1 – OBJECTIVES AND PROCEDURES

The primary objective of an external quality assessment (EQA) is to provide participating clinical laboratories with evidence of the accuracy of their results by participating in periodic blind surveys. This assessment helps ensure the validity of the results for each of the clinical laboratory tests evaluated by the EQA. It also provides evidence of the laboratories’ competence.

An EQA allows participants to detect anomalies in order to implement appropriate corrective actions. It contributes to trend analysis as a complement to Internal Quality Control (IQC) and to the estimation of measurement uncertainty.

It is a quality improvement tool used to identify opportunities for improvement and to implement corrective actions as part of the laboratory’s risk analysis.

For this irreplaceable improvement tool to fully achieve its objective, it is necessary that the participation of the LBMs be honest, that the educational aspect of the EQA be a priority, and that the EQA organizers be impartial.

Beyond providing information on the accuracy of results, the EQA is a fundamental educational tool for participants, particularly when programs include clinical cases and pre- or post-analytical assessments. The EQA helps maintain laboratory proficiency (ISO 15189 accreditation for clinical laboratories).

It is also a tool for post-market surveillance of DMDIVs and for reactovigilance.

Confidentiality guaranteed by an anonymous code, linked to a single geographical site. The reports, certificates and summaries are all attached to this laboratory code.

One registration covers 2 analytical systems (or 2 techniques) at the same geographical site (except for the GDS, COOX, and HELI programs). Beyond that, an additional registration is required (except for the BD program, which covers 6 analytical systems per registration).

The transfer of samples between sites is not permitted; duplicate processing of the same sample is reserved for the same geographical site.

Personalized reports sent by e-mail, with the PDF attached. They can also be downloaded at any time from your PBQ CONNECT laboratory interface.

2 – CONTROL MATERIALS

Control materials are appropriate for the tests assessed:

• Manufactured products : produced by manufacturers to our specifications and checked by ProBioQual.
• Fresh human samples : prepared and packaged by our teams.
• Digital media : standardised slides, images and videos for remote analysis.

3 – PROGRAMME CYCLE

Registration for a quality control programme is a complete, indivisible service. Here is how each cycle works:

1 – Programme launch — ProBioQual sends the registration confirmation via email. An email is sent notifying recipients that the program’s technical note—which contains all the information needed to complete the EQA—is available. Information regarding the shipment of control materials (in one or more shipments) or the availability of digitized materials is also sent via email.

2 – Results submission — The laboratory submits its results online before the entry deadline, in line with the schedule (a response form can be downloaded in the event of a technical problem).
Manual entry in the member area or automatic data transfer — see section 4.

3 – Statistical processing and report — ProBioQual performs statistical analysis by peer group (N≥7) and for all results. A customized report is sent within 15 days of the data entry deadline. The report includes: score, z-score, bias, histogram, graphical tracking of the score and z-score, “Long-Term CV” and “Long-Term Bias,” overall statistics (robust means & CVs, acceptability limits, Youden diagrams), and interpretation and comments from expert biologists.

Results are evaluated (graded and z-scores are calculated) whenever possible.

4 – Programme close — At the end of the programme, ProBioQual sends the participation certificate and the annual report: summary of scores, z-scores and bias per analyte, measurement uncertainty report.

All year round — download all your results and statistical values in Excel format from the member area.

To view an example of an EQA report: Click here

4 - REMOTE TRANSMISSION OF RESULTS

Time saving and limitation of input errors

Automatic transmission of EQA results in HPRIM, HL7 or CDA format is possible for the majority of analytes with quantitative results.

warning This option does not apply to qualitative results (serology, bacteriology, toxicology identification, etc.).

This service is free, provided that your laboratory can send files via one of the following platforms:

• MSSanté
• Bioserveur
• Apicrypt

Laboratories outside France without access to any of these networks may, exceptionally, transmit their files by unencrypted email.

This transmission channel delivers your EQA results exactly like your patient results. HPRIM, HL7 and CDA formats do not transmit the techniques or instruments used: it is the laboratory’s responsibility to check its codings upon receipt of the entry acknowledgement email, and to correct them if necessary in its PBQ Connect member area.

The full procedure is available in your member area, HPRIM menu. For any questions: secretariat@probioqual.com