ESP Lung External Quality Assessment Scheme

Information for Participants

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.

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 an educational grant from Pfizer. 

The ESP EQA schemes are accredited by BELAC conform the ISO 17043Exit this websiteDownload PDF Document, 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 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.orgExit this website). 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.

 

Stay informed on the next ESP schemes

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. When the registration is open, all laboratories that have an account will receive an invitation through e-mail to register for the ESP Lung EQA scheme online.

 

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 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 2017 round are:

  • ALK FISH + ALK FISH digital: 300 EUR
  • ALK IHC + technical assessment: 350 EUR
  • Molecular NSCLC scheme (EGFR (mandatory), KRAS (optional), BRAF (optional)): 550 EUR
  • ROS1 FISH + ROS1 FISH digital: 300 EUR
  • ROS1 IHC + technical assessment: 350 EUR
  • Educational scheme: 100 EUR
  • PD-L1 pilot EQA scheme: 200 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 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:

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 NSCLC scheme

  • EGFR variant analysis (mandatory)
  • KRAS variant analysis (optional)
  • BRAF Variant analysis (optional)

10

10 resection specimens, possible cell-line

550 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

Educational scheme

  • EGFR – ALK – ROS1

/

Theoretical, paper-based cases

100 EUR

PD-L1 pilot EQA scheme
  • PD-L1
10 resections and digital cases 200 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 several samples.

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.

 

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 for entering participation.

 

Timeline ESP Lung EQA Scheme

The ESP Lung EQA Scheme 2016

 

The ESP Lung EQA Scheme 2016 consists of 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).

 

ALK SCHEME

  • September - October 2016: results and evaluation reports will be discussed with the assessors and steering committee
  • November 2016: results of the ESP Lung EQA Scheme, part I will be available

EGFR SCHEME

  • 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

  • December 2016: distribution of the samples (you will receive an email when the samples are sent)
  • Deadline for submission of the results and written reports: 28 days after receiving the samples
  • December-January, 2016: results and evaluation reports will be discussed with the assessors and steering committee
  • February 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 December 2016, the exact time schedule will be announced later

 

The ESP Lung EQA Scheme 2017

 

From 2017, a new set-up will be adopted during which the cases for a given marker will be distributed three times a year, as compared to once yearly in 2016. We believe this will decrease the work load for the participants, as no more than 4 samples will be received for a given subscheme.

ROUND 1

  • March 2017: Sample distribution (nr depending on subschemes for which registered, Table 1)
  • Report submission for participants to the ALK (FISH and/or IHC) or PD-L1 subscheme
  • April 2017: Partial assessment of the results
  • May 2017: Partial assessment results available

ROUND 2

  • June 2017: Sample distribution (nr depending on subschemes for which registered, Table 1)
  • July 2017: Release of correct sample outcomes for round 2.

ROUND 3

  • October 2017: Sample distribution (nr depending on subschemes for which registered, Table 1)
  • Report submission for participants to the ROS1 (FISH and/or IHC) or molecular subscheme
  • November 2017: Full integrated assessment of 2017 scheme EQA results.
  • December 2017: EQA scheme results available for round 1-3.

    Overview sample distribution

    March 2017

    June 2017

    October 2017

    Total number of samples / subscheme

    Subschemes

    #

    #

    #

    #

    - Molecular NSCLC scheme

    EGFR (mandatory),

    BRAF (optional),

    KRAS (optional)

    3

    /

    3

    /

    4

    R

    10

    - ALK IHC

    3

    R, T

    1

    /

    1

    /

    5

    - ALK FISH

    3

    R

    1

    /

    1

    /

    5

    -ALK FISH digital

    (mandatory for ALK FISH participants)

    1

    /

    2

    /

    2

    /

    5

    - ROS1 IHC

    0

    /

    2

    /

    3

    R, T

    5

    - ROS1 FISH

    0

    /

    2

    /

    3

    R

    5

    -ROS1 FISH digital

    (mandatory for ROS1 FISH participants)

    3

    /

    2

    /

    0

    /

    5

    - PD-L1 (pilot)

    3

    R, T

    4

    /

    3

    /

    10

    - Educational

    /

    /

    /

    Table 1.Set-up of Lung ESP EQA scheme.

    R = submitting reports; T = technical assessment.

    All laboratories with an account on the website will be informed via e-mail on the scheme updates and will receive an invitation when registrations are open.

Steering committee members and technical experts

  • Al Dieri R. - ESPQA - Director Operations, Brussels, Belgium
  • Dequeker E. – Biomedical Quality Assurance Research Unit, University of Leuven, Belgium
  • Keppens C. - Biomedical Quality Assurance Research Unit, University of Leuven, Belgium
  • 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
  • van Krieken H. - European Society for Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands
  • Zwaenepoel K. - Antwerp University Hospital, Belgium

Medical expert

  • ’t Hart N. – University Medical Center Groningen, The Netherlands

ESPQA Foundation

Barastraat 6

1070 Brussels

Tel. +32 (0) 25 20 80 36

e-mail:

Website: www.esp-pathology.orgExit this website

 

Confidentiality

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.

 

 



Last changed: 2016-12-05