July 2025
ESfEQA GmbH Siemensstr. 38 – 69123 Heidelberg
General Terms for Participation in ESfEQA EQA Surveys
1. Participation
Participation in ESfEQA external quality assessment (EQA) surveys is open to anyone who performs laboratory tests in their own practice or in a managed medical laboratory. The following conditions for participation apply.
2. Consent to conditions of participation
By registering with ESfEQA GmbH, the participant agrees to these general terms and conditions of participation.
3. Assignment of services
Individual elements of EQA schemes (e.g. pretesting of values, packaging and shipping) may be assigned to subcontractors. ESfEQA is responsible for the work of the subcontractors.
4. ESfEQA catalog
The ESfEQA portfolio of EQA schemes and analytes contained in individual programs are described in the ESfEQA catalog. Depending on the availability of samples and number of participants, ESfEQA reserves the right not to offer the entire spectrum of analytes for each EQA survey or sample.
5. Schedule
The schedule, published in the ESfEQA catalog, contains deadlines for ordering and result submission, as well as the testing periods. Once the deadline for ordering has passed, acceptance of late orders is at ESfEQA’s discretion. Results must be submitted to ESfEQA electronically, or using a result entry form, on or before the closing date. All deadlines and calendar dates are in the same time zone as ESfEQA’s place of business in Heidelberg, Germany (i.e. GMT+1).
6. Cancelation of EQA surveys
ESfEQA reserves the right to cancel or postpone EQA surveys. This information will be provided to participants before the original sample shipping date and ESfEQA will endeavor to offer an alternative date in a timely manner.
7. Registration
For participation in ESfEQA EQA surveys registration is required. This can be done online, or by sending the necessary information to ESfEQA by email to: surveys@esfeqa.eu. The following information is required: laboratory name, name of the organization/hospital, name of participant, number of analyti-cal devices, and e-mail address.
8. Ordering of samples.
Distribution of ESfEQA EQA surveys is usually carried out by international distributors. If there is no distributor available in the participant’s region, sales can be carried out directly by ESfEQA. The ordering process between participants and distributors is the responsibility of the parties involved. As a rule, an EQA program is ordered for a full calendar year. Orders placed during the year generally include the survey samples up to the end of the current calendar year.
9. Homogeneity and stability of EQA samples
The EQA survey samples selected by ESfEQA were examined and evaluated with regard to homo-geneity and stability.
10. Designation of EQA samples
The EQA samples can be distinguished by their identifier, which has the following format: program acronym_survey year_survey number_sample number. For example, the sample CM4_2025_01_a belongs to the quarterly program Cardiac Marker (CM4) in the year 2025 and is sample “a” of the first survey. Samples with the same designation are not necessarily identical, i.e. different results can be obtained despite the same designation. ESfEQA correctly allocates samples to the original batch and thus to the target values.
11. Shipping of EQA samples
EQA samples are shipped by postal or parcel service. Due to governmental restrictions, or insufficient sample stability, shipping of individual EQA programs to specific countries may be excluded.
12. Instructions for Use
Instructions for Use (IFU) for each EQA survey are available on the ESfEQA website (www.esfeqa.eu). A printout of the IFU is usually enclosed with the sample package. Each IFU includes instructions for sample preparation and stability.
13. Use of EQA samples
Usually, EQA samples should be treated exactly like patient samples, measured in the same way as routine samples according to manufacturer’s instructions for instruments and reagents. They may only be used for the purpose of participating in an EQA survey and may not be used in a misappropriated manner. Generally normal laboratory procedure for testing potentially hazardous and potentially infectious samples also applies to EQA samples.
14. Submission of survey results
Where applicable, submission of results includes the actual measured value as well as method, instrument and reagent used. The input mask in TEQA (ESfEQA’s evaluation software application) displays the required information for each EQA program. A drop-down list of methods, instruments and reagents is provided in the configuration section.
If a participant’s method, instrument or reagent is not listed in TEQA, participants can add this information using the input mask “coding request”. They can select their specific method, instrument and reagent to create a new configuration prior to entering their test results.
The selection of method, instrument and reagent, as well as submission of results, must be performed using the TEQA web application. Participants receive their login data (username and password) from ESfEQA, which is required to enter results. The password consists of at least 8 characters, including at least 2 special characters. Username and password are to be treated confidentially by the participant. An alternative to result submission via the TEQA web application, is the result form, that can be sent to ESfEQA either by e-mail (surveys@esfeqa.eu) or fax (+49 6221 4166-790). Result forms specific for each EQA program are provided on the ESfEQA website. ESfEQA encourages all participants to submit their results online via the secured TEQA web application, for the sake of data security and convenience. ESfEQA evaluates all survey results submitted by participants by the deadline. In the event of loss or late arrival of their data the participant bears the risk. ESfEQA is not obliged to evaluate results submitted after the submission deadline.
Quantitative results are generally reported with a value and a unit. The participant determines the number of digits for reporting. In general, results should be reported as measured. However, results submitted as “< test range’ (e.g. “< 10”) or “> test range” (e.g. “>2000“) are not valid.
For results below the test range, the lower test range limit should be reported (e.g. “10”).
For samples with analyte concentrations above the test range, the sample can be diluted (if recommended for particular applications) or the upper test range limit (e.g. “2000”) can be submitted as the result. Several units are usually available for entering quantitative results. The units are converted into the standard unit used by ESfEQA.
Laboratories are obliged to treat their results confidentially and not to pass them on to third parties until the EQA survey report has been received. If ESfEQA becomes aware of the passing on or falsi-fication of results or the collusion between participants, ESfEQA reserves the right to exclude those concerned from further participation in EQA surveys conducted by ESfEQA as well as to exclude the issuance of reports.
15. Number of results per participant
For each EQA sample and analyte, up to 3 values per participant can be submitted. The values have to be determined by different analytical devices that are independent from each other.
16. Correction of transmitted results
Participants can edit their results, using a change request via the TEQA web application, up until the deadline for result submission of the EQA survey. ESfEQA must check and accept change requests before results are edited accordingly. A change request can also be submitted by participants via e-mail or fax to ESfEQA, up until the deadline for result submission. Participants who submitted their results via the TEQA web application can only use a change request via the TEQA web application.
17. Evaluation of EQA results
For each analyte in ESfEQA EQA surveys, the type of target value determination and acceptance criterion are predefined. For quantitative parameters, the target value is usually the consensus value of participants results. This value is calculated according to ISO 13528:2022-08 ‘Statistical methods for use in proficiency testing by interlaboratory comparison’ using robust statistics.
Samples provided for testing of qualitative parameters are thoroughly tested with different analytical systems before being used as control material, thereby setting the target value.
System-specific differences are taken into account, if appropriate and feasible, with a corresponding statistical evaluation. The broadest possible distinction according to method, device and/or reagent used, is made available to participants (M-, I-, R-group). The minimum number of results of an evaluation group is 5. If this number is not reached in the survey, the individual result has to be compared to the robust mean of the next largest group that can be evaluated. Usually, this is the group consisting of participants using the same method (M group), or the general group containing the results of all participants. The definition of the evaluation group is documented in the survey report.
For quantitatively determined analytes, the maximum permissible ranges of the target value are predefined. The permissible range for each analyte is derived from its medical relevance as well as the reference interval. In the report display, the upper limit of the permissible range corresponds to a z-value of 3 and the lower limit to a z-value of -3.
18. Survey reports
In general, the participants will receive reports electronically via the TEQA web application within 10 days (for monthly programs), or three weeks (for quarterly and semi-annual programs) after the deadline for submission of the results. The reports include the results submitted by the participant evaluated in comparison to target values. The data is displayed both in tabular and illustrated form (e. g., Histogram, Shewhart chart, Youden plot). The reports are intended for external quality assurance of laboratories. They may not be published, passed on or used for purposes other than quality assurance without the written consent of ESfEQA.
19. Fees
The fees for the participation are set and communicated to the participants by the responsible distrib-utor of ESfEQA programs in their geographical area/country. Due to the high variability of shipping, handling and customs costs, the prices may vary between various countries. Please contact your distributor for the participation fee.
20. Certificates
For each EQA program participants receive a certificate of participation. In addition, participants receive a certificate for those parameters which met the specified performance criteria in the respective EQA survey. Both certificates are made available to participants via the TEQA web application. The certificates are issued simultaneously with the reports.
21. Loss and damage of EQA test material
In the event of sample loss or damage, ESfEQA should be notified immediately. If possible, ESfEQA will send replacement samples without acknowledging any claims. However, the contract is fulfilled on the date of dispatch of the original sample material.
22. Complaints and appeals
After receipt of an EQA survey report, a complaint/appeal can be made within a period of 4 weeks. After expiry of this period, any claims by the participant based on a complaint /appeal are excluded. In the event of a justified complaint/appeal, ESfEQA will decide whether to reimburse the amount paid for the EQA survey, or to provide a substitute EQA survey. ESfEQA GmbH does not reimburse any costs incurred for reagents, time expenditure etc. unless ESfEQA GmbH is liable in accordance with paragraph 23 of these General Terms and Conditions for Participation.
23. Warranty ESfEQA shall only be liable for damages of any kind in the case of intent and gross negligence, if the other prerequisites for claims are met. In all other respects, liability for damages of any kind, regardless of the basis of the claim, including liability for culpa in contrahendo, is excluded.
24. Confidentiality Individual EQA data is kept confidential. It is only known to the corresponding participant, their distributor and ESfEQA employees. ESfEQA collects, processes and uses personal data of the participant only to the extent necessary for the performance of EQA surveys, the preparation of the reports and for the purpose of quality assurance. This includes the forwarding of the data identifiable by subscriber and device number for quality assurance measures to the respective manufacturer of the analytical systems (device and reagent).
ESfEQA GmbH
Siemensstrasse 38
69123 Heidelberg
Germany
Phone: + 49 (0)6221 4166-700
Fax: + 49 (0)6221 4166-790
E-mail: info@esfeqa.eu
www.esfeqa.eu