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EQC guide · Results

Evaluating EQA results

An EQA report is only useful if someone reads it — and acts on it
An EQA report is only useful if someone reads it — and acts on itEQC guide · Evaluating results

An EQA report is only useful if someone reads it properly and acts on it. This page explains the scores in a typical report, why the peer group matters, how to see a problem coming before a result fails, and what to do when one does.

Which scores appear in an EQA report?

Most reports for quantitative tests show the laboratory’s result against a target value and express the difference in one or more scores. The common ones:

ScoreWhat it measuresHow to read it
z-scoreDifference from the assigned value in units of the standard deviation for proficiency assessment|z| ≤ 2 satisfactory, 2 < |z| < 3 questionable, |z| ≥ 3 unsatisfactory
SDI (standard deviation index)Difference from the peer-group mean in units of the peer-group SDClose to 0 is good; beyond ±2 needs an investigation
Deviation in %Difference from the target in percentCompared with fixed acceptance limits (for example CLIA limits or national rules)
CVR (CV ratio)The laboratory’s CV divided by the peer-group CVAbove 1.5 points to higher imprecision than comparable laboratories
Grade or score per roundShare of acceptable results across all analytes of a distributionShows the overall picture; the single analytes still need review

z-score limits follow ISO 13528:2022, the standard for statistical methods in proficiency testing; providers may use their own limits and name them in the report.

Reading a z-score

Limits after ISO 13528: |z| ≤ 2 satisfactory, 2 < |z| < 3 questionable, |z| ≥ 3 unsatisfactory

z-score zones|z| zone: unsatisfactoryunsatisfactory|z| zone: questionablequestionable|z| zone: satisfactorysatisfactory|z| zone: questionablequestionable|z| zone: unsatisfactoryunsatisfactory-4-3-2-10+1+2+3+4z = +1.2: acceptable, but watch the trend

Why does the peer group matter?

Because many methods do not agree with each other, and a comparison across all methods would flag a laboratory for using a different platform rather than for an error. Peer groups compare results only with laboratories using the same method, analyser and often reagent. That is essential for immunoassays and PT/INR, and useful almost everywhere else.

Peer grouping has one limit: if a whole method is biased, the peer group shares the bias and every member looks fine. Accuracy-based surveys with commutable samples and reference-method targets close that gap and show trueness, not only agreement.

How do you see a problem before a result fails?

By reading the reports as a series rather than one by one. A single result outside the limits can be chance; a bias that grows in one direction over three rounds is a method moving away from the truth, even while every result is still acceptable.

  • Plot z-scores or SDI per analyte across rounds and look for runs on one side of zero.
  • Compare the EQA bias with the internal QC means of the same period; a shift in both points to calibration or reagents.
  • Review all disciplines at least quarterly, and after every change of analyser, reagent or calibrator lot.
  • Use the EQA bias in the sigma calculation that sets the internal QC rules.

A bias that grows over rounds

Illustrative z-scores of one analyte across eight EQA rounds

Trend of z-scores over eight rounds-3-20+2+3Round 1: z = +0.2R1Round 2: z = -0.3R2Round 3: z = +0.4R3Round 4: z = +0.9R4Round 5: z = +1.3R5Round 6: z = +1.6R6Round 7: z = +2.2R7Round 8: z = +2.6R8From round 4 the bias grows in one direction —investigate now, before a result fails

What should a laboratory do after an unacceptable result?

Investigate before correcting anything, and always ask whether patient results were affected. A proven sequence:

  1. Check for clerical errors: transcription, units, the method or instrument code entered in the report.
  2. Check the sample: storage, reconstitution, stability and the time between receipt and analysis.
  3. Review the internal QC data of the same period and the calibration and reagent-lot history.
  4. Re-test residual EQA material if it is still stable, to separate a one-off event from a method problem.
  5. Assess patient impact: re-test retained patient samples from the period if the method was wrong.
  6. Classify the root cause, define the corrective action and document both as CAPA.
  7. Check effectiveness in the next distribution, and close the CAPA only when the result is acceptable again.

What are the typical root causes?

Most unacceptable results fall into a small number of categories, and the category decides the corrective action. Classifying every case also shows patterns over time.

CategoryExamplesTypical action
ClericalTranscription error, wrong unit, wrong method code, results for two samples swappedSecond-person check or electronic transfer from the LIS
Sample handlingWrong reconstitution volume, sample analysed too late, wrong storage temperatureWork instruction for EQA samples, training
MethodCalibration bias, reagent lot, method not fit for the concentration rangeRecalibration, lot verification, method review
EquipmentMaintenance overdue, worn component, temperature faultService, maintenance plan, instrument log review
EQA material or evaluationNon-commutable sample, wrong or too small peer group, wrong targetQuery to the provider, change of peer group or scheme
No cause foundInvestigation complete without a findingDocument the investigation, increase monitoring for the next rounds

From an unacceptable result to a closed CAPA

CAPA cycle in six stepsCAPAISO 15189 clause 8.71Detect: unacceptable result2Contain: hold, assess patients3Investigate: root cause4Correct the cause5Verify in the next round6Document & review

How are qualitative results assessed?

Not by scores but by agreement with the expected answer, often weighted by clinical relevance. The criteria differ by discipline:

  • Microbiology: identification to species level, S/I/R category and MIC against the reference, and turnaround time.
  • Molecular diagnostics: correct detection and genotype, Ct values or copy numbers within range, correct variant calls and interpretation in the report.
  • Immunohistochemistry: NordiQC grades each protocol as optimal, good, borderline or poor; borderline needs optimisation, poor means the protocol is unfit for diagnostic use and needs urgent optimisation.
  • Morphology: agreement of the cell classification or diagnosis with the expert panel.

What must be documented?

Everything an assessor needs to follow a sample from arrival to the closed CAPA. In practice that is a short, repeatable set of records:

  • the EQA register and the schedule of distributions;
  • receipt, storage and handling of each sample;
  • the results as submitted, and who submitted them;
  • the review of each report, signed and dated;
  • investigations, CAPA and the check of effectiveness;
  • the quarterly summary as input for the management review.

Further reading


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