External quality assessment schemes for inorganic elements in the clinical laboratory: Lessons from the OELM scheme

Abstract Background Reporting on the presence of antimicrobial resistance is of considerable concern both for individual patient care and for understanding the underlying health status within the community at large. Antimicrobial resistance is solely dependent upon clinical laboratory detection and thus can be impacted upon by the quality and competence of medical laboratories. Proficiency testing or external quality assessment (PT/EQA) is the international standard for the direct measurement of medical laboratory performance on critical testing. Methods An international, intercontinental collaborative retrospective study of medical laboratory performance in antibiotic resistance was performed by the Microbiology Working Group (MWG) of the European Organisation for External Quality Assurance for Laboratory Medicine (EQALM) with particular examination of laboratory performance on the testing and reporting of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and carbapenem-resistant Enterobacteriaceae (CRE). Results The results of 1880 medical laboratories were compiled. Strictly accurate reporting of isolates as resistant occurred with MRSA 96.9%, with VRE 91.3% and with CRE 93.1% of the time. On the other hand, very major errors (reporting of false susceptibility) were observed with 2.2% of MRSA and 2.4% of VRE and 0.8% of CRE. Major errors (false resistance) were reported for vancomycin susceptibility testing for MRSA at a rate of 0.6%. Conclusions Depending on how clinical physicians read and understand microbiology susceptibility reports, proficient acceptable results were reported either between 91% and 94% of the time, or between 97% and 100%. While very major errors are infrequently reported, they were found in all regions and could potentially cause poor treatment decisions by clinicians. A collective analysis of multi-program PT/EQA information can provide valuable insights into the testing and reporting practices of medical laboratories.

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Improvement of interpretation in cystic fibrosis clinical laboratory reports: longitudinal analysis of external quality assessment data

European Journal of Human Genetics ◽

10.1038/ejhg.2012.131 ◽

2012 ◽

Vol 20 (12) ◽

pp. 1209-1215 ◽

Cited By ~ 10

Author(s):

Sarah Berwouts ◽

Emmanuelle Girodon ◽

Martin Schwarz ◽

Manfred Stuhrmann ◽

Michael A Morris ◽

...

Keyword(s):

Cystic Fibrosis ◽

Quality Assessment ◽

Longitudinal Analysis ◽

Clinical Laboratory ◽

External Quality Assessment ◽

Assessment Data ◽

External Quality

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

Clinical Chemistry ◽

10.1373/clinchem.2005.061887 ◽

2006 ◽

Vol 52 (4) ◽

pp. 728-736 ◽

Cited By ~ 29

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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External quality assessment: best practice

Journal of Clinical Pathology ◽

10.1136/jclinpath-2013-201621 ◽

2014 ◽

Vol 67 (8) ◽

pp. 651-655 ◽

Cited By ~ 18

Author(s):

David James ◽

Darren Ames ◽

Berenice Lopez ◽

Rachel Still ◽

Wiliam Simpson ◽

...

Keyword(s):

Quality Assurance ◽

Quality Assessment ◽

Proficiency Testing ◽

Best Practice ◽

Clinical Laboratory ◽

External Quality Assessment ◽

External Quality ◽

Accredited Laboratories ◽

Eqa Schemes

There is a requirement for accredited laboratories to participate in external quality assessment (EQA) schemes, but there is wide variation in understanding as to what is required by the laboratories and scheme providers in fulfilling this. This is not helped by a diversity of language used in connection with EQA; Proficiency testing (PT), EQA schemes, and EQA programmes, each of which have different meanings and offerings in the context of improving laboratory quality.We examine these differences, and identify what factors are important in supporting quality within a clinical laboratory and what should influence the choice of EQA programme. Equally as important is how EQA samples are handled within the laboratory, and how the information provided by the EQA programme is used.EQA programmes are a key element of a laboratory's quality assurance framework, but laboratories should have an understanding of what their EQA programmes are capable of demonstrating, how they should be used within the laboratory, and how they support quality. EQA providers should be clear as to what type of programme they provide – PT, EQA Scheme or EQA Programme.

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Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2017-1199 ◽

2018 ◽

Vol 56 (9) ◽

pp. 1447-1457 ◽

Cited By ~ 5

Author(s):

Yanyan Qin ◽

Rui Zhou ◽

Wei Wang ◽

Hongyi Yin ◽

Yanmin Yang ◽

...

Keyword(s):

Quality Assessment ◽

Proficiency Testing ◽

Clinical Laboratory ◽

External Quality Assessment ◽

Clinical Chemistry ◽

Effective Means ◽

Specific Antigen ◽

Plasma Sodium ◽

External Quality ◽

Quantitative Measurements

Abstract Background: Measurement uncertainty (MU) is a parameter associated with the result of a measurement that characterizes its dispersion. We report results for estimating MU following the application of a top-down procedure using only proficiency test data to establish uncertainty levels for various analytes. Methods: Data were obtained from 142 laboratories participating in the Beijing Center for Clinical Laboratory (BCCL) proficiency testing/external quality assessment (PT/EQA) schemes. The 24-month study included six selected PT shipments to obtain estimates for 50th percentile (median) and 90th percentile MUs and to compare those estimates to usual analytic goals. The number of laboratory participants varied for each trial. The expanded uncertainty (U) was calculated using a cover factor of k=2 for a confidence interval of 95%. All reproducibility, method and laboratory biases came from the PT/EQA data. Results: The median U (k=2) ranged from 3.2% (plasma sodium, indirect ion selective electrode) to 32.8% (triglycerides, free glycerol blanking) for clinical chemistry analyte means from participants in the same method group. Immunoassay analyte median U results ranged from 11.3% (CA125 tumor marker, Roche) to 33.8% (prostate-specific antigen [PSA], Abbott). The range for median U was 3.5% (red blood cell [RBC], Abx) to 30.3% (fibrinogen [FBG], other) for hematology and coagulation analytes. The MUs for most analytes satisfied quality requirements. Conclusions: The use of PT/EQA data, when available, provides an effective means for estimating uncertainties associated with quantitative measurements. Thus, medical laboratories can calculate their own MUs. Proficiency testing organizers can provide participants with an additional MU estimate using only EQA data, which may be updated at the end of each survey.

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Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-0265 ◽

2018 ◽

Vol 56 (10) ◽

pp. 1587-1590 ◽

Cited By ~ 7

Author(s):

Ferruccio Ceriotti ◽

Christa Cobbaert

Keyword(s):

Quality Assessment ◽

Clinical Laboratory ◽

External Quality Assessment ◽

Clinical Chemistry ◽

Reference Method ◽

External Quality ◽

The Third ◽

Fit For Purpose ◽

Source Of Information

Abstract The article tries to reply to the following three questions: Are External Quality Assessment Schemes (EQAS) really fit for purpose? Are all schemes equivalent and sufficiently harmonized? Is the role of EQAS similar and necessary in all branches of laboratory medicine? Although the reply to the first two questions is, unfortunately, negative for several reasons (lack of commutable material with reference method values, EQAS with different scopes, etc.), the reply to the third one is positive: EQAS are a necessary source of information on trueness and accuracy and must be fully developed for all the branches of the clinical laboratory.

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International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020

Eurosurveillance ◽

10.2807/1560-7917.es.2020.25.27.2001223 ◽

2020 ◽

Vol 25 (27) ◽

Cited By ~ 8

Author(s):

Veerle Matheeussen ◽

Victor M Corman ◽

Oliver Donoso Mantke ◽

Elaine McCulloch ◽

Christine Lammens ◽

...

Keyword(s):

Quality Assessment ◽

Clinical Laboratory ◽

External Quality Assessment ◽

Molecular Testing ◽

The European Union ◽

Online Questionnaire ◽

External Quality ◽

Diagnostic Assays ◽

Testing Performance ◽

Quality Assessment Study

Laboratory preparedness with quality-assured diagnostic assays is essential for controlling the current coronavirus disease (COVID-19) outbreak. We conducted an external quality assessment study with inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) samples to support clinical laboratories with a proficiency testing option for molecular assays. To analyse SARS-CoV-2 testing performance, we used an online questionnaire developed for the European Union project RECOVER to assess molecular testing capacities in clinical diagnostic laboratories.

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