Review of negative Papanicolaou tests. Is the retrospective 5-year review necessary?

New federal regulations require review of all available negative gynecologic smears within the previous 5 years for each patient with a current high grade squamous intraepithelial lesion (HGSIL) or above. Two university hospitals retrospectively reviewed all patients who had HGSIL or above and who had prior negative smears. During 18 months, 35,807 Papanicolaou tests were reported, from which we identified 44 patients with 80 negative smears before presenting with HGSIL or above. These 80 negative smears were rescreened and, on review, there was agreement with the original diagnosis in 66 cases (82.5%). Fourteen (17.5%) smears were reclassified: 2 unsatisfactory, 6 atypical squamous/glandular cells of undetermined significance, 3 low grade SIL, and 3 HGSIL or above. Of the 12 cases satisfactory for reclassification, 9 (75%) occurred within 2 years before the HGSIL or above. Two cases of atypical squamous/glandular cells occurred within 4 years. One case of HGSIL occurred more than 4 years before, but a negative Pap smear had been reclassified within the year before the diagnosis of HGSIL. The authors conclude that a 2-year retrospective review, which identified 75% of our false-negative cases, is an effective and efficient quality control and assurance practice.