Tabbara S O, Sidawy M K
Department of Pathology, George Washington University Medical Center, Washington, D.C. 20037, USA.
Diagn Cytopathol. 1996 Feb;14(1):84-6. doi: 10.1002/(SICI)1097-0339(199602)14:1<84::AID-DC17>3.0.CO;2-9.
The CLIA '88 regulations require the laboratory to review at least 10% of the gynecologic cases interpreted as negative that are examined by each cytotechnologist. The review must include negative cases selected at random and from patients identified as a high risk group. To evaluate the validity of this regulation, we reviewed the results of the 10% rescreen over a 24-mo period. The rescreening by pathologists detected epithelial abnormalities in 4/2,124 negative cases (0.18%). Subsequently, biopsy-proven squamous intraepithelial lesions were found in all four cases. Three different cytotechnologists were responsible for the four false-negative interpretations. Our results show that 10% rescreen of negative smears may detect a few false-negative cases. However, it is a time-consuming and inefficient mean to evaluate the performance of cytotechnologists. Quality control in gynecologic cytopathology is essential, but it is equally important that laboratories concentrate their resources and energy on methods proven to be effective.
1988年的《临床实验室改进修正案》规定，实验室必须对每位细胞技术人员检查的、被判定为阴性的妇科病例至少复查10%。复查必须包括随机抽取的阴性病例以及从被认定为高危人群的患者中抽取的病例。为评估该规定的有效性，我们回顾了24个月内10%复查的结果。病理学家的复查在2124例阴性病例中检测出4例上皮异常（0.18%）。随后，在所有这4例病例中均发现了经活检证实的鳞状上皮内病变。这4例假阴性解读由3位不同的细胞技术人员负责。我们的结果表明，对阴性涂片进行10%的复查可能会检测出一些假阴性病例。然而，这是一种评估细胞技术人员工作表现既耗时又低效的方法。妇科细胞病理学的质量控制至关重要，但同样重要的是，实验室应将资源和精力集中在已被证明有效的方法上。
