机构：[1]Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China[2]Department of Laboratory Medicine, Padova University Hospital, Padova, Italy
Background Quality indicators (QIs) are crucial tools in measuring the quality of laboratory services. Based on the general QIs of the Working Group "Laboratory Errors and Patient Safety (WG-LEPS)" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), specific QIs have been established in order to monitor and improve the quality of molecular diagnostics, and to assess the detection level of associated disease. Methods A survey was conducted on 46 independent commercial laboratories in China, investigated using questionnaires and on-site inspections. Specific QIs established were mainly based on the specific laboratory work-flow for molecular diagnoses. The specific QI results from three volunteer laboratories were collected and used to validate their effectiveness. Results Of the 46 laboratories participating in the study, 44 (95.7%), conducted molecular diagnostics. Of 13 specific established QIs, six were priority level 1, and seven, priority level 3. At pre-evaluation of data from the three volunteering laboratories, it was found that the newly classified specific QIs had outstanding advantages in error identification and risk reduction. Conclusions Novel specific QIs, a promising tool for monitoring and improving upon the total testing process in molecular diagnostics, can effectively contribute to ensuring patient safety.
基金：
Beijing Municipal Administration of Hospitals; National Clinical Key Specialty Construction P; National Natural Science Foundation of ChinaNational Natural Science Foundation of China
第一作者机构：[1]Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China
通讯作者：
通讯机构：[2]Department of Laboratory Medicine, Padova University Hospital, Padova, Italy
推荐引用方式(GB/T 7714)：
Zhou Rui,Wei Yali,Sciacovelli Laura,et al.A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China.[J].Clinical chemistry and laboratory medicine.2019,57(6):822-831.doi:10.1515/cclm-2018-0966.
APA：
Zhou Rui,Wei Yali,Sciacovelli Laura,Plebani Mario&Wang Qingtao.(2019).A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China..Clinical chemistry and laboratory medicine,57,(6)
MLA：
Zhou Rui,et al."A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China.".Clinical chemistry and laboratory medicine 57..6(2019):822-831
