The Establishment And Application Of Laboratory Quality Control Methods For Routine Immunoquantitative Of Patient Sample Data

Objective:The quality control?QC?system of the laboratory is the core of medical testing.The quality control method of patient data is an important method of QC and has not been fully applied.Therefore,the feasibility of using patient data for internal quality control is worth exploring.Method:All patients who were admitted to the outpatient clinic,physical examination and all departments of the Jiujiang University Affiliated Hospital from January 1,2018 to April 30,2019 were selected.This study used a retrospective survey to collect patient sample data and baseline data.And the screened indicators and data are analyzed to obtain the quality control target value for statistical analysis.Calculate the minimum sample size based on the sample standard deviation and the overall standard deviation obtained from the analysis.During the same period,patient data was collected from May 1,2019 to July31,2019.The established quality control method was used to verify its effectiveness.The quality control method was used to evaluate and the 6?quality rule was used to test its performance.Result:1.According to the statistical analysis data,combined with the size of the CV value,the selected items are close to the normal distribution and the index with the smaller CV value is used as the quality control target value.AFP,CEA,CA125,CA153,CA199,and tPSA select the average value of daily samples as quality control points,FT3 selects P2.5 as quality control points,and FT4 and TSH selects P90 as quality control points.It shows that the mean value of patient data as the quality control point is the target value of most projects,which is close to the normal distribution,more stable,and has less variation.2.The minimum sample size is a prerequisite for ensuring the stability of quality control.We replace the standard deviation of the analysis method with the cumulative standard deviation of the daily statistics,and calculate the mean value of the patient sample,the population standard deviation and the standard deviation of the analysis method,respectively,to obtain the minimum sample size.The minimum sample size of AFP is 36,the minimum sample size of CEA is 75,the minimum sample size of CA125 is 75,the minimum sample size of CA153 is 46,the minimum sample size of CA199 is 63,the minimum sample size of tPSA is 44,the minimum sample size of FT3 is 29,The minimum sample size for FT4 is 11,and the minimum sample size for TSH is 47.The above sample size data can meet the quality control needs in daily work.3.Patient data as the quality control point CV value is compared with the quality control quality control CV value,AFP,CEA,CA125,CA153,CA199,tPSA,TSH are greater than the CV value of the quality control product;FT3,FT4 patient data CV value is less than the quality control product CV.The degree of variability of patient data is greater than traditional quality control,and the method of increasing the sample size can overcome this disadvantage.4.In the same period,the quality control method was used to evaluate patient data,and it was found that the patient data method was more sensitive to random errors,and the degree of data variation of FT3 and FT4 was smaller.AFP,CEA,and FT4 use patient data to indicate violations of the 1_3SS rule,while quality control over the same period significantly exceeded the 1_2SS rule.CA199 and CA153 violated 1_2SS on the same day.5.Use 6? to evaluate the performance of the two methods.The FT3 and FT4projects use patient data to perform better than the quality control quality control method,and the CV value of the patient data normal mean method is lower than the quality control quality control method.Conclusion:Studies have shown that the use of patient data for quality control of routine immune quantification projects is feasible with a certain sample size,and the quality control method with quality control has a similar quality control effect and has a more sensitive ability to judge out of control.Can be used as a supplement to conventional quality control.