Avaliação do impacto da implementação do método de revisão aleatória de 10% das amostras negativas na garantia da qualidade dos exames citopatológicos realizados no laboratório municipal em Manaus-AM

Abstract

Quality control programs in cytopathology are essential for evaluating laboratory performance to minimize errors and implement corrective actions, thereby ensuring efficacy in cervical cancer screening through preventive examinations. This study assessed the impact of implementing of the random review method of 10% of negative samples on the quality improvement measures in a laboratory in Manaus, Amazonas, Brazil. It is a descriptive, retrospective, and quantitative study that compared the quality indicators of the Professor Sebastião Ferreira Marinho Municipal Specialty Laboratory before and after restructuring the method of random review of 10% of negative samples (pre-2018 and post-2018) over the period from 2007 to 2021. The study revealed that the mortality rate from cervical cancer stabilized over the years, from 12.18 % per 100,000 women in 2007 to 15.79% in 2021, despite temporary peaks in 2013 and 2014. Most of the results of the quality indicators found remained within the standards of the literature, although there have been variations occurred over the years. Initially, between 2007 and 2010, the Positivity Index (PI) showed results below the recommended levels, ranging from 1.1 to 1.7. From 2011 to 2021, it remained within the expected range, starting to increase in 2011 (2.8) and fluctuating between 2.5 and 4.9 from 2012 to 2021. There was no significant disagreement between routine cytologists and Internal Quality Monitoring (IQM) reviewers, with most discrepancies concentrated in the categories of ASC-US (Atypical Squamous Cells of Undetermined Significance) and LSIL (Low-grade Squamous Intraepithelial Lesion). No significant disagreement was observed between the morning and afternoon work shifts of the cytologists. These findings underscore the importance of implementing measures aimed at detecting, correcting, and reducing deficiencies in laboratory processes, thereby enhancing procedures and minimizing diagnostic errors.