| 郑浩喻靓胡娟江铭磊龚燕高翔郭林.6σ 质量管理方法在临床化学检测性能评价中的应用[J].现代生物医学进展英文版,2012,12(17):3297-3301. |
| 6σ 质量管理方法在临床化学检测性能评价中的应用 |
| The Analysis and Evaluation of the Quality Control in Clinical Laboratoryby the Six Sigma(6σ) QualityManagement Method |
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| DOI： |
| 中文关键词: 六西格玛 质量控制 质量目标指数 |
| 英文关键词: Six Sigma Quality Control Quality goal index |
| 基金项目: |
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| 中文摘要: |
| 目的：应用六西格玛（6σ）质量管理方法分析临床生化检验项目质量控制数据，评价其分析性能，设计生化检验项目的质量
控制方法并指导其质量改进。方法：收集2010 年度临床生化检验项目室内质量控制及室间质量评价的数据，按照美国临床实验
室改进修正法案允许总误差（TEa）标准，采用公式值=[TEa%- 偏倚(bias%)]/ 变异系数（CV%），计算检验项目的σ 值，绘制标准化
6σ 性能决定图，评价检验项目分析性能，设计质量控制方案，计算检验项目的质量目标指（QGI），查找导致性能不佳的主要原因，
提出优先改进方法。结果：临床生化检验项目中, 常规生化和干式生化的检验项目达到6 西格玛水平分别占66.6%和58.4%，达到
5～6 西格玛水平分别占4.8%和8.3%，达到4～5 西格玛水平分别占4.8%和8.3%，4. 达到3～4 西格玛水平分别占4.8%和
16.7%，在3 西格玛水平以下分别占19%和8.3%，全部检验项目的平均σ 值分别为9.33 和6.95。在12 个6σ 值<6 的检验项目中
有50%要优先改进精密度，25%需要优先改进准确度，其余则两者都要改进。结论：6σ 质量管理方法可以有效地应用于临床化学
检测性能评价，设计个性化的质量控制方案可更有效地控制质量，有助于不断提高临床实验室生化检验项目质量水平。 |
| 英文摘要: |
| Objective: To analyze the data of quality control and evaluate its performance in clinical laboratory by applying the six
sigma(6σ) quality management method, design chemical test project quality control method and improve the method. Methods: The data
were collected from internal quality control and external quality assessment in clinical laboratory during 2010. The total allow able analytical
error (TEa) was defined according to the Clinical Laboratory Improvement Amendments. The value was calculated according to the
equation σ = (TEa%-bias%) /coefficient of variation (CV%). The normalized decision chart and normalized operational process specification
chart were made for evaluating the analysis performance. The quality control strategy based on 6σ was also designed and used for
the evaluation of the clinical detections. The quality goal index was also calculated for finding out the problems. Results: 66.6% and
58.4%, 4.8% and 8.3%, 4.8% and 8.3%,4.8% and16.7%, 19% and 8.3%. All the analysis results were over 6, 5～6, 4～5 , 3～4and <3σ
metric respectively with the average of 9.33. Of all the analysis less than 6σ metric, 50% needed to be improved for the imprecision. 25%
needed to be improved for the Accuracy, the rest of The rests are both improved. Conclusions: Effective application of 6σ quality
management method in Performance Evaluation of Clinical Chemical Test Items, Design personalized quality control schemes can be
more effective control of quality, 6σ quality management method is helpful in finding out the influence factors and it is an effective tool
for quality management in clinical laboratory. |
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