临床实验室甲状腺功能检测项目应用西格玛度量运行大小列线图设计多阶段质量控制策略

Using Sigma-metric SQC Run Size Nomogram to Design a Multistage Quality Control Strategy for Thyroid Function Testing Items in Clinical Laboratory

目的基于患者风险设计甲状腺功能检测项目的多阶段质控策略。方法利用国家卫生健康委员会临床检验中心内分泌室间质评回报结果和日常质控数据获得偏移百分差和室内质控变异系数,并计算西格玛(σ)度量值。估算实验室甲状腺功能检测项目的最大日工作量和期望报告间隔,应用σ度量运行大小列线图设计甲状腺功能检测项目的质控程序并在实验室内运行1周,计算质控开支占总成本的比例。结果促甲状腺激素(thyroid stimulating hormone,TSH)、游离三碘甲状原氨酸(free T3,FT3)、游离甲状腺素(free T4,FT4)、三碘甲状原氨酸(total triiodothyronine,TT3)和甲状腺素(total thyroxine,TT4)的σ度量值分别为6.06,3.68,4.36,4.35和2.28。TSH的起始质控程序为1_(3s)N2,监控质控程序为1_(3s)N1;FT3和TT4的起始质控程序为MR N4,监控质控程序为MR N4;FT4和TT3起始质控程序均为MR N2,监控质控程序均为1_(3s)N2。运行1周质控程序,TSH和TT3未监测到失控点,FT4监测到1个失控点,FT3监测到4个失控点,TT4监测到2个失控点。TSH,FT4,TT3,FT3和TT4的质控开支占总成本的比例分别为3.3%,5.3%,5.3%,10.3%和10.3%。结论应用西格玛度量运行大小列线图设计甲状腺功能检测项目的多阶段质量控制策略可以降低患者伤害的风险。

Objective To design a multistage quality control strategy for thyroid function testing items based on patient risk.Methods The bias was obtained from the results of the endocrine external quality assessment of the National Center for Clinical Laboratories,and the coefficient of variation of the internal quality control was obtained from the daily quality control data,and then the sigma metrics value was calculated.Estimating the laboratory’s maximum daily workload and expected reporting interval for thyroid function testing,applied the sigma metric to run the nomogram to design quality control procedures for thyroid function testing items and was run in the laboratory for 1 week,and calculate the proportion of quality control expenses to total costs.Results Theσmetrics values of TSH,FT3,FT4,TT3 and TT4 were 6.06,3.68,4.36,4.35 and 2.28,respectively.The initial quality control program for TSH was 1_(3s)N2,and the monitoring quality control program was 1_(3s)N1.The initial quality control for FT3 and TT4 was MR N4,and the monitoring quality control was MR N4.The initial quality control for FT4 and TT3 was MR N2,and the monitoring the quality control was 1_(3s)N2.After running the quality control program for 1 week,TSH and TT3 did not detect out of control point,FT4 detected 1 out of control point,FT3 detected 4 out of control points,and TT4 detected 2 out of control points.The proportion of quality control expenses in TSH,FT4,TT3,FT3 and TT4 to the total cost was 3.3%,5.3%,5.3%,10.3%and 10.3%,respectively.Conclusion Applyingσmetrics to run size nomograms to design and analyze multistage quality control strategies for projects can minimize the risk of patient harm.