Implications of mandating amended reports following retrospective review of Papanicolaou smears.

Abstract

The Clinical Laboratory Improvement Amendments of 1988 requires a 5-year retrospective review of negative or normal smears in patients with diagnoses of high-grade squamous intraepithelial lesions or cancer, and amended reports are required when discrepancies that would affect current patient care are found. Notwithstanding the requirements of the Clinical Laboratory Improvement Amendments of 1988, one laboratory has been required by a State Department of Health to issue amended reports even when the discrepancy did not affect current patient care. The implications of notifying the patient and her physician of any discrepancy in a Papanicolaou smear may lead to media attention and litigation. This paper outlines how amended reports and/or correspondence to patients and physicians can be utilized to generate media attention and litigation and what laboratories can do to combat the litigation.