Journal of Capital Medical University ›› 2021, Vol. 42 ›› Issue (5): 706-714.doi: 10.3969/j.issn.1006-7795.2021.05.003

• Laboratory Medicine and Clinic • Previous Articles     Next Articles

Comparative study of patient-based quality control (PBQC) and traditional quality control methods

Liu Yu1,2, Zhang Shunli1, Yue Yuhong1,3, Zhang Rui1,4*   

  1. 1. Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100021, China;
    2. Department of Clinical Laboratory, Beijing TongRen Hospital, Capital Medical University, Beijing 100730, China;
    3. Beijing Center for Clinical Laboratories, Beijing 100021, China;
    4. Central Laboratory of Hebei Yanda Hospital, Sanhe 065201, Hebei Province, China
  • Received:2021-08-24 Published:2021-10-29
  • Contact: Key Medical Specialties of 2021 “Sailing” Program (ZYLX202137), Beijing Key Clinical Specialty Excellence Project (Laboratory).

Abstract: Objective To compare the patient-based quality control(PBQC)with the traditional quality control method in some biochemical items detection, increase the interoperability and correlation between routine quality control data and clinical patient data, and improve the accuracy of detection results. Methods The data of blood glucose (Glu), glycosylated albumin (GA), glycosylated hemoglobin (HbA1c), triglyceride (TG), total cholesterol (TC), and blood homocysteine (HCY) within the normal reference range from 18 to 55 years old were collected continuously for 25 days to obtain the daily mean and median. The routine quality control data of the above biochemical test items in the same period were collected. The total mean, median and standard deviation were calculated with 6σ the quality management methods to evaluate the performance of moving average method, moving median method and conventional quality control method based on patient data. The patient data for another 20 days were collected, with a positive deviation of 5%, and compared with the data of the previous 25 days. Whether the patient was in control or not was judged according to the Westgard quality control rules. Results In the routine quality control methods, Glu, GA, HbA1c, TG, TC, and HCY were the most important, with the σ values 2.85, 0.89, 3.64, 15.03, 5.14 and 2.83 respectively, corresponding to the performance evaluation medium, poor, good, excellent, excellent, and medium. Based on the moving mean method and median method of patient data, the changes of Glu, GA, HbA1c, TG, TC and HCY were analyzed, with the σ values 3.05, 2.90; 2.63,1.58; 4.49,0.84; 3.38,2.45; 4.39,3.59; and 1.61,0.93; respectively, corresponding to the performance evaluation good, medium; medium, poor; excellent, poor; good, medium; excellent, good; and poor, poor. The out of control of other detection items except triglyceride could be detected by PBQC method with 5% error. Conclusion Under the comprehensive evaluation of 6 σ quality management, the moving average method of PBQC and the conventional quality control method was compared with each other, and their performance was equivalent and complementary. The moving average method of PBQC on Glu, GA and HbA1c projects performed better, whilst routine quality control method on TG and HCY project was better. The moving average method of PBQC could be used as an effective quality control method to assist conventional quality control.

Key words: patient-based quality control, routine quality control, laboratory management, moving average method

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