Trueness verification in European external quality assessment schemes: time to care about the quality of the samples

2003 ◽  
Vol 63 (3) ◽  
pp. 195-202 ◽  
Author(s):  
L. M. THIENPONT ◽  
D. STÖCKL ◽  
B. FRIEDECKÝ ◽  
J. KRATOCHVÍLA ◽  
M. BUDINA
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality

Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys

2015 ◽  
Vol 53 (10) ◽  
Author(s):  
James O. Westgard ◽  
Sten A. Westgard
Keyword(s):  
Quality Assessment ◽  
Proficiency Testing ◽  
External Quality Assessment ◽  
Objective Assessment ◽  
Analytical Quality ◽  
External Quality ◽  
Proficiency Assessment ◽  
Laboratory Examinations ◽  
Intended Use

AbstractThere is a need to assess the quality being achieved for laboratory examinations that are being utilized to support evidence-based clinical guidelines. Application of Six Sigma concepts and metrics can provide an objective assessment of the current analytical quality of different examination procedures.A “Sigma Proficiency Assessment Chart” can be constructed for data obtained from proficiency testing and external quality assessment surveys to evaluate the observed imprecision and bias of method subgroups and determine quality on the Sigma scale.Data for hemoglobin AAssessment of quality on the Sigma scale provides evidence of the analytical performance that is being achieved relative to requirements for intended use and should be useful for identifying and prioritizing improvements that are needed in the analytical quality of laboratory examinations. In spite of global and national standardization programs, bias is still a critical limitation of current HbA

scholarly journals The results of external quality assessment programme on urine leukocyte and erythrocyte counting in Poland

2020 ◽  
Vol 30 (2) ◽  
pp. 278-286
Author(s):  
Agnieszka Ćwiklińska ◽  
Barbara Kortas-Stempak ◽  
Maciej Jankowski ◽  
Gabriela Bednarczuk ◽  
Aleksandra Fijałkowska ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Particle Analysis ◽  
External Quality ◽  
Automated Method ◽  
Percentage Difference ◽  
Target Values ◽  
Important Diagnostic Tool ◽  
Manual Methods

Introduction: Urine particle analysis is an important diagnostic tool. The aim of this study was to evaluate the quality of urine leukocyte (WBC) and erythrocyte (RBC) counting results obtained with manual and automated methods in Polish laboratories participating in the international external quality assessment (EQA) programme. Materials and methods: 1400 WBC and RBC counting results were obtained from 183 laboratories in EQA surveys organised by Labquality (Helsinki, Finland) from 2017 to 2019. The between-laboratory coefficient of variation (CV), the percentage difference between the laboratories' results and target values (Q-score (%)), as well as modified Youden plots were analysed. Results: For automated method groups, the medians of inter-laboratory CVs varied from 14% to 33% for WBC counting and from 10% to 39% for RBC counting. For manual method groups, the medians of CV varied from 53% to 71% (WBC) and from 55% to 70% (RBC), and they were significantly higher, in comparison to CVs for most automated method groups (P < 0.001). The highest percentage of results outside the target limits (36%) and the highest range of Q-score (%) (from - 93% to 706%) were observed for laboratories which participated in the surveys for the first or second time. The percentage of deviating results and the ranges of Q-score decreased with an increased frequency of laboratories’ participation in the surveys. Conclusions: The quality of manual methods of urine WBC and RBC counting is unsatisfactory. There is an urgent need to take actions to improve laboratories’ performance and to increase harmonisation of the results.

Quality Assessment of Tumor Marker Determinations: A Proposal for a Supraregional Scheme

1994 ◽  
Vol 9 (1) ◽  
pp. 48-52
Author(s):  
A. Piffanelli ◽  
M. Giganti ◽  
P. Colamussi ◽  
C. Cittanti ◽  
D. Pelizzola ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Tumor Marker ◽  
Tumor Markers ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
Realistic Information ◽  
Eqa Schemes

The use of tumor marker tests has increased progressively in the last decade concomitant with the advent of new monoclonal antibodies and their growing use in clinical oncology for various follow-up programs. External quality assessment (EQA) schemes widely adopted in clinical chemistry, have been extended in the last decade to immunoassays of hormones and tumor markers. EQA results can provide realistic information on the quality of the assays, performed under routine conditions. The goal of this article is to report the main results and discrepancies encountered so far in External Quality Assessment programs on tumor markers.

scholarly journals Thirteen Years of an International External Quality Assessment Scheme for Genotyping: Results and Recommendations

2016 ◽  
Vol 62 (8) ◽  
pp. 1084-1095 ◽  
Author(s):  
Verena Haselmann ◽  
Wolf J Geilenkeuser ◽  
Simona Helfert ◽  
Romy Eichner ◽  
Svetlana Hetjens ◽  
...  
Keyword(s):  
Genetic Testing ◽  
Quality Assessment ◽  
Error Rate ◽  
External Quality Assessment ◽  
Molecular Genetic ◽  
Genetic Diagnostics ◽  
External Quality ◽  
Sequence Variations ◽  
Therapeutic Decisions

Abstract BACKGROUND Suboptimal laboratory procedures resulting in genotyping errors, misdiagnosis, or incorrect reporting bear greatly on a patient's health management, therapeutic decisions made on their behalf, and ultimate outcome. Participation in external quality assessment (EQA) is a key element of quality assurance in molecular genetic diagnostics. Therefore, the Reference Institute for Bioanalytics has tried for 13 years to improve the quality of genetic testing by offering an EQA for different clinically relevant sequence variations. METHODS Within each of the biannual EQA schemes offered, up to 18 samples of lyophilized human genomic DNA were provided for up to 50 different molecular genetic tests. Laboratories were asked to use their routine procedures for genotyping. At least 2 expert peer assessors reviewed the final returns. Data from 2002 to 2014 were evaluated. RESULTS In total, 82 462 reported results from 812 characterized samples were evaluated. Globally, the number of participants increased each year along with the number of sequence variations offered. The error rate decreased significantly over the years with an overall error rate of 1.44%. Additionally, a decreased error rate for samples repeated over time was noted. Interestingly, the error rate showed a high difference depending on the locus analyzed and the method used. CONCLUSIONS Based on the evaluation of this long-term EQA scheme, various recommendations can be given to improve the quality of molecular genetic testing, such as the use of 2 different methods for genotyping. Furthermore, some methods are inappropriate for analysis of certain sequence variations.

scholarly journals A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer

Oncotarget ◽  
2018 ◽  
Vol 9 (29) ◽  
pp. 20524-20538 ◽  
Author(s):  
Cleo Keppens ◽  
Véronique Tack ◽  
Nils ‘t Hart ◽  
Lien Tembuyser ◽  
Ales Ryska ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality ◽  
Biomarker Analysis

scholarly journals Data connectivity: A critical tool for external quality assessment

2016 ◽  
Vol 5 (2) ◽  
Author(s):  
Ben Cheng ◽  
Brad Cunningham ◽  
Debrah I. Boeras ◽  
Patron Mafaune ◽  
Raiva Simbi ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Disease Surveillance ◽  
External Quality Assessment ◽  
Point Of Care ◽  
External Quality ◽  
Central Database ◽  
Operational Metrics ◽  
Real Time Information ◽  
Time Information

Point-of-care (POC) tests have been useful in increasing access to testing and treatment monitoring for HIV. Decentralising testing from laboratories to hundreds of sites around a country presents tremendous challenges in training and quality assurance. In order to address these concerns, companies are now either embedding connectivity in their new POC diagnostic instruments or providing some form of channel for electronic result exchange. These will allow automated key performance and operational metrics from devices in the field to a central database. Setting up connectivity between these POC devices and a central database at the Ministries of Health will allow automated data transmission, creating an opportunity for real- time information on diagnostic instrument performance as well as the competency of the operator through external quality assessment. A pilot programme in Zimbabwe shows that connectivity has significantly improve the turn-around time of external quality assessment result submissions and allow corrective actions to be provided in a timely manner. Furthermore, by linking the data to existing supply chain management software, stock-outs can be minimised. As countries are looking forward to achieving the 90-90-90 targets for HIV, such innovative technologies can automate disease surveillance, improve the quality of testing and strengthen the efficiency of health systems.

scholarly journals Benchmark for Evaluating the Quality of DNA Sequencing: Proposal from an International External Quality Assessment Scheme

2006 ◽  
Vol 52 (4) ◽  
pp. 728-736 ◽  
Author(s):  
Simon J Patton ◽  
Andrew J Wallace ◽  
Rob Elles
Keyword(s):  
Dna Sequencing ◽  
Quality Assessment ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
Sequence Data ◽  
False Negative ◽  
Read Length ◽  
External Quality ◽  
External Quality Assessment Scheme

Abstract Background: In the past 15 years, clinical laboratory science has been transformed by the use of technologies that cross the traditional boundaries between laboratory disciplines. However, during this period, issues of quality have not always been given adequate attention. The European Molecular Genetics Quality Network (EMQN) has developed a novel external quality assessment scheme for evaluation of DNA sequencing. We report the results of an international survey of the quality of DNA sequencing among 64 laboratories from 21 countries. Methods: Current practice for DNA sequence analysis was established by use of an online questionnaire. Participating laboratories were provided with 4 DNA samples of validated genotype. Evaluation of the results included assessing the quality of sequence data, variant genotypes, and mutation nomenclature. To accommodate variations in mutation nomenclature, variants indicated by participants were scored for compliance with 3 acceptable marking schemes. Results: A total of 346 genotypes were analyzed. Of these, 19 (5%) genotyping errors were made. Of these, 10 (53%) were false-negative and 9 (47%) were false-positive results. A further 27 (8%) errors were made in naming mutations. Results were analyzed for 3 indicators of data quality: PHRED quality scores, Quality Read Length, and Quality Read Overlap. Most laboratories produced results of acceptable diagnostic quality as judged by these indicators. The results were used to calculate a consensus benchmark for DNA sequencing against which individual laboratories could rank their performance. Conclusions: We propose that the consensus benchmark can be used as a baseline against which the aggregate and individual laboratory standard of DNA sequencing may be tracked from year to year.

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