Davey D D
Department of Pathology and Laboratory Medicine, University of Kentucky Medical Center, Lexington 40536-0093, USA.
Arch Pathol Lab Med. 1997 Mar;121(3):296-8.
Five-year retrospective review of negative or normal smears in patients with newly diagnosed high-grade squamous intraepithelial lesions or cancer is a federal regulation for all laboratories practicing gynecologic cytology under the Clinical Laboratory Improvement Amendments of 1988. Amended reports are required when significant discrepancies are found that would affect patient care. The focus of this regulation is current patient care. Two studies have found a retrospective discrepancy rate of about 10% when the threshold for discrepancy was at least dysplasia. Higher rates are reported when missed atypical cases are counted as discrepancies. Retrospective review highlights problem areas for laboratory education and quality improvement efforts, but liability concerns have been a detrimental consequence of this regulation. Clarification that amended reports be issued only when current patient care is affected should aid laboratories in complying with this regulation.
对新诊断为高级别鳞状上皮内病变或癌症患者的阴性或正常涂片进行五年回顾性审查，是1988年《临床实验室改进修正案》要求所有从事妇科细胞学检查的实验室遵守的一项联邦规定。当发现会影响患者护理的重大差异时，需要修正报告。该规定的重点是当前患者护理。两项研究发现，当差异阈值至少为发育异常时，回顾性差异率约为10%。若将漏诊的非典型病例计为差异，则报告的差异率更高。回顾性审查突出了实验室教育和质量改进工作的问题领域，但责任问题一直是该规定的一个有害后果。明确仅在当前患者护理受到影响时才发布修正报告，应有助于实验室遵守该规定。
