Quality Control in Clinical Laboratories

1989 ◽  
pp. 629-640
Author(s):  
D. Stamm
Keyword(s):  
Quality Control ◽  
Clinical Laboratories

A simulation study of the Westgard multi-rule quality-control system for clinical laboratories

1990 ◽  
Vol 36 (3) ◽  
pp. 462-465 ◽  
Author(s):  
R Wood
Keyword(s):  
Monte Carlo Simulation ◽  
Quality Control ◽  
Monte Carlo ◽  
Control System ◽  
Simulation Study ◽  
Quality Control System ◽  
Power Curve ◽  
Clinical Laboratories

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.

scholarly journals Consistency of BRCA1 and BRCA2 Variant Classifications Among Clinical Diagnostic Laboratories

2017 ◽  
pp. 1-10 ◽  
Author(s):  
Stephen E. Lincoln ◽  
Shan Yang ◽  
Melissa S. Cline ◽  
Yuya Kobayashi ◽  
Can Zhang ◽  
...  
Keyword(s):  
Quality Control ◽  
American Medical Association ◽  
Scientific Evidence ◽  
Genetic Data ◽  
National Society ◽  
Brca1 And Brca2 ◽  
Clinical Genetic ◽  
Clinical Laboratories ◽  
Clinical Variant ◽  
Predisposition Genes

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.

scholarly journals Quality Control in Clinical Laboratories

10.5772/15865 ◽  
2011 ◽  
Author(s):  
Petros Karkalousos ◽  
Angelos Evangelopoulos
Keyword(s):  
Quality Control ◽  
Clinical Laboratories

A Dual Quality Control System for Large Clinical Laboratories

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

National surveys on internal quality control for blood gas analysis and related electrolytes in clinical laboratories of China

2018 ◽  
Vol 56 (11) ◽  
pp. 1886-1896
Author(s):  
Min Duan ◽  
Wei Wang ◽  
Haijian Zhao ◽  
Chuanbao Zhang ◽  
Falin He ◽  
...  
Keyword(s):  
Quality Control ◽  
Blood Gas Analysis ◽  
Gas Analysis ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Blood Gas ◽  
Pass Rates ◽  
Measurement Systems ◽  
Continuous Quality ◽  
Clinical Laboratories

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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