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

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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Multiallelic Synthetic Quality Control Material: Lessons Learned from the Cystic Fibrosis External Quality Assessment Scheme

Genetic Testing and Molecular Biomarkers ◽

10.1089/gtmb.2011.0015 ◽

2011 ◽

Vol 15 (9) ◽

pp. 579-586 ◽

Cited By ~ 1

Author(s):

Sarah Berwouts ◽

Todd M. Christensen ◽

Jill Brandon ◽

Bassem A. Bejjani ◽

David E. Barton ◽

...

Keyword(s):

Cystic Fibrosis ◽

Quality Control ◽

Quality Assessment ◽

External Quality Assessment ◽

Lessons Learned ◽

Quality Control Material ◽

Control Material ◽

External Quality ◽

External Quality Assessment Scheme

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An Examination of the Hexokinase Method for Serum Glucose Assay Using External Quality Assessment Data

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/000456328602300111 ◽

1986 ◽

Vol 23 (1) ◽

pp. 92-96 ◽

Cited By ~ 2

Author(s):

A. Westwood ◽

D. G. Bullock ◽

T. P. Whitehead

Keyword(s):

Quality Assessment ◽

External Quality Assessment ◽

Serum Glucose ◽

Assessment Data ◽

External Quality ◽

Glucose Assay

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Quality assessment in cytogenetic and molecular genetic testing: the experience of the Italian Project on Standardisation and Quality Assurance

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2004.148 ◽

2004 ◽

Vol 42 (8) ◽

Cited By ~ 19

Author(s):

Domenica Taruscio ◽

Vincenzo Falbo ◽

Giovanna Floridia ◽

Marco Salvatore ◽

Chiara Pescucci ◽

...

Keyword(s):

Cystic Fibrosis ◽

Quality Assessment ◽

External Quality Assessment ◽

Fragile X ◽

Molecular Genetic ◽

Adenomatous Polyposis ◽

Polyposis Coli ◽

External Quality ◽

Familial Adenomatous Polyposis Coli ◽

Analytical Accuracy

AbstractThe first Italian national trial of external quality assessment in genetic testing was organised within the framework of the “Italian National Project for Standardisation and Quality Assurance of Genetic Tests”. Sixty-eight Public Health Service laboratories volunteered for the trial, which involved molecular genetic tests (cystic fibrosis, β-thalassaemia, familial adenomatous polyposis coli and fragile-X syndrome) and cytogenetic tests (prenatal and postnatal, the latter included cancer cytogenetics). The response rate was high (88.2%). The level of analytical accuracy was good, i.e., the percentage of laboratories that correctly genotyped all samples was 89.3% for cystic fibrosis, 90.9% for β-thalassaemia, 100% for familial adenomatous polyposis coli (despite two laboratories did not complete the analysis because the amount of DNA was considered insufficient), and 90.5% for fragile-X syndrome. Written reports differed widely and were judged “inadequate” in over 50% of cases. Most laboratories from the present study already have experience in previous European external quality assessments for at least one genetic test; this can explain the higher analytical accuracy in the Italian external quality assessment with respect to quality control programmes in other countries. Collaborative networks are strongly suggested to improve the quality of the reports.

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Customer satisfaction survey to improve the European cystic fibrosis external quality assessment scheme

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2011.215 ◽

2011 ◽

Vol 49 (8) ◽

Author(s):

Sarah Berwouts ◽

Elisabeth Dequeker

Keyword(s):

Cystic Fibrosis ◽

Customer Satisfaction ◽

Quality Assessment ◽

Gap Analysis ◽

External Quality Assessment ◽

Satisfaction Survey ◽

User Friendliness ◽

External Quality ◽

External Quality Assessment Scheme ◽

Customer Satisfaction Survey

AbstractThe Cystic Fibrosis European Network, coordinated from within the Katholieke Universiteit Leuven, is the provider of the European cystic fibrosis external quality assessment (EQA) scheme. The network aimed to seek feedback from laboratories that participated in the cystic fibrosis scheme in order to improve services offered. In this study we analysed responses to an on-line customer satisfaction survey conducted between September and November 2009.The survey was sent to 213 laboratories that participated in the cystic fibrosis EQA scheme of 2008; 69 laboratories (32%) responded. Scores for importance and satisfaction were obtained from a five-point Likert scale for 24 attributes. A score of one corresponded to very dissatisfied/very unimportant and five corresponded to very satisfied/very important. Means were calculated and placed in a two-dimensional grid (importance-satisfaction analysis). Means were subtracted from each other to obtain gap values (gap-analysis).No attribute had a mean score below 3.63. The overall mean of satisfaction was 4.35. Opportunities for improvement enclosed clarity, usefulness and completeness of the general report and individual comments, and user-friendliness of the electronic datasheet.This type of customer satisfaction survey was a valuable instrument to identify opportunities to improve the cystic fibrosis EQA scheme. It should be conducted on a regular basis to reveal new opportunities in the future and to assess effectiveness of actions taken. Moreover, it could be a model for other EQA providers seeking feedback from participants. Overall, the customer satisfaction survey provided a powerful quality of care improvement tool.

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Mutation nomenclature in practice: Findings and recommendations from the cystic fibrosis external quality assessment scheme

Human Mutation ◽

10.1002/humu.21569 ◽

2011 ◽

Vol 32 (11) ◽

pp. 1197-1203 ◽

Cited By ~ 27

Author(s):

Sarah Berwouts ◽

Michael A. Morris ◽

Emmanuelle Girodon ◽

Martin Schwarz ◽

Manfred Stuhrmann ◽

...

Keyword(s):

Cystic Fibrosis ◽

Quality Assessment ◽

External Quality Assessment ◽

External Quality ◽

External Quality Assessment Scheme

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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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The Italian External Quality Assessment Program for Cystic Fibrosis Sweat Chloride Test: Does Active Participation Improve the Quality?

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17093196 ◽

2020 ◽

Vol 17 (9) ◽

pp. 3196

Author(s):

Marco Salvatore ◽

Annalisa Amato ◽

Giovanna Floridia ◽

Federica Censi ◽

Gianluca Ferrari ◽

...

Keyword(s):

Cystic Fibrosis ◽

Quality Assessment ◽

External Quality Assessment ◽

Diagnostic Testing ◽

Signs And Symptoms ◽

Third Party ◽

External Quality ◽

Assessment Program ◽

Facility Assessment ◽

Sweat Chloride

(1) Background: Diagnostic testing for cystic fibrosis (CF) is based on a sweat chloride test (SCT) considering the appropriate signs and symptoms of the disease and results of a gene mutation analysis. In 2014, the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF SCT (Italian EQA-SCT), which is now a third party service carried out by the ISS. (2) Methods: The ongoing scheme is prospective, enrollment is voluntary, and the payment of a fee is required. Results are shared through a dedicated web-facility. Assessment covers the analysis, interpretation, and reporting of results. (3) Results: Thirteen, fifteen, sixteen, and fifteen different laboratories, respectively, participated from 2015 to 2016 and from 2018 to 2019 in the Italian EQA-SCT scheme. Eleven different laboratories participated each year in all four rounds of the Italian EQA-SCT. (4) Conclusions: The overall results obtained from the laboratories participating constantly clearly show that their qualitative and quantitative performance improved significantly. This is due to the opportunity—after receiving the EQA results—to constantly review their performance and address any inconsistencies. We firmly believe that participation in the EQA program will improve the quality of participating laboratories and that EQA participation should become mandatory as a fundamental requirement for laboratory accreditation.

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