风险质量控制方案在甲状腺功能检测项目的应用

目的　设计风险质量控制方案应用于实验室甲状腺功能项目测定的质量控制（Quality Control, QC）中,并与传统QC方法比较。方法　首先评估实验室甲状腺功能五项的西格玛值(σ),基于风险质量控制策略设计QC方案。方案中:促甲状腺激素(TSH)和游离三碘甲状原氨酸（FT3）的质控规则采用13s, N2;游离甲状腺素(FT4)采用13s/22s/R4s,N2;三碘甲状原氨酸（T3）采用13s/22s/R4s/41s,N4;甲状腺素(T4) 采用13s/22s/R4s/41s/6x, N6。QC事件频率为每40份样本测定一次质控材料。传统质量控制规则采用13s/22s/R4s/41s/10x,N2作为对照。运行两种质量控制方案一个月并进行比较。结果　通过比较发现,σ值较高的TSH,FT3,FT4项目在质控监测过程中性能稳定,风险质量控制和传统质量控制均无失控点。而σ值较低的T3,T4项目在质控监测中稳定性略差,传统质量控制中虽未出现失控点,但风险质量控制过程中就发现失控点,且σ值越低的项目失控点就越多。结论　通过传统质量控制和风险质量控制的应用比较,风险质量控制更能有效的监测分析过程的稳定性。

Application of Risk Quality Control Plan in Thyroid Function Tests

Objective　To design a risk quality control scheme for quality control (QC) of thyroid function measurement in laboratory, and compared with traditional QC methods. Methods　The sigma values (σ) of five items of thyroid function in laboratory were first evaluated to design QC scheme based on risk quality control strategy. Thyroid stimulating hormone (TSH) and free triiodothyronine (FT3) quality control rules using 13S, N2. The free thyroxine (FT4) was 13S/22S/R4S, N2. Triiodothyronine (T3) was 13s/22s/R4s/41s, N4; thyroxine (T4) was used 13s/22s/R4s/41s/6x, and N6. QC event frequency was measured once every 40 samples. 13s/22s/R4s/41s/10x, of traditional quality control rules N2 as control. Run two quality control schemes for one month and compare them. Results　TSH,FT3 and FT4 items with high σ value had stable performance during quality control monitoring. There were no runaway points in risk quality control and traditional quality control. The stability of T3,T4 items with low σ value in quality control monitoring was slightly poor. Although there was no point of control in traditional quality control, but the risk quality control process found out of control, and the lower the σ value, the more out of control points. Conclusion　 By comparing the application of traditional quality control and risk quality control, risk quality control can effectively monitor the stability of the analysis process.