scholarly journals Quality Control in Clinical Laboratories

Author(s):  
Petros Karkalousos ◽  
Angelos Evangelopoulos
1990 ◽  
Vol 36 (3) ◽  
pp. 462-465 ◽  
Author(s):  
R Wood

Abstract A particular version of the Westgard-Barry-Hunt-Groth (Westgard) multi-rule quality-control system is studied by Monte Carlo simulation. The principal focus is on the amount of distortion in the working power curve caused by skewness in the distribution of analyte measurements. The effect of using only the first two rejection modes of the Westgard system is also studied.


2017 ◽  
pp. 1-10 ◽  
Author(s):  
Stephen E. Lincoln ◽  
Shan Yang ◽  
Melissa S. Cline ◽  
Yuya Kobayashi ◽  
Can Zhang ◽  
...  

Purpose Genetic tests of cancer predisposition genes, BRCA1 and BRCA2, inform significant clinical decisions for both physicians and patients. Most uncovered variants are benign, and determining which few are pathogenic—disease causing—is sometimes challenging and can potentially be inconsistent among laboratories. The ClinVar database makes deidentified clinical variant classifications from multiple laboratories publicly available for comparison and review, per recommendations by the American Medical Association, the American College of Medical Genetics, the National Society for Genetic Counselors, and other organizations. Methods Classifications of more than 2,000 BRCA1/2 variants in ClinVar that represent approximately 22,000 patients were dichotomized as clinically actionable or not actionable and compared among as many as seven laboratories. The properties of these variants and classification differences were investigated in detail. Results Per-variant concordance was 98.5% (CI, 97.9% to 99.0%). All discordant variants were rare; thus, per-patient concordance was estimated to be higher (99.7%). ClinVar facilitated resolution of many of the discordant variants, and concordance increased to 99.0% per variant and 99.8% per patient when reclassified, but not yet resubmitted, variants and submission errors were addressed. Most of the remaining discordances seemed to involve either legitimate differences in expert judgment regarding particular scientific evidence or were classifications that predated the availability of important scientific evidence. Conclusion Significant classification disagreements among professional clinical laboratories represented in ClinVar are infrequent yet important. Unrestricted sharing of clinical genetic data allows detailed interlaboratory quality control and peer review, as exemplified by this study.


1972 ◽  
Vol 58 (1) ◽  
pp. 37-42 ◽  
Author(s):  
Darrol W. Heggen ◽  
Howard A. I. Newman ◽  
Martin D. Keller

2018 ◽  
Vol 56 (11) ◽  
pp. 1886-1896
Author(s):  
Min Duan ◽  
Wei Wang ◽  
Haijian Zhao ◽  
Chuanbao Zhang ◽  
Falin He ◽  
...  

Abstract Background: Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. Methods: IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl−) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. Results: The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl− got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl− were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. Conclusions: The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.


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