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Proficiency testing of diagnosis in histopathology and immunohistochemistry of breast pathology in China: results from a pilot work of National Single Disease Quality Control Program for breast cancer

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机构: [1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Pathol, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China [2]Fudan Univ, Shanghai Canc Ctr, Dept Pathol, Shanghai 200032, Peoples R China [3]Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai 200032, Peoples R China [4]Hebei Med Univ, Hosp 4, Dept Pathol, Shijiazhuang 050011, Peoples R China [5]Peking Univ, Canc Hosp & Inst, Dept Pathol, Key Lab Carcinogenesis & Translat Res,Minist Educ, Beijing 100142, Peoples R China [6]Natl Accreditat Serv Conform Assessment, Special Stand Lab Accreditat Dept, 8 Nanhuashi St, Beijing 100062, Peoples R China [7]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Off Canc Diag & Treatment Qual Control,Natl Clin R, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
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关键词: Breast pathology Proficiency testing Quality control Accuracy Histopathology Immunohistochemistry

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Aim Pathologists are currently supposed to be aware of both domestic and international guidelines for breast cancer diagnosis, but it is unclear how successfully these guidelines have been integrated into routine clinical practice in China. Thus, this national proficiency testing (PT) scheme for breast pathology was set up to conduct a baseline assessment of the diagnostic capability of pathologists in China.Methods This national PT plan is designed and implemented according to the "Conformity assessment-General requirements for proficiency testing" (GB/T27043-2012/ISO/IEC 17043:2010). Five cases of breast cancer with six key items, including histologic type, grade, ER, PR, HER2, and Ki67, were selected for testing among 96 participants. The final PT results were published on the website of the National Quality Control Center for Cancer (http://117.133.40.88:3927/cn/col22/362).Results Our study demonstrated that the median PT score was 89.5 (54-100). Two institutions with scores < 67 were deemed unacceptable. The accuracy of histologic type, ER, PR, HER2, and Ki67 was satisfactory (all > 86%). However, the histologic grade showed low accuracy (74.0%). The unacceptable results mainly included incorrect evaluation of histologic grade (36.7%), inaccurate evaluation of ER/PR/HER2/Ki67 (28.2%), incorrect identification of C-AD as IBC-NST (15.7%), inappropriate use of 1+/2+/3+ rather than staining percentage for ER/PR (6.1%), misclassification of ER/PR < 1% weak expression as positive staining (1.4%), and no evaluation of histologic grade in ILC, MC, and IMC (5.8%).Conclusions our nationwide PT program exhibited a satisfactory baseline assessment of the diagnostic capability of pathologists in China. More importantly, we identify some areas for further improvement.

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出版当年[2025]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
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大类 | 3 区 医学
小类 | 3 区 肿瘤学
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Q2 ONCOLOGY

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第一作者机构: [1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Dept Pathol, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
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