ESP LUNG EQA Scheme

For more information about the ESP QA Lung Scheme, please follow this link: http://lung.eqascheme.org/

Introduction

The European Society of PathologyExit this website (ESP) established an EQA program for testing biomarker mutations in non-small cell lung carcinoma (NSCLC). This program aims to ensure optimal accuracy and proficiency in lung cancer biomarker testing across all countries.

The practical organization of this European EQA program is done in collaboration with the members of the ESP Lung EQA scheme steering committee and the Biomedical Quality Assurance Research Unit of the KU Leuven, lead by Prof. Dr. E Dequeker. The ESP Lung EQA program works in close contact with Prof. Dr. H van Krieken, president of the ESP.
This scheme is in collaboration with UK NEQAS ICC&ISH. The ESP EQA schemes are accredited by BELAC conform the ISO 17043, which is the international standard for conformity assessment of proficiency testing.

A pilot ESP Lung EQA scheme was run in 2012 in two rounds. The first pilot round contained only ALK testing (IHC or FISH), while the second consisted of a combined EGFR, KRAS and ALK (IHC, FISH or RT-PCR) testing.

The ESP Lung EQA Scheme 2014 was organized in two separate rounds: EGFR mutation analysis followed by ALK testing (FISH, FISH digital cases, IHC and/or RT-PCR) and ROS1 testing (FISH and/or IHC). The ESP Lung EQA Scheme 2015 will be organized in three separate rounds: first ALK testing (by FISH, IHC and/or RT-PCR), followed by ROS1 testing (by FISH and/or IHC) and then EGFR mutation analysis. It is possible to register separately for each different marker and technique. New in 2015 is the technical assessment for IHC, for which an IHC slide is to be sent for pathology review and microscopic assessment (joint program with UKNEQAS).

The aim of the ESP Lung EQA scheme is to evaluate the reliability of biomarker testing in NSCLC including the correct identification of the presence of aberrations and the writing of a clinical laboratory report. Participation in an EQA program provides the opportunity for laboratories to verify and improve their diagnostic practices. Each laboratory performing biomarker testing for NSCLC can participate to the ESP lung EQA scheme. Laboratories performing adequate in the EQA round will be published on the ESP website.

The ESP EQA is one of the founding members of the International Quality Network for Pathology (IQN Path, www.iqnpath.org). The mission of IQN Path is to improve clinical implementation of tissue-based biomarkers through multi-stakeholder cooperation. This central association will enable an exchange of expertise between key opinion leaders, will facilitate the development of multidisciplinary guidelines, develop workshops and training, and will promote EQA.

Registration

Laboratories interested to participate in the ESP Lung EQA scheme need to create an account to obtain a username and password. They can do so by filling in this form. With this username and password the laboratory can log in to the ESP Lung EQA participant's area. Laboratories that have participated to the ESP Colon EQA Scheme, can log in using the same username and password as for the ESP Colon EQA scheme.

In the ESP Lung EQA participant's area, the laboratory can access the registration form for the current ESP Lung EQA scheme once registration is available, submit results and written reports, and consult results of previous years if available.

Each year, all laboratories that have an account will receive an invitation through e-mail to register for the ESP Lung EQA scheme online. An identification number, the EQA ID number, is assigned automatically to each participant upon registration.

An invoice will be prepared and sent by e-mail to the participant once the registration form is submitted. This is a manual process which takes on average one week.

The registration fees for the different subschemes of the 2015 round are:

• ALK FISH: 300 EUR
• ALK IHC: 300 EUR
• ALK RT-PCR: 300 EUR
• ROS1 FISH: 300 EUR
• ROS1 IHC: 300 EUR
• EGFR: 550 EUR

Coordination

Coordination of the whole organization as well the evaluation of the results will be done by the EQA scheme coordination center in Leuven together with the medical/technical experts and the steering committee. The ESP Lung EQA coordination center will be responsible for sending the samples to the participants and takes the final responsibility for the EQA scheme, in close contact with the steering committee.

Samples
Samples are prepared and validated in collaboration with different expert laboratories. We assure that these tasks are performed by competent laboratories. Samples will be clearly labeled with a specimen ID. The laboratory needs to test these samples using routine protocols and report within 2 weeks after arrival of the samples.

Please find in the table below an overview of the schemes, the number and types of samples, and the fees:

The materials distributed are provided as specimens for the sole purpose of enabling external quality assessment at the recipient's laboratory during the current distribution and must not be tested for any other target than that which is requested by the EQA scheme. They do not constitute in vitro medical diagnostic devices (IVDs), and no claim is made that they may be suitable for any other purpose or at any other point in time.

Submitting results and reports:

The participants should provide feedback on the biomarkers tested for, the methods used, and the obtained results by filling in the online datasheets. They should also send digitized written reports for several samples.

Laboratories participating in IHC should send one slide for technical microscopic assessment, which is part of a joint program with UKNEQAS.

The laboratory should submit written reports for several samples, which are specified in the instructions manual and mock clincical data is provided in the request form. A report represents the report that a laboratory normally issues to the medical doctor who requested the test. Therefore genotype and interpretation information should be present in the reports submitted to the EQA coordination center. Reporting is allowed in the national language, but preferred in English. Reports are preferable submitted as .doc, .docx or .pdf files.

All results are assessed by two independent assessors and final consensus scores are decided at an assessment meeting, together with all the assessors and the steering committee group.

Results of the ESP Lung EQA scheme will be announced after discussion with the steering committee. These results will be made available anonymously among the participants but each participating laboratory will also receive individual feedback.

The ESP Lung EQA Scheme allows participants to react on the score and/or comments they received. All appeals should be sent via e-mail to lung.eqa@med.kuleuven.be before the appealing deadline that is indicated in the general report. The appeals will be collected and will be discussed by the assessors. The laboratories will receive an individual answer and after this, the marks become final.

Laboratories that participated successfully will be listed on the ESP website. All participants will receive a certificate for entering participation.

The ESP Lung EQA Scheme 2015 will be organized in three separate rounds: first ALK testing (by FISH, IHC and/or RT-PCR), followed by ROS1 testing (by FISH and/or IHC) and then EGFR mutation analysis.

Registrations for all schemes (ALK, ROS1, EGFR) will open in the beginning of 2015. It is possible to register separately for each subscheme (ALK FISH, ALK IHC, ALK RT-PCR, ROS1 FISH, ROS1 IHC, EGFR).

EGFR SCHEME

• February 2015 – May 2015: online registration open for EGFR
• First week of November: distribution of the samples (you will receive an email when the samples are sent)
• Deadline for submission of the results and written reports: 14 days after receiving the samples
• January - Februari 2016: results and evaluation reports will be discussed with the assessors and steering committee
• March - April 2016: results of the ESP Lung EQA Scheme, part III will be available.

The ESP Lung EQA Scheme 2016 will be organized in four separate rounds: first ALK testing (by FISH and/or IHC), followed by EGFR mutation analysis, and then by ROS1 testing (by FISH and/or IHC).It is possible to register separately for each different marker and technique.An additional educational scheme will be organized which includes a number of theoretical cases to evaluate the interpretation of EGFR, ALK andROS1 results.

Registrations for all schemes (ALK, EGFR, ROS1, educational scheme) will open in the beginning of March 2016. It is possible to register separately for each subscheme (ALK FISH, ALK IHC, EGFR, ROS1 FISH, ROS1 IHC, educational scheme).

ALK SCHEME

• March – April, 2016: online registration open for ALK
• June 2016: distribution of the samples (you will receive an email when the samples are sent)
• Deadline for submission of the results and written reports: 14 days after receiving the samples
• July-August 2016: results and evaluation reports will be discussed with the assessors and steering committee
• September 2016: results of the ESP Lung EQA Scheme, part I will be available

EGFR SCHEME

• March – May, 2016: online registration open for EGFR
• September 2016: distribution of the samples (you will receive an email when the samples are sent)
• Deadline for submission of the results and written reports: 14 days after receiving the samples
• October -November, 2016: results and evaluation reports will be discussed with the assessors and steering committee
• January 2017: results of the ESP Lung EQA Scheme, part II will be available

ROS1 SCHEME

• March – June, 2016: online registration open for ROS1
• October 2016: distribution of the samples (you will receive an email when the samples are sent)
• Deadline for submission of the results and written reports: 14 days after receiving the samples
• November-December, 2016: results and evaluation reports will be discussed with the assessors and steering committee
• January 2017: results of the ESP Lung EQA Scheme, part III will be available

EDUCATIONAL SCHEME

• March – June, 2016: online registration open for the educational scheme
• Case reports will be distributed in November 2016, the exact time schedule will be announced later

• Dequeker E. – University Hospital Leuven, Belgium
• Groen H. - University Medical Center Groningen, The Netherlands
• Keppens C. - Biomedical Quality Assurance Research Unit, Leuven, Belgium
• Lopez-Rios F. - University Hospital Sanchinarro Madrid, Spain
• Miller K. – UK NEQAS, London, United Kingdom
• Pauwels P. – Antwerp University Hospital, Belgium
• Ryska A. - Charles University Medical Faculty and Faculty Hospital in Hradec Kralove, Czech Republic
• Schuuring E. – University Medical Center Groningen, The Netherlands
• ’t Hart N. – University Medical Center Groningen, The Netherlands
• Tembuyser L. - Biomedical Quality Assurance Research Unit, Leuven, Belgium
• van Krieken H. - European Society for Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands
• Zwaenepoel K. - Antwerp University Hospital, Belgium

The fact of participation, raw data and the individual report are confidential between the individual laboratory and the European QA coordinator (and in exceptional circumstances the president of the ESP). All persons involved sign a confidentiality agreement.

* Please also view for information: www.alktesting.org

Labs that participated in the Lung EQA scheme with success
Labs that participated in the KRAS EQA scheme with success