Performance of Laboratories after 10 Years of Participating in External Quality Monitoring in Cervical Cytology.

OBJECTIVE: To evaluate the performance of laboratories accredited by the National Health System that perform cytopathology examination of the uterine cervix after 10 years of participation in external quality monitoring (eQM). STUDY DESIGN: Seven laboratories were assessed in this study. To assess the concordance of the representation of epithelia and results, 6,536 examinations (3,433 in 2007 and 3,103 in 2017) were reviewed. Statistical analysis was performed using the κ coefficient as well as the χ2 and the Fisher exact test (p < 0.05). RESULTS: All laboratories showed adequate infrastructure and internal quality monitoring. Regarding the representation of the epithelia, the concordance remained excellent (κ between 0.84 and 0.94). In 2007, 26 false-negative results (FN), 157 false-positive results (FP), and 79 delays in clinical conduct (DCC) were identified (κ = 0.80). In 2017, 24 FN, 42 FP, and 38 DCC were identified (κ = 0.90). Five laboratories showed improvement in concordance from 2007 to 2017. We observed significant improvement in cytomorphological criteria of the results: atypical squamous cells of undetermined significance (p < 0.001), atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (p < 0.016), and low-grade squamous intraepithelial lesion (p < 0.001). We also observed a considerable improvement in the results of cellular abnormalities in glandular epithelium (p < 0.0504). CONCLUSIONS: Ten years after the implementation of eQM, improvements in the concordance of results were observed as well as reductions in FN, FP, and DCC in all laboratories monitored.

Impact of Implementing 100% Rapid Review as a Quality Control Tool in Cervical Cytology.

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.

Reproducibility of cervical cytopathology following an intervention by an external quality control laboratory.

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.

Evaluation of quality indicators of cervical cytopathology tests carried out in a municipality of Paraná, Brazil / Avaliação dos indicadores de qualidade dos exames citopatológicos do colo do útero realizados em um município do Paraná, Brasil

ABSTRACT Introduction: Although the criteria and recommendations are well defined to improve the quality of cervical cytopathology tests (Pap smear) in Brazil, the quality indicators of several laboratories are below the recommended standards. Objective: To evaluate the quality indicators of cervical cytopathology tests carried out by the Brazilian Unified Health System [Sistema Único de Saúde (SUS)]. Method: Cross-sectional study based on the results of cervical cytopathology tests conducted in the municipality of Cascavel, Paraná, Brazil, from January 2012 to December 2018. The study included 141,191 tests and the following variables were analyzed: sample suitability, cervical cytopathology tests result, and internal quality monitoring indicators recommended by the Brazilian Ministry of Health. Results: The percentage of unsatisfactory tests did not exceed 0.97%. The representation of the squamocolumnar junction ranged from 63% to 67.4%. The percentage of altered exams among the satisfactory samples ranged from 0.46% to 6.44%. The positivity index ranged from 0.46% to 6.44%, while the high-grade squamous intraepithelial lesion/satisfactory indicator ranged from 0.21% to 1.06%, atypical squamous cells of undetermined significance/altered ranged from 22.47% to 49.93%, atypical squamous cells of undetermined significance/satisfactory ranged from 0.1% to 2.57%: and atypical squamous cells of undetermined significance/squamous intraepithelial lesions ranged from 0.31 to 1.02. Conclusion: In 2012 and 2013, the high-grade squamous intraepithelial lesion/satisfactory and the positivity index indicators were below the recommended parameters, and in the remaining years, these indicators were within the parameters recommended. Consequently, a greater number of truly cancer precursor lesions were identified, demonstrating the importance of internal quality control in the prevention of cervical cancer.

RESUMEN Introducción: Aunque criterios y recomendaciones están bien definidos para la mejora de calidad de las pruebas citopatológicas en Brasil, los indicadores de calidad de varios laboratorios se encuentran por debajo de los estándares recomendados. Objetivo: Evaluar los indicadores de calidad de las pruebas citopatológicas de cuello uterino realizadas por el sistema público de salud en Brasil (SUS). Método: Estudio transversal basado en los resultados de pruebas colpocitológicas llevadas a cabo en el municipio de Cascavel, Paraná, Brasil, de enero de 2012 a diciembre de 2018. Se incluyeron 141.191 pruebas; las siguientes variables se analizaron: adecuación de la muestra, resultado de la prueba citopatológica e indicadores de monitoreo interno de calidad recomendados por el Ministerio de Salud. Resultados: El porcentaje de pruebas insatisfactorias no superó 0,97%. La representación de la unión escamo-columnar varió de 63% a 67,4%. El porcentaje de pruebas alteradas entre las muestras satisfactorias varió de 0,46% a 6,44%. El índice de positividad varió de 0,46% a 6,44%, mientras el indicador de lesión intraepitelial de alto grado/satisfactorios, de 0,21% a 1,06%; atipias escamosas de significado indeterminado/alterados, de 22,47% a 49,93%; atipias escamosas de significado indeterminado/satisfactorios, de 0,1% a 2,57%; y razón atipias escamosas de significado indeterminado/lesiones intraepiteliales escamosas, de 0,31 a 1,02. Conclusión: En 2012 y 2013, los indicadores de lesión epitelial de alto grado/satisfactorios e índice de positividad se encontraban por debajo de los parámetros recomendados; en los otros años, esos indicadores estaban dentro de los parámetros recomendados. Por consiguiente, se identificó mayor número de lesiones realmente precursoras del cáncer, demostrando la importancia del control interno de calidad en la prevención del cáncer de cuello uterino.

RESUMO Introdução: Ainda que critérios e recomendações estejam bem definidos para melhoria da qualidade do exame citopatológico no Brasil, os indicadores de qualidade de vários laboratórios apresentam-se abaixo dos padrões recomendados. Objetivo: Avaliar os indicadores de qualidade dos exames citopatológicos do colo do útero realizados pelo Sistema Único de Saúde (SUS). Método: Estudo transversal com base nos resultados dos exames citopatológicos realizados no município de Cascavel, Paraná, Brasil, de janeiro de 2012 a dezembro de 2018. Foram incluídos 141.191 exames; as seguintes variáveis foram analisadas: adequabilidade da amostra, resultado do exame citopatológico e indicadores de monitoramento interno da qualidade recomendados pelo Ministério da Saúde. Resultados: A porcentagem de exames insatisfatórios não ultrapassou 0,97%. A representação da junção escamocolunar variou de 63% a 67,4%. A porcentagem de exames alterados entre as amostras satisfatórias variou de 0,46% a 6,44%. O índice de positividade variou de 0,46% a 6,44%, enquanto o indicador lesão intraepitelial de alto grau/satisfatórios, de 0,21% a 1,06%; atipias escamosas de significado indeterminado/alterados, de 22,47% a 49,93%; atipias escamosas de significado indeterminado/satisfatórios, de 0,1% a 2,57%; e razão atipias escamosas de significado indeterminado/lesões intraepiteliais escamosas, de 0,31 a 1,02. Conclusão: Em 2012 e 2013, os indicadores de lesão intraepitelial de alto grau/satisfatórios e índice de positividade encontravam-se abaixo dos parâmetros recomendados; nos demais anos, esses indicadores estavam dentro dos parâmetros recomendados. Consequentemente, foi identificado um maior número de lesões verdadeiramente precursoras do câncer, demonstrando a importância do controle interno da qualidade na prevenção do câncer do colo do útero.

[Impact of training about cervical cancer screening on health professionals working in basic health care units]. / Impacto da capacitação dos profissionais de saúde sobre o rastreamento do câncer do colo do útero em unidades básicas de saúde.

PURPOSE: To evaluate the impact of training professionals involved in the screening for cervical cancer in Basic Health Units in the city of Goiânia (GO). METHODS: This was and intervention study in which the following data contained in the cervical cytopathology test form were examined: the woman's personal data, anamnesis, clinical examination and identification of the professional responsible for the collection. Professional training was evaluated by comparing the forms referring to the period from January 2007 to April 2009, before training, with the forms referring to the period from July 2010 to December 2012, after training. The Pearson χ2 test was used to analyze the results of training, with the 5% level of significance. RESULTS: After training, there was a significantly increased frequency of recording patient schooling (from 67.2 to 92.6%, p<0.001), telephone number (from 78.9 to 98.7%, p<0.001), cervical inspection (from 86.8 to 96.6%, p<0.001), and signs suggestive of sexually transmitted diseases (from 80.8 to 93.5%, p<0.001). There was a reduction in the frequency of performing the exam within an interval of less than one year (p<0.001) and of one year (p<0.001). There was a reduction in the frequency of Pap smear testing in women under 25 years of age, from 22.0 to 17.9% (p<0.001). There was a significant increase in the proportion of satisfactory samples from 70.4 to 80.2% (p<0.001). A reduction of confounding factors was observed. The desiccation frequency was 2.9% before training and 2.0% after training (p<0.001). There was an increase in the frequency of representation of endocervical cells from 79.5 to 88.5% (p<0.001). CONCLUSION: After training, there was a significant improvement in completing the application form, the performance of such tests regarding frequency and the age range recommended by the Ministry of Health, and the adequacy of the sample.

Avaliação dos Indicadores da Qualidade dos Exames Citopatológicosdo Colo do Útero de Laboratórios Privados do Estado de GoiásCredenciados pelo Sistema Único de Saúde / Assessment of Quality Indicators in Cervical Cytopathology Tests from Unified Health System-Accredited Private Laboratories in the State of Goiás

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...

Impacto da capacitação dos profissionais de saúde sobre o rastreamento do câncer do colo do útero em unidades básicas de saúde / Impact of training about cervical cancer screening on health professionals working in basic health care units

OBJETIVO: Avaliar o impacto da capacitação dos profissionais envolvidos no rastreamento do câncer do colo do útero (CCU) em Unidades Básicas de Saúde (UBSs) do município de Goiânia (GO). MÉTODOS: Estudo de intervenção cujas variáveis estudadas foram: os dados pessoais da mulher, anamnese, exame clínico e identificação do profissional responsável pela coleta (informações contidas no formulário de requisição do exame citopatológico do colo do útero). A avaliação da capacitação dos profissionais foi realizada por meio da comparação dos formulários referentes ao período de janeiro de 2007 a abril de 2009, antes da capacitação, com os formulários de julho de 2010 a dezembro de 2012, após a capacitação. Para avaliar o resultado da capacitação foi utilizado o teste do χ2 de Pearson, com nível de significância de 5%. RESULTADOS: Após a capacitação, houve aumento significativo da frequência de preenchimento da escolaridade, de 67,2 para 92,6% (p<0,001), do telefone, de 78,9 para 98,7% (p<0,001), da inspeção do colo, de 86,8 para 96,6% (p<0,001) e sinais sugestivos de doenças sexualmente transmissíveis (DST), de 80,8 para 93,5% (p<0,001). Houve redução da frequência de realização do exame no intervalo menor que um ano (p<0,001) e de um ano (p<0,001). Houve redução da frequência de realização do exame citopatológico em mulheres com menos de 25 anos de idade, de 22,0 para 17,9% (p<0,001). Houve um aumento significativo da proporção de amostras satisfatórias, de 70,4 para 80,2% (p<0,001). Foi verificada redução da ocorrência de fatores obscurecedores. A frequência de dessecamento ...

PURPOSE: To evaluate the impact of training professionals involved in the screening for cervical cancer in Basic Health Units in the city of Goiânia (GO). METHODS: This was and intervention study in which the following data contained in the cervical cytopathology test form were examined: the woman's personal data, anamnesis, clinical examination and identification of the professional responsible for the collection. Professional training was evaluated by comparing the forms referring to the period from January 2007 to April 2009, before training, with the forms referring to the period from July 2010 to December 2012, after training. The Pearson χ2 test was used to analyze the results of training, with the 5% level of significance. RESULTS: After training, there was a significantly increased frequency of recording patient schooling (from 67.2 to 92.6%, p<0.001), telephone number (from 78.9 to 98.7%, p<0.001), cervical inspection (from 86.8 to 96.6%, p<0.001), and signs suggestive of sexually transmitted diseases (from 80.8 to 93.5%, p<0.001). There was a reduction in the frequency of performing the exam within an interval of less than one year (p<0.001) and of one year (p<0.001). There was a reduction in the frequency of Pap smear testing in women under 25 years of age, from 22.0 to 17.9% (p<0.001). There was a significant increase in the proportion of satisfactory samples from 70.4 to 80.2% (p<0.001). A reduction of confounding factors was observed. The desiccation frequency was 2.9% before training and 2.0% after training (p<0.001). There was an increase in the frequency of representation of endocervical cells from 79.5 to 88.5% (p<0.001). CONCLUSION: After training, there was a significant improvement in completing the application form, the performance of such tests regarding frequency and the age range recommended by the Ministry of Health, and the adequacy of the sample. .