Research progress on internal statistical quality control procedures for quantitative tests in clinical laboratories
10.3760/cma.j.issn.1009-8158.2019.10.013
- VernacularTitle: 临床检验定量测定项目室内统计质量控制程序的研究进展
- Author:
Huizhen SUN
1
,
2
;
Wei WANG
1
;
Haijian ZHAO
1
;
Yuxuan DU
1
;
Jiali LIU
1
;
Zhiguo WANG
1
,
2
Author Information
1. National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing 100730, China
2. Graduate School, Peking Union Medical College, Beijing 100730, China
- Publication Type:Review
- Keywords:
Quality control;
Risk management;
Diagnostic tests, routine;
Total quality management
- From:
Chinese Journal of Laboratory Medicine
2019;42(10):879-883
- CountryChina
- Language:Chinese
-
Abstract:
The laboratory medicine is aimed to support clinical decisions and patient health by providing accurate results. The internal statistical quality control (SQC) can help laboratories detecting the instability of the analytical system and preventing laboratories from reporting the patient results with medically important errors, so it is essential to ensure the quality of testing results and patient safety. The traditional methods of designing SQC strategy are based on the probability of error detection (Ped) and the probability of false rejection (Pfr). With the introduction of risk management concepts, the design of SQC strategy began to be based on the patient risk parameter [MaxE(Nuf)] proposed by Parvin, which means the maximum increase in the number of unacceptable patient results reported compared to the in-control condition during the existence of an undetected out-of control error condition. MaxE(Nuf) is related to the SQC frequency and patient risk, which is very essential for optimizing the SQC frequency and designing a risk-based SQC strategy.
