六西格玛在临床生化检验质量控制中的应用

Six sigma theory's role in quality control of the clinical biochemical examination

目的运用标准化西格玛方法评价临床生化检验阶段性能,发现问题,指导质量改进。方法收集本实验室2013年-2015年室内质控和参加卫生部临床检验中心室间质评的数据,计算累计变异系数(CV)和累计偏倚(Bias),根据检验项目的 CV、Bias及总允许误差(TEa)计算西格玛值(σ),评价临床生化实验室检验阶段性能,并设计质量控制方案。计算QGI值,查找导致性能不佳的主要原因,指导质量改进。结果 3年的统计结果达到6σ的分别占48.3%、48.4%、46.7%,未达到3σ的分别占20.6%、17.2%、23.4%。3年的平均σ值分别为6.29、6.09、5.66。连续3年达到6σ值的检测项目有AMY、CK、MG、DBIL、IgG、PHOS。连续3年未达到3σ值的检测项目有Na、ALB、Cl、UREA。未达到3σ值的所有检测项目的 QGI值均<0.8,需要优先改进精密度。结论运用六西格玛理论能更为严谨的评价临床生化检验阶段性能,以此设计个体化的质量控制方案可更有效地指导质量改进。

Objective Apply the standard sigma metrics to assess the performance of clinical biochemical laboratory, then find problems and promote quality improvement. Methods We collected the data from internal quality control and participating in the ministry of health clinical inspection center＇s qualitative evaluation during 2013 - 2015. Then we calculated the cumulative variation coefficient（CV） and cumulative bias（ Bias）, according to the CV, Bias and total allowable error（TEa） of the test to calculate the Sigma value（（r）, to evaluate the performance of clinical biochemistry laboratory test, and to design the quality control plan. To calculate the QGI alue, and find out the main reasons leading to poor performance, so as to guide quality im- provement. Results The statistical results of three years to achieve 66 accounted for 48.3%, 48.4%, 46.7%, not reached 36 accounted for 20.6% , 17.2% and 23.4% , respectively. The average sigma value of the three years were 6.29, 6.09, 5.66, respectively. In the continuous three years, the test items achieved 66 included AMY, CK, MG, DBIL, IgG and PHOS, and not achieved 36 in the 3 years included Na, ALB, C1 and UREA. All the test items＇s QGI that did not achieve 36 were less than 0.8, so it need improve the precision priority. Conclusion Applying the six sigma theory, we can evaluate the clinical biochemical laboratory more rigorously. To design the individualized quality control scheme can more effectively guide the quali- ty improvement.