Cystic Fibrosis European Network

Datasheet

What is the datasheet?

The datasheet is an on-line form available in the EQA participant’s area when logged in. Within this form the laboratory should indicate which genotypes were found, which assay was used to test the EQA samples and which variants were tested for. In addition, the laboratory should upload written reports, including interpretation, and the raw data of the analysis. All submitted datasheet are evaluated by a team of assessors.

Which documents do I need to submit when I participate in the CF EQA scheme?

All participants have to submit an electronic datasheet, which can be found on their personal EQA participant’s area. In addition, laboratories have to submit written reports on-line. These reports represent the report a laboratory normally issues to the medical doctor who requested the CF test. Therefore genotype and interpretation should be present in the reports. Finally the CF Network strongly advises to submit raw data of the analysis as this might be helpful during the assessment in case of unclear results. All documents should be submitted on-line via the EQA participant’s area once logged in.

Are there example reports available?

The CF Network has some example reports available in order to show what is expected in a written report. However, caution is necessary when using these examples. Laboratories should submit written reports as they would normally do when they receive a request to analyze a CF sample and should adapt the interpretation to the clinical case.Example reports can be found here.

What are the preferred files to submit reports and raw data in?

Reports are preferable submitted as .doc, .docx or .pdf files. Raw data are preferable submitted as .tiff, .ppt, .pptx, .pdf, .jpg or .gif.

.fsa or .ab1 files are not allowed as they cannot be opened by the CF Network.

Which languages are allowed to report in?

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 eventual errors are due to a translation problem.

Are my results confidential?

All people involved in the organization and evaluation of the scheme have to sign a confidentiality agreement. The fact of participation itself is not confidential and is shared with the EuroGentest/Orphanet Quality Assurance database . The raw data, the reports and the performance scores are confidential between the individual laboratory and CF Network and will not be released to any third party. An exception is made for the Australasian laboratories, where the EQA participation of the different laboratories is coordinated by the Human Genetics Society of Australasia. For these laboratories, all data, samples and reports are communicated to the HGSA Molecular Genetics Quality Assessment Program coordinator.

Do I need to make reports and raw data anonymous?

Laboratories may write anonymous reports, but this is not obligated, as all quality assessors signed a confidential agreement on this.

Can I send reports and raw data by post?

The CF Network strongly advises to submit reports and raw data online in the electronic datasheet and not by post or via e-mail after submitting the datasheet. This allows having all data at one place, easy to access by assessors and participants at any time and at any place. In case the CF Network receives reports and raw data online and via post, only the online copy will be used for assessment. Therefore, we strongly suggest sending only one set of results to avoid confusion.

Can I make a change to submitted reports or results?

In case a laboratory wants to send a new version of their report(s), the CF Network should be contacted via e-mail: . Clearly define in the e-mail what and why the report has changed. CF Network is able to re-open the datasheet. The laboratory can attach then the corrected report or raw data and has to submit the datasheet again. A confirmation of the datasheet will be sent automatically.

In case the laboratory wants to change something in the datasheet, the CF Network should be contacted via e-mail: . CF Network is able to re-open the datasheet. The laboratory can make the necessary changes and has to submit the datasheet again. A confirmation of the datasheet will be sent automatically.

Can I see my datasheet once it is submitted?

A laboratory can see the submitted datasheet, after logging in, in the EQA participant’s area under the ‘History of your CF EQA participation’ section. Once the datasheet is submitted a confirmation including a copy of the datasheet is sent to all contact persons.

What shall I do when the datasheet does not work properly?

In case you encounter any technical error when filling out the datasheet, please contact . As a last resort, we will send you a word copy of the datasheet. The CF Network will copy the data of the word file into the datasheet.



Last changed: 2010-04-29


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