Characterizing the role of informal payments in the delivery of pathology and clinical laboratory services.

OBJECTIVES: Informal payments (IPs) are unofficial cash or in-kind payments for goods or services that should be covered by the health care system. They are a common but regressive method of financing health care in low- and lower-middle-income countries (LMICs). This study aims to characterize the prevalence and impact of IPs on pathology and laboratory medicine (PALM) services. METHODS: From September 2021 to September 2022, PALM staff were surveyed about the frequency, determinants, and impacts of IPs in their respective workplaces. RESULTS: In total, 268 responses were received, and 46.6% (125/268) reported experience with IPs. These 125 participants were more likely to work in the public sector and in LMICs. Approximately 65% reported accepting IPs to perform tests or release results. Obtaining faster results was the most commonly perceived reason for patients offering IPs. Overall, participants reported that IPs had more negative than positive impacts on their workplace. CONCLUSIONS: This represents a first step in characterizing IPs within PALM and how this practice may affect access to these services in LMICs. Specifically, the fact that faster turnaround time was the most frequently perceived reason for offering IPs uncovers a potential barrier to improving PALM capacity in these regions.

Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates.

Importance: The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability. Objective: To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data. Design, Setting, and Participants: A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022. Main Outcomes and Measures: A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC. Results: A total of 16 905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.

FDA's proposed rule for the regulation of laboratory-developed tests.

In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/cleared tests. We outline here concerns from the clinical and public health microbiology laboratory perspective. It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs. This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laboratories and, therefore, patients and the providers who care for them. Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity. Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle. Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity. Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burdensome adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns. Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports. A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.

Eastern Mediterranean Health Journal [2024; Vol.30, Issue 1] / [المجلة الصحية لشرق المتوسط [2024; المجلد 30 , العدد 1

Eastern Mediterranean Health Journal is the official health journal published by the Eastern Mediterranean Regional Office of the World Health Organization. It is a forum for the presentation and promotion of new policies and initiatives in health services; and for the exchange of ideas concepts epidemiological data research findings and other information with special reference to the Eastern Mediterranean Region. It addresses all members of the health profession medical and other health educational institutes interested NGOs WHO Collaborating Centres and individuals within and outside the Region.

المجلة الصحية لشرق المتوسط هى المجلة الرسمية التى تصدرعن المكتب الاقليمى لشرق المتوسط بمنظمة الصحة العالمية. وهى منبر لتقديم السياسات والمبادرات الجديدة فى الصحة العامة والخدمات الصحية والترويج لها، و لتبادل الاراء و المفاهيم والمعطيات الوبائية ونتائج الابحاث وغير ذلك من المعلومات، و خاصة ما يتعلق منها باقليم شرق المتوسط. وهى موجهة الى كل اعضاء المهن الصحية، والكليات الطبية وسائر المعاهد التعليمية، و كذا المنظمات غير الحكومية المعنية، والمراكز المتعاونة مع منظمة الصحة العالمية والافراد المهتمين بالصحة فى الاقليم و خارجه

La Revue de Santé de la Méditerranée Orientale est une revue de santé officielle publiée par le Bureau régional de l’Organisation mondiale de la Santé pour la Méditerranée orientale. Elle offre une tribune pour la présentation et la promotion de nouvelles politiques et initiatives dans le domaine de la santé publique et des services de santé ainsi qu’à l’échange d’idées de concepts de données épidémiologiques de résultats de recherches et d’autres informations se rapportant plus particulièrement à la Région de la Méditerranée orientale. Elle s’adresse à tous les professionnels de la santé aux membres des instituts médicaux et autres instituts de formation médico-sanitaire aux ONG Centres collaborateurs de l’OMS et personnes concernés au sein et hors de la Région.

Sistema Obligatorio de Garantía de Calidad en Salud: aplicación al laboratorio clínico / Mandatory Quality Assurance System in Health: application to the clinical laboratory

En 1993, el Estado estableció el Sistema General de Seguridad Social en Salud, en el que se introdujeron los diferentes mecanismos legales para promover la calidad en las instituciones prestadoras de servicios de salud en el país. A partir de allí, se implantaron diferentes decretos. En la actualidad, el Sistema Obligatorio de Garantía de Calidad en Salud (SOGCS) se encuentra reglamentado en el Decreto 780 de 2016, Decreto Único Reglamentario del Sector Salud. El SOGCS está integrado por cuatro componentes principales: el Sistema Único de Habilitación (SUH), la Auditoría para el Mejoramiento de la Calidad, el Sistema Único de Acreditación (SUA) y el Sistema de Información para la Calidad en Salud, para dirigir y evaluar el desempeño de estas instituciones en términos de calidad y satisfacción social; además, se adoptó el Manual de Inscripción de Prestadores y Habilitación de Servicios de Salud, el cual contiene las condiciones mínimas que deben cumplir los servicios de salud ofertados y prestados en el país, para brindar seguridad a los usuarios en el proceso de la atención en salud. Dicho manual tiene por objeto definir las condiciones de verificación para la habilitación, como la capacidad técnico-administrativa, suficiencia patrimonial y financiera, y la capacidad tecnológica y científica. En este artículo se revisarán algunos conceptos generales del Sistema Obligatorio de Garantía de Calidad en Salud, así como los estándares y criterios de habilitación para laboratorios clínicos

In 1993, the State established the General System of Social Security in Health, in which different legal mechanisms were introduced to promote quality in the institutions providing health services in the country. From then on, different decrees were implemented. Currently, the Mandatory Health Quality Assurance System (SOGCS) is regulated by Decree 780 of 2016, the Sole Regulatory Decree of the Health Sector. SOGCS is made up of four main components: the Single Qualification System (SUH), the Audit for Quality Improvement, the Single Accreditation System (SUA) and the Health Quality Information System, to direct and evaluate the performance of these institutions in terms of quality and social satisfaction; in addition, the Health Services Provider Registration and Qualification Manual was adopted, which contains the minimum conditions that health services in the country must meet to provide security to users in the health care process. The purpose of this manual is to define the verification conditions for accreditation, such as technical-administrative capacity, patrimonial and financial sufficiency, and technological and scientific capacity. This article will review some general concepts of the Mandatory System of Quality Assurance in Health, as well as the standards and qualification criteria for clinical laboratories

Avaliação da qualidade na gestão de estoque em laboratório clínico no município de Fortaleza, Ceará / Quality assessment in stock management in a clinical laboratory in Fortaleza Municipality, Ceará

Objetivo: Este trabalho visa discutir sobre a correta gestão de insumos em um laboratório de análises clínicas. Nesse tipo de atividade, o Sistema de Gestão da Qualidade embasa uma série de processos visando garantir a fidedignidade dos resultados, pautados em processos bem estabelecidos. A gestão de insumos e estoque é uma atividade integrada entre os diversos setores existentes na empresa, fundamental para a garantia da qualidade do exame. Dessa forma, falhas na política de qualidade podem desencadear prejuízos materiais, institucionais e humanos. Métodos: Para tanto, realizou-se análise em um laboratório clínico privado de Fortaleza, Ceará, de modo observacional, prospectivo e descritivo, desenvolvido como estudo de caso. Resultados: Verificou-se que, apesar de sistemas de gestão de estoque serem adotados, não há treinamento efetivo e documentação detalhada que norteie todos os processos do setor. Conclusão: A ausência de processos bem definidos de gestão de estoque pode ser interferente importante na correta liberação dos laudos de exames, gerando prejuízos importantes à organização e ao cliente.

Objective: This paper aims to discuss the correct management of inputs in a clinical analysis laboratory. In this type of activity, the Quality Management System is based on a series of processes aimed at guaranteeing the reliability of results, based on well-established processes. The management of inputs and stock is an integrated activity among the various sectors existing in the company, essential for ensuring the quality of the exam. Thus, failures in quality policy can trigger material, institutional and human losses. Methods: For this purpose, an analysis was carried out in a private clinical laboratory in Fortaleza, Ceará, in an observational, prospective and descriptive manner, developed as a case study. Results: It was found that, although inventory management systems are adopted, there is no effective training and detailed documentation to guide all processes in the sector. Conclusion: The absence of well-defined inventory management processes can be an important interferer in the correct release of examination reports, generating significant losses to the organization and the customer.

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.

Impacto de la implementación de un sistema documental en el aseguramiento de la calidad en un laboratorio de análisis clínicos de un hospital público / Impact of the implementation of a documentary system on quality assurance in a clinical analysis laboratory of a public hospital

El objetivo de este trabajo fue establecer el impacto de la implementación de un sistema de gestión de calidad (SGC) en el desempeño del laboratorio de análisis clínicos del Hospital Materno Provincial. Se diseñaron diez indicadores de calidad (IC), que se midieron pre y posimplementación del sistema documental. Se encontró para el indicador solicitud médica incorrecta (SMI) una disminución de 11,2% a 6% cuando se implementó la gestión documental. Para el indicador omisión del diagnóstico (OD), el porcentaje bajó de 41,6% a 27,9% luego de la intervención. Se encontró un 5% de errores en ingreso al sistema informático del laboratorio (EI-SIL) en situación basal y 3,9% posimplementación, mientras que el indicador muestras mal remitidas (MMR) disminuyó de 3,1% a 1,9%. El 58% de los analitos disminuyó el índice de error total (IET) y el 80% aumentó el valor de sigma luego de la intervención. El 61% de los analitos disminuyó el valor de incertidumbre, mejorando de esta manera el desempeño de los métodos analíticos. El porcentaje de valores críticos (VC) comunicados al médico terapeuta antes de los 60 minutos aumentó del 20 al 54% después de la implementación de la gestión documental, mientras que el indicador reimpresión de informes (RI) disminuyó de 5,2 a 1,8%. El tiempo de respuesta (TAT) disminuyó de 164 a 125 minutos. La implementación de un SGC bajo los requisitos de normas internacionales mejoró el conocimiento y funcionamiento de los procesos del laboratorio clínico, evidenciado por la disminución de los errores en las etapas preanalítica, analítica y posanalítica.

The purpose of this study was to analyze the impact of implementing a quality management system (QMS) in the performance of a clinical laboratory of Hospital Materno Provincial. Ten quality indexes (QI) have been designed; they were measured before and after the implementation of the document management system (DMS). For the "incorrect medical application" index, there was a reduction from 11.2% to 6% when the DMS was implemented. For the "diagnostic omission" index, the percentage decreased from 41.6% to 27.9% after the implementation. Five per cent of mistakes were found in the admission of the laboratory computer system in the baseline state and 3.9% of the mistakes were found after implementation of the system. Meanwhile, the "incorrect sent samples" index decreased from 3.1% to 1.9%. Fifty eight per cent of the analytes decreased the total error index and 80% of them increased the sigma value after the intervention. Sixty one per cent of the analytes decreased the uncertainty value, thus improving the performance of analytical methods. The percentage of critical values communicated to the physician before the 60 minutes increased from 20% to 54% after the implementation of the DMS, while the "reprint of reports" index decreased from 5.2% to 1.8%. The turn around time (TAT) decreased from 164 to 125 minutes. The implementation of a QMS, under the requirements of international standards, improved the knowledge and the functioning of different processes of the clinical laboratory. This has been evidenced by the decrease of mistakes in the pre-analytical, analytical and post-analytical phases.

O objetivo deste trabalho foi estabelecer o impacto da implementação de um sistema de gestão de qualidade (SGC) no desempenho do laboratório de análises clínicas do Hospital Materno Provincial. Foram desenhados dez indicadores de qualidade (IQ), que foram medidos antes e depois da implementação do sistema documental. Foi achada uma diminuição de 11,2% para 6% no indicador solicitação médica incorreta, (SMI) quando se aplica a gestão documental. Para o indicador omissão do diagnóstico, a porcentagem baixou de 41,6% para 27,9% após a intervenção. Foram encontrados 5% de erros em entrada ao sistema informático do laboratório (EI-SIL) em situação basal e 3,9% pós-implantação, enquanto que o indicador amostras mal encaminhadas (AME) diminuiu de 3,1% para 1,9%. cincuenta e ocho por ciento dos analitos diminuíram o índice de erro total (IET) e 80% aumentou o valor de sigma após a intervenção. Sesenta e uno por ciento dos analitos diminuiu o valor de dúvidas, melhorando desta maneira o desempenho dos métodos analíticos. A porcentagem de valores críticos (VC) comunicados ao médico terapeuta antes dos 60 minutos aumentou de 20 para 54% depois da implementação da gestão documental, enquanto que o indicador reimpressão de relatórios diminuiu de 5,2 para 1,8%. O tempo de resposta diminuiu de 164 para 125 minutos. A implementação de um SGC sob os requisitos de normas internacionais melhorou o conhecimento e funcionamento dos processos do laboratório clínico, evidenciado pela diminuição dos erros nas etapas pré-analítica, analítica e pós-analítica.

Aplicación de Seis Sigma en el Laboratorio Clínico / Six Sigma Application in the Clinical Laboratory

Seis Sigma es un método de mejora de procesos que se focaliza en disminuir la variabilidad de los mismos. El enfoque más común es contar los defectos, determinar el porcentaje, convertirlos a una tasa de defectos por millón y luego usar una tabla para buscar la métrica sigma apropiada. El segundo enfoque consiste en utilizar la medida de la variación del proceso para estimar la métrica sigma. En el laboratorio clínico se pueden aplicar ambos conceptos según la etapa del laboratorio en la cual se pretenda usar la métrica sigma. Para ambos enfoques un proceso de 6 sigmas es considerado un proceso eficiente, de alta calidad. En este trabajo se planteó para la etapa preanalítica una meta mínima de 4 sigmas. Algunos procesos muestran un buen desempeño con indicadores de calidad con sigmas mayores de 4. Sin embargo, varios de ellos tienen sigmas menores que la meta propuesta demostrando ser los más vulnerables. En Química Clínica y Hematología, la elección del requisito de calidad es el punto clave para armonizar la métrica sigma junto a la estrategia para la obtención del error sistemático y aleatorio. En este trabajo se muestran las diferentes estrategias para relacionar el desempeño basado en el sigma del proceso analítico con las reglas de validación de las corridas analíticas.

Six Sigma is a method for improvement of processes that focuses on reducing their variability. The most common approach is to count the defects, determine the percentage, convert them to a defect rate per million and then use a table to find the appropriate sigma metric. The second approach consists of using the process variation measure to estimate the sigma metric. In the clinical laboratory, both concepts can be applied according to the stage of the laboratory in which the sigma metric is intended to be used. For both approaches, a 6 sigma process is considered an efficient, high quality process. In this work, a minimum goal of 4 sigma was raised for the preanalytical stage. Some processes show good performance with quality indicators with sigma greater than 4. However, several of them have sigma lower than the proposed goal proving to be the most vulnerable. In Clinical Chemistry and Hematology, the choice of the quality requirement is the key point to harmonize the Sigma metric together with the strategy to obtain systematic and random error. This paper shows the different strategies to relate the performance based on the sigma of the analytical process with the validation rules of the analytical runs.

Seis Sigma é um método de melhoria de processos focado na redução da sua variabilidade. A abordagem mais comum é contar os defeitos, determinar a porcentagem, convertê-los numa taxa de defeitos por milhão e, depois disso, usar uma tabela para procurar a métrica sigma apropriada. A segunda abordagem consiste em usar a medida da variação do processo para estimar a métrica sigma. No laboratório clínico, podem ser aplicados os dois conceitos de acordo com a fase do laboratório em que se pretenda usar a métrica sigma. Para ambas as abordagens, um processo de 6-sigmas é considerado um processo eficiente e de alta qualidade. Neste trabalho, uma meta mínima de 4 sigmas foi definida para o estágio pré-analítico. Alguns processos mostram bom desempenho com indicadores de qualidade com sigmas maiores que 4. No entanto, vários deles têm sigmas menores que a meta proposta provando ser os mais vulneráveis. Em Química Clínica e Hematologia, a escolha do requisito de qualidade é o ponto chave para harmonizar a métrica sigma juntamente com a estratégia para obter o erro sistemático e aleatório. Este artigo mostra as diferentes estratégias para relacionar o desempenho baseado no sigma do processo analítico com as regras de validação das execuções analíticas.

Modelo de gestión impuesto por la transformación tecnológica en los laboratorios de análisis clínicos. Impacto en el Hospital Garrahan a treinta años de historia / Management model imposed by the technological transformation in clinical analysis laboratories. Impact at Hospital Garrahan on thirty years of history

Las actividades del laboratorio de análisis clínicos están fuertemente identificadas con el ritmo del cambio tecnológico. En los últimos treinta años se vive un cambio de época que afecta la cultura y la experiencia humana en todos sus aspectos. Este cambio modifico el modelo de producción. En el laboratorio ha incorporado tecnología que combina la química, la robótica, la óptica y la informática, y se ha impuesto como premisa externa de cambio un modelo de gestión global que afecta la forma de trabajo, la gestión y el rol de los profesionales (bioquímicos y técnicos). El hospital Garrahan inscribe su historia dentro de este periodo histórico y el proceso de cambio ha generado y genera incertidumbre, resistencia y adecuaciones al nuevo paradigma impuesto. Nos fijamos como objetivo analizar el impacto de este cambio sobre la gestión de procesos del laboratorio de nuestro hospital. Comprobamos que la demanda del laboratorio se incrementó al ritmo del crecimiento de consultas y egresos de pacientes, y de como este aumento demando adecuaciones de gestión, modificaciones arquitectónicas, incorporación de tecnologías (algunas emergentes), aumento en la trazabilidad de muestras y resultados, y mejoras en la seguridad del paciente en todos sus aspectos. Describimos el nuevo paradigma, sus ventajas, las adecuaciones hechas y los tiempos en que se fueron realizados. Concluimos sugiriendo un rol para los profesionales del laboratorio en función del paradigma en curso

Activities at the laboratory of clinical analysis are closely related to the pace of technological change. Over the past 30 years there has been a change of times affecting human culture and experience in all its aspects. This change has modified the model of production. The laboratory has incorporated technology combining chemistry, robotics, and optics, as well as information technology, and the premise of a global management model has been imposed affecting the way of working, administration, and the role of professionals (biochemists and technicians). Garrahan hospital has written its own history in this historical period and process of change has produced uncertainty, resistance as well as adaptation to this new paradigm. Our aim has been to analyze the impact of this change on the management of processes of the laboratory of our hospital. We have observed that the demand of the laboratory has increased at the same pace as the increase of patient visits and discharges. This increase has required modifications in the management and facilities, incorporation of new technologies (some of them state of the art), improved traceability of the samples and results, and improvements in patient safety in all aspects. Here we describe the new paradigm, its advantages, adaptations made, and improved times introduced. In our conclusions, we consider the new role for laboratory professionals in this paradigm.

Strategic framework for strengthening health laboratory services 2016–2020

The strategic framework for strengthening health laboratory services is intended to guide countries in developing sustainable national health laboratory systems in order to improve clinical and public health services in a cross-cutting manner and ensure better preparedness for, surveillance of, and response to epidemic-prone diseases, health security issues and other potential emergencies of public health concern. The strategic framework is built around six interrelated strategic goals, each comprising a menu of activities and corresponding desired outcomes, from which Member States can draw based on their national priorities, resources, capacities, regulations and specific contexts. A monitoring and evaluation framework is also outlined and includes country and regional indicators

Gestión de riesgos en los laboratorios clínicos / Risk management in clinical laboratories

Las pruebas de laboratorio tienen un impacto crítico en la toma de decisiones médicas. Sin embargo, en el ciclo, que inicia con la solicitud del médico y termina con la interpretación final, pueden ocurrir errores en cualquier etapa. La evaluación de las causas que generan estos errores y la toma de medidas para detectarlos y prevenirlos, antes de que causen daño, es crítico en el proceso analítico. Esto se logra a través de la gestión de riesgos (GR). La norma EP23­A, Control de calidad en el laboratorio basado en la gestión de riesgos, del Clinical Laboratory Standards Institute (CLSI), introduce los principios de la GR para los laboratorios clínicos. Esta directriz permite desarrollar un plan de GR, individualizado. Este artículo resume los principios de la GR en los laboratorios clínicos...

Laboratory tests have a critical impact on medical decision making. However, in the cycle, which starts with the physicianÆs request and ends with the final interpretation, errors may occur at any stage. The evaluation of the causes of these errors and to take measures to detect and prevent them before they cause harm, is critical in the analytical process. This is achieved through risk management (RM). EP23 Guideline: quality control based risk management laboratory, of the Clinical Laboratory Standards Institute (CLSI), introduces the principles of RM for clinical laboratories. This directive allows develop a plan of RM, individualized. This article summarizes the principles of the RM in clinical laboratories...

Medical diagnosis and corporate use of Brazilian territory: an analysis of the spatial productive circuit of diagnostic reagents

The formation of what Milton Santos called the technical-scientific and informational milieu is marked by the profound interaction between science and technique, both under shelter of the market. In this milieu, we see new technical objects arising, whose content is given by science. When dealing specifically with medicine, this trait is still more remarkable, which is evident, for instance, when we analyze technical diagnosis systems in the current period, for they come to configure specialized economic segments with high added value production. In this article, we discuss how a significant set of companies focused on diagnosis concurs to a new type of urbanization in Brazilian territory, considering the Health Economy and the health-industry complex. Marked by the corporate use of territory, this urbanization is shaped by the establishment of spatial productive circuits and their respective circles of space cooperation, and one of its main characteristics has been the concentration and centralization of capital.

A formação daquilo que o geógrafo Milton Santos denominou meio técnico-científico-informacional é marcada pela profunda interação entre ciência e técnica, ambas sob a égide do mercado. Nesse meio, vemos surgirem novos objetos técnicos, cujo conteúdo é dado pela ciência. Quando tratamos especificamente da medicina, essa característica é ainda mais marcante, o que fica manifesto, por exemplo, quando analisamos os atuais sistemas técnicos de diagnóstico, que acabam configurando segmentos econômicos especializados com produção de alto valor agregado. Neste artigo, buscou-se tratar da economia da saúde e do complexo industrial que a envolve discutindo como um conjunto significativo de empresas voltadas ao diagnóstico concorre para um novo tipo de urbanização no território brasileiro. Marcada pelo uso corporativo do território, essa urbanização se conforma pelo estabelecimento de circuitos espaciais produtivos, dos quais focaremos aqui os da saúde e seus respectivos círculos de cooperação no espaço. Veremos, então, que entre suas principais características estão a concentração e a centralização do capital.

Rational use of blood calcium determinations / Uso racional da dosagem de cálcio no sangue

CONTEXT AND OBJECTIVE: This study was motivated by the recent excessive increase in requests for blood calcium determinations and laboratory tests in general, in the Hospital das Clínicas complex of Faculdade de Medicina, Universidade de São Paulo (HCFMUSP). Its aim was to suggest rules for the determination of total and ionized calcium in our intensive care units, emergency department, wards and outpatient services, thus contributing towards improving the quality of medical care and achieving more appropriate use of human and financial resources. DESIGN AND SETTING: Critical analysis on clinical and laboratory data and the pertinent scientific literature, conducted by the study group for rational clinical laboratory use, which is part of the Central Laboratory Division, HCFMUSP. METHODS: The study group reviewed scientific publications, statistics and clinical and laboratory data concerning requests for total and ionized calcium determinations in the settings of intensive care units, emergency department, wards and outpatient services. RESULTS: From this critical analysis, clinical decision flow diagrams aimed at providing guidance for ordering these tests were constructed. CONCLUSIONS: Use of the proposed flow diagrams may help to limit the numbers of inappropriate requests for ionized and total calcium determinations, with consequent reductions in the number of tests, risks to patients and unnecessary costs. .

CONTEXTO E OBJETIVO: Este trabalho foi motivado pelo recente aumento excessivo de solicitações de dosagem de cálcio no sangue, assim como de exames laboratoriais em geral, no complexo do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP). Seu objetivo foi sugerir regras para a determinação de cálcio total e iônico nas nossas unidades de terapia intensiva, pronto-socorro, enfermarias e ambulatórios e contribuir para a melhoria da qualidade da assistência médica, com utilização mais adequada dos recursos humanos e financeiros. TIPO DO ESTUDO E LOCAL: Análise crítica de dados clínicos, laboratoriais e da literatura médica pertinente, realizada pelo grupo de estudos para o uso racional do laboratório clínico, vinculado à Divisão de Laboratório Central do HCFMUSP. MÉTODOS: O grupo de estudos reviu publicações científicas, estatísticas e dados clínico-laboratoriais relativos às solicitações de cálcio total e iônico nos ambientes das unidades de terapia intensiva, prontos-socorros, enfermarias e ambulatórios. RESULTADOS: A partir dessa análise crítica, foram construídos fluxogramas de decisão clínica que visam orientar a requisição desses testes. CONCLUSÕES: A utilização dos fluxogramas propostos pode ajudar a limitar a solicitação inadequada das dosagens de cálcio total e iônico, com consequente redução do número de exames, de riscos para os pacientes e de custos desnecessários. .