Analysis of Quality Indicators of Preanalytical and Analytical Phases in Cervical Pap Smear Cytology: A Cross-sectional Study
Introduction: The Pap smear is a procedure used to collect cells from the cervix to screen for cancerous and dysplastic precancerous cells under a microscope. Internal quality control refers to the measures taken within a laboratory to ensure the accuracy, reliability and consistency of cytology res...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2025-04-01
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| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://jcdr.net/articles/PDF/20931/75084_CE[Ra1]__F(IS)_QC(AN_SS)_PF1(RI_SL_SS)_PFA_NC(IS)_PN(IS).pdf |
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| Summary: | Introduction: The Pap smear is a procedure used to collect cells from the cervix to screen for cancerous and dysplastic precancerous cells under a microscope. Internal quality control refers to the measures taken within a laboratory to ensure the accuracy, reliability and consistency of cytology results. It ensures that the technical quality of products in the preanalytical and analytical phases meets pre-established tolerance limits.
Aim: To assess the quality indicators of the preanalytical and analytical phases of cervical Pap smear cytology in order to evaluate Non Conformity (NC) through root cause analysis for appropriate corrective and preventive measures.
Materials and Methods: The cross-sectional study was conducted in the cytology section of the Department of Pathology at Mahatma Gandhi Medical College and Research Institute in Puducherry, India, planned and executed over a period of twelve months, starting in June 2023 and concluding in May 2024. The study cohort comprised 366 female patients who underwent Papanicolaou (Pap) smear testing as a routine screening test, systematically recruited from both the Outpatient (OP) clinics and the inpatient wards of the study Institute. Grading was performed for each parameter in the preanalytical and analytical phases using the Visual Analogue Scoring System (VASS). The grades used were: 3 - Good satisfactory smears; 2 - Extended time in fixative, average nuclear and cytoplasmic staining; 1 - Drying artefacts, air bubbles; and 0 - Inadequate smears, no clinicopathological correlation.
Results: A total of 366 cases were studied and the study demonstrated strong adherence to quality standards, with 94.2% correct slide labelling and 98% excellence in fixation and transportation processes. Findings from the analytical phase revealed that 83% of smears were of excellent quality, with a swift Turnaround Time (TAT) of 90% processed within 24 hours and a clinicopathological correlation rate of 73.49%. Interobserver variation was minimal, with a 96.17% agreement among pathologists. The study identified significant preanalytical errors, primarily due to human factors. The quality indicators met grade 3 in the majority of the samples, indicating robust diagnostic reliability. Grades 0, 1 and 2 in all parameters were categorised as NC and were evaluated for root cause analysis, followed by appropriate corrective and preventive measures.
Conclusion: Standardised protocols and continuous training can minimise variability and enhance the quality of smear preparation, fixation and staining, thereby ensuring that high standards are consistently met. The study proposes VASS as a validated benchmark system for evaluating the quality aspects of cytological smears. Additionally, focusing on value-added activities will optimise resource utilisation and enhance overall efficiency. |
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| ISSN: | 2249-782X 0973-709X |