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OBJECTIVE: We aimed to evaluate the impact of implementing 100% rapid review (100% RR) as a quality control tool in cervical smear cytology. DESIGN: A cross-sectional study was conducted in which cytology findings, false-negative results, and quality indicators were evaluated. The variables were analyzed in 2004, the year in which 100% RR was implemented, and again in 2013, i.e., 10 years on. RESULTS: Detection of atypical squamous cells of undetermined significance (ASC-US) increased from 0.90% in 2004 to 2.47% in 2013 by routine screening. Detection of atypical squamous cells, cannot exclude a high-grade squamous intraepithelial lesion (ASC-H) increased from 13.33% in 2004 to 36.27% in 2013 by 100% RR. Detection of high-grade squamous intraepithelial lesion (HSIL) increased from 0.64% in 2004 to 4.29% in 2013 by routine screening, and increased from 0% in 2004 to 19.61% in 2013 by 100% RR. There was a significant increase (p = 0.00001) in the identification of false-negative results of ASC-US, low-grade squamous intraepithelial lesion, ASC-H, HSIL, and atypical glandular cells. All quality indicators had increased in 2013 when compared to 2004 results. CONCLUSIONS: Ten years after the implementation of the 100% RR method, improvements were found in the detection of atypia and precursor lesions and in quality indicators.

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BACKGROUND: This study assessed the effects of a continued education program on the agreement between cervical cytopathology exams interpreted by local laboratories and interpretation made by an external quality control laboratory (LabMEQ). METHODS: Overall, 9,798 exams were analyzed between 2007 and 2008, prior to implementation of a continued education program, and 10,028 between 2010 and 2011, following implementation. Continued education consisted of theoretical and practical classes held every two months. The chi-square test and the kappa coefficient were used in the statistical analysis. RESULTS: Following implementation of continued education, the rate of false-negative results, and those leading to delays in clinical management fell in eight laboratories and the rate of false-positive results in five. Agreement between the results reported by the laboratories and the findings of LabMEQ, evaluated according to clinical management, remained excellent in three laboratories (kappa >0.80 and <1.0), went from good (kappa >0.60 and <0.80) to excellent in seven and from excellent to good in two. Agreement regarding the identification of metaplastic epithelium was poor (kappa = 0.25) but progressed to excellent following the implementation of continued education (kappa = 0.950). Agreement between cytopathology results improved significantly following implementation of continued education in cases reported as unsatisfactory (P < 0.001), atypical squamous cells of undetermined significance, cannot exclude high-grade squamous intraepithelial lesion (P < 0.001), low-grade squamous intraepithelial lesion (P < 0.001), and glandular atypia (P < 0.001). CONCLUSION: Continued education contributed towards improving the reproducibility of cervical cytopathology, decreased the rates of false-negative and false-positive results, and reduced delays in clinical management.

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Embora existam normas de controle da qualidade dos exames citopatológicos, a maioria dos laboratóriosbrasileiros apresenta indicadores abaixo do esperado. Objetivo: Avaliar cinco indicadores de monitoramento interno daqualidade dos laboratórios privados, credenciados pelo Sistema Único de Saúde, monitorados e não monitorados porum Laboratório de Monitoramento Externo da Qualidade no Estado de Goiás. Método: Estudo transversal. Foramincluídos 153.258 exames realizados em 44 laboratórios, sendo 14 monitorados e 30 não monitorados, de janeiro adezembro de 2012, utilizando dados do Siscolo. Resultados: Os laboratórios monitorados apresentaram 1.837 examesalterados; dos quais 855 foram classificados como atipias em células escamosas, 905 lesões intraepiteliais e 350 lesõesintraepiteliais de alto grau; enquanto os não monitorados apresentaram 2.535 exames alterados, com 1.436 atipiasem células escamosas, 890 lesões intraepiteliais e 244 lesões intraepiteliais de alto grau. Aproximadamente 60% doslaboratórios monitorados e 26% dos não monitorados apresentaram índice de positividade ≥ 3%, 72% dos monitorados,e 10% dos não monitorados apresentaram percentual de exames compatíveis com lesão intraepitelial de alto grau entreos exames satisfatórios ≥ 0,4%. Cerca de 7% dos monitorados e 29% dos não monitorados apresentaram percentual deatipias escamosas de significado indeterminado entre os exames alterados ≥ 60%. Conclusão: A maioria dos laboratóriosque apresentaram indicadores dentro dos parâmetros recomendados participa do monitoramento externo da qualidade...

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OBJECTIVE: To evaluate the performance of rapid prescreening (RPS) and 100% rapid review (RR-100%) as internal quality control (IQC) methods assessed by outcome at colposcopy, histopathology and repeat cytopathology for cases with false-negative results on cervical cytopathology at routine screening (RS). STUDY DESIGN: Out of 12,208 cytology smears analyzed, 900 were abnormal. Of these, 656 were identified at RS, and 244 were false-negative, with 90.2% identified at RPS and 57.4% at RR-100%. Of the 900 abnormal cases, 436 were submitted for additional testing. RESULTS: Of the 244 women with cytopathological abnormalities identified only by the IQC methods, 114 had supplementary examinations: 35 were submitted for colposcopy, 22 for biopsy and 99 for repeat cytopathology. The sensitivity of RPS for the detection of abnormalities identified on colposcopy, histopathology and repeat cytopathology was 87.5% (95% CI 67.6-97.3), 82.4% (95% CI 56.6-96.2) and 95.7% (95% CI 85.2-99.5), respectively. The sensitivity of RR-100% was 54.2% (95% CI 32.8-74.4), 52.9% (95% CI 27.8-77.0) and 47.8% (95% CI 32.9-63.1), respectively. RPS was more sensitive than RR-100% when compared to the findings on colposcopy (p = 0.011) and repeat cytopathology (p = 0.000). When compared to colposcopy, histopathology and repeat cytopathology, the sensitivity of RS was 83.2% (95% CI 76.1-88.9), 85.7% (95% CI 78.1-91.5) and 73.3% (95% CI 66.0-79.7), respectively. CONCLUSION: RPS performed better than RR-100% when compared to the results of colposcopy and repeat cytopathology.

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PURPOSE: To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. METHODS: The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. RESULTS: Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. CONCLUSION: An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

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PURPOSE: To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. METHODS: The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. RESULTS: Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. CONCLUSION: An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills ...

OBJETIVOS: Verificar o impacto da educação continuada realizada pelo Laboratório de Monitoramento Externo da Qualidade nos indicadores de monitoramento interno da qualidade dos exames citopatológicos. MÉTODOS: O estudo avaliou os indicadores de monitoramento interno da qualidade dos exames citopatológicos de 12 laboratórios monitorados pelo Laboratório de Monitoramento Externo da Qualidade, totalizando 185.194 exames, sendo 98.133 referentes ao período antes da educação continuada e 87.061 após a educação continuada. Os dados para avaliar os indicadores foram obtidos por meio do Sistema de Informações do Câncer do Colo do Útero disponibilizados pelo Departamento de Informática do Sistema Único de Saúde. RESULTADOS: Verificou-se que, após a educação continuada, quatro laboratórios mantiveram o índice de positividade (IP) dentro do recomendado, quatro que estavam abaixo passaram a ter o IP dentro do recomendado, um permaneceu baixo, dois permaneceram muito baixo e um passou de muito baixo para baixo. Em relação ao indicador percentual de exames compatíveis com lesão intraepitelial escamosa de alto grau, cinco laboratórios mantiveram o índice dentro do recomendado, três que estavam abaixo do recomendado passaram a ter esse índice acima de 0,4 e quatro permaneceram abaixo do recomendado. Os indicadores atipias de significado indeterminado/alterados e razão atipias de significado indeterminado/lesões intraepiteliais mantiveram-se dentro do recomendado em todos os laboratórios. CONCLUSÃO: Observou-se melhora nos indicadores de positividade e percentual de exames compatíveis com lesão intraepitelial de alto grau, mostrando que o papel desempenhado pelo Laboratório de Monitoramento Externo da Qualidade contribui para o aprimoramento ...

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Introdução: O adequado seguimento para mulheres com exames citopatológicos alterados é importante para o tratamento das lesões precursoras em sua fase inicial. Objetivo: Avaliar se as mulheres atendidas nas Unidades de Atenção Básica com exames citopatológicos alterados foram submetidas adequadamente às condutas preconizadas pelo Ministério da Saúde. Método: O estudo analisou 12.208 resultados de exames citopatológicos de mulheres atendidas nas Unidades de Atenção Básica à Saúde em Goiânia, no período de 2006 a 2008, através dos prontuários das Unidades de Atenção Básica e Média Complexidade. O programa Epi-info 3.5.1 foi utilizado para análise dos dados. Resultados:Dos 12.208 resultados analisados, 90,74% foram classificados como negativos, 1,88% como insatisfatórios, 4,74% como lesões menos graves, e 2,43% como lesões de média gravidade. Do total de 579 mulheres com exames citopatológicos classificados como células escamosas atípicas de significado indeterminado, possivelmente não neoplásicas/lesãointraepitelial de baixo grau, 41,62% realizaram citopatologia de seguimento, 14,85% e 10,19% realizaram colposcopia e biópsia, respectivamente. Das 297 mulheres com resultados citopatológicos classificados como células escamosas atípicas de significado indeterminado, não se pode excluir lesão de alto grau/lesão intraepitelial de alto grau, 42,76%realizaram citopatologia de seguimento, 35,02% e 28,96% realizaram colposcopia e biópsia, respectivamente. Das 24 mulheres com resultado citopatológico classificado como células glandulares atípicas/adenocarcinoma invasor, 20,83% realizaram citopatologia de seguimento, e 16,67% e 12,50% das mulheres realizaram colposcopia e biópsia, respectivamente. Conclusão: A maioria das mulheres com exames citopatológicos alterados possivelmente não foi submetida às condutas preconizadas conforme as recomendações do Ministério da Saúde

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OBJECTIVE: To compare the variability of screening tests held at laboratories with the Unit for External Quality Control (UEQC), checking the frequency of cases that were discordant, false-positive, false-negative, unsatisfactory or that had a delay in clinical management and diagnostic agreement. MATERIALS AND METHODS: The study analyzed 10,053 screening tests from January 2007 to December 2008, including all positive cases, all those that fall under unsatisfactory and at least 10% of negative screening tests. The magnitude of the agreement was analyzed using the kappa coefficient. RESULTS: Out of the 10,053 cases analyzed, 7.59% were considered disagreeing, and it was estimated that 1.1% were false-negative. There was a delay in the clinical procedure regarding 2.44% cases. There were 2.82% of cases identified as false-positive and 1.24% as unsatisfactory. The diagnostic agreement was excellent (kappa = 0.81). The agreement of most laboratories concerning screening tests was classified as very good. The agreement of the sample adequacy was reasonable (kappa = 0.30) and the agreement regarding the representation of epithelia was considered excellent. CONCLUSION: Most laboratories showed very good agreement; however, it is worthy of note that to establish the standardization of diagnostic criteria, and enhance the accuracy of screening and improve the quality of cytopathology test results, it is necessary to perform external quality control.

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The objective of this study was to evaluate the frequency and the significance of cytomorphological criteria defined in studies as being predictive of neoplasia in cervical smears of women with a cytological diagnosis of atypical glandular cells (AGC) or adenocarcinoma in situ (AIS). Women (n = 103) with cytological findings suggestive of AGC or AIS, whose diagnoses were later established by histopathology, were included in the study. The criteria analyzed and classified as present or absent in cervical smears previously classified as AGC-NOS (not otherwise specified), AGC-FN (favor neoplasia), or AIS were as follows: irregular nuclear membranes; scanty cytoplasm; dyskeratotic cells; increased nuclear/cytoplasmic ratio; nucleoli; overlapping; papillary clusters, feathering; loss of polarity; nuclear enlargement; coarsely granular chromatin; and pseudostratified strips. Histopathology resulted in neoplastic diagnoses in 55 cases (53.3%) and nonneoplastic diagnoses in 48 cases (46.6%). Coarsely granular chromatin was observed in 62.5% of cases with a diagnosis of neoplasia. Feathering was present in 80% of cases of histopathological AIS. Loss of polarity and coarsely granular chromatin were significantly associated with neoplastic diagnosis considering all subcategories of glandular abnormalities diagnosis. In AGC-SOE subclassification, coarsely granular chromatin was significantly associated with neoplastic diagnosis. The presence of nucleoli was significantly associated with neoplastic diagnosis in cervical smears qualified as AGC-FN and AIS. Nuclear enlargement, increased nuclear/cytoplasmic ratio, coarsely granular chromatin and overlapping cells were found in all the subclassifications of glandular cell abnormalities irrespective of the histopathological results. Chromatin aspects, polarity, and presence of nucleoli can predict neoplasia.

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O exame citopatológico é o método mais difundido mundialmente para o rastreamento do câncer do colo do útero e de suas lesões precursoras, porém sua vulnerabilidade a erros de coleta e preparação da lâmina e a subjetividade na interpretação dos resultados podem comprometer a sua sensibilidade e especificidade. Os fatores relacionados à adequabilidade da amostra têm sido considerados responsáveis por resultados falso-negativos, como a não representação de células endocervicais e/ou zona de transformação, a presença de sangue, o infiltrado leucocitário e os artefatos de fixação. Esses fatores retratam os erros da coleta e contribuem para os resultados falso-negativos relacionados a erros de escrutínio e de interpretação. Dessa forma, considerando esses fatores que podem comprometer a adequabilidade da amostra citológica cervical, o presente artigo revisa a literatura e discute estudos sobre o tema.

The cytopathological test is the most widely used method worldwide for screening of cervical cancer and its precursor lesions, but their vulnerability to errors of collection, preparation of the blade and subjectivity in the interpretation of results may jeopardize its sensitivity and specificity. Factors related to suitability of the sample have been considered as responsible for false-negative results, such as the non-representation of endocervical cells and/or transformation zone, the presence of blood, leukocyte infiltration and artifacts of attachment. These factors usually portray the errors of collection, which may also lead to false-negative results associated with scrutiny and interpretation errors. Therefore, considering the factors that may compromise the cervical cytological sample adequability, this article reviews the literature and brings a discussion on studies on the subject.

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