scholarly journals Frequency of Participation to External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers. (Preprint)

10.2196/27980 ◽  
2021 ◽  
Author(s):  
Joséphine Lantoine ◽  
Anne Brysse ◽  
Vinciane Dideberg ◽  
Kathleen Claes ◽  
Sofie Symoens ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Rare Diseases ◽  
Human Genetics ◽  
External Quality Assessment ◽  
External Quality

scholarly journals Frequency of Participation to External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers. (Preprint)

2021 ◽  
Author(s):  
Joséphine Lantoine ◽  
Anne Brysse ◽  
Vinciane Dideberg ◽  
Kathleen Claes ◽  
Sofie Symoens ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Rare Diseases ◽  
Human Genetics ◽  
External Quality Assessment ◽  
Accreditation Body ◽  
External Quality ◽  
Quality Controls ◽  
Medical Centers ◽  
National Public Health ◽  
Eqa Schemes

BACKGROUND The participation to quality controls, also called External Quality Assessment (EQA) schemes, is required for the ISO15189 accreditation of the medical centers of human genetics. However, directives on the minimal frequency of participation to genetic quality controls schemes are lacking or too heterogeneous, with a possible impact on healthcare quality. OBJECTIVE The aim of this project is to develop Belgian guidelines on the frequency of participation to quality controls for genetic testing in the context of rare diseases. METHODS A group of experts has analyzed 90 EQA schemes offered by accredited providers and focused on analyses used for the diagnosis of rare diseases. On that basis, the experts developed practical recommendations about the minimal frequencies of participation of the medical centers of human genetics to quality controls and how to deal with poor performances and change management. These guidelines were submitted to the Belgian Accreditation Body and then reviewed and approved by the Belgian College of Human Genetics and Rare Diseases and by the National Institute for Health and Disability Insurance. RESULTS The guidelines offer a decisional algorithm for the minimal frequency of participation to human genetics EQA schemes. This algorithm has been developed taking into account the scopes of the EQA schemes, the levels of experience and the annual volumes of the center of human genetics in the performance of the tests considered. They include 3 key principles : (i) the recommended annual assessment of all genetic techniques and technological platforms, if possible through EQAs covering the technique, genotyping and clinical interpretation, (ii) the triennial assessment of the genotyping and interpretation of specific germline mutations and pharmacogenomics analyses, (iii) the documentation of actions undertaken in the case of poor performances and the participation to a quality control the following year. The use of a Bayesian statistical model has been proposed to help the centers of human genetics to determine the theoretical number of tests that should be annually performed in order to achieve a certain threshold of performance (e.g. maximal error rate of 1%). Besides, the guidelines insist on the role and responsibility of the national public health authorities in the follow-up of the quality of analyses performed by the medical centers of human genetics, and demonstrate the cost-effectiveness of the rationalization of the frequency of participation to these quality controls. CONCLUSIONS These guidelines have been developed based on the analysis of a large panel of EQA schemes and data collected from the Belgian Medical Centers of Human Genetics. They are totally applicable to other countries and will facilitate and improve the quality management and financing systems of the medical centers of human genetics. CLINICALTRIAL not applicable

scholarly journals The versatility of external quality assessment for the surveillance of laboratory and in vitro diagnostic performance: SARS-CoV-2 viral genome detection in Austria

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Christoph Buchta ◽  
Jeremy V. Camp ◽  
Jovana Jovanovic ◽  
Peter Chiba ◽  
Elisabeth Puchhammer-Stöckl ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Positive Sample ◽  
Performance Criteria ◽  
External Quality ◽  
Assay Sensitivity ◽  
Dilution Series ◽  
Test Systems

Abstract Objectives External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. Methods Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. Results A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample (C t ∼35.9, ∼640 copies/mL). Twenty (22%) laboratories reported results of mutation detection. Twenty-five (19%) test systems included amplification of human RNA as evidence of proper sampling. The overall linearity of C t values from individual test systems for the dilution series was good, but inter-assay variability was high. Both operator-related and systematic failures appear to have caused incorrect results. Conclusions Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.

Commutability of possible external quality assessment materials for progesterone measurement

2021 ◽  
Vol 87 ◽  
pp. 39-45
Author(s):  
Xilian Yi ◽  
Yufei Wang ◽  
Tianjiao Zhang ◽  
Jie Zeng ◽  
Haijian Zhao ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality

Appropriateness of cholesterol and triglycerides reporting checked by External Quality Assessment programs

2003 ◽  
Vol 333 (2) ◽  
pp. 221-230 ◽  
Author(s):  
Sandra Secchiero ◽  
Laura Sciacovelli ◽  
Lorena Zardo ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality
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