Participation
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Participation

EMQN EQA scheme participation is on a voluntary, confidential basis. As a member, you will be actively encouraged to participate in all relevant schemes. Participation is anonymous - laboratories are identified in the database by a code known only to the EMQN office staff.

 
 
Scheme Participation
 

An EQA scheme takes the form of a practical and/or theoretical exercise, usually with three clinical questions and matching DNA samples.Where possible, EQA schemes are offered in two or more languages, English and the scheme organiser's national language. Laboratories are expected to report back to the scheme organiser in one of the languages offered. 

 

The basic process of scheme participation is outlined in the figure below (click on a timeline item to get more information).

Participation
Appeals Results Assessment Replacement Delivery Sample Delivery Reporting Testing Receive Samples Register for Scheme EMQN Registration
 
EMQN membership
 

To become a member of EMQN you must register with the network (there is a charge for this). The registration period runs from the 1st January to 31st December each year. As a registered member you receive a username and password, which you can use to login to the EMQN website and access its member services.

The first person to register with EMQN for a lab MUST BE THE MAIN CONTACT PERSON (i.e., head of lab, quality manager etc).

Information required for registration

You need the following information to hand before registering with EMQN:

  • Your up to date contact details including a valid email address and a correspondence address.

  • An address for delivery of EQA samples, which can be set to the correspondence address. Please note that YOU MUST NOT USE A PO BOX NUMBER FOR DELIVERIES. All our deliveries are made by overnight courier and they will not deliver to a PO Box. Failure to provide an alternative delivery address may result in you EQA samples being delayed or not sent at all.

  • A contact person and address for billing information, which can be set to the correspondence address.

  • A VAT number for your institution. This is obligatory.

  • A purchase order number (if you have one).

The registration process

When you have the required information, go to the registration wizard.

Apart from the information mentioned above, you will also be asked for a preferred user name for logging on to the system (which defaults to your email address) and a password to be used for logging on.

When received, EMQN will process the request as soon as practicable. However, there will be inherent delays in the process as details must be checked. It can take upto 5 working days to process a new account request.

Once your account has been approved, you will receive a confirmatory email and will be able to log on to the EMQN system using the approved user name and your password. If you have suggested a user name which clashes with an existing name then an alternative will be requested.

You will be able to change your password at any time, or request a new password in the event that you have forgotten it. However, your user name cannot be altered; it is used for authorisation and auditing purposes.

Important note: Your account will hold a record of you EQA scheme participation for every year remain a member of EMQN. If the main contact holder changes, please inform the EMQN office immediately so that we can advised on the best approach to keeping your labs record of participation.

Billing and payment

EMQN batches up all invoices for a single institution. We invoice once a year - usually during October and / or November. All invoices come from our host institution which is "Central Manchester University Hospital NHS Foundation Trust". Please note that EMQN reserves the right to with hold its services from any laboratory that fails to pay its invoice. If you are having problems paying, then please contact the EMQN office in Manchester (office@emqn.org).

Laboratory Reference Number

Participating laboratories are allocated a unique laboratory reference number - this number will remain the same for all subsequent rounds of EQA. Quote this number in all correspondence with EMQN.  It is the responsibility of the ‘primary contact’ to provide EMQN with up to date information when registering with the network. Failure to do so may result in delays when processing your requests. A laboratory can request EMQN to change to its primary contact at any time.

 
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Scheme registration
 

As a member of EMQN you are able to register online for any EMQN EQA scheme. Once registered, you are able to check all details online - including dates for scheme activities and scheme documentation.

EQA registration is available from May through to November. As a member, you will be notified of the schemes by email. A charge per scheme is made for particpating in each scheme, except for pilot schemes, which are free. An early registration discount is available.

You must make all registrations through the EMQN website using the username and password supplied  when you register with the network.

 
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Sample dispatch
 

For practical EQA exercises sufficient sample material (for example DNA, tissue, plasma etc.) is supplied to perform all necessary analyses. You will be notified in advance, through the website, of the planned date of sample dispatch for each scheme.

Materials for the schemes are obtained from either lymphoblastoid cell lines, reference material providers, normal volunteers or patients through special arrangements with collaborating physicians, or participating laboratories. In all cases, informed consent has been given for the use of the sample in EQA.

EQA samples are validated by the scheme organiser and at least one other expert centre. Genotypes are generally checked by more than one analytical method.

You will receive advanced warning of dispatches sent to you. Please check that the delivery address on the system is up to date. A tracking number will sent to you in an email from the courier (e.g., DHL, FEDEX etc). If you do not receive your sample within 5 days of shipping you must contact the EMQN office

 
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Sample receipt
 

Each sample dispatch will be accompanied with a dispatch note, a covering letter giving basic instructions, reporting dates and where to get more information.

The materials provided are stable at +4oC (unless otherwise stated); however, long-term storage at -20oC is recommended.

The materials distributed are provided as specimens for the sole purpose of enabling external quality assessment at the recipients laboratory - they are not controls for patient tests and must NOT be used as such.

You will receive all the samples, for all the schemes you are participating in, at the same time. Check the dispatch note carefully, and check the samples for damage. Notify the EMQN immediately of any discrepancies or problems. There will be storage information with the samples.

The samples themselves will be marked in the usual way, including patient name. You will not be provided with patient referral details: these will be a part of the scheme details, which you will need to download from the website.

 
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Replacement Samples
 

Repeat EQA materials cannot be guaranteed, but will be sent if available. EMQN will require a justification, and reserve the right to charge for replacement samples to cover reasonable costs. Testing of replacements must be within the same timeframe as the originals.

 
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Laboratory testing
 

Your laboratory is asked to perform its normal range of tests on the samples. Assessors take note of best practice guidelines, so you are advised to check available guidelines before beginning your EQA tests. Before testing, refer to the scheme documents, which are available online. You must keep your results private and not collude with other laboratories. If you cannot complete your tests for any reason then contact EMQN. If the testing process fails you can request replacement samples.

 
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Reporting
 

You are asked to prepare a report in your normal laboratory format and style and submit it in an approved file format. Example reports are available to EMQN members. Include your interpretation of the genotype in the context of the mock clinical information supplied with each sample. If you do not offer clinical interpretation of the genotype result, then you must supply a document clarifying why no clinical interpretation is given.

Genetic test reports may be transmitted to other non-genetics health professionals and may also cross national boundaries. Therefore, whilst we recognise the different legislative requirements in various parts of the world, it is EMQN policy to encourage a comprehensive 'stand-alone report' following relevant best practice guidance where available. For general guidance on reporting, please see European Journal of Human Genetics 2013:10.1038/ejhg.2013.125. It is advisable that you include the analytical limitations of your test in the report.

Your returns must be anonymous and identified only by your individual EMQN laboratory reference number. Reports are submitted via the network website.  Do not upload password-protected files. Also, make sure that the report is in a language accepted by the scheme (as detailed in the scheme instructions); use of any other language may affect the EMQN’s ability to assess your submission.

The deadline for return of reports is usually 8 weeks from receipt of samples. Specific EQA scheme documentation will provide more information, so please check them carefully.

 
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Assessment
 

The genotypes of the scheme samples are published exactly 7 days of the closing date for reporting.

Marks are allocated according to fixed criteria agreed by the scheme organiser and assessors prior to receiving the returns. Marking is divided into two categories: genotyping and interpretation (except for pilot schemes, for which interpretation is not marked). Reports are marked by the scheme organiser and two expert assessors from different countries - at least one having experience of EQA schemes. You are advised to check your results as soon as the scheme genotypes are published. This is important for patient care, as the EQA may identify a systematic problem with your testing proceedures.

The aim of each EMQN EQA schemes is primarily educational; it is an opportunity for your laboratory to critically review its performance. Where possible, the standards expected follow best practice guidelines. Schemes test the ability of your lab to provide accurate genotyping and interpret the results; they also assess clerical accuracy.

No score is awarded for clerical accuracy, although the assessors will identify key points that they feel should be mentioned in your report. Other aspects are marked out of 2.0, where marking is subtractive with deductions for errors, missing information or erroneous conclusions.

All marking is checked and differences resolved at a meeting between the scheme organiser and assessors.

 
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Individual Laboratory Reports
 

You will receive an individual laboratory report (ILR) for each scheme in which you participate. The report will give a breakdown of your overall score in the form of a simple grid and includes any agreed comments from the assessors. If any laboratory is considered to have performed poorly in an EQA, direct contact will be made by the EMQN office staff with the laboratory’s primary contact person.

 
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Final Scheme Reports
 

For each scheme, a final report summarising the correct genotypes, expected interpretative points, average scores and any re-occuring problems / mistakes is made available via the website to all participating laboratories. The final scheme report allows you to review your own performance, and make changes to your laboratory’s practices if considered necessary. Final scheme reports form an important part of the EMQN continuous improvement model, and all participants are urged to study them carefully.

 
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Appeals
 

If you do not agree with the marks you have received for an EQA, you are given a period of time (up to 21 days after the release of results) to submit a written appeal to the EMQN Office. An appeal must be submitted online, using a form available from the website. The appeal will be considered by the scheme assessment team and a response commincated back to the the lab via the EMQN Office. In cases where the scheme organiser and assessors cannot come to a conclusion, the appeal is forwarded to the EMQN board for a decision. The EMQN cannot consider any appeal submitted after the set deadline, so in this case the originally assigned marks will stand.

 
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Confidentiality
 

Laboratory information is confidential between you and the EMQN office (and in exceptional circumstances the Scheme Organiser and Management Board). Only your laboratory’s allocated unique EMQN reference number will identify its scores within distributed summary reports. The fact that your laboratory participates in EMQN schemes is not confidential. However, the raw data and performance scores although there are exceptions which are:

  • Individual participants' performance information may be shared with national/regional authorities with responsibility for laboratory standards and/or patient safety following approval by the EMQN board.
  • Aggregate performance information may be shared with a relevant national coordinators following approval by the EMQN board.
  • Performance information of laboratories registered with the HGSA/RCPA Quality Assurance Programs (QAP) is shared with HGSA/RCPA.
  • Performance information of Swiss laboratories is shared with CSCQ.

 

Please see the following documents for the relevant terms and conditions of membership and EQA scheme participation:

 

 
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Feedback to EMQN
 

The EMQN office welcomes written comments about EMQN schemes at any time. Confidential communications about a scheme should be made to the EMQN Office. More general points should be made through the EMQN administrator. A customer satisfaction survey is sent out with each final scheme report.

 
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Complaints procedure
 

Most complaints received by the EMQN consist of minor misunderstandings or problems with specimens. These can usually be resolved over the telephone with the EMQN office staff. If a complaint is received it will be logged along with the action taken. The EMQN Office Staff will attempt to address the complaint as soon as possible by letter. If the participant is not satisfied with the response by the EMQN Office Staff then the matter will be brought to the EMQN management board at their next meeting. A response will be made in light of the advice given by the management board. Participants who feel that their cause for complaint requires a more formal response is invited to contact the EMQN Chairman in writing.

 
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Collusion
 

Scheme participants are reminded that it is the duty of the scheme provider to prevent collusion between participating laboratories. Participants found colluding in their scheme returns may be excluded from participation in future scheme.

 
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Subcontracted activities
 

EMQN is responsible for all design, planning, review and oversight of EQA schemes. Some activities such as the manufacture of materials or peer review by scheme assessors are sub contracted, however, EMQN remains responsible for the oversight of all work by sub contractored activities.

 
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