Orientador: Márjorie de Assis Golim / Resumo: O sistema de qualidade é de suma importância em laboratórios clínicos para avaliação de processos analíticos de maneira que os resultados liberados sejam verdadeiros. Para a metodologia de imunofenotipagem celular por citometria de fluxo as amostras devem ser frescas e os exames realizados preferencialmente dentro de 48 horas. É relevante utilizar amostras de controle de qualidade internos (CQI) padronizadas, de modo que possam ser repetidas rotineiramente, como referencial de qualidade. No Brasil, poucos serviços comercializam amostras preservadas para uso como CQI. Deste modo, a padronização in house com validação de processo para obtenção de amostras que possam ser utilizadas para esta finalidade é relevante. O objetivo deste trabalho foi desenvolver controle de qualidade interno para as rotinas de quantificação de células progenitoras hematopoéticas (CPH), utilizando solução preservante e avaliar a reprodutibilidade e estabilidade ao longo do tempo. Foram preparadas soluções preservantes contendo diferentes concentrações de anticoagulantes e fixadores, e destas, foi selecionada uma composição, originalmente padronizada neste estudo. Foram utilizados 5mL de sangue periférico, sendo este acrescido da solução a ser testada. Imediatamente, realizou-se a quantificação das populações de CPH em tubo Trucount®, usando anti-CD45, anti-CD34 e 7-AAD, conforme indicado pelo fabricante. A leitura foi realizada em citômetro de fluxo modelo FACSCalibur®-BD, para obtenção dos valores abs... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: The quality system is of paramount importance in clinical laboratories for evaluating analytical processes in order to consider true the released results. The samples must be performed fresh preferably within 48 hours for the cell immunophenotyping methodology by flow cytometry. It is relevant to use standardized internal quality control (IQC) samples, thus they could be repeated routinely, as a quality benchmark. In Brazil, only a few services commercialize preserved samples for use as IQC. Therefore, it is relevant to use in-house standardization with process validation to obtain samples that can be used for this purpose. The objective of this work was to develop an IQC for a daily routine quantification of hematopoietic stem cells (HSCs) by using a preservative solution and to evaluate the reproducibility and stability over time. Preservative solutions containing different concentrations of anticoagulants and fixatives were prepared, and from these, a composition was selected, which was previously originally standardized in this study. 5mL of peripheral blood were used, which was added to the solution to be tested. The HSCs populations were immediately quantified in a Trucount® tube, using anti-CD45, anti-CD34 and 7-AAD, as indicated by the manufacturer. The reading was performed in a flow cytometer model FACSCalibur®-BD in order to obtain the absolute values of HSCs on day zero, 7, 21, 35 and 49. During this period, the samples were kept refrigerated (2 to 8ºC). The value... (Complete abstract click electronic access below) / Mestre

L'anàlisi qualitatiu ha estat sempre molt important en el control antidopatge i constitueix cada cop més una part molt significativa de l'activitat diària d'altres tipus de laboratoris. Tanmateix, no existeixen guies o documents específics per ajudar els laboratoris a implantar sistemes de qualitat quan es disposa d'aquest tipus de mètodes. L'objectiu general d'aquesta tesi ha estat el desenvolupament de les eines necessàries per assegurar la qualitat i fiabilitat dels resultats produïts per mètodes d'anàlisi qualitatius, treballant en tres aspectes fonamentals per a l'assegurament de la qualitat dels resultats als laboratoris d'anàlisi: la validació de mètodes, el control intern de la qualitat, i els exercicis d'intercomparació.S'ha elaborat un protocol de validació, s'ha implantat un sistema de control intern de la qualitat per a mètodes d'anàlisi qualitatius i, finalment, s'han elaborat protocols per a la preparació de mostres que seran utilitzades com a materials d'assaig en exercicis d'intercomparació o com a materials de referència, i per realitzar estudis d'homogeneïtat i d'estabilitat, que han estat aplicats a l'estudi de l'estabilitat de substàncies d'interès en control antidopatge. / Qualitative analysis has been very important in antidoping control and its becoming a significant part of the daily activity of other type of laboratories. However, there is a lack of guidance or specific documents to help laboratories to implement quality assurance systems when using these type of methods. The aim of this thesis has been the development of the necessary tools to ensure the quality and reliability of results released by qualitative analytical methods, working in the three main aspects of quality assurance in the analytical laboratory: method validation, internal quality control and intercomparison exercises.A protocol for method validation has been proposed and an internal quality control system for qualitative methodologies has been established. Finally, protocols for the preparation of samples to be used in intercomparison exercises or as reference materials, including homogeneity and stability studies, have been prepared. These protocols have been applied to study the stability of substances with especial interest in antiodoping control.

Made available in DSpace on 2014-08-20T13:44:50Z (GMT). No. of bitstreams: 1 dissertacao_cristiane_brisolara.pdf: 435276 bytes, checksum: ec757953db838368371dc056217a1761 (MD5) Previous issue date: 2009-12-14 / Analysis of data referring to the tests made on reception of soybean seed harvested on Cereal Ouro farms, a company originally from Rio Grande do Sul, currently installed in Rio Verde/Goiás, during 2007/2008 crop, in order to analyze through the results of the tests conducted by the internal quality control (CIQ), the importance of establishing evaluation parameters used at the reception on the quality of soybean seed lots. The CIQ, an important tool of the company, helps to identify problems and its possible causes and, in decision making, reducing large-scale risks at any stage of the production, since it generated information about the performance potential of the seeds. The evaluations about the quality of soybean seed received in seed processing unit (UBS) included tests of percentage of moisture, percentage of mechanical damage (by testing sodium hypochlorite), percentage of broken seeds, percentage of green seed by sieve size and vigor, and viability, by tetrazolium test. The results were compared to tests done after the formation of the lots, which passed by germination, emergence in sand and tetrazolium tests. Concluding that there is a tendency of soybean seeds maintain high quality during the storage, showing that the quality standards adopted on reception must be strict. / Análise de dados referente aos testes feitos na recepção da semente de soja colhida nas fazendas da Cereal Ouro, empresa originária do Rio Grande do Sul e atualmente instalada em Rio Verde, município do Estado de Goiás, durante a safra 2007/2008, com objetivo de analisar através dos resultados dos testes realizados pelo controle interno de qualidade (CIQ), a importância da determinação de parâmetros de avaliação usados na recepção sobre a qualidade final dos lotes da semente de soja. O CIQ, importante ferramenta da empresa, auxilia na identificação de problemas e suas possíveis causas, e na tomada de decisão, reduzindo em larga escala os riscos em qualquer das fases de produção, pois gera informações detalhadas sobre o potencial de desempenho das sementes. As avaliações da qualidade da semente de soja recebida na unidade de beneficiamento de sementes (UBS) incluíram os testes de percentual de umidade, percentual de dano mecânico (através do teste de hipoclorito de sódio), percentual de sementes quebradas, percentual de sementes esverdeadas por tamanho de peneira e vigor e viabilidade pelo teste de tetrazólio. Os resultados destas avaliações foram comparados aos testes feitos após a formação dos lotes da semente de soja, os quais passaram pelos testes de germinação, emergência em areia e tetrazólio. Concluindo-se que Há uma tendência de as sementes de soja manterem elevada qualidade no armazenamento, evidenciando que os padrões de qualidade adotados na recepção devem ser rigorosos.

Abstract Point-of-care testing (POCT) is defined as laboratory tests performed outside the traditional clinical laboratory close to the patient at the time and place where care is received, such as hospitals and healthcare centers. The main reason for the use of POCT is that they provide rapid results and enable prompt interventions, with hopefully improved patient outcomes. All phases of laboratory procedure are included in POCT offering many opportunities for errors, which can influence on patients’ treatment. The measurements are more often performed by nurses than by laboratory professionals. These nurses have different kinds of professional backgrounds, e.g. public health nurses, registered and practical nurses, with minimal or no knowledge of laboratory procedures. The aim of the study was to develop a two-step training and management strategy for nurses to do POCT in hospital and primary healthcare center. In accordance with the strategy, with reasonable investment of laboratory resources, designated contact nurses were first trained in POCT by laboratory professionals, after which the contact nurses trained other nurses in POCT their respective units. Blood glucose, the most common point-of-care (POC) test, was chosen as an example to investigate the influence of training on the quality of the test performed by nurses. The quality of blood glucose measurements was studied by analyzing the control results obtained by nurses and biomedical laboratory scientists (BLSs). The study participants included nurses who were either untrained or trained to do POCT by using the developed interactive two-step training strategy. In conclusion, the nurses trained by using interactive two-step strategy achieved near-similar quality of blood glucose measurements as BLSs. The good quality of glucose measurements, once achieved by training, was also sustained in the long-term. / Tiivistelmä Määritelmän mukaan vieritutkimuksiksi kutsutaan laboratoriotutkimuksia, joita tehdään perinteisen laboratorion ulkopuolella, tarvittaessa lähellä potilasta sairaalassa ja perusterveydenhuollon alueella. Pääasiassa vieritutkimuksia tehdään silloin kun tulos halutaan saada nopeasti ennen hoitopäätöstä tai tulevaa toimenpidettä. Vieritutkimusten tekeminen sisältää kaikki laboratoriotyön vaiheet ja jokaisessa vaiheessa on mahdollisuus tehdä virheitä, jotka voivat vaikuttaa potilaiden hoitoon. Laboratorioammattilaisten sijaan määrityksiä tekevät yhä useammin hoitajat sairaalan eri yksiköissä ja perusterveydenhuollon alueella. Näillä hoitajilla on erilainen ammatillinen peruskoulutus, kuten perushoitajan tai sairaanhoitajan koulutus, ja heillä on vähän tai ei ollenkaan tietoa laboratoriomenetelmistä. Tämän tutkimuksen tarkoituksena oli kehittää hoitajien vieritutkimustoimintaan koulutus- ja hallintomalli, joka toimisi sekä sairaalassa että terveyskeskuksessa. Strategian perusteena oli käyttää suhteellisen vähän laboratorioresursseja ja päästä silti hyvään laadulliseen lopputulokseen. Strategiaksi valittiin kaksiportainen, vuorovaikutteinen koulutusmalli, jossa laboratorioammattilaiset kouluttivat sairaalan ja perusterveydenhuollon yksiköissä ns. yhdyshenkilöt, jotka puolestaan kouluttivat edelleen oman yksikkönsä muut hoitajat tekemään vieritutkimuksia. Veren glukoosimääritys, joka on yleisin vieritutkimus, valittiin esimerkkitutkimukseksi tutkittaessa koulutuksen vaikutusta hoitajien tekemien vieritutkimusten laatuun. Veren glukoosimääritysten laatutasoa tutkittiin analysoimalla hoitajien ja laboratoriohoitajien tekemien kontrollinäytteiden tuloksia. Tutkimukseen osallistui hoitajia, jotka oli koulutettu kehitetyllä vuorovaikutteisella kaksiportaisella koulutusstrategialla vieritutkimusten tekemiseen, sekä hoitajia, jotka eivät olleet saaneet vastaavaa koulutusta. Koulutusmallin avulla hoitajien suorittamien vieritutkimusten laatu parani ja he saavuttivat lähes saman laatutason kuin laboratoriohoitajat. Hyvä, kerran saavutettu glukoosimääritysten laatutaso säilyi myös pitkällä aikajaksolla.

The purpose of quality control within internal auditing functions is to ensure that internal auditing functions add value by providing a quality service. The aim of this research project was to investigate the importance of quality control within internal auditing functions as prescribed by the standards and guidelines of the internal auditing profession. It was also attempted to determine to what extent these standards and guidelines are applied within internal auditing functions in South Africa. The study concluded that quality control is not adequately applied within all internal auditing functions in South Africa. Compliance with the internal auditing standards (implemented on 1 January 2002) should contribute to improve the situation. The internal auditors’ professional body should motivate internal auditing functions to exercise quality control according to the internal auditing standards. This will uplift the image of the internal auditing profession and ensure the future existence of internal auditing functions. / Auditing / M.Comm.

Made available in DSpace on 2014-07-29T15:25:16Z (GMT). No. of bitstreams: 1 Suelene Brito do Nascimento.pdf: 777082 bytes, checksum: f9660425f3055477271c6efbe8608c9e (MD5) Previous issue date: 2011-09-29 / False-negative rates constitute a common problem in the daily routine of cytopathology laboratories. Among the various internal quality control methods, 10% random review is the least effective in detecting false-negative results in routine screening. On the other hand, good results have been found with 100% rapid review and with rapid prescreening. Nevertheless, no studies comparing these two methods have been reported. Objective: To compare the performance of rapid prescreening and 100% rapid review as internal quality control methods in cervical cytopathology. Methods: Over 27 months, 12,208 cervical cytology smears collected from Units of Primary Health Care of Goiânia were submitted to rapid prescreening and routine screening at Rômulo Rocha Center for Clinical Analyses at the School of Pharmacy, Federal University of Goiás, Goiânia, Goiás, Brazil. The 100% rapid review method was performed on all smears classified as negative at routine screening. Conflicting results obtained with either method were reviewed in detail to define final diagnosis, which was considered the gold-standard for evaluating the performance of rapid prescreening and 100% rapid review. In cases with abnormal cytology were evaluated the results of colposcopy, histopathology and of the new cytopathology. The sensitivity and specificity of internal quality control methods were estimated when compared to the final diagnosis, and to follow-up colposcopy, histopathology and at new cytopathology. Results: Compared to the final diagnosis, the sensitivity of routine screening and rapid prescreening was 72.9% (IC 95%: 70,0%-75,8%) and 75.6% (IC 95%: 72,8%-78,4%), respectively. Taking into account only those smears classified as negative at routine screening, the sensitivity of rapid prescreening and RR-100% was 90.2% (IC 95%: 86,4-93,9) and 57.0% (50,8%-63,2%), respectively. Rapid prescreening identified 220 (1.8%), while RR-100% identified 140 (1.15%) of the 244 (2.0%) cases with false-negative results at routine screening. The sensitivity of rapid prescreening in detect abnormal cases at follow-up colposcopy, histopathology and at new cytopathology was 87.5% (CI95%; 74.3%-100.7%) 82,4% (CI95%: 64.2%-100.,5%), 95.7% (CI95%:89.8%-101.5%), respectively, the sensitivity of 100% rapid review was 54.2% (CI95%: 34.2%-74.1%), 52.9% (CI95%: 29.2%-76.7%), 47.8% (CI95%: 33.4%-62.3%) respectively and the sensibility of routine screening was 83.2% (CI95%: 77.1%-89.3%), 85.7% (CI95%: 79.4%-92.0%), 73.3% (CI95%: 66.6%-79.9%), respectively. Conclusions: Rapid prescreening was more effective than 100% rapid review for the detection of false-negative results at routine screening, with a better performance when compared to final diagnosis, to follow-up colposcopy and at new cytopathology. The methods showed similar performance when compared at follow-up histopathology. Therefore, according to the results of this study, rapid prescreening provides subsidies to improve the performance of cervical cytopathology tests, whose the principal function of which is to detect cervical cancer precursor lesions. / As altas taxas de resultados falso-negativos são problemas enfrentados na rotina dos laboratórios de citopatologia. Dentre os métodos de controle interno da qualidade, a revisão de 10% é a menos eficiente para detectar os resultados falso-negativos do escrutínio de rotina. No entanto, há evidências de que a revisão rápida de 100% e o pré-escrutínio rápido apresentam bons resultados na sua detecção. Porém, não existem estudos que compararam estes dois métodos. Objetivo: Comparar o desempenho do pré-escrutínio rápido e da revisão rápida de 100% como métodos de controle interno da qualidade dos exames citológicos do colo do útero. Métodos: Durante 27 meses 12.208 esfregaços citológicos cervicais provenientes das Unidades de Atenção Básica à Saúde do município de Goiânia foram submetidos ao pré-escrutínio rápido e ao escrutínio de rotina no Centro de Análises Clínicas Rômulo Rocha da Faculdade de Farmácia da Universidade Federal de Goiás-Goiânia-GO-Brasil. A revisão rápida de 100% foi realizada nos esfregaços negativos no escrutínio de rotina. Os resultados discordantes por qualquer dos métodos foram revisados detalhadamente para definição do diagnóstico citológico final, considerado padrão ouro para avaliar o desempenho do pré-escrutínio rápido e da revisão rápida de 100%. Nos casos com anormalidades citológicas foi avaliado o resultado dos exames colposcópicos, histológicos e da nova citologia. Foram estimadas a sensibilidade e a especificidade dos métodos de controle interno da qualidade quando comparados ao diagnóstico citológico final, ao exame colposcópico, histológico e ao novo exame citológico. Resultados: Comparado ao diagnóstico citológico final a sensibilidade do escrutínio de rotina e do pré-escrutínio rápido foi de 72,9% (IC 95%: 70,0%-75,8%) e 75,6% (IC 95%: 72,8%-78,4%), respectivamente. A sensibilidade do pré-escrutínio rápido e da revisão rápida de 100%, levando em conta os esfregaços negativos no escrutínio de rotina foi 90,2% (IC 95%: 86,4-93,9) e 57,0% (50,8%-63,2%), respectivamente. O pré-escrutínio rápido identificou 220 (1,8%) e a revisão rápida de 100% 140 (1,15%) dos 244 (2,0%) falso-negativos do escrutínio de rotina. A sensibilidade do pré-escrutínio rápido na detecção de anormalidades colposcópicas, histoológicas e no novo exame citológico foi de 87,5% (IC95%: 74,3%-100,7%), 82,4% (IC95%: 64,2%-100,5%), 95,7% (IC95%: 89,8%-101,5%), respectivamente, a sensibilidade da revisão rápida de 100% foi de 54,2% (IC95%: 34,2%-74,1%), 52,9% (IC95%: 29,2%-76,7%), 47,8% (IC95%: 33,4%-62,3%), respectivamente e a sensibilidade do escrutínio de rotina foi de 83,2% (IC95%: 77,1%-89,3%), 85,7% (IC95%: 79,4%-92,0%), 73,3% (IC95%: 66,6%-79,9%), respectivamente. Conclusões: O pré-escrutínio rápido foi mais eficiente que a revisão rápida de 100% para detectar resultados falso-negativos do escrutínio de rotina obtendo melhor desempenho quando comparado ao diagnóstico citológico final, ao resultado do exame colposcópico e ao novo exame citológico. Os métodos apresentaram desempenho semelhante quando comparado ao resultado do exame histológico. Portanto, de acordo com os resultados desse estudo, o pré-escrutínio rápido fornece subsídios para melhorar o desempenho dos exames citológicos, cuja principal função é detectar as lesões precursoras do câncer do colo do útero.

The purpose of quality control within internal auditing functions is to ensure that internal auditing functions add value by providing a quality service. The aim of this research project was to investigate the importance of quality control within internal auditing functions as prescribed by the standards and guidelines of the internal auditing profession. It was also attempted to determine to what extent these standards and guidelines are applied within internal auditing functions in South Africa. The study concluded that quality control is not adequately applied within all internal auditing functions in South Africa. Compliance with the internal auditing standards (implemented on 1 January 2002) should contribute to improve the situation. The internal auditors’ professional body should motivate internal auditing functions to exercise quality control according to the internal auditing standards. This will uplift the image of the internal auditing profession and ensure the future existence of internal auditing functions. / Auditing / M.Comm.