PMID- 30022883
OWN - NLM
STAT- MEDLINE
DCOM- 20190422
LR  - 20220408
IS  - 1330-0962 (Print)
IS  - 1846-7482 (Electronic)
IS  - 1330-0962 (Linking)
VI  - 28
IP  - 2
DP  - 2018 Jun 15
TI  - Sigma metrics for assessing the analytical quality of clinical chemistry assays: 
      a comparison of two approaches: Electronic supplementary material available 
      online for this article.
PG  - 020708
LID - 10.11613/BM.2018.020708 [doi]
LID - 020708
AB  - INTRODUCTION: Two approaches were compared for the calculation of coefficient of 
      variation (CV) and bias, and their effect on sigma calculation, when different 
      allowable total error (TEa) values were used to determine the optimal method for 
      Six Sigma quality management in the clinical laboratory. MATERIALS AND METHODS: 
      Sigma metrics for routine clinical chemistry tests using three systems (Beckman 
      AU5800, Roche C8000, Siemens Dimension) were determined in June 2017 in the 
      laboratory of Peking Union Medical College Hospital. Imprecision (CV%) and bias 
      (bias%) were calculated for ten routine clinical chemistry tests using a 
      proficiency testing (PT)- or an internal quality control (IQC)-based approach. 
      Allowable total error from the Clinical Laboratory Improvement Amendments of 1988 
      and the Chinese Ministry of Health Clinical Laboratory Center Industry Standard 
      (WS/T403-2012) were used with the formula: Sigma = (TEa - bias) / CV to calculate 
      the Sigma metrics (sigma(CLIA), sigma(WS/T)) for each assay for comparative analysis. 
      RESULTS: For the PT-based approach, eight assays on the Beckman AU5800 system, 
      seven assays on the Roche C8000 system and six assays on the Siemens Dimension 
      system showed sigma(CLIA) > 3. For the IQC-based approach, ten, nine and seven 
      assays, respectively, showed sigma(CLIA) > 3. Some differences in sigma were therefore 
      observed between the two calculation methods and the different TEa values. 
      CONCLUSIONS: Both methods of calculating sigma can be used for Six Sigma quality 
      management. In practice, laboratories should evaluate Sigma multiple times when 
      optimizing a quality control schedule.
FAU - Guo, Xiuzhi
AU  - Guo X
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Zhang, Tianjiao
AU  - Zhang T
AD  - National Center for Clinical Laboratories, Beijing Hospital, National Center of 
      Gerontology, Beijing, P.R. China.
FAU - Gao, Xuehui
AU  - Gao X
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Li, Pengchang
AU  - Li P
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - You, Tingting
AU  - You T
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Wu, Qiong
AU  - Wu Q
AD  - Clinical Laboratory, Affiliated Hospital of Chifeng University, Inner Mongolia, 
      P.R. China.
FAU - Wu, Jie
AU  - Wu J
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Zhao, Fang
AU  - Zhao F
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Xia, Liangyu
AU  - Xia L
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Xu, Ermu
AU  - Xu E
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Qiu, Ling
AU  - Qiu L
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
FAU - Cheng, Xinqi
AU  - Cheng X
AD  - Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese 
      Academic Medical Science and Peking Union Medical College, Beijing, P.R. China.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - Croatia
TA  - Biochem Med (Zagreb)
JT  - Biochemia medica
JID - 9610305
SB  - IM
MH  - *Clinical Chemistry Tests
MH  - Humans
MH  - Total Quality Management/*methods
PMC - PMC6039159
OTO - NOTNLM
OT  - Six Sigma
OT  - allowable total error
OT  - internal quality control
OT  - proficiency testing
COIS- Potential conflict of interest: None declared.
EDAT- 2018/07/20 06:00
MHDA- 2019/04/23 06:00
PMCR- 2018/06/15
CRDT- 2018/07/20 06:00
PHST- 2017/12/01 00:00 [received]
PHST- 2018/03/13 00:00 [accepted]
PHST- 2018/07/20 06:00 [entrez]
PHST- 2018/07/20 06:00 [pubmed]
PHST- 2019/04/23 06:00 [medline]
PHST- 2018/06/15 00:00 [pmc-release]
AID - bm-28-2-020708 [pii]
AID - 10.11613/BM.2018.020708 [doi]
PST - ppublish
SO  - Biochem Med (Zagreb). 2018 Jun 15;28(2):020708. doi: 10.11613/BM.2018.020708.