A Quality Control Study of Liquid-Based Cytology Test Papanicolaou: Design and Implementation Aspects of Laboratory Information Systems for Continuous Quality Control

During the last decade, there is a stringent and ongoing requirement by regulatory bodies, and often enforced by law, for the implementation of measures increasing the confidence of cytological laboratories (expressed as requirement for accreditation via ISO 15189 or 17025). In this study, we present a quality control and assurance (QC&QA) method and results based on Cytology-Histology (C-H) and Cytology-Cytology (C-C) comparisons, on the basis of real data related to cervical cancer. The proposed QC&QA methodology allows the assessment of laboratory performance over time and the assessment of the laboratory as a facility and individual personnel as well. Moreover, we propose a high-level design for a Laboratory Information System capable of supporting the proposed methodology. The usual methodology to regularly control laboratory performance (once or twice per year), is not nowadays efficient, LIS implementation following the proposed scheme can support instant QC&QA, thus ensuring laboratories confidence and timely initiation of corrective actions.