenesis and increasing sexual activity. The blood measurement of this hormone is essential for the diagnosis of neuroendocrine disorders, such as hypogonadism. However, there is lack of standardization regarding patient preparation for the hormone collection in clinical laboratories. Objective: Evaluate the effect of pre-analytical variables, including fasting, circadian and seasonal variation on testosterone levels in healthy young males. Material and methods: Forty-two volunteers were selected for the study, in the city of Barbacena, Minas Gerais. Four blood samples were collected from each of the participants, three in the winter: the first one in the morning after fasting; the second in the afternoon, without fasting; the third, in the next day morning, without fasting; and the last one taken in the summer, in the morning, after fasting. Results: The analyses showed that there was a significant decrease in total testosterone levels when there was no fasting for eight hours prior to collection and in the afternoon compared to the morning, both with p < 0.001. There was no significant difference in the results obtained in winter and summer. Conclusion: It is recommended that clinical laboratories standardize the collection of total testosterone by performing the test in the morning and after an eight-hour fast, in order to reduce variability and ensure reliability in the results.

RESUMEN Introducción: La testosterona es la principal hormona reguladora de funciones reproductoras masculinas, participando directamente en la espermatogénesis y en el aumento de la actividad sexual. La medición sanguínea de esa hormona es fundamental en el diagnóstico de trastornos neuroendocrinos, como el hipogonadismo. Sin embargo, hay poca estandarización en la preparación adecuada del paciente para la recolección de la hormona en laboratorios clínicos. Objetivo: Evaluar el efecto de variables preanalíticas, incluyendo ayuno, variación circadiana y estacional en las mediciones de testosterona en hombres jóvenes sanos. Material y métodos: Se eligieron 42 voluntarios para el estudio, en la ciudad de Barbacena, Minas Gerais. Se tomaron cuatro muestras de sangre de cada uno de los participantes, de las cuales tres en invierno: la primera, matutina, en ayunas; la segunda, vespertina, sin ayunas; la tercera, el dia siguiente, matutina, sin ayunas; el última se recolectó en verano, por la mañana, en ayunas. Resultados: Los análisis demostraron que hubo reducción significativa en los niveles de testosterona total cuando no se realizó el ayuno de ocho horas antes de la recolección y en el período vespertino en comparación al matutino, ambos con valor de p < 0,001. No hubo diferencia significativa en los resultados obtenidos en invierno y en verano. Conclusión: Se recomienda que los laboratórios clínicos estandarizen la recolección de testosterona total con la realización de la prueba en el período matutino y en ayuno de ocho horas, para reducir la variación y garantizar la confiabilidad de los resultados.

RESUMO Introdução: A testosterona é o principal hormônio regulador das funções reprodutivas masculinas, participando diretamente da espermatogênese e do aumento da atividade sexual. A dosagem sanguínea desse hormônio é fundamental no diagnóstico de distúrbios neuroendócrinos, como o hipogonadismo. Entretanto, há pouca padronização no preparo adequado do paciente para a coleta do hormônio em laboratórios clínicos. Objetivo: Avaliar o efeito de variáveis pré-analíticas, incluindo realização de jejum, variação circadiana e sazonal nas dosagens de testosterona em jovens saudáveis do sexo masculino. Material e métodos: Foram selecionados 42 voluntários para o estudo, na cidade de Barbacena, Minas Gerais. Quatro amostras de sangue de cada um dos participantes foram coletadas, sendo três no inverno: a primeira de manhã, em jejum; a segunda à tarde, sem jejum; a terceira no dia seguinte, de manhã, sem jejum. A última foi coletada no verão, na parte da manhã, em jejum. Resultados: As análises demonstraram que houve diminuição significativa dos níveis de testosterona total quando não foi realizado jejum de 8 horas antes da coleta e no período da tarde em comparação ao período da manhã, ambos com valor de p < 0,001. Não houve diferença significativa nos resultados obtidos no inverno e no verão. Conclusão: Recomendamos que os laboratórios clínicos padronizem a coleta de testosterona total com a realização do exame no período da manhã e em jejum de 8 horas, a fim de reduzir a variabilidade e garantir a confiabilidade nos resultados.

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.

El cumplimiento del procedimiento pre-analítico contribuye a la seguridad del paciente. Laboratorio clínico primer nivel de atención. Distrito 09d17-milagro-salud. 2018-2019 / Compliance with the pre-analytical procedure contributes to the safety of the patient. Clinical laboratory first level of care. District 09d17-Milagro-Salud. 2018-2019

El procedimiento pre-analítico en el laboratorio clínico es un conjunto de pasos que inician a partir de la orden de examen realizada por el médico, verificación de la identificación del paciente, criterios de aceptación y rechazo de la muestra, recolección de la muestra, identificación de la muestra, transporte seguro, en temperatura y tiempo apropiado. Luego ingresan para su preparación, y termina en el momento que se inicie con el análisis de las pruebas. Objetivos: Determinar el cumplimiento del procedimiento pre-analítico que contribuye a la seguridad del paciente en el laboratorio clínico. Método: El presente, es un estudio observacional, de tipo cuantitativo, de alcance descriptivo no experimental, de corte transversal. Resultados: de acuerdo a los resultados obtenidos de 112 muestras, con base a la ficha de observación, se logró evidenciar que ha habido muestras con calidad inadecuada como son las hemolizadas, coagulas y contaminadas. Y por estar en esas condiciones, son rechazadas por el laboratorio clínico, lo que conlleva a que se realice otra toma en el paciente, causando malestar, demora en la entrega de sus resultados e insatisfacción. También se evidencia que las muestras hemolizadas son mayores a las coaguladas y contaminadas. Conclusión: Este estudio ha ayudado a conocer que en los puestos de toma de muestra no se está implementando las normas de calidad para evitar errores que han estado causando malestar en los pacientes. Así como también, los puestos de toma de muestra no disponen de equipos para ayudar a conservar las muestras y trazabilidad de sus análisis(AU)

The pre-analytical procedure in the clinical laboratory is a set of steps that start from the order of examination carried out by the doctor, verification of the patient's identification, criteria for acceptance and rejection of the sample, collection of the sample, identification of the sample, safe transport, at appropriate temperature and time. Then they enter for their preparation, and it ends when the analysis of the tests begins. Objectives: To determine compliance with the pre-analytical procedure that contributes to patient safety in the clinical laboratory. Method: This is an observational, quantitative, descriptive, non-experimental, cross-sectional study. Results: according to the results obtained from 112 samples, based on the observation file, it was possible to show that there have been samples with inadequate quality such as hemolizada, coagulated and contaminated ones. In addition, because they are in these conditions, the clinical laboratory the clinical laboratory rejected them, which leads to another taking in the patient, causing discomfort, delay in the delivery of results and dissatisfaction. It is also evident that hemolizada samples are greater than those that are coagulated and contaminated. Conclusion: This study has helped to know that in the sampling stations not implemented quality standards to avoid errors that have been causing discomfort in patients. As well as, the sampling stations do not have equipment to help conserve the samples their traceability and analyzes(AU)

Comparación de dos tipos de recipientes para analizar gases en sangre y otras mediciones relacionadas contra jeringas con heparinato de litio liofilizado / Comparison of two types of containers to analyze blood gases and other related measurements against syringes with lyophilized lithium heparinate / Comparação de dois tipos de recipientes para analisar gases em sangue e outras medições relacionadas contra seringas com heparinato de lítio liofilizado

El estudio de gases en sangre involucra pruebas relacionadas con el equilibrio ácido-base y estado de oxigenación (pH, pO2, SO2, pCO2, HCO3 -). Además, en los equipos multiparamétricos se realizan otras determinaciones (mediciones relacionadas) como: Na+, K+, Cl-, Ca2+, glucosa y lactato. El objetivo de este trabajo fue comparar los resultados de medición de dos tipos de recipientes (tipo 2: jeringa preparada en el laboratorio con heparinato de Na+ líquido diluido y tipo 3: microtubo con heparinato de Li líquido) contra el recipiente recomendado por el CLSI en su guía 46-A2 (tipo 1: jeringa con heparinato de Li liofilizado balanceado con zinc). El análisis se hizo desde un punto de vista estadístico y clínico para establecer la posibilidad de usar indistintamente estos tres tipos de recipientes. Se analizaron un total de 254 muestras. Para evaluar la aceptación clínica de los resultados se tomó como estándar de calidad la variabilidad biológica. No se encontraron diferencias clínicamente significativas en los analitos del recipiente tipo 2 respecto del tipo 1, excepto para Ca2+. Se rechazaron desde el punto de vista clínico varios analitos del recipiente tipo 3. En conclusión, el uso del recipiente tipo 3 fue inapropiado. Sin embargo, el recipiente tipo 2 sería apto para el análisis de este tipo de muestras.

Blood gas analysis involves tests related to the acid-base balance and oxygenation state (pH, pO2, SO2, pCO2, HCO3 -). In multiparametric equipment, some ion and metabolite (related measurements) are performed: Na+, K+, Cl-, Ca²+, glucose and lactate. The objective of this study was to compare two types of containers (type 2: syringe prepared in the laboratory with diluted liquid sodium heparinate and type 3: microtube with liquid lithium heparinate) against the container recommended by CLSI in its guide 46-A2 (type 1: syringe with lyophilized lithium heparinate balanced with inc). The analysis was made from a statistical and clinical point of view to establish the possibility of indiscriminately using these three types of containers. A total of 254 samples were analyzed. To establish the clinical acceptance of the results, the biological variability quality standard was used. No clinically significant differences were found in the analytes of the type 2 container compared to type 1, except for Ca+. Several analytes of the type 3 container were rejected from the clinical point of view. In conclusion, the use of the type 3 container is inappropriate; however, the type 2 container would be suitable for the analysis of this type of samples.

O estudo de gases em sangue envolve testes relacionados com o equilíbrio ácido-base e estado de oxigenação (pH, pO2, SO2, pCO2, HCO3 -). Além disso, nos equipamentos multiparâmetros, outras determinações (medições relacionadas) como: Na+ , K+, Cl-, Ca2+, glicose e lactato são realizadas. O objetivo deste trabalho foi comparar os resultados de medição de dois tipos de recipientes (tipo 2: seringa preparada no laboratório com heparinato de Na+ líquido diluído e tipo 3: microtubo com heparinato de Li líquido) contra o recipiente recomendado pelo CLSI em seu guia 46-A2 (tipo 1: seringa com heparinato de Li liofilizado equilibrado com zinco). A análise foi feita do ponto de vista estatístico e clínico, para estabelecer a possibilidade de utilização indiscriminada desses três tipos de recipientes. Um total de 254 amostras foram analisadas. Para avaliar a aceitação clínica dos resultados, a variabilidade biológica foi tomada como padrão de qualidade. Não foram encontradas diferenças clinicamente significativas nos analitos do recipiente tipo 2 em relação ao tipo 1, exceto para Ca²+. Vários analitos do recipiente tipo 3 foram rejeitados do ponto de vista clínico. Em conclusão, o uso do contêiner tipo 3 foi inadequado. No entanto, o recipiente tipo 2 seria apto para a análise deste tipo de amostras.

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.

Effect of Time Interval between Collection, Plasma Separation and Analysis and the Effect of Temperature on the Laboratory Results of Plasma Glucose Estimation

Introduction:In a clinical laboratory, consistency of test results cannot be solely achieved by controlling the accuracy in the analytical phase of glucose estimation alone. Considering the high chances of pre-analytical errors, due consideration has to be given for storage criteria as well.Aims: Aim is to find out the quantitative alterations and the useful time interval between collection and analysis and the effect of temperature on the laboratory results of plasma glucose.Study Design:Cross sectional study.Place and Duration of Study:Study was conducted at Department of Biochemistry, Kasturba Medical College Hospitals, Mangaluru between 2015 and 2016.Methodology:In this study, 17 apparently healthyvolunteers aged 20-30 years wereenrolled with their consent.Plasma glucose levels were estimated by glucose oxidase-peroxidase kit method in semi-autoanalyzer at different temperatures and at different time intervals after collection and at room temperature but separating plasma at different time intervals and correlating it with the initial value.Results:The mean of plasma glucose when estimated immediately after separation of plasma was 78.16 ± 13.28 mg/dL. Only when glucose was estimated within 2hrs when stored at 2-8° Celsius after plasma separation (71.57 ±12.64), non-significant difference was noted(p value –0.696) otherwise as the temperature and time interval for estimation increases, the value of glucose decreases significantly. The effect of delayed separation of plasma showed that as the time of separation increases the value of glucose decreases significantly in the sample.Conclusion:Most mistakes occur before the samples are analysed, either during sampling or preparation for analysis. Thus, proper storage temperature and time must be considered for plasma glucose estimation, if measurement cannot be done immediately

An Analysis of Preanalytical Errors and Turnaround Time in Emergency Biochemistry Laboratory in a Tertiary Care Hospital in New Delhi

In modern diagnostics, it is extremely important to maintain and ensure quality of laboratory results dispatched. It is part of the total quality management and an essential criterion for accreditation of the laboratory. The analysis of biochemistry samples can be broadly divided into three phases: pre-analytical, analytical and post-analytical phase. We wanted to identify the commonly occurring pre-analytical errors and determine the turnaround time in the emergency biochemistry laboratory at a tertiary care hospital in Delhi.METHODSA cross-sectional study was done on a total of 2,73,111 samples received in the emergency biochemistry laboratory from September 2018 to August 2019 and an analysis of occurrence of pre-analytical errors was done, retrospectively. Additionally, the turnaround time of the laboratory was evaluated over a period of two months from July 2019 to August 2019 and average time was recorded. Data was collected from entry registers and rejected samples registers.RESULTSIn this study it was found that 10.58 % of the total samples received were rejected. Moreover, overall turnaround time was found to be 108 minutes (median value). In the present study, haemolysis was the most common reason for sample rejection. (63.14% of total rejections). Additionally, the second most common error was inadequate samples. 6570 samples were rejected due to this reason (22.73%).CONCLUSIONSHaemolysis was the most common cause of rejection in the emergency biochemistry laboratory. Also, it was seen that the most time-consuming step was analysis in auto-analyser with respect to contribution to turnaround time. As a matter of fact, Pre-analytical errors can adversely affect the treatment of patients. However, most of the errors can be reduced by proper training of the staff and checking competency thoroughly by conduction of practical and theory assessment of laboratory personnel at frequent intervals

A Study of Analysis of Critical Values at Emergency Biochemistry Laboratory in a Tertiary Care Hospital in India.

One of the important functions of a clinical biochemistry laboratory is clear, accurate, and rapid communication of a critical value to clinicians1. Critical value reporting is one of the requirements for laboratory accreditation. This study aimed to analyse the critical values data at a tertiary care hospital in New Delhi, India in the emergency laboratory setting and compare it with the available data from previous studies.METHODSThis is a retrospective study of emergency biochemistry samples done over a period of two months from July 2019 to September 2019. The critical values data of several biochemical parameters generated from the testing of samples on Beckman Coulter Olympus AU 480 during three months period were analysed. Statistical analysis was conducted using Microsoft Excel 2016 program.RESULTS183056 tests were analysed, and 11875 critical alerts were generated the incidence of which varied from 0.8% for glucose (children) to 10.6% for serum potassium in children. Frequency of critical values for serum potassium is highest followed by serum sodium. Also, critical values for serum potassium in paediatric patients is higher than in adults. It can be stated that there is a need to study of frequency of critical values in emergency as well as routine laboratories to identify the parameters with maximum critical values and also recognize the underlying causes for the same and take suitable measures.CONCLUSIONSThe frequency of critical value for serum potassium, is highest followed by serum sodium, in case of samples received from adult patients. Also, frequency of critical values for serum potassium in paediatric patients is even higher than adults. These values show that these critical biochemical values can be detrimental to these patients and timely notification to the clinician is very important so that necessary actions could be taken to correct them. Further studies of critical values in emergency labs is required to observe trends and identify the underlying causes and suggest suitable remedial measures if any.

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.

Pre-analytical variables evaluation in laboratory tests of patients attended at the Vitória da Conquista Central laboratory, Bahia, Brazil / Avaliação de variáveis pré-analíticas em exames laboratoriais de pacientes atendidos no Laboratório Central de Vitória da Conquista, Bahia, Brasil

ABSTRACT Introduction: Laboratory tests are intended to provide information necessary to clarify diagnoses or specific situations that cannot be elucidated by other means. Laboratory analyses are subject to several interferences. Even healthy individuals could suffer variations in laboratory tests due to biological factors, which may lead to misinterpretation of the results. Objective: Assess the pre-analytical variables in patients' laboratory tests at the Vitória da Conquista Central Laboratory, Bahia, Brazil. Material and method: This is a cross-sectional study with a descriptive approach and the use of a questionnaire as a research instrument. Data were collected through individual interviews, carried out at the laboratory. Results: The sample consisted of 425 patients, with female predominance (76.5%). Regarding patient instructions for laboratory tests, 94.6% had not been given any previous guidance, and 68.5% used some kind of medication, which could produce alterations in the exams. The use of the antihypertensive agents captopril, enalapril, hydrochlorothiazide or propranolol was associated with increased serum urea [odds ratio (OR) = 7.2, confidence interval (CI) = 95%, 1.87-27.58; p = 0.002], and smoking was associated with increased red blood cells count (OR = 3.7, CI = 95%, 0.86-15.75; p = 0.02). Conclusion: The findings indicate that pre-analytical variables remain an important focus for attention to the clinical laboratory. The correct data collection of patients' conditions is critical to support the post-analytical phase with useful information for the production of reliable exams and serve as a useful interpretation to diagnosis.

RESUMEN Introducción: Las pruebas de laboratorio tienen como objetivo proporcionar información necesaria a la aclaración de diagnósticos o situaciones específicas que no se pueden esclarecer por otros modos. Los análisis de laboratorio están sujetos a diversos interferentes. Incluso individuos sanos pueden presentar variaciones en las pruebas derivadas de factores que pueden crear equivocaciones en la interpretación de los resultados. Objetivo: Evaluar la influencia de variables preanalíticas en pruebas de laboratorio de pacientes atendidos en el Laboratório Central de Vitória da Conquista, Bahía, Brasil. Material y método: Estudio transversal con enfoque descriptivo y empleo de cuestionario como herramienta de investigación. Los datos fueron recogidos mediante entrevistas individuales, realizadas en el establecimiento investigado. Resultados: La muestra se compuso por 425 pacientes, con predominio de mujeres (76,5%). En cuanto a instrucciones para realización de las pruebas, el 94,6% de los pacientes no recibieron ningún tipo de orientación previa y el 68,5% utilizaban algún tipo de medicamento que puede producir alteraciones en pruebas. El uso de los antihipertensivos captopril, enalapril, hidroclorotiazida o propranolol estuvo asociado con el aumento de la urea sérica [oportunidad relativa (OR) = 7,2; intervalo de confianza (IC) = 95%, 1,87-27,58; p = 0,002]. El tabaquismo se ha asociado al aumento de eritrocitos (OR = 3,7; IC = 95%, 0,86-15,75; p = 0,02). Conclusión: Los hallazgos clínicos indican que variables preanalíticas son importante causa de atención para el laboratorio clínico. La correcta recogida de datos acerca de las condiciones de los pacientes es esencial para instrumentar la fase postanalítica con información relevante para la realización de pruebas fiables y que sean útiles para el proceso del diagnóstico.

RESUMO Introdução: Os exames laboratoriais têm como objetivo fornecer informações necessárias para o esclarecimento de diagnósticos ou situações específicas não passíveis de serem elucidadas por outros meios. As análises laboratoriais estão sujeitas a diversos interferentes. Mesmo indivíduos saudáveis podem apresentar variações nos exames decorrentes de fatores que podem gerar equívocos na interpretação dos resultados. Objetivos: Avaliar a influência de variáveis pré-analíticas em exames laboratoriais de pacientes atendidos no Laboratório Central do município de Vitória da Conquista, Bahia, Brasil. Material e método: Trata-se de um corte transversal com abordagem descritiva e utilização de questionário como instrumento de pesquisa. Os dados foram coletados por meio de entrevistas individuais, realizadas na instituição pesquisada. Resultados: A amostra foi composta por 425 pacientes, com predomínio de indivíduos do sexo feminino (76,5%). No que se refere a instruções para realização dos exames laboratoriais, 94,6% dos pacientes não receberam nenhum tipo de orientação prévia e 68,5% utilizavam algum tipo de medicamento que pode produzir alterações em exames. O uso dos anti-hipertensivos captopril, enalapril, hidroclorotiazida ou propranolol esteve associado ao aumento da ureia sérica [odds ratio (OR) = 7,2; intervalo de confiança (IC) = 95%, 1,87-27,58; p = 0,002]. O tabagismo associou-se ao aumento de eritrócitos (OR = 3,7; IC = 95%, 0,86-15,75; p = 0,02). Conclusão: Os achados indicam que variáveis pré-analíticas são importante fonte de atenção para o laboratório clínico. A correta coleta de dados acerca das condições dos pacientes é fundamental para instrumentar a fase pós-analítica com informações relevantes para a produção de exames fidedignos e que sejam úteis ao processo do diagnóstico.

Tomar mate previo a la flebotomía no interfiere en las pruebas bioquímicas de rutina / Drinking mate prior to phlebotomy does not interfere with routine biochemical tests

En este estudio se evaluó el efecto de tomar mate en las pruebas bioquímicas de rutina. Se extrajo sangre a 32 mujeres voluntarias luego de 12 horas de ayuno y a la hora (T1), dos horas (T2) y tres horas (T3) posteriores a la toma de 5 mates. Se estudiaron parámetros hematológicos y analitos de química clínica. Los resultados se analizaron empleando pruebas estadísticas para muestras relacionadas. Se calculó la diferencia porcentual media (DM%) de cada analito en cada hora respecto del valor basal y se comparó con el valor de referencia del cambio (VRC). Una DM% mayor que el VRC se consideró clínicamente significativa. En T1, T2 y T3 los recuentos de neutrófilos, eosinófilos y linfocitos fueron más bajos que en T0, también los niveles de glucosa, urea, creatinina y cistatina C fueron más bajos que en T0, mientras que los valores de proteínas totales, colesterol transportado por lipoproteínas de baja densidad y la actividad enzimática de lactato deshidrogenasa fueron más altos que en T0. En todos los casos los cambios fueron estadísticamente significativos, aunque no lo fueron desde el punto de vista clínico. Tomar 5 mates antes de la flebotomía no interfiere en los resultados de las pruebas bioquímicas de rutina.

In the present study the effect of drinking mate in routine biochemical tests was evaluated. Blood was collected from 32 female volunteers after a 12 h fasting period. In addition, 1 hour (T1), 2 hours (T2), and 3 hours (T3) after drinking 5 mates, blood was collected again. Hematological parameters and clinical chemistry analytes were studied. The results were analyzed using statistical tests for related samples. Mean difference % (MD%) was calculated for each analyte and was further compared with reference change value (RCV). The MDs% higher than RCV were considered clinically significant. At T1, T2, and T3 the count neutrophils, eosinophils and lymphocytes were lower than at T0. Also glucose, urea, creatinine, and cystatin C values were lower than at T0 whereas total proteins, LDL-C, and LD enzymatic activity values were higher than at T0. In all cases, variability was statistically significant but not clinically significant. Drinking 5 mates prior to phlebotomy does not interfere with the results of routine biochemical tests.

Neste trabalho, o efeito de beber chimarrão foi avaliado em testes bioquímicos de rotina. O sangue foi extraído de 32 mulheres voluntárias após 12 horas de jejum, e uma hora (T1), duas horas (T2) e três horas (T3) após a tomada de 5 chimarrões. Parâmetros hematológicos e analitos de química clínica foram estudados. Os resultados foram analisados utilizando testes estatísticos para amostras relacionadas. A diferença percentual média% (DM%) de cada analito em cada hora foi calculada em relação ao valor basal e comparada com o valor de referência da modificação (VRM). Uma DM% maior que o VRM foi considerada clinicamente significativa. Em T1, T2 e T3 as contagens de neutrófilos, eosinófilos e linfócitos foram mais baixas que em T0, Também os níveis de glicose, ureia, creatinina e cistatina C foram mais baixos que em T0, ao passo que os valores de proteínas totais, colesterol transportado por lipoproteínas de baixa densidade e a atividade enzimática de lactato desidrogenase foram mais altos que em T0. Em todos os casos as alterações foram estatisticamente significativas, embora do ponto de vista clínico não o tenham sido. Tomar 5 chimarrões antes da flebotomia não interfere nos resultados dos testes bioquímicos de rotina.

Avaliação da técnica de aperto de punho como interferente pré-analítico na dosagem do potássio / Evaluation of the wrist tightening technique as a pre-analytical interference in the potassium dosage

Objetivo: avaliar as alterações do potássio em relação a frequência de aperto de punho pelos participantes da pesquisa, buscando contribuir para um melhor entendimento sobre os aspectos quantitativos em relação ao uso da técnica de aperto de punho durante a flebotomia, para verificar com que frequência o aperto de punho poderá contribuir para a elevação do potássio. Método: Foram realizadas duas coletas sanguíneas de cada indivíduo. Em um primeiro momento, mantendo as mãos relaxadas durante flebotomia e, segundo, bombeando o punho durante o procedimento de flebotomia para avaliar as alterações do potássio em relação a frequência de aperto de punho. Resultados: De um modo geral, observa-se que houveram alterações em praticamente todas as dosagens e que indivíduos poderiam ter sido diagnosticados incorretamente com uma hipercalemia, podendo ser submetidos a tratamentos desnecessários. Conclusão: A técnica de aperto de punho durante a flebotomia deve ser evitada, pois uma significativa porcentagem dos casos apresentou uma elevação de potássio não condizente com o nível sérico de potássio normal do indivíduo.

Objective: To evaluate potassium alterations in relation to wrist grip frequency by the research participants, seeking to contribute to a better understanding of the quantitative aspects regarding the use of wrist grip technique during phlebotomy, to verify how often wrist may contribute to potassium elevation. Method: Two blood samples were collected from each individual. At first, keeping the hands relaxed during phlebotomy and secondly, pumping the fist clenching the phlebotomy procedure to evaluate potassium changes in relation to the frequency of wrist tightening. Results: In general, it was observed that there were changes in practically all dosages and that individuals could have been misdiagnosed with hyperkalemia and could be submitted to unnecessary treatments. Conclusion: The technique of wrist tightening during phlebotomy should be avoided, since a significant percentage of the cases presented a potassium elevation that does not correspond to the individual's normal serum potassium level.

Pre-analytical errors in clinical chemistry laboratory of a tertiary care hospital

Background: Pre-analytical errors account for up to 70% of all mistakes made in laboratory diagnostics, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage. Pre-analytical errors influence the total error thus hindering TQM in laboratory, consequently decreasing the accuracy and reliability of the results generated. This study was conducted with the aim to determine nature and frequency of the occurrence of pre-analytical errors.Methods: This prospective analytical study was designed to evaluate the pre-analytical errors observed in a total of 13,892 out-patient and inpatient samples. Samples received for routine clinical chemistry analysis were screened for pre-analytical errors. Samples received for other investigations were excluded. We recorded all nonconformities and errors occurring over a 3-month period and corrective measures were suggested to minimise them. Laboratory personnel were asked to register rejections, and pre-analytical causes for rejection of ward as well as out-patient samples collected in the laboratory. Types of inappropriateness were evaluated as follows: hemolyzed, blood collection in wrong tubes, clotted blood, inappropriate timing of collection, improperly labelled samples, insufficient volume of specimen and lipemic samples.Results: A total of 13,892 samples from the outpatient department and in-house patients were received by our clinical biochemistry laboratory during the period from April 2019 to June 2019. Out of these 404 samples were found unsuitable for further processing. This accounted for 2.9% of all samples collected in the laboratory and pre-analytical errors were responsible for these samples to be rejected over a period of 3 months. Rejections arose as a result of the following reasons: 0.92% were rejected due to hemolysis; 0.58% were blood collected in wrong tubes; 0.55% were clotted blood; 0.26% had inappropriate timing of collection; 0.24% were mislabeled samples; 0.20% had insufficient sample quantity and 0.14% were lipemic samples.Conclusions: Of all the samples received in the lab, the overall percentage of rejection is 2.9%. Substantial number of samples undergo repeated testing because of rejection owing to pre-analytical errors. The efforts should be aimed to reduce the rates of rejected samples can provide to improve the quality of laboratory based health care processes.

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.