ESP Lung External Quality Assessment Scheme

Information for Participants

• Introduction
• Registration
• Set up of the schemes and kind of samples
• Data analysis and evaluation of EQA scheme results
• Communication of results
• Timeline of the ESP Lung EQA scheme
• Steering committee members
• Confidentiality

Introduction

The European Society of Pathology (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.

From 2017, the organisation of the ESP EQA programmes will be done together with the new ESP-QA foundation.

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. Raed Al Dieri, scientific director of the ESP.

The scheme is supported by Bristol-Myers Squibb (BMS), AstraZeneca Belgium (for PD-L1), Amgen Europe, Roche Pharma Belgium, Roche Turkey, Roche Romania, Pfizer Poland, Pfizer Croatia, Pfizer Serbia and Central Balkan Countries (Montenegro, Albania, Macedonia, Kosovo), and Pfizer Czech Republic/Hungary/Slovakia.

The ESP EQA schemes are accredited by BELAC conform the ISO 17043 PT-215, which is the international standard for conformity assessment of proficiency testing.

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 adequately in the EQA round will be published on the ESP website if they gave consent for this.

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.

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 via 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 can take some time to prepare. The invoice is sent via e-mail and it can always be consulted online after login, in the section 'History of your EQA participation'.

The registration fees for the different subschemes of the 2020 scheme are:

• ALK FISH + ALK FISH digital:  300 EUR
• ALK IHC + technical assessment:  350 EUR
• Molecular DNA scheme (EGFR (mandatory), KRAS (optional), BRAF (optional), c-MET (optional)):  550 EUR
• Molecular RNA scheme (ALK, ROS1, c-MET RNA analysis): 400 EUR
• ROS1 FISH + ROS1 FISH digital:  300 EUR
• ROS1 IHC + technical assessment:  350 EUR
• PD-L1 EQA scheme: 350 EUR

Set up of the schemes and kind of samples

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 4 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:

Scheme	Number of samples	Sample type	Registration fee
ALK
ALK FISH*	10	5 resections, 5 digital cases	300 EUR
ALK IHC**	5	5 resections	350 EUR
Molecular DNA scheme
EGFR variant analysis (mandatory) KRAS variant analysis (optional) BRAF variant analysis (optional) Genomic MET analysis (optional)	10	10 resection specimens, possibly cell-line	550 EUR
Molecular RNA scheme
RNA based ALKanalysis RNA based ROS1analysis RNA based METanalysis	5	5 resection specimens, possibly cell-line	400 EUR
ROS1
ROS1 FISH*	10	5 resections or possibly cell-lines, 5 digital cases	300 EUR
ROS1 IHC**	5	5 resections or possibly cell-lines	350 EUR
PD-L1 EQA scheme
PD-L1	12	8 resections (TMA's) and 4 digital cases	350 EUR

*Includes the evaluation of FISH digital cases.

**Technical assessment: pathology review and microscopic assessment.

 

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. Laboratories participating in IHC should send all stained slides to the EQA coordination center for technical microscopic assessment. They should also send digitized written reports for one sample.

The laboratory should submit written reports for one of the samples per subscheme, 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.

 

Data analysis and evaluation of EQA scheme results

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. Evaluation of the results is based on consensus publications and ISO standards relevant to the field.

 

Communication of results

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  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 of participation.

For the 2020 Lung EQA scheme, full integrative results of all three rounds will be provided at the end of the scheme. Correct outcomes for the distributed samples are made available at the end of each round. Participants who require a partial certificate at the end of round 1 and/or 2 for quality purposes can be provided with a preliminary certificate for these rounds.

 

Last changed: 2022-03-21