Impact of the new Bethesda System 2001 on specimen adequacy of conventional cervicovaginal smears.

The Bethesda System (TBS) 2001 workshop addressed the issue of specimen adequacy by recommending the elimination of the "satisfactory but limited by" category and its replacement by a semiquantitative method for assessing squamous cellularity. The purpose of this study is to compare the rate of unsatisfactory specimens of conventional cervicovaginal smears (CVS) before and after the implementation of the TBS 2001 recommendations. TBS 2001 recommendations were implemented in our laboratory on January 1st, 2002. Data were compared from conventional CVS evaluated 6 mo prior and 6 mo after the implementation of TBS 2001. The total number of conventional CVS for the second half of 2001 was 5,808, 21 of which were considered unsatisfactory for evaluation (0.36%). Fourteen of these 21 cases had a repeat CVS, one case was diagnosed as low-grade squamous intraepithelial lesion (LSIL), and one was inadequate. In contrast, there were 288 unsatisfactory CVS out of 5,459 cases (5.3%) in the first half of 2002. Of these, 154 CVS were repeated, five cases were designated as ASCUS, and three were LSIL. Twenty-one cases had a second inadequate diagnosis, eight of these were repeated and all were negative for intraepithelial lesion or malignancy. In our laboratory, the use of the new Bethesda System guidelines yielded more than a 10-fold increase in the rate of unsatisfactory conventional CVS. This led to numerous additional office visits to obtain a repeat CVS. Only eight repeat CVS identified epithelial cell abnormalities. The implications of our findings are that TBS 2001 guidelines regarding satisfactory conventional CVS result in increased healthcare cost without identifying a significant number of new epithelial cell abnormalities. Copyright 2004 Wiley-Liss, Inc.