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医学实验室认可评审中计量要素的常见问题与改进对策

Common Problems and Improvement Countermeasures of Metrological Elements in Medical Laboratory Accreditation Review

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【作者】 梁志杰曾家伟吴竞雄李灏

【Author】 LIANG Zhijie;ZENG Jiawei;WU Jingxiong;LI hao;Foshan Hospital of Traditional Chinese Medicine;

【通讯作者】 曾家伟;

【机构】 佛山市中医院

【摘要】 在中国合格评定国家认可委员会(China National Accreditation Service for Conformity Assessment,CNAS)对医学实验室认可评审过程中,计量要素是确保检测结果准确可靠的重要环节,也是评审中的关键内容。系统分析了当前医学实验室在计量要素管理中存在的常见问题,主要包括仪器设备校准不规范、计量器具未按期检定、量值溯源体系不完善、人员计量意识薄弱、计量记录不完整或缺失等问题。这些问题不仅影响实验室的认可通过率,还可能对临床诊断和患者安全构成潜在风险。

【Abstract】 In the process of accreditation review of medical laboratories by the China National Accreditation Service for Conformity Assessment(CNAS), metrological elements are an important link to ensure the accuracy and reliability of test results and also a key content in the review. This article systematically analyzes the common problems existing in the management of metrological elements in current medical laboratories, mainly including: non-standard calibration of instruments and equipment, failure to verify metrological instruments on schedule, incomplete traceability system of measurement values, weak metrological awareness of personnel, incomplete or missing metrological records, etc. These problems not only affect the accreditation pass rate of laboratories, but also may pose potential risks to clinical diagnosis and patient safety.

  • 【文献出处】 计量科学与技术 ,Metrology Science and Technology , 编辑部邮箱 ,2025年11期
  • 【分类号】R197.3
  • 【下载频次】8
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