Frable William J, Pedigo Mary Ann, Powers Celeste N, Yarrell Cheryl, Ortiz Becky, Clark Mary E, Ebron Tameka
Department of Pathology, Virginia Commonwealth University Medical Center, Richmond, VA, USA.
Diagn Cytopathol. 2012 Aug;40(8):691-7. doi: 10.1002/dc.21598. Epub 2010 Dec 31.
A rapid prescreening or rapid rescreening method for quality assurance in cervical cytology has been used in Europe and in Canada but has not been accepted in the United States. The rapid prescreen method was tested in a cytology laboratory that serves an academic medical center with a high-risk population for cervical cancer. For a period of 3 months, a tray of 20 sequentially numbered Surepath™ liquid-based preparations, randomly selected from the cervical cytology daily workload, were each prescreened in a random fashion for 1 minute. Experienced cytotechnologists performed the rapid prescreen. Results were recorded as negative, further review needed, or epithelial cell abnormality, category specified. The 20 cervical cytology preparations were then replaced in their same position in the daily workload for routine screening performed by another cytotechnologist. Final interpretation was by a cytopathologist as requested or required by Clinical Laboratory Improvement Amendments of 1988. The rapid prescreen data was tabulated and compared with data for a similar time period using the laboratory's normal quality assurance program. Seven hundred and twelve cases underwent rapid prescreen. Six hundred and forty-two were interpreted as negative. Twenty-six cases were interpreted as low-grade squamous intraepithelial lesion (LGSIL) or higher. Forty-four cases were classified as needing further review. For the 642 negative cases by rapid prescreening, routine screening reported 537 as negative and 105 as either abnormal or needed cytopathologist review. The error rate for the rapid prescreen is 50 of 712 (7.0%); for LGSIL and above 19 of 712 (2.6%). Of the 105 abnormal cases or those submitted for cytopathologist review, 31 were interpreted as atypical squamous cells of undermined significance (ASCUS), 41 cases as reactive/repair, 17 as LGSIL, 4 as unsatisfactory, 1 as atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesion (ASC-H), 8 as the presence of endometrial cells in a women aged >40, 1 as malignant melanoma, and 2 as within normal limits with the presence of Actinomyces. The laboratory's routine quality assurance program selects cases, 10% of initially interpreted negative cases plus any gynecologic cytology on patients with a prior abnormal cervical cytology, or history of cervical epithelial cell abnormality. This quality assurance program averages 29% of cases, 4,045 of a total of 13,767, in 2008. Thirty-seven (0.9%) cases were detected in this rescreen (ASCUS, 16 cases; LGSIL, 13 cases; 1 high-grade squamous intraepithelial lesion; 4 ASC-H; and 3 atypical glandular cells of undetermined significance). Eliminating ASCUS cases, eight significant cases were detected, with an error rate of 0.2%. In this cytology laboratory, the rapid prescreen did not prove as reliable as routine quality assurance program for cervical cytology cases.
一种用于宫颈细胞学质量保证的快速预筛查或快速重新筛查方法已在欧洲和加拿大使用,但在美国尚未被接受。该快速预筛查方法在一个为具有宫颈癌高危人群的学术医疗中心服务的细胞学实验室中进行了测试。在3个月的时间里,从宫颈细胞学日常工作量中随机选取一盘20个按顺序编号的Surepath™液基制剂,每个制剂以随机方式进行1分钟的预筛查。经验丰富的细胞技术人员进行快速预筛查。结果记录为阴性、需要进一步复查或上皮细胞异常(指定类别)。然后将这20个宫颈细胞学制剂放回日常工作量中的相同位置,由另一名细胞技术人员进行常规筛查。最终解读由细胞病理学家根据1988年《临床实验室改进修正案》的要求进行。快速预筛查数据被制成表格,并与使用该实验室正常质量保证程序的类似时间段的数据进行比较。712例病例接受了快速预筛查。642例被解读为阴性。26例被解读为低级别鳞状上皮内病变(LGSIL)或更高级别。44例被分类为需要进一步复查。对于快速预筛查的642例阴性病例,常规筛查报告537例为阴性,105例为异常或需要细胞病理学家复查。快速预筛查的错误率为712例中的50例(7.0%);LGSIL及以上为712例中的19例(2.6%)。在105例异常病例或提交给细胞病理学家复查的病例中,31例被解读为意义不明确的非典型鳞状细胞(ASCUS),41例为反应性/修复性,17例为LGSIL,4例为不满意,1例为非典型鳞状细胞,不能排除高级别鳞状上皮内病变(ASC-H),8例为40岁以上女性子宫内膜细胞存在,1例为恶性黑色素瘤,2例在正常范围内伴有放线菌。该实验室的常规质量保证程序选择病例,即最初解读为阴性病例的10%加上任何先前宫颈细胞学异常或有宫颈上皮细胞异常病史患者的妇科细胞学检查。2008年,该质量保证程序平均涵盖29%的病例,共13767例中的4045例。在这次重新筛查中检测到37例(0.9%)病例(ASCUS,16例;LGSIL,13例;1例高级别鳞状上皮内病变;4例ASC-H;3例意义不明确的非典型腺细胞)。排除ASCUS病例后,检测到8例有意义的病例,错误率为0.2%。在这个细胞学实验室中,对于宫颈细胞学病例,快速预筛查并未证明像常规质量保证程序那样可靠。