Diagnóstico da rede de atendimento laboratorial de hanseníase no Departamento Regional de Saúde XV, São José do Rio Preto, São Paulo / Diagnóstico de la red de atención de laboratorio de lepra en el Departamento Regional de Salud XV, São José do Rio Preto, São Paulo, Brasil / Diagnosis of the leprosy laboratory care network in Regional Health Department XV, São José do Rio Preto, São Paulo, Brazil

Objetivo: Apresentar o diagnóstico situacional da rede laboratorial para hanseníase na região de São José do Rio Preto, SP, Brasil. Métodos: Pesquisa de avaliação com desenho descritivo. Os dados foram coletados por meio de formulário online preenchido pelos responsáveis pelo programa de hanseníase, em 2018. Resultados: Todos os 102 municípios que compõem a região enviaram os dados solicitados, 84 (82,4%) solicitavam a baciloscopia; e destes, 68 receberam capacitação. Do total, 11,7% enviavam baciloscopia para outros laboratórios sem respeitar a rede de referência. Apenas 59 (57,8%) solicitavam a biópsia, e destes, 47 tinham médico responsável pela coleta e 31 não respeitavam a rede de referência para encaminhamento das biópsias. Foram descritos, como aspectos que dificultavam o diagnóstico dos casos de hanseníase na região, a falta de sala adequada, poucos profissionais capacitados, ausência de material para transporte e de requisição de exames impressa. Conclusão: A rede laboratorial se encontra fragilizada, necessitando reestruturação.

Objetivo: Presentar el diagnóstico de la situación de la red de laboratorios para lepra en la región de São José do Rio Preto, SP, Brasil. Métodos: Estudio de evaluación con diseño descriptivo. Los datos fueron recolectados a través de un formulario en línea por cada persona responsable del programa de lepra en 2018. Resultados: Los 102 municipios que conforman la región enviaron los datos solicitados, el 82,4% (84/102) solicitaba la baciloscopia y de estos 68 recibieron capacitación. Del total, el 11.7% enviaba la baciloscopia a otros laboratorios sin respetar la red de referencia. Solo el 57,8% (59/102) solicitó una biopsia, y de estos, 47 tenía un médico responsable de la recolección y 31 no respetaron la red de referencia para enviar las biopsias. Los aspectos que dificultan el diagnóstico de casos de lepra en la región SJRP se describieron como la falta de una sala adecuada, profesionales capacitados, ausencia de material para el transporte y de solicitudes de exámenes impresos. Conclusión: La red de laboratorios está fragilizada y debe ser respetada en su composición inicial o reexaminada y reorganizada.

Objective: To present the situational diagnosis of the leprosy laboratory reference network in the region of São José do Rio Preto, SP, Brazil. Methods: This was an evaluation study with a descriptive design. The data were collected by means of an online form filled in by those in charge of the leprosy program in 2018. Results: All 102 municipalities that make up the region provided the requested data, 82.4% (84/102) requested slit-skin smear microscopy and of these 68 received training. Of the total, 11.7% sent slit-skin smears to other laboratories outside the reference network. Only 57.8% (59/102) requested a biopsy, of these 47 had a doctor responsible for taking the biopsy sample and 31 did not send biopsy samples for analysis in the reference network. Lack of an adequate room, few trained professionals, absence of material for transportation and absence of printed test requisitions were described as aspects that hinder leprosy case diagnosis in the region. Conclusion: The laboratory network is fragile and needs to be restructured.

Laboratorio de diagnóstico clínico y/o de vigilancia epidemiológica: norma técnica No. 22-2019-DRACES / Laboratory for clinical diagnosis and / or epidemiological surveillance: technical standard No. 22-2019-DRACES

La tinta del documento está bastante opaca. DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de los laboratorios de diagnóstico clínico y/o de vigilancia epidemiológica, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica tanto al sector público, privado, social o subsector de la seguridad social, en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico. En el capítulo II, incluye una clasificación del nivel de laboratorios, describiendo sus características, servicios, horarios, materiales técnicos y equipos.

Documentos de arquivo produzidos pela atividade científica: uma análise dos cadernos de laboratório do Instituto Oswaldo Cruz / Archival documents produced by scientific work: an analysis of laboratory notebooks from the Instituto Oswaldo Cruz

Resumo Analisa o caderno de laboratório, espécie documental produzida a partir dos registros da atividade científica, e seus diferentes tipos, bem como seu uso e seus formatos na pesquisa biomédica. A reflexão se apoia na pesquisa em andamento sobre os documentos dos laboratórios do Instituto Oswaldo Cruz e na relação destes com os conceitos, métodos, técnicas e práticas da arquivologia. A metodologia compreendeu, além de pesquisa bibliográfica, a aplicação de questionário, entrevistas e diagnóstico dos arquivos, nos quais se buscou identificar a gênese documental, as espécies/tipologias presentes e as práticas de manutenção e uso dos registros provenientes de 15 laboratórios. Discute ainda o caderno aberto de laboratório, formato disseminado no âmbito do debate contemporâneo da ciência aberta.

Abstract This article analyzes the different types of laboratory notebooks, a type of document produced from the records of scientific work, along with their uses and formats in biomedical research. This reflection is based on current research involving documents from laboratories at the Instituto Oswaldo Cruz and their relationship with the concepts, methods, techniques, and practices of archive studies. The methodology includes bibliographic research, a questionnaire, interviews, and archive diagnostics, which were aimed at identifying the originating documentation, the types which are present, and the practices involved in maintaining and using records from 15 laboratories. We also discuss the open lab notebook, a format

National laboratory policies and plans in sub-saharan african countries: gaps and opportunities

Background: The 2008 Maputo Declaration calls for the development of dedicated national laboratory policies and strategic plans supporting the enhancement of laboratory services in response to the long-lasting relegation of medical laboratory systems in sub-Saharan Africa.Objectives: This study describes the extent to which laboratories are addressed in the national health policies and plans created directly following the 2008 momentum for laboratory strengthening.Method: National health policies and plans from 39 sub-Saharan African countries, valid throughout and beyond 31 December 2010 were collected in March 2012 and analysed during 2013.Results: Laboratories were addressed by all countries. Human resources were the most addressed topic (38/39) and finances and budget were the least addressed (< 5/39). Countries lagging behind in national laboratory strategic planning at the end of 2013 (17/39) were more likely to be francophone countries located in West-Central Africa (13/17) and have historically low HIV prevalence. The most common gaps anticipated to compromise the implementation of the policies and plans were the disconnect between policies and plans, under-developed finance sections and monitoring and evaluating frameworks, absence of points of reference to define gaps and shortages, and inappropriate governance structure.Conclusion: The availability of laboratory policy and plan implementation can be improved by strictly applying a more standardised methodology for policy development, using harmonised norms to set targets for improvement and intensifying the establishment of directorates of laboratory services directly under the authority of Ministries of Health. Horizontal programmes such as the Global Health Security Agenda could provide the necessary impulse to take the least advanced countries on board

Human pancreatic islet transplantation: an update and description of the establishment of a pancreatic islet isolation laboratory

Type 1 diabetes mellitus (T1DM) is associated with chronic complications that lead to high morbidity and mortality rates in young adults of productive age. Intensive insulin therapy has been able to reduce the likelihood of the development of chronic diabetes complications. However, this treatment is still associated with an increased incidence of hypoglycemia. In patients with “brittle T1DM”, who have severe hypoglycemia without adrenergic symptoms (hypoglycemia unawareness), islet transplantation may be a therapeutic option to restore both insulin secretion and hypoglycemic perception. The Edmonton group demonstrated that most patients who received islet infusions from more than one donor and were treated with steroid-free immunosuppressive drugs displayed a considerable decline in the initial insulin independence rates at eight years following the transplantation, but showed permanent C-peptide secretion, which facilitated glycemic control and protected patients against hypoglycemic episodes. Recently, data published by the Collaborative Islet Transplant Registry (CITR) has revealed that approximately 50% of the patients who undergo islet transplantation are insulin independent after a 3-year follow-up. Therefore, islet transplantation is able to successfully decrease plasma glucose and HbA1c levels, the occurrence of severe hypoglycemia, and improve patient quality of life. The goal of this paper was to review the human islet isolation and transplantation processes, and to describe the establishment of a human islet isolation laboratory at the Endocrine Division of the Hospital de Clínicas de Porto Alegre – Rio Grande do Sul, Brazil.

Use of laboratory test results in patient management by clinicians in Malawi

Background: Malawi has a high burden of infectious disease. The expansion of programmes targeting these diseases requires a strong laboratory infrastructure to support both diagnosis and treatment.Objectives: To assess the use of laboratory test results in patient management and to determine the requirements for improving laboratory services. Methods: A cross-sectional study was conducted in 2012 to survey practising clinicians.Two hospitals were purposively selected for observations of clinicians ordering laboratory tests. Twelve management-level key informants were interviewed. Descriptive statistics were conducted. Results: A total of 242 clinicians were identified and 216 (89%) were interviewed. Of these; 189 (87%) reported doubting laboratory test results at some point. Clinicians most often doubted the quality of haematology (67%); followed by malaria (53%) and CD4 (22%) test results. A total of 151 (70%) clinicians reported using laboratory tests results in patient management. Use of laboratory test results at all times in patient management varied by the type of health facility (P 0.001). Ninety-one percent of clinicians reported that laboratories required infrastructure improvement. During 97 observations of clinicians' use of laboratory test results; 80 tests were ordered; and 73 (91%) of these were used in patient management. Key informants reported that the quality of laboratory services was good and useful; but that services were often unavailable. Conclusion: Gaps in the public laboratory system were evident. Key recommendations to enhance the use of laboratory test results in patient management were to strengthen the supply chain; reduce turn-around times; improve the test menu and improve the laboratory infrastructure

The world´s microbiology laboratories can be a global microbial sensor network / Los laboratorios de microbiología del mundo pueden convertirse en una red de detección microbiana

The microbes that infect us spread in global and local epidemics, and the resistance genes that block their treatment spread within and between them. All we can know about where they are to track and contain them comes from the only places that can see them, the world´s microbiology laboratories, but most report each patient´s microbe only to that patient´s caregiver. Sensors, ranging from instruments to birdwatchers, are now being linked in electronic networks to monitor and interpret algorithmically in real-time ocean currents, atmospheric carbon, supply-chain inventory, bird migration, etc. To so link the world´s microbiology laboratories as exquisite sensors in a truly lifesaving real-time network their data must be accessed and fully subtyped. Microbiology laboratories put individual reports into inaccessible paper or mutually incompatible electronic reporting systems, but those from more than 2,200 laboratories in more than 108 countries worldwide are now accessed and translated into compatible WHONET files. These increasingly web-based files could initiate a global microbial sensor network. Unused microbiology laboratory byproduct data, now from drug susceptibility and biochemical testing but increasingly from new technologies (genotyping, MALDI-TOF, etc.), can be reused to subtype microbes of each genus/species into sub-groupings that are discriminated and traced with greater sensitivity. Ongoing statistical delineation of subtypes from global sensor network data will improve detection of movement into any patient of a microbe or resistance gene from another patient, medical center or country. Growing data on clinical manifestations and global distributions of subtypes can automate comments for patient´s reports, select microbes to genotype and alert responders.

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Quality perception in research laboratories from Fiocruz after QMS implementation / A percepção da qualidade em laboratórios de pesquisa da Fiocruz após a implementação do SGQ / La percepción de la calidad en los laboratorios de investigación Fiocruz después de la implementación del SGC

Quality Management System has been implemented at the René Rachou Research Center since 2003. This study investigated its importance for collaborators (Cs) in laboratories. This was a quantitative and descriptive study performed in a group of 113 collaborators. It was based on the World Health Organization handbook: Quality Practices in Basic Biomedical Research. The questionnaires evaluated the parameters using the Likert scale. Biosafety, training and ethics were considered to be the most important parameters. Supervision and quality assurance, data recording, study plan, SOPs and file storage achieved intermediate evaluation. The lower frequency of responses was obtained for result report, result verification, personnel and publishing practices. Understanding the perception of the collaborators allows the development of improvement actions aiming the construction of a training program directing strategies for disseminating quality.

El Sistema de Gestión de la Calidad ha sido implementado en el Centro de Investigación René Rachou desde el año 2003. En este estudio se investigó la importancia de dicho sistema para los trabajadores de los laboratorios de investigación. Se realizó un estudio de tipo cuantitativo, descriptivo con un grupo de 113 trabajadores. Fueron utilizadas las guías sobre Prácticas de Calidad en Investigación Biomédica Básica (QPBR) de la Organización Mundial de la Salud. El cuestionario evalúa los parámetros de esta guía utilizando la Escala Likert. Bioseguridad, formación y ética fueron los factores considerados como los más importantes dentro del cuestionario. Supervisión y Control de calidad, registro de datos, plan de estudios, POP y el archivo obtuvieron una puntuación intermedia. La puntuación más baja fue obtenida por el informe, la verificación de resultados, el personal y las prácticas de publicación. Conocer las opiniones de los trabajadores permitirá el desarrollo de acciones para la mejora del Sistema de Gestión de la Calidad, contribuyendo al desarrollo de un programa de capacitación y de estrategias para la difusión de la calidad.

O Sistema de Gestão da Qualidade vem sendo implementado no Centro de Pesquisas René Rachou desde 2003. Este estudo investigou sua importância para os colaboradores dos laboratórios de pesquisa. Tratou-se de um estudo quantitativo, descritivo, realizado com um grupo de 113 colaboradores. Utilizou-se a diretriz Práticas de Qualidade na Pesquisa Biomédica Básica (QPBR), da Organização Mundial de Saúde. Os questionários aplicados avaliaram os parâmetros dessa diretriz utilizando a escala Likert. Biossegurança, treinamento e ética foram os fatores considerados mais importantes. Supervisão e garantia da Qualidade, registro de dados, plano de estudo, POP e arquivo obtiveram uma avaliação intermediária. A menor avaliação foi obtida para relatório, verificação de resultados, pessoal e práticas de publicação. Entender a percepção dos colaboradores permitirá o desenvolvimento de ações de melhoria, contribuindo para a construção de um programa de treinamento e estratégias de disseminação da qualidade.

Diagrama de Ishikawa e 5W2H como ferramentas de gestão da qualidade em laboratórios de análises clínicas / Ishikawa diagram and 5W2H as quality management tools in clinical analysis laboratory

Introdução: As ferramentas da qualidade são técnicas gerenciais utilizadas para definir, mensurar, analisar e propor soluções de problemas que interferem nas instituições empresariais e comerciais , como por exemplo, no laboratório de análises clínicas facilitando a solução e resolução destes, diminuindo os custos para a instituição e assegurando aos clientes a prestação de serviços mais qualificados. Objetivos: Analisar a aplicação das ferramentas da qualidade Diagrama de Ishikawa e 5W2H para otimização dos processos gerenciais em um laboratório de análises clínicas. Métodos: Analisaram-se registros de reclamações de clientes atendidos em um laboratório de análises clínicas da Região do Vale dos Sinos, no período de junho a agosto de 2013. Utilizou-se o Diagrama de Ishikawa para a identificação e a análise das reclamações e o 5W2H para a proposição de soluções dos mesmos.Resultados: Foram relatadas sete reclamações (uma da área técnica e seis relacionadas com recepção e coleta). Por meio da utilização das ferramentas foi possível mapear e identificar os problemas, planejar e identificar oportunidades de melhorias nos processos, a fim de promover a garantia da qualidade. Discussão: as ferramentas da qualidade, além de permitirem a avaliação do setor, contribuem também para o bom desempenho dos processos e para o alcance e evolução da qualidade em análises clínicas. É necessário haver comprometimento de toda a organização, onde o trabalho de treinamento e reciclagem deve ser constante. Conclusão: As ferramentas utilizadas permitiram a melhor visualização dos problemas, facilidade na busca de ações corretivas e preventivas, além de maior confiabilidade.

Normas técnicas para la habilitación de laboratorios de análisis clínicos / Technical standards for the habilitation of clinical analysis laboratories

Define los requisitos que deben cumplir los laboratorios de análisis clínicos, para obtener la habilitación y funcionamiento por parte de la autoridad sanitaria competente dependiente del Ministerio de Salud Pública y Bienestar Social, el cual faculta el funcionamiento de estos establecimientos según Código Sanitario Ley 836/80.

Logistica de coleta e transporte de material biologico e organizacao do laboratorio central no ELSA-Brasil / Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil

O Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) é um estudo de coorte multicêntrico com o objetivo de identificar os fatores de risco associados ao diabetes tipo 2 e à doença cardiovascular na população brasileira. O artigo descreve as estratégias de coleta, processamento, transporte e de controle de qualidade dos exames de sangue e urina no ELSA. O estudo optou pela centralização dos exames em um único laboratório. O processamento das amostras foi realizado nos laboratórios locais, reduzindo o peso do material a ser transportado e diminuindo os custos do transporte para o laboratório central no Hospital da Universidade de São Paulo. O estudo incluiu exames para avaliação de diabetes, resistência à insulina, dislipidemias, alterações eletrolíticas, hormônios tireoidianos, ácido úrico, alterações de enzimas hepáticas, inflamação e hemograma completo. Além desses exames, foram estocados DNA de leucócitos, amostras de urina, plasma e soro. O laboratório central realizou aproximadamente 375.000 exames.

The ELSA (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a multicenter cohort study which aims at the identification of risk factors associated with type 2 diabetes and cardiovascular diseases in the Brazilian population. The paper describes the strategies for the collection, processing, transportation, and quality control of blood and urine tests in the ELSA. The study decided to centralize the tests at one single laboratory. The processing of the samples was performed at the local laboratories, reducing the weight of the material to be transported, and diminishing the costs of transportation to the central laboratory at the Universidade de São Paulo Hospital. The study included tests for the evaluation of diabetes, insulin resistance, dyslipidemia, electrolyte abnormalities, thyroid hormones, uric acid, hepatic enzyme abnormalities, inflammation, and total blood cell count. In addition, leukocyte DNA, urine, plasma and serum samples were stored. The central laboratory performed approximately 375,000 tests.

Indicadores de desempenho e decisão sobre terceirização em rede pública de laboratórios / Performance indicators and decision making for outsourcing public health laboratory services

OBJETIVO: Elaborar indicadores de desempenho e terceirização em rede de laboratórios clínicos, baseados em sistemas de informações e registros administrativos públicos. MÉTODOS: A rede tinha 33 laboratórios com equipamentos automatizados, mas sem informatização, 90 postos de coleta e 983 funcionários, no município de Rio de Janeiro, RJ. As informações foram obtidas de registros administrativos do Sistema de Informações de Orçamentos Públicos para a Saúde e do Sistema de Informações Ambulatoriais e Hospitalares do Sistema Único de Saúde. Os indicadores (produção, produtividade, utilização e custos) foram elaborados com dados colhidos como rotina de 2006 a 2008. As variações da produção, custos e preços unitários dos testes no período foram analisadas por índices de Laspeyres e de Paasche, específicos para medir a atividade dos laboratórios, e pelo Índice de Preços ao Consumidor Amplo do Instituto Brasileiro de Geografia e Estatística. RESULTADOS: A produção foi de 10.359.111 testes em 2008 (aumento de 10,6% em relação a 2006) e a relação testes/funcionário cresceu 8,6%. As despesas com insumos, salários e prestador conveniado aumentaram, respectivamente 2,3%, 45,4% e 18,3%. Os testes laboratoriais por consulta e internação cresceram 10% e 20%. Os custos diretos totalizaram R$ 63,2 milhões em 2008, com aumento de 22,2% em valores correntes no período. Os custos diretos deflacionados pelo Índice de Preços ao Consumidor Amplo (9,5% para o período) mostram aumento do volume da produção de 11,6%. O índice de volume específico para a atividade, que considera as variações do mix de testes, mostrou aumento de 18,5% no preço unitário do teste e de 3,1% no volume da produção. CONCLUSÕES: Os indicadores, em especial os índices específicos de volume e preços da atividade, constituem uma linha de base de desempenho potencial para acompanhar laboratórios próprios e terceirizados. Os indicadores de desempenho econômicos elaborados mostram a necessidade de informatização da rede, antecedendo a decisão de terceirização.

OBJECTIVE: To develop performance indicators for outsourcing clinical laboratory services, based on information systems and public administrative records. METHODS: In the municipality of Rio de Janeiro, Southern Brazil, the public health laboratory network comprised 33 laboratories with automated equipment (but no integrated information system), 90 primary care units (where sample collection was performed) and 983 employees. Information records were obtained from the administrative records of the Budget Information System for Public Health and the Outpatient and Hospital Information System of the Unified Health System. Performance indicators (production, productivity, usage and costs) were generated from data collected routinely from 2006 to 2008. The variations in production, costs and unit prices for tests were analyzed by Laspeyres and Paasche indices, which specifically measure laboratory activity, and by the Consumer Price Index from the Brazilian Institute of Geography and Statistics. RESULTS: A total of 10,359,111 tests were performed in 2008 (10.6% increase over 2006), and the test/employee ratio grew by 8.6%. The costs of supplies, wages and providers increased by 2.3%, 45.4% and 18.3%, respectively. The laboratory tests per visit and hospitalizations increased by 10% and 20%, respectively. The direct costs totaled R$ 63.2 million in 2008, representing an increase of 22.2% in current values during the period analyzed. The direct costs deflated by the Brazilian National Consumer Price Index (9.5% for the period) showed an 11.6% increase in production volumes. The activity-specific volume index, which considers changes in the mix of tests, showed increases of 18.5% in the test price and 3.1% in the production volume. CONCLUSIONS: The performance indicators, particularly the specific indices for volume and price of activity, constitute a baseline of performance potential for monitoring private laboratories and contractors. The economic performance indicators demonstrated the need for network information system integration prior to an outsourcing decision.

Strengthening laboratory management towards accreditation: the Lesotho experience

Introduction: The Lesotho Ministry of Health and Social Welfare's (MOHSW) 5-year strategic plan; as well as their national laboratory policy and yearly operational plans; directly addresses issues of accreditation; indicating their commitment to fulfilling their mandate. As such; the MOHSW adopted the World Health Organization Regional Headquarters for Africa's Stepwise Laboratory Quality Improvement Toward Accreditation (WHO-AFRO-SLIPTA) process and subsequently rolled out the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme across the whole country; becoming the first African country to do so. Methods: SLMTA in Lesotho was implemented in two cohorts. Twelve and nineteen laboratory supervisors and quality officers were enrolled in Cohort 1 and Cohort 2; respectively. These 31 participants represented 18 of the 19 laboratories nationwide. For the purposes of this programme; the Queen Elizabeth II (QE II) Central Laboratory had its seven sections of haematology; blood bank; cytology; blood transfusion; microbiology; tuberculosis laboratory and chemistry assessed as separate sections. Performance was tracked using the WHO-AFRO-SLIPTA checklist; with assessments carried out at baseline and at the end of SLMTA. Two methods were used to implement SLMTA: the traditional 'three workshops' approach and twinning SLMTA with mentorship. The latter; with intensive follow-up visits; was concluded in 9 months and the former in 11 months. A standard data collection tool was used for site visits.Results: Of the 31 participants across both cohorts; 25 (81) graduated (9 from Cohort 1 and 16 from Cohort 2). At baseline; all but one laboratory attained a rating of zero stars; with the exception attaining one star. At the final assessment; 7 of the 25 laboratories examined at baseline were still at a rating of zero stars; whilst 8 attained one star; 5 attained two stars and 4 attained three stars. None scored above three stars. The highest percentage improvement for any laboratory was 51; whereas the least improved dropped by 6 when compared to its baseline assessment.The most improved areas were corrective actions (34) and documents and records (32). Process improvement demonstrated the least improvement (10). Conclusion: The SLMTA programme had an immediate; measurable and positive impact on laboratories in Lesotho. This success was possible because of the leadership and ownership of the programme by the MOHSW; as well as the coordination of partner support

A utilidade dos indicadores da qualidade no gerenciamento de laboratórios clínicos / Usefulness of quality indicators in the management of clinical laboratories

O uso dos indicadores da qualidade vem sendo valorizado na gestão dos laboratórios clínicos para otimizar a qualificação e a quantificação das falhas nos diferentes processos laboratoriais, bem como para auxiliar a implantação de medidas corretivas e preventivas e apontar a eficácia das ações tomadas. O objetivo deste trabalho é discorrer sobre a evolução da qualidade na área da saúde, com ênfase na área laboratorial. Alguns indicadores laboratoriais citados na literatura nas fases pré-analítica, analítica e pós-analítica também são apresentados e discutidos neste artigo. Por fim, destaca-se a experiência brasileira do Programa de Indicadores Laboratoriais desenvolvido pela Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML) em parceria com a Control-Lab e o projeto Model of Quality Indicator, em fase de desenvolvimento pela International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

The use of quality indicators has been appreciated in laboratory management so as to optimize quality and error quantification in several laboratory processes. Furthermore, it assists in the implementation of preventive and corrective measures and it shows their corresponding efficiency. The objective of the present study is to discuss the evolution of quality, mainly in the laboratory area, focusing on the importance of quality indicators in laboratory management. Some pre-analytical, analytical and post-analytical laboratory indicators are also presented and discussed in this work. Finally, we highlight the Brazilian initiative in the Laboratory Indicator Program developed by the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML) in partnership with Control-Lab and the Model of Quality Indicator project, which has been developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

Introducción de la gestión por procesos en un laboratorio de pesquisa neonatal / Introduction of process management in a neonatal screening laboratory

El laboratorio de pesquisa neonatal comparte la necesidad, como cualquier organización, de optimizar sus resultados y aproximarse a las necesidades de los pacientes, así como a las de las personas que desarrollan su labor profesional prestando servicios de salud. Para alcanzar estos objetivos, es fundamental un enfoque hacia el cliente. Este enfoque es imposible sin la gestión y mejora de los procesos. La gestión basada en los procesos permite el análisis, diseño, implementación, seguimiento y control de las actividades de cada uno de sus procesos, integrándolos funcionalmente para alcanzar sus objetivos. El objetivo de este trabajo es introducir el sistema de gestión por procesos en un laboratorio de pesquisa neonatal. Para ello, fue necesario seguir una secuencia metodológica que constó de 4 fases. Fase I: análisis estratégico de la organización, Fase II: análisis del proceso, Fase III: análisis estratégico del proceso y Fase IV: diseño del proceso. El análisis estratégico de la organización (fase I) ha permitido identificar tres procesos claves: 1) solicitud de segundas muestras, 2) citación de pacientes y 3) evaluación del desempeño. Se puede concluir que la implementación de un sistema de gestión por procesos no significa desmontar lo establecido, sino formalizarlo y sistematizarlo, añadiendo lo necesario para mejorar. El laboratorio de pesquisa neonatal, debe gestionar sus procesos como una unidad organizativa para mejorar la eficiencia, seguimiento y control.

Descentralización del diagnóstico de influenza pandémica en Chile: implementación laboratorios regionales de RT-PCR / Decentralization of pandemic influenza diagnosis in Chile: implementing regional laboratories RT-PCR

Debido a la pandemia de influenza A (H1N1) en el mundo, el Ministerio de Salud en Chile desarrolló un proyectodestinado a fortalecer la capacidad de los laboratorios descentralizados, mediante utilización de la técnica de biología molecular RT-PCR. El proyecto contempló: 1) Readecuación de los espacios físicos en los laboratorios clínicos, 2) compra de equipamiento, 3) adquisición de reactivos e insumos de laboratorio, 4) adquisición de materiales para la toma de muestra, 5) capacitación del recurso humano y 6) verificación del correcto funcionamiento del laboratorio. Al 2010, se encuentran funcionando 6 laboratorios que emplean RT-PCR; se ha obtenido un 100 por ciento de concordancia de las muestras y las autoridades centrales han elaborado un algoritmo de derivación de muestras respiratorias por parte de los 29 Servicios de Salud a los laboratorios regionales, basado en grupos objetivos establecidos en la vigilancia de influenza.

Due to pandemic influenza A (H1N1) in the world, the Ministry of Health in Chile developed a project to strengthen decentralized laboratory capacity through the use of molecular biology technique RT-PCR. The project included: 1) Renovating the physical space in clinical laboratories, 2) purchasing equipment, 3) purchasing laboratory reagents and supplies, 4) acquiring materials for sample collection, 5) human resource training 6) verifying the proper functioning of the laboratory. By 2010, 6 laboratories employing RT-PCR are running, a 100 percent match of the samples has been obtained and the central authorities have developed an algorithm for derivation of respiratory specimens from the 29 Health Services to regional laboratories based on target groups established in the surveillance of influenza.

Avaliação da distribuição de reativos para diagnóstico in vitro destinados às ações de vigilância e controle de agravos / Evaluation of the distribution of in vitro diagnostic reagents for the surveillance and control of diseases

Neste trabalho apresentamos um panorama do armazenamento de reativos para diagnóstico in vitro distribuídos pelo Ministério da Saúde aos Laboratórios Centrais de Saúde Pública – LACEN, e da Central Nacional de Distribuição de Insumos Estratégicos – CENADI. Foi realizada avaliação normativa considerando-se os componentes de estrutura e processo, destacando-se a importância da adoção das Boas Práticas de Armazenamento - BPA, no aprimoramento dos processos de trabalho. Foram avaliados quinze LACEN nas cinco regiões brasileiras. Foram verificados itens de BPA adotados em cada unidade avaliada. Foi evidenciado que os setores de armazenamento das unidades laboratoriais e do nível central carecem de maiores investimentos em capacitação e, em alguns casos, em estrutura física. O planejamento das aquisições também foi abordado e mostrou-se insatisfatório, conforme evidenciado pelo indicador de desabastecimento. Acreditamos que os desafios e pontos positivos destacados neste estudo possam contribuir para a melhoria dos processos de planejamento, aquisição e armazenamento de reativos para diagnóstico in vitro no âmbito do MS.

Strengthening public health laboratories in the WHO African Region: a critical need for disease control

Despite the progress and efforts being made to strengthen laboratory capacities in the Region; challenges remain. The purpose of this document is to raise awareness on the need to strengthen public health laboratory services and propose actions for building national laboratory capacity

Field and laboratory preparedness: challenges to rolling out new multidrug-resistant tuberculosis diagnostics / Preparativos de campo y laboratorio: retos para la introducción de nuevos diagnósticos de la tuberculosis multirresistente

OBJECTIVES: In a pilot implementation project of the microscopic-observation drug-susceptibility methodology, we conducted a process evaluation to identify health system and logistic challenges that need to be addressed in order to harness the benefits of rolling out promising new diagnostic tools for multidrug-resistant tuberculosis (MDRTB). METHODS: Regional data relating to health system practices and performance related to the MDRTB diagnostic algorithm were collected at health center, local, and regional laboratories. RESULTS: Parallel implementation of a new test and an existing method creates demands on funds, personnel, sample transport, and information systems in addition to new test startup costs. Obviating the need for primary culture at intermediate laboratories through direct drug susceptibility testing (DST) at the regional reference laboratory significantly reduces delay. Field application of well-defined national guidelines for DST is patchy. If fidelity to national guidelines were perfect, DST requests would increase more than 50-fold, with important implications for laboratory capacity. CONCLUSIONS: Implementing a new MDRTB diagnostic presents challenges to the laboratory environment, the existing DST process, and the application of national guidelines in peripheral clinics. Assessing each element can maximize efficient use of a new tool. Specifically, strengthening systems for transferring samples to the laboratory and delivering results to the requesting clinic in addition to investing in personnel and laboratory resources are integral to harnessing the benefits of high-performance new diagnostic tests and can bring added value to other programs in the health care system.

OBJETIVOS: En un proyecto piloto para la implementación de la metodología de observación microscópica para determinar la susceptibilidad a medicamentos se identificaron los retos logísticos y del sistema de salud que se deben atender para aprovechar los beneficios de nuevas y prometedoras herramientas diagnósticas para la tuberculosis resistente a múltiples medicamentos (TRMM). MÉTODOS: Los datos regionales sobre las prácticas y el desempeño del sistema de salud relacionados con los algoritmos de diagnóstico de la TRMM se recogieron en los centros de salud y los laboratorios locales. RESULTADOS: La implementación paralela de una nueva prueba y el método actual crea demandas de recursos, personal, transportación de las muestras y sistemas de información adicionales a los costos de introducción de la nueva prueba. Eliminar la necesidad de cultivos primarios en laboratorios intermedios mediante la prueba de susceptibilidad a los medicamentos (PSM) directa en el laboratorio regional de referencia reduce significativamente la demora. La aplicación en el terreno de directivas nacionales bien definidas para las PSM es desigual. Si la fidelidad a las directivas nacionales fuera perfecta, la demanda de PSM aumentaría más de 50 veces, con implicaciones importantes para la capacidad de laboratorio. CONCLUSIONES: La implementación de un nuevo diagnóstico de TRMM presenta retos para el sistema de laboratorio, el proceso actual de PSM y la aplicación de las directivas nacionales en las clínicas periféricas. La evaluación de cada elemento puede optimizar el uso eficiente de una nueva herramienta diagnóstica. En particular, el fortalecimiento de los sistemas de transportación de muestras al laboratorio y el envío de los resultados a las clínicas solicitantes, además de la inversión en personal y recursos de laboratorio, son requisitos para aprovechar los beneficios de las nuevas pruebas diagnósticas de alto rendimiento y pueden brindar valor añadido ...