Evaluation of quality assurance in the cytopathology laboratory of a tertiary care hospital in Eastern India

Abstract

Background: In this era of evidence-based medicine, clinical laboratories play a critical role in patient diagnosis and management. Aims: The present study aims to study the quality assurance in the cytopathology laboratory of a tertiary care hospital in the Eastern region of India. Materials and Methods: An observational, retrospective, and analytic study for 1 year was conducted. The sample size was 600. Simple random samples were selected including pleural fluids, ascitic fluids, cerebrospinal fluids, cervical cytology Pap smears, fine needle aspiration (FNA) cytology, and guided FNA samples. Results: Maintenance of authentication of reports and ISO accreditation showed no deficiency, whereas report generation, dispatch, and documentation of duplicate reports showed the highest deficiency (593, 98.8%) in maintaining quality assurance. Incomplete requisition was the most common cause of registration failure (3, 42.8%), whereas samples sent in wrong vials was the most common cause of sample collection failure (3, 37.5%). The presence of artifacts was the major factor affecting smearing technique (3, 50%). Lack of compliance to standardized protocol in manual staining and mechanical factors of automated strainers affected the staining quality (3, 37.5% each). Power cut and lack of adequate UPS backup affected the productivity of equipment mostly (3, 50%). Technical issues were the major factor affecting turnaround time (3, 50%). Lack of manpower at the report dispatch counter and logistics affected report generation and dispatch (2, 33.3% each). Randomly selected reports were crosschecked with histology and prediction accuracy measures were calculated. Conclusion: The preanalytical, analytical, and postanalytical factors have to be maintained adequately for ensuring quality assurance.