目的 探讨一种基于试剂盒内自带质控品条件下的稳定有效的质控管理措施。方法 选取中国人民解放军联勤保障部队第九〇七医院检验科2022年11月2日—2023年7月22日室内质控数据进行分析。更换试剂批次时试剂盒内质控品批次也同时更换，观察试剂盒内自带质控品和第三方质控品室内质控Levey-Jennings图变化，评估各批次允许不精密度[以变异系数(coefficient of variation，CV)表示]。采用固定试剂盒内自带质控品批次，更换试剂批次时试剂自带质控品批次不更换，观察试剂盒内自带质控品和第三方质控品Levey-Jennings图变化，评估各批次和累积允许不精密度(以CV表示)，比较 σ 值差异。结果 同时更换试剂及自带质控品共3个批次，虽然自带质控品和第三方质控品各批次CV均符合实验室质量控制目标CV≤10％。但是每次更换批号，第三方质控Levey-Jennings图出现明显批间差，用试剂自带质控品Levey-Jennings图则批内稳定，无法提示试剂批间差。采用固定试剂盒内自带质控品批次，更换试剂批次时试剂盒内自带质控品批次不更换的情况下，更换3个批次试剂，试剂盒内自带质控品和第三方质控品一样每次更换试剂批次Levey-Jennings图都出现较大差异，且自带质控品和第三方质控品各批次和累积CV均符合实验室质量控制目标CV≤10％，σ值均达到世界一流水平。试剂盒内自带质控品也可以反映试剂批间差，与第三方质控品达到一样的效果。结论 通过改进试剂盒内自带质控品的使用管理措施，可以优化质控效率，降低临床安全隐患。
Study on Improvement Measures for Indoor Quality Control Management Using the Internal Quality Control Material Provided in the Reagent Kit
Objective To explores a stable and effective quality control management approach based on the use of in-kit internal quality controls. Methods The indoor quality control data of department of clinical laboratory,the 907th Hospital of the Joint Logistics Support Force of the People's Liberation Army of China from November 2,2022 to July 22,2023 were selected and analyzed. Changing both reagent batches and in-kit internal quality control batches simultaneously. The Levey-Jennings charts for in-kit and third-party controls were observed to assess precision[expressed as the coefficient of variation (CV)]for each batch. Maintaining a fixed in-kit internal quality control batch while changing reagent batches. The Levey-Jennings charts for in-kit and third-party controls were observed to assess precision (CV) for each batch and cumulative precision,and differences in σ values were compared. Results Simultaneously changing reagent and in-kit control batches for three cycles showed that CV for both in-kit and third-party controls met the laboratory's quality control target (CV≤10％). However,when changing reagent batches,significant inter-batch differences were observed in the third-party control Levey-Jennings charts,while the in-kit control charts remained stable within batches,providing no indication of inter-batch differences. Maintaining a fixed in-kit internal quality control batch while changing reagent batches for three cycles showed significant differences in Levey-Jennings charts each time,for both in-kit and third-party controls. However,CV for each batch and cumulative CV met the laboratory's quality control target (CV≤10％),and σ values reached world-class levels. In-kit internal quality controls were effective in reflecting inter-batch differences,achieving similar results to third-party controls. Conclusion By improving the management of in-kit internal quality controls,it is possible to optimize quality control efficiency and reduce clinical safety risks.
万方数据
维普
