Maria Elizabete Mendes

A utilidade dos indicadores da qualidade no gerenciamento de laboratórios clínicos

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).

Tradescantia pallida cv. purpurea Boom in the Characterization of Air Pollution by Accumulation of Trace Elements

Abstract Tradescantia pallida cv. purpurea, a plant species widely employed for ornamentation in Brazil, has been successfully used for monitoring the genotoxicity of various agents by the micronucleus assay. To amplify knowledge about its suitability as a bioindicator species, its capacity for accumulating trace elements from urban air pollution was evaluated. T. pallida was rooted using standardized soil, and the vases were distributed in two highly polluted sites of the urban area of São Paulo, Brazil (Cerqueira César and Congonhas districts), and in one unpolluted control site situated approximately 50 km from downtown São Paulo (in Caucaia do Alto). Approximately six months after exposure to pollutants, adult leaves of this plant were collected monthly for 12 months. The leaves were washed with deionized water, dried, and ground for analyses. Characterization of element levels was carried out by neutron activation analysis. Powdered samples and standards were irradiated at the IEA-R1 nuclear reactor for short and long periods, and concentrations of As, Ba, Br, Ca, Ce, Cl, Cr, Co, Fe, K, La, Mn, Na, Rb, Sb, Sc, Sr, Th, and Zn were determined. Analysis of variance applied to the results indicated that samples from polluted sites present the highest concentrations of Ba, Ce, Cr, Co, Fe, La, Sb, and Sc (p < 0.05). Discriminant analysis revealed that it was possible to distinguish the two polluted areas with a precision of 97.5%, based on the amount of pollutant elements measured in the plants at each site. The results indicated the potential use of T. pallida as an accumulator plant for air pollution biomonitoring.

Bioequivalence of a new cyclosporine a formulation to Neoral.

New cyclosporine A (CsA) formulations must prove their bioequivalence to Neoral®, the reference CsA formulation, to allow free prescription for the patients. The aim of this study was to compare the pharmacokinetics (PK) of a new CsA formulation (Zinograf-ME), produced by Strides-Arcolab, to Neoral and to demonstrate their interchangeability in stable renal transplant recipients. Twelve-hour PK studies were obtained from 18 (13 M/5 F) adult patients (mean age 44.7 ± 12 years). They received their renal allografts from 13 cadaver and 5 living donors. Before enrollment, all patients were receiving a third generic CsA for a mean of 48 months. Nine patients were also under azathioprine and 9 under mycophenolate mofetil; 17 received prednisone. A single oral dose of either Zinograf or Neoral was administered. The first PK study was performed with one formulation, and 1 week later, a second PK was done with the other formulation. During the washout period, patients continued taking the third CsA formulation. The drug substitution was done milligram-for-milligram. The CsA whole-blood level was measured by TDx immunoassay. Mean ± SD of area under the curve (AUC), maximum concentration (C max), and concentration at the second hour (C2) of Zinograf were not statistically different from those with Neoral (4019 ± 1466 vs 3971 ± 1325 ng·h/mL, 998 ± 376 vs 1021 ± 356 ng/mL, and 707 ± 254 vs 734 ± 229 ng/mL, respectively). In the same way, the Zinograf 90% confidence interval for either C max (−123, +77 ng/mL) or AUC (−214, +311 ng·mL/h) were within the Neoral bioequivalence interval for the same parameters (±204 ng/mL and ±794 ng·mL/h, respectively). These data demonstrate that the ZinografME CsA formulation is bioequivalent to Neoral.

Practical aspects of the use of FMEA tool in clinical laboratory risk management

INTRODUCAO: O artigo apresenta a ferramenta de analise do modo e do efeito de falhas (FMEA) dentro de um laboratorio clinico por meio da introducao de nova tecnologia para gasometria e calcio ionico serico em analisadores multiparâmetros do tipo testes laboratoriais remotos (TLR) ou point of care testing (POCT). OBJETIVO: Apresentar a FMEA como ferramenta de gestao de riscos e de melhoria em um laboratorio publico ao introduzir novas tecnologias. METODOS: A mudanca de analisadores de gases multiparâmetros do tipo POCT foi definida e descrita como um processo. A seguir, foram apresentados os criterios para a avaliacao dos riscos e a sua quantificacao. Foram estudados os modos de falha pelos quais algo poderia falhar nos componentes desse processo. Estabeleceram-se tres planos de acoes que envolviam melhorias a serem introduzidas na mudanca de tecnologia. A FMEA foi aplicada em dois momentos: no inicio do projeto e apos a implantacao das medidas propostas. RESULTADOS: O primeiro plano envolveu medidas administrativas vinculadas ao processo licitatorio; a segunda acao preventiva envolveu a possibilidade de qual fornecedor venceria a licitacao, estudando-se a eficiencia do analisador e seu impacto na produtividade; o terceiro conjunto de acoes foi dirigido as melhorias no relacionamento com o corpo clinico para minimizar as eventuais reclamacoes. As ultimas acoes referiram-se a contratacao de novos funcionarios para atender a demanda crescente. CONCLUSAO: A FMEA revelou-se um instrumento de melhoria de desempenho para o laboratorio, que de maneira proativa identifica, prioriza e mitiga os riscos do paciente.

Modelo de implantação de plano de gerenciamento de resíduos no laboratório clínico

INTRODUCTION: As far as environmental awareness is concerned, one of the main challenges in society has been to implement and optimize systems that perform the appropriate disposal of waste generated by several human activities. In Brazil, both the development and implementation of a Health Services Waste Management Program - HSWMP (Plano de Gerenciamento de Residuos de Servicos de Saude [PGRSS]) are legally required. OBJECTIVE: This article describes the implementation of HSWMP in the Central Laboratory Division of University of Sao Paulo Medical School Hospital - CLD/USP-MSH (Divisao de Laboratorio Central do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo [DLC/HC-FMUSP]) comprising material, human and physical area resources. METHOD: The process started with the incorporation of the concept of sustainability into the Integrated Management System - IMS (Sistema Integrado de Gestao [SIG]), which focuses on the non-generation, minimization and recycling of health services waste in order to preserve natural resources and reduce environmental impact. CONCLUSION: The HSWMP facilitated communication, information dissemination, awareness, competence and training of all parties involved. Several activities were conducted simultaneously, which resulted in behavioral changes.

Perigos e riscos na medicina laboratorial: identificação e avaliação

Workplace hazards are related to any potentially harmful source in terms of lesions, injuries and health damage or a combination of these factors. The risks are consequences of laboratory hazards. Clinical laboratories pose multiple occupational hazards, which are categorized as biological, physical, chemical, ergonomic and accident prone. It is important to identify risks, assess the impacts that may affect the enterprise and establish prioritization criteria for making decisions. Furthermore, it is essential to implement strategies and preventive actions in order to avoid flaws or potential damage. Not only does this article propose a systematic identification and assessment of hazards, health risks and occupational safety within clinical laboratories, but it also discusses their applications in operational practice.

Improvement of an HPLC method to determine urinary δ-aminolevulinic acid

INTRODUCAO E OBJETIVO: A proposta deste estudo foi avaliar e aprimorar uma metodologia de cromatografia liquida de alta eficiencia (CLAE)(11, 12), a fim de determinar o acido δ-aminolevulinico urinario (ALA-U) utilizando volumes reduzidos de amostra. METODO: O metodo baseia-se na formacao de um composto fluorescente e posterior corrida cromatografica de 15 minutos. RESULTADOS: O metodo apresentou linearidade, precisao e recuperacao adequadas. Os resultados para as amostras de urina testadas foram 1,2 ± 0,9 mg/l (media ± desvio padrao) de ALA-U. CONCLUSAO: O metodo foi considerado adequado para analises de rotina de ALA-U.

Avaliação da interferência do ácido ascórbico na detecção da glicosúria

INTRODUCTION: Ascorbic acid (vitamin C) is commonly used as a vitamin supplement. It is a water soluble vitamin, which is excreted through urine and may interfere in laboratory tests as well as redox reactions for urinary glucose detection. OBJECTIVE: This study aims to assess ascorbic acid interference in glycosuria detection by dry chemistry method (reagent strips). MATERIAL AND METHODS: Urine samples were evaluated by using Clinitek Atlas chemistry analyzer (Siemens Healthcare Diagnostics Inc., USA). Four urine samples with different glucose concentrations were selected: 100 mg/dl, 250 mg/dl, 500 mg/dl and > 1,000 mg/dl. 5 aliquots were created for each glucose concentration and a solution of ascorbic acid 200 mg/dl was added, sufficient to obtain a final ascorbic acid concentration of 20 mg/dl in the first tube, 50 mg/dl in the second tube, 270 mg/dl in the third tube, 1,000 mg/dl the fourth tube, and 2,000 mg/dl in the fifth tube. After the addition of ascorbic acid, the samples were reassessed by using Clinitek Atlas chemistry analyzer. RESULTS: There was no interference at concentrations of 20 mg/dl. However, there was ascorbic acid interference at concentrations higher than or equal to 50 mg/dl, which was characterized by false-negative results for urinary glucose detection. CONCLUSION: The results corroborated the interference of ascorbic acid in dry chemistry method (reagent strips) inasmuch as it underestimates urinary glucose levels.

A importância da qualidade da água reagente no laboratório clínico

Water is a reagent used in most laboratory tests and, therefore, must follow stringent quality control standards. The urban water supply has organic molecules, inorganic ions, particles, colloids, gases, bacteria and their products, which may alter laboratory test results and cause occasional errors and mechanical failures in diagnostic equipment. To remove these impurities, it is necessary to use a combination of purification technologies. There are several organizations that specify reagent water standards to minimize its interference in laboratory assays. Most laboratories set standards established by the Clinical and Laboratory Standards Institute (CLSI), which classifies the type of water as follows: clinical laboratory reagent water (CLRW), special reagent water (SRW) and instrumental feed water (IFW). The quality monitoring is performed by means of assessing the resistivity, conductivity, total organic carbon (TOC), microbial control and endotoxins. The parameters are evaluated in accordance with the frequency determined by the standard used. In this article we discuss the importance of water employed in laboratory procedures, its quality control and its interference in laboratory assays.

Indicadores de sustentabilidade em medicina laboratorial

The article presents the conceptual principles on sustainable development and sustainability. Furthermore, it evaluates the progress and impacts on the economy, environment and society. It discusses the applicability of the concepts of corporate sustainability in laboratory medicine and the challenges of deployment in the clinical laboratory. The impact of sustainability indicators and their role in management are also critically reviewed from the perspective of social and environmental balance. Additionally, the text provides some tools for evaluation and interpretation of indicators and their corresponding application in the critical analysis process. Lastly, the article describes the importance of sustainability indicators in the practice of benchmarking and its applicability in the clinical laboratory