背景:2022年,我们的团队启动了开创性的国家能力验证(PT)计划,用于乳腺癌的病理诊断,在整个中国迅速建立信誉。旨在不断监测和提高中国病理学家的乳腺病理学水平,第二轮PT计划于2023年启动,将扩大参与机构的数量,并将在全国范围内对HER20,1+的解释进行调查,和2+/FISH-类别在中国。
方法:当前一轮PT方案中采用的方法与2022年上一周期的方法非常相似,该方法是根据“合格评估-能力测试的一般要求”(GB/T27043-2012/ISO/IEC17043:2010)设计和实施的。更重要的是,我们使用基于统计的方法来生成分配值,以增强其鲁棒性和可信度。
结果:最终PT结果,发表在国家癌症质量控制中心网站(http://117.133.40.88:3927),表明所有参与者都通过了测试。然而,一些机构在对HER20,1+,和2+/FISH-精度低于59%,认为不满意。尤其是,HER20例的一致率仅为78.1%,表明在区分HER20和低HER2表达方面存在挑战。同时,还注意到组织学类型和等级解释改善的领域.
结论:我们的PT方案在中国诊断乳腺癌方面表现出很高的水平。但它也发现了对HER20,1+,和2+/FISH-在一些机构。更重要的是,我们的研究强调了在HER2染色光谱的最低端评估中的挑战,这是进一步研究的关键领域。同时,它还表明需要改进组织学类型和等级的解释。这些发现加强了健全质量保证机制的重要性,就像这项研究中进行的全国性PT计划一样,保持高诊断标准,并确定需要进一步培训和增强的领域。
BACKGROUND: In 2022, our team launched the pioneering national proficiency testing (PT) scheme for the pathological diagnosis of breast cancer, rapidly establishing its credibility throughout China. Aiming to continuously monitor and improve the proficiency of Chinese pathologists in breast pathology, the second round of the PT scheme was initiated in 2023, which will expand the number of participating institutions, and will conduct a nationwide investigation into the interpretation of
HER2 0, 1+, and 2+/FISH- categories in China.
METHODS: The methodology employed in the current round of PT scheme closely mirrors that of the preceding cycle in 2022, which is designed and implemented according to the \"Conformity assessment-General requirements for proficiency testing\"(GB/T27043-2012/ISO/IEC 17043:2010). More importantly, we utilized a statistics-based method to generate assigned values to enhance their robustness and credibility.
RESULTS: The final PT results, published on the website of the National Quality Control Center for Cancer ( http://117.133.40.88:3927 ), showed that all participants passed the testing. However, a few institutions demonstrated systemic biases in scoring
HER2 0, 1+, and 2+/FISH- with accuracy levels below 59%, considered unsatisfactory. Especially, the concordance rate for
HER2 0 cases was only 78.1%, indicating challenges in distinguishing
HER2 0 from low
HER2 expression. Meanwhile, areas for histologic type and grade interpretation improvement were also noted.
CONCLUSIONS: Our PT scheme demonstrated high proficiency in diagnosing breast cancer in China. But it also identified systemic biases in scoring
HER2 0, 1+, and 2+/FISH- at some institutions. More importantly, our study highlighted challenges in the evaluation at the extreme lower end of the HER2 staining spectrum, a crucial area for further research. Meanwhile, it also revealed the need for improvements in interpreting histologic types and grades. These findings strengthened the importance of robust quality assurance mechanisms, like the nationwide PT scheme conducted in this study, to maintain high diagnostic standards and identify areas requiring further training and enhancement.