Papanicolaou smear 5-year retrospective review: what is required by the Clinical Laboratory Improvement Amendments of 1988?

Abstract

Five-year retrospective review of negative or normal smears in patients with newly diagnosed high-grade squamous intraepithelial lesions or cancer is a federal regulation for all laboratories practicing gynecologic cytology under the Clinical Laboratory Improvement Amendments of 1988. Amended reports are required when significant discrepancies are found that would affect patient care. The focus of this regulation is current patient care. Two studies have found a retrospective discrepancy rate of about 10% when the threshold for discrepancy was at least dysplasia. Higher rates are reported when missed atypical cases are counted as discrepancies. Retrospective review highlights problem areas for laboratory education and quality improvement efforts, but liability concerns have been a detrimental consequence of this regulation. Clarification that amended reports be issued only when current patient care is affected should aid laboratories in complying with this regulation.