La gestión de la calidad y la acreditación ISO 15189 en los laboratorios clínicos de Latinoamérica / Quality management and ISO 15189 accreditation in clinical laboratories in Latin America / Gestão da qualidade e acreditação ISO 15189 nos laboratórios clínicos da América Latina

Resumen El presente trabajo fue realizado por el Grupo de Trabajo Gestión de Acreditación de la Confederación Latinoamericana de Bioquímica Clínica (COLABIOCLI) con el objetivo de conocer el estado de los Laboratorios Clínicos (LC) con respecto a la gestión de la calidad y el estatus de la acreditación ISO 15189 en Latinoamérica. La investigación fue de tipo observacional, transversal y descriptiva; se utilizó como herramienta la encuesta y como instrumento el cuestionario. Los resultados se expresaron en frecuencias simples y porcentajes y se analizaron por estadística descriptiva. En las 253 encuestas aceptadas participaron LC de 15 de 16 países integrantes de COLABIOCLI. El 80% de los LC tenían procedimientos de la fase preanalítica y posanalítica. Más del 85% contaba con registros de gestión de la calidad y participaban en programas de evaluación externa de la calidad (PEEC), principalmente en las disciplinas de química clínica (mayor del 80%) y hematología (mayor del 70%). El 7,51% estaban acreditados por ISO 15189 y 10,27% certificados por ISO 9001. La gestión de la calidad y los PEEC presentan un importante avance en los LC de Latinoamérica; sin embargo, es deseable que todas las partes interesadas armonicen intereses, para que este proceso sea introducido paulatinamente y como parte de las normativas y/o regulaciones obligatorias respectivas, lo que podrá contribuir a que más LC se acrediten en base a ISO 15189 en la región.

Abstract The present work was carried out by the Accreditation Management Working Group of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) with the aim of knowing the status of Clinical Laboratories (LC, for its acronym in Spanish) with respect to quality management and the status of the ISO 15189 accreditation in Latin America. The research was observational, cross-sectional, and descriptive, using the survey as a tool and the questionnaire as an instrument. The results were expressed in simple frequencies and percentages and analysed by descriptive statistics. LCs from 15 of the 16 member countries of COLABIOCLI participated in the 253 surveys accepted. Eighty percent of LCs had pre-analytical and post-analytic procedures, and more than 85% had quality management records and participated in external quality assessment services (EQAS), mainly in the disciplines of clinical chemistry (greater than 80%) and hematology (greater than 70%); 7.51% were ISO 15189 accredited and 10.27% ISO 9001 certified. Although quality management and EQAS represent an important advance in LCs in Latin America, it is desirable that all stakeholders harmonise interests, so that this process is introduced gradually and as part of the respective mandatory standards and/or regulations, thus contributing to more LCs being accredited based on ISO 15189 in the region.

Resumo O presente trabalho foi realizado pelo Grupo de Trabalho de Gestão de Acreditação da Confederação Latino-Americana de Bioquímica Clínica (COLABIOCLI) com o objetivo de conhecer o status dos Laboratórios Clínicos (LC) com relação à gestão da qualidade e o status da acreditação ISO 15189 na América Latina. A pesquisa foi observacional, transversal e descritiva, utilizando a enquete como ferramenta e o questionário como instrumento. Os resultados foram expressos em frequências simples e porcentagens e analisados por estatística descritiva. LCs de 15 dos 16 países membros do COLABIOCLI participaram das 253 pesquisas aceitas; 80% dos LCs tinham procedimentos da fase pré-analítica e pós-analítica, e mais de 85% tinham registros de gestão da qualidade e participavam de programas de avaliação externa da qualidade (PEEC), principalmente nas disciplinas de química clínica (maior de 80%) e hematologia (maior de 70%); 7,51% estavam acreditados pela ISO 15189 e 10,27% certificados pela ISO 9001. Embora a gestão da qualidade e os PEECs apresentem um importante avanço nos LCs da América Latina, é desejável que todas as partes interessadas harmonizem interesses, para que esse processo seja introduzido gradualmente e como parte das respectivas normas e/ou regulações obrigatórias, o que poderá contribuir para que mais LCs sejam acreditados com base na ISO 15189 na região.

Experiencia de un programa de estandarización de creatinina en una región de ingresos bajos de Latinoamérica / Experience of a creatinine standardisation programme in a low-income region of Latin America / Experiência de um programa de padronização de creatinina em uma região de baixa renda da América Latina

Resumen Los programas de estandarización de creatinina mantienen su vigencia. El objetivo es describir la experiencia adquirida durante el desarrollo de un programa de estandarización de creatinina en una provincia de bajos recursos y mostrar los aspectos que se deben considerar para su escalabilidad en un contexto semejante. El programa se desarrolló en etapas: en la primera (2010) se realizó el relevamiento de 49 laboratorios clínicos (LC) distribuidos en toda la provincia del Chaco, Argentina. En la segunda (2012) se ajustó el error aleatorio (EA) aplicando protocolos internacionales (CLSI EP-5A). En la tercera etapa (2014-2015) se procesaron paneles de sueros con concentraciones asignadas por un método trazable al de referencia y al estándar internacional (CG-IDMS). Se aplicaron protocolos internacionales para evaluar el error total (ET) de la determinación en cada laboratorio (CLSI EP-10A). En 2016, aplicando herramientas de calidad, se evaluaron las barreras en el proceso. Se observó en el EA: para un nivel de 1,00 mg/dL, ningún LC alcanzó los niveles deseables; para un nivel de 2,5 mg/dL solo 9 (23%) los alcanzaron. Concluida la segunda y tercera etapa, solo 18 laboratorios (48,7%) lograron ajustar el EA y/o ET, pero resultó dificultoso sostenerlo en el tiempo. Los reactivos, calibradores y controles son producidos por la industria y depende del estado el control de los mismos. La homogeneidad del equipamiento depende de la accesibilidad económica y del volumen de trabajo. El medio ambiente, la temperatura y la calidad del agua siguen siendo una dificultad para la escalabilidad.

Abstract Creatinine standardisation programmes remain valid. The objective of this work is to describe the experience acquired during the development of a creatinine standardisation programme in a low-resource province and show the aspects that should be considered for its scalability in a similar context. The programme was developed in stages. The first one was carried out in 2010. It consists of a structured survey completed by 49 clinical laboratories (CL) distributed throughout the province. In the second stage (2012) the random error (RE) was adjusted by applying international protocols (CLSI EP-5A). In the third stage (2014-2015), panels of sera were processed with concentrations assigned by a method traceable to the reference and the international standard (CG-IDMS). International protocols were applied to evaluate the total error (TE) of the determination in each laboratory (CLSI EP-10A). In 2016, applying quality tools, the barriers in the process were evaluated. In the RE, it was observed: for a level of 1.00 mg/dL, no CL reached the desirable levels; for a level of 2.5 mg/dL only 9 (23%) CL achieved them. Once the second and third stages were completed, only 18 laboratories (48.7%) managed to adjust the RE and/or TE, but it was difficult to sustain it over time. With respect to materials, reagents, calibrators, and controls, they are produced by the industry depending on the state of their control. The homogeneity of the equipment depends on economic accessibility and volume of work. The environment, temperature, and water quality are a barrier to scalability.

Resumo Os programas de padronização da creatinina permanecem válidos. O objetivo é descrever a experiência adquirida durante o desenvolvimento de um programa de padronização de creatinina em uma província com poucos recursos e mostrar os aspectos que devem ser levados em consideração para sua escalabilidade em um contexto semelhante. O programa foi desenvolvido em etapas: Na primeira (2010), foi realizado um levantamento de 49 laboratórios clínicos (LC) distribuídos em toda a provincia do Chaco, na Argentina. Na segunda etapa (2012) o erro aleatório (EA) foi ajustado através da aplicação de protocolos internacionais (CLSI EP-5A). Na terceira etapa (2014-2015), foram processados paineis de soros com concentrações atribuídas por método rastreável à referência e ao padrão internacional (CG-IDMS). Protocolos internacionais foram aplicados para avaliar o erro total (ET) da determinação em cada laboratório (CLSI EP-10A). Em 2016, aplicando ferramentas de qualidade, foram avaliadas as barreiras no processo. Observou-se na EA: para o nível de 1,00 mg/dL nenhuma LC atingiu os níveis desejáveis; para um nível de 2,5 mg/dL, apenas 9 (23%) os atingiram. Concluídas a segunda e terceira etapas, apenas 18 laboratórios (48,7%) conseguiram ajustar o EA e/ou o ET, mas foi difícil sustentá-lo ao longo do tempo. No que diz respeito aos reagentes, calibradores e controles, eles são produzidos pela indústria. dependendo do estado o seu controle. A homogeneidade do equipamento depende da acessibilidade econômica e do volume de trabalho. O meio ambiente, a temperatura e a qualidade da água continuam sendo uma dificuldade para a escalabilidade.

Importancia del laboratorio en los ensayos clínicos

Los resultados de los exámenes que se realizan en el laboratorio clínico deben constituir una parte esencial en la evaluación de los sujetos incluidos en los ensayos clínicos para la introducción de nuevos medicamentos. En este artículo se describen los aspectos más importantes del trabajo en el laboratorio durante el desarrollo de un ensayo donde se emplean nuevas tecnologías. Los ensayos clínicos no solo mejoran los indicadores de salud de la población, sino que, además, exigen los mejores estándares de diagnóstico y evaluación del tratamiento, a través de nuevas tecnologías, donde se incluye el laboratorio clínico.

The results of the exams that are carried out in the clinical laboratory should constitute an essential part in the evaluation of people included in clinical trials for the introduction of new medications. In this article the most important aspects of work in the laboratory are described, during the development of a trial where new technologies are used. Clinical trials not only improve health indicators of the population, but also, demand the best diagnosis standards and evaluation of the treatment, through new technologies, where clinical laboratory is included.

Un acercamiento al devenir histórico de la especialidad de Laboratorio Clínico en Villa Clara / An approach to the historical development of the Clinical Lab specialty in Villa Clara

Introducción: el conocimiento de la historia es necesario para dejar constancia del origen y desarrollo de las diferentes especialidades en Villa Clara. Objetivo: exponer una síntesis de elementos históricos sobre la especialidad de Laboratorio Clínico en Villa Clara, posterior al triunfo de la Revolución cubana y la evolución de dicha especialidad. Métodos: se realizó una revisión bibliográfica con análisis crítico-reflexivo sobre el contenido de los documentos. Fueron revisados los archivos de la especialidad, libros y materiales afines al tema tratado, se realizaron entrevistas al personal de laboratorio clínico para indagar sobre años anteriores y hasta la actualidad; se incluyeron las tesis de doctorado, maestrías, artículos originales y de revisión publicados entre 2005 y 2019 en español e inglés. La búsqueda fue realizada en las bases de datos SciELO y Google académico entre enero y marzo de 2020. Desarrollo: se expuso el devenir histórico de la referida especialidad en Villa Clara y los profesionales que participaron, se mostraron aspectos sobre la formación de los recursos humanos, la evolución de la especialidad y los nuevos retos. Conclusiones: se socializaron algunos elementos históricos sobre la especialidad de Laboratorio Clínico en Villa Clara, en la etapa posterior al triunfo de la Revolución cubana como reconocimiento a todos aquellos que contribuyeron al inicio y desarrollo de dicha especialidad que hoy cumple con los estándares de calidad exigidos.

Introduction: knowledge of history is necessary to record the origin and development of the different specialties in Villa Clara. Objective: present a synthesis of historical elements about the specialty of Clinical Laboratory in Villa Clara, after the triumph of the Cuban Revolution and the evolution of said specialty. Methods: a bibliographic review was carried out with reflective critical analysis of the content of the bibliographies. The files of the specialty, books and materials related to the topic discussed were reviewed, interviews were conducted with clinical laboratory personnel to inquire about previous years and up to the present; Doctoral theses, master's degrees, original and review articles published from 2005 to 2019 in Spanish and English were included. The search was carried out in the SciELO and Google academic databases from January to March 2020. Development: the historical development of the specialty in Villa Clara and the professionals who participated were explained, aspects of the training of human resources, the evolution of the specialty and the new challenges were shown. Conclusions: some historical elements were socialized about the specialty of Clinical Laboratory in Villa Clara, in the stage after the triumph of the Cuban Revolution in recognition of all those who contributed to the beginning and development of said specialty that today meets the required quality standards.

Sentinel laboratory compliance with best practices in Burkina Faso's antimicrobial resistance surveillance network

Background: Standardising procedures is the best way to harmonise and strengthen the quality of laboratory-based antimicrobial resistance surveillance. Since 2018, Burkina Faso has developed and disseminated the national manual of procedures for performing antibiotic susceptibility tests in sentinel laboratories within its national antimicrobial resistance surveillance network. Objective: Our study aimed to assess these sentinel laboratories' compliance with good practices for antibiotics susceptibility tests. Methods: Four teams evaluated the antimicrobial resistance sentinel sites laboratories throughout Burkina Faso from 19 to 28 September 2022. Eighteen out of 19 sentinel laboratories were evaluated. A four-member technical committee designed and validated the evaluation tool composed of three Microsoft Excel sheets. The evaluation emphasised quality controls for culture media, antibiotic discs and compliance with antimicrobial susceptibility testing procedures by the laboratories. Excel software was used for data recording and graphs and table design. The free R software version 4.2.0 was used for descriptive statistics. An overall score below 80% was considered noncompliance. Results: Most (83.33%) of the sentinel laboratories conducted at least one quality control activity for culture media, and 66.67% conducted at least one quality control activity for antibiotic discs. Over three-quarters (76.47%) of the laboratories were more than 80% compliant with the modified Kirby Bauer antimicrobial susceptibility testing method. Conclusion: The evaluation revealed the noncompliance of sentinel laboratories with the national procedure manual, particularly in the quality control component. What this study adds: This study has provided baseline data on the sentinel laboratories' compliance with the national antimicrobial susceptibility testing procedures manual, particularly in areas performing quality control checks or meeting quality indicators for culture media and antibiotic discs.

Fundamentos teóricos para un sistema de gestión de la calidad en el Laboratorio Provincial de Biología Molecular

El establecimiento de un sistema de gestión de la calidad es obligatorio para algunas instituciones de salud, entre las que se encuentra el Laboratorio de Biología Molecular, esto queda explícito en la Regulación D 03-21, que plantea la obligatoriedad de su cumplimiento para los laboratorios clínicos que se basan en técnicas de biología molecular. El objetivo del presente texto es exponer los presupuestos teóricos que sustentan un estudio sobre la gestión de la calidad en el mencionado laboratorio. Se realiza una revisión documental a partir de artículos publicados en el período comprendido de 2012-2022. Del total de las fuentes consultadas en las plataformas de acceso a bases de datos de la red de información de la salud cubana Infomed: PubMed, Scopus, SciELo, Redalyc, y Dialnet, se seleccionaron 33 para la revisión al considerar que abordaban el tema con mayor profundidad. La adopción de un sistema de gestión de la calidad garantiza y gestiona el alto nivel de los servicios, aumenta la satisfacción del cliente y el prestigio de la organización.

The establishment of a quality management system is mandatory for some health institutions, among which is the Molecular Biology Laboratory. This is explicit in Regulation D 03-21, which makes compliance mandatory for laboratories. clinical trials that are based on molecular biology techniques. The objective of this text is to present the theoretical assumptions that support a study on quality management in the aforementioned laboratory. A documentary review is carried out based on articles published in the period from 2012-2022. Of the total sources consulted on the database access platforms of the cuban health information network Infomed: PubMed, Scopus, SciELo, Redalyc, and Dialnet, 33 were selected for the review considering that they addressed the topic with greater depth. The adoption of a quality management system guarantees and manages the high level of services, increases customer satisfaction and the prestige of the organization.

Procedimiento para desarrollar la función calidad en laboratorios clínicos docentes en la Universidad Médica de Camagüey / Procedure to Develop the Quality Function in Teaching Clinical Laboratories at The Medical University of Camagüey

Introducción: Garantizar la obtención de resultados analíticos de calidad en el trabajo de los laboratorios clínicos resulta de vital importancia, de ahí se infiere la necesidad de formar profesionales competentes que dominen y pongan en práctica la normativa nacional e internacional vigente relacionada con la calidad, el papel de la función calidad es hacer que ésta sea un aspecto inseparable del desempeño y la responsabilidad de cada empleado. Objetivo: Establecer el procedimiento para el desarrollo de la gestión de la función calidad en los laboratorios clínicos docentes. Métodos: Se realizó una investigación en sistemas y servicios de salud, en la cual se aplicaron técnicas y herramientas propias de la ciencia aplicada de la calidad. Resultados: Diseño de un procedimiento, con su representación en forma de diagrama de flujo con la explicación de los pasos incluidos en él, posteriormente se describe el procedimiento para garantizar su adecuación y aplicabilidad en cualquier institución que así lo considere pertinente. Conclusiones: El procedimiento diseñado para el desarrollo de la función calidad establece la secuencia lógica de pasos a seguir para lograr su implementación(AU)

Introduction: Guaranteeing procurement of quality analytical results in the work of clinical laboratories is of vital importance, hence the need to train competent professionals who master and put into practice the current national and international regulations related to quality. The role of the quality function is to make this an inseparable aspect of the performance and responsibility of each employee. Objective: To establish the procedure for the development of quality function management in teaching clinical laboratories. Methods: Research was carried out on health systems and services, in which techniques and tools from applied quality science were applied. Results: Design of a procedure was achieved with representation in the form of a flow chart with the explanation of the steps included in it. Then the procedure is described to guarantee adequacy and applicability in any institution that considers it relevant. Conclusions: The procedure designed for the development of the quality function establishes the logical sequence of steps to follow to achieve its implementation(AU)

Sistema de procedimientos para la formación interdisciplinar de la habilidad diagnosticar en residentes de dermatología / A System of Procedures for the Interdisciplinary Training of the Dill To Diagnose in Dermatology Residents

Introducción: En las prácticas de laboratorio se adquiere la habilidad que permite corroborar el diagnóstico de las enfermedades de la piel y anejos después de un diagnóstico presuntivo, con la utilización del método clínico. Esto se respalda en las exigencias establecidas en los documentos normativos de ese proceso formativo. Objetivo: Proponer un sistema de procedimientos para la formación interdisciplinar de la habilidad "diagnosticar enfermedades dermatológicas en los residentes de dermatología, a partir de insuficiencias detectadas en el programa de la especialidad. Métodos: La investigación fue cualitativa, con un estudio descriptivo en el Hospital Provincial General Docente Dr. Antonio Luaces Iraola, de Ciego de Ávila, desde 2018 hasta 2022. Se trabajó con toda la población conformada por 16 residentes de primer año en dermatología. Se utilizaron métodos de nivel teórico, empírico y estadístico. Resultados: En el sistema de procedimientos propuesto, se concretan fortalezas y debilidades, objetivo general, orientaciones metodológicas, precisión de los objetivos específicos y sistema de acciones para cada procedimiento, y sistema de control y evaluación de la efectividad de las acciones realizadas. La demostración de la formación de la habilidad diagnosticar, a través de un caso clínico real, reveló como esencial la consecutividad lógica de las acciones del residente desde la atención médica del caso y la formulación del diagnóstico presuntivo hasta el establecimiento del diagnóstico corroborativo en los laboratorios de anatomía patológica, microbiología y parasitología médica. Conclusiones: Se aporta un sistema de procedimientos que posibilita la formación de la habilidad "diagnosticar enfermedades dermatológicas en los residentes, con carácter secuencial, interdisciplinar e investigativo(AU)

Introduction: Laboratory practices provide the ability that allows corroborating the diagnosis of skin and adnexal diseases after a presumptive diagnosis, with the use of the clinical method. This is supported by the requirements established in the standardization documents of this training process. Objective: To propose a system of procedures for the interdisciplinary training of the skill to diagnose dermatological diseases in Dermatology residents, based on insufficiencies detected in the specialty program. Methods: The research was qualitative and consisted in a descriptive study carried out in Hospital General Docente Dr. Antonio Luaces Iraola, of Ciego de Avila, from 2018 to 2022. The work was done with the entire population made up of 16 first-year residents in Dermatology. Theoretical, empirical and statistical methods were used. Results: In the proposed system of procedures, strengths and weaknesses are specified, together with general objective, methodological guidelines, precision of specific objectives and system of actions for each procedure, as well as system of control and evaluation of the effectiveness of the actions. Demonstrating the received formation for the diagnostic skill, through a real clinical case, revealed as essential the logical consecutivity of the resident's actions from the medical attention of the case and the formulation of the presumptive diagnosis to the establishment of the corroborative diagnosis in the laboratories of pathological anatomy, microbiology and medical parasitology. Conclusions: A system of procedures is provided that makes possible the formation of the skill to diagnose dermatological diseases in residents, with sequential, interdisciplinary and investigative character(AU)

Sistema de información y gestión de resultados para laboratorios - GestLab

Introducción: Los procesos establecidos para el procesamiento, análisis y resultado final de las muestras de PCR, así como el control de los suministros médicos, aún se realizan de forma manual, trayendo consigo la introducción del error humano y un elevado tiempo en la entrega de los resultados. Objetivo: Presentar un sistema que automatiza los procesos de análisis, procesamiento y resultado final de las muestras de PCR, además del control de los suministros médicos en los laboratorios y centros de toma de muestras. Métodos: Con la utilización de las tecnologías para el desarrollo de programas y las herramientas de código abierto, se obtuvo un sistema automatizado para analizar y procesar las muestras de PCR. Resultados: Se implementó un sistema que automatiza el procesamiento, análisis y resultado final de las muestras de PCR, control de los suministros médicos en los laboratorios y centros de toma de muestras. Conclusiones: El sistema automatizado elimina los procesos manuales de análisis, procesamiento y resultado final de las muestras de PCR, control de los suministros médicos en los laboratorios, centros de toma de muestras y logra mayor rapidez en la respuesta a los pacientes.

Introduction: The processes established for the processing, analysis and final result of the PCR samples, as well as the control of the medical supplies to perform these, are still carried out manually, bringing with it the introduction of human error; and a high time in the delivery of the results. Objective: To present a system that automates the processes of analysis, processing and final result of PCR samples, in addition to the control of medical supplies in laboratories and sampling centers. Methods: With the use of technologies for the development of programs and open-source tools, an automated system was obtained to analyze and process the PCR samples. Results: A system was implemented that automates the processing, analysis and final result of PCR samples, control of medical supplies in laboratories and sampling centers. Conclusions: The automated system eliminates the manual processes of analysis, processing and final result of PCR samples, control of medical supplies in laboratories, sample collection centers and achieves faster response to patients.

Sampling data of fresh frozen plasma, cryoprecipitates and leukocyte-free platelet quality monitoring in Hebei Province from 2015 to 2021: a retrospective analysis / 中国输血杂志

【Objective】 To form the sampling data interval by retrospectively analyzing the sampling data of quality monitoring of fresh frozen plasma, cryoprecipitates and leukocyte-free platelets in all blood stations in Hebei Province during the past 7 years. 【Methods】 The data of blood component sampling from 12 blood station quality control laboratories in Hebei from 2015 to 2021 were collected. The FⅧ content and plasma protein content of fresh frozen plasma, the FⅧ content and fibrinogen content of cryoprecipitates, and the leukocyte residuals, red blood cell mixed and platelet content of leukocyte-free platelets were taken as the objects for discrete point and fitted curve analysis. 【Results】 The FⅧ level of fresh frozen plasma: (1.36±1.1) IU/mL, 5 blood stations showed a representative overall high or low or fluctuated characteristics; Fresh frozen plasm-plasma protein items: overall mean ±SD: (61.13±16.7) g/L, four blood stations showed scattered distribution or continuous high value scattered points; Cryoprecipitates FⅧ: the overall mean ±SD: (134.25±58.7) IU/mL, four blood stations showed the differentiation characteristics of continuous high, low or stable in the middle; Cryoprecipitates-fibrinogen items: the overall mean ±SD: (215.27±83.5) mg, five blood stations showed the overall high or low and fluctuated. Leukocyte-free apheresis platelet-to-leukocyte residual items: overall mean ±SD: 0.37±0.96 (×106/bag), two blood stations showed a relatively high representative overall characteristics, and the rest were concentrated between 0 and 1; The total mean ±SD of platelet-to-red blood cell mixture without leukocyte was 2.45±2.82 (×109/bag), with obvious segmented concentrated distribution, and scattered distribution in 3 blood centers. Platelet content: the overall mean ±SD was 3.14±1.55 (×1011/bag), many deviations were noticed in 3 blood stations, and 1 blood station showed representative overall high characteristics. 【Conclusion】 This analysis shows that the distribution status of each blood station in different items is similar. The distribution status of discrete point groups and the change trend of the concentrated part of the fitting curve show that there are some differences in the monitoring level between the quality control laboratories of each blood station, and the update of detection instruments and reagents and the selection of detection methods greatly affect the test results. The summary data presented the index interval framework formed in the past 7 years, which helped to understand the difference between the results of each laboratory, correct the accuracy of the test results, better play the guiding role of quality monitoring in the blood preparation process, and continue to enhance the standardization of the whole process of blood collection and supply in the province.

Management Practice of Outsourcing Hospital Tests to Independent Clinical Laboratories / 中国医疗器械杂志

With the development of medical technology and the deepening of medical reform, hospital laboratory test continues to expand. Affected by factors such as technology and cost, the business of outsourcing laboratory test to independent clinical laboratories develops rapidly. However, this cooperation mode has not been carried out for a long time and lacks systematic management experience. Through the analysis of the motivation of hospital delivery, this study expounds the classification, judgment basis and requirements for suppliers of third-party clinical laboratory delivery, as well as the operation practice of laboratory test delivery, so as to provide reference for more standardized and effective testing delivery for hospitals.

Monitoring nucleic acid contamination and assessing biosecurity risk in temporary 2019-nCoV nucleic acid testing laboratory from designated infectious disease care facilities / 中华检验医学杂志

Objective:To monitor nucleic acid contamination and evaluate the biosecurity risk in a temporary 2019-nCoV nucleic acid testing laboratory situated within designated infectious disease care facilities.Methods:Quantitative real-time PCR technology was used to detect nucleic acid contamination in samples collected from high-risk experimental activity areas and the surface of the laboratory staff′s personal protective equipment. Sampling was conducted every Monday from March 14 to May 16, 2022, both during and after disinfection procedures.Results:A total of 760 samples were collected from 40 sampling sites. A total of 27 out of 100 samples (27%) collected from 8 sampling sites in the sample processing area were positive. Among them, the contaminated area of biological safety cabinet, the outer surface of the sample transport box, and the sample rack were found to have the highest positive detection rates, with rates of 5/10, 4/10, and 6/10, respectively. Ten out of 140 samples (7.1%) obtained from 7 sampling sites in the nucleic acid detection area showed positive results. The inner wall of sample transfer window and the door handle of the nucleic acid detection area had the highest positive detection rates, both at 4/20. The Ct values for the target genes from the positive samples in the sample processing area were significantly higher than those from the nucleic acid detection area. The detection rate for nucleic acid contamination on the surface of the personal protective equipment of the laboratory staff was 20% (16/80), and the positive detection rate of the outer gloves from operator during the experiment reached 9/10. After disinfection, the nucleic acid residues on the surfaces of the various areas of the 2019-nCoV nucleic acid laboratory and the surfaces of the personal protective equipment of the laboratory staff were observed to be effectively removed.Conclusions:During experimental operation, the positive detection rate and nucleic acid contamination intensity of 2019-nCoV are higher in the sample processing area compared to those in the nucleic acid detection area. The laboratory staff are exposed to high biosecurity risk during the experiment. Implementing a scientific disinfection process can significantly reduce the risk of 2019-nCoV residues from the laboratory environment and the surface of the personal protective equipment of the laboratory staff, ensuring the accuracy of inspections and the safety of the laboratory staff.

Experience on the establishment of laboratory clinic and functional importance of laboratory clinic / 中华检验医学杂志

With the continuous development of laboratory medicine, the establishment of laboratory clinic has attracted more attention from hospital management departments and laboratory departments. In this paper, we discuss the establishment and function of laboratory clinic from five aspects: the formation of laboratory physician team, the location and equipment, the scope, the regulation and the value and clinical importance, referring to the training project of foreign laboratory physicians and initial experience of domestic hospital laboratory clinics. At present, the establishment of laboratory clinic in most hospitals is still in the active exploratory stage. The standardized rules and regulations of establishment and operation, and the training of multi-disciplinary physicians are the essential requirements and prerequisites for the sustainable development of the laboratory clinics.

A descriptive assessment of the National Institute of Public Health’s role in supporting the COVID-19 response in Cambodia, 2020–2021

@#Objective: This paper examines the contributions made by the National Institute of Public Health to Cambodia’s response to the coronavirus disease (COVID-19) pandemic during 2020–2021. Methods: The activities conducted by the Institute were compared with adaptations of the nine pillars of the World Health Organization’s 2020 COVID-19 strategic preparedness and response plan. To gather relevant evidence, we reviewed national COVID-19 testing data, information about COVID-19-related events documented by Institute staff, and financial and technical reports of the Institute’s activities. Results: The main contributions the Institute made were to the laboratory pillar and the incident management and planning pillar. The Institute tested more than 50% of the 2 575 391 samples for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing and provided technical advice about establishing 18 new laboratories for SARS-CoV-2 testing in the capital city of Phnom Penh and 11 provinces. The Institute had representatives on many national committees and coauthored national guidelines for implementing rapid COVID-19 testing, preventing transmission in health-care facilities and providing treatment. The Institute contributed to six other pillars, but had no active role in risk communication and community engagement. Discussion: The Institute’s support was essential to the COVID-19 response in Cambodia, especially for laboratory services and incident management and planning. Based on the contributions made by the Institute during the COVID-19 pandemic, continued investment in it will be critical to allow it to support responses to future health emergencies in Cambodia.

Application of large-scale imaging equipment in high-level biosafety laboratories for animals / 医疗卫生装备

The obstacles and risks of the application of imaging devices such as CT,PET/CT,MRI and in vivo imaging system in animal biosafety level 3/4(ABSL-3/4)laboratories were proposed.Combined with the experience of applying imaging devices in ABSL-3/4 laboratories,the key issues were discussed such as application scheme,risk assessment and control,disinfection and sterilization methods.Some suggestions were put forward for applying large-scale imaging equipment in ABSL-3/4 laboratories.References were provided for ABSL-3/4 laboratories equipped with imaging devices.[Chinese Medical Equipment Journal,2023,44(9):69-73]

Status and Prospect of Management Policy and System for High-level Pathogenic Microorganism Laboratories in China / 中山大学学报(医学科学版)

High-level pathogenic microorganism laboratories are strategic scientific and technological forces of national biosafety， so it is significant to improve the policy and system management and strengthen the safety supervision. This paper reviewed the current status of management policy and system of high-level pathogenic microorganism laboratories， summarized the problems and challenges in terms of safety laws and regulations， supervision mechanism， hierarchical and classified management， standards and norms， legal person responsibility system， occupational access system and personnel training system. This paper also proposed targeted policy suggestions that might underlie the biosafety management of high-level pathogenic microorganism laboratories in China.

Hematological parameters: is there a difference between those released by the hematological analyzer and to the customer?

ABSTRACT Objective This study aimed to compare the hematological parameters released by hematological analyzers with those released in customer reports. Methods We conducted a descriptive study in the laboratories of a medium-sized municipality in the state of Minas Gerais registered in the National Register of Health Establishments. Interviews were conducted using a questionnaire to obtain information regarding the parameters released by the analyzers and those available in the customer's report. Results Sixteen laboratories were evaluated, and none of them released all the parameters obtained from the hematological analyzers to customers. The red blood cell distribution width was released in 88% of the laboratories, atypical lymphocytes in 70%, mean platelet volume in 50%, platelet distribution width and platelet count in 20%. No laboratory released information on reticulocytes, fraction of immature reticulocytes and immature granulocytes, nucleated erythrocyte count, immature platelet fraction and reticulocyte hemoglobin, and large platelet rate. Conclusion All evaluated clinical analysis laboratories had at least one parameter that was not released in the customer's report despite being released by the hematological analyzers. The lack of knowledge on the part of professionals about the clinical importance of each parameter of the complete blood count results in a loss in patient assessment, and it is important to include these parameters in the complete blood count report.

Desafios dos laboratórios públicos da área de saúde ambiental para implantação e manutenção dos requisitos de normativas da qualidade para monitoramento da água de consumo humano / Challenges for public laboratories in the environmental health area for implementation and maintenance of quality regulatory requirements for monitoring human consumption water

Resumo Introdução O Ministério da Saúde (MS) é responsável pela vigilância da qualidade da água de consumo humano. A confiabilidade nos resultados do monitoramento de parâmetros analíticos minimiza riscos à saúde pública. Objetivo Retratar aspectos funcionais, a aplicação de ferramentas da qualidade e a aderência dos laboratórios públicos que atuam no monitoramento da água de consumo humano aos requisitos da norma ABNT NBR ISO/IEC 17025. Método A pesquisa foi realizada com 30 laboratórios públicos de todas as regiões do país, respondendo a um questionário elaborado com 49 perguntas sobre a formação e capacidade dos profissionais, garantia da validade dos resultados e sobre a determinação de parâmetros da qualidade da água. Resultados Dos 161 profissionais, 46% possuem mais de 10 anos de experiência e 65% têm formação superior. Capacitações específicas foram requeridas por todos. A validação dos métodos analíticos não foi realizada por 59%. Materiais de referência certificados são acessados por 41% e apenas 18% têm facilidade em adquiri-los. A participação em ensaios de proficiência foi reportada por 68% dos laboratórios, mas com poucos parâmetros avaliados e dificuldades em contratar provedores. Conclusão Evidenciou-se a necessidade de ações para fortalecimento da metrologia em laboratórios públicos que atuam na vigilância da qualidade da água.

Abstract Background The Ministry of Health (MS) is responsible for drinking water quality surveillance. Reliability in the results of monitoring analytical parameters minimizes public health risks. Objective To present functionals aspects and the application of quality tools by public laboratories that work to monitor the quality of drinking water. Method A survey was conducted with 30 public laboratories from all regions of the country, answering a questionnaire elaborated with 49 questions about the training and capacity of professionals, guaranteeing the validity of the results and about the determination of basic parameters of water quality. Results Of the 161 professionals, 46% have more than 10 years of experience and 65% have higher education. Specific training was required by everyone. The validation of the analytical methods was not performed by 59%. Reference materials are accessed by 41% and only 18% can acquire them easily. Participation in proficiency tests was reported by 68% of the laboratories, but with few parameters evaluated and difficulties in hiring providers. Conclusion The need for actions to strengthen metrology in public laboratories that work in water quality surveillance was highlighted.

Major changes will take place on ISO15189 "Medical laboratories: requirements for quality and competence" / 中华检验医学杂志

Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.

Application of delta checks in clinical laboratories / 中华检验医学杂志

The delta checks are one of the patient-based quality control options to identify the errors and the significant changes in patients′ condition. Compared with the traditional internal quality control method, the delta checks have the characteristics of real-time monitoring, with no additional detecting cost, thus the delta checks are widely used in clinical laboratories. In addition, the delta checks are also useful in the auto-verification system to screen out the abnormal results for manual verification. This article reviewed the delta checks′ development history, parameters selection, application values in quality control and auto-verification.