Cystic Fibrosis European Network

Cystic Fibrosis External Quality Assessment process

First time participants

Laboratories interested to participate in the CF EQA scheme need to have a username and password. With this username and password the laboratory can log in to the EQA participant's area. In the participants area the laboratory can access the registration form for the current EQA scheme, can submit reports and consult results of previous years. In case your laboratory does not have a username and password, please get one by filling in this form.

Repeat participants

CF EQA timeline
Beginning of June - end of August: Online registration open
Mid September: Distribution of the samples to the registered participants
Beginning of October - end of November: Datasheet open and submission of the genotype results and written reports
Beginning of January: Release of genotypes
Beginning of January – beginning of March: Assessment
End of May: General evaluation report and individual comments of the CF EQA scheme available online, certificates sent by post
Till the end of June: Appealing phase for laboratories
Beginning of July: CF Network responds to the appeals and marks become final

Registration
Registration opens June 1 and the deadline is August 31. Early June, all laboratories that have an account (username and password) will receive an invitation via e-mail to register for the CF EQA scheme on-line. An identification number (e.g. 20090056) is assigned to each participant automatically upon registration. Make sure you mention this identification number or EQA ID in all correspondence and on reports and raw data.
A copy of the registration form will be sent to the e-mail address of all active contact persons linked to the laboratory. When the confirmation e-mail did not arrive, please check whether the final 'Submit' button was clicked on the registration form.

Payment information
All participating laboratories should pay 200 euro. An electronic invoice will be generated and sent to the laboratory by e-mail, once the registration form is submitted. This is a manual process which takes on average one week. In addition, this invoice is attached to the EQA participant's area. If a laboratory wishes to receive a copy of the invoice by postal mail, they should contact the . For the registrations via the Australian Quality Assurance Program (QAP), payment will be handled through QAP.
Please remit payment within 30 days after receipt of your invoice. Make sure you specify the correct structured communication (+++xxx/xxxx/xxxxx+++) with your payment. Without this reference, your payment cannot be processed automatically, which can cause a delay in the registration of the payment by our financial department, and other problems.

Payment can be made only by bank transfer and without charges to the beneficiary,
in the name of K.U.Leuven, Krakenstraat 3, 3000 Leuven
IBAN code: BE09 4320 0000 1157 (mandatory for international bank transfers)
BIC/SWIFT code: KREDBE BB
Bank name: K.B.C.
Bank address: Bedrijvenkantoor Leuven, Brusselsesteenweg 100, B-3000 Leuven, Belgium

Figure of the CF EQA scheme process

Samples
Three purified DNA samples (15µl, conc ~ 1µg/3µl), harboring homozygous or heterozygous CFTR mutations, will be sent to the registered laboratories with the request to test for the presence of CFTR mutations, using the routine protocols. The samples are accompanied by mock clinical cases. The samples will be distributed to the laboratories from the middle of September.

Analysis and reporting
The laboratories have about 8 weeks to analyze the samples with the detection assay they routinely use and should submit written reports and raw data by November 30. These reports and raw data should be uploaded via an electronic datasheet, available when the laboratory logs in to the CF Network website. The CF Network strongly advises NOT to send reports and raw data by post or via e-mail.

Report:
The laboratory should submit a report for each mock clinical case. A report represents the report a laboratory normally issues to the medical doctor who requested the CF test. Therefore genotype and interpretation information should be present in the reports submitted to the CF Network. Reporting is allowed in six languages: English, French, German, Spanish, Italian and Dutch. A report in the native language can be submitted in addition. This will be consulted when there is doubt that these errors are due to a translation problem. Laboratories may write anonymous reports, but this is not obligated, as all quality assessors signed a confidential agreement on this. Reports are preferable submitted as .doc, .docx or .pdf files. Example reportsExit this website are available on the CF Network website. When using example reports, it is essential to formulate an interpretation based on the context of the clinical situation.

Raw data:
Raw data of the analysis might be helpful during the assessment in case of unclear results. Raw data are preferable submitted as .tiff, .ppt, .pptx, .pdf, .jpg or .gif.

Assessment
The scheme organizer together with a panel of quality assessors will evaluate the reports and raw data. A general evaluation report and individual comments are prepared and made available on-line by the end of May. This is notified by e-mail to all active contact persons. Participants who did not make genotype mistakes and no serious errors in their submitted reports receive a certificate for successful participation by post. Results of the CF EQA scheme will be sent only to those laboratories that paid the registration fee. Laboratories that did not receive a certificate in the current year and at least once in the two previous years will receive an additional letter inviting them to contact the assessors to discuss their results and ways to improve their performance. Each laboratory that submitted at least genotype results will able to download a letter of participation from the website at the end of the EQA cycle. This letter does not confirm that the participation was successful.

Appeals
The CF Network allows people to react on the score and/or comments they received. All appeals should be sent via e-mail to before the end of June. The CF Network will collect all appeals and they will be discussed by the assessors. Answers will be given to the laboratories after July 1, and then the marks become final.



Last changed: 2010-08-23


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