Made available in DSpace on 2014-07-29T15:29:21Z (GMT). No. of bitstreams: 1 dissertacao cinara.pdf: 960645 bytes, checksum: 9e3f7530f507e4177c883e16350478e2 (MD5) Previous issue date: 2010-03-03 / Introduction: The External Quality Monitoring (MEQ) was developed from recommendations of the National Cancer Institute, in order to evaluate the performance of cytopathology diagnostic of the cervix and provide subsidies for continuing education to professionals in laboratories that provide services to public health. Objectives: To evaluate the results of Pap cervical smear between the laboratories accredited by the Single Health System (SUS) according to the diagnostic of the Unit of External Quality Monitoring (UMEQ), checking the frequency of the results of Pap cervical smear, the discordant cases, false positives (FP), false negative (FN) and diagnostic agreement. Methods: A total of 14 laboratories accredited by the SUS indicated by the Municipal Secretary of Health in Goiânia-GO participated in this study. It was reviewed the period from January 2007 to December 2008, Pap cervical smear tests selected by the Information System of Cancer of the cervix including all positive cases, all unsatisfactory ones and at least 5% of negative test results which should achieve at least 10% of the monthly routine of each laboratory, totaling 10,053 tests. These were reviewed by professionals from UMEQ / Faculty of Pharmacy from Federal University of Goiás. It was considered discordant cases in which there was a change in clinical management in accordance with the criteria established by the Ministry of Health. To place the cytological cervical results the Bethesda System was used. The magnitude of agreement was evaluated between the diagnoses using the kappa coefficient. The level of agreement considering its respective confidence intervals of 95% depending on the need to assign different weights to the disagreements were classified as follows: less than 0 - very bad agreement, 0 to 0.2, bad agreement; from 0.2 to 0.4 - reasonable agreement, from 0.4 to 0.6 - good agreement, from 0.6 to 0.8 - very good agreement and from 0.8 to 1.0 excellent. Results: There was disagreement between the UMEQ and laboratories of origin in 763 (7,59%) cases, of these 110 (1,1%) were FN distributed in: 37 (0,37%) atypical squamous cells of undetermined significance (ASC-US), 22 (0,22%) intraepithelial low-grade squamous lesions (LSIL), 30 (0,30%) atypical squamous cells cannot exclude a high-grade lesion (ASC-H), 12 (0,13%) squamous intraepithelial lesions of high grade (HSIL), an (0,01%) intraepithelial lesion of high-grade with suspicious features for invasion, six (0,07%) atypical glandular cells and two (0,02%) adenocarcinomas in situ. There was a delay in clinical management in 245 (2,44%) cases, of these 85 (0,84%) were initially classified as ASC-US and 160 (1,50%) as LSIL.The cases of ASC-US were distributed in: 53 (0,53%) ASC-H, 31 (0,31%) HSIL and an (0,01%) atypical glandular. The cases of LSIL were distributed in: 19 (0,19%) ASC-H, 139 (1,38%) HSIL and two (0,02%) atypical glandular cells. It was considered 283 (2,82%) FP cases and 125 (1,24%) initially negative cases that were reclassified as unsatisfactory. The agreement between the laboratories of origin and the UMEQ was excellent (Kappa = 0.81). It was found that for the evaluation of agreement of each laboratory, the majority showed very good agreement. The agreement of the sample adequacy was considered reasonable (Kappa = 0.30). Conclusion: Most laboratories showed very good agreement, however, it is worth mentioning that MEQ is an exercise of improvement needed to establish the standardization of diagnostic criteria and improve the accuracy of cervical smear. / O Monitoramento Externo da Qualidade (MEQ) foi elaborado a partir de recomendações do Instituto Nacional do Câncer, com o intuito de avaliar o desempenho dos diagnósticos citopatológicos do colo do útero e fornecer subsídios para educação continuada aos profissionais dos laboratórios que prestam serviços à rede pública de saúde. Objetivos: Avaliar os resultados dos exames citopatológicos do colo do útero dos laboratórios credenciados pelo Sistema Único de Saúde (SUS) de acordo com o diagnóstico da Unidade de Monitoramento Externo da Qualidade (UMEQ), verificando a frequência dos resultados dos exames citopatológicos do colo do útero, dos casos discordantes, falsopositivos (FP), falso-negativos (FN) e a concordância diagnóstica. Métodos: Participaram deste estudo 14 laboratórios credenciados pelo SUS indicados pela Secretária Municipal de Saúde de Goiânia-GO. Foram revisados, no período de janeiro de 2007 a dezembro de 2008, exames citopatológicos do colo do útero selecionados pelo Sistema de Informações do Câncer do Colo do Útero incluindo todos os casos positivos, todos os insatisfatórios e no mínimo 5% dos exames negativos devendo atingir no mínimo 10% da rotina mensal de cada laboratório, totalizando 10.053 exames. Estes foram revisados por profissionais da UMEQ/ Faculdade de Farmácia da Universidade Federal de Goiás. Foram considerados discordantes os casos em que houve mudança de conduta clínica de acordo com os critérios estabelecidos pelo Ministério da Saúde. Para a classificação dos resultados citopatológicos do colo do útero utilizou-se o Sistema de Bethesda. Avaliou-se a magnitude da concordância entre os diagnósticos utilizando o coeficiente Kappa. O nível de concordância ponderado com seus respectivos intervalos de confiança de 95% em função da necessidade de se atribuir diferentes pesos para as discordâncias foi classificado da seguinte forma: menor que 0 - concordância péssima; de 0 a 0,2-concordância ruim; de 0,2 a 0,4- concordância razoável; de 0,4 a 0,6- concordância boa; de 0,6 a 0,8- concordância muito boa e de 0,8 a 1,0- excelente. Resultados: Houve discordância entre a UMEQ e os laboratórios de origem em 763 (7,59%) casos, destes, 110 (1,1%) foram FN distribuídos em: 37 (0,37%) células escamosas atípicas de significado indeterminado (ASC-US), 22 (0,22%) lesões intra-epiteliais escamosas de baixo grau (LSIL), 30 (0,30%) células escamosas atípicas não é possível excluir uma lesão de alto grau (ASC-H), 12 (0,13%) lesões intraepiteliais escamosas de alto grau (HSIL), uma (0,01%) lesão intra-epitelial de alto grau com características suspeitas de invasão, seis (0,07%) atipias glandulares e dois (0,02%) adenocarcinomas in situ. Houve retardo na conduta clínica em 245 (2,44%) casos, destes, 85 (0,84%) foram inicialmente classificados como ASC-US e 160 (1,50%) como LSIL. Os casos de ASC-US distribuíram-se em: 53 (0,53%) ASC-H, 31 (0,31%) HSIL e uma (0,01%) atipia glandular. Os casos de LSIL distribuíram-se em: 19 (0,19%) ASC-H, 139 (1,38%) HSIL e duas (0,02%) atipias glandulares. Foram considerados 283 (2,82%) casos FP e 125 (1,24%) casos inicialmente negativos foram reclassificados como insatisfatórios. A concordância entre os laboratórios de origem e a UMEQ foi excelente (Kappa=0,81). Verificou-se que para a avaliação da concordância de cada laboratório, a maioria apresentou concordância muito boa. A concordância da adequabilidade da amostra foi considerada razoável (Kappa=0,30). Conclusão: A maioria dos laboratórios apresentou concordância muito boa, no entanto, vale ressaltar que o MEQ é um exercício de aprimoramento necessário para se estabelecer a padronização dos critérios diagnósticos e melhoria da acurácia dos exames citopatológicos.

The use of hair and oral fluid for drugs of abuse testing has increased over the last years. For this reason, the assurance that results provided using these matrices are reliable and error-free is needed. The objective of this thesis is to develop tools to assess the quality of results provided by laboratories analysing drugs of abuse in hair and in oral fluid and to evaluate the effect on the quality of results of different actions carried out. For this reason, intercomparison exercises have been organized and some studies have been performed to develop appropriate quality control materials. Regarding the analysis of drugs of abuse in hair, nine different intercomparison exercises have been organized. The evaluation of qualitative and quantitative results reported by laboratories together with the study of the methodology used, has led to know the quality of the results, to identify the sources of error and to know the corrective actions that should be developed. Concerning the quality control material, these exercises have enabled to know the influence on the results of the type of hair used to perform the analysis. Concerning the analysis of drugs of abuse in oral fluid, a method has been developed to identify and quantify 6-monoacetyl morphine, morphine, codeine, cocaine and benzoylecgonine in oral fluid samples. On the other hand, stability studies of the main drugs of abuse in oral fluid have been done to establish the optimal preparation, transport and storage conditions, and finally, two intercomparison exercises have been conducted to know the performance of analytical laboratories when analysing drugs of abuse in oral fluid and to know the stability of some drugs of abuse in two commercial collection devices. / La creixent utilització del cabell i del fluid oral per a l’anàlisi de drogues d’abús, ha portat a la necessitat d’assegurar que els resultats obtinguts utilitzant aquestes matrius són fiables i lliures d’error. L’objectiu d’aquesta tesi és desenvolupar eines que permetin avaluar la qualitat dels resultats dels laboratoris que analitzen drogues d’abús en cabell i en fluid oral i avaluar l’efecte de diferents accions sobre la qualitat final dels resultats. Per això s’han organitzat exercicis interlaboratori i s’han realitzat estudis per desenvolupar material d’assaig adequat. Pel que fa a l’anàlisi de drogues d’abús en cabell, s’han realitzat nou exercicis interlaboratori. A través de l’avaluació dels resultats qualitatius i quantitatius informats pels laboratoris i mitjançant l’estudi de la metodologia emprada, ha estat possible conèixer la qualitat dels resultats obtinguts, detectar les fonts d’error i conèixer quines mesures correctives caldria desenvolupar. Pel que fa al material d’assaig, aquests exercicis han permès conèixer la influència que té, en els resultats, el tipus de cabell del qual es parteix per realitzar l’anàlisi. Pel que fa a l’anàlisi de drogues d’abús en fluid oral, s’ha desenvolupat i validat un mètode analític que ha permès identificar i quantificar 6-monoacetil morfina, morfina, codeïna, cocaïna i benzoïlecgonina en mostres de fluid oral. Per altra banda, s’han realitzat estudis d’estabilitat de les principals drogues en fluid oral que han permès establir les condicions òptimes de preparació, transport i conservació del material d’assaig i, per últim, s’han realitzat dos exercicis interlaboratori que han permès conèixer la qualitat dels resultats analítics obtinguts pels laboratoris i també l’estabilitat de les drogues en dos dispositius de recollida comercials.