Participants Manual

ELIGIBILITY AND REGISTRATION
GenQA services are designed for public and private sector clinical laboratories/centres serving clinicians or patients. Clinical laboratories, laboratories with purely research or industrial roles, manufacturers of diagnostic instruments and reagents, and other laboratories are welcome to participate.  Manufacturers may do so on a 'technical and analytical/genotyping' only basis, i.e. receiving samples and returning results with no clinical interpretation provided.  All laboratories must agree to the current conditions of participation Joint Working Group Conditions of Participation which are based upon those set by the UK Joint Working Group on Quality Assurance.

EQA MATERIALS AND DISTRIBUTIONS
GenQA distributes slides, images, fixed cell suspensions, cells, DNA, formalin-fixed parraffin-embedded (FFPE) tissue, fresh tissue, plasma, blood spot cards, whole blood samples and saliva, for EQA purposes. Material is provided, where possible, by a suitable, accredited laboratory providing a diagnostic service. Images from submitted cases are also captured by the Scheme Office. All EQA material is validated by at least two independent laboratories prior to being released.

Some EQAs have more than one distribution. Participants are given from 4 to 16 weeks to submit their results depending on the EQA test(s) required.

Participants are informed once samples are sent allowing readiness for them to be received. All participating laboratories are emailed informing them of the distribution. If samples do not arrive by the date given in the EQA open email or EQA instructions, it is the participant's responsibility to inform the Scheme on info@genqa.org.  In which case, all possible measures will be taken to distribute repeat samples and documentation as soon as possible.

For the practical exercises, in any given round of EQA, sufficient material is usually supplied to perform all necessary analyses plus a modest number of repeat analyses. DNA, blood, saliva and fixed cell suspension EQA samples provided can be stored temporarily at +4°C. However long-term storage at -40°C is recommended for DNA. Blood spot cards and FFPE tissue sections (rolled and slide mounted) can be stored at ambient temperature. Cells distributed for the preimplantation genetic testing schemes should be treated exactly as detailed in the accompanying distribution paperwork. Fresh tissue should be processed as outlined in the accompanying distribution paperwork.

The material used for the practical schemes resembles as closely as possible the relevant clinical material routinely tested in the participating laboratories, such as DNA, cells, blood, blood spots or tissue sections. 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 disease/genes/variants 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.

If any participant believes that the EQA samples have been affected by conditions during transportation, have issues with sample labelling or any other factor which may have an impact on the ability to obtain a result, the laboratory MUST contact the Scheme as soon as possible on  info@genqa.org

Various aspects of the EQA activities are subcontracted e.g. supply of EQA material and validation testing. All subcontractors are regularly reviewed to ensure the standard of the Scheme is not comprised and adheres to the ISO 17043 standard. GenQA is responsible for this work.

Any changes to the planned EQAs shall be communicated to participants by the Scheme as soon as possible.

IMPORT DISTRIBUTION DOCUMENTATION
Many countries have specific regulations related to the import of clinical samples from overseas. These regulations often require specific documentation or import licences to be provided by the receiver of the samples. If required, then not having the correct licence or documentation will result in a substantial delay in receiving the samples and may make it impossible for you to participate in the EQA you are enrolled in. EQA charges will not be refunded in these cases. If you require any assistance regarding this please contact the Scheme.

In the case of import licences, it is important to ensure that you have the correct and valid licence to cover all types of samples which are subject to the regulations (e.g. DNA, fixed cell suspension, cells, FFPE sections, fresh tissue, whole blood, plasma and saliva).

For other types of documentation, it may be possible to prepare the papers in advance to expedite the customs process and it must be completed by you as the receiver. 

REPORTING RESULTS
Participants are asked to provide full interpretative reports in their normal laboratory style, unless specifically requested to use a form to submit results or participating in a genotyping only EQA. All returns should be anonymous and identified solely by their individual laboratory reference number and submitted in pdf format. All returns must be submitted by the laboratories via their own account on the website. All reports will be marked against the current HGVS/ISCN nomenclature when appropriate.

The Scheme will send out reminders close to the EQA submission deadlines, however, it is the Participants’ responsibility to be aware of EQA dates relevant to their laboratory. Non-submission of results may lead to the laboratory receiving a ’Poor Performance’ designation.

Submissions are accepted in English and, for some EQAs in French, German, Italian and Spanish. The EQA specific instructions will contain details of the languages accepted for each given EQA round.

SCORING
Reports are marked by a team of peer assessors with appropriate experience in the EQA field, against peer ratified marking criteria. Scoring is divided into three categories, Analysis/Genotyping, Interpretation and Clerical Accuracy each marked out of 2.0 marks. All scoring is independently checked by at least a second expert. Any discrepancy in the sets of marking are resolved by the Senior Scheme Staff or the appropriate Specialist Advisory Group.

There are two performance categories (see performance monitoring for more information):  Satisfactory or Poor

INDIVIDUAL LABORATORY REPORTS (ILR) AND EQA SUMMARY REPORTS
Individual Laboratory Reports detailing the scores and assessors' feedback comments specifically assigned to the laboratory are distributed after every EQA run.

ILRs give the result, score and performance designation for each EQA. Pilot and exploratory pilot EQAs are marked and scored but no performance status is applied. ILRs are designed to be informative and easy to interpret. Reports share the following features:

  • Analytical/genotyping, interpretative and clerical accuracy scores;
  • Educational feedback comments on the submitted individual reports (some may incur a deduction of marks);
  • General comments and recommendations;
  • Performance status.

An EQA Summary Report summarising the EQA participation, validated results, performance and discussion on any issues arising from the EQA run is published at the same time. Participating laboratories are informed by email when the ILRs and EQA Summary Reports are available to download.

The EQA clinical cases and EQA Summary Reports are copyright of GenQA and cannot be used for any purposes other than internal laboratory EQA review without prior written permission from the Scheme Directors. Results for any EQA distribution should be checked to ensure that they correspond to your laboratory’s submission.  If there are discrepancies, the Scheme should be informed immediately so that the necessary corrections can be made and a new ILR issued.

APPEALS
Laboratories usually have 15 working days to appeal any penalty points/comments given in their Individual Laboratory Reports starting from the date the original ILR is published. Laboratories wishing to appeal must download the appeals form from the associated EQA webpage, complete it and re-upload it prior to the appeals deadline given on the website. Any appeals received after the closing date will not be accepted.

No appeals are accepted for pilot EQAs but comments by participants are welcome and can be communicated to the Scheme by email.

All appeals are reviewed anonymously by the relevant Specialist Advisory Group (SAG). Please note the appeals process may take six to eight weeks to ensure they are reviewed appropriately. Formal notification of the outcome of the appeal will be given to the laboratory by the Scheme. The decision of the SAG is final. If the appeal is successful an amended ILR will be issued. Any changes to scores/comments through successful appeals will be considered by the relevant SAG if applied to for laboratories that did not appeal.

FINAL SCORES
Following the appeal period for each EQA scheme, the scores are finalised and will not be amended thereafter. Scheme reports will include a summary of the mean scores obtained across the EQA run to give participants a measure of their own performance against other participating laboratories. Individual laboratory identities will not be disclosed.

Participants will be notified by email once the final ILRs and EQA Summary Reports are available online.

DISQUALIFICATION
If GenQA detects any incidence of EQA result sharing prior to EQA report submission or any other form of collusion then the Scheme Directors shall investigate. If collusion is suspected, the laboratory(s) will be withdrawn from the EQA assessment. Their ILR(s) will state that the laboratory has been found colluding with another participant, and no participation certificate will be issued. GenQA reserves the right to disqualify any participating laboratory from future EQAs if there is evidence of falsification or collusion with another participating laboratory.

ASSESSORS
Assessors are members of the profession with extensive experience of reporting complex results and are usually recruited by advertisement or peer referral. Expert advisors may act as EQA assessors and it is expected that each assessor will not be involved in their laboratory’s EQA participation in the EQA they are assessing in any way.

Assessors may advise in the design of the EQA to ensure that the EQA cases reflect appropriate clinical case scenarios and also advise on the marking criteria. The assessors are responsible for scrutinising and assessing technical, analytical/genotyping and interpretive performance in consultation with the senior Scheme staff and the Specialist Advisory Group. GenQA is always interested to hear from any individual wishing to be an assessor, please contact the Scheme to discuss details.

COMPLAINTS
The nature of the majority of issues and minor misunderstandings or problems with specimens and reports, can usually be resolved over the telephone or by email (info@genqa.org) for the purposes of informal feedback.

Formal complaints need to be made in writing (email or letter) and will, where possible, be dealt with within 14 days of receipt. If outside bodies need to be involved in resolving the complaint then the originating laboratory will be informed of the delay and will be kept informed of the progress.

If appropriate, the formal written complaint is discussed with the relevant Specialist Advisory Group (SAG) or the Advisory Board and the Scheme Director(s) will reply to the complainant. The Chair of the relevant SAG or the Advisory Board will respond to any complaints sent directly to them after consultation with the Scheme Directors(s) and the relevant SAG or the Advisory Board. Addresses for the SAG chairs and the Chair of the Advisory Board are available from the website and the Scheme Office to any participants who wish to express comments or concerns about the Scheme and its operation.

If difficulties persist, then participants with continued justified cause for complaint about any aspect of the service should communicate their concerns in writing to the Chair of the relevant SAG - though a preliminary telephone call may be helpful in clarifying the issue and establishing the requisite action.

  • Where the complaint is about Scheme logistics, or a matter related to performance assessment and EQA design, it is more appropriate to contact the Scheme Directors; 
  • If the complaint concerns the conduct of the Scheme Directors, Deputy Scheme Directors or Quality Manager, then the OUH Operational Services Manager for Pathology and Laboratories or NHS Lothian Operational Services Manager for Laboratory Medicine should be contacted; 
  • Complaints are logged, and the action taken is recorded and audited by the Scheme;
  • If the complaint concerns the conduct of the SAG or Scientific Advisory Board, the respective Chair should be contacted or the Scheme Director(s);
  • If contacting the Specialist Advisory Group does not deliver satisfactory results, the Chair of the Advisory Board should be contacted or the Scheme Director(s);
  • If the issue concerns a persistent poor performance designation, the Chair of the NQAAP (UK) or relevant national bodies may also be contacted or the Scheme Director(s);
  • Where lack of compliance with ISO 17043 standards is suspected by the complainant, the Chief Executive of UKAS may be contacted; 
  • Where the UK NEQAS Consortium code of practice itself is the issue of concern, the Chair of the UK NEQAS Executive is appropriate.

In all cases, GenQA staff will provide the names and addresses of the relevant individuals where appropriate.

PARTICIPANTS MEETINGS AND FEEDBACK
Comments about the Scheme are welcome at any time and should be made in writing to the Scheme Directors, Dr Sandi Deans (Sandi.Deans@ed.ac.uk) or Dr Ros Hastings (ros.hastings@ouh.nhs.uk)

Feedback questionnaires are used from time to time to poll opinions and to assist in developing the Scheme according to participants' needs.

Participants’ meetings will be held at the ACGS, ESHG, ECA, ESP and ESHRE conferences. All participants are notified of the meeting and agenda in advance. An attendance register is taken and presentations given may be available from the Scheme Office. The meetings will focus on specific EQAs or issues and will be advertised in advance so participants are aware of the meeting content. There will be opportunity for open discussions.

Best Practice meetings are held for participants annually and are focussed on specific genomic testing areas. Detailed information is given on the website prior to the meetings.

If you would like to suggest an EQA to be provided by GenQA then please contact the Scheme Directors, Dr Sandi Deans (Sandi.Deans@ed.ac.uk) or Dr Ros Hastings (ros.hastings@ouh.nhs.uk).

 

COPYRIGHT

GenQA logo – The GenQA logo is copyright. It must not be used on laboratory documents, promotional material or websites without the written consent of the Scheme Office.

© Copyright GenQA

Images GenQA images, EQA cases, reports and documents are copyright and may not be copied, distributed, published or used for publicity and promotion in any form without the written consent of the Scheme Director on each and every occasion, though performance data may be shared with individual clients (e.g. GPs, clinicians, pharmaceutical companies) without consultation. 

Participants’ Manual - No part of this participants’ manual may be copied, distributed or published in any form without the written permission of the Scheme Director on each and every occasion. © Copyright GenQA

Last updated: Thursday, 22 November 2018
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