Application of statistical process control to volume of red cells in additive solution
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摘要: 目的:采用统计过程控制(SPC)分析悬浮红细胞制品的容量,评估采集制备过程中对容量控制的满意程度。方法:随机抽取1 214袋悬浮红细胞成分制品称重,扣除血袋皮重后除以产品比重计算容量。用Minitab软件对数据统计分析。结果:1.0 U、1.5 U和2.0 U的悬浮红细胞容量值分别为:(151±9.93)mL(n=421)、(227±11.95)mL(n=448)和(304±13.51)mL(n=345)。3个规格在x±3s的容量范围控制分别为124~178 mL、193~261 mL和264~345 mL,其过程能力指数(Cpk)分别为0.9、1.0、1.0;在x±10%的容量范围控制分别为136~166 mL、204~250 mL和274~334 mL,Cpk分别为0.50、0.64、0.74。用累积和CUSUM控制图可以检出报警点。结论:悬浮红细胞血液成分的容量指标基本处于正常波动,x±10%的容量控制范围比x±3s窄。1.0 U悬浮红细胞的容量控制能力较差,与献血者性别分布有关。追溯CUSUM控制图报警点,可反映制备过程导致的异常波动。悬浮红细胞容量控制的过程能力还可提高。Abstract: Objective:The statistical process control was used to analyze the fluctuation of the volume index of red cells in additive solution collected and.We assessed the degree to which volume control occurs during the operation of blood collection and processing. Method:Random sample weighing,after deducting blood bag skin weight,divided by product density to calculate the capacity of red cells in additive solution.The data was statistically analyzed by Minitab software. Result:The volume values of 1.0 U,1.5 U and 2.0 U red cells in additive solution were (151±9.93)mL(n=421),(227±11.95)mL(n=448)and (304±13.51)mL(n=345)respectively.The volume control in range of x±3s of three standards of red blood cells in additive solution were 124-178 mL,193-261 mL and 264-345 mL(Cpk 0.9,1,1),while in range of x±10%,were 136-166 mL、204-250 mL and 274-334 mL(Cpk 0.50,0.64,0.74).Alarm points can be detected by using CUSUM control charts.Conclusion:The volume of red cells in additive solution was basically in the normal fluctuation process,the volume control range of x±10% was narrow than the x±3s.The capacity of volume control for 1.0 U red cells in additive solution was relatively poor,which may be related to the sex distribution of the sampling donors.Tracing the alarm points of the CUSUM control chart can reflect the abnormal fluctuations caused by the preparation process.The process capacity of the volume control of red blood cells in additive solution can be improved.
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Key words:
- red cells in additive solution /
- statistical process control /
- Cpk /
- CUSUM chart
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