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美国细胞病理学学会关于自动巴氏试验筛查的工作量建议:由自动筛查时代的生产力与质量保证特别工作组制定。

American Society of Cytopathology workload recommendations for automated Pap test screening: developed by the productivity and quality assurance in the era of automated screening task force.

作者信息

Elsheikh Tarik M, Austin R Marshall, Chhieng David F, Miller Fern S, Moriarty Ann T, Renshaw Andrew A

机构信息

Cleveland Clinic, Cleveland, Ohio, USA.

出版信息

Diagn Cytopathol. 2013 Feb;41(2):174-8. doi: 10.1002/dc.22817. Epub 2012 Feb 20.

Abstract

Based on current literature and the best available research to date, the current FDA workload limits for automated image-assisted screening, including the ThinPrep Imaging System and the FocalPoint GS, of 100 slides/day (imaged only slides counted as 0.5) are extremely high and may be associated with significant reduction in sensitivity. This task force has proposed six recommendations relating to cytotechnologist (CT) workload in automated image-guided Pap test screening, which have already been endorsed by major pathology professional societies. These evidence-based recommendations, however, pertain only to gynecologic specimens with image-assisted screening, as there is no current available data to justify modifying screening practices regarding non-gynecologic specimens. The proposed recommendations are as follow: 1) CT workday should not include more than 7 hours of Pap test screening in a 24-hr period, and an 8-hr shift day must include at least 2 paid mini-breaks of 15 minutes each and a 30-minute lunch break. 2) Future Studies examining CT workload should use actual hours of screening rather than lesser number of hours extrapolated to 8-hour days. 3) Average laboratory CT workload should NOT exceed 70 slides/day (slides counted per 2010 FDA bulletin). 4) Proportion of imaged slides that undergo full manual review should be at least either 15%, or twice (2×) the epithelial cell abnormality (ECA) rate, whichever is greater. 5) ECA-adjusted workload measure is a promising method for calculating and monitoring CT workload, but further studies of this method are necessary before full endorsement. 6) CT productivity and workload limits are just one aspect of a good quality assurance program in a cytology laboratory, so other quality indicators to assess CT performance are essential.

摘要

根据当前文献和迄今为止可获得的最佳研究,美国食品药品监督管理局(FDA)目前对包括ThinPrep成像系统和FocalPoint GS在内的自动图像辅助筛查的工作量限制为每天100张玻片(仅成像的玻片计为0.5张),这一限制极高,可能会导致灵敏度显著降低。该特别工作组针对自动图像引导的巴氏试验筛查中的细胞技术专家(CT)工作量提出了六项建议,这些建议已得到主要病理学专业协会的认可。然而,这些基于证据的建议仅适用于采用图像辅助筛查的妇科标本,因为目前没有可用数据支持修改非妇科标本的筛查做法。建议如下:1)CT工作日在24小时内进行巴氏试验筛查的时间不应超过7小时,8小时轮班日必须包括至少两次各15分钟的带薪短休息和一次30分钟的午餐休息。2)未来研究CT工作量时应使用实际筛查小时数,而非推算至8小时工作日的较少小时数。3)实验室CT平均工作量每天不应超过70张玻片(根据2010年FDA公告计算玻片数)。4)进行全面人工复查的成像玻片比例应至少为15%,或上皮细胞异常(ECA)率的两倍,以较大者为准。5)ECA调整后的工作量测量方法是计算和监测CT工作量的一种有前景的方法,但在全面认可之前,有必要对该方法进行进一步研究。6)CT生产力和工作量限制只是细胞学实验室优质质量保证计划的一个方面,因此评估CT表现的其他质量指标至关重要。

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