PMID- 32951270
OWN - NLM
STAT- MEDLINE
DCOM- 20211022
LR  - 20211022
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 35
IP  - 1
DP  - 2021 Jan
TI  - Evaluation of the analytical performance of endocrine analytes using sigma 
      metrics.
PG  - e23581
LID - 10.1002/jcla.23581 [doi]
LID - e23581
AB  - BACKGROUND: (a) To evaluate the clinical performance of endocrine analytes using 
      the sigma metrics (sigma) model. (b) To redesign quality control strategies for 
      performance improvement. METHODS: The sigma values of the analytes were initially 
      evaluated based on the allowable total error (TEa), bias, and coefficient of 
      variation (CV) at QC materials level 1 and 2 in March 2018. And then, the 
      normalized QC performance decision charts, personalized QC rules, quality goal 
      index (QGI) analysis, and root causes analysis (RCA) were performed based on the 
      sigma values of the analytes. Finally, the sigma values were re-evaluated in 
      September 2018 after a series of targeted corrective actions. RESULTS: Based on 
      the initial sigma values, two analytes (FT3 and TSH) with sigma > 6, only needed one 
      QC rule (1(3S) ) with N2 and R500 for QC management. On the other hand, seven 
      analytes (FT4, TT4, CROT, E2, PRL, TESTO, and INS) with sigma < 4 at one QC material 
      level or both needed multiple rules (1(3S) /2(2S) /R(4S) /4(1S) /10(X) ) with N6 
      and R10-500 depending on different sigma values for QC management. Subsequently, 
      detailed and comprehensive RCA and timely corrective actions were performed on 
      all the analytes base on the QGI analysis. Compared with the initial sigma 
      values, the re-evaluated sigma metrics of all the analytes increased 
      significantly. CONCLUSIONS: It was demonstrated that the combination of sigma 
      metrics, QGI analysis, and RCA provided a useful evaluation system for the 
      analytical performance of endocrine analytes.
CI  - (c) 2020 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley 
      Periodicals LLC.
FAU - Liu, Yanming
AU  - Liu Y
AUID- ORCID: 0000-0003-2663-3474
AD  - Department of Laboratory Medicine, YueBei People's Hospital, Shaoguan, China.
AD  - Guangdong Provincial Key Laboratory of Medical Molecular Diagnostics, Institute 
      of Aging Research, Guangdong Medical University, Dongguan, China.
FAU - Cao, Yue
AU  - Cao Y
AD  - Department of Medical Technology, Medical College of Shaoguan University, 
      Shaoguan, China.
FAU - Liu, Xijun
AU  - Liu X
AD  - Department of Laboratory Medicine, YueBei People's Hospital, Shaoguan, China.
FAU - Wu, Liangyin
AU  - Wu L
AD  - Department of Laboratory Medicine, YueBei People's Hospital, Shaoguan, China.
FAU - Cai, Wencan
AU  - Cai W
AD  - Department of Laboratory Medicine, YueBei People's Hospital, Shaoguan, China.
LA  - eng
GR  - B201826/Guangdong Medical Research Fund/
GR  - Y19042/Shaoguan Health Bureau Research Fund/
GR  - Outstanding Research Fund of YueBei People's Hospital/
GR  - 2018sn095/Shaoguan Science and Technology Fund/
PT  - Journal Article
DEP - 20200920
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
RN  - 0 (Biomarkers)
SB  - IM
MH  - Adult
MH  - *Biomarkers/analysis/metabolism
MH  - Clinical Chemistry Tests/*standards
MH  - Diagnostic Techniques, Endocrine/*standards
MH  - Female
MH  - Humans
MH  - Male
MH  - Metabolic Diseases/diagnosis
MH  - *Quality Control
MH  - *Total Quality Management
MH  - Young Adult
PMC - PMC7843286
OTO - NOTNLM
OT  - corrective action
OT  - internal quality control
OT  - quality goal index
OT  - root cause analysis
OT  - sigma metrics
COIS- The authors stated that there are no conflicts of interest regarding the 
      publication of this article.
EDAT- 2020/09/21 06:00
MHDA- 2023/02/25 06:00
PMCR- 2020/09/20
CRDT- 2020/09/20 20:41
PHST- 2020/07/30 00:00 [received]
PHST- 2020/08/24 00:00 [revised]
PHST- 2020/08/29 00:00 [accepted]
PHST- 2020/09/21 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2020/09/20 20:41 [entrez]
PHST- 2020/09/20 00:00 [pmc-release]
AID - JCLA23581 [pii]
AID - 10.1002/jcla.23581 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2021 Jan;35(1):e23581. doi: 10.1002/jcla.23581. Epub 2020 Sep 
      20.