Rev Bras Ginecol Obstet 2016; 38(02): 065-070
DOI: 10.1055/s-0035-1571175
Original Article
Thieme Publicações Ltda Rio de Janeiro, Brazil

Quality Indicators of Cervical Cytopathology Tests in the Public Service in Minas Gerais, Brazil

Indicadores de qualidade dos exames citopatológicos da rede pública em Minas Gerais, Brasil
Alessandra Hermógenes Gomes Tobias
1   Post-Graduate Program in Pharmaceutical Sciences, Department of Clinical Analysis, School of Pharmacy, Universidade Federal de Ouro Preto, Ouro Preto, MG, Brazil
,
Rita Goreti Amaral
2   School of Pharmacy, Universidade Federal de Goiás, Goiânia, GO, Brazil
,
Elói Martins Diniz
3   State Health Department of Minas Gerais, Belo Horizonte, MG, Brazil
,
Cláudia Martins Carneiro
1   Post-Graduate Program in Pharmaceutical Sciences, Department of Clinical Analysis, School of Pharmacy, Universidade Federal de Ouro Preto, Ouro Preto, MG, Brazil
› Author Affiliations
Further Information

Publication History

18 September 2015

16 November 2015

Publication Date:
01 February 2016 (online)

Abstract

Objective The objective of this study is to assess the performance of cytopathology laboratories providing services to the Brazilian Unified Health System (Sistema Único de Saúde – SUS) in the State of Minas Gerais, Brazil.

Methods This descriptive study uses data obtained from the Cervical Cancer Information System from January to December 2012. Three quality indicators were analyzed to assess the quality of cervical cytopathology tests: positivity index, percentage of atypical squamous cells (ASCs) in abnormal tests, and percentage of tests compatible with high-grade squamous intraepithelial lesions (HSILs). Laboratories were classified according to their production scale in tests per year ≤ 5,000; from 5,001 to 10,000; from 10,001 to 15,000; and ≥ 15,001. Based on the collection of variables and the classification of laboratories according to production scale, we created and analyzed a database using Microsoft Office Excel 97–2003.

Results In the Brazilian state of Minas Gerais, 146 laboratories provided services to the SUS in 2012 by performing a total of 1,277,018 cervical cytopathology tests. Half of these laboratories had production scales ≤ 5,000 tests/year and accounted for 13.1% of all tests performed in the entire state; in turn, 13.7% of these laboratories presented production scales of > 15,001 tests/year and accounted for 49.2% of the total of tests performed in the entire state. The positivity indexes of most laboratories providing services to the SUS in 2012, regardless of production scale, were below or well below recommended limits. Of the 20 laboratories that performed more than 15,001 tests per year, only three presented percentages of tests compatible with HSILs above the lower limit recommended by the Brazilian Ministry of Health.

Conclusion The majority of laboratories providing services to the SUS in Minas Gerais presented quality indicators outside the range recommended by the Brazilian Ministry of Health.

Resumo

Objetivo Avaliar o desempenho dos laboratórios de citopatologia prestadores de serviço para o Sistema Único de Saúde (SUS) no estado de Minas Gerais, Brasil.

Métodos estudo descritivo com base nos dados obtidos do Sistema de Informação do Câncer do Colo do Útero no período de janeiro a dezembro de 2012. Para avaliação da qualidade dos exames citopatológicos do colo do útero, foram analisados três indicadores de qualidade: índice de positividade, percentual de ASC (células escamosas atípicas) entre os exames alterados e percentual de exames compatíveis com HSIL (Lesão intraepitelial escamosa de alto grau). Os laboratórios foram classificados conforme escala de produção em: ≤ 5.000; entre 5.001 e 10.000; entre 10.001 e 15.000 e ≥ 15.001. Após a coleta das variáveis e classificação dos laboratórios conforme escala de produção foi elaborado um banco de dados, o qual foi analisado por meio do programa Microsoft Office Excel 97-2003.

Resultados Em 2012, no estado de Minas Gerais, 146 laboratórios prestaram serviço para o SUS realizando um total de 1.277.018 exames citopatológicos do colo do útero. Metade desses laboratórios apresentou escala de produção ≤ 5.000 exames/ano, e efetuaram 13,1% do total de exames do estado, por outro lado 13,7% dos laboratórios apresentaram escala de produção > 15.001 exames/ano e efetuaram 49,2% do total de exames do estado. O índice de positividade apresentado pela maioria dos laboratórios que prestaram serviço para o SUS no ano de 2012, independente de sua escala de produção, foi abaixo ou muito abaixo do recomendado. Dentre os 20 laboratórios que efetuaram mais de 15.001 exames por ano, somente três apresentaram o percentual de exames compatíveis com HSIL acima do recomendado pelo Ministério da Saúde.

Conclusão A maioria dos laboratórios prestadores de serviço para o SUS no estado de Minas Gerais apresentou indicadores de qualidade fora dos parâmetros recomendados pelo Ministério da Saúde.

 
  • References

  • 1 Saslow D, Solomon D, Lawson HW , et al; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin 2012; 62 (3) 147-172
  • 2 Vale DBAP, Morais SS, Pimenta AL, Zeferino LC. Assessment of the cervical cancer screening in the Family Health Strategy in Amparo, São Paulo State, Brazil. Cad Saude Publica 2010; 26 (2) 383-390
  • 3 Gullo CE, Dami AL, Barbosa AP , et al. Results of a control quality strategy in cervical cytology. Einstein (Sao Paulo) 2012; 10 (1) 86-91
  • 4 Gajjar K, Ahmadzai AA, Valasoulis G , et al. Histology verification demonstrates that biospectroscopy analysis of cervical cytology identifies underlying disease more accurately than conventional screening: removing the confounder of discordance. PLoS ONE 2014; 9 (1) e82416
  • 5 Cuzick J, Clavel C, Petry KU , et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int J Cancer 2006; 119 (5) 1095-1101
  • 6 Michelow P, McKee G, Hlongwane F. Rapid rescreening of cervical smears as a quality control method in a high-risk population. Cytopathology 2006; 17 (3) 110-115
  • 7 Azara CZ, Manrique EJ, Alves de Souza NL, Rodrigues AR, Tavares SB, Amaral RG. External quality control of cervical cytopathology: interlaboratory variability. Acta Cytol 2013; 57 (6) 585-590
  • 8 Djemli A, Khetani K, Auger M. Rapid prescreening of Papanicolaou smears: a practical and efficient quality control strategy. Cancer 2006; 108 (1) 21-26
  • 9 Yunes-Díaz E, Ruiz PA, Lazcano-Ponce E. Assessment of the validity and reproducibility of the Pap smear in Mexico: necessity of a paradigm shift. Arch Med Res 2015; 46 (4) 310-316
  • 10 Brasil. Ministério da Saúde. Instituto Nacional de Câncer José Alencar Gomes da Silva. Manual de gestão da qualidade para laboratório de citopatologia. Rio de Janeiro: INCA; 2012
  • 11 Brasil. Ministério da Saúde. Portaria n. 3.388, de 30 de dezembro de 2013. Redefine a Qualificação Nacional em Citopatologia na prevenção do câncer do colo do útero (QualiCito), no âmbito da Rede de Atenção à Saúde das Pessoas com Doenças Crônicas. Diário Oficial da União, Brasília (Dec. 31, 2013); Sec. 1:42
  • 12 Bortolon PC, Silva MAF, Corrêa FM , et al. Avaliação da qualidade dos laboratórios de citopatologia do colo do útero no Brasil. Rev Bras Cancerol 2012; 58 (3) 435-444
  • 13 Brasil. Ministério da Saúde. DATASUS [Internet]. SISCOLO/SISMAMA. 2015 . Available at: http://w3.datasus.gov.br/siscam/index.php . Accessed on Jan 23, 2015
  • 14 Pajtler M, Audy-Jurković S, Skopljanac-Macina L, Antulov J, Barisić A, Milicić-Juhas V. Rapid cervicovaginal smear screening: method of quality control and assessing individual cytotechnologist performance. Cytopathology 2006; 17 (3) 121-126
  • 15 Confortini M, Di Stefano C, Biggeri A , et al. Daily peer review of abnormal cervical smears in the assessment of individual practice as an additional method of internal quality control. Cytopathology 2014; ; [Epub ahead of print]
  • 16 Mattosinho de Castro Ferraz MdaG, Dall' Agnol M, di Loreto C , et al. 100% rapid rescreening for quality assurance in a quality control program in a public health cytologic laboratory. Acta Cytol 2005; 49 (6) 639-643
  • 17 International Agency for Research on Cancer. Cervix cancer screening. Lyon: IARC Press; 2005. . (IARC Handbooks of Cancer Prevention, vol. 10)
  • 18 Tworek JA, Henry MR, Blond B, Jones BA. College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization. Arch Pathol Lab Med 2013; 137 (2) 158-163
  • 19 Davey DD, Neal MH, Wilbur DC, Colgan TJ, Styer PE, Mody DR. Bethesda 2001 implementation and reporting rates: 2003 practices of participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med 2004; 128 (11) 1224-1229
  • 20 Fernandes F, Furtado Y, Russomano F , et al. Diagnóstico citopatológico de ASC-US e ASC-H no Serviço Integrado Tecnológico em Citologia do INCA. Rev Bras Cancerol 2012; 58 (3) 453-459
  • 21 Eversole GM, Moriarty AT, Schwartz MR , et al. Practices of participants in the college of american pathologists interlaboratory comparison program in cervicovaginal cytology, 2006. Arch Pathol Lab Med 2010; 134 (3) 331-335
  • 22 Cormier K, Schaaf M, Hamilton S, Tickman RJ, Perez-Reyes N, Sturgis CD. NILM Pap slides from women 30 years of age and older with positive high-risk HPV DNA. Focused rescreening prior to report issuance, an enhanced quality control measure. Am J Clin Pathol 2014; 141 (4) 494-500
  • 23 Ázara CZS, Manrique EJC, Tavares SBN, de Souza NL, Amaral RG. Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory. Rev Bras Ginecol Obstet 2014; 36 (9) 398-403
  • 24 Amaral AF, Araújo ES, Magalhães JC, Silveira EA, Tavares SBN, Amaral RG. [Impact of training about cervical cancer screening on health professionals working in basic health care units]. Rev Bras Ginecol Obstet 2014; 36 (4) 182-187
  • 25 Brasil. Ministério da Saúde. Instituto Nacional de Câncer José Alencar Gomes da Silva. Coordenação de Prevenção e Vigilância. Estimativa 2014: incidência de câncer no Brasil. Rio de Janeiro: INCA; 2014