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, the laboratory can submit reports and the laboratory can 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 May - end of July: 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 – end of April: Assessment
End of April: General evaluation report and individual comments of the CF EQA scheme available online, certificates sent by post
Till the end of May: Appealing phase for laboratories
Beginning of June: CF Network responds to the appeals and marks become final
Registration
Early May, 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.
The CF network collaborates with the HGSA/RCPA Quality Assurance Programs (QAP) for the registration of Australasian laboratories. These laboratories should enroll through the HGSA/RCPA QAP.
Payment information
All participating laboratories should pay 250 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 15 work days. 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 Australasian laboratories, payment will be handled through the HGSA/RCPA 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:
Account holder: K.U.Leuven
Account number: 432-0000011-57
Bank's name: K.B.C.
Bank address: Bedrijvenkantoor Leuven, Brusselsesteenweg 100, B-3000 Leuven, Belgium
IBAN code: BE09 4320 0000 1157
BIC/SWIFT code: KREDBE BB
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.
New samples:
In case the CF EQA samples did not arrive or arrived broken, the package will be resend at our costs.
Additional samples:
The samples contain enough DNA to perform CFTR testing with the current available testing methods. However, if you need additional DNA, we can send samples, but the transport cost of 50 euro will be charged to your laboratory.
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 reports 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 (e.g. agarose gel, INNO-LiPA strip, ...) 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 April. This is notified by e-mail to all active contact persons. All participants will receive a certificate of participation by post. The certificate will specify whether participation was successfull or not. Results of the CF EQA scheme will be sent only to those laboratories that paid the registration fee. Laboratories that did not partcipate successfully 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 May. The CF Network will collect all appeals and they will be discussed by the assessors. Answers will be given to the laboratories after June1, and then the marks become final.
Last changed: 2011-09-06
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