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. 2024 Jan 2;24(1):23.
doi: 10.1186/s12885-023-11777-3.

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

Xuemin Xue #  1 , Lei Guo #  1 , Changyuan Guo #  1 , Lin Li  1 , Lin Yang  1 , Xin Wang  1 , Wei Rao  1 , Pei Yuan  1 , Jiali Mu  1 , Jiangtao Li  1 , Bingning Wang  1 , Quan Zhou  1 , Wentao Yang  2   3 , Yueping Liu  4 , Weicheng Xue  5 , Rujing Jia  6 , Wenjing Yang  7 , Jianming Ying  8
Affiliations

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

Xuemin Xue et al. BMC Cancer. .

Abstract

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.

Keywords: Accuracy; Breast pathology; Histopathology; Immunohistochemistry; Proficiency testing; Quality control.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Performance evaluation system for PT results of six key items
Fig. 2
Fig. 2
Overall characteristics of participating institutions across China. A Geographic distribution of 96 institutions in 26 provinces/municipalities/autonomous regions was demonstrated in the map of China. B Grades of 96 institutions were showed in the donut charts. C Classifications of 96 institutions were showed in the donut charts. D Bed capacity between general and specialized hospitals was showed
Fig. 3
Fig. 3
The detailed variability on the various parameters among the experts. A The detailed variability of histologic type, histologic grade and HER2. B The detailed variability of ER, PR and Ki67
Fig. 4
Fig. 4
Overall performance of six key items. A Overall performance of six key items by 96 institutions. B Overall performance of six key items across each individual case
Fig. 5
Fig. 5
Overall distribution of PT scores. A Overall distribution of PT scores across 96 institutions. B Distribution of PT scores between general and specialized hospitals (b) were exhibited
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