scholarly journals Mapping the coverage, availability and uptake of External Quality Assessment programmes across One Health sectors in Asia

2021 ◽  
Author(s):  
Ondari D Mogeni ◽  
Freshwork Ayalew Abegaz ◽  
Jong-Hoon Kim ◽  
Hea Sun Joh ◽  
Vicky Gaedt Kastbjerg ◽  
...  
Keyword(s):  
Quality Assessment ◽  
One Health ◽  
External Quality Assessment ◽  
External Quality ◽  
Laboratory Surveillance ◽  
Readiness Level ◽  
Support Mechanisms ◽  
Eqa Schemes

Abstract Introduction Establishing effective external quality assessment (EQA) programmes is an important element in ensuring the quality of, and building capacity for, antimicrobial resistance (AMR) laboratory surveillance. Objectives To understand the current coverage of, and challenges to participation in, EQAs in National Reference Laboratories (NRLs) across One Health (OH) sectors in Asia. Methods Current EQA coverage was evaluated through desktop review, online surveys and interviews of both EQA participants and providers. EQA coverage was mapped and summarized by laboratory type and ‘readiness’ level and identified challenges evaluated qualitatively. Results Of the 31 identified NRLs [16 Human Health (HH) and 15 Animal/Food Safety laboratories (A/FS)], 14 HH and 7 A/FS laboratories currently participated in international EQA schemes and several participated in two or more different schemes. Seven laboratories were currently not participating in any EQA scheme and two of these (one HH and one A/FS) do not currently perform microbiology; six HH NRLs provided national EQAs. Of the eight surveyed international EQA providers, three were based in Asia and all offered varying programmes in terms of pathogens, frequency and support mechanisms for reporting and follow-up. Only one provider currently served laboratories across all OH sectors. Conclusions The current coverage of EQA programmes for AMR in Asia was heterogeneous across countries but especially across OH sectors. This updated overview of the coverage and challenges associated with participation in, and provision of, EQAs for AMR suggest the benefit and relevance of introducing one comprehensive and high-quality EQA programme across OH sectors in Asia.

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 Results of the UK NEQAS for Molecular Genetics reference sample analysis

2018 ◽  
Vol 71 (11) ◽  
pp. 989-994 ◽  
Author(s):  
Susan D Richman ◽  
Jennifer Fairley ◽  
Jacqueline A Hall ◽  
Nakul Nataraj ◽  
Mrudul Bhide ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Genetics ◽  
External Quality Assessment ◽  
Single Gene ◽  
Reference Sample ◽  
Human Cell Line ◽  
External Quality ◽  
Gene Testing ◽  
Variant Frequency ◽  
Eqa Schemes

AimsIn addition to providing external quality assessment (EQA) schemes, United Kingdom National External Quality Assessment service (UK NEQAS) for Molecular Genetics also supports the education of laboratories. As an enhancement to the Molecular Pathology EQA scheme, a human cell-line reference sample, manufactured by Thermo Fisher Scientific (AcroMetrix), was provided for analysis. This contained many variants, present at frequencies between 1% and 17.9%.MethodsOne hundred and one laboratories submitted results, with a total of 2889 test results on 53 genes being reported. Known polymorphisms, 46/2889 (1.59%) results, were excluded. Variants detected in the seven most commonly reported (and clinically relevant) genes, KRAS, NRAS, BRAF, EGFR, PIK3CA, KIT and PDGFRA, are reported here, as these genes fall within the scope of UK NEQAS EQA schemes.ResultsNext generation sequencing (NGS) was the most commonly performed testing platform. There were between 5 and 27 validated variants in the seven genes reported here. Eight laboratories correctly reported all five NRAS variants, and two correctly reported all eight BRAF variants. The validated mean variant frequency was lower than that determined by participating laboratories, with single-gene testing methodologies showing less variation in estimated frequencies than NGS platforms. Laboratories were more likely to correctly identify clinically relevant variants.ConclusionsOver 100 laboratories took the opportunity to test the ‘educational reference sample’, showing a willingness to further validate their testing platforms. While it was encouraging to see that the most widely reported variants were those which should be included in routine testing panels, reporting of variants was potentially open to interpretation, thus clarity is still required on whether laboratories selectively reported variants, by either clinical relevance or variant frequency.

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.

scholarly journals External quality assessment for molecular diagnostic laboratories in Belgium: Can we improve it?

2019 ◽  
Vol 25 (1) ◽  
pp. 39-49
Author(s):  
Kelly Dufraing ◽  
Els Lierman ◽  
Anne Vankeerberghen ◽  
Sabine Franke ◽  
Els Dequeker
Keyword(s):  
Quality Assessment ◽  
Performance Monitoring ◽  
External Quality Assessment ◽  
Molecular Diagnostic ◽  
Real Patient ◽  
External Quality ◽  
Molecular Tests ◽  
Clinical Biology ◽  
Eqa Schemes ◽  
Selection Of

AbstractExternal quality assessment (EQA) is an essential part of performance monitoring for molecular laboratories. At the moment, a national law regulates participation in EQA schemes for clinical biology and pathology in Belgium. This study aimed (1) to get insights on how laboratories organize their EQA participation, (2) to poll satisfaction with the current situation (selection of EQA programs in advance by a governmental body), (3) to provide guidance for choosing the most relevant EQA provider and (4) to propose a new model for national performance monitoring. A survey was sent to Belgian laboratories performing molecular tests in the field of microbiology, hematology and pathology with (1) general questions on how they select an EQA provider and (2) their satisfaction of each provider. In total, 25 molecular laboratories [microbiology (N = 13), hematology (N = 8) and pathology (N = 4)] from 14 different hospitals completed the survey regarding their EQA organization. All three laboratory groups indicated to prefer EQA schemes using real patient materials as well as those with varying targets and concentrations. For molecular microbiology and hematology, schemes with a syndromic approach are sought. Since annual participation in EQA becomes burdensome in most laboratories, this paper also offers a risk-based strategy for determining the participation frequency. Based on the needs of Belgian laboratories, three proposals were made: (1) for the proper selection of an EQA scheme, (2) for determining the minimal participation frequency and (3) for the national organization of EQA schemes.

External quality assessment (EQA) for CoaguChek monitors

2010 ◽  
Vol 103 (05) ◽  
pp. 936-941 ◽  
Author(s):  
Joergen Jespersen ◽  
A. M. H. P. van den Besselaar ◽  
Felix van der Meer ◽  
Gualtiero Palareti ◽  
Armando Tripodi ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Concerted Action ◽  
External Quality ◽  
Test Strips ◽  
Italian Studies ◽  
Large Numbers ◽  
Treatment Procedures ◽  
Eqa Schemes

SummaryAnticoagulant control facilities are being overwhelmed by requests for monitoring and large numbers of patients are not therefore receiving treatment. Procedures designed for point-of-care testing have therefore been developed, the most popular being the CoaguChek. The need for external quality assessment (EQA) of monitors used by patients in self-management has been stressed in a European Commission (EC) Directive. It would not however be feasible for all CoaguChek monitors to be enrolled in national or regional EQA schemes which take time to organise and analyse. The European Concerted Action on Anticoagulation (ECAA) has therefore evolved a simpler system. Its value has been assessed in collaboration with the European Concerted Action on Thrombosis (ECAT). 523 monitors were tested at nine clinics which asked patients to bring their CoaguChek instruments to be assessed with the ECAA/ECAT procedure based on a set of 5 plasma samples with certified international normalised ratios (INR). 15% or more deviation from the certified INR on a single certified plasma sample from the set was defined by the ECAA as the limit of acceptable performance. One hundred and six (20.3%) of the monitors tested showed significant deviation and higher than average incidence of significant INR deviations reported with one specific numbered lot of test strips. Recent ECAA/ECAT, Danish and Italian studies report regular EQA of CoaguChek monitors is essential. There is general agreement that this should be performed at reasonably frequent intervals, at six months or whenever there is a change of the manufacturer’s test strips.

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