国家癌症中心病理科乳腺癌规范化质量控制工作经验总结

Experience for the implementation of pathological quality control measures for breast cancer in the Pathology Department of the National Cancer Center

女性乳腺癌是2020年全球癌症发病率的第一大原因和癌症死亡率的第五大原因。随着中国乳腺癌筛查和早诊早治的普及,以及治疗水平的不断进步,目前乳腺癌患者5年生存率已大幅提升,但不同地区间诊断和治疗水平仍存在较大差异。目前临床乳腺癌治疗决策高度依赖于病理诊断所提供的各项指标,包括组织学类型、分级、肿瘤体积、脉管侵犯、淋巴结转移情况、切缘情况、激素受体,以及遗传学改变等。因此,病理科医生需要提供一份规范且准确的病理报告,协助临床医生制订更为精准有效的治疗策略,提高患者生存预后和生存质量。然而,病理诊断工作环节较多,从乳腺癌标本送检、接收、固定、取材、脱水、包埋、切片、苏木精-伊红染色、免疫组织化学检测、基因检测、医生阅片到最后病理资料归档,均可影响到乳腺癌最终的病理诊断;并且流程环节越靠前,对后续诊断的影响越大,可弥补性越低。而乳腺癌质量控制(以下简称质控)的目的,就是保证这些病理诊断工作环节标准规范地运行。因此,本文总结国家癌症中心病理科乳腺癌质控工作中的经验,阐述乳腺癌标本在接收、固定、取材、制片、诊断、格式化报告、信息化管理、中国合格评定国家认可委员会ISO15189医学实验室质量管理体系建立以及乳腺癌单病种病理诊断能力验证计划实施等方面的质控要点,以期为我国乳腺癌病理质控工作提供借鉴。

Breast cancer in females has been identified as first cause of global cancer incidence rate and ranks fifth in terms of cancer-related mortality in the year 2020.In China,the widespread implementation of breast cancer screening,coupled with advancements in treatment,has led to a notable increase in the 5-year survival rate of breast cancer patients.However,there exist substantial variations in the diagnosis and treatment across various regions.Currently,clinical treatment decisions of breast cancer are reliant on the parameters provided by pathology,encompassing histological type,grading,tumor volume,vascular invasion,lymph node metastasis,surgical margins,hormone receptors,and genetic alterations.Hence,it is crucial for pathologists to offer a uniform and precise pathological report to assist oncologists in formulating more accurate and effective treatment strategies,thereby enhancing the patient's prognosis and quality of life.Nevertheless,numerous steps are involved in the process of pathological diagnosis,including the registration,reception,fixation,sampling,dehydration,embedding,sectioning,hematoxylin and eosin staining,immunohistochemistry,gene detection,pathologist interpretation,and final storage and archiving of pathological material.They all could have potential impacts on the final pathological diagnosis.The earlier the step of process,the greater the impact on subsequent diagnosis and the lower the recoverability.Implementing quality control measures for breast cancer is to ensure the standardized operation of these steps.Herein,we provide an overview of the quality control work of breast cancer within the Pathology Department of the National Cancer Center,including specimen receiving,fixing,sampling,staining,diagnosis,template-based synoptic reporting system,laboratory information system,establishment of quality management system based on the China National Accreditation Service for Conformity Assessment-ISO15189,and setting up proficiency testing scheme for pathological diagnosis capability of breast cancer.The aim of this article is to provide useful experience for the implementation of breast cancer pathological quality control measures in China.