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

Abstract

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.

Variations in Practice Guideline Adherence for Abnormal Cervical Cytology in a County Healthcare System

“…While assessment of adequacy is an integral part of the overall evaluation of a cervical cytology smear, data show that there are often no significant differences in the incidence of squamous abnormalities following an unsatisfactory smear compared to a negative smear. 24,25 There was a large discrepancy in the appropriateness of care for low-grade cytological abnormalities (LSIL and ASCUS) that were managed through accelerated cytological evaluation rather than immediate colposcopy with histological evaluation. Although more than 70% of LSIL cases spontaneously revert to normal, about 30% of these patients will have CIN II/III or invasive cancer diagnosed at initial evaluation or during surveillance.…”

Clinical Significance of Unsatisfactory Conventional Pap Smears Owing to Inadequate Squamous Cellularity Defined by the Bethesda 2001 Criterion

“…A more recent study by Fidda et al 13 Although our study specifically addressed adequacy with regard to conventional Pap smears, the issue of specimen adequacy for liquid-based preparations is becoming more important because the use of such methods is more widespread. The Bethesda 2001 guidelines define adequacy of the squamous component for liquid-based preparations as a minimum of 5,000 cells.…”

Cervical cancer screening programme in Limpopo province: January 2007 to December 2010

“…Smears are evaluated in the laboratory by trained cytotechnicians and pathologists using the 2001 Bethesda System to report cervical cytology results. 8 All clinical specimens that are analysed within the NHLS laboratory network in South Africa are captured electronically through a real-time laboratory information system onto a centralised data repository, called the Central Data Warehouse (CDW). The data on the CDW include all the demographical information and results that are captured on the laboratory information system.…”