Performance and Reproducibility of Gynecologic Cytology Interpretation Using the FocalPoint System

Stein, Maíra Degiovani; Fregnani, José Humberto Tavares Guerreiro; Scapulatempo, Cristovam; Mafra, Allini; Campacci, Natália; Longatto‐Filho, Adhemar

doi:10.1309/ajcpwl36jxmresfh

Cited by 14 publications

(16 citation statements)

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“…Finally, LBC offers an opportunity to introduce a high level of internal quality assurance in cytological diagnoses with a reproducible use of computer-guided image screening [24] that potentially reduces the margin of false-negative results and enhances the sensitivity of the Pap test evaluation [25], besides permitting the implementation of combined analyses of cytology and HPV molecular tests [26]. It is important to mention that between 2009 and 2011 the National Institute of Science and Technology of the Diseases Associated to the Papillomavirus (INCT-HPV) performed an assessment study of molecular techniques and proposed new algorithms for cervical cancer screening, which showed a very high negative predictive value (>99%) and high sensitivity [14].…”

Section: Discussionmentioning

confidence: 99%

Critical Analyses of the Introduction of Liquid-Based Cytology in a Public Health Service of the State of São Paulo, Brazil

et al. 2015

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Objective: The aim of this study was to compare the performance of the current conventional Pap smear with liquid-based cytology (LBC) preparations. Study Design: Women routinely undergoing their cytopathological and histopathological examinations at Fundação Oncocentro de São Paulo (FOSP) were recruited for LBC. Conventional smears were analyzed from women from other areas of the State of São Paulo with similar sociodemographic characteristics. Results: A total of 218,594 cases were analyzed, consisting of 206,999 conventional smears and 11,595 LBC. Among the conventional smears, 3.0% were of unsatisfactory preparation; conversely, unsatisfactory LBC preparations accounted for 0.3%. The ASC-H (atypical squamous cells - cannot exclude high-grade squamous intraepithelial lesion) frequency did not demonstrate any differences between the two methods. In contrast, the incidence of ASC-US (atypical squamous cells of undetermined significance) was almost twice as frequent between LBC and conventional smears, at 2.9 versus 1.6%, respectively. An equal percentage of high-grade squamous intraepithelial lesions were observed for the two methods, but not for low-grade squamous intraepithelial lesions, which were more significantly observed in LBC preparations than in conventional smears (2.2 vs. 0.7%). The index of positivity was importantly enhanced from 3.0% (conventional smears) to 5.7% (LBC). Conclusions: LBC performed better than conventional smears, and we are truly confident that LBC can improve public health strategies aimed at reducing cervical lesions through prevention programs.

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Section: Discussionmentioning

confidence: 99%

Critical Analyses of the Introduction of Liquid-Based Cytology in a Public Health Service of the State of São Paulo, Brazil

et al. 2015

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“…El desempeño del Papanicolaou depende de una serie de factores 10 , entre los que se encuentra la calidad de toma de muestra; en este estudio, sólo 3,7% de las muestras fueron inadecuadas, indicando que, en Chile, la baja sensibilidad del Papanicolaou no estaría relacionada con este punto. Otro factor del desempeño es la interpretación del frotis.…”

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Examen de detección de virus papiloma humano en el tamizaje de cáncer cervicouterino en un Servicio de Salud de Santiago, Chile

et al. 2015

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“…Automation in the cytopathology lab may be helpful in reducing errors pertaining to smear preparation, staining, and mounting, yet cost may be an important limitation, especially in resource-limited settings. However, studies have concluded that the benefit of automation in quality out powers this limitation [13]. …”

Section: Discussionmentioning

confidence: 99%

Study of the Pre-Analytical Phase of an ISO 15189: 2012-Certified Cytopathology Laboratory: A 5-Year Institutional Experience

Chandra

Kusum

et al. 2018

Acta Cytologica

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Objective: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards. Methods: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system. Results: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period. Conclusion: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab.

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Performance and Reproducibility of Gynecologic Cytology Interpretation Using the FocalPoint System

Abstract: FocalPoint safely screened high-grade lesions, which can be valuable for high-workload routines.

Cited by 14 publications

References 16 publications

Critical Analyses of the Introduction of Liquid-Based Cytology in a Public Health Service of the State of São Paulo, Brazil

Critical Analyses of the Introduction of Liquid-Based Cytology in a Public Health Service of the State of São Paulo, Brazil

Examen de detección de virus papiloma humano en el tamizaje de cáncer cervicouterino en un Servicio de Salud de Santiago, Chile

Study of the Pre-Analytical Phase of an ISO 15189: 2012-Certified Cytopathology Laboratory: A 5-Year Institutional Experience

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