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ERIC works initially with laboratories to achieve accuracy of testing through the ERIC certification process that ensures the initial quality control of TP53 or IG gene analyses. GenQA and UK NEQAS LI assure the maintenance of testing accuracy and competency of previously ERIC-certified laboratories through participation in their UKAS accredited EQAs and are aimed at laboratories that have already received ERIC certification for TP53 and/or IGH testing (http://www.ericll.org/diagnostics).
External quality assessment (EQA) is an overarching/umbrella term, which describes the services offered via both ERIC certification, and the proficiency testing offered by GenQA and UK NEQAS LI. EQA allows a laboratory to compare their own test performance, to that of an external source, such as the performance of a reference laboratory, or a peer group of laboratories.
Within both ERIC certification networks and GenQA/UK NEQAS LI EQA programs, the participants receive a set of test samples to be analysed and reported according to their standard procedures, within a given time period. The accuracy of the results produced is then evaluated, and laboratories receive the outcome of the assessment of their results together with a statement of the quality of the laboratory report.
Participating in EQAs helps your laboratory to meet the national/international guidelines and standards, necessary for laboratory accreditation, and demonstrates that your laboratory is committed to providing the highest quality of analysis for all patients.
EQA is one of the critical elements of a laboratory quality management system. Laboratories in most European countries are expected to be accredited to the ISO 15189: 2012 standard and are therefore required to participate in EQA programs where available.
Both the ERIC certification and the GenQA/UK NEQAS LI EQAs follow a similar assessment process, adhering to ERIC recommendations for analysis and interpretation of TP53 and IG somatic hypermutation status testing. The ERIC certification process is for the initial certification, GenQA/UK NEQAS LI EQAs are for maintenance of the competency in the subsequent years.
The laboratory should initially pass the ERIC certification. Once you successfully completed the ERIC certification, the next year you may enrol in GenQA/UK NEQAS LI EQA for proficiency testing and maintenance.
ERIC Certification provides each successful laboratory with a certificate, and a letter summarising their performance. Any unsuccessful laboratories will be provided with necessary guidance to re-apply at the next round of ERIC certification.
GenQA UK NEQAS LI provide the outcome of EQA participation to laboratories in the format of an Individual Laboratory Report (ILR). This ILR outlines the laboratory’s individual scores and includes any specific individual comments/recommendations for the participating laboratory.
Participants of GenQA/UK NEQAS LI proficiency testing EQAs also have access to a “live” online certificate (available to download), which indicates the laboratory’s performance in all relevant GenQA EQAs.
In addition, GenQA also provides a general Summary Report for each EQA, which details a summary of performance of all laboratories, thereby allowing participants to compare their assay performance across time, methods, and networks.
GenQA UK NEQAS LI TP53 and IGHV EQAs were previously in pilot phase, therefore the ILRs between 2019-2021 indicated the laboratory’s score within the EQA, but gave no final performance outcome designation, i.e., “satisfactory performance” or “poor performance”. Beginning in 2022, both GenQA UK NEQAS LI CLL TP53 and CLL IGHV EQAs are fully accredited against ISO 17043 standards, therefore participant ILR will now include a performance outcome (satisfactory or poor), as well as an EQA score.
In the ERIC Certification, five samples are issued for testing per round, and the certificate is valid for a maximum of three years (or until the key lab personnel changes). GenQA provides three test samples and laboratories must participate annually.
You can use either next generation sequencing or Sanger sequencing when participating in both ERIC certification, and GenQA UK NEQAS LI EQAs.
DNA samples are provided by both ERIC and GenQA UK NEQAS LI for TP53 analysis.
For IGHV testing ERIC provides DNA or cDNA while the samples provided by GenQA UK NEQAS LI includes DNA or cDNA or lyophilised cells, from which participants can extract DNA or prepare cDNA for analysis.
Participation in the ERIC certification is free.
The GenQA UK NEQAS LI participation fee for 2023, is £385 per EQA. Note that there is no annual registration fee.
Laboratories from evolving economies can benefit from a discounted price for GenQA UK NEQAS LI EQA participation. In addition to GenQAs evolving economies policy (https://genqa.org), participants in GenQA UK NEQAS LI EQAs can also apply for additional financial support provided by ERIC (http://www.ericll.org) as part of this collaborative approach.
Non-ERIC certified laboratories (First round of certification) should register at: http://www.ericll.org/diagnostics. For further information please email: office@ericll.org
ERIC-certified laboratories (Subsequent rounds of certification) should enrol at: https://genqa.org. For further information, contact info@genqa.org or office@ericll.org
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